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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-021 - Crizotinib Efficacy in ALK-Positive Advanced NSCLC Chinese Patients (ID 261)
09:30 - 17:00 | Author(s): Y. Song
Anaplastic lymphoma kinase (ALK) is a new tyrosine kinase target that has been validated recently in NSCLC. Crizotinib, an oral, small-molecule, tyrosine kinase inhibitor that targets ALK, MET and ROS-1, has been reported to be particularly effective and to have acceptable toxicity in advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC). In a phase 1, open-label, multicenter trial evaluating the efficacy and adverse event profile of crizotinib in a cohort of 82 ALK-positive lung cancer patients, treatment for a mean duration of 6.4 months achieved an overall response rate (ORR) of 57%, and the estimated probability of 6-months’ progression-free survival (PFS) was 72%. Mild gastrointestinal disturbances were the main adverse effects observed in this study. Subsequently, updated data from a study involving 143 patients confirmed the durable response and tolerable adverse effect profile of crizotinib in patients with ALK-positive NSCLC.
A total of 72 patients with ALK-positive NSCLC who received crizotinib between June 1, 2013 and October 15, 2014 at Shanghai Chest Hospital, Shanghai JiaoTong University, were prospectively enrolled in the study. All were histologically diagnosed and staged as clinically advanced (stage IV, or stage IIIB with pleural effusion) NSCLC. All patients received oral crizotinib 250 mg twice daily in 28-day cycles. The tumor response was assessed after the first cycle of crizotinib therapy and subsequently after every 2 cycles using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. Tolerability was assessed at least twice per cycle until crizotinib was discontinued.
The patients tended to be young (mean age 55 years, range 31-83 years), never or light smokers (smoking index <400), and to have an adenocarcinoma histology. Most (49/72; 68.1%) had received previous anticancer treatment before crizotinib therapy. Sixty-seven patients (93%) were able to be assessed for efficacy. The objective response rate (ORR) and disease control rate (DCR) were 52.2% (95% CI 40.5%-63.9%) and 64.2% (95% CI 52.75%-75.7%), respectively. The estimated median progression-free survival (PFS) for all 67 patients was 10.3 months (95% CI 8.6-12.0 months). Mild visual disturbances, nausea, vomiting, diarrhea and constipation were the most commonly reported adverse effects.Figure 1
crizotinib was well tolerated and showed promising efficacy in Chinese patients with ALK-positive, advanced NSCLC. Further prospective, multicenter studies with a larger sample size are needed to confirm these findings.
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