Phase II trial evaluating the efficacy of capeOX in elderly patients with advanced gastric cancer using geriatric assessment (TCOG GI-1601).

Authors

null

Hisashi Hosaka

Department of Gastroenterology, Gunma Prefectural Cancer Center, Ota, Gunma, Japan;

Hisashi Hosaka , Keisho Chin , Ryohei Kawabata , Osamu Muto , Yoshiaki Shindo , Naoki Nagata , Hiroshi Yabusaki , Hiroshi Imamura , Shunji Endo , Tomomi Kashiwada , Masato Nakamura , Jun Hihara , Michiya Kobayashi , Fumio Nagashima , Daisuke Takahari , Naoki Ishizuka , Kensei Yamaguchi

Organizations

Department of Gastroenterology, Gunma Prefectural Cancer Center, Ota, Gunma, Japan; , Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; , Department of Surgery, Sakai City Medical Center, Sakai, Japan; , Department of Medical Oncology, Japanese Red Cross Akita Hospital, Akita, Japan; , Department of Gastroenterological Surgery, Nakadori General Hospital, Akita, Japan; , Department of Gastroenterological Surgery, Kitakyushu General Hospital, Kitakyushu, Japan; , Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan; , Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan; , Department of Gastroenterological Surgery, Yao Municipal Hospital, Yao, Japan; , Department of Internal Medicine, Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University, Saga, Japan; , Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan; , Department of Gastroenterological Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan; , Kochi Medical School Hospital, Cancer Treatment Center, Nankoku, Japan; , Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan; , Clinical Planning and Strategy Department Center for Development of Advanced Cancer Therapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; , Department of Gastroenterological Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan;

Research Funding

Pharmaceutical/Biotech Company
Yakult Honsha

Background: CapeOX is a standard regimen for treating advanced gastric cancer (AGC). However, limited data are available for its use in the elderly patients. Geriatric assessment (GA) assessment is also considered important other than the age. Therefore, we conducted a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CapeOX as a first-line therapy for AGC in elderly patients. We performed GA assessments using the G8, and the MINI-COG. Methods: The inclusion criteria were: HER2-negative or unknown status, age 70 years or older, PS 0 or 1, no history of chemotherapy or radiotherapy, and an evaluable lesion based on the RECIST v1.1 guidelines. The initial treatment plan consisted of capecitabine (1,000 mg/m2, b.i.d., on days 1–14), and oxaliplatin (130 mg/m2, on day 1) every three weeks. After the initial feasibility assessment, the treatment plan was modified and consisted of capecitabine (750 mg/m2, b.i.d., on days 1–14) and oxaliplatin (100 mg/m2, on day 1) every three weeks. The primary endpoint was overall survival (OS). G8 assessments were performed before the beginning of the treatment, every three months after the start of the treatment, and at the end of the treatment. MINI-COG assessments were performed before the beginning of the treatment, and at the end of the treatment. Results: Between November 2016 and June 2020, 108 patients were enrolled, out of which 104 were evaluated. Thirty-nine patients received the initial treatment whereas sixty-five patients received the modified treatment. The primary endpoint was met. The median OS, progression-free survival (PFS), and time-to-treatment failure (TTF) were 12.9 (95% CI: 11.7–14.8), 5.8 (95% CI: 5.1–7.1), and 4.3 (95% CI: 3.9–5.7) months, respectively, for all patients. The median OS, PFS, and TTF for the initial treatment plan were 13.4 (95% CI: 9.6–16.0), 5.8 (95% CI: 4.1–7.9), and 5.3 (95% CI: 3.5–7.3) months, respectively, and for the modified treatment plan were 12.8 (95% CI: 11.3–15.3), 5.7 (95% CI: 4.4–7.0), and 4.2 (95% CI: 3.7–5.7) months, respectively. The most common grade 3/4 toxicities in the initial treatment plan patients were neutropenia (17.9%), anemia (12.8%), thrombocytopenia (12.8%), anorexia (10.3%), and nausea (10.3%) and in the modified treatment plan patients were (13.8%) and anorexia (12.3%). Mean G8 score was 11.4 before the treatment, 13.4 during the treatment and 11.6 at the end of the treatment. Mean MINI-COG score was 4.0 before the treatment, and 4.1 at the end of the treatment and the positive screen for dementia was 13.5% before the treatment and 11.4% at the end of the treatment. Conclusions: Our results show that the modified treatment plan is favorable for the elderly patients with gastric cancer based on the OS and the toxicities. Clinical trial information: 000022450.

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Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

000022450

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr 348)

DOI

10.1200/JCO.2023.41.4_suppl.348

Abstract #

348

Poster Bd #

E9

Abstract Disclosures