Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer
Identifieur interne : 001810 ( Istex/Corpus ); précédent : 001809; suivant : 001811Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer
Auteurs : Willem W. Ten Bokkel Huinink ; Bengt Bergman ; Assad Chemaissani ; Wolfgang Dornoff ; Peter Drings ; Piikko-Liisa Kellokumpu-Lehtinen ; K. Liippo ; Karin Mattson ; Joachim Von Pawel ; Sergio Ricci ; Christer Sederholm ; Rolf A. Stahel ; Gunnar Wagenius ; N. V Walree ; Christian ManegoldSource :
- Lung Cancer [ 0169-5002 ] ; 1999.
English descriptors
- KwdEn :
Abstract
This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m2 was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.
Url:
DOI: 10.1016/S0169-5002(99)00067-7
Links to Exploration step
ISTEX:372B48DCF485F91DFF5CC0C96A1DAEC20A304C8CLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title><author><name sortKey="Ten Bokkel Huinink, Willem W" sort="Ten Bokkel Huinink, Willem W" uniqKey="Ten Bokkel Huinink W" first="Willem W" last="Ten Bokkel Huinink">Willem W. Ten Bokkel Huinink</name><affiliation><mods:affiliation>E-mail: wtbh@nki.nl</mods:affiliation></affiliation><affiliation><mods:affiliation>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Bergman, Bengt" sort="Bergman, Bengt" uniqKey="Bergman B" first="Bengt" last="Bergman">Bengt Bergman</name><affiliation><mods:affiliation>Salgrenska Sjukhuset, Gothenberg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Chemaissani, Assad" sort="Chemaissani, Assad" uniqKey="Chemaissani A" first="Assad" last="Chemaissani">Assad Chemaissani</name><affiliation><mods:affiliation>Städtisches Krankenhaus, Köln-Merheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, Wolfgang" sort="Dornoff, Wolfgang" uniqKey="Dornoff W" first="Wolfgang" last="Dornoff">Wolfgang Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromäerinnen, Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Drings, Peter" sort="Drings, Peter" uniqKey="Drings P" first="Peter" last="Drings">Peter Drings</name><affiliation><mods:affiliation>Thoraxklinik, Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, Piikko Liisa" sort="Kellokumpu Lehtinen, Piikko Liisa" uniqKey="Kellokumpu Lehtinen P" first="Piikko-Liisa" last="Kellokumpu-Lehtinen">Piikko-Liisa Kellokumpu-Lehtinen</name><affiliation><mods:affiliation>Tampere University Hospital, Pinkonlinna, Finland</mods:affiliation></affiliation></author><author><name sortKey="Liippo, K" sort="Liippo, K" uniqKey="Liippo K" first="K" last="Liippo">K. Liippo</name><affiliation><mods:affiliation>Turku University Hospital, Paimio, Finland</mods:affiliation></affiliation></author><author><name sortKey="Mattson, Karin" sort="Mattson, Karin" uniqKey="Mattson K" first="Karin" last="Mattson">Karin Mattson</name><affiliation><mods:affiliation>University Hospital, Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name><affiliation><mods:affiliation>Zentralkrankenhaus, Gauting, Germany</mods:affiliation></affiliation></author><author><name sortKey="Ricci, Sergio" sort="Ricci, Sergio" uniqKey="Ricci S" first="Sergio" last="Ricci">Sergio Ricci</name><affiliation><mods:affiliation>S. Chiara Hospital, Pisa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Sederholm, Christer" sort="Sederholm, Christer" uniqKey="Sederholm C" first="Christer" last="Sederholm">Christer Sederholm</name><affiliation><mods:affiliation>Universitets Sjukhuset, Linkoping, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Stahel, Rolf A" sort="Stahel, Rolf A" uniqKey="Stahel R" first="Rolf A" last="Stahel">Rolf A. Stahel</name><affiliation><mods:affiliation>Universitätsspital, Zürich, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Wagenius, Gunnar" sort="Wagenius, Gunnar" uniqKey="Wagenius G" first="Gunnar" last="Wagenius">Gunnar Wagenius</name><affiliation><mods:affiliation>Akademsika Sjukhuset, Uppsala, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Walree, N V" sort="Walree, N V" uniqKey="Walree N" first="N. V" last="Walree">N. V Walree</name><affiliation><mods:affiliation>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Manegold, Christian" sort="Manegold, Christian" uniqKey="Manegold C" first="Christian" last="Manegold">Christian Manegold</name><affiliation><mods:affiliation>Thoraxklinik, Heidelberg, Germany</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C</idno><date when="1999" year="1999">1999</date><idno type="doi">10.1016/S0169-5002(99)00067-7</idno><idno type="url">https://api.istex.fr/document/372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001810</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001810</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title><author><name sortKey="Ten Bokkel Huinink, Willem W" sort="Ten Bokkel Huinink, Willem W" uniqKey="Ten Bokkel Huinink W" first="Willem W" last="Ten Bokkel Huinink">Willem W. Ten Bokkel Huinink</name><affiliation><mods:affiliation>E-mail: wtbh@nki.nl</mods:affiliation></affiliation><affiliation><mods:affiliation>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Bergman, Bengt" sort="Bergman, Bengt" uniqKey="Bergman