417O - Non-hematological toxicity and timing of B12/Folate supplementation in NSCLC patients on pemetrexed based chemotherapy: Secondary analysis of the P...

Date 19 November 2017
Event ESMO Asia 2017 Congress
Session Thoracic malignancies 2
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Non-Small-Cell Lung Cancer, Metastatic
Lung and other Thoracic Tumours
Palliative and Supportive Care
Presenter Milind Baldi
Citation Annals of Oncology (2017) 28 (suppl_10): x124-x143. 10.1093/annonc/mdx671
Authors M. Baldi1, K.T. Prasad1, D. Behera1, J. Kaur2, N. Singh1
  • 1Pulmonary Medicine And Critical Care, PGIMER, Chandigarh, 160012 - Chandigarh/IN
  • 2Department Of Biochemistry, PGIMER, Chandigarh, 160012 - Chandigarh/IN

Abstract

Background

Vitamin B12 & folic acid supplementation (B12-FAS) reduces the incidence & severity of toxicity in pemetrexed based chemotherapy. It is recommended to initiate B12-FAS, 5-7 days before the 1st cycle. Observational & prospective single arm studies have not shown any increase in toxicity when pemetrexed was started earlier than recommended duration of B12-FAS.

Methods

This is a secondary analysis of PEMVITASTART – an open label randomized trial that assessed differences in hematological toxicity between patients initiated on pemetrexed-platinum chemotherapy following 5-7 days of B12-FAS (Delayed arm; DA) versus those receiving B12-FAS simultaneously (≤24 hours) with chemotherapy initiation (Immediate arm; IA). Eligible patients had locally advanced/metastatic non-squamous NSCLC & ECOG PS0-2. Block randomization was 1:1 into DA & IA. All enrolled patients received 3 weekly pemetrexed-platinum doublet [500mg/m2 AND cisplatin (65mg/m2) OR carboplatin AUC 5.0mg/ml/min) each on D1] for a maximum of 6 cycles. Supplementation was 1000 µgm FA PO daily & 3 weekly 1000 µgm im vitamin B12. Herein, we present the non-hematological toxicity profile of PEMVITASTART.

Results

Of the 161 patients recruited (81 IA, 80 DA), 150 (77 IA, 73 DA) received ≥ 1 cycle & were included in modified ITT analysis. Baseline parameters were matched except for more females in DA (IA = 10.4%, DA = 23.3%, p = 0.03). The overall incidence of severe (≥grade 3) non hematological adverse events (AEs) was 25.3% (n = 38). The incidence of any grade & severe non hematological AEs was equal in both arms [any grade: IA 79.3% (n = 61), DA 78.1% (n = 57) p value=0.87; grade 3/4: IA 23.3% (n = 18), DA 27.4% (n = 20) p value=0.57], Table.Table: 417O

Non hematological AEs in PEMVITASTART

Any gradeGrade 3/4
IADAp valueIADA
Neuropathy16(20.77%)14(19.17%)0.813(3.89%)2(2.73%)
Anorexia32(41.55%)30(41.09%)0.954(5.19%)3(4.10%)
Fatigue30(38.96%)29(39.72%)0.924(5.19%)9(12.32%)
Vomitting13(16.88%)20(27.39%)0.124(5.19%)4(5.47%)
Diarrhea21(27.27%)22(30.13%)0.705(6.49%)4(5.47%)
Constipation10(12.98%)6(8.21%)0.3400
Mucositis10(12.98%)9(12.32%)0.902(2.59%)1(1.36%)

Conclusions

Secondary analysis of PEMVITASTART shows simultaneous B12-FAS initiation with pemetrexed-based chemotherapy is feasible with acceptable non hematological toxicity profile.

Clinical trial identification

NCT02679443 First received: February 1, 2016 Last updated: April 22, 2017 Last verified: April 2017

Legal entity responsible for the study

PGIMER, Chandigarh

Funding

PGIMER, Chandigarh

Disclosure

All authors have declared no conflicts of interest.