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Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320).

Abstract
Background Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness. Methods We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0-1 and < 75 years of age. Patients were treated at 3-week intervals with AMR plus ERL. The primary endpoint was the PFS, and the secondary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity. The trough ERL concentration (Ctrough) was measured as an exploratory study to analyze the relationship between the efficacy/safety and pharmacokinetics. Results From June 2013 to July 2016, 25 patients were enrolled in this trial. The PFS according to the central test was 3.6 months (95% confidence interval 2.1-5.1). The RR and DCR were 24.0% and 64.0%, respectively. We had no treatment-related deaths in this study. Conclusions The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial. In our study, the pharmacokinetic analysis showed that the Ctrough of ERL was elevated with combination therapy. This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation. Clinical trial information UMIN 000010582.
AuthorsSakiko Otani, Jiichiro Sasaki, Yoshiro Nakahara, Tomoya Fukui, Satoshi Igawa, Katsuhiko Naoki, Akihiro Bessho, Shinobu Hosokawa, Nobuaki Fukamatsu, Yukiko Nakamura, Takashi Kasai, Tomohide Sugiyama, Takaaki Tokito, Nobuhiko Seki, Akinobu Hamada, Hiroaki Okamoto, Noriyuki Masuda
JournalInvestigational new drugs (Invest New Drugs) Vol. 39 Issue 2 Pg. 530-536 (04 2021) ISSN: 1573-0646 [Electronic] United States
PMID33159674 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
Chemical References
  • Anthracyclines
  • Antineoplastic Agents
  • amrubicin
  • Erlotinib Hydrochloride
  • ErbB Receptors
Topics
  • Adult
  • Aged
  • Anthracyclines (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
  • Antineoplastic Agents (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Carcinoma, Non-Small-Cell Lung (drug therapy, genetics)
  • ErbB Receptors (genetics)
  • Erlotinib Hydrochloride (administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
  • Humans
  • Lung Neoplasms (drug therapy, genetics)
  • Male
  • Middle Aged
  • Progression-Free Survival

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