Abstract 220P
Background
Amrubicin (AMR) is one of the standard second-line treatment for platinum-refractory small-cell lung cancer. However, standard second-line treatment in advanced extra pulmonary neuroendocrine carcinoma (NEC) has not been established. This study evaluated the efficacy and safety of AMR monotherapy in patients with advanced hepatobiliary and pancreatic (HBP) NEC with disease progression after platinum therapy.
Methods
We retrospectively investigated patients with advanced HBP NEC who received AMR monotherapy at the National Cancer Center Hospital East between January 2013 and December 2023. The inclusion criteria were: 1) histologically confirmed advanced HBP NEC based on the WHO 2022 classification; 2) ≥18 years old; 3) disease have progressed after platinum therapy.
Results
A total of 31 patients were included. Primary sites included the pancreas in 15, biliary tract in 14, and liver in two patients. Number of prior regimens was 1 in 20 (65%), 2 in 9 (29%) and ≥3 in 2 patients (6%). The AMR dose was 40 mg/m2 in 30 (97%) patients. The objective response rate was 13% and the disease control rate was 48%. Median progression-free survival (PFS) was 2.5 (95% confidence interval [CI]: 1.4-3.9) months and overall survival (OS) was 4.7 (95% CI: 3.3-10.5) months. Thirteen patients (42%) received subsequent treatment after disease progression. Grade 4 neutropenia and febrile neutropenia were observed in 19 (61%) and four patients (13%), respectively. One treatment related death occurred due to pneumocystis pneumonia by neutropenia. In univariate analysis, factors such as Ki-67≥60%, treatment line of AMR monotherapy and tumor response for prior-platinum therapy were not identified as prognostic factors for PFS and OS of AMR monotherapy.
Conclusions
The efficacy of AMR monotherapy in HBP NEC was modest, with a high incidence of neutropenia. The developments of other therapeutic regimens for HBP NEC are needed.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
H. Imaoka: Financial Interests, Personal, Invited Speaker: Yakult Honsha, AstraZeneca, Nihon Servier, Kaneka Medix, Medico's Hirata, SB Kawasumi Laboratories; Financial Interests, Personal, Advisory Board: Nihon Servier; Financial Interests, Personal, Expert Testimony: Kaneka Medix; Financial Interests, Institutional, Invited Speaker: Ono Pharmaceutical, Novartis, Nihon Servier. S. Mitsunaga: Financial Interests, Advisory Board: Chugai, Astellas, Toray, Ajinomoto, Pfizer; Financial Interests, Invited Speaker: Ono, Toray, Otsuka. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eisai, Nihon Servier, Novartis, Bristol Myers Squibb, MSD, Boehringer Ingelheim, Astellas Pharma, GSK; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, Nihon Servier, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Fujifilm Toyama Chemical, Incyte Biosciences Japan, Takeda, Ono, MSD, Taisho Pharmaceutical, Nippon Kayaku, Guardant Health Japan, Nobelpharma, Chugai, Nihon Servier, Takeda, Novartis, Eisai, Rakuten Medical; Financial Interests, Institutional, Invited Speaker: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Ono, Novartis, J-Pharma, Chiome Bioscience, Nihon Servier, Delta-Fly Pharma, Syneos Health, Merus.N.V., Merck biopharma, Boehringer Ingelheim, Invitae, Nobelpharma. All other authors have declared no conflicts of interest.