A 3-week schedule of gemcitabine plus cisplatin as induction chemotherapy for Stage III non-small cell lung cancer.

BACKGROUND: Our aim was to explore the activity and feasibility of gemcitabine plus cisplatin as induction chemotherapy in patients with Stage IIIA N(2) and selected IIIB non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: From September 1997 to July 2000, 70 chemonaive patients with Stage III NSCLC, median age of 64 years, World Health Organization performance status 0, 1, or 2, and the ability to tolerate a pneumonectomy entered the study and received gemcitabine 1250 mg/m(2) on days 1 and 8 and cisplatin 70 mg/m(2) on day 2 every 3 weeks. After three cycles of induction chemotherapy, patients underwent resection or radiotherapy. RESULTS: Responses were seen in 40 of the 69 assessable patients, for an intent-to treat overall response rate of 57.1% (95% confidence interval, 45-62%), with 4.2% complete response. Response rates were 68 and 35% in patients with Stage IIIA and IIIB disease, respectively. The overall pathological CR rate after induction chemotherapy was 3%, with an overall pathological downstaging rate of 20%. Median survival for all patients was 14.5 months, with an estimated 1-year survival rate of 67% (95% CI, 54.3-79.5%). The estimated time to treatment failure was 12.6 months. Grade 3/4 thrombocytopenia was the main hematologic toxicity, occurring in 26% of patients, but was not associated with life-threatening bleeding. Febrile neutropenia was rare and other severe non-hematologic toxicities were uncommon. CONCLUSIONS: The 3-week schedule of gemcitabine plus cisplatin is highly active as induction chemotherapy in Stage IIIA N(2) unresectable NSCLC. This suggests a need for a multimodality approach upfront, such as concurrent chemoradiation therapy, particularly in patients with Stage IIIB disease.