B" first="Bengt" last="Bergman">Bengt Bergman</name><affiliation><mods:affiliation>Salgrenska Sjukhuset, Gothenberg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Chemaissani, Assad" sort="Chemaissani, Assad" uniqKey="Chemaissani A" first="Assad" last="Chemaissani">Assad Chemaissani</name><affiliation><mods:affiliation>Städtisches Krankenhaus, Köln-Merheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, Wolfgang" sort="Dornoff, Wolfgang" uniqKey="Dornoff W" first="Wolfgang" last="Dornoff">Wolfgang Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromäerinnen, Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Drings, Peter" sort="Drings, Peter" uniqKey="Drings P" first="Peter" last="Drings">Peter Drings</name><affiliation><mods:affiliation>Thoraxklinik, Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, Piikko Liisa" sort="Kellokumpu Lehtinen, Piikko Liisa" uniqKey="Kellokumpu Lehtinen P" first="Piikko-Liisa" last="Kellokumpu-Lehtinen">Piikko-Liisa Kellokumpu-Lehtinen</name><affiliation><mods:affiliation>Tampere University Hospital, Pinkonlinna, Finland</mods:affiliation></affiliation></author><author><name sortKey="Liippo, K" sort="Liippo, K" uniqKey="Liippo K" first="K" last="Liippo">K. Liippo</name><affiliation><mods:affiliation>Turku University Hospital, Paimio, Finland</mods:affiliation></affiliation></author><author><name sortKey="Mattson, Karin" sort="Mattson, Karin" uniqKey="Mattson K" first="Karin" last="Mattson">Karin Mattson</name><affiliation><mods:affiliation>University Hospital, Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name><affiliation><mods:affiliation>Zentralkrankenhaus, Gauting, Germany</mods:affiliation></affiliation></author><author><name sortKey="Ricci, Sergio" sort="Ricci, Sergio" uniqKey="Ricci S" first="Sergio" last="Ricci">Sergio Ricci</name><affiliation><mods:affiliation>S. Chiara Hospital, Pisa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Sederholm, Christer" sort="Sederholm, Christer" uniqKey="Sederholm C" first="Christer" last="Sederholm">Christer Sederholm</name><affiliation><mods:affiliation>Universitets Sjukhuset, Linkoping, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Stahel, Rolf A" sort="Stahel, Rolf A" uniqKey="Stahel R" first="Rolf A" last="Stahel">Rolf A. Stahel</name><affiliation><mods:affiliation>Universitätsspital, Zürich, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Wagenius, Gunnar" sort="Wagenius, Gunnar" uniqKey="Wagenius G" first="Gunnar" last="Wagenius">Gunnar Wagenius</name><affiliation><mods:affiliation>Akademsika Sjukhuset, Uppsala, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Walree, N V" sort="Walree, N V" uniqKey="Walree N" first="N. V" last="Walree">N. V Walree</name><affiliation><mods:affiliation>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Manegold, Christian" sort="Manegold, Christian" uniqKey="Manegold C" first="Christian" last="Manegold">Christian Manegold</name><affiliation><mods:affiliation>Thoraxklinik, Heidelberg, Germany</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Lung Cancer</title><title level="j" type="abbrev">LUNG</title><idno type="ISSN">0169-5002</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1999">1999</date><biblScope unit="volume">26</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="85">85</biblScope><biblScope unit="page" to="94">94</biblScope></imprint><idno type="ISSN">0169-5002</idno></series><idno type="istex">372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C</idno><idno type="DOI">10.1016/S0169-5002(99)00067-7</idno><idno type="PII">S0169-5002(99)00067-7</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0169-5002</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cisplatin</term><term>Efficacy</term><term>Etoposide</term><term>Gemcitabine</term><term>Non-small cell lung cancer</term><term>Quality of life</term><term>Randomized Phase II study</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m2 was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.</div></front></TEI><istex><corpusName>elsevier</corpusName><author><json:item><name>Willem W ten Bokkel Huinink</name><affiliations><json:string>E-mail: wtbh@nki.nl</json:string><json:string>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</json:string></affiliations></json:item><json:item><name>Bengt Bergman</name><affiliations><json:string>Salgrenska Sjukhuset, Gothenberg, Sweden</json:string></affiliations></json:item><json:item><name>Assad Chemaissani</name><affiliations><json:string>Städtisches Krankenhaus, Köln-Merheim, Germany</json:string></affiliations></json:item><json:item><name>Wolfgang Dornoff</name><affiliations><json:string>Mutterhaus der Borromäerinnen, Trier, Germany</json:string></affiliations></json:item><json:item><name>Peter Drings</name><affiliations><json:string>Thoraxklinik, Heidelberg, Germany</json:string></affiliations></json:item><json:item><name>Piikko-Liisa Kellokumpu-Lehtinen</name><affiliations><json:string>Tampere University Hospital, Pinkonlinna, Finland</json:string></affiliations></json:item><json:item><name>K Liippo</name><affiliations><json:string>Turku