This single-arm, multicenter, phase II study examined the objective response rate and toxicity after neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with stage IB-IIIA non-small cell lung cancer. Treatment consisted of three 21-day cycles of gemcitabine (1000 mg/m(2)) on days 1 and 8 and cisplatin (75 mg/m(2)) on day 1 of each cycle. Surgery was performed 4-5 weeks after day 1 of the last cycle of study therapy. A total of 52 patients from five investigative sites in Russia were enrolled in the study, of which 50 (96.2%) received study therapy. Of the 49 patients who were evaluable for response, six (12.2%) had a complete response and 16 (32.7%) had a partial response, resulting in an overall response rate of 44.9%. Disease progression occurred in four out of the 49 (8.2%) patients. Radical tumor resection was performed in 38 out of the 49 (77.6%) patients. A total of 41 patients were assessed for a pathological complete response, of which four (9.8%) patients had pathological complete tumor regression. Postsurgical restaging was performed in 36 out of the 41 (87.8%) patients. Tumor downstaging occurred in 16 out of the 36 (44.4%) patients. Grade 3/4 neutropenia and thrombocytopenia were experienced by 28.0%/6.0% patients and 6.0%/2.0% patients, respectively. Grade 3 anemia occurred in 4.0% of the patients. Nonhematological toxicity was mild. Overall mortality was 30.0% (15 out of 50 patients), predominantly from progressive disease. The 1-year overall survival rate was 74.4% (95% confidence interval: 61.3-87.6%). Neoadjuvant chemotherapy with gemcitabine and cisplatin showed a good safety profile with an encouraging possibility of curative surgery in patients with early-stage non-small cell lung cancer.
Trial registration: ClinicalTrials.gov NCT00191841.