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S. Jung
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-053 - A Randomized, Open Label, Phase II Study Comparing Pemetrexed plus Cisplatin versus Pemetrexed Alone in EGFR Mutant NSCLC after EGFR-TKI: QOL Data (ID 5401)
14:30 - 14:30 | Author(s): S. Jung
- Abstract
Background:
Various therapeutic strategies are available for NSCLC patients who develop disease progression on first-line EGFR-TKI. Platinum doublet is usually recommended, however, it has not been established which cytotoxic regimens are preferable for these patients. We conducted a prospective randomized phase II trial to compare the clinical outcomes between pemetrexed plus ciplatin combination therapy with pemetrexed monotherapy after failure of first-line EGFR-TKI.
Methods:
Patients with non-squamous NSCLC harboring activating EGFR mutation who have progressed on first-line EGFR-TKI were randomly assigned in a ratio of 1:1 to pemetrexed plus cisplatin or pemetrexed alone. Patients were treated with pemetrexed 500 mg/m[2] and cisplatin 70 mg/m[2] for four cycles, followed by maintenance pemetrexed as single agent every 3 weeks or treated with pemetrexed 500 mg/m[2] monotherapy every 3 weeks until progression. Primary objective wasPFS, and secondary objectives include overall response rate (ORR), OS, health-related quality of life (HRQOL), safety and toxicity profile. The HRQOL was assessed every 2 cycles by using EORTC QLQ-C30 and EORTC QLQ-LC13.
Results:
96 patients were randomized and 91 patients were treated at 14 centers in Korea. The characteristics of pemetrexed plus cisplatin (PC) arm (N=48) and pemetrexed alone (P) arm (N=48) were well balanced; the median age was 60 vs. 64 years old; 37 vs. 33 patients were females; 39 vs. 43 patients were ECOG PS 1. The ORR of PC arm (N=46) was 34.8% (16/46), while P arm (N=45) was 17.8% (8/45). With 20.4 (range 4.1-33.4) months of follow-up, the median PFS was 5.4 months (95% confidence interval [CI], 4.5-6.3) in PC arm and 6.4 months (95% CI, 3.6-9.2) in P arm (p=.313). One-year survival rate was 77% for PC arm, 68% for P arm, respectively. The most common adverse events include anorexia (N=34, 37.4%), nausea (N=24, 26.4%), neuropathy (N=10, 11.0%) and skin change (N=10, 11.0%). Adverse events ≥ Grade 3 were in 12 patients (26.1%) in PC arm and 8 patients (17.8%) in P arm. Dose reduction (5 vs. 2 patients) and dose delay (10 vs. 4 patients) were required more often in PC arm. With 385 pairs of questionnaire of EORTC QLQ-C30 and QLO-LC13 obtained from 94 patients, overall, the time trends of HRQOL were not significantly different between two arms. Further analysis of survival data will be updated.
Conclusion:
Pemetrexed plus cisplatin combination therapy showed higher response rate than pemetrexed monotherapy without significant difference in PFS. There was no significant difference in quality of life between two arms.
