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Found 1 Presentation For Request "1317P"
1317P - Survival, quality of life (QoL) and geriatric outcomes of elderly patients (pt) with advanced non-small cell lung cancer (NSCLC), treated with pembrolizumab (P) in the first-line setting
- Remei Blanco (Barcelona, Spain)
Abstract
Background
NSCLC has a median onset at 70 years (y). Median overall survival (OS) of elderly pt (EP) with advanced NSCLC is near 8 months (m) in the 1st line setting. Many trials have established the role of immunotherapy in metastatic NSCLC, but EP have been underrepresented in them. So, we conducted this trial to evaluate safety and efficacy of 1st line P in EP with advanced NSCLC, along with QoL and geriatric issues. Our main objective was OS at one y. Secondary Objectives were outcomes in QoL and geriatric parameters, Objective Response Rate (ORR) and Progression-free Survival (PFS) according to RECIST 1.1, median Disease-specific survival (DSS), OS at 2 y, and safety profile.
Methods
This was a non-randomized, open label phase II trial led in 12 Spanish sites. Eligibility criteria required pt >70 y, PS 0-1, stage IIIB-IIIC-IV untreated NSCLC, PD-L1 >1% and wild-type EGFR/ALK. All pt had basal QoL and Comprehensive Geriatric Assessments. They received P 200 mg Q3W for a maximum of 2 y. Radiologic, geriatric, and QoL follow-up were done every 9 weeks for one y. Our statistical plan set that 74 pt accrued over 12 m, with 12 m of follow-up, could test with an alpha and beta errors of 0.05 and 0.10 whether P could improve median OS to 12 m.
Results
We accrued 75 pt from Feb 2018 to Nov 2019, and 74 of them received P. Mean age was 78.0 (70-91). Mean Charlson Index was 2.53 and mean Edmonton Frail Score was 4.23. Other cognitive, functional and nutritional features will be reported. Treatment-related toxicity has been seen in 55 pt (74,3%). Grade 1, 2 and 3 adverse events have been identified in 24, 26, and 5 pt. Grade 3 toxicities were diarrhea (1 pt), thrombocytopenia (1 pt), renal disorder (1 pt), and pneumonitis (2 pt). No grade 4-5 adverse event has been detected until now. ORR was Partial Response, Stable Disease and Progression Disease in 18 (29%), 30 (48.3%), and 14 (22.5%) pt. At the time of this analysis, we had no data for response in 12 pt. Outcomes in QoL and Geriatric tests, as well as preliminary PFS, DSS and OS data will be presented in the meeting.
Conclusions
Single P seems safe and effective in EP with untreated, PD-L1 positive, advanced NSCLC.
Clinical trial identification
EudraCT: 2016-004353-32 NIH: NCT03293680.
Legal entity responsible for the study
Fundacion GECP.
Funding
Merck Sharp & Dohme.
Disclosure
All authors have declared no conflicts of interest.