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 : 002110 ( Main/Exploration ); précédent : 002109; suivant : 002111Single-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 [Pays-Bas] ; Bengt Bergman [Suède] ; Assad Chemaissani [Allemagne] ; Wolfgang Dornoff [Allemagne] ; Peter Drings [Allemagne] ; Piikko-Liisa Kellokumpu-Lehtinen [Finlande] ; K. Liippo [Finlande] ; Karin Mattson [Finlande] ; Joachim Von Pawel [Allemagne] ; Sergio Ricci [Italie] ; Christer Sederholm [Suède] ; Rolf A. Stahel [Suisse] ; Gunnar Wagenius [Suède] ; N. V Walree [Pays-Bas] ; Christian Manegold [Allemagne]Source :
- Lung Cancer [ 0169-5002 ] ; 1999.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme, Qualité de la vie.
English descriptors
- KwdEn :
- Antineoplastic agent, Bronchopulmonary, Chemotherapy, Cisplatin, Comparative study, Drug combination, Efficacy, Etoposide, Fluorine Organic compounds, Gemcitabine, Human, Non small cell carcinoma, Non-small cell lung cancer, Platinum II Complexes, Pyrimidine nucleoside, Quality of life, Randomized Phase II study, Treatment.
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
Affiliations:
- Allemagne, Finlande, Italie, Pays-Bas, Suisse, Suède
- Bade-Wurtemberg, Canton de Zurich, District de Karlsruhe, Hollande-Septentrionale, Toscane
- Amsterdam, Heidelberg, Pise, Zurich
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Le document en format XML
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<term>Efficacy</term>
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<term>Fluorine Organic compounds</term>
<term>Gemcitabine</term>
<term>Human</term>
<term>Non small cell carcinoma</term>
<term>Non-small cell lung cancer</term>
<term>Platinum II Complexes</term>
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<term>Gemcitabine</term>
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<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>
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