Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10773

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    P1.10-030 - Comparative Pharmacokinetics of Two Formulations of Pemetrexed in Indian Adult Chemo-Naive, Adenocarcinoma Non-Small Cell Lung Cancer Patients. (ID 1565)

    09:30 - 09:30  |  Author(s): M. Gurjer
    • Abstract

    Background
    Pemetrexed (Alimta, Eli Lilly) with platinum doublet is an effective drug for first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Innovator products are generally highly priced which limits their utility in developing countries. In India, a generic formulation (Pemgem, Dr. Reddy’s Laboratories) is marketed at 25% the cost of Alimta. Results of a study comparing the pharmacokinetic and safety profile of the two formulations of pemetrexed are discussed here.

    Methods
    This study was approved by TMC-ACTREC-IRB and registered with Clinical Trials Registry- India (CTRI). Patients were enrolled from a tertiary care cancer hospital in India as per predefined selection criteria mentioned the protocol. Pemetrexed (500 mg/m[2]) was administered as a 10 minute short infusion. All patients received standard premedication. Pharmacokinetic blood samples were collected at predose and 10 minutes (just before end of infusion), 15 min., 30 min., 50 min., 1 hr., 1 hr. 20 min., 2 hrs.,4 hrs.,6 hrs., 8 hrs. and 24 hrs after starting the infusion. Plasma pemetrexed levels were determined by a validated HPLC method. Toxicity was graded using CTCAE v. 4.03. Quality of life questionnaire was taken at baseline and at end of 3rd cycle.

    Results
    Twenty four patients were enrolled on the study, eight in Alimta arm and sixteen in Pemgem arm. Patient demographics were comparable in the two arms. Mean Area Under the Concentration-Time Curve (AUC~0-24 hr~) was 222.06 vs. 253.7 mg h/L and mean C~max ~was 106.5 and 130.7 mg/L in Pemgem and Alimta arms respectively. Volume of distribution of pemetrexed was 16.59 and 17.56 L, clearance was 3.83 vs. 4.3 L/hr and half-life was 3.29 and 2.43 hr in the two arms respectively. Toxicity was comparable between the groups. However, a higher incidence of grade III/IV hyponatrimia (25%) was observed in our patients which needs to be investigated further. Global health status improved significantly in both treatment arms at the end of 3 cycles compared to baseline. Pooled data of selected Quality of Life indices is shown below. Table 1: Mean difference in selected Quality of Life indices (3rd Cycle Vs. Baseline)

    QOL scale	Mean difference	SEM	P value
    Global health status	18.39	3.10	0.001
    Pain	-7.77	3.46	0.023
    Dysponea	-7.77	3.81	0.05
    Insomnia	-4.44	3.06	0.017
    Haemoptysis	-3.33	2.10	0.043

    Conclusion
    Pemgem had similar pharmacokinetic and safety profile as Alimta. Generic substitution would be cost effective and likely to yield comparable efficacy.