Trifluridine/tipiracil plus bevacizumab in elderly patients with previously untreated metastatic colorectal cancer (KSCC1602): A multicenter, phase II clinical trial.

Authors

Eiji Oki

Eiji Oki

Department of Surgery and Science, Kyushu University, Fukuoka, Japan

Eiji Oki , Akitaka Makiyama , Yuji Miyamoto , Masahito Kotaka , Hirofumi Kawanaka , Keisuke Miwa , Akira Kabashima , Masahiro Hamanoue , Takafumi Ohchi , Tomomi Kashiwada , Mototsugu Shimokawa , Hiroshi Saeki , Yoshito Akagi , Hideo Baba , Masaki Mori

Organizations

Department of Surgery and Science, Kyushu University, Fukuoka, Japan, Department of Hematology/Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan, Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan, Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan, National Beppu Cancer Center, Beppu, Japan, Kurume University Hospital, Kurume, Japan, National Oita Cancer Center, Oita, Japan, Department of Surgery, Imakiire General Hospital, Kagoshima, Japan, Kurume University School of Medicine, Kurume, Japan, Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan, Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan, Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, Department of Surgery, Kurume University, Kurume, Japan, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan, Kyushu University, Fukuoka, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: Elderly patients are often intolerable in combination of cytotoxic agents. Recently, Trifluridine/tipiracil plus bevacizumab has been shown as good candidate for the vulnerable patients. We aimed to assess the efficacy and safety of trifluridine/tipiracil plus bevacizumab in elderly patients with metastatic colorectal cancer. Methods: Patients aged 70 years and older with previously untreated, unresectable, metastatic colorectal cancer, who were not deemed to be candidates for oxaliplatin-based or irinotecan-based chemotherapy regimens, were included in this trial. Treatment consisted of trifluridine/tipiracil (35 mg/m2 orally a day on day 1-5 and day 8-12) with bevacizumab (5mg/kg intravenously on day 1 and day 15), given every 4 weeks until disease progression. The primary endpoint was progression-free survival (PFS). The secondary endpoints were response rate (ORR), Overall survival (OS) and adverse events (AEs). Results: Between 2017 January and 2018 March, 39 patients were enrolled in this study. The characteristics of patients were male/female : 17/22, median age : 77.5 (range: 70-88) and PS: 0/1 : 31/8. The ORR of 37 patients were assessed by the central review committee. The best response was 40.5(15/37) % (95% CI: 24.8-57.9), and the disease control rate was 86.5 (32/37) % (95% CI: 71.2–95.5). The AEs which were frequent as grade 3 or 4 were leucopenia (71.8 %), neutropenia (48.7 %), anorexia (12.8 %), febrile neutropenia (10.3 %) and fatigue (10.3 %). No treatment related death was reported. Conclusions: The combination of trifluridine/tipiracil plus bevacizumab is an effective and well-tolerated regimen for elderly patients with metastatic colorectal cancer. Hematological adverse events were need for caution. The primary endpoint of PFS will be presented in the end of this year. Clinical trial information: UMIN000025241.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Advanced Disease

Clinical Trial Registration Number

UMIN000025241

Citation

J Clin Oncol 37, 2019 (suppl; abstr 3548)

DOI

10.1200/JCO.2019.37.15_suppl.3548

Abstract #

3548

Poster Bd #

40

Abstract Disclosures