التفاصيل البيبلوغرافية
| العنوان: |
A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer. |
| المؤلفون: |
Schmittel, A.1, Sebastian, M.2, Fischer von Weikersthal, L.3, Martus, P.4, Gauler, T. C.5, Kaufmann, C.1, Hortig, P.6, Fischer, J. R.7, Link, H.8, Binder, D.9, Fischer, B.2, Caca, K.10, Eberhardt, W. E. E.5, Keilholz, U.1 |
| المصدر: |
Annals of Oncology. Aug2011, Vol. 22 Issue 8, p1798-1804. 7p. |
| مصطلحات موضوعية: |
*SMALL cell lung cancer, *ETOPOSIDE, *DISEASE progression, *HEMATOLOGY, *DRUG toxicity, *RANDOMIZED controlled trials, *MEDICAL statistics |
| مستخلص: |
Background: This trial was designed to prove superiority of irinotecan over etoposide combined with carboplatin in extensive-disease small-cell lung cancer.Patients and methods: Patients were randomly assigned to receive carboplatin area under the curve 5 mg ·min/ml either in combination with irinotecan 50 mg/m2 on days 1, 8, and 15 (IP) or etoposide 140 mg/m2 on days 1–3 (EP). Primary end point was progression-free survival (PFS) at 6 months. Secondary end points were overall survival (OS), response rate, and toxicity.Results: Of 226 patients, 216 were eligible. Median PFS was 6.0 months [95% confidence interval (CI) 5.0–7.0] in the IP arm and 6.0 months (95% CI 5.2–6.8) in EP arm (P = 0.07). Median survival was 10.0 months (95% CI 8.4–11.6) and 9.0 months (95% CI 7.6–10.4) in the IP and EP arm (P = 0.06), respectively. Hazard ratios for disease progression and OS were 1.29 (95% CI 0.96–1.73, P = 0.095) and 1.34 (95% CI 0.97–1.85, P = 0.072), respectively. No difference in response rates was observed. Grade 3 and 4 hematologic toxicity favored the IP arm, whereas diarrhea was significantly more frequent in the IP arm.Conclusion: This trial failed to show superiority of irinotecan over etoposide in combination with carboplatin. [ABSTRACT FROM AUTHOR] |
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