University Hospital, Paimio, Finland</json:string></affiliations></json:item><json:item><name>Karin Mattson</name><affiliations><json:string>University Hospital, Helsinki, Finland</json:string></affiliations></json:item><json:item><name>Joachim von Pawel</name><affiliations><json:string>Zentralkrankenhaus, Gauting, Germany</json:string></affiliations></json:item><json:item><name>Sergio Ricci</name><affiliations><json:string>S. Chiara Hospital, Pisa, Italy</json:string></affiliations></json:item><json:item><name>Christer Sederholm</name><affiliations><json:string>Universitets Sjukhuset, Linkoping, Sweden</json:string></affiliations></json:item><json:item><name>Rolf A Stahel</name><affiliations><json:string>Universitätsspital, Zürich, Switzerland</json:string></affiliations></json:item><json:item><name>Gunnar Wagenius</name><affiliations><json:string>Akademsika Sjukhuset, Uppsala, Sweden</json:string></affiliations></json:item><json:item><name>N.v Walree</name><affiliations><json:string>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</json:string></affiliations></json:item><json:item><name>Christian Manegold</name><affiliations><json:string>Thoraxklinik, Heidelberg, Germany</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Cisplatin</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Etoposide</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Gemcitabine</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Non-small cell lung cancer</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Randomized Phase II study</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Quality of life</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Efficacy</value></json:item></subject><language><json:string>eng</json:string></language><originalGenre><json:string>Full-length article</json:string></originalGenre><abstract>This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m2 was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.</abstract><qualityIndicators><score>7.486</score><pdfVersion>1.2</pdfVersion><pdfPageSize>535 x 675 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>7</keywordCount><abstractCharCount>2285</abstractCharCount><pdfWordCount>4486</pdfWordCount><pdfCharCount>30373</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>321</abstractWordCount></qualityIndicators><title>Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title><pii><json:string>S0169-5002(99)00067-7</json:string></pii><refBibs><json:item><author><json:item><name>R.P Abratt</name></json:item><json:item><name>W.R Bezwoda</name></json:item><json:item><name>G Falkson</name></json:item><json:item><name>L Goedhals</name></json:item><json:item><name>D Hacking</name></json:item><json:item><name>T.A Rugg</name></json:item></author><host><volume>12</volume><pages><last>1540</last><first>1535</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>Efficacy and safety profile of gemcitabine in non-small cell lung cancer: a phase II study</title></json:item><json:item><author><json:item><name>H Anderson</name></json:item><json:item><name>B Lund</name></json:item><json:item><name>F Bach</name></json:item><json:item><name>N Thatcher</name></json:item><json:item><name>J Walling</name></json:item><json:item><name>H.H Hansen</name></json:item></author><host><volume>12</volume><pages><last>1826</last><first>1821</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>Single agent activity of weekly gemcitabine in advanced non-small cell lung cancer: a phase II study</title></json:item><json:item><host><author></author></host></json:item><json:item><author><json:item><name>B Bergman</name></json:item><json:item><name>N.K Aaronson</name></json:item><json:item><name>S Ahmedzai</name></json:item><json:item><name>S Kaasa</name></json:item><json:item><name>M Sullivan</name></json:item></author><host><volume>30A</volume><pages><last>642</last><first>635</first></pages><author></author><title>Eur. J. Cancer.</title></host><title>The EORTC QLQ-LC13: a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials</title></json:item><json:item><author><json:item><name>P Bonomi</name></json:item><json:item><name>D Finkelstein</name></json:item><json:item><name>A Chang</name></json:item></author><host><volume>17</volume><pages><last>217</last><first>215</first></pages><author></author><title>Am. J. Clin. Oncol.</title></host><title>Phase II trial of acivicin versus etoposide-cisplatin in non-small cell lung cancer. An Eastern Cooperative Oncology Group study</title></json:item><json:item><author><json:item><name>P.D Bonomi</name></json:item><json:item><name>D.M Finkelstein</name></json:item><json:item><name>J.C Ruckdeschel</name></json:item><json:item><name>R.H Blum</name></json:item><json:item><name>M.D Green</name></json:item><json:item><name>B Mason</name></json:item></author><host><volume>7</volume><pages><last>1613</last><first>1602</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>Combination chemotherapy versus single agents followed by combination chemotherapy in stage IV non-small cell lung cancer: a study of the Eastern Oncology Group</title></json:item><json:item><author><json:item><name>A Coates</name></json:item><json:item><name>S Abraham</name></json:item><json:item><name>S.B Kaye</name></json:item><json:item><name>T Sowerbutts</name></json:item><json:item><name>C Frewin</name></json:item><json:item><name>R.M Fox</name></json:item></author><host><volume>19</volume><pages><last>208</last><first>203</first></pages><author></author><title>Eur. J. Cancer. Clin. Oncol.