Single-agent gemcitabine versus cisplatin-etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer
Identifieur interne : 001B30 ( Istex/Corpus ); précédent : 001B29; suivant : 001B31Single-agent gemcitabine versus cisplatin-etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer
Auteurs : C. Manegold ; B. Bergman ; A. Chemaissani ; W. Dornoff ; P. Drings ; P. Kellokumpu-Lehtinen ; K. Liippo ; K. Mattson ; J. V. Pawel ; S. Ricci ; C. Sederholm ; R. A. Stahel ; G. Wagenius ; N. V. Walree ; W. Ten Bokkel-HuininkSource :
- Annals of Oncology [ 0923-7534 ] ; 1997-06.
Abstract
Background This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer. Patients and methods Gemcitabine 1,000 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 PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. Results 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide). Conclusions In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.
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DOI: 10.1023/A:1008207731111
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><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><author><name sortKey="Manegold, C" sort="Manegold, C" uniqKey="Manegold C" first="C." last="Manegold">C. Manegold</name><affiliation><mods:affiliation>Thoraxklinik Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bergman, B" sort="Bergman, B" uniqKey="Bergman B" first="B." last="Bergman">B. Bergman</name><affiliation><mods:affiliation>Salgrenska Sjukhuset Goteborg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Chemaissani, A" sort="Chemaissani, A" uniqKey="Chemaissani A" first="A." last="Chemaissani">A. Chemaissani</name><affiliation><mods:affiliation>Städtisches Krankenhaus Köln-Merheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromäerinnen Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Drings, P" sort="Drings, P" uniqKey="Drings P" first="P." last="Drings">P. Drings</name><affiliation><mods:affiliation>Thoraxklinik Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, P" sort="Kellokumpu Lehtinen, P" uniqKey="Kellokumpu Lehtinen P" first="P." last="Kellokumpu-Lehtinen">P. 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, K" sort="Mattson, K" uniqKey="Mattson K" first="K." last="Mattson">K. Mattson</name><affiliation><mods:affiliation>University Hospital Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Pawel, J V" sort="Pawel, J V" uniqKey="Pawel J" first="J. V." last="Pawel">J. V. Pawel</name><affiliation><mods:affiliation>Zentralkrankenhaus Gautmg Germany</mods:affiliation></affiliation></author><author><name sortKey="Ricci, S" sort="Ricci, S" uniqKey="Ricci S" first="S." last="Ricci">S. Ricci</name><affiliation><mods:affiliation>S. Chiara Hospital Pisa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Sederholm, C" sort="Sederholm, C" uniqKey="Sederholm C" first="C." last="Sederholm">C. Sederholm</name><affiliation><mods:affiliation>Universitets Sjukhuset Linkoping, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Stahel, R A" sort="Stahel, R A" uniqKey="Stahel R" first="R. A." last="Stahel">R. A. Stahel</name><affiliation><mods:affiliation>Universitätsspital Zürich Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Wagenius, G" sort="Wagenius, G" uniqKey="Wagenius G" first="G." last="Wagenius">G. 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="Ten Bokkel Huinink, W" sort="Ten Bokkel Huinink, W" uniqKey="Ten Bokkel Huinink W" first="W." last="Ten Bokkel-Huinink">W. Ten Bokkel-Huinink</name><affiliation><mods:affiliation>Netherlands Cancer Institute Amsterdam, The Netherlands</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:C7A4E04864DB521864AA5032A280D9EA4472DD13</idno><date when="1997" year="1997">1997</date><idno type="doi">10.1023/A:1008207731111</idno><idno type="url">https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001B30</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001B30</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">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><author><name sortKey="Manegold, C" sort="Manegold, C" uniqKey="Manegold C" first="C." last="Manegold">C. Manegold</name><affiliation><mods:affiliation>Thoraxklinik Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bergman, B" sort="Bergman, B" uniqKey="Bergman B" first="B." last="Bergman">B. Bergman</name><affiliation><mods:affiliation>Salgrenska Sjukhuset Goteborg, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Chemaissani, A" sort="Chemaissani, A" uniqKey="Chemaissani A" first="A." last="Chemaissani">A. Chemaissani</name><affiliation><mods:affiliation>Städtisches Krankenhaus Köln-Merheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><affiliation><mods:affiliation>Mutterhaus der Borromäerinnen Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Drings, P" sort="Drings, P" uniqKey="Drings P" first="P." last="Drings">P. Drings</name><affiliation><mods:affiliation>Thoraxklinik Heidelberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, P" sort="Kellokumpu Lehtinen, P" uniqKey="Kellokumpu Lehtinen P" first="P." last="Kellokumpu-Lehtinen">P. 