Phase I Study Evaluating the Combination of Afatinib with Carboplatin and Pemetrexed After First-line EGFR-TKIs

Satoshi Watanabe1, O U Yamaguchi2, A I Masumoto2

  • 1Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.

Anticancer Research
|August 1, 2018
PubMed
Abstract

Insights

Afatinib combined with carboplatin and pemetrexed showed good clinical efficacy in EGFR-mutated non-small-cell lung cancer patients. The recommended dose of 20 mg/day afatinib was well tolerated, with a 30% overall response rate.

Area of Science:

  • Oncology
  • Pharmacology
  • Medical Research

Background:

  • Previous studies explored first-generation EGFR-TKIs with chemotherapy.
  • No prior analysis investigated afatinib with platinum-doublet chemotherapy.

Purpose of the Study:

  • To assess the safety and efficacy of afatinib combined with carboplatin and pemetrexed.
  • To determine the recommended dose for this combination therapy in EGFR-mutated NSCLC patients post-first-generation EGFR-TKI progression.

Main Methods:

  • A study involving ten EGFR-mutated non-small-cell lung cancer (NSCLC) patients.
  • Patients received varying doses of afatinib (20 or 30 mg/day) along with carboplatin and pemetrexed.
  • Safety and antitumor efficacy were evaluated.

Main Results:

  • Recommended afatinib dose identified as 20 mg/day due to dose-limiting toxicities at higher doses.
  • Observed dose-limiting toxicities included diarrhea, hypokalemia, elevated serum amylase, and thrombocytopenia.
  • Achieved an overall response rate of 30% and a median progression-free survival of 13.7 months.

Conclusions:

  • This is the first study to evaluate the combination of afatinib, carboplatin, and pemetrexed.
  • The combination therapy, at the recommended dose, demonstrated good tolerability.
  • The regimen showed promising clinical efficacy in the studied patient population.

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