A phase II trial of neoadjuvant cisplatin-fluorouracil followed by postoperative intraperitoneal floxuridine-leucovorin in patients with locally advanced gastric cancer Journal Article
| Authors: | Brenner, B.; Shah, M. A.; Karpeh, M. S.; Gonen, M.; Brennan, M. F.; Coit, D. G.; Klimstra, D. S.; Tang, L. H.; Kelsen, D. P. |
| Article Title: | A phase II trial of neoadjuvant cisplatin-fluorouracil followed by postoperative intraperitoneal floxuridine-leucovorin in patients with locally advanced gastric cancer |
| Abstract: | Background: The aim of the study was to evaluate the efficacy and toxicity of neoadjuvant chemotherapy with intravenous (i.v.) cisplatin and fluorouracil (5-FU), surgery and postoperative intraperitoneal (i.p.) floxuridine (FUdR) and leucovorin (LV) in patients with locally advanced gastric cancer. Patients and methods: Preoperative staging was confirmed by laparoscopy (LAP). Two cycles of i.v. cisplatin (20 mg/m 2/day, rapid infusion) and 5-FU (1000 mg/m 2, continuous 24-h infusion), given on days 1-5 and 29-34, were followed by a radical gastrectomy and a D2 lymphadenectomy. Patients having R0 resections were to receive three cycles of i.p. FUdR (1000 mg/m 2) and LV (240 mg/m 2), given on days 1-3, 15-17 and 29-31. Intraperitoneal chemotherapy was begun 5-10 days from surgery. Results: Thirty-eight patients were treated. Both preoperative and postoperative chemotherapy were well tolerated. T stage downstaging (pretreatment LAP versus surgical pathological stage) was seen in 23% of patients. The R0 resection rate was 84%. Neither an increase in postoperative morbidity nor operative mortality was noted. With a median follow-up of 43.0 months, 15 patients (39.5%) are still alive (median survival 30.3 months). Good pathologic response, seen in five patients (15%), was associated with better survival (P = 0.053). Peritoneal and hepatic failures were found in 22% and 9% of patients, respectively. Quality of life seemed to be preserved. Conclusions: Neoadjuvant cisplatin/5-FU followed by postoperative i.p. FUdR/LV can be safely delivered to patients undergoing radical gastrectomy and D2 lymphadenectomy. The R0 resection and the survival rates are encouraging. An association between pathologic response and patient outcome was suggested. © 2006 Oxford University Press. |
| Keywords: | adult; clinical article; controlled study; treatment outcome; aged; disease-free survival; middle aged; survival analysis; survival rate; treatment failure; overall survival; clinical trial; drug tolerability; fatigue; neutropenia; cancer localization; postoperative period; cisplatin; fluorouracil; advanced cancer; diarrhea; drug efficacy; postoperative care; chemotherapy, adjuvant; combined modality therapy; neoadjuvant therapy; cancer staging; follow up; neoplasm staging; laparoscopy; preoperative evaluation; lymphadenectomy; adenocarcinoma; quality of life; controlled clinical trial; phase 2 clinical trial; blood toxicity; leukopenia; nausea; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; dehydration; peripheral neuropathy; morbidity; continuous infusion; drug fatality; liver failure; feasibility studies; folinic acid; adjuvant chemotherapy; gastrectomy; surgical mortality; stomach cancer; neoadjuvant chemotherapy; floxuridine; leucovorin; stomach neoplasms; endoscopy, digestive system; peritoneal disease; injections, intraperitoneal; intraperitoneal treatment; locally advanced gastric cancer |
| Journal Title: | Annals of Oncology |
| Volume: | 17 |
| Issue: | 9 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2006-09-01 |
| Start Page: | 1404 |
| End Page: | 1411 |
| Language: | English |
| DOI: | 10.1093/annonc/mdl133 |
| PUBMED: | 16788003 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 17" - "Export Date: 4 June 2012" - "CODEN: ANONE" - "Source: Scopus" |
