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Titolo:
A multicenter randomized clinical trial comparing paclitaxel-cisplatin-etoposide versus cisplatin-etoposide as first-line treatment in patients with small-cell lung cancer
Autore:
Mavroudis, D; Papadakis, E; Veslemes, M; Tsiafaki, X; Stavrakakis, J; Kouroussis, C; Kakolyris, S; Bania, E; Jordanoglou, J; Agelidou, M; Vlachonicolis, J; Georgoulias, V;
Indirizzi:
Univ Crete, Sch Med, Dept Med Oncol, Heraklion, Greece Univ Crete Heraklion Greece Sch Med, Dept Med Oncol, Heraklion, Greece Sotiria Gen Hosp Athens, Dept Pulm Dis 1, Athens, Greece Sotiria Gen Hosp Athens Athens Greece , Dept Pulm Dis 1, Athens, Greece Univ Athens, Sotiria Gen Hosp Athens, Sch Med, Dept Pulm Dis, Athens, Greece Univ Athens Athens Greece thens, Sch Med, Dept Pulm Dis, Athens, Greece Sismanogl Gen Hosp Athens, Dept Pulm Dis 2, Athens, Greece Sismanogl Gen Hosp Athens Athens Greece Dept Pulm Dis 2, Athens, Greece Agios Savvas Anticanc Hosp Athens, Dept Med Oncol 1, Athens, Greece Agios Savvas Anticanc Hosp Athens Athens Greece Oncol 1, Athens, Greece Univ Crete, Sch Med, Dept Biostat, Heraklion, Greece Univ Crete Heraklion Greece e, Sch Med, Dept Biostat, Heraklion, Greece
Titolo Testata:
ANNALS OF ONCOLOGY
fascicolo: 4, volume: 12, anno: 2001,
pagine: 463 - 470
SICI:
0923-7534(200104)12:4<463:AMRCTC>2.0.ZU;2-T
Fonte:
ISI
Lingua:
ENG
Soggetto:
PHASE-II; CARCINOMA; CHEMOTHERAPY; CARBOPLATIN;
Keywords:
cisplatin; etoposide; paclitaxel; randomized trial; small-cell lung cancer;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Mavroudis, D Univ Gen Hosp Heraklion, Dept Med Oncol, POB 1352, Heraklion 71110, Crete,Greece Univ Gen Hosp Heraklion POB 1352 Heraklion Crete Greece71110
Citazione:
D. Mavroudis et al., "A multicenter randomized clinical trial comparing paclitaxel-cisplatin-etoposide versus cisplatin-etoposide as first-line treatment in patients with small-cell lung cancer", ANN ONCOL, 12(4), 2001, pp. 463-470

Abstract

Background: Previous phase I-II studies have shown that the combination ofpaclitaxel-cisplatin-etoposide (TEP) is very active and well tolerated in patients with small-cell lung cancer (SCLC). In order to compare the TEP combination to cisplatin-etoposide (EP) regimen as front-line treatment in patients with SCLC, we conducted a randomised multicenter study. Patients and methods: One hundred thirty-three chemotherapy-naive patientswith histologically proven limited or extensive stage SCLC were randomisedto receive either paclitaxel 175 mg/m(2) i.v. three-hour infusion on day 1and cisplatin 80 mg/m(2) i.v. on day 2 and etoposide 80 mg/m(2) i.v. on days 2-4 with G-CSF support (5 mcg/kg s.c. days 5-15) or cisplatin 80 mg/m(2)i.v. on day 1 and etoposide 120 mg/m(2) i.v. on days 1-3 in cycles every twenty-eight days. Results: Due to excessive toxicity and mortality observed in the TEP arm, an early interim analysis was performed and the study was closed. Sixty-twopatients received two hundred sixty-one cycles of TEP and seventy-one patients three hundred twenty-three cycles of EP. The two patient groups were well balanced for age, sex, performance status, stage of disease and the presence of abnormal LDH at diagnosis. In an intention-to-treat overall analysis both regimens were equally active with a complete and partial response rate of 50% (95% confidence interval (CI): 37.5%-62.4%) for TEP and 48% (95%CI: 36.2%-59.5%) for EP (P = 0.8). The median time to disease progression was 11 months for TEP and 9 months for EP (P = 0.02). The duration of response, one-year survival and overall survival were similar in the two arms. Similarly, in an intention-to-treat subgroup analysis of patients with limited or extensive stage disease, there was no difference in the activity between the two regimens except of a longer median time to disease progression in the extensive stage in favour of the TEP regimen, eight versus six months (P = 0.04). However, there were eight toxic deaths in the TEP arm versus none in the EP arm (P = 0.001). Moreover, the TEP regimen was associated with more severe toxicity than the EP regimen in terms of grade 4 neutropenia(P = 0.04), grade 3-4 thrombocytopenia (P = 0.02), febrile neutropenia (P = 0.08), grade 3-4 diarrhea (P = 0.01), grade 3-4 asthenia (P = 0.05) and grade 3 neurotoxicity (P = 0.06). Conclusions: In this early terminated study, the TEP regimen was significantly more toxic than the EP regimen. The TEP regimen is associated with significant toxicity and mortality, and should not be used outside of a protocol setting. For future investigations, dose and schedule modifications are necessary to reduce toxicity.

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Documento generato il 31/03/20 alle ore 23:59:45