Gemcitabine-cisplatin given on day 1 every 3 weeks in advanced non-small cell lung cancer.

Objective: To determine the activity and toxicity of a higher dose intensity of the gemcitabine plus cisplatin combination in patients with non-small cell lung cancer (NSCLC).

Methods: Between June 2001-June 2003, patients with locally advanced or metastatic NSCLC and ECOG performance status 0-2 entered prospectively the study. Cisplatin dose was 80 mg/m(2) and gemcitabine 2 g/m(2). Both drugs were given on day 1 and cycles were repeated every 3 weeks. Three-four chemotherapy cycles were given, followed by thoracic radiotherapy, followed by another 2-3 chemotherapy cycles post radiotherapy.

Results: 35 patients (34 males, 1 female) with a median age of 65 years (range 42-75) were enrolled. NSCLC histological subtypes were: adenocarcinoma 3, large cell carcinoma 3, and squamous cell carcinoma 29. Twenty patients had stage IIIB and 15 stage IV. A median of 6 cycles (range 4-6) were administered. Grade 2 nausea (11/35) and vomiting (6/35) and grade 1 alopecia (23/35) were the most common nonhematological side effects. No patient needed dose reduction because of toxicity. Grade 2 hematological toxicity was seen in 10/35 patients. Only one case developed grade 4 hematological toxicity after the 4th cycle (febrile neutropenia). No patient achieved complete response. The partial response (PR) rate was 27.5% and stable disease (SD) rate was 28.5%. Median overall survival (OS) was 12.5 months (range 3-20) and progression-free survival (PFS) 5 months (range 0-13).

Conclusions: This regimen allows the delivery of higher dose of gemcitabine with cisplatin, has favorable toxicity profile and good antitumor activity.