Sho Sato1, Chikara Kunisaki2, Yusaku Tanaka1, Kei Sato1, Hiroshi Miyamoto1, Norio Yukawa1, Yoshiro Fujii1, Jun Kimura3, Ryo Takagawa4, Masazumi Takahashi5, Takashi Kosaka6, Hirotoshi Akiyama6, Yusuke Saigusa7, Masataka Taguri7, Takeharu Yamanaka7, Itaru Endo6. 1. Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan. 2. Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan s0714@med.yokohama-cu.ac.jp. 3. Department of Surgery, Yokosuka Kyousai Hospital, Yokosuka, Japan. 4. Department of Surgery, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan. 5. Department of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan. 6. Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan. 7. Department of Clinical Statistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Abstract
BACKGROUND/AIM: Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated antitumor activity against advanced gastric cancer. However, gastric cancer patients can be difficult to treat with the recommended dose because of the high incidence of adverse toxicities. The aim of this study was to evaluate the safety and effectiveness of low-dose nab-paclitaxel in a multicenter, single-arm, phase II study. PATIENTS AND METHODS: Treatment included low doses of 180 mg/m2 nab-paclitaxel administered on day 1 of each 21-day cycle. The primary endpoint was defined as the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), safety, and overall survival (OS). A total of 34 patients were enrolled in the full-analysis set. RESULTS: The ORR was 5.9%. The median PFS and OS were 2.4 months and 9.2 months, respectively. The most common grade 3/4 toxicities were anemia (8.8%), neutropenia (5.9%), appetite loss (5.9%) and peripheral sensory neuropathy (5.9%). No treatment-related deaths occurred. CONCLUSION: The tri-weekly low dose of nab-paclitaxel therapy is effective towards advanced gastric cancer patients with good tolerability and an acceptable margin of safety. Copyright
BACKGROUND/AIM: Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated antitumor activity against advanced gastric cancer. However, gastric cancerpatients can be difficult to treat with the recommended dose because of the high incidence of adverse toxicities. The aim of this study was to evaluate the safety and effectiveness of low-dose nab-paclitaxel in a multicenter, single-arm, phase II study. PATIENTS AND METHODS: Treatment included low doses of 180 mg/m2 nab-paclitaxel administered on day 1 of each 21-day cycle. The primary endpoint was defined as the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), safety, and overall survival (OS). A total of 34 patients were enrolled in the full-analysis set. RESULTS: The ORR was 5.9%. The median PFS and OS were 2.4 months and 9.2 months, respectively. The most common grade 3/4 toxicities were anemia (8.8%), neutropenia (5.9%), appetite loss (5.9%) and peripheral sensory neuropathy (5.9%). No treatment-related deaths occurred. CONCLUSION: The tri-weekly low dose of nab-paclitaxel therapy is effective towards advanced gastric cancerpatients with good tolerability and an acceptable margin of safety. Copyright
Authors: C La Raja; C Foppa; A Maroli; C Kontovounisios; N Ben David; M Carvello; A Spinelli Journal: Tech Coloproctol Date: 2022-03-28 Impact factor: 3.699