In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 4561-4561
Abstract:
4561 Background: Phase II and III trials combining docetaxel, cisplatin and fluorouracil (DCF) every 3 weeks (wks) have shown superior efficacy but high rates of hematological toxicity in advanced gastric cancer. To reduce toxicity while containing the efficacy of DCF, we conducted a protocol using split doses of docetaxel (T), cisplatin (P), leucovorin (L), fluorouracil (F) (T-PLF). Methods: Chemo-naive patients (pts) with advanced gastroesophageal adenocarcinomas received T 50 mg/m 2 , P 50 mg/m 2 day 1, 15, 29 and L 500 mg/m 2 plus F 2,000 mg/m 2 d1, 8, 15, 22, 29, 36 qd49. Because significant reductions to 〈 80% of initial drug doses became necessary in 80% of pts, the regimen was amended after the first 15 pts. After the amendment the agents were administered as follows: T 40 mg/m 2 , P 40 mg/m 2 , L 200 mg/m 2 , F 2,000 mg/m 2 . The primary objective was the overall response rate (ORR) according to RECIST. Results: From 03/04 to 08/05 we included 60 pts: median age 53 yrs, (26–76); 24 pts had locally advanced tumors (LA) and 36 pts had metastatic disease (MET). Pts received a median of 2 (range 0–4) cycles. Reductions to 〈 80% of drug doses were reported in 80% versus 60% of pts pre/post amendment. Reported adverse events were: neutropenia 23%, febrile neutropenia 5%, diarrhea 20%, nausea 8%, emesis 8% and fatigue 20%. The ORR according to RECIST was 46.6% (95%CI 33.3–61.4). Only 6.6% were primarily progressive. 23/24 pts with LA underwent secondary resection (96%). Complete resections (R0) were achieved in 87%. After a median follow-up of 25.5 months, median overall survival (OS) is 17.9 months (95%CI 11.5 -24.3). Median TTP is 9.4 months (95% CI 8.3–10.5). For pts with MET, median TTP is 8.1 months and median OS is 15.1 months. Conclusion: The T-PLF regimen is highly active, safe and has a favorable toxicity profile. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.4561
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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