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, K" sort="Mattson, K" uniqKey="Mattson K" first="K." last="Mattson">K. Mattson</name><affiliation><mods:affiliation>University Hospital Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Pawel, J V" sort="Pawel, J V" uniqKey="Pawel J" first="J. V." last="Pawel">J. V. Pawel</name><affiliation><mods:affiliation>Zentralkrankenhaus Gautmg Germany</mods:affiliation></affiliation></author><author><name sortKey="Ricci, S" sort="Ricci, S" uniqKey="Ricci S" first="S." last="Ricci">S. Ricci</name><affiliation><mods:affiliation>S. Chiara Hospital Pisa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Sederholm, C" sort="Sederholm, C" uniqKey="Sederholm C" first="C." last="Sederholm">C. Sederholm</name><affiliation><mods:affiliation>Universitets Sjukhuset Linkoping, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Stahel, R A" sort="Stahel, R A" uniqKey="Stahel R" first="R. A." last="Stahel">R. A. Stahel</name><affiliation><mods:affiliation>Universitätsspital Zürich Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Wagenius, G" sort="Wagenius, G" uniqKey="Wagenius G" first="G." last="Wagenius">G. 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="Ten Bokkel Huinink, W" sort="Ten Bokkel Huinink, W" uniqKey="Ten Bokkel Huinink W" first="W." last="Ten Bokkel-Huinink">W. Ten Bokkel-Huinink</name><affiliation><mods:affiliation>Netherlands Cancer Institute Amsterdam, The Netherlands</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="1997-06">1997-06</date><biblScope unit="volume">8</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="525">525</biblScope><biblScope unit="page" to="529">529</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">C7A4E04864DB521864AA5032A280D9EA4472DD13</idno><idno type="DOI">10.1023/A:1008207731111</idno><idno type="ArticleID">8.6.525</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer. Patients and methods Gemcitabine 1,000 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 PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. Results 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide). Conclusions In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>C. Manegold</name><affiliations><json:string>Thoraxklinik Heidelberg, Germany</json:string></affiliations></json:item><json:item><name>B. Bergman</name><affiliations><json:string>Salgrenska Sjukhuset Goteborg, Sweden</json:string></affiliations></json:item><json:item><name>A. Chemaissani</name><affiliations><json:string>Städtisches Krankenhaus Köln-Merheim, Germany</json:string></affiliations></json:item><json:item><name>W. Dornoff</name><affiliations><json:string>Mutterhaus der Borromäerinnen Trier, Germany</json:string></affiliations></json:item><json:item><name>P. Drings</name><affiliations><json:string>Thoraxklinik Heidelberg, Germany</json:string></affiliations></json:item><json:item><name>P. 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>K. Mattson</name><affiliations><json:string>University Hospital Helsinki, Finland</json:string></affiliations></json:item><json:item><name>J. v. Pawel</name><affiliations><json:string>Zentralkrankenhaus Gautmg Germany</json:string></affiliations></json:item><json:item><name>S. Ricci</name><affiliations><json:string>S. Chiara Hospital Pisa, Italy</json:string></affiliations></json:item><json:item><name>C. Sederholm</name><affiliations><json:string>Universitets Sjukhuset Linkoping, Sweden</json:string></affiliations></json:item><json:item><name>R. A. Stahel</name><affiliations><json:string>Universitätsspital Zürich Switzerland</json:string></affiliations></json:item><json:item><name>G. 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>W. ten Bokkel-Huinink</name><affiliations><json:string>Netherlands Cancer Institute Amsterdam, The Netherlands</json:string></affiliations></json:item></author><subject><json:item><value>Original articles</value></json:item><json:item><value>cisplatin</value></json:item><json:item><value>etoposide</value></json:item><json:item><value>gemcitabine</value></json:item><json:item><value>non-small-cell lung cancer</value></json:item><json:item><value>randomised phase II study</value></json:item></subject><articleId><json:string>8.6.525</json:string></articleId><language><json:string>unknown</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Background This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer. Patients and methods Gemcitabine 1,000 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 PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. Results 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide). Conclusions In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.