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O15 - NSCLC - Chemotherapy II (ID 109)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:G. Richardson, J.V. Heymach
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside Auditorium A, Level 1
O15.07 - Final results of CTONG 0806: a phase II trial comparing pemetrexed with gefitinib as second-line treatment of advanced non-squamous NSCLC patients with wild-type EGFR (ID 1920)
10:30 - 12:00 | Author(s): H. Yan
Both Pemetrexed and gefitinib are standard second-line treatments for advanced non-squamous NSCLC in East Asia. The CTONG 0806, a multi-center, randomized, controlled, open-label phase II trial was designed to explore the efficacy of pemetrexed versus gefitinib as second-line treatment in advanced non-squamous NSCLC with wild-type EGFR.
Patients with locally advanced or metastatic non-squamous NSCLC previously treated with platinum-based chemotherapy and with wild-type EGFR detected by direct sequencing were randomized to receive gefitinib orally 250 mg/day (G arm) or pemetrexed 500 mg/m iv day 1 every 21 days (P arm) until disease progression or unacceptable toxicity. Primary endpoint was progression-free survival (PFS). Secondary endpoints included 4-month and 6-month PFS rate, overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life and safety. Independent Review Committee (IRC) evaluated all pictorial data.
From Feb. 2009 to Aug. 2012, 161 patients were enrolled and 157 were evaluable (81 in G arm and 76 in P arm). Baseline characteristics were balanced between arms. The primary endpoint of median PFS was met with 4.8 months in P arm versus 1.6 months in G arm（HR 0.54, 95% CI 0.40~0.75, P<0.001), which was confirmed by IRC evaluation (5.6 vs. 1.7 months, HR 0.53, 95% CI 0.38~0.75, P<0.001). Significant difference between two arms was also seen in terms of 4-month PFS rate, 6-month PFS rate and DCR (Table 1). Median OS showed the trend of superiority in P arm (12.4 vs. 9.6 months, HR 0.72, 95% CI 0.49 ~ 1.04, P=0.077). In 108 patients having enough tumor tissue, EGFR mutation status was tested again by Scorpion amplification refractory mutation system (ARMS) and 32 were found to be positive. In 76 patients with wild-type EGFR confirmed by ARMS (35 in P arm and 41 in G arm), median PFS was 4.0 vs. 1.3 months (HR 0.42, 95% CI 0.26~0.67, P<0.001). More skin rash and diarrhea were seen in G arm while more fatigue and ALT increase were in P arm. CTCAE grade 3 or 4 adverse events was 12.3% in G arm and 32.9% in P arm (P=0.002). The detailed survival analysis and biomarkers analysis will be presented on the ground.
Table1. Efficacy of pemetrexed and gefitinib evaluated by investigators and IRC
Evaluated by Investigators Evaluated by IRC Pemetrexed arm Gefitinib arm P Pemetrexed Gefitinib arm P PFS 4.8months 1.6months <0.001 5.6months 1.7months <0.001 HR 0.54，95% CI 0.40 ~ 0.75 HR 0.53, 95% CI 0.38 ~ 0.75 4-month PFS rate 59.0% 33.0% <0.001 62.0% 37.0% <0.001 6-month PFS rate 43.0% 23.0% <0.001 48.0% 27.0% <0.001 ORR 13.2% 13.6% 0.938 14.5% 12.3% 0.695 DCR 60.5% 29.6% <0.001 61.9% 30.8% <0.001 OS 12.4months 9.6months 0.077 HR 0.72，95% CI 0.49 ~ 1.04
CTONG0806 is the first trial to show significant improvement in PFS, DCR and a trend of improving OS with pemetrexed compared with gefitinib in second-line setting for EGFR wild-type advanced non-squamous NSCLC.
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