8081 Background: To evaluate the benefit of adding cisplatin or carboplatin (P) to docetaxel (D) chemotherapy (CT) in patients with the first metastatic relapse after perioperative chemotherapy and surgery. Methods: Patients (Pts) with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radiotherapy (local or metastatic relapse), disease progression after perioperative chemotherapy and surgery and PS 0-1. Pts were randomized to D 75 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC5 every 3 weeks (Arm A) or alone (Arm B). The primary endpoint was progression-free survival (PFS). Results: Due to low accrual the trial was interrupted after inclusion of 88 patients. From November 2007 to August 2012, 68 males and 20 females, median age (range) 61 (41-75), ECOG PS 0/1/ 49%/50%, squamous histology 39%, Arm A and Arm B 44 patients each, were enrolled. Interval from last cycle of perioperative CT ou last cycle of adjuvant CT was ≥ 12 months in 69% of pts. 79.5% of patients received DP full treatment. A non-statistically significant increase in PFS favoring combined CT was observed with a HR of 0.73 (95% CI: 0.46-1.15; p = 0.18), median PFS 8 months vs 5.6. Objective response rate was increased in the P-containing arm; p <10-4). However, overall survival was not improved by the addition of P to D; the HR for death was 0.90 (95% CI: 0.55-1.48; p = 0.68) median OS 15.9 months vs 12.4 months. Overall grade 3/4 toxicity was observed in 36 pts (DP) vs 30 (D) : neutropenia (32 pts vs 26), febrile neutropenia (8 vs 3), non-hematological toxicities (18 vs 6). Conclusions: PFS and OS weresurprisingly longer than expected in this cohort of NSCLC patients with metastasis, and comparable with that observed in historical cohorts of NSCLC treated in first-line. DP resulted in a non significant 27% reduction of hazard of progression as compared to D alone. A reduced statistical power related to a slow and insufficient accrual may explain this lack of significance. Considering survival data and toxicity profile, we suggest that these patients behave like first-line patients and may probably be treated accordingly with a platinum-based doublet. Clinical trial information: NCT00535275.
Predictive biomarkers in patients with resected non-small cell lung cancer treated with perioperative chemotherapy