MA 03.02 Timing of B12/Folate Supplementation in NSCLC Patients on Pemetrexed Based Chemotherapy: Final Results of the PEMVITASTART Randomized Trial

Singh, N.; Baldi, Milind; Kaur, Jasneet; K, Krishna Prasad; Kapoor, Rishabh; Behera, D

doi:10.1016/j.jtho.2017.09.461

Cited by 3 publications

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“…In the current study, we found that the interval between supplementation of vitamin B12 and folate and first dose of pemetrexed (<7 vs ≥ 7 days, and ≤1 vs >1 day) did not significantly alter the primary end-point and grade 3–4 toxicities. Multiple prospective and retrospective studies [12, 13, 14] have addressed the issue of lead-in time of vitamin supplementation before pemetrexed, and have also found that giving vitamin supplementation closer to the day of starting pemetrexed, had no significant effect on grades 3–4 cytopenias, and non-haematological toxicities. Our results suggest that the lead-in time for vitamin supplementation could be shortened to 1 day before first cycle of pemetrexed.…”

Section: Discussionmentioning

confidence: 99%

A prospective observational study of on-treatment plasma homocysteine levels as a biomarker of toxicity, depression and vitamin supplementation lead-in time pre pemetrexed, in patients with non-small cell lung cancer and malignant mesothelioma

et al. 2019

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ObjectivesVitamin supplementation reduces pemetrexed toxicity. Raised plasma homocysteine reflects deficiency in vitamin B12 and folate, and is suppressed by supplementation. This observational study of 112 patients receiving pemetrexed-based chemotherapy assessed homocysteine levels after 3 weeks of vitamin supplementation, hypothesising high levels would correlate with ongoing deficiency, thus increased toxicity.Material and methodsPrimary endpoint was the composite of proportion of patients with treatment delay/ dose reduction/ drug change or hospitalisation during the first six weeks of chemotherapy, comparing those with normal plasma homocysteine (successfully supplemented, SS) and those with high homocysteine (unsuccessfully supplemented, USS). Secondary endpoints included toxicity and analyses for depression. Post-hoc analysis examined correlation between interval of vitamin and folate supplementation and pemetrexed on primary endpoint and grade 3–4 toxicities.ResultsEighty-four patients (84%) were successfully supplemented (SS group). The proportion of patients undergoing a treatment delay/ dose reduction/ drug change or hospitalisation in SS group was 44.0% (95% confidence interval [CI] 33.2%–55.3%) and in USS group was 18.8% (95% CI 4.0%–45.6%) (p = 0.09). Twelve percent of patients gave a past history of depression however 66% of patients had an on study Hospital Anxiety and Depression (HAD) score of >7. Supplementation status was not associated with depression. The median overall survival (OS) was 11.8 months (95% CI 8.6–16.5) in the SS group and 8.8 months (95% CI 6.6–16.2) in the US group (p = 0.5). The number of days (<7 or ≥ 7 days) between vitamin B12 and folate initiation and pemetrexed administration, had no effect on the primary endpoint and grade 3–4 toxicities.ConclusionOn-treatment homocysteine levels were not a biomarker of toxicity or depression. Standard vitamin supplementation is adequate in the majority of patients receiving pemetrexed. High HAD score were noted in this population giving an opportunity for mental health intervention. The lead-in time for vitamin supplementation can be short.

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Section: Discussionmentioning

confidence: 99%