Adjuvant chemotherapy is recommended for completely resected stage II-IIIa NSCLC. Indirect comparison meta-analysis of adjuvant vs neoadjuvant therapy showed no difference in survival. This study was conducted to compare DFS between adjuvant chemotherapy and neoadjuvant chemotherapy among patients with resectable NSCLC.
Patients with stage IB-IIIA NSCLC were eligible. They were randomly assigned to 3 cycles adjuvant DC (Docetaxel: 75mg/m2, Carboplatin :AUC = 5 on day 1 every 3wks) or 3 cycles neoadjuvant DC at the same schedule followed by surgery 3-6 wk after chemotherapy. The primary end point was 3 years Disease Free Survival (DFS); secondary end points were 3yrs and 5yrs Overall Survival (OS) and Safety. Planned sample size is 410. The trial was closed early due to slow accrual.
Between March 2006 and May 2011, 214 patients were screened from 13 institutes, among them 198 patients were randomized. 97 were assigned to neoadjuvant (N) arm and 101 to the adjuvant (A) arm. The median age was 58, male accounted for 80.3%, adenocarcinoma 48.5%, stage Ib, II a, II b and IIIa were 32.5%, 12.2%, 28.4% and 26.9%, respectively. Two arms were balanced. 100% cases received neoadjuvant chemo and 87.4% finished the planned adjuvant chemotherapy. No unexpected toxicities were seen and 41.2% of patients experienced grade 3-4 neutropenia. One chemotherapy related death in A arm. One patient died of perioperative pulmonary embolism in N arm. the ORR was 34% and 12.4% patients developed PD In N arm. The 3yrs DFS was 56.0% (A) vs 43.0% (N) with HR 0.76, 95%CI 0.51-1.13, p = 0.172. 3yrs OS was 68.0% vs 64.0% with HR0.88, 95%CI 0.54-1.43, P = 0.602. The 5yrs DFS was 50.0% (A) vs 33.0% (N), HR0.69, 95%CI 0.48-1.00, P = 0.051, 5yrs OS was 60.0%(A) vs 43.0% (N), HR0.66, 95%CI 0.44-1.00, P = 0.049.
Adjuvant chemotherapy or neoadjuvant with docetaxel plus carboplatin in resectable clinical stage IB-IIIA NSCLC are feasible and safe. The final results showed no difference in 3yrs DFS and OS between two arms. 5yrs OS in arm A was superior to arm N.
Clinical trial identification
Legal entity responsible for the study
Chinese Society of Lung Cancer
Y-L. Wu: Speaker fees from Roche, AstraZeneca, Eli Lilly, Pfizer and Sanofi. All other authors have declared no conflicts of interest.