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 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.
Gallardo-Rincón
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Medical Oncology Department, Instituto Nacional de Cancerología, Tlalpan, Mexico DF, Mexico.
Oñate-Ocaña
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Calderillo-Ruiz
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D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000714:Anastomosis, Surgical / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005743:Gastrectomy; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D058766:Levoleucovorin; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011300:Preoperative Care; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology / Q000601:surgery; D015996:Survival Rate
D005047:Etoposide; D058766:Levoleucovorin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil