450P - Retrospective study of anamorelin therapy for unresectable or recurrent pancreatic cancer with cancer cachexia

Background

Anamorelin (ANAM), a ghrelin receptor agonist, was effective in increasing skeletal muscle mass, weight gain, and appetite in the Ono-7643-05 study for gastrointestinal cancer, including pancreatic cancer (PC) with cancer cachexia (CC), and ANAM was approved in Japan as the world's first treatment for CC. In the Ono-7643-05 study, weight gain and appetite improvement were observed at 3 weeks, and the ANAM package insert states that ANAM should be discontinued if no effectiveness is observed within 3 weeks. The data on factors associated with discontinuation within the first 3 weeks may facilitate the decision to initiate or continue ANAM.

Methods

Patients with unresectable or recurrent PC who started ANAM between 21 April 2021 and 31 March 2022 at the National Cancer Center Hospital and National Cancer Center Hospital East were retrospectively analyzed. Patient characteristics and reasons for discontinuation of ANAM at 3 weeks were collected. Using the clinical data at the time of ANAM initiation, logistic regression analysis was performed to evaluate the background factors associated with the discontinuation of ANAM within 3 weeks.

Results

The study included 110 patients (median age: 70 years; male: 55; Eastern Cooperative Oncology Group performance status 0/1/2/3/unknown: 15/70/15/6/4; prior chemotherapy regimen 0/1/2/3 or more/best supportive care: 5/59/24/15/7 patients). ANAM was discontinued within 3 weeks in 47 patients. The main reasons for discontinuation were disease progression in 23 patients (49%), adverse events (AEs) in 12 patients (26%), and the ineffectiveness of ANAM in 8 patients (17%). The main AEs were gastrointestinal disorders such as nausea and vomiting. Multivariate analysis of factors correlated with the discontinuation of ANAM within 3 weeks revealed a significant association with a Glasgow prognostic score (GPS) of 2.

Conclusions

Among PC patients with CC, the discontinuation rate at 3 weeks after starting ANAM was 43%. The main reason for discontinuation was disease progression. A GPS of 2, which may reflect a high degree of inflammation and low nutritional status, was associated with discontinuation within 3 weeks. Appropriate patient selection may improve the continuation rate of ANAM.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Center Hospital.

Funding

National Cancer Center Hospital and National Cancer Center Hospital East.

Disclosure

A. Ohba: Financial Interests, Personal, Invited Speaker: Yakult, Ono, Servier, Taiho, Eisai; Financial Interests, Personal, Advisory Board: Zymeworks; Financial Interests, Institutional, Local PI: Ono, Chugai, Novartis. S. Mitsunaga: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical CO., LTD. T. Satake: Financial Interests, Institutional, Local PI: Ono, NIHON Servier. H. Imaoka: Financial Interests, Personal, Invited Speaker: Yakult Honsha, AstraZeneca, Nihon Servier, Kaneka Medix, SB KAWASUMI LABORATORIES; Financial Interests, Personal, Advisory Board: Nihon Servier, Kaneka Medix; Financial Interests, Personal, Writing Engagement: Medico's Hirata; Financial Interests, Institutional, Local PI: Ono Pharmaceutical, Novartis, Nihon Servier. C. Morizane: Financial Interests, Personal, Advisory Board: Yakult, MSD, Servier, Boehringer Ingelheim, AstraZeneca, Taiho Pharmaceutical, Merck biopharma; Financial Interests, Personal, Invited Speaker: Novartis, Teijin Pharma; Financial Interests, Institutional, Coordinating PI: Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical, Eisai, MSD K.K., J-Pharma, AstraZeneca, Merck biopharma; Financial Interests, Institutional, Funding: Daiichi Sankyo RD Novare, Hitachi. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, Takeda, Ono, MSD, Taisho Pharmaceutical, Nippon Kayaku, Guardant Health Japan; Financial Interests, Institutional, Coordinating PI: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Ono, Novartis, J-Pharma, Pfizer, Chiome Bioscience, NIHON Servier, Delta-Fly Pharma, Syneos Health, Merus.N.V., Merck biopharma, Boehringer Ingelheim, Invitae; Financial Interests, Personal, Steering Committee Member: Chugai, NIHON Servier, Takeda, Novartis, Eisai, Rakuten Medical. T. Okusaka: Financial Interests, Personal, Advisory Board: Eisai, Nihon Servier, AstraZeneca, Ono Pharmaceutical, FUJIFILM Toyama Chemical, Daiihon-Sumitomo, Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eisai, Chugai Pharma, Nihon Servier, Incyte, Johnson & Johnson, Daiichi Sankyo, Taiho; Financial Interests, Institutional, Local PI: AstraZeneca, Chugai Pharma, Eisai, Novartis, Bristol Myers Squibb, MSD, Incyte, Syneos Health. All other authors have declared no conflicts of interest.