SAN FRANCISCOPlatinum-based chemotherapy with either gemcitabine
(Gemzar) or 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
In addition, he said, phase III experience with a 3-week schedule of
cisplatin (Platinol)/gemcitabine using two cisplatin doses (100 and 70 mg/m²)
showed similar efficacy with both cisplatin doses but lower toxicity with the
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 (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
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.