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局部晚期和不可切除胃癌的术前化疗:依托泊苷、阿霉素和顺铂的II期研究

Preoperative chemotherapy in locally advanced and nonresectable gastric cancer: a phase II study with etoposide, doxorubicin, and cisplatin.

作者信息

Wilke H, Preusser P, Fink U, Gunzer U, Meyer H J, Meyer J, Siewert J R, Achterrath W, Lenaz L, Knipp H

机构信息

Department of Hematology/Oncology, Hannover University, Medical School, West Germany.

出版信息

J Clin Oncol. 1989 Sep;7(9):1318-26. doi: 10.1200/JCO.1989.7.9.1318.

DOI:10.1200/JCO.1989.7.9.1318
PMID:2769330
Abstract

Thirty-four patients with locally advanced, nonresectable gastric cancer (staged by laparotomy) received etoposide, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and cisplatin (EAP). Thirty-three patients were evaluable for response and toxicity. Second-look surgery with removal of residual tumor by gastrectomy and lymphadenectomy was performed in case of complete/partial remission (CR/PR) after EAP. After successful resection (R0- and R1-resection), two cycles of EAP were administered for consolidation therapy. Patients refusing reoperation received up to six cycles of EAP. The response rate (CR/PR) after EAP was 70% (23/33), including a 21% (7/33) rate of clinical CRs (CCRs). Two patients had minor remission (MR)/no change and seven had progressive disease. There was one early death. Nineteen of 23 responders (5 CCRs, 14 clinical PRs [CPRs]) and one patient with MR underwent second-look surgery. Five CCRs were pathologically confirmed; 10 patients with CPR were without evidence of disease (NED) after resection. In three patients (CPR), R1-resections (microscopically tumor-cell positive proximal margin) were performed; two patients are disease-free, 22+ and 33+ months after consolidation chemotherapy. In two patients, the tumor was again considered nonresectable. Twenty patients were disease-free after EAP +/- surgery +/- consolidation chemotherapy. Toxicity was primarily hematologic. Leukopenia and thrombocytopenia of World Health Organization (WHO) grade 3 occurred in 30% and 9%, respectively and grade 4 in 18% and 9% of the patients, respectively. There was no increased peri- or postoperative morbidity. After a median follow-up of 20 months for disease-free patients, the relapse rate is 60% (12/20). The median survival time for all patients is 18 months and for disease-free patients 24 months. EAP is highly effective in locally advanced gastric cancer, and offers a chance for surgery with curative intention in patients with an otherwise fatal prognosis.

摘要

34例局部晚期、不可切除的胃癌患者(经剖腹探查分期)接受了依托泊苷、阿霉素(多柔比星;阿德里亚实验室,俄亥俄州哥伦布市)和顺铂(EAP方案)治疗。33例患者可评估疗效和毒性。若EAP方案治疗后达到完全/部分缓解(CR/PR),则行二次手术,通过胃切除术和淋巴结清扫术切除残留肿瘤。成功切除(R0和R1切除)后,给予两个周期的EAP方案进行巩固治疗。拒绝再次手术的患者接受最多六个周期的EAP方案治疗。EAP方案治疗后的缓解率(CR/PR)为70%(23/33),其中临床完全缓解(CCR)率为21%(7/33)。2例患者病情轻度缓解(MR)/无变化,7例患者病情进展。有1例早期死亡。23例缓解患者中的19例(5例CCR,14例临床部分缓解[CPR])和1例MR患者接受了二次手术。5例CCR经病理证实;10例CPR患者术后无疾病证据(NED)。3例患者(CPR)进行了R1切除(显微镜下肿瘤细胞阳性近端切缘);2例患者在巩固化疗后22个月和33个月无疾病。2例患者肿瘤再次被认为不可切除。20例患者在EAP±手术±巩固化疗后无疾病。毒性主要为血液学毒性。世界卫生组织(WHO)3级白细胞减少和血小板减少分别发生在30%和9%的患者中,4级分别发生在18%和9%的患者中。围手术期或术后发病率无增加。无疾病患者的中位随访时间为20个月,复发率为60%(12/20)。所有患者的中位生存时间为18个月,无疾病患者为24个月。EAP方案对局部晚期胃癌高度有效,并为预后不良的患者提供了根治性手术的机会。

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