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Q. Zhou
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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
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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)
11:35 - 11:45 | Author(s): Q. Zhou
- Abstract
- Presentation
Background
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.Methods
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[2] 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.Results
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 Conclusion
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.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:
- Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
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P1.11-044 - Progression-free survival is a poor surrogate endpoint for overall survival in the first line EGFR-TKI treatment in advanced non-small-cell lung cancer with EGFR mutation (ID 2969)
09:30 - 09:30 | Author(s): Q. Zhou
- Abstract
Background
（Although epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs), gefitinib and erlotinib have shown antitumor activity in patients with non-small cell lung cancer (NSCLC) , it is unclear if progrssion-free survival（PFS）could be a good surrogate endpoint for overall survival(OS) in the clinical trials of first-line EGFR-TKIs treatment in patients with advanced NSCLC, especially with activating EGFR mutation.）Methods
A PubMed search identified 12 randomized trials comparing first-line EGFR-TKIs treatment with chemotherapy in patients with advanced NSCLC. A total of 1816 patients were enrolled and EGFR mutation status was known in 554 patients. Linear regression analysis was carried out to estimate the correlation of PFS, response rate (RR), and survival post-progression (SPP) with OSResults
PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）Conclusion
Our findings indicate that PFS is a poor surrogate endpoint for OS in the first line EGFR-TKI treatment in advanced EGFR mutation NSCLC. Further studies are needed to search for appropriate surrogate endpoint for OS.