</title></host><title>On the receiving end—patients perception of the side-effects of cancer chemotherapy</title></json:item><json:item><host><author></author></host></json:item><json:item><author><json:item><name>H.M Dhingra</name></json:item><json:item><name>M Valdivieso</name></json:item><json:item><name>D.T Carr</name></json:item><json:item><name>D.F Chiuten</name></json:item><json:item><name>P Farha</name></json:item><json:item><name>W.K Murphy</name></json:item></author><host><volume>3</volume><pages><last>183</last><first>176</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>Randomized trial of three combinations of cisplatin with vindesine and/or VP-16 in the treatment of advanced NSCLC</title></json:item><json:item><author><json:item><name>L.H Einhorn</name></json:item><json:item><name>P.J Loehrer</name></json:item><json:item><name>S.D Williams</name></json:item><json:item><name>S Meyers</name></json:item><json:item><name>T Gabrys</name></json:item><json:item><name>S.R Nattan</name></json:item></author><host><volume>4</volume><pages><last>1043</last><first>1037</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>Random prospective study of vindesine versus vindesine plus cisplatin, plus mitomycin in advanced non-small cell lung cancer</title></json:item><json:item><author><json:item><name>U Gatzemeier</name></json:item><json:item><name>F.A Shepherd</name></json:item><json:item><name>T Le Chevalier</name></json:item><json:item><name>P Weynants</name></json:item><json:item><name>B Cottier</name></json:item><json:item><name>H.J.M Groen</name></json:item></author><host><volume>32A</volume><pages><last>248</last><first>243</first></pages><author></author><title>Eur. J. Cancer</title></host><title>Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study</title></json:item><json:item><author><json:item><name>J.D Hainsworth</name></json:item><json:item><name>D.H Johnson</name></json:item></author><host><volume>12</volume><pages><last>349</last><first>345</first></pages><author></author><title>Am. J. Clin. Oncol.</title></host><title>Chemotherapy of advanced NSCLC: a randomized trial of three cisplatin-based chemotherapy regimens</title></json:item><json:item><author><json:item><name>J Klastersky</name></json:item><json:item><name>J.P Sculier</name></json:item><json:item><name>H Lacroix</name></json:item><json:item><name>G Dabouis</name></json:item><json:item><name>G Bureau</name></json:item><json:item><name>P Liebert</name></json:item></author><host><volume>8</volume><pages><last>1562</last><first>1556</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>A randomized study comparing cisplatin or carboplatin with etoposide in patients with advanced NSCLC. EORTC protocol 07861</title></json:item><json:item><author><json:item><name>J Klastersky</name></json:item><json:item><name>J.P Sculier</name></json:item><json:item><name>P Ravez</name></json:item><json:item><name>P Libert</name></json:item><json:item><name>J Michel</name></json:item><json:item><name>G Vandermoten</name></json:item></author><host><volume>4</volume><pages><last>1786</last><first>1780</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>A randomized study comparing a high and a standard dose of cisplatin in combination with etoposide in the treatment of advanced NSCLC</title></json:item><json:item><author><json:item><name>C Manegold</name></json:item><json:item><name>B Bergman</name></json:item><json:item><name>A Chemaissani</name></json:item><json:item><name>W Dornoff</name></json:item><json:item><name>P Drings</name></json:item><json:item><name>P Kellokumpu-Lehtinen</name></json:item></author><host><volume>8</volume><pages><last>5</last><first>1</first></pages><author></author><title>Ann. Oncol.</title></host><title>Single-agent gemcitabine versus cisplatin-etoposide: early results of a randomised phase II study in locally advanced or metastatic non-small cell lung cancer</title></json:item><json:item><host><author></author></host></json:item><json:item><author><json:item><name>S.J Pocock</name></json:item><json:item><name>R Simon</name></json:item></author><host><volume>31</volume><pages><last>115</last><first>103</first></pages><author></author><title>Biometrics</title></host><title>Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial</title></json:item><json:item><author><json:item><name>R Rosso</name></json:item><json:item><name>F Salvati</name></json:item><json:item><name>A Ardizzoni</name></json:item><json:item><name>C Gallo Curcio</name></json:item><json:item><name>A Rubagotti</name></json:item><json:item><name>M Belli</name></json:item></author><host><volume>66</volume><pages><last>134</last><first>130</first></pages><author></author><title>Cancer</title></host><title>Etoposide versus etoposide plus high dose cisplatin in the management of advanced non-small cell lung cancer</title></json:item><json:item><author><json:item><name>J.C Ruckdeschel</name></json:item><json:item><name>D.M Finkelstein</name></json:item><json:item><name>D.S Ettinger</name></json:item><json:item><name>R.H Creech</name></json:item><json:item><name>B.A Mason</name></json:item><json:item><name>R.A Joss</name></json:item></author><host><volume>4</volume><pages><last>22</last><first>14</first></pages><author></author><title>J. Clin. Oncol.