</abstract><qualityIndicators><score>8.553</score><pdfVersion>1.2</pdfVersion><pdfPageSize>592 x 853 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>6</keywordCount><abstractCharCount>1884</abstractCharCount><pdfWordCount>3553</pdfWordCount><pdfCharCount>23051</pdfCharCount><pdfPageCount>5</pdfPageCount><abstractWordCount>259</abstractWordCount></qualityIndicators><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><refBibs><json:item><author></author><host><volume>311</volume><pages><last>909</last><first>899</first></pages><author></author><title>BMJ</title><publicationDate>1995</publicationDate></host><title>Non-small-Cell Lung Cancer Collaborative Group Chemotherapy in non-small-cell lung cancer: A meta-analysis using updated data on individual patients from 52 randomised clinical trials</title><publicationDate>1995</publicationDate></json:item><json:item><author><json:item><name>Rp Abratt</name></json:item><json:item><name>Wr Bezwoda</name></json:item><json:item><name>G Falkson</name></json:item></author><host><volume>12</volume><pages><last>40</last><first>1535</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1994</publicationDate></host><title>Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: A phase II study</title><publicationDate>1994</publicationDate></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></author><host><volume>12</volume><pages><last>6</last><first>1821</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1994</publicationDate></host><title>Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: A phase II study</title><publicationDate>1994</publicationDate></json:item><json:item><author><json:item><name>U Gatzemeier</name></json:item><json:item><name>Fa Shepherd</name></json:item><json:item><name>Le Chevalier</name></json:item><json:item><name>T </name></json:item></author><host><volume>32</volume><pages><last>8</last><first>243</first></pages><issue>2</issue><author></author><title>Eur J Cancer</title><publicationDate>1996</publicationDate></host><title>Activity of gemcitabine in patients with non-small-cell lung cancer: A multicenter extended phase II study</title><publicationDate>1996</publicationDate></json:item><json:item><author><json:item><name>Fv Fossella</name></json:item><json:item><name>Sm Lippman</name></json:item><json:item><name>Dm Shin</name></json:item></author><host><volume>15</volume><pages><last>6</last><first>310</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1997</publicationDate></host><title>Maximum-tolerated dose defined for single-agent gemcitabine: A phase I dose-escalation study in chemotherapy-naive patients with advanced nonsmall-cell lung cancer</title><publicationDate>1997</publicationDate></json:item><json:item><author><json:item><name>L Crino</name></json:item><json:item><name>G Scagliotti</name></json:item><json:item><name>M Marangolo</name></json:item></author><host><volume>15</volume><pages><last>303</last><first>297</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1997</publicationDate></host><title>Cisplatin-gemcitabine combination in advanced non-small-cell lung cancer: A phase II study</title><publicationDate>1997</publicationDate></json:item><json:item><author><json:item><name>Rp Abratt</name></json:item><json:item><name>Wr Bezwoda</name></json:item><json:item><name>L Goedhals</name></json:item></author><host><volume>15</volume><pages><last>9</last><first>744</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1997</publicationDate></host><title>Weekly gemcitabine with monthly cisplatin: Effective chemotherapy for advanced non-small-cell lung cancer</title><publicationDate>1997</publicationDate></json:item><json:item><author><json:item><name>A Ardizzoru</name></json:item><json:item><name>C Martin</name></json:item></author><host><volume>5</volume><pages><last>295</last><first>60</first></pages><author></author><title>Ann Oncol</title><publicationDate>1994</publicationDate></host><title>Gemcitabine toxicity profile and efficacy unaffected by age in advanced non-small-cell lung cancer (NSCLC)</title><publicationDate>1994</publicationDate></json:item><json:item><author><json:item><name>Sj Pocock</name></json:item><json:item><name>R Simon</name></json:item></author><host><volume>31</volume><pages><last>15</last><first>103</first></pages><author></author><title>Biometrics</title><publicationDate>1975</publicationDate></host><title>Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial</title><publicationDate>1975</publicationDate></json:item><json:item><author><json:item><name>L Crino</name></json:item><json:item><name>M Tonato</name></json:item><json:item><name>S Darwish</name></json:item></author><host><volume>26</volume><pages><last>6</last><first>52</first></pages><author></author><title>Cancer