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Annals of Oncology 15:1048-1055, 2004
© 2004 European Society for Medical Oncology

Front-line paclitaxel–vinorelbine versus paclitaxel–carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial

Purpose: This randomized phase III trial of advanced or metastatic non-small-cell lung cancer (NSCLC) was designed to compare a standard treatment such as carboplatin (CRP)–paclitaxel (PCT) with a new combination, vinorelbine (VRL)–PCT—two agents acting in microtubules.

Patients and methods: Three hundred and sixty patients (stage IIIa, IIIb and IV) were included and evaluated for response rate, survival and toxicity. Arm A patients were treated with the control combination of CRP 6 AUC and PCT 175 mg/m2 repeated every 3 weeks for six cycles, and arm B with the investigational combination of VRL 25 mg/m2 and PCT 135 mg/m2 repeated every 2 weeks for nine cycles. The patients were well balanced with respect to gender, disease stage and performance status. Arm A received 849 cycles (mean 4.59 per patient) and arm B 951 cycles (mean 5.39 per patient).

Results: Complete and partial response rates were 45.95% and 42.86% for arms A and B, respectively. Median survival was 11 and 10 months, 1-year survival 42.7% and 37.85% and 2-year survival 10.12% and 19% for arms A and B, respectively. Toxicity was similar in all patients, except for neutropenia, which was significantly greater in arm B.

Conclusions: PCT combined with VRL produces similar (non-significant) response rates, survival and toxicity (except for neutropenia, as noted above) to standard CRP–PCT treatment in untreated advanced-stage NSCLC.

G. P. Stathopoulos1,*, M. Veslemes2, N. Georgatou3, D. Antoniou4, P. Giamboudakis5, K. Katis8, D. Tsavdaridis9, S. K. Rigatos1, I. Dimitroulis7, S. Bastani6, S. Loukides10, K. Vergos11, K. Marossis3, T. Grigoratou4, E. Kalatzi5, M. Charalambatou8, A. Paspalli3, P. Michalopoulou4, M. Stoka3 and A. Gerogianni4

1 First Department of Medical Oncology, 2 University Clinic, 3 Fifth Clinic, 4 Seventh Clinic, 5 Tenth Clinic, 6 Third Clinic 7 Sixth Clinic, Errikos Dynan Hospital, Athens, Sotiria Hospital Clinics, Athens; 8 Thriacion Hospital, Athens; 9 IKA, Thessaloniki; 10 401 Army Hospital, Athens; 11 Naval Hospital, Athens, Greece

*Correspondence to: Dr G. P. Stathopoulos, Semitelou 5, 115 28 Athens, Greece. Tel: +30-210-7752600; Fax: +30-210-7251736;Email: dr-gps{at}ath.forthnet.gr

Key words: non-small-cell lung cancer, paclitaxel, paclitaxel versus carboplatin, vinorelbine


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