</title></host><title>A randomized trial of the four most active regimens for metastatic non-small cell lung cancer</title></json:item><json:item><author><json:item><name>J.C Ruckdeschel</name></json:item></author><host><volume>10</volume><pages><last>44</last><first>39</first></pages><author></author><title>Semin. Oncol.</title></host><title>The role of standard dose etoposide in the management of NSCLC</title></json:item><json:item><host><author></author></host></json:item><json:item><host><author></author></host></json:item></refBibs><genre><json:string>research-article</json:string></genre><host><volume>26</volume><pii><json:string>S0169-5002(00)X0042-6</json:string></pii><pages><last>94</last><first>85</first></pages><issn><json:string>0169-5002</json:string></issn><issue>2</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><title>Lung Cancer</title><publicationDate>1999</publicationDate></host><categories><wos><json:string>science</json:string><json:string>respiratory system</json:string><json:string>oncology</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>oncology & carcinogenesis</json:string></scienceMetrix></categories><publicationDate>1999</publicationDate><copyrightDate>1999</copyrightDate><doi><json:string>10.1016/S0169-5002(99)00067-7</json:string></doi><id>372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C</id><score>0.24097002</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>ELSEVIER</publisher><availability><p>©1999 Elsevier Science Ireland Ltd</p></availability><date>1999</date></publicationStmt><notesStmt><note type="content">Fig. 1: Kaplan–Meier survival curves for all protocol-qualified patients receiving gemcitabine (n=67) and cisplatin/etoposide (n=72).</note><note type="content">Table 1: Characteristics of enrolled patients</note><note type="content">Table 2: Efficacy (protocol-qualified)</note><note type="content">Table 3:</note><note type="content">Table 4: Major clinical toxicity</note><note type="content">Table 5: Haematologic toxicity</note><note type="content">Table 6: Mean EORTC QLQ-C30-LC13 Scores (standard deviation)</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title><author xml:id="author-1"><persName><forename type="first">Willem W</forename><surname>ten Bokkel Huinink</surname></persName><email>wtbh@nki.nl</email><note type="correspondence"><p>Corresponding author. Tel.: +31-20-5122569; fax: +31-20-5122572</p></note><affiliation>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</affiliation></author><author xml:id="author-2"><persName><forename type="first">Bengt</forename><surname>Bergman</surname></persName><affiliation>Salgrenska Sjukhuset, Gothenberg, Sweden</affiliation></author><author xml:id="author-3"><persName><forename type="first">Assad</forename><surname>Chemaissani</surname></persName><affiliation>Städtisches Krankenhaus, Köln-Merheim, Germany</affiliation></author><author xml:id="author-4"><persName><forename type="first">Wolfgang</forename><surname>Dornoff</surname></persName><affiliation>Mutterhaus der Borromäerinnen, Trier, Germany</affiliation></author><author xml:id="author-5"><persName><forename type="first">Peter</forename><surname>Drings</surname></persName><affiliation>Thoraxklinik, Heidelberg, Germany</affiliation></author><author xml:id="author-6"><persName><forename type="first">Piikko-Liisa</forename><surname>Kellokumpu-Lehtinen</surname></persName><affiliation>Tampere University Hospital, Pinkonlinna, Finland</affiliation></author><author xml:id="author-7"><persName><forename type="first">K</forename><surname>Liippo</surname></persName><affiliation>Turku University Hospital, Paimio, Finland</affiliation></author><author xml:id="author-8"><persName><forename type="first">Karin</forename><surname>Mattson</surname></persName><affiliation>University Hospital, Helsinki, Finland</affiliation></author><author xml:id="author-9"><persName><forename type="first">Joachim</forename><surname>von Pawel</surname></persName><affiliation>Zentralkrankenhaus, Gauting, Germany</affiliation></author><author xml:id="author-10"><persName><forename type="first">Sergio</forename><surname>Ricci</surname></persName><affiliation>S. Chiara Hospital, Pisa, Italy</affiliation></author><author xml:id="author-11"><persName><forename type="first">Christer</forename><surname>Sederholm</surname></persName><affiliation>Universitets Sjukhuset, Linkoping, Sweden</affiliation></author><author