Chemotherapy Pharmacol</title><publicationDate>1990</publicationDate></host><title>A randomised trial of 3 cisplatin containing regimens in NSCLC. A study of the Umbrian Lung Cancer Group</title><publicationDate>1990</publicationDate></json:item><json:item><author><json:item><name>Jc Ruckdeschel</name></json:item></author><host><volume>10</volume><pages><last>44</last><first>39</first></pages><author></author><title>Semin Oncol</title><publicationDate>1992</publicationDate></host><title>The role of standard dose etoposide in the management of NSCLC</title><publicationDate>1992</publicationDate></json:item><json:item><author><json:item><name>P Bonomi</name></json:item><json:item><name>D Finkelstein</name></json:item><json:item><name>Chang,A </name></json:item></author><host><volume>17</volume><pages><last>7</last><first>215</first></pages><author></author><title>Am J Clin Oncol</title><publicationDate>1994</publicationDate></host><title>Phase II trial of acivicin versus etoposide-cisplatin in non-small-cell lung cancer. An Eastern Cooperative Oncology Group study</title><publicationDate>1994</publicationDate></json:item><json:item><author><json:item><name>Hm Dhingra</name></json:item><json:item><name>M Valdivieso</name></json:item><json:item><name>Dt Carr</name></json:item></author><host><volume>3</volume><pages><last>83</last><first>176</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1985</publicationDate></host><title>Randomised trial of three combinations of cisplatin with vindesine and/or VP-16 in the treatment of advanced NSCLC</title><publicationDate>1985</publicationDate></json:item><json:item><author><json:item><name>Jd Hainsworth</name></json:item><json:item><name>Dh Johnson</name></json:item><json:item><name>Nsclc Chemotherapy</name></json:item></author><host><volume>12</volume><pages><last>9</last><first>345</first></pages><author></author><title>Am J Clin Oncol</title><publicationDate>1989</publicationDate></host><title>A randomised trial of three cisplatin-based chemotherapy regimens</title><publicationDate>1989</publicationDate></json:item><json:item><author><json:item><name>J Klastersky</name></json:item><json:item><name>Jp Sculier</name></json:item><json:item><name>H Lacroix</name></json:item></author><host><volume>8</volume><pages><last>62</last><first>1556</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1990</publicationDate></host><title>A randomised study comparing cisplatin or carboplatin with etoposide in patients with advanced NSCLC. EORTC protocol 07861</title><publicationDate>1990</publicationDate></json:item><json:item><author><json:item><name>Jc Ruckdeschel</name></json:item><json:item><name>Dh Finkelstein</name></json:item><json:item><name>Ds Ettinger</name></json:item></author><host><volume>4</volume><pages><last>21</last><first>14</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1986</publicationDate></host><title>A randomised trial of the four most active regimens for metastatic NSCLC</title><publicationDate>1986</publicationDate></json:item><json:item><author><json:item><name>Jk Weick</name></json:item><json:item><name>J Crowley</name></json:item><json:item><name>Rb Natale</name></json:item></author><host><volume>9</volume><pages><last>62</last><first>1157</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1991</publicationDate></host><title>A randomised trial of five cisplatin containing regimens in patients with metastatic NSCLC. A Southwest Oncology Group Study</title><publicationDate>1991</publicationDate></json:item><json:item><author><json:item><name>J Klastersky</name></json:item><json:item><name>Jp Sculier</name></json:item><json:item><name>P Ravez</name></json:item></author><host><volume>4</volume><pages><last>6</last><first>1780</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1986</publicationDate></host><title>A randomised study comparing a high and a standard dose of cisplatin in combination with etoposide in the treatment of advanced NSCLC</title><publicationDate>1986</publicationDate></json:item><json:item><author><json:item><name>Pd Bonomi</name></json:item><json:item><name>Dm Finkelstein</name></json:item><json:item><name>Jc Ruckdeschel</name></json:item></author><host><volume>7</volume><pages><last>13</last><first>1602</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1989</publicationDate></host><title>Combination chemotherapy versus single agents followed by combination chemotherapy in stage IV non-small-cell lung cancer: A study of the Eastern Cooperative Oncology Group</title><publicationDate>1989</publicationDate></json:item><json:item><author><json:item><name>Ml Slevin</name></json:item><json:item><name>L Stubbs</name></json:item><json:item><name>Hj Plant</name></json:item></author><host><volume>300</volume><pages><last>60</last><first>1458</first></pages><author></author><title>BMJ</title><publicationDate>1990</publicationDate></host><title>Attitude