LBA41_PRA RANDOMIZED PHASE III STUDY OF DOCETAXEL PLUS CISPLATIN VERSUS PEMETREXED PLUS CISPLATIN IN FIRST LINE NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSQ-NSCLC)

ABSTRACT Aim: For patients with NSq-NSCLC, pemetrexed(A) plus cisplatin(P) was superior to gemcitabine(G) plus cisplatin(P) in terms of efficacy and toxicity. However, there have been no prospective phase III trial directly comparing the efficacy of AP with docetaxel + cisplatin (DP) in NSq-NSCLC. The objective of this study is to prove the non-inferiority of progression free survival (PFS) of DP compared to AP. Methods: We undertook an open-label phase III trial with recruitment between August 2011, and December 2013, at 14 centers in Korea. Patients with chemotherapy-naive NSq-NSCLC were randomized into 3 weekly cisplatin 70 mg/m2 with either docetaxel 60mg/m2 (DP) or pemetrexed 500mg/m2 (AP) for up to 4 cycles with stratification strata of performance status and sex. The primary objective was to assess PFS and the secondary endpoints were response rate, overall survival (OS) and safety. Treatment response was evaluated according to RECIST version 1.1. Results: After 149 patients were randomized into AP (n = 77) and DP (n = 72) arm, study team finished enrollment because of approval and popular use of maintenance pemetrexed treatment in Korea. Clinical characteristics including sex, age, and performance status were well balanced between the arms. Number of cycles and relative dose intensity were not significantly different between the arms. Partial remission was observed in 24 (31.2%) and 24 (33.3%) cases of AP and DP group, respectively. Median PFS was 4.7 months (95% confidence interval, CI 4.4 ∼ 5.1) in AP arm and 4.6 months (3.7 ∼ 5.6) in DP arm. Rate of grade 3 or 4 neutropenia and febrile neutropenia, number of serious adverse events were significantly higher in DP compared to AP arm (Table 1). Conclusions: Although both regimens showed similar PFS and response rate, more frequent adverse events and higher toxicities were observed in DP arm. (ClinicalTrials.gov Identifier: NCT01282151) Disclosure: Y. Kim: This study was funded by Sanofi Aventis Korea. All other authors have declared no conflicts of interest. Comparison of treatment, response, and adverse events. Pemetrexed/Cisplatin (n = 77) Docetaxel/Cisplatin (n = 72) Age, mean(SD) 63.0 ± 8.9 63.8 ± 9.8 Sex 53/24 50/22 ECOG PS (0/1/2) 14/55/8 17/48/7 Histology ADC/LCC/NSCLC 75/0/2 69/1/2 Stage (IIIB/IV) 5/72 3/69 Cycles (1/2/3/4/6) 7/16/2/49/3 11/14/1/45/1 Cycles mean(range) 3.4 (1-6) 3.2 (1-6) Total number of Cycles 259 228 Cycles delayed 17 (6.7%) 18 (7.9%) Doses reduced 16 (6.3%) 21 (9.3%) Relative dose-intensity (%) 97.6 ± 5.7 96.2 ± 6.9 Response (PR/SD/PD/NE) 24/33/10/10 24/25/15/8 PFS (m) 4.7 (4.4-5.1) 4.6 (3.7-5.6) Overall survival (m) 19.7 (10.8-28.6) 28.0 (7.5-48.5) Neutropenia grade 3/4 1 (1.3%) 10 (13.9%) ** Febrile Neutropenia 1 (1.3%) 8 (11.1%) * Total number of SAE 42 (16.2%) 70 (30.7%) *** SAE cases 17 (22.1%) 29 (40.3%) * * p