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A Comparative Pharmacokinetic Study of 2 Pemetrexed Formulations in Indian Adult Chemonaive Patients With Adenocarcinoma Stage III/IV Non–Small Cell Lung Cancer
Author(s) -
Kavathiya Krunal,
Gurjar Murari,
Patil Anand,
Naik Madhura,
Noronha Vanita,
Joshi Amit,
Gota Vikram,
Prabhash Kumar
Publication year - 2017
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.347
Subject(s) - pemetrexed , medicine , pharmacokinetics , lung cancer , adenocarcinoma , area under the curve , pharmacodynamics , stage (stratigraphy) , urology , pharmacology , nuclear medicine , gastroenterology , oncology , cancer , chemotherapy , cisplatin , paleontology , biology
The study aimed to compare the pharmacokinetics of 2 pemetrexed formulations (Pemgem, Dr. Reddy's Laboratories w.r.t; Alimta, Eli Lilly) in adult chemonaive subjects with adenocarcinoma stage III/IV non–small cell lung cancer. All patients received 500 mg/m 2 pemetrexed (Alimta or Pemgem) as a 10‐minute infusion on day 1 of a 21‐day cycle. Plasma pemetrexed concentrations were determined on day 1 of cycle 1. Area under the concentration–time curve (AUC 0–inf ) and the maximum plasma concentration (C max ) were estimated using noncompartment analysis and compared between the 2 arms. Forty‐eight patients were enrolled in the study, 24 in each arm. Patient demographics were comparable in both arms. Mean AUC 0–inf for the generic and innovator formulations was 218.2 ± 19.18 and 223.6 ± 34.24 μg·h/mL, respectively, and mean C max was 119 ± 13.44 and 113 ± 7.26 μg/mL, respectively. Volume of distribution of pemetrexed was 17.5 and 27.6 L, clearance was 4.2 versus 4.72 L/h, and half‐life was 4.3 and 4.83 h in the 2 arms respectively. Both formulations showed comparable response rates (objective response of 45% versus 50% in the Pemgem and Alimta arms, respectively) and similar safety profiles. To conclude, Pemgem showed pharmacokinetic and safety profiles similar to Alimta. Substitution of Alimta with Pemgem will be cost‐effective and likely to yield comparable efficacy.