Randomized trial of adjuvant chemotherapy (Cx) with cisplatin plus gemcitabine (CG) versus cisplatin plus docetaxel (CD) in patients (pts) with completely resected non-small cell lung cancer (NSCLC) with quality of life (QoL) as the primary objective

Abstract

7532 Background: Adjuvant Cx with vinorelbine plus cisplatin (VC) improves survival of resected NSCLC but has an immediate negative impact on QoL (Bezjak, JCO 2008). In advanced stages NSCLC, GC and DC have comparable efficacy and might be superior to VC in QoL outcomes. This trial was designed to provide with data on other adjuvant Cx regimens for pts with resected NSCLC. Methods: Pts with stage IB to III resected (R0) NSCLC, without major postoperative complication, were eligible. Surgery has to be standardized. Cx consisted of cisplatin (75 mg/m2, D1) plus gemcitabine 1,250 mg/m2 (D1,8) or docetaxel (75 mg/m2 D1) for 3 cycles. The primary endpoint was QoL (EORTC QLQC30) and the trial was designed to detect a 10 points difference in QoL scores (α=0.05; power 80%). Relapse-free survival, overall survival (OS), safety profile and costs were the secondary endpoints. Results: 136 pts (median age: 57 yrs, 74% males, pTNM: 32% IB, 34% II, 34% III; histology: 55% ADC, 23% SCC) were included. 67 and 69 pts were randomized in the GC and DC arms, respectively. Surgery was a (bi)lobectomy in 85% of cases. No imbalance was found between arms regarding major pts characteristics. Overall, a Gr3/4 hematological toxicity occurs for 33.8% and 21.7% of pts (p=0.11) and a Gr3/4 non-hematological toxicity occurs for 33.8% and 26.1% of pts (p=0.33), in the GC and DC arms. Compliance to QoL assessment was good (93%). At inclusion, global health status (GHS) scores (/100) were comparable between arms (mean score, 63.5 and 62.7, in the GC and DC arms, p=0.8). At the end of treatment (3rd month), GHS scores have slightly improve (mean score, 64.5 and 65.4, in the GC and DC arms, p=0.8). At the time of analysis, 15 pts (7 GC, 8 DC) have died. At 1 year, 100 and 96.8% of the pts were alive in the GC and DC arms; At 2 years, 92.9 and 89.8% of the pts were alive in the GC and DC arms (log-rank, p=0.88). Conclusions: Adjuvant GC and DC have comparable effect on post-operative QoL and equivalent efficacy among pts with resected NSCLC. The GC and DC efficacy, safety profiles and QoL outcomes favorably compare with the results reported for the VC regimen. Detailed analyses will be presented at the meeting. [Table: see text]