Kazumasa Fujitani1, Kohei Shitara2, Atsuo Takashima3, Keisuke Koeda4, Hiroki Hara5, Norisuke Nakayama6, Shuichi Hironaka7,8, Kazuhiro Nishikawa9, Yutaka Kimura10, Kenji Amagai11, Hisashi Hosaka12, Yoshito Komatsu13, Ken Shimada14, Ryohei Kawabata15, Hideki Ohdan16, Yasuhiro Kodera17, Masato Nakamura18, Takako Eguchi Nakajima19,20, Yoshinori Miyata21, Toshikazu Moriwaki22, Tetsuya Kusumoto23, Kazuo Nishikawa8, Kazuhiro Ogata24, Masashi Shimura25, Satoshi Morita26, Wasaburo Koizumi27. 1. Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056, Japan. fujitani@gh.opho.jp. 2. Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 3. Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan. 4. Department of Medical Safety Science, Iwate Medical University, Morioka, Japan. 5. Department of Gastroenterology, Saitama Cancer Center, Ina-machi, Japan. 6. Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan. 7. Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan. 8. Department of Medical Oncology and Hematology, Faculty of Medicine, Oita University, Oita, Japan. 9. Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan. 10. Department of Surgery, Sakai City Medical Center, Sakai, Japan. 11. Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan. 12. Division of Gastroenterology, Gunma Prefectural Cancer Center, Ohta, Japan. 13. Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan. 14. Division of Medical Oncology, Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan. 15. Department of Surgery, Osaka Rosai Hospital, Osaka, Japan. 16. Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 17. Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. 18. Aizawa Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan. 19. Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. 20. Kyoto Innovation Center for Next Generation Clinical Trials and iPS Cell Therapy, Kyoto University Hospital, Kyoto, Japan. 21. Department of Medical Oncology, Saku Central Hospital Advanced Care Center, Saku, Japan. 22. Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan. 23. Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan. 24. Medical Affairs Department, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan. 25. Data Science Department, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan. 26. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 27. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
Abstract
BACKGROUND: This study evaluated the association between early tumor response at 8 weeks, previously reported as a positive outcome prognosticator, and health-related quality of life (HRQOL) in advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial. METHODS: HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D) utility index score in patients with complete response (CR) + partial response (PR) and progressive disease (PD) at 8 weeks, and time-to-deterioration (TtD) of the EQ-5D score, with the preset minimally important difference (MID) of 0.05, was compared between these populations. Among the enrolled patients, 143 and 160 patients were assessable in weekly solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX) arm, respectively. RESULTS: Changes of the EQ-5D score from baseline to 8 weeks in the nab-PTX arm were 0.0009 and - 0.1229 in CR + PR and PD patients, respectively; the corresponding values for the Sb-PTX arm were - 0.0019 and - 0.1549. For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR. The median TtD was 3.9 and 2.2 months in patients with CR + PR and PD, respectively, for nab-PTX [hazard ratio (HR) = 0.595, 95% confidence interval (CI) 0.358-0.989]. For Sb-PTX, the corresponding values were 4.7 and 2.0 months (HR = 0.494, 95% CI 0.291-0.841). CONCLUSIONS: Early tumor shrinkage was associated with maintained HRQOL in AGC patients on the second-line chemotherapy with taxanes.
BACKGROUND: This study evaluated the association between early tumor response at 8 weeks, previously reported as a positive outcome prognosticator, and health-related quality of life (HRQOL) in advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial. METHODS: HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D) utility index score in patients with complete response (CR) + partial response (PR) and progressive disease (PD) at 8 weeks, and time-to-deterioration (TtD) of the EQ-5D score, with the preset minimally important difference (MID) of 0.05, was compared between these populations. Among the enrolled patients, 143 and 160 patients were assessable in weekly solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX) arm, respectively. RESULTS: Changes of the EQ-5D score from baseline to 8 weeks in the nab-PTX arm were 0.0009 and - 0.1229 in CR + PR and PD patients, respectively; the corresponding values for the Sb-PTX arm were - 0.0019 and - 0.1549. For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR. The median TtD was 3.9 and 2.2 months in patients with CR + PR and PD, respectively, for nab-PTX [hazard ratio (HR) = 0.595, 95% confidence interval (CI) 0.358-0.989]. For Sb-PTX, the corresponding values were 4.7 and 2.0 months (HR = 0.494, 95% CI 0.291-0.841). CONCLUSIONS: Early tumor shrinkage was associated with maintained HRQOL in AGC patients on the second-line chemotherapy with taxanes.
Entities:
Keywords:
Advanced gastric cancer; Early tumor response; Health-related quality of life; Paclitaxel; Second-line chemotherapy
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