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Annals of Surgical Oncology, Vol 7, Issue 1 45-50, Copyright © 2000 by Society of Surgical Oncology


ARTICLES

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

D. Gallardo-Rincon, L. F. Onate-Ocana and G. Calderillo-Ruiz
Medical Oncology Department, Instituto Nacional de Cancerologia, Tlalpan, Mexico DF, Mexico.

BACKGROUND: Gastric cancer is the most frequent gastrointestinal cancer in Mexico. Only 33% of cases are resectable. Our aim was to determine the activity and toxicity of the cisplatin, etoposide, leucovorin, and 5-fluorouracil combination in initially unresectable tumors and to determine its ability to permit resection. METHODS: Sixty patients with unresectable gastric adenocarcinoma were treated with cisplatin 80 mg/m2, etoposide 80 mg/m2, leucovorin 25 mg/m2, and 5-fluorouracil 800 mg/m2 by central intravenous catheter for 4 consecutive days. Two courses of this combination were followed by surgical resection. 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. Major 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 length of survival was 7.46 and 13.3 months for nonresponders and responders, respectively (P = .011). CONCLUSIONS: The cisplatin, etoposide, leucovorin, and 5-fluorouracil combination is active in advanced gastric cancer and the toxicity level is acceptable. This treatment permits a 17.5% resection rate in previously unresectable tumors. A randomized trial of surgery vs. neoadjuvant chemotherapy plus surgery is warranted.


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