title: A Comparative Pharmacokinetic Study of 2 Pemetrexed Formulations in Indian Adult Chemonaive Patients With Adenocarcinoma Stage III/IV Non-Small Cell Lung Cancer.
abstract: 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/m2pemetrexed (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 (AUC0-inf) and the maximum plasma concentration (Cmax) 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 AUC0-inffor the generic and innovator formulations was 218.2 ± 19.18 and 223.6 ± 34.24 μg·h/mL, respectively, and mean Cmaxwas 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.
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer, Mumbai, India.
authors.forename: Krunal
authors.initials: K
authors.lastname: Kavathiya
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer, Mumbai, India.
authors.forename: Murari
authors.initials: M
authors.lastname: Gurjar
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer, Mumbai, India.
authors.forename: Anand
authors.initials: A
authors.lastname: Patil
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer, Mumbai, India.
authors.forename: Madhura
authors.initials: M
authors.lastname: Naik
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Vanita
authors.initials: V
authors.lastname: Noronha
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Amit
authors.initials: A
authors.lastname: Joshi
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment Research and Education in Cancer, Mumbai, India.
authors.forename: Vikram
authors.initials: V
authors.lastname: Gota
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Kumar
authors.initials: K
authors.lastname: Prabhash
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000473:pathology; D004339:Drug Compounding / Q000145:classification*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068437:Pemetrexed
keywords: Alimta; NSCLC; Pemgem; comparative pharmacokinetics; pemetrexed