Naoto Takahashi1, Mitsuro Kanda2, Takaki Yoshikawa3, Nobuhiro Takiguchi4, Kazumasa Fujitani5, Katsufumi Miyamoto6, Yuichi Ito7, Osamu Takayama8, Motohiro Imano9, Norio Mitsumori10, Junichi Sakamoto11, Satoshi Morita12, Yasuhiro Kodera13. 1. Department of Surgery, Jikei University School of Medicine, Kashiwa Hospital, Chiba, Japan. 2. Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. 3. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan. 4. Division of Gastroenterological Surgery, Chiba Cancer Center, Chiba, Japan. 5. Department of Surgery, Osaka Prefectural General Medical Center, Osaka, Japan. 6. Department of Surgery, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan. 7. Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 8. Department of Surgery, Itami City Hospital, Itami, Japan. 9. Department of Surgery, Faculty of Medicine, Kinki University, Higashiosaka, Japan. 10. Department of Surgery, Jikei University School of Medicine, Tokyo, Japan. 11. Tokai Central Hospital, Kakamigahara, Japan. 12. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 13. Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. ykodera@med.nagoya-u.ac.jp.
Abstract
BACKGROUND: Intraperitoneal administration of paclitaxel had been considered a promising option to treat peritoneal metastasis, the most frequent pattern of recurrence in gastric cancer after D2 gastrectomy, but its safety and efficacy after gastrectomy had not been fully explored. METHODS: A phase II randomized comparison of postoperative intraperitoneal (IP) vs. intravenous (IV) paclitaxel was conducted. Patients with resectable gastric linitis plastica, cancer with minimal amount of peritoneal deposits (P1), or cancer positive for the peritoneal washing cytology (CY1) were eligible. After intraoperative confirmation of the above disease status and of resectability, patients were randomized to be treated either by the IP therapy (paclitaxel 60 mg/m2 delivered intraperitoneally on days 0, 14, 21, 28, 42, 49, and 56) or the IV therapy (80 mg/m2 administered intravenously using the identical schedule) before receiving further treatments with evidence-based systemic chemotherapy. The primary endpoint was 2-year survival rate. RESULTS: Of the 86 patients who were randomized intraoperatively, 83 who actually started the protocol treatment were eligible for analysis (n = 39, IP group; n = 44, IV group). The 2-year survival rate of the IP and IV groups was 64.1% (95% CI 47.9-76.9) and 72.3% (95% CI 56.3-83.2%), respectively (p = 0.5731). The IP treatment did not confer significant overall or progression-free survival benefits, and was associated with particularly poor performance in patients with residual disease, including the CY1 P0 population. CONCLUSIONS: We were unable to prove superiority of the IP paclitaxel over IV paclitaxel delivered after surgery to control advanced gastric cancer with high risk of peritoneal recurrence.
RCT Entities:
BACKGROUND: Intraperitoneal administration of paclitaxel had been considered a promising option to treat peritoneal metastasis, the most frequent pattern of recurrence in gastric cancer after D2 gastrectomy, but its safety and efficacy after gastrectomy had not been fully explored. METHODS: A phase II randomized comparison of postoperative intraperitoneal (IP) vs. intravenous (IV) paclitaxel was conducted. Patients with resectable gastric linitis plastica, cancer with minimal amount of peritoneal deposits (P1), or cancer positive for the peritoneal washing cytology (CY1) were eligible. After intraoperative confirmation of the above disease status and of resectability, patients were randomized to be treated either by the IP therapy (paclitaxel 60 mg/m2 delivered intraperitoneally on days 0, 14, 21, 28, 42, 49, and 56) or the IV therapy (80 mg/m2 administered intravenously using the identical schedule) before receiving further treatments with evidence-based systemic chemotherapy. The primary endpoint was 2-year survival rate. RESULTS: Of the 86 patients who were randomized intraoperatively, 83 who actually started the protocol treatment were eligible for analysis (n = 39, IP group; n = 44, IV group). The 2-year survival rate of the IP and IV groups was 64.1% (95% CI 47.9-76.9) and 72.3% (95% CI 56.3-83.2%), respectively (p = 0.5731). The IP treatment did not confer significant overall or progression-free survival benefits, and was associated with particularly poor performance in patients with residual disease, including the CY1 P0 population. CONCLUSIONS: We were unable to prove superiority of the IP paclitaxel over IV paclitaxel delivered after surgery to control advanced gastric cancer with high risk of peritoneal recurrence.
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