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 |
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Authors: | Dolores Gallardo-Rincón MD Luis F. Oñate-Ocaña MD Germán Calderillo-Ruiz MD |
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Affiliation: | (1) Medical Oncology Department, Internal Medicine Division Instituto Nacional de Cancerología, Mexico D. F., Mexico;(2) Gastroenterology Department, Surgery Division, Instituto Nacional de Cancerología, Mexico D. F., Mexico;(3) Departamento de Gastroenterología, Instituto Nacional de Cancerología, Avenida San Fernando 22, Colonia Toriello Guerra, Tlalpan, México D. F., 14000, México |
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Abstract: | 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 5.039) 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 5.011).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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Keywords: | Gastric adenocarcinoma Neoadjuvant chemotherapy Unresectable Radical surgery P-ELF combination |
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