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M. Kondo
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MA07 - ALK-ROS1 in Advanced NSCLC (ID 385)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
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MA07.03 - Alectinib (ALC) versus Crizotinib (CRZ) in ALK-Positive Non-Small Cell Lung Cancer (ALK+ NSCLC): Primary Results from Phase III Study (J-ALEX) (ID 5597)
11:12 - 11:18 | Author(s): M. Kondo
- Abstract
- Presentation
Background:
ALK inhibitors are the standard treatment for ALK+ NSCLC and the comparison between 2 ALK inhibitors will be valuable in determining therapeutic strategy for ALK+ NSCLC patients (pts). We conducted the randomized open-label Phase III trial designed to prove the superior PFS of ALC to CRZ in ALK-inhibitor naïve ALK+ NSCLC.
Methods:
ALK+ NSCLC pts were randomized 1:1 either to receive ALC (300 mg b.i.d.) or CRZ (250 mg b.i.d.) and stratified by ECOG PS (0/1 vs 2), treatment line (1[st] vs 2[nd]), and clinical stage (IIIB/IV vs recurrence). Primary endpoint was PFS according to the blinded independent review board. Secondary endpoints included overall survival, objective response rate, and safety. Under an assumption of expected hazard ratio (HR) of 0.643, 164 events were required to have 80% power with 2-sided alpha of 0.05. Three interim analyses (IA) for early stopping due to efficacy were planned after 33%, 50%, and 75% of required PFS events occurred.
Results:
207 pts were enrolled at 41 centers in Japan between November 2013 and August 2015. Independent data monitoring committee recommended the release of study data because the superiority in PFS had been demonstrated for ALC based on second IA. The PFS HR of ALC arm to CRZ arm was 0.34 (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not Reached (NR)) in ALC arm while it was 10.2 months (95%CI: 8.2-12.0) in CRZ arm. ALC demonstrated favorable result of PFS in each sub-group for instance, treatment line (1[st] line: HR = 0.30, ALC: NR vs CRZ: 10.2 months, 2[nd] line: HR = 0.39, ALC: 20.3 months vs CRZ: 8.2 months), brain metastases at baseline (yes: HR = 0.08, ALC: NR vs CRZ: 10.2 months, no: HR = 0.39, ALC: 20.3 moths vs CRZ: 10.0 months) and clinical stage (stage IIIb/IV: HR = 0.31 ALC: 20.3 months vs CRZ: 8.3 months, recurrence: HR = 0.49, ALC: NR vs CRZ: 11.6 months). Grade 3-4 AEs (ALC: 26% vs CRZ: 52%), discontinuation of study drug due to AEs (ALC: 9% vs CRZ: 20%) and dose interruptions due to AEs (ALC: 29% vs CRZ: 74%) occurred with lower rate in the ALC arm. There were no treatment-related deaths in either arm.
Conclusion:
ALC demonstrated prolonged PFS compared with CRZ in all sub-groups with a favorable AE profile representing a potential new standard treatment for 1[st] line ALK+ NSCLC pts.
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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): M. Kondo
- 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
