SAN FRANCISCOPlatinum-based chemotherapy with either gemcitabine(Drug information on gemcitabine) (Gemzar) or paclitaxel(Drug information on paclitaxel) (Taxol) caused fewer terminations of therapy for progressive disease or adverse events than the reference regimen of platinum with vinorelbine (Navelbine) in advanced non-small-cell lung cancer (NSCLC).
The study results were presented at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO abstract 1227).
Giorgio V. Scagliotti, MD, speaking for the Italian Lung Cancer Project, Obassano (Torino), Italy, said that the study protocol was based on phase II and III experience of the Italian Lung Cancer Project showing relevant activity in NSCLC for both gemcitabine and paclitaxel in combination with a platinum agent.
In addition, he said, phase III experience with a 3-week schedule of cisplatin(Drug information on cisplatin) (Platinol)/gemcitabine using two cisplatin doses (100 and 70 mg/m²) showed similar efficacy with both cisplatin doses but lower toxicity with the lower dose.
In this study, the investigators randomized 607 patients to receive cisplatin 75 mg/m² on day 2 and gemcitabine 1,250 mg/m² on days 1 and 8, every 3 weeks; carboplatin(Drug information on carboplatin) (Paraplatin) to AUC 6 on day 1 and paclitaxel 225 mg/m² on day 1, every 3 weeks; or cisplatin 100 mg/m² on day 1 and vinorelbine 25 mg/m² weekly for 12 weeks then every other week, given every 4 weeks.
Patients had stage IIIb disease (pleural effusion or N3 supraclavicular involvement) or stage IV NSCLC and were chemo-, radio-, and immunotherapy naïve. About 80% were stage IV, and about 8% had prior surgery.