to chemotherapy: Comparing views of patients with cancer with those of doctors, nurses and general public</title><publicationDate>1990</publicationDate></json:item><json:item><author><json:item><name>Lh Einhorn</name></json:item><json:item><name>Pj Loehrer</name></json:item><json:item><name>Sd Williams</name></json:item></author><host><volume>4</volume><pages><last>3</last><first>1037</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1986</publicationDate></host><title>Random prospective study of vindesine versus vindesine plus cisplatin, plus mitomycin in advanced non-small-cell lung cancer</title><publicationDate>1986</publicationDate></json:item><json:item><author><json:item><name>B Sorensen</name></json:item><json:item><name>Hh Hansen</name></json:item><json:item><name>P Dambernowsky</name></json:item></author><host><volume>5</volume><pages><last>77</last><first>1169</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1987</publicationDate></host><title>Chemotherapy for adenocarcinoma of the lung (WHO III): A randomised study of vindesine versus lomustine, cyclophosphamide, and methotrexate versus all four drugs</title><publicationDate>1987</publicationDate></json:item><json:item><author><json:item><name>J Klastersky</name></json:item><json:item><name>Jp Sculier</name></json:item><json:item><name>G Bureau</name></json:item></author><host><volume>7</volume><pages><last>92</last><first>1087</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1989</publicationDate></host><title>Cisplatin versus cisplatin plus etoposide in the treatment of advanced non-small-cell lung cancer</title><publicationDate>1989</publicationDate></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 Ardizzoru</name></json:item></author><host><volume>66</volume><pages><last>4</last><first>130</first></pages><author></author><title>Cancer</title><publicationDate>1990</publicationDate></host><title>Etoposide versus etoposide plus high-dose cisplatin in the management of advanced nonsmall-cell lung cancer</title><publicationDate>1990</publicationDate></json:item><json:item><author><json:item><name>M Kawahara</name></json:item><json:item><name>K Furuse</name></json:item><json:item><name>K Nagohesa</name></json:item></author><host><volume>68</volume><pages><last>9</last><first>714</first></pages><author></author><title>Cancer</title><publicationDate>1991</publicationDate></host><title>A randomized study of cisplatin versus cisplatin plus vindesine for non-small-cell lung cancer</title><publicationDate>1991</publicationDate></json:item><json:item><author><json:item><name>Mh Veeder</name></json:item><json:item><name>Jr Jett</name></json:item><json:item><name>Jo Su</name></json:item></author><host><pages><last>2281</last><first>70</first></pages><author></author><title>Cancer</title><publicationDate>1992</publicationDate></host><title>A phase III trial of mitomycin C alone versus mitomycin C, vinblastine and cisplatin for metastatic squamous cell lung cancer</title><publicationDate>1992</publicationDate></json:item><json:item><author><json:item><name>A Depierre</name></json:item><json:item><name>Le Beau</name></json:item><json:item><name>B Chasting</name></json:item><json:item><name>C </name></json:item></author><host><pages><last>340</last><first>12</first></pages><author></author><title>Proc Am Soc Clin Oncol</title><publicationDate>1993</publicationDate></host><title>Results of a phase III randomized study of vinorelbine-cisplatin in non-small-cell lung cancer</title><publicationDate>1993</publicationDate></json:item><json:item><author><json:item><name>G Giaccone</name></json:item><json:item><name>T Splinter</name></json:item><json:item><name>J Fester</name></json:item></author><host><volume>12</volume><pages><first>331</first></pages><author></author><title>Proc Am Soc Clin Oncol</title><publicationDate>1993</publicationDate></host><title>Cisplatin combined with teniposide improves response and survival over VM alone in nonsmall-cell lung cancer: A randomized trial of the EORTC Lung Cancer Cooperative Group</title><publicationDate>1993</publicationDate></json:item><json:item><author><json:item><name>Le Chevalier</name></json:item><json:item><name>T Brisgand</name></json:item><json:item><name>D Doulliard</name></json:item><json:item><name>Jy </name></json:item></author><host><volume>12</volume><pages><last>7</last><first>360</first></pages><author></author><title>J Clin Oncol</title><publicationDate>1994</publicationDate></host><title>Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: Results of a European multicenter trial including 612 patients</title><publicationDate>1994</publicationDate></json:item><json:item><author><json:item><name>J Van Meerbeck</name></json:item><json:item><name>C