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 : 002432 ( Main/Exploration ); précédent : 002431; suivant : 002433Single-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 [Allemagne] ; B. Bergman [Suède] ; A. Chemaissani [Allemagne] ; W. Dornoff [Allemagne] ; P. Drings [Allemagne] ; P. Kellokumpu-Lehtinen [Finlande] ; K. Liippo [Finlande] ; K. Mattson [Finlande] ; J. V. Pawel ; S. Ricci [Italie] ; C. Sederholm [Suède] ; R. A. Stahel ; G. Wagenius [Suède] ; N. V. Walree [Pays-Bas] ; W. Ten Bokkel-Huinink [Pays-Bas]Source :
- Annals of Oncology [ 0923-7534 ] ; 1997-06.
Descripteurs français
- Pascal (Inist)
- Activité biologique, Anticancéreux, Association médicamenteuse, Bronchopulmonaire, Carcinome non petite cellule, Chimiothérapie, Cisplatine, Essai clinique phase II, Etoposide, Fluor Composé organique, Gemcitabine, Homme, Interaction médicamenteuse, Platine II Complexe, Podophyllotoxine dérivé, Pyrimidine nucléoside, Randomisation, Stade avancé, Toxicité, Traitement, Voie intraveineuse.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Advanced stage, Antineoplastic agent, Biological activity, Bronchopulmonary, Chemotherapy, Cisplatin, Drug combination, Drug interaction, Etoposide, Fluorine Organic compounds, Gemcitabine, Human, Intravenous administration, Non small cell carcinoma, Phase II trial, Platinum II Complexes, Podophyllotoxine derivatives, Pyrimidine nucleoside, Randomization, Toxicity, Treatment.
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.
Url:
DOI: 10.1023/A:1008207731111
Affiliations:
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Dornoff</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Mutterhaus der Borromäerinnen Trier</wicri:regionArea></affiliation></author><author><name sortKey="Drings, P" sort="Drings, P" uniqKey="Drings P" first="P." last="Drings">P. Drings</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Thoraxklinik Heidelberg</wicri:regionArea></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 wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>Tampere University Hospital Pinkonlinna</wicri:regionArea></affiliation></author><author><name sortKey="Liippo, K" sort="Liippo, K" uniqKey="Liippo K" first="K." last="Liippo">K. Liippo</name><affiliation wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>Turku University Hospital Paimio</wicri:regionArea></affiliation></author><author><name sortKey="Mattson, K" sort="Mattson, K" uniqKey="Mattson K" first="K." last="Mattson">K. Mattson</name><affiliation wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>University Hospital Helsinki</wicri:regionArea></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><wicri:noCountry code="no comma">Zentralkrankenhaus Gautmg Germany</wicri:noCountry></affiliation></author><author><name sortKey="Ricci, S" sort="Ricci, S" uniqKey="Ricci S" first="S." last="Ricci">S. Ricci</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>S. Chiara Hospital Pisa</wicri:regionArea></affiliation></author><author><name sortKey="Sederholm, C" sort="Sederholm, C" uniqKey="Sederholm C" first="C." last="Sederholm">C. Sederholm</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Universitets Sjukhuset Linkoping</wicri:regionArea></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><wicri:noCountry code="no comma">Universitätsspital Zürich Switzerland</wicri:noCountry></affiliation></author><author><name sortKey="Wagenius, G" sort="Wagenius, G" uniqKey="Wagenius G" first="G." last="Wagenius">G. Wagenius</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Akademsika Sjukhuset Uppsala</wicri:regionArea></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 wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Sint Antonius Ziekenhuis Nieuwegein</wicri:regionArea></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 wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Netherlands Cancer Institute Amsterdam</wicri:regionArea></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><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>Biological activity</term><term>Bronchopulmonary</term><term>Chemotherapy</term><term>Cisplatin</term><term>Drug combination</term><term>Drug interaction</term><term>Etoposide</term><term>Fluorine Organic compounds</term><term>Gemcitabine</term><term>Human</term><term>Intravenous administration</term><term>Non small cell carcinoma</term><term>Phase II trial</term><term>Platinum II Complexes</term><term>Podophyllotoxine derivatives</term><term>Pyrimidine nucleoside</term><term>Randomization</term><term>Toxicity</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Activité biologique</term><term>Anticancéreux</term><term>Association médicamenteuse</term><term>Bronchopulmonaire</term><term>Carcinome non petite cellule</term><term>Chimiothérapie</term><term>Cisplatine</term><term>Essai clinique phase II</term><term>Etoposide</term><term>Fluor Composé organique</term><term>Gemcitabine</term><term>Homme</term><term>Interaction médicamenteuse</term><term>Platine II Complexe</term><term>Podophyllotoxine dérivé</term><term>Pyrimidine nucléoside</term><term>Randomisation</term><term>Stade avancé</term><term>Toxicité</term><term>Traitement</term><term>Voie intraveineuse</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></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><affiliations><list><country><li>Allemagne</li><li>Finlande</li><li>Italie</li><li>Pays-Bas</li><li>Suède</li></country></list><tree><noCountry><name sortKey="Pawel, J V" sort="Pawel, J V" uniqKey="Pawel J" first="J. V." last="Pawel">J. V. Pawel</name><name sortKey="Stahel, R A" sort="Stahel, R A" uniqKey="Stahel R" first="R. A." last="Stahel">R. A. Stahel</name></noCountry><country name="Allemagne"><noRegion><name sortKey="Manegold, C" sort="Manegold, C" uniqKey="Manegold C" first="C." last="Manegold">C. Manegold</name></noRegion><name sortKey="Chemaissani, A" sort="Chemaissani, A" uniqKey="Chemaissani A" first="A." last="Chemaissani">A. Chemaissani</name><name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name><name sortKey="Drings, P" sort="Drings, P" uniqKey="Drings P" first="P." last="Drings">P. Drings</name></country><country name="Suède"><noRegion><name sortKey="Bergman, B" sort="Bergman, B" uniqKey="Bergman B" first="B." last="Bergman">B. Bergman</name></noRegion><name sortKey="Sederholm, C" sort="Sederholm, C" uniqKey="Sederholm C" first="C." last="Sederholm">C. Sederholm</name><name sortKey="Wagenius, G" sort="Wagenius, G" uniqKey="Wagenius G" first="G." last="Wagenius">G. Wagenius</name></country><country name="Finlande"><noRegion><name sortKey="Kellokumpu Lehtinen, P" sort="Kellokumpu Lehtinen, P" uniqKey="Kellokumpu Lehtinen P" first="P." last="Kellokumpu-Lehtinen">P. Kellokumpu-Lehtinen</name></noRegion><name sortKey="Liippo, K" sort="Liippo, K" uniqKey="Liippo K" first="K." last="Liippo">K. Liippo</name><name sortKey="Mattson, K" sort="Mattson, K" uniqKey="Mattson K" first="K." last="Mattson">K. Mattson</name></country><country name="Italie"><noRegion><name sortKey="Ricci, S" sort="Ricci, S" uniqKey="Ricci S" first="S." last="Ricci">S. Ricci</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Walree, N V" sort="Walree, N V" uniqKey="Walree N" first="N. V." last="Walree">N. V. Walree</name></noRegion><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></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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