Neoadjuvant chemotherapy with P-ELF (cisplatin, etoposide, leucovorin, 5-fluorouracil) followed by radical resection in patients with initially unresectable gastric adenocarcinoma: A phase II study

Background: Gastric cancer is the most frequent gastrointestinal cancer in Mexico. Only 33% of cases are resectable. Our aim was to determine the acti vity and toxicity of the cisplatin, etoposide, leucovorin, and 5-fluorourac il combination in initially unresectable tumors and to determine its abilit y to permit resection. Methods: Sixty patients with unresectable gastric adenocarcinoma were treat ed with cisplatin 80 mg/m(2), etoposide 80 mg/m(2), leucovorin 25 mg/m(2), and 5-fluorouracil 800 mg/m(2) by central intravenous catheter for 4 consec utive days. Two courses of this combination were followed by surgical resec tion. Results: The overall response rate was 36.8% (20 partial responses and one complete response). By using logistic regression analysis, the tumor, node, and metastasis stage (risk ratio, 2.04; 95% confidence interval, 1.03-4.02 ; P = .039) was identified as the response determinant to chemotherapy. Maj or toxicity was grade 3 or 4 neutropenia in 67% of patients. Ten resections were performed (17.5%); five were curative and five palliative. Operative morbidity and mortality rates were 40% and 10%, respectively. The median le ngth of survival was 7.46 and 13.3 months for nonresponders and responders, respectively (P = .011). Conclusions: The cisplatin, etoposide, leucovorin, and 5-fluorouracil combi nation is active in advanced gastric cancer and the toxicity level is accep table. This treatment permits a 17.5% resection rate in previously unresect able tumors. A randomized trial of surgery vs, neoadjuvant chemotherapy plu s surgery is warranted.