학술논문
Protocol of a phase II study investigating the efficacy and safety of trifluridine/tipiracil plus ramucirumab as a third-line or later treatment for advanced gastric cancer.
Document Type
Academic Journal
Author
Nakanishi K; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Tanaka C; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Kanda M; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Miyata K; Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Machida N; Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.; Sakai M; Department of Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan.; Kobayashi D; Department of Surgery, Komaki City Hospital, Komaki, Japan.; Teramoto H; Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.; Ishiyama A; Department of Surgery, Okazaki City Hospital, Okazaki, Japan.; Sato B; Department of Surgery, Kainan Hospital, Yatomi, Japan.; Oshima T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.; Kajikawa M; Department of Surgery, Gifu Prefectural Tajimi Hospital, Tajimi, Japan.; Matsushita H; Department of Surgery, Tosei General Hospital, Seto, Japan.; Ishigure K; Department of Surgery, Konan Kosei Hospital, Konan, Japan.; Yamashita K; Department of Surgery, Toyohashi Medical Center, Toyohashi, Japan.; Fujitake S; Department of Surgery, Nishio Municipal Hospital, Nishio, Japan.; Sueoka S; Department of Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan.; Asada T; Department of Surgery, Gifu Prefectural Tajimi Hospital, Tajimi, Japan.; Shimizu D; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Sugita S; Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Kuwatsuka Y; Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.; Maeda O; Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.; Furune S; Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.; Murotani K; The Biostatistics Center, Graduate School of Medicine, Kurume University, Kurume, Japan.; Ando Y; Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.; Ebata T; Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Kodera Y; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Source
Publisher: Nagoya University School Of Medicine Country of Publication: Japan NLM ID: 0412011 Publication Model: Print Cited Medium: Internet ISSN: 2186-3326 (Electronic) Linking ISSN: 00277622 NLM ISO Abbreviation: Nagoya J Med Sci Subsets: MEDLINE
Subject
Language
English
Abstract
In Japan, systemic chemotherapy is the standard treatment for unresectable, advanced, or recurrent gastric cancer. However, numerous patients with gastric cancer do not receive late-line treatment because of the rapid progression of gastric cancer. Additionally, late-line treatments, such as nivolumab, trifluridine tipiracil (FTD/TPI), or irinotecan, have limited effects on improving clinical symptoms and delaying the onset of symptoms associated with cancer progression. Recently, a combination of FTD/TPI and ramucirumab was reported to have a high response rate in late-line treatment; however, owing to patient selection bias and a high rate of hematologic toxicity in that previous study, this regimen may not be feasible in real-world clinical applications. Our objective is to conduct a single-arm phase II study to assess the safety and efficacy of FTD/TPI plus ramucirumab combination therapy for gastric cancer after third-line treatment under real-world clinical conditions. This study will recruit 32 patients according to eligibility criteria and administer FTD/TPI (35 mg/m 2 ) and intravenous ramucirumab (8 mg/kg). The primary endpoint will be the time to treatment failure. The secondary endpoints will include the overall survival time, progression-free survival time, overall response rate, disease control rate, relative dose intensity, and incidence of adverse events. The results will add new insights for improving the late-line treatment of advanced gastric cancer.
Competing Interests: The authors declare the following financial interests/personal relationships that may be considered potential competing interests: Dr Nakanishi reports personal fees from Taiho Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, and Daiichi Sankyo Company, Ltd, outside the scope of the submitted work. Dr Kodera reports grants and personal fees from Taiho Pharmaceutical Co, Ltd, Chugai Pharma, MSD, Nihon Kayaku, Yakult, Lilly Japan, Ono Pharmaceutical Co, Ltd, Covidien, Daiichi Sankyo Company, Ltd, Tsumura, Johnson & Johnson, and Abbvie; grants from Takeda, Kaken Pharma, EA Pharma, Otsuka, Sanofi, Abbot, Bayer, and Pfizer; and personal fees from Miyarisan, Amgen, and Olympus, outside the scope of the submitted work. Dr Ando reports grants and personal fees from Chugai Pharmaceutical Co, Ltd, Kyowa Kirin Co, Ltd, Nippon Kayaku Co, Ltd, Yakult Honsha Co, Ltd, Ono Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co, Ltd, Novartis Pharma KK, Daiichi Sankyo Company, Ltd, and Eisai Co, Ltd; personal fees from Eli Lilly Japan KK, Bayer Holding Ltd, Sawai Pharmaceutical Co, Ltd, MSD KK, Astellas Pharma Inc., Otsuka Holdings Co, Ltd, Sanwa Kagaku Kenkyusho Co, Ltd, Hisamitsu Pharmaceutical Co, Inc., SymBio Pharmaceuticals, Aptitude Health, and Alfresa Pharma Corporation; and grants from BeiGene, Ltd, outside the scope of the submitted work. Dr Murotani reports personal fees from Taiho Pharmaceutical Co, Ltd, outside the scope of the submitted work. The other authors declare that no financial or material support was received for this study.
Competing Interests: The authors declare the following financial interests/personal relationships that may be considered potential competing interests: Dr Nakanishi reports personal fees from Taiho Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, and Daiichi Sankyo Company, Ltd, outside the scope of the submitted work. Dr Kodera reports grants and personal fees from Taiho Pharmaceutical Co, Ltd, Chugai Pharma, MSD, Nihon Kayaku, Yakult, Lilly Japan, Ono Pharmaceutical Co, Ltd, Covidien, Daiichi Sankyo Company, Ltd, Tsumura, Johnson & Johnson, and Abbvie; grants from Takeda, Kaken Pharma, EA Pharma, Otsuka, Sanofi, Abbot, Bayer, and Pfizer; and personal fees from Miyarisan, Amgen, and Olympus, outside the scope of the submitted work. Dr Ando reports grants and personal fees from Chugai Pharmaceutical Co, Ltd, Kyowa Kirin Co, Ltd, Nippon Kayaku Co, Ltd, Yakult Honsha Co, Ltd, Ono Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co, Ltd, Novartis Pharma KK, Daiichi Sankyo Company, Ltd, and Eisai Co, Ltd; personal fees from Eli Lilly Japan KK, Bayer Holding Ltd, Sawai Pharmaceutical Co, Ltd, MSD KK, Astellas Pharma Inc., Otsuka Holdings Co, Ltd, Sanwa Kagaku Kenkyusho Co, Ltd, Hisamitsu Pharmaceutical Co, Inc., SymBio Pharmaceuticals, Aptitude Health, and Alfresa Pharma Corporation; and grants from BeiGene, Ltd, outside the scope of the submitted work. Dr Murotani reports personal fees from Taiho Pharmaceutical Co, Ltd, outside the scope of the submitted work. The other authors declare that no financial or material support was received for this study.