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Induction of a Pathological Complete Response by Four Courses of Neoadjuvant Chemotherapy for Gastric Cancer: Early Results of the Randomized Phase II COMPASS Trial |
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| Authors: | Takaki Yoshikawa MD PhD Kazuaki Tanabe MD Kazuhiro Nishikawa MD Yuichi Ito MD Takanori Matsui MD Yutaka Kimura MD PhD Naoki Hirabayashi MD Shoki Mikata MD Makoto Iwahashi MD Ryoji Fukushima MD Nobuhiro Takiguchi MD Isao Miyashiro MD Satoshi Morita PhD Yumi Miyashita Aakira Tsuburaya MD Junichi Sakamoto MD |
| Institution: | 1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan 2. Department of Gastrointestinal Surgery, Hiroshima University, Hiroshima, Japan 3. Department of Surgery, Osaka General Medical Center, Osaka, Japan 4. Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan 5. Department of Surgery, Aichi Cancer Center, Aichi Hospital, Okazaki, Japan 6. Department of Surgery, NTT West Japan Osaka Hospital, Osaka, Japan 7. Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan 8. Department of Upper Gastrointestinal Surgery, Osaka-Rosai Hospital, Osaka, Japan 9. Department of Surgery, Wakayama Medical University, Wakayama, Japan 10. Department of Surgery, Teikyo University, Tokyo, Japan 11. Department of Gastroenterological Surgery, Chiba Cancer Center, Chiba, Japan 12. Department of Gastrointestinal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan 13. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan 14. Data Center, Nonprofit Organization ECRIN, Aichi, Japan 15. Young Leaders’ Program, Nagoya University Graduate School of Medicine, Nagoya, Japan |
| Abstract: | BackgroundThe prognosis for stage 3 gastric cancer is not satisfactory, even with S-1 adjuvant chemotherapy. A randomized phase II trial was conducted to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) using a two-by-two factorial design for locally advanced gastric cancer. The primary endpoint was overall survival. We clarified the impact of these regimens on the secondary endpoints, including the clinical and pathological responses, chemotherapy-related toxicities, and surgical results.MethodsPatients received S-1 (80 mg/m2 for 21 days with 1 week’s rest)/cisplatin (60 mg/m2 at day 8) or paclitaxel/cisplatin (80 and 25 mg/m2, respectively, on days 1, 8, and 15 with 1 week’s rest) as neoadjuvant chemotherapy.ResultsEighty-three patients were assigned to arm A (two courses of SC, n = 21), arm B (four courses of SC, n = 20), arm C (two courses of PC, n = 21), and arm D (four courses of PC, n = 21). Pathological response rate was 43 % in arm A, 40 % in arm B, 29 % in arm C, and 38 % in arm D. Pathological complete response was only observed in arms B (10 %) and D (10 %). Most bone marrow toxicities, nausea, vomiting, alopecia, and fatigue were slightly higher but acceptable in arms B and D. Grade 3/4 surgical morbidities were not commonly observed in all four arms.ConclusionsPathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities, regardless of a SC or PC regimen. |
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