5-Fluorouracil Administered as a 48-Hour Semiintermittent Infusion in Combination with Leucovorin, Cisplatin and Epirubicin

Phase II Study in Advanced Gastric Cancer Patients

Giacomo Allegrini, Alfredo Falcone, Roberta Di Marsico, Monica Lencioni, Gianluca Masi, Costanza Galli, Samanta Cupini, Elisabetta Pfanner, Lorenzo Marcucci, Pier Franco Conte

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

The main objective of this study was to determine the feasibility and the antitumor activity of a chemotherapy regimen with a 48-hour infusion of 5-fluorouracil (5-FU), leucovorin (LV), cisplatin (CDDP), and epirubicin (EPIDX) administered every 3 weeks in patients with locally advanced or metastatic gastric cancer. Thirty-three patients received CDDP 60 mg/m2 over 30 minutes followed by 1-LV 250 mg/m2 over 2 hours followed by EPIDX 60 mg/m2 over 5 minutes (bolus) and followed by 5-FU 3,800 mg/m 2 as a 48-hour semiintermittent continuous infusion, with 67% of total daily dose administered between 4 pm and midnight. Four patients had a locally advanced disease and 29 had metastatic disease. A total of 171 cycles were administered. Most relevant toxicities were stomatitis (grade III in 2% of cycles and 12% of patients) and neutropenia (grade III-IV in 8% of cycles and 28% of patients) with 3 (9%) patients experiencing I episode of febrile neutropenia. No toxic deaths occurred. Thirty-one patients were evaluable for response. In 3 patients (9.6%) a complete response and in 11 patients (35.4%) a partial response was observed, for an objective response rate of 45% (95% C.I. 27-64%). Median progression-free and overall survival were 5.9 and 9.8 months, respectively. In conclusion, this regimen is feasible in an outpatient setting with acceptable and manageable toxicities, and it is associated with promising antitumor activity, time to progression, and survival.

Original languageEnglish
Pages (from-to)101-105
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume27
Issue number1
DOIs
Publication statusPublished - Feb 2004

Fingerprint

Epirubicin
Leucovorin
Fluorouracil
Cisplatin
Stomach Neoplasms
Febrile Neutropenia
Stomatitis
Poisons
Neutropenia
Disease-Free Survival
Outpatients
Drug Therapy
Survival

Keywords

  • 5-FU
  • Advanced gastric cancer
  • Cisplatin
  • Epirubicin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

5-Fluorouracil Administered as a 48-Hour Semiintermittent Infusion in Combination with Leucovorin, Cisplatin and Epirubicin : Phase II Study in Advanced Gastric Cancer Patients. / Allegrini, Giacomo; Falcone, Alfredo; Di Marsico, Roberta; Lencioni, Monica; Masi, Gianluca; Galli, Costanza; Cupini, Samanta; Pfanner, Elisabetta; Marcucci, Lorenzo; Conte, Pier Franco.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 27, No. 1, 02.2004, p. 101-105.

Research output: Contribution to journalArticle

Allegrini, Giacomo ; Falcone, Alfredo ; Di Marsico, Roberta ; Lencioni, Monica ; Masi, Gianluca ; Galli, Costanza ; Cupini, Samanta ; Pfanner, Elisabetta ; Marcucci, Lorenzo ; Conte, Pier Franco. / 5-Fluorouracil Administered as a 48-Hour Semiintermittent Infusion in Combination with Leucovorin, Cisplatin and Epirubicin : Phase II Study in Advanced Gastric Cancer Patients. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2004 ; Vol. 27, No. 1. pp. 101-105.
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abstract = "The main objective of this study was to determine the feasibility and the antitumor activity of a chemotherapy regimen with a 48-hour infusion of 5-fluorouracil (5-FU), leucovorin (LV), cisplatin (