xml:id="author-12"><persName><forename type="first">Rolf A</forename><surname>Stahel</surname></persName><affiliation>Universitätsspital, Zürich, Switzerland</affiliation></author><author xml:id="author-13"><persName><forename type="first">Gunnar</forename><surname>Wagenius</surname></persName><affiliation>Akademsika Sjukhuset, Uppsala, Sweden</affiliation></author><author xml:id="author-14"><persName><forename type="first">N.v</forename><surname>Walree</surname></persName><affiliation>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</affiliation></author><author xml:id="author-15"><persName><forename type="first">Christian</forename><surname>Manegold</surname></persName><affiliation>Thoraxklinik, Heidelberg, Germany</affiliation></author></analytic><monogr><title level="j">Lung Cancer</title><title level="j" type="abbrev">LUNG</title><idno type="pISSN">0169-5002</idno><idno type="PII">S0169-5002(00)X0042-6</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1999"></date><biblScope unit="volume">26</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="85">85</biblScope><biblScope unit="page" to="94">94</biblScope></imprint></monogr><idno type="istex">372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C</idno><idno type="DOI">10.1016/S0169-5002(99)00067-7</idno><idno type="PII">S0169-5002(99)00067-7</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1999</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m2 was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Cisplatin</term></item><item><term>Etoposide</term></item><item><term>Gemcitabine</term></item><item><term>Non-small cell lung cancer</term></item><item><term>Randomized Phase II study</term></item><item><term>Quality of life</term></item><item><term>Efficacy</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1999-05-29">Modified</change><change when="1999">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Elsevier, elements deleted: ce:floats; body; tail"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"><istex:entity SYSTEM="gr1" NDATA="IMAGE" name="gr1"></istex:entity></istex:docType><istex:document><converted-article version="4.5.2" docsubtype="fla" xml:lang="en"><item-info><jid>LUNG</jid><aid>901</aid><ce:pii>S0169-5002(99)00067-7</ce:pii><ce:doi>10.1016/S0169-5002(99)00067-7</ce:doi><ce:copyright type="full-transfer" year="1999">Elsevier Science Ireland Ltd</ce:copyright></item-info><head><ce:title>Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</ce:title><ce:author-group><ce:author><ce:given-name>Willem W</ce:given-name><ce:surname>ten Bokkel Huinink</ce:surname><ce:cross-ref refid="AFF1"><ce:sup>a</ce:sup></ce:cross-ref><ce:cross-ref refid="CORR1">*</ce:cross-ref><ce:e-address>wtbh@nki.nl</ce:e-address></ce:author><ce:author><ce:given-name>Bengt</ce:given-name><ce:surname>Bergman</ce:surname><ce:cross-ref refid="AFF2"><ce:sup>b</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Assad</ce:given-name><ce:surname>Chemaissani</ce:surname><ce:cross-ref refid="AFF3"><ce:sup>c</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Wolfgang</ce:given-name><ce:surname>Dornoff</ce:surname><ce:cross-ref refid="AFF4"><ce:sup>d</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Peter</ce:given-name><ce:surname>Drings</ce:surname><ce:cross-ref refid="AFF5"><ce:sup>e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Piikko-Liisa</ce:given-name><ce:surname>Kellokumpu-Lehtinen</ce:surname><ce:cross-ref refid="AFF6"><ce:sup>f</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>K</ce:given-name><ce:surname>Liippo</ce:surname><ce:cross-ref refid="AFF7"><ce:sup>g</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Karin</ce:given-name><ce:surname>Mattson</ce:surname><ce:cross-ref refid="AFF8"><ce:sup>h</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Joachim</ce:given-name><ce:surname>von Pawel</ce:surname><ce:cross-ref refid="AFF9"><ce:sup>i</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Sergio</ce:given-name><ce:surname>Ricci</ce:surname><ce:cross-ref refid="AFF10"><ce:sup>j</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Christer</ce:given-name><ce:surname>Sederholm</ce:surname><ce:cross-ref refid="AFF11"><ce:sup>k</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Rolf A</ce:given-name><ce:surname>Stahel</ce:surname><ce:cross-ref refid="AFF12"><ce:sup>l</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Gunnar</ce:given-name><ce:surname>Wagenius</ce:surname><ce:cross-ref refid="AFF13"><ce:sup>m</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>N.v</ce:given-name><ce:surname>Walree</ce:surname><ce:cross-ref refid="AFF14"><ce:sup>n</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Christian</ce:given-name><ce:surname>Manegold</ce:surname><ce:cross-ref refid="AFF5"><ce:sup>e</ce:sup></ce:cross-ref></ce:author><ce:affiliation id="AFF1"><ce:label>a</ce:label><ce:textfn>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="AFF2"><ce:label>b</ce:label><ce:textfn>Salgrenska Sjukhuset, Gothenberg, Sweden</ce:textfn></ce:affiliation><ce:affiliation id="AFF3"><ce:label>c</ce:label><ce:textfn>Städtisches