Preoperative gemcitabine plus cisplatin had a statistically significant impact on outcomes among patients with stage IIB/IIIA non–small-cell lung cancer in a phase III randomized study comparing surgery alone or surgery plus preoperative chemotherapy. The 3-year progression-free survival rates were 55.4% for patients receiving chemotherapy plus surgery vs 36.1% in patients having surgery alone (P = .002). “The survival benefit at 3 years for patients with IIB/IIIA disease was 23.4%,” the researchers reported in the Journal of Clinical Oncology.1
Actual enrollment totaled 270 patients with stage I, II, or IIIA disease randomly assigned at 45 European centers in 15 countries. “Enrollment was stopped early following the documentation of positive results from randomized trials of adjuvant chemotherapy, because the investigators felt it would be unethical to continue the study with a surgery only treatment arm,” the authors said.
The positive effect of preoperative chemotherapy was “almost exclusively evident” among patients with IIB/IIIA disease. “Differences in the IB/IIA group were nonsignificant likely because of lack of power,” the researchers wrote. Two other trials that suggested a benefit from preoperative chemotherapy found no difference in treatment effect by stage (the Southwest Oncology Group 9900 trial) or showed that patients with earlier stages of disease had a greater benefit from chemotherapy (the Depierre et al trial).
The primary analysis of the total study population revealed an absolute difference of 5.1% in 3-year progression-free survival in favor of the chemotherapy-plus-surgery arm (52.9% vs 47.9%; P = .03) and 7.8% in 3-year overall survival also favoring chemotherapy plus surgery (67.6% vs 59.8%; P = .02).
Grade 3/4 hematologic toxicity in the chemotherapy-plus-surgery arm was 32%. No patients in the surgery-alone arm experienced hematologic events. Grade 3/4 nonhematologic events occurred in 16% of patients receiving chemotherapy plus surgery and 11% of patients receiving surgery alone. ■
1. Scagliotti GV, et al: J Clin Oncol, November 28, 2011 (early release online).