Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
Ann Surg Oncol. 2011 Dec;18(13):3726-31. doi: 10.1245/s10434-011-1770-8. Epub 2011 May 17.
The present study was designed to assess the feasibility and efficiency of intraperitoneal and intravenous neoadjuvant chemotherapy in gastric cancer patients with peritoneal dissemination.
The study subjects were 25 treatment-naïve patients with gastric cancer. Patients with positive cytology or with peritoneal carcinomatosis received neoadjuvant intraperitoneal and systemic chemotherapy (NIPS), comprising intraperitoneal (i.p.) mitomycin C (MMC) and cisplatin (CDDP), followed by two cycles of intravenous triplet chemotherapy of docetaxel, 5-fluorouracil (5-FU), and CDDP. Gastrectomy with lymph node dissection was performed after NIPS in patients free of peritoneal deposits, confirmed by staging laparoscopy.
Seventeen patients had measurable lymph node metastases by the RECIST criteria. CT examination showed response to the treatment in ten (59%, 0 complete response, 10 partial response). Of the 25 patients, 14 (56%) showed negative results on peritoneal cytology with no macroscopic peritoneal metastasis, whereas the remaining 11 were cancer cell-positive on peritoneal cytology or macroscopic peritoneal metastasis even after NIPS. The median survival time for all 25 patients was 16.7 months. Prognosis was better in patients who showed negative cytology and disappearance of peritoneal cancer metastases after NIPS than in those with positive cytology or existing peritoneal deposits (P < 0.0001). The predominant toxicity was myelosuppression and grade 3-4 leukopenia and neutropenia occurred in 20 (80%) patients, which were manageable. No treatment-related mortality was observed during and after NIPS and surgery.
The results of this prospective phase II study indicated that the newly designed NIPS was highly effective and well tolerated in patients with advanced gastric cancer and peritoneal dissemination.
本研究旨在评估腹腔内和静脉新辅助化疗在伴有腹膜转移的胃癌患者中的可行性和疗效。
研究对象为 25 例未经治疗的胃癌患者。细胞学阳性或腹膜转移患者接受新辅助腹腔内和全身化疗（NIPS），包括腹腔内（i.p.）丝裂霉素 C（MMC）和顺铂（CDDP），然后进行两周期的多西紫杉醇、5-氟尿嘧啶（5-FU）和 CDDP 静脉三联化疗。NIPS 后，在分期腹腔镜检查确认无腹膜沉积物的患者中进行胃切除术和淋巴结清扫。
17 例患者根据 RECIST 标准可测量淋巴结转移。CT 检查显示 10 例（59%，0 例完全缓解，10 例部分缓解）对治疗有反应。25 例患者中，14 例（56%）腹膜细胞学检查结果为阴性，无肉眼腹膜转移，而其余 11 例腹膜细胞学检查或肉眼腹膜转移阳性，即使经过 NIPS 治疗后也如此。25 例患者的中位总生存期为 16.7 个月。与腹膜细胞学检查阳性或存在腹膜沉积物的患者相比，NIPS 后腹膜细胞学检查阴性且腹膜癌转移消失的患者预后更好（P<0.0001）。主要毒性为骨髓抑制，20 例（80%）患者发生 3-4 级白细胞减少和中性粒细胞减少，可控制。NIPS 和手术期间及之后未观察到与治疗相关的死亡。
这项前瞻性 II 期研究的结果表明，新设计的 NIPS 对伴有腹膜转移的晚期胃癌患者具有高度疗效和良好耐受性。
