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H. Kim
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- 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): H. Kim
- 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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P3.02b-072 - A Multicenter Phase II Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (ID 4320)
14:30 - 14:30 | Author(s): H. Kim
- Abstract
Background:
The role of EGFR tyrosine-kinase inhibitors in the second-line for patients with squamous non-small-cell lung cancer (NSCLC) remains unclear. We conducted a prospective phase II study to assess use of gefitinib in patients with squamous NSCLC as second-line chemotherapy, and investigated the predictive and prognostic value of a proteomic signature using VeriStrat test.
Methods:
Between December 2011 and October 2015, 56 patients with histologically confirmed, second-line, Stage IIIB or IV NSCLC were enrolled in 9 centres in Republic of Korea. Patients were treated with gefitinib (250 mg per day orally). The proteomic test classification was masked for patients and investigators. The primary end point was disease control rate (DCR) at 8-weeks, and the secondary end points included toxicity, progression-free survival (PFS), overall survival (OS), and correlation between the serum proteomic test classification and treatment. This study is registered with ClinicalTrials.gov, number NCT01485809.
Results:
The median age was 69 years (range, 41-83) and 55 (98%) patients were male, and 49 (88%) had an ECOG PS of 1. Fifty five (98%) of patients had received platinum-based chemotherapy. The DCR at 8 weeks was 50.0% (95% confidence interval [CI] 34.8-63.4). With a median follow-up of 5.5 months, the median PFS and OS were 2.8 (95% CI 1.3-4.3) and 6.4 (5.4-7.4) months, respectively. The most common adverse event were rash (16 [29%]) and diarrhea (14 [25%]). Pretreatment plasma was available for 50 samples, and VeriStrat testing was successful in 45 samples (90%) with 71% classified as Good. The median PFS were 3.2 (95% CI 1.9-4.7) and 2.4 (1.5-3.3) months for VeriStrat Good vs. Poor patients, respectively (p=0.639). The median OS of VeriStrat Good was longer than those of VeriStrat Poor (11.4 [5.7-17.0] vs 4.8 [2.5-7.0] months), which was not statistically significant (p=0.052).
Conclusion:
These data suggest that gefitinib is modest activity as second-line chemotherapy in patients with squamous NSCLC. Serum proteomic test using VeriStrat is not prognostic for both OS and PFS among squamous NSCLC patients treated with gefitinib.
