Abstract
LBA7012 Background: At the time of study design, phase III trials had found improved survival in stage IIIA NSCLC patients (pts) treated with preop but not adjuvant chemotherapy. A large phase II trial in early stage NSCLC found preop PC feasible and improved survival over historical controls. S9900 was undertaken to determine whether preop PC could improve survival compared to surgery alone. ACOSOG, ECOG, NCCTG, and NCIC also participated. Methods: Consenting pts with clinical stage T2N0, T1–2N1, and T3N0–1 NSCLC (excluding superior sulcus tumors) were stratified by clinical stage (IB/IIA vs. IIB/IIIA) and randomized to preop PC (P:225 mg/m2 over 3 hours, C:AUC=6) on day 1, every 3 weeks x 3 or surgery alone. Eligible pts had performance status 0–1, age ≥ 18 years (yrs), predicted post-resection FEV1 ≥ 1.0L. Surgery was at least a lobectomy and mediastinal nodal sampling. The primary endpoint was an increase in median survival by 33% over expected 2.7 yrs for surgery. Planned sample size of this prospective, randomized trial was 600 pts, giving 81% power using a one-sided test with .025 significance level. Current median follow-up is 24 months. Survival data will be compared using log-rank. Results: S9900 closed to new pt entry in 07/04 following the positive adjuvant data. 354 pts were accrued; 174-surgery alone, 180-preop PC. Pt characteristics: median age 64 yrs, 66% male, 36% PS 1, 63% T2N0, 5% T1N1, 19% T2N1, 10% T3N0, 4% T3N1, 31% adenocarcinoma. Treatment-related deaths during PC-3, within 30 days of surgery-7 on PC arm, 4 on control. Updated survival will be presented at ASCO as the Data & Safety Monitoring Committee felt this an appropriate venue for data release. Conclusions: Although closed early secondary to positive adjuvant data, this study is one of the largest randomized trials examining preop chemotherapy in early stage NSCLC. As such, it represents a landmark regarding feasibility of this approach. A randomized trial comparing preop to adjuvant chemotherapy has been proposed to the North American Lung Intergroup. Supported by SWOG CA30102. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis, Bristol-Myers Squibb, Lilly Oncology Aventis, Bristol-Myers Squibb, Lilly Oncology
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