Author of

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17872

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    P2.06-030 - Optimum Duration of Vitamin B12/Folate Supplementation in NSCLC Patients on Pemetrexed Based Chemotherapy: The PEMVITASTART Randomized Trial (ID 3903)

    14:30 - 14:30  |  Author(s): J. Kaur
    • Abstract
    • Slides

    Background:
    Pemetrexed, an anti-folate drug, is the preferred chemotherapeutic agent for non-squamous NSCLC histology. Addition of vitamin B12 and folic acid (folate; 350–1000μg PO daily) supplementation to pemetrexed containing regimens reduces the incidence and severity of myelosuppression without diminishing antitumor efficacy. Folate supplementation and vitamin B12 (1000μg intramuscular every nine weeks) should be started one week before the first cycle of chemotherapy and continued for atleast three weeks beyond the last cycle. However, observational and prospective single arm studies have not shown any increase in toxicity when pemetrexed was started prior to completion of the recommended duration (one week) of supplementation.
    
    Methods:
    The current study is an open-label, randomized trial (PEMVITASTART; NCT02679443) to evaluate differences in pemetrexed-related hematological toxicity amongst patients initiated on chemotherapy following 5-7 days of vitamin B12 and folate supplementation (Delayed Arm) compared to those in whom the above supplementation is started simultaneously with (within 24 hours of) chemotherapy initiation (Immediate Arm). Eligible patients are chemo-naïve WITH cytologically/histopathologically proven non-squamous NSCLC AND locally advanced/metastatic (Stage IIIB/IV) disease (OR Stage IIIA not scheduled for upfront surgical resection) AND ECOG PS 0-2. Prior molecular targeted therapy is an exclusion but previous radiation therapy is permitted if completed atleast four weeks before enrollment. Other important exclusion criteria include hemoglobin <9 gm/dL, administration of erythropoiesis stimulating agents (ESAs) or packed RBC (PRBC) transfusions in the past four months and symptomatic untreated brain metastasis. Randomization is 1:1 into delayed and immediate arms. All enrolled patients will receive pemetrexed in standard dose of 500 mg/m2 in combination with either cisplatin (65 mg/m2) or carboplatin (AUC 5.0mg/mL/min) each drug being given on day 1 of a 3-week cycle. Primary Outcome: Incidence of any grade hematological toxicity (NCI-CTC AE v3.0); Secondary Outcomes: a) Incidence of grade 3/4 hematological toxicity b) Number of granulocyte colony stimulating factors (G-CSFs), ESAs and PRBCs administered c) Relative Dose Intensity (RDI) delivered d) Number of Inter-Cycle Delays (≥ 7 day duration). Other Pre-specified Outcomes: Changes in serum levels of folic acid and homocysteine after third/sixth cycle. Enrolled patients will be followed up till three weeks beyond completion of pemetrexed-platinum doublet chemotherapy (average 18 weeks). Radiological Responses will be assessed by RECIST v1.0. IEC approval has been obtained and patients are enrolled after giving informed consent. The single centre study was opened to accrual in July 2015 and will continue till atleast 128 patients are enrolled. Clinical trial information: NCT02679443
    
    Results:
    Not Applicable
    
    Conclusion:
    Not Applicable
    
    

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