Krankenhaus, Köln-Merheim, Germany</ce:textfn></ce:affiliation><ce:affiliation id="AFF4"><ce:label>d</ce:label><ce:textfn>Mutterhaus der Borromäerinnen, Trier, Germany</ce:textfn></ce:affiliation><ce:affiliation id="AFF5"><ce:label>e</ce:label><ce:textfn>Thoraxklinik, Heidelberg, Germany</ce:textfn></ce:affiliation><ce:affiliation id="AFF6"><ce:label>f</ce:label><ce:textfn>Tampere University Hospital, Pinkonlinna, Finland</ce:textfn></ce:affiliation><ce:affiliation id="AFF7"><ce:label>g</ce:label><ce:textfn>Turku University Hospital, Paimio, Finland</ce:textfn></ce:affiliation><ce:affiliation id="AFF8"><ce:label>h</ce:label><ce:textfn>University Hospital, Helsinki, Finland</ce:textfn></ce:affiliation><ce:affiliation id="AFF9"><ce:label>i</ce:label><ce:textfn>Zentralkrankenhaus, Gauting, Germany</ce:textfn></ce:affiliation><ce:affiliation id="AFF10"><ce:label>j</ce:label><ce:textfn>S. Chiara Hospital, Pisa, Italy</ce:textfn></ce:affiliation><ce:affiliation id="AFF11"><ce:label>k</ce:label><ce:textfn>Universitets Sjukhuset, Linkoping, Sweden</ce:textfn></ce:affiliation><ce:affiliation id="AFF12"><ce:label>l</ce:label><ce:textfn>Universitätsspital, Zürich, Switzerland</ce:textfn></ce:affiliation><ce:affiliation id="AFF13"><ce:label>m</ce:label><ce:textfn>Akademsika Sjukhuset, Uppsala, Sweden</ce:textfn></ce:affiliation><ce:affiliation id="AFF14"><ce:label>n</ce:label><ce:textfn>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</ce:textfn></ce:affiliation><ce:correspondence id="CORR1"><ce:label>*</ce:label><ce:text>Corresponding author. Tel.: +31-20-5122569; fax: +31-20-5122572</ce:text></ce:correspondence></ce:author-group><ce:date-received day="5" month="2" year="1999"></ce:date-received><ce:date-revised day="29" month="5" year="1999"></ce:date-revised><ce:date-accepted day="1" month="6" year="1999"></ce:date-accepted><ce:abstract><ce:section-title>Abstract</ce:section-title><ce:abstract-sec><ce:simple-para>This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m<ce:sup>2</ce:sup> was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m<ce:sup>2</ce:sup> on day 1, and etoposide 100 mg/m<ce:sup>2</ce:sup> on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.</ce:simple-para></ce:abstract-sec></ce:abstract><ce:keywords class="keyword"><ce:section-title>Keywords</ce:section-title><ce:keyword><ce:text>Cisplatin</ce:text></ce:keyword><ce:keyword><ce:text>Etoposide</ce:text></ce:keyword><ce:keyword><ce:text>Gemcitabine</ce:text></ce:keyword><ce:keyword><ce:text>Non-small cell lung cancer</ce:text></ce:keyword><ce:keyword><ce:text>Randomized Phase II study</ce:text></ce:keyword><ce:keyword><ce:text>Quality of life</ce:text></ce:keyword><ce:keyword><ce:text>Efficacy</ce:text></ce:keyword></ce:keywords></head></converted-article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer</title></titleInfo><name type="personal"><namePart type="given">Willem W</namePart><namePart type="family">ten Bokkel Huinink</namePart><affiliation>E-mail: wtbh@nki.nl</affiliation><affiliation>The Netherlands Cancer Institute, Av. Leeuwenhoekhvis 121, Plesmanlann, 1066 Amsterdam, The Netherlands</affiliation><description>Corresponding author. Tel.: +31-20-5122569; fax: +31-20-5122572</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bengt</namePart><namePart type="family">Bergman</namePart><affiliation>Salgrenska Sjukhuset, Gothenberg, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Assad</namePart><namePart type="family">Chemaissani</namePart><affiliation>Städtisches Krankenhaus, Köln-Merheim, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Wolfgang</namePart><namePart type="family">Dornoff</namePart><affiliation>Mutterhaus der Borromäerinnen, Trier, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter</namePart><namePart type="family">Drings</namePart><affiliation>Thoraxklinik, Heidelberg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Piikko-Liisa</namePart><namePart type="family">Kellokumpu-Lehtinen</namePart><affiliation>Tampere University Hospital, Pinkonlinna, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K</namePart><namePart type="family">Liippo</namePart><affiliation>Turku University Hospital, Paimio, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karin</namePart><namePart type="family">Mattson</namePart><affiliation>University Hospital, Helsinki, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joachim</namePart><namePart type="family">von Pawel</namePart><affiliation>Zentralkrankenhaus, Gauting, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sergio</namePart><namePart type="family">Ricci</namePart><affiliation>S. Chiara Hospital, Pisa, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christer</namePart><namePart type="family">Sederholm</namePart><affiliation>Universitets Sjukhuset, Linkoping, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rolf A</namePart><namePart type="family">Stahel</namePart><affiliation>Universitätsspital, Zürich, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gunnar</namePart><namePart type="family">Wagenius</namePart><affiliation>Akademsika