Induction of a Pathological Complete Response by Four Courses of Neoadjuvant Chemotherapy for Gastric Cancer: Early Results of the Randomized Phase II COMPASS Trial
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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DOI：
10.1245/s10434-013-3055-x
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发表时间：
2014-01-01
影响因子：
3.7
通讯作者：
Sakamoto, Junichi
中科院分区：
文献类型：
--
作者：
Yoshikawa, Takaki;Tanabe, Kazuaki;Sakamoto, Junichi
背景即使使用S-1辅助化疗，3期胃癌的预后也不理想。进行了一项随机II期试验，采用2 × 2析因设计比较局部晚期胃癌的2个和4个疗程的新辅助S-1/顺铂（SC）和紫杉醇/顺铂（PC）。主要终点是总生存期。我们阐明了这些方案对次要终点的影响，包括临床和病理学反应，化疗相关毒性和手术结果。患者接受S-1（80 mg/m2，21天，停药1周）/顺铂（60 mg/m2，第8天）或紫杉醇/顺铂（80和25 mg/m2，第1、8和15天，停药1周）作为新辅助化疗。83例患者被分配至A组（2个疗程的SC，n = 21）、B组（4个疗程的SC，n = 20）、C组（2个疗程的PC，n = 21）和D组（4个疗程的PC，n = 21）。A组、B组、C组和D组的病理学缓解率分别为43%、40%、29%和38%。仅在B组（10%）和D组（10%）中观察到病理学完全缓解。B组和D组的大多数骨髓毒性、恶心、呕吐、脱发和疲乏略高，但可接受。在所有四组中均未观察到3/4级手术发病率。无论SC或PC方案，4个疗程的新辅助化疗均可诱导病理完全缓解，且毒性无明显增加。
Background. The 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.Methods. Patients received S-1 (80 mg/m(2) for 21 days with 1 week's rest)/cisplatin (60 mg/m(2) at day 8) or paclitaxel/cisplatin (80 and 25 mg/m(2), respectively, on days 1, 8, and 15 with 1 week's rest) as neoadjuvant chemotherapy.Results. Eighty-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.Conclusions. Pathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities, regardless of a SC or PC regimen.