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J. Cho
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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): J. Cho
- 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.
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P3.02c - Poster Session with Presenters Present (ID 472)
- 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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P3.02c-035 - Comparison of RECIST to Immune-Related Response Criteria (irRC) in Patients with NSCLC Treated with Immune-Check Point Inhibitor (ID 4962)
14:30 - 14:30 | Author(s): J. Cho
- Abstract
Background:
Immune check point inhibitor has become essential therapeutic option for advanced non-small cell lung cancer (NSCLC). Immune-related response in NSCLC has not been well evaluated, thus we assessed the tumor response using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) and immune-related response criteria (irRC) to identify atypical response in patients with advanced NSCLC treated with immunotherapeutic agents.
Methods:
Patients received immune check point inhibitors (pembrolizumab, atezolizumab, nivolumab, pembrolizumab plus tremelimumab) at Samsung Medical Center between July 2014 and October 2015. The tumor response was assessed according to both RECIST v1.1 and irRC. Pseudoprogression was defined as progressive disease at any time of assessment and not at next assessment per RECIST v1.1 or irRC.
Results:
Figure 1 Total 41 patients were analyzed, most of patients (80.5%) received anti-PD-1 agents (pembrolizumab or nivolumab) and 6 patients were treated with anti-PD-L1, atezolizumab, 2 patients received combination treatment with pembrolizumab and tremelimumab. Two patients showed pseudoprogression followed by regression per RECIST v1.1 not per irRC. 4 patients with progressive disease per RECIST v1.1 were partial response per irRC, objective response was 29.2% per RECIST v1.1 and 34.1% per irRC, respectively. There was no significant difference in response rate between two methods (p=0.923). The median duration of follow-up was 19.8 months, and the median progression-free survival of all patients was 4.5 months (95% CI 2.7-6.3)
Conclusion:
These results suggest that pseuoprogression is not frequently observed in NSCLC, and conventional RECIST v1.1 might underestimate the benefit of immune check point inhibitors. Given the small number of patients studied and short-term follow-up, further study will be warranted whether treatment with immune checkpoint inhibitor beyond RECIST progression can be benefit to patient with advanced NSCLC.
