Safety of Same-Day Vitamin B12 Supplementation in Patients Receiving Pemetrexed for the Treatment of Non-Small-Cell Lung Cancer or Pleural Mesothelioma: A Retrospective Analysis

Our plain-English summary of Safety of Same-Day Vitamin B12 Supplementation in Patients Receiving Pemetrexed for the Treatment of Non-Small-Cell Lung Cancer or Pleural Mesothelioma: A Retrospective Analysis, by Z. Schlei, W. Tan, M.G. Faber, et al (Clinical Lung Cancer, 2018).

The study

• Authors: Z. Schlei, W. Tan, M.G. Faber, H. Chen, A. Meagher, G.K. Dy
• Journal: Clinical Lung Cancer
• Published: 2018;19(6):467-475
• Cited by: 6 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Background: Pemetrexed is a folate analog inhibitor for the treatment of non-small-cell lung cancer (NSCLC) and malignant pleural mesothelioma. Folic acid and vitamin B12 supplementation before initiating pemetrexed is necessary because of high rates of cytopenias without supplementation. However, the timing of supplementation has not been thoroughly investigated.

Patients And Methods: This was a single-center, retrospective study investigating patients receiving pemetrexed from January 1, 2012, to June 30, 2015, who received same-day vitamin B12 supplementation versus ≥ 1 day before pemetrexed. The objective was to evaluate safety outcomes in patients who received vitamin B12 on the same day as pemetrexed (group A) versus vitamin B12 ≥ 1 day (group B) before pemetrexed.

Results: Two hundred eighty-one patients met the inclusion criteria: 137 patients in group A (same-day administration of vitamin B12) and 144 patients in group B (median time of vitamin B12 administration before pemetrexed, 7 days; range, 1-42 days). Mean changes in hematologic indices from cycle (C) 1 to C2 or C2 to C3 did not differ significantly between groups. There were no significant differences in clinical events between C1 and C2 or C2 and C3 requiring supportive care. There was a significant difference noted in treatment delay in C3 [28/114 (24.6%) group A vs. 14/118 (11.9%) group B, P = .0164]. In group A, significant predictors of delay in C3 were baseline hemoglobin (mean 13.3 g/dL vs. 12.4 g/dL, P = .0137) and ANC (mean 6 × 109/L vs. 5 × 109/L, P = .0003).

Conclusion: Same-day vitamin B12 and pemetrexed administration is a safe practice in NSCLC and malignant pleural mesothelioma patients.

Copyright © 2018 Elsevier Inc. All rights reserved.

In plain English

This single-center review of medical records covered January 2012 to June 2015 at Roswell Park Comprehensive Cancer Center in Buffalo, New York. It did not study asbestos exposure. It studied when patients got a vitamin B12 injection relative to the chemotherapy drug pemetrexed. Of 281 patients with newly diagnosed non-small cell lung cancer or pleural mesothelioma (22 had pleural mesothelioma), 137 got vitamin B12 on the same day as their first pemetrexed (group A) and 144 got it one or more days before (group B). Changes in blood counts between cycles did not differ significantly between groups. The one exception was neutrophil percentage change from cycle 1 to cycle 2. Hospitalizations, transfusions and antibiotic use also did not differ significantly. Delays before cycle 3 were more common in group A: 28 of 114 (24.6%) versus 14 of 118 (11.9%) in group B. Group A's most common reason was patient preference. The authors concluded that same-day vitamin B12 was safe. They noted the limits of a single-center retrospective study and a lack of control for folic acid use.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Single-center retrospective chart review comparing two groups
• Who was studied: 281 adult patients with newly diagnosed non-small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) treated with pemetrexed at Roswell Park Comprehensive Cancer Center (RPCCC), Buffalo, NY, January 1, 2012 to June 30, 2015. There were 137 in group A and 144 in group B. Per Table 1, 22 patients had pleural mesothelioma (12 in group A, 10 in group B). Of 511 patients who received pemetrexed, 230 were excluded.
• Exposure: Not an asbestos exposure study. The comparison was the timing of vitamin B12 (1000 mcg by intramuscular injection) given with pemetrexed, with or without cisplatin or carboplatin. Group A got vitamin B12 the same day as pemetrexed. Group B got it one or more days before (median 7 days, range 1 to 42 days).
• Main results:
  • Changes in hemoglobin, platelets and absolute neutrophil count from cycle 1 to cycle 2, or from cycle 2 to cycle 3, did not differ significantly between group A and group B.
  • The percentage change in absolute neutrophil count from cycle 1 to cycle 2 differed significantly: -28.4% in group A versus -8.2% in group B (p=0.0419).
  • Delays in cycle 3 were more frequent in group A, 28 of 114 (24.6%), than in group B, 14 of 118 (11.9%), p=0.0164.
  • Within group A, patients whose cycle 3 was delayed had lower baseline hemoglobin than those not delayed: median 12.6 g/dL versus 13.4 g/dL, p=0.0137.
  • Within group A, patients whose cycle 3 was delayed had lower baseline absolute neutrophil count than those not delayed: median 3.9 versus 5.7 (times 10 to the 9th per liter), p=0.0003. Lower baseline white blood cell count was also associated with delay: median 6.2 versus 8.3, p=0.0009.
  • Group A had more cycle 3 delays due to patient preference than group B. Group A also had numerically more delays due to neutropenia or infection.
  • There were no significant differences between groups in clinical events requiring supportive care between cycles 1 and 2 or cycles 2 and 3. These events were neutropenic fever, hospitalization and anemia, and the care included antibiotics, stomatitis treatment and transfusions.
• The authors' conclusion: The authors concluded that same-day administration of vitamin B12 with pemetrexed is safe. They recommended it as a standard option in clinical trials using pemetrexed.
• Limitations the authors state:
  • The study had the inherent limitations of a single-center retrospective design and did not control for adherence to or use of folic acid during pemetrexed therapy.
  • Documentation was sometimes lacking for patients who needed extra supportive care between cycles, presumably because they were treated at outside facilities.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Pemetrexed (Alimta), Lung Cancer, Pleural Mesothelioma.

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