Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Overall survival in PEMVITASTART randomized trial comparing immediate vs. conventional strategies of vitamin supplementation in NSCLC patients on 1st line pemetrexed-platinum chemotherapy.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e20538)
Author(s): Navneet Singh, Valliappan Muthu, Kuruswamy Thurai Prasad, Milind Baldi; Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
Background: PEMVITASTART (NCT02679443) was an open label phase II randomized trial [Singh N, et al. Cancer (DOI: 10.1002/cncr.32028)] involving locally advanced/metastatic non-squamous NSCLC patients treated with 1st line pemetrexed-platinum chemotherapy (CTx). The trial assessed the hematological toxicity profile in Delayed Arm (DA; conventional strategy) in whom CTx was initiated after 5-7 days of vitamin B12/folate supplementation (B12-FAS) vs. Immediate Arm (IA) in whom patients received B12-FAS simultaneously (≤24 hours) with CTx initiation. All outcomes were reported in modified ITT population (patients who received ≥1 cycle). A non-significant trend towards better radiological responses was observed in IA (PR 33% vs. 18%; p = 0.06). Herein, we report exploratory post-hoc analysis of overall survival (OS) for the mITT population (n = 150; 77 IA, 73 DA) of PEMVITASTART. Methods: OS was calculated from date of enrolment to date of death/last follow up. Survival cutoff date was 28 months after last patient enrolment. Median OS was calculated by Kaplan-Meier method and group differences analyzed by log-rank test. Factors affecting OS were assessed by Cox proportional hazards (CPH) analysis and hazard ratios [HRs] with 95% confidence intervals (CIs) calculated (from univariate and stepwise multivariate models). Results: Median OS was 12.7 m (95% CI 8.0–17.4) and did not differ between IA [15.0 m (10.5-19.4)] and DA [11.7 m (4.1-19.3)]. 1 yr and 2 yr survival rates were similar (IA 42% and 21% vs. DA 44% and 23%). On univariate CPH analysis, factors associated with better OS were female gender, ECOG PS 0, absence of metastatic disease and receipt of maintenance pemetrexed CTx (mPEM) while current/ex-smoker status, disease progression (as best response) and age ≥70 years were a/w worse OS. Baseline Hb and homocysteine (both assessed as continuous variables) and receipt of packed RBC transfusions/ESAs for anemia correction did not influence OS. On multivariate CPH analysis, current/ex-smokers HR 2.2 (95% CI 1.3-3.7; p < 0.01) and mPEM HR 0.5 (95% CI 0.3-0.9; p = 0.01) were both significant. Median OS for current/ex-smokers was 7.4m (95% CI 5.4-9.4) vs. 25.6m (95% CI 16.2-35.0) for non-smokers (log rank p < 0.001) while for patients receiving mPEM, it was 22.7m (95% CI 9.9-35.4) vs. 9.7m (95% CI 4.9-14.5) for those not receiving mPEM (log rank p = 0.02). Conclusions: Smoking status and mPEM were strong and independent prognostic factors for OS in the PEMVITASTART trial. Clinical trial information: NCT02679443