Debruyne</name></json:item><json:item><name>Pe Postmus</name></json:item></author><host><volume>9</volume><pages><first>400</first></pages><author></author><title>Eur Resp J</title><publicationDate>1996</publicationDate></host><title>Sequential phase II studies with paclitaxel and gemcitabine in malignant pleural mesothelionia</title><publicationDate>1996</publicationDate></json:item></refBibs><genre><json:string>research-article</json:string></genre><host><volume>8</volume><publisherId><json:string>annonc</json:string></publisherId><pages><last>529</last><first>525</first></pages><issn><json:string>0923-7534</json:string></issn><issue>6</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1569-8041</json:string></eissn><title>Annals of Oncology</title></host><categories><wos><json:string>science</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>1997</publicationDate><copyrightDate>1997</copyrightDate><doi><json:string>10.1023/A:1008207731111</json:string></doi><id>C7A4E04864DB521864AA5032A280D9EA4472DD13</id><score>0.2511016</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">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><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>© 1997 Kluwer Academic Publishers</p></availability><date>1997</date></publicationStmt><notesStmt><note>Correspondence to: Prof. Dr. C. Manegold Thoraxklinik Department of Medical Oncology Amalienstrasse 5 D-69126 Heidelberg Germany</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">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><author xml:id="author-1"><persName><forename type="first">C.</forename><surname>Manegold</surname></persName><affiliation>Thoraxklinik Heidelberg, Germany</affiliation></author><author xml:id="author-2"><persName><forename type="first">B.</forename><surname>Bergman</surname></persName><affiliation>Salgrenska Sjukhuset Goteborg, Sweden</affiliation></author><author xml:id="author-3"><persName><forename type="first">A.</forename><surname>Chemaissani</surname></persName><affiliation>Städtisches Krankenhaus Köln-Merheim, Germany</affiliation></author><author xml:id="author-4"><persName><forename type="first">W.</forename><surname>Dornoff</surname></persName><affiliation>Mutterhaus der Borromäerinnen Trier, Germany</affiliation></author><author xml:id="author-5"><persName><forename type="first">P.</forename><surname>Drings</surname></persName><affiliation>Thoraxklinik Heidelberg, Germany</affiliation></author><author xml:id="author-6"><persName><forename type="first">P.</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">K.</forename><surname>Mattson</surname></persName><affiliation>University Hospital Helsinki, Finland</affiliation></author><author xml:id="author-9"><persName><forename type="first">J. v.</forename><surname>Pawel</surname></persName><affiliation>Zentralkrankenhaus Gautmg Germany</affiliation></author><author xml:id="author-10"><persName><forename type="first">S.</forename><surname>Ricci</surname></persName><affiliation>S. Chiara Hospital Pisa, Italy</affiliation></author><author xml:id="author-11"><persName><forename type="first">C.</forename><surname>Sederholm</surname></persName><affiliation>Universitets Sjukhuset Linkoping, Sweden</affiliation></author><author xml:id="author-12"><persName><forename type="first">R. A.</forename><surname>Stahel</surname></persName><affiliation>Universitätsspital Zürich Switzerland</affiliation></author><author xml:id="author-13"><persName><forename type="first">G.</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">W.</forename><surname>ten Bokkel-Huinink</surname></persName><affiliation>Netherlands Cancer Institute Amsterdam, The Netherlands</affiliation></author></analytic><monogr><title level="j">Annals of Oncology</title><idno type="pISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="1997-06"></date><biblScope unit="volume">8</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="525">525</biblScope><biblScope unit="page" to="529">529</biblScope></imprint></monogr><idno type="istex">C7A4E04864DB521864AA5032A280D9EA4472DD13</idno><idno type="DOI">10.1023/A:1008207731111</idno><idno type="ArticleID">8.6.525</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1997</date></creation><abstract><p>Background This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer. Patients and methods Gemcitabine 1,000 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 PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. Results 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide). Conclusions In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.