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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
P1.01-059 - Combination Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel for Patients with Recurrent/Metastatic NSCLC and PS of 2 (ID 9169)
09:30 - 16:00 | Author(s): P. Triozzi
Chemotherapy and immunotherapy have been shown to be beneficial for patients with non-small cell lung cancer (NSCLC) and performance status (PS) of 0 or 1; there still is debate, however, regarding its efficacy for patients with a PS of 2 which comprises approximately 30% of the NSCLC population. Pre-clinical data have demonstrated that low dose carboplatin/paclitaxel have resulted in superior immune efficacy compared to the maximum tolerated dose regimen. Given the significant unmet need for treatment options in this patient population, our study evaluated low-dose weekly carboplatin/paclitaxel combined with pembrolizumab in patients with NSCLC and a PS of 2.
Patients with metastatic or recurrent NSCLC and PS of 2 were randomized to single agent pembrolizumab at 200mg every 3 weeks or pembrolizumab plus weekly carboplatin AUC 1 and paclitaxel 25 mg/m irrespective to PDL-1 status. Response was determined using immune-related RECIST, and toxicity was graded using CTCAE 4.0.
Between 6/2016 and 2/2017, 20 patients were enrolled, and 19 patients were evaluable for response. The median age was 69 years (54-83). All 19 patients (100%) had a PS of 2. Ten patients were randomized to the single agent arm and 9 patients to the combination arm. Six patients received the therapy as second line (2 combination arm and 4 single agent arm). Mean 3 week cycles per patient: 9 (4-16) in combination arm and 7 (2-14) in single arm group. Response at 9 weeks in the combination arm: partial response (PR) 6 (67%), stable disease (SD) 2 (22%), and progressive disease (PD) 1 (11%). Response at 9 weeks in the single agent arm, PR 2 (20%), SD 4 (40%), and PD 4 (40%). Adverse events in combination arm: 1 (11%) discontinued therapy due to grade 3 fatigue, 3 (33%) discontinued carboplatin due to allergic reactions at 7, 9, and 10 months of treatment but continued pembrolizumab and paclitaxel, and 1 (11%) on hormone replacement therapy due to treatment-induced hypothyroidism. Adverse events in single agent arm: 1 (10%) discontinued treatment due to complete A-V block successfully resolved with pacemaker insertion, and 2 (20%) are on hormone replacement therapy due to treatment-induced hypothyroidism.
Combination pembrolizumab and weekly low dose carboplatin/paclitaxel is an active and well tolerated regimen in patients with advanced NSCLC with PS of 2.
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