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Annals of Oncology Advance Access originally published online on October 27, 2006
Annals of Oncology 2007 18(2):324-330; doi:10.1093/annonc/mdl396
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© 2006 European Society for Medical Oncology

lung cancer

Efficacy of the combination of cisplatin with either gemcitabine and vinorelbine or gemcitabine and paclitaxel in the treatment of locally advanced or metastatic non-small-cell lung cancer: a phase III randomised trial of the Southern Italy Cooperative Oncology Group (SICOG 0101)

P Comella1,*, G Filippelli2, G De Cataldis3, B Massidda4, G Frasci1, L Maiorino5, C Putzu6, S Mancarella7, S Palmeri8, R Cioffi9, M Roselli10, F Buzzi11, V Milia12, A Gambardella13, D Natale14, M Bianco15, M Ghiani16 and P Masullo17

1 Department of Medical Oncology, National Tumor Institute, Naples
2 Medical Oncology, City Hospital, Paola
3 Medical Oncology, Da Procida Hospital, Salerno
4 Chair of Medical Oncology, University Medical School, Cagliari
5 Medical Oncology, San Gennaro Hospital, Naples
6 Chair of Medical Oncology, University Medical School, Sassari
7 Medical Oncology, City Hospital, Campi Salentino
8 Chair of Medical Oncology University Medical School, Palermo
9 Pneumology, City Hospital, Caserta
10 Chair of Medical Oncology, Tor Vergata University Medical School, Rome
11 Medical Oncology, City Hospital, Terni
12 Medical Oncology, City Hospital, Macomer
13 Chair of Geriatrics, Second University Medical School, Naples
14 Medical Oncology, City Hospital, Penne
15 Medical Oncology, San Leonardo Hospital, Castellammare
16 Medical Oncology, City Hospital, Oristano
17 Medical Oncology, City Hospital, Vallo della Lucania; Italy

* Correspondence to: Dr P. Comella, Department of Medical Oncology, National Tumor Institute, Via M. Semmola, Naples, Italy. Tel: +39 0815903227; Fax: +39 0815903821; E-mail: pasqualecomella{at}libero.it

Background: Triplet regimens were occasionally reported to produce a higher response rate (RR) than doublets in locally advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was conducted to assess (i) whether the addition of cisplatin (CDDP) to either gemcitabine (GEM) and vinorelbine (VNR) or GEM and paclitaxel (PTX) significantly prolongs overall survival (OS) and (ii) to compare the toxicity of PTX-containing and VNR-containing combinations.

Patients and methods: Stage III or IV NSCLC patients were randomly assigned to (i) GEM 1000 mg/m2 and VNR 25 mg/m2 on days 1 and 8 (GV arm); (ii) GEM 1000 mg/m2 and PTX 125 mg/m2 on days 1 and 8 (GT arm); (iii) GV plus CDDP 50 mg/m2 on days 1 and 8 (PGV arm); and (iv) GT plus CDDP 50 mg/m2 on days 1 and 8 (PGT arm). Treatments were repeated every 3 weeks for a maximum of six cycles.

Results: A total of 433 (stage III, 160; stage IV, 273) patients were randomly allocated to the study. RR was 48% [95% confidence interval (CI), 42% to 54%] for triplets and 35% (95% CI, 32% to 38%) for doublets (P = 0.004). Median progression-free survival (6.1 versus 5.5 months, P = 0.706) and median OS (10.7 versus 10.5 months, P = 0.379) were similar. CDDP significantly increased the occurrence of severe neutropenia (35% versus 13%), thrombocytopenia (14% versus 4%), anaemia (9% versus 3%), vomiting (6% versus 0.5%), and diarrhoea (6% versus 2%). Conversely, frequency of severe neutropenia (30% versus 17%) and thrombocytopenia (11% versus 6%) was significantly higher with VNR-containing regimens.

Conclusions: Adding CDDP to GV or GT significantly increased RR, but did not prolong the OS of patients. Among doublets, the GT regimen should be preferred in view of its better safety profile.

Key words: cisplatin, gemcitabine, non-small-cell lung cancer, paclitaxel, vinorelbine

Received for publication July 18, 2006. Revision received September 7, 2006. Accepted for publication September 14, 2006.


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