</p></abstract><textClass><keywords scheme="keyword"><list><item><term>Original articles</term></item></list></keywords></textClass><textClass><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>randomised phase II study</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1997-06">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-12-22">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">annonc</journal-id><journal-id journal-id-type="publisher-id">annonc</journal-id><journal-id journal-id-type="pmc">annonc</journal-id><journal-title>Annals of Oncology</journal-title><issn pub-type="epub">1569-8041</issn><issn pub-type="ppub">0923-7534</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">8.6.525</article-id><article-id pub-id-type="doi">10.1023/A:1008207731111</article-id><article-categories><subj-group><subject>Original articles</subject></subj-group></article-categories><title-group><article-title>Single-agent gemcitabine <italic>versus</italic> cisplatin-etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Manegold</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="au1"><sup>1</sup></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Bergman</surname><given-names>B.</given-names></name><xref ref-type="aff" rid="au2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Chemaissani</surname><given-names>A.</given-names></name><xref ref-type="aff" rid="au3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dornoff</surname><given-names>W.</given-names></name><xref ref-type="aff" rid="au4"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Drings</surname><given-names>P.</given-names></name><xref ref-type="aff" rid="au1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kellokumpu-Lehtinen</surname><given-names>P.</given-names></name><xref ref-type="aff" rid="au5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Liippo</surname><given-names>K.</given-names></name><xref ref-type="aff" rid="au6"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Mattson</surname><given-names>K.</given-names></name><xref ref-type="aff" rid="au7"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pawel</surname><given-names>J. v.</given-names></name><xref ref-type="aff" rid="au8"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ricci</surname><given-names>S.</given-names></name><xref ref-type="aff" rid="au9"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Sederholm</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="au10"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>Stahel</surname><given-names>R. A.</given-names></name><xref ref-type="aff" rid="au11"><sup>11</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wagenius</surname><given-names>G.</given-names></name><xref ref-type="aff" rid="au12"><sup>12</sup></xref></contrib><contrib contrib-type="author"><name><surname>Walree</surname><given-names>N. v.</given-names></name><xref ref-type="aff" rid="au13"><sup>13</sup></xref></contrib><contrib contrib-type="author"><name><surname>ten Bokkel-Huinink</surname><given-names>W.</given-names></name><xref ref-type="aff" rid="au14"><sup>14</sup></xref></contrib><aff id="au1"><sup>1</sup><institution>Thoraxklinik</institution> <addr-line>Heidelberg, Germany</addr-line></aff><aff id="au2"><sup>2</sup><institution>Salgrenska Sjukhuset</institution> <addr-line>Goteborg, Sweden</addr-line></aff><aff id="au3"><sup>3</sup><institution>Städtisches Krankenhaus</institution> <addr-line>Köln-Merheim, Germany</addr-line></aff><aff id="au4"><sup>4</sup><institution>Mutterhaus der Borromäerinnen</institution> <addr-line>Trier, Germany</addr-line></aff><aff id="au5"><sup>5</sup><institution>Tampere University Hospital</institution> <addr-line>Pinkonlinna, Finland</addr-line></aff><aff id="au6"><sup>6</sup><institution>Turku University Hospital</institution> <addr-line>Paimio, Finland</addr-line></aff><aff id="au7"><sup>7</sup><institution>University Hospital</institution> <addr-line>Helsinki, Finland</addr-line></aff><aff id="au8"><sup>8</sup><institution>Zentralkrankenhaus Gautmg</institution> <addr-line>Germany</addr-line></aff><aff id="au9"><sup>9</sup><institution>S. Chiara Hospital</institution> <addr-line>Pisa, Italy</addr-line></aff><aff id="au10"><sup>10</sup><institution>Universitets Sjukhuset</institution> <addr-line>Linkoping, Sweden</addr-line></aff><aff id="au11"><sup>11</sup><institution>Universitätsspital Zürich</institution> <addr-line>Switzerland</addr-line></aff><aff id="au12"><sup>12</sup><institution>Akademsika Sjukhuset</institution> <addr-line>Uppsala, Sweden</addr-line></aff><aff id="au13"><sup>13</sup><institution>Sint Antonius Ziekenhuis</institution> <addr-line>Nieuwegein, The Netherlands</addr-line></aff><aff id="au14"><sup>14</sup><institution>Netherlands Cancer Institute</institution> <addr-line>Amsterdam, The Netherlands</addr-line></aff></contrib-group><author-notes><corresp id="cor1"><italic>Correspondence to</italic>: Prof. Dr. C. Manegold Thoraxklinik Department of Medical Oncology Amalienstrasse 5 D-69126 Heidelberg Germany</corresp></author-notes><pub-date pub-type="ppub"><month>6</month><year>1997</year></pub-date><volume>8</volume><issue>6</issue><fpage>525</fpage><lpage>529</lpage><history><date date-type="received"><day>31</day><month>1</month><year>1997</year></date><date date-type="accepted"><day>24</day><month>3</month><year>1997</year></date></history><copyright-statement>© 1997 Kluwer Academic Publishers</copyright-statement><copyright-year>1997</copyright-year><abstract><sec><title>Background</title><p>This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer.