Neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) in locally advanced gastric cancer: a prospective phase II study.
Neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) in locally advanced gastric cancer: a prospective phase II study.
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DOI：
10.1007/s10120-003-0245-4
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发表时间：
2003-01-01
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影响因子：
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通讯作者：
Fink, Ulrich
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文献类型：
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作者：
Ott, Katja;Sendler, Andreas;Fink, Ulrich
背景：局部进展期胃癌（cT 3，cT 4，N+，M0）患者，即使完全切除，预后也很差。本研究的目的是评价PLF（顺铂/亚叶酸[亚叶酸]/5-氟尿嘧啶[FU]）方案新辅助化疗在这些患者中的毒性和疗效。研究的主要终点是毒性和对化疗的反应。次要终点是完全切除率，生存率和第一个网站failure.METHODS：49例胃腺癌患者参加。根据腹部计算机断层扫描（CT）、超声内镜和腹腔镜进行分期。目的是进行两个周期（每个周期包含六个疗程）的术前化疗，包括顺铂50 mg/m2，高剂量亚叶酸（HD-FA）500 mg/m2和HD 5-FU（HD-5-FU）2000 mg/m2（PLF）。化疗后，所有患者均接受手术治疗。要评估的反应，生存，和第一个网站的失败，病人必须接受至少一个周期的化疗。结果：观察到的毒性是低的，3级毒性在不到5%的患者和两个事件的4级毒性（腹泻和肺栓塞）。42例患者（86%）接受了至少一个周期的化疗。这些患者的临床应答率为26%（11/42例患者）。在76%的患者（32/42）中，完全切除是可能的。存活患者的中位随访时间为58个月（范围：38至80+个月）。42例可评估缓解的患者的中位生存时间为25.4个月（范围：6至80+个月）。完全切除后，中位生存时间为32个月（范围，7.6至80+个月）。临床反应患者的中位生存时间尚未确定，但5年生存率为90%。32例完全切除的患者中有20例（62.5%）复发。失败的第一个网站是腹膜传播10例;局部和远处复发是罕见的。结论：新辅助化疗与PLF局部晚期胃癌患者的毒性低，疗效合理，允许管理门诊的基础上。临床反应良好的患者在完全切除后有很好的预后。新辅助化疗和完全切除后腹膜播散的发展仍然是非肠型肿瘤患者未解决的问题。
BACKGROUND: Patients with locally advanced gastric cancer (cT3, cT4, N+, M0) have a dismal prognosis, despite complete resection. The objective of this study was to evaluate the toxicity and efficacy of neoadjuvant chemotherapy using the PLF (cisplatin/leucovorin [folinic acid]/5-fluorouracil [FU]) regimen in these patients. Primary endpoints of the study were the toxicity and the response to chemotherapy. Secondary endpoints were the rate of complete resection, survival, and first site of failure.METHODS: Forty-nine patients with adenocarcinoma of the stomach were enrolled. Staging was based on abdominal computed tomography (CT) scans, endosonography, and laparoscopy. The intention was to administer two cycles (each containing six courses) of preoperative chemotherapy, consisting of cisplatin 50 mg/m(2), high-dose folinic acid (HD-FA) 500 mg/m(2), and HD 5-FU (HD-5-FU) 2000 mg/m(2) (PLF). Following chemotherapy all patients were referred to surgery. To be evaluable for response, survival, and first site of failure, the patient had to receive at least one cycle of chemotherapy.RESULTS: Toxicity observed was low, with grade 3 toxicity in fewer than 5% of the patients and two events of grade 4 toxicity (diarrhea and pulmonary embolism). Forty-two of the patients (86%) received at least one cycle of chemotherapy. The clinical response rate in these patients was 26% (11/42 patients). In 76% of the patients (32/42), a complete resection was possible. The median duration of follow-up for the surviving patients was 58 months (range, 38 to 80+ months). The median survival time for the 42 patients assessable for response was 25.4 months (range, 6 to 80+ months). After complete resection, median survival time was 32 months (range, 7.6 to 80+ months). The median survival time for clinically responding patients has not yet been determined, but 5-year survival is 90%. Twenty of the 32 completely resected patients (62.5%) had recurrences. First site of failure was peritoneal dissemination in 10 patients; locoregional and distant recurrences were rare.CONCLUSION: Neoadjuvant chemotherapy with PLF in patients with locally advanced gastric cancer has low toxicity and reasonable efficacy, allowing administration on an outpatient basis. Clinically responding patients have an excellent outcome after complete resection. The development of peritoneal dissemination even after neoadjuvant chemotherapy and complete resection remains an unsolved problem in patients with nonintestinal type tumors.