Sjukhuset, Uppsala, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.v</namePart><namePart type="family">Walree</namePart><affiliation>Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christian</namePart><namePart type="family">Manegold</namePart><affiliation>Thoraxklinik, Heidelberg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="Full-length article"></genre><originInfo><publisher>ELSEVIER</publisher><dateIssued encoding="w3cdtf">1999</dateIssued><dateModified encoding="w3cdtf">1999-05-29</dateModified><copyrightDate encoding="w3cdtf">1999</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">This randomized study was designed to determine the response rates, survival and toxicities of single-agent gemcitabine (GEMZAR™) and a combination of cisplatin/etoposide in chemonaive patients with non-resectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine 1000 mg/m2 was given as a 30-min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small cell lung cancer, measurable disease, Zubrod performance status 0–2, no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. One hundred and forty-seven patients were enrolled, 72 in the gemcitabine and 75 in the cisplatin/etoposide arm. Patient characteristics were well-matched across both arms. Sixty-seven gemcitabine and 72 cisplatin/etoposide patients were qualified for efficacy analysis. There were no complete responses, but 12 partial responses in the gemcitabine arm and 11 in the cisplatin/etoposide arm, for protocol-qualified response rates of 17.9% (95% CI: 9.6–29.2%) and 15.3% (95% CI: 7.9–25.7%), respectively. Median survival times were 6.6 months (95% CI: 4.9–7.3 months) for gemcitabine and 7.6 months (95% CI: 5.4–9.3 months) for cisplatin/etoposide. The 1-year survival probability estimate was 26% for gemcitabine and 24% for cisplatin/etoposide. There were no statistically significant between-group differences in time-to-event measures, but patients in the gemcitabine arm had a greater probability of achieving a tumour response after 2 months (probability estimate: 8 vs. 0%) and of the response lasting at least 6 months (73 vs. 45%). Clinical and haematologic toxicity was more pronounced in the cisplatin/etoposide arm. Quality-of-life measures indicated a significant worsening of symptomatology in the cisplatin/etoposide arm for hair loss, nausea and vomiting, and appetite loss. This randomized study provides further evidence that single-agent gemcitabine is an active and effective therapy for patients with non-resectable, locally advanced or metastatic NSCLC and good performance status, and that it is better tolerated than the combination cisplatin/etoposide.</abstract><note type="content">Fig. 1: Kaplan–Meier survival curves for all protocol-qualified patients receiving gemcitabine (n=67) and cisplatin/etoposide (n=72).</note><note type="content">Table 1: Characteristics of enrolled patients</note><note type="content">Table 2: Efficacy (protocol-qualified)</note><note type="content">Table 3: </note><note type="content">Table 4: Major clinical toxicity</note><note type="content">Table 5: Haematologic toxicity</note><note type="content">Table 6: Mean EORTC QLQ-C30-LC13 Scores (standard deviation)</note><subject lang="en"><genre>Keywords</genre><topic>Cisplatin</topic><topic>Etoposide</topic><topic>Gemcitabine</topic><topic>Non-small cell lung cancer</topic><topic>Randomized Phase II study</topic><topic>Quality of life</topic><topic>Efficacy</topic></subject><relatedItem type="host"><titleInfo><title>Lung Cancer</title></titleInfo><titleInfo type="abbreviated"><title>LUNG</title></titleInfo><genre type="journal">journal</genre><originInfo><dateIssued encoding="w3cdtf">199911</dateIssued></originInfo><identifier type="ISSN">0169-5002</identifier><identifier type="PII">S0169-5002(00)X0042-6</identifier><part><date>199911</date><detail type="volume"><number>26</number><caption>vol.</caption></detail><detail type="issue"><number>2</number><caption>no.</caption></detail><extent unit="issue pages"><start>73</start><end>136</end></extent><extent unit="pages"><start>85</start><end>94</end></extent></part></relatedItem><identifier type="istex">372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C</identifier><identifier type="DOI">10.1016/S0169-5002(99)00067-7</identifier><identifier type="PII">S0169-5002(99)00067-7</identifier><accessCondition type="use and reproduction" contentType="copyright">©1999 Elsevier Science Ireland Ltd</accessCondition><recordInfo><recordContentSource>ELSEVIER</recordContentSource><recordOrigin>Elsevier Science Ireland Ltd, ©1999</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Rhénanie/explor/UnivTrevesV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001810 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 001810 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Rhénanie
|area= UnivTrevesV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:372B48DCF485F91DFF5CC0C96A1DAEC20A304C8C
|texte= Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer
}}
| This area was generated with Dilib version V0.6.31. |  |