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N. Murata
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-028 - A Phase I/II Study of Carboplatin, Pemetrexed, and Concurrent Radiation Therapy for Patients with Locally Advanced NSCLC. CJLSG0912 (ID 4175)
14:30 - 14:30 | Author(s): N. Murata
- Abstract
Background:
A combined concurrent therapy with a platinum-based regimen and radiation is recognized as a standard for patients with unresectable stage Ⅲ lung cancer. Though combined therapy has improved survival, little improvement was reported after that for decades. Pemetrexed is a new generation drug which is widely recognized as a safe and effective agent for patients with stage Ⅳ lung cancer. Moreover pemetrexed is expected to have a synergistic effect with radiation in vitro study. The purpose of this study was to investigate safety and toxicity profile of a regimen of pemetrexed/carboplatin (Pem/CBDCA) plus concurrent thoracic radiotherapy (TRT) followed by consolidation therapy with Pem/CBDCA for Japanese patients with unresectable non-small cell lung cancer (NSCLC).
Methods:
We planned a multi-institutional open clinical phase Ⅰ/Ⅱ trial of Pem (500 mg/m[2]) /CBDCA (AUC=5) plus concurrent TRT for patients with stage ⅢA/ⅢB NSCLC. Patients were administered two cycles of Pem/CBDCA with three-weeks interval and delivered 60 Gy radiotherapy in 30 fractions concurrently. Additional two cycles of Pem/CBDCA with a three-weeks interval were administered after the safety of concurrent therapy was confirmed. Regarding a phase Ⅰ study, we confirmed a safety of this therapy every three consecutive patients. In case that three or more DLTs in first six patients occurred, a dose of CBDCA was to be decreased from AUC 5 to 4. We planned to enroll thirty patients in this study in total of phaseⅠandⅡ.
Results:
Six patients were included in the phase I study. Median follow-up period was 27.4 month. DLTs were observed in two out of six patients. This fulfilled preplanned criterion to conclude therapeutic dose. The most frequent non-hematologic adverse event was esophagitis (66.7%). Neutropenia was observed rather frequently (83.3%), but no patients developed febrile neutropenia. As to two cases of DLT, one patient experienced grade 2 radiation pneumonitis. The other patient presented prolonged leukocytopenia. Other four patients completed scheduled therapy. Five patients (83.3%) got PR. Two-year survival was 100%. Disease progression was observed in three patients during study period. Because of slow accrual, phase Ⅱ study was not conducted.
Conclusion:
Present therapy is feasible for Japanese patients with unresectable stage Ⅲ NSCLC. Trial registration: UMIN000008426
