Neoadjuvant chemotherapy with gemcitabine and cisplatin in stage IIIA/B non-small cell lung cancer.

ABSTRACT

PURPOSE: We studied cisplatin plus gemcitabine as induction (neoadjuvant) therapy in patients with stage III non-small cell lung cancer (NSCLC) to assess its objective remission rate, resectability, survival, and toxicity. PATIENTS AND METHODS: Patients with stage III NSCLC received 2 cycles of gemcitabine 1250 mg/m2 on days 1, 8, and 15, plus cisplatin 100 mg/m2 on day 2. Subsequently, patients were assigned to local therapy--surgery or radiotherapy. RESULTS: Twenty-nine eligible patients (male/female 21/8) with a median age of 59 years (range, 43-71 years) were enrolled between October 1996 and February 1999. A total of 80 cycles were given, with a median of 3 per patient (range, 1-4 cycles). Overall, toxicities were mild; only one patient had febrile neutropenia, and there were no grade 4 non-hematological toxicities. There was one toxic death following afebrile grade 4 neutropenia. Overall clinical response rate (2 complete responses [CRs] + 16 partial responses [PRs]) was 62% (95% CI, 45%-79%); 10 patients had stable disease and none progressed; one patient was not evaluable. Eight of the 18 operated patients had pathological response 1 CR and 7 downstagings to N(-); 14 patients were resected. Median survival was 17 months (95% CI, 13-21 months), with 1-year and 2-year actuarial survival rates of 61% and 29%, respectively. CONCLUSIONS: Gemcitabine plus cisplatin is a very active and well-tolerated induction regimen in stage III NSCLC. Comparative studies with other standard regimens are warranted.