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K. Hayashi
Author of
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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-099 - A Retrospective Study of the Efficacy and Safety of Nivolumab in Our Clinical Practice: A Single Institutional Experience (ID 5938)
14:30 - 14:30 | Author(s): K. Hayashi
- Abstract
Background:
Nivolumab is a fully humanized, IgG4 antibody that inhibits the programmed cell death protein 1 (PD-1) immune checkpoint. It has demonstrated durable responses and tolerability in patients with treatment resistant, advanced non-small-cell lung cancer (NSCLC). This retrospective study evaluates the efficacy and safety of nivolumab, which was approved for the treatment of advanced NSCLC in December 2015 in Japan.
Methods:
This study comprised 50 patients with advanced or recurrent NSCLC who were administered with nivolumab 3mg/kg IV every 2 weeks from December 2015 through April 2016 at Matsusaka Municipal Hospital.
Results:
Patient demographics were as follows: a median age of 69 years (range: 53–86); 17 females and 33 males; 12 non-smokers and 38 former or current smokers; 47 patients with ECOG performance status (PS) of 0 or 1 and three with a PS of 2; seven patients with postoperative recurrence, nine with post-definitive chemoradiotherapy, 31 with stage IV disease, and three with others; 14 patients with squamous cell carcinoma, 33 with adenocarcinoma, two with pleomorphic carcinoma, and one with NSCLC NOS; 17 patients received nivolumab as second-line and 33 patients as third-line therapy or later; and six patients with EGFR mutation and one with ALK rearrangement. Among 50 patients, nine showed partial response, 17 showed stable disease, and 22 showed progressive disease, 2 were not evaluated yet. Five patients experienced an initial increase in the size of their tumor lesions, but with a subsequent decrease in tumor burden. At the time of submission, the median PFS was 3.8 months, with OS yet to be evaluated. Grade 3–4 AEs occurred in seven patients, with Grade 5 AEs occurring in only one patient.
Conclusion:
Early data from this study suggests that nivolumab is effective and well tolerated in patients with advanced or recurrent NSCLC in a real clinical setting.