</p></sec><sec><title>Patients and methods</title><p>Gemcitabine 1,000 mg/m<sup>2</sup> was given as a 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m<sup>2</sup> on day 1, and etoposide 100 mg/m<sup>2</sup> on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small-cell lung cancer, measurable disease, Zubrod PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases.</p></sec><sec><title>Results</title><p>146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT<sub>3</sub> antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide).</p></sec><sec><title>Conclusions</title><p>In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.</p></sec></abstract><kwd-group><kwd>cisplatin</kwd><kwd>etoposide</kwd><kwd>gemcitabine</kwd><kwd>non-small-cell lung cancer</kwd><kwd>randomised phase II study</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><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></titleInfo><titleInfo type="alternative" contentType="CDATA"><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></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Manegold</namePart><affiliation>Thoraxklinik Heidelberg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Bergman</namePart><affiliation>Salgrenska Sjukhuset Goteborg, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</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">W.</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">P.</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">P.</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">K.</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">J. v.</namePart><namePart type="family">Pawel</namePart><affiliation>Zentralkrankenhaus Gautmg Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</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">C.</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">R. 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">G.</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">W.</namePart><namePart type="family">ten Bokkel-Huinink</namePart><affiliation>Netherlands Cancer Institute Amsterdam, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><subject><topic>Original articles</topic></subject><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">1997-06</dateIssued><copyrightDate encoding="w3cdtf">1997</copyrightDate></originInfo><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Background This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer. Patients and methods Gemcitabine 1,000 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 PS 0–2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases. Results 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8–30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9–25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cisplatin-etoposide). Conclusions In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.</abstract><note type="author-notes">Correspondence to: Prof. Dr. C. Manegold Thoraxklinik Department of Medical Oncology Amalienstrasse 5 D-69126 Heidelberg Germany</note><subject><genre>keywords</genre><topic>cisplatin</topic><topic>etoposide</topic><topic>gemcitabine</topic><topic>non-small-cell lung cancer</topic><topic>randomised phase II study</topic></subject><relatedItem type="host"><titleInfo><title>Annals of Oncology</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0923-7534</identifier><identifier type="eISSN">1569-8041</identifier><identifier type="PublisherID">annonc</identifier><identifier type="PublisherID-hwp">annonc</identifier><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>8</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>525</start><end>529</end></extent></part></relatedItem><identifier type="istex">C7A4E04864DB521864AA5032A280D9EA4472DD13</identifier><identifier type="DOI">10.1023/A:1008207731111</identifier><identifier type="ArticleID">8.6.525</identifier><accessCondition type="use and reproduction" contentType="copyright">© 1997 Kluwer Academic Publishers</accessCondition><recordInfo><recordContentSource>OUP</recordContentSource></recordInfo></mods></metadata><annexes><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/C7A4E04864DB521864AA5032A280D9EA4472DD13/annexes/pdf</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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