Rationale and Design of PEMVITASTART—An Open-label Randomized Trial Comparing Simultaneous Versus Standard Initiation of Vitamin B 12 and Folate Supplementation in Nonsquamous, Non–Small-cell Lung Cancer Patients Undergoing First-line Pemetrexed-based Chemotherapy
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Abstract
Pemetrexed is the preferred chemotherapeutic drug for nonsquamous, non-small-cell
lung cancer patients whenever the predictive molecular biomarkers for targeted therapy
have either not been assessed or are absent. As per manufacturers' instructions, supplementation
with folic acid (FA; folate) at a dose of 350 to 1000 μg daily should be started seven
days before the first dose of pemetrexed-based chemotherapy and continued during therapy
and for 21 days after therapy cessation. Vitamin B12 injections (1000 μg intramuscularly)
should also be started one week before the first dose of chemotherapy. However, the
evidence for delaying chemotherapy by one week for the purpose of providing vitamin
B12 and FA supplementation is not robust. Observational and prospective single-arm
studies have not shown any increased toxicity if pemetrexed was started earlier than
the recommended duration of supplementation. In a resource-constrained setting, the
standard (conventional) approach would lead to one additional visit and a 1-week chemotherapy
delay, both of which could be inconvenient for patients. Hence, an open-label, randomized
trial (PEMVITASTART [Vitamin Supplementation in NSCLC Patients on Pemetrexed Based
Chemotherapy]; ClinicalTrials.gov identifier, NCT02679443) is being undertaken to
evaluate whether any differences exist in pemetrexed-related hematologic toxicity
among patients who receive delayed initiation of chemotherapy (after 5-7 days of vitamin
B12 and FA supplementation [delayed arm]) compared with those for whom vitamin B12
and FA supplementation is started simultaneously (within 24 hours) of chemotherapy
initiation (immediate arm). The present report describes the rationale and detailed
design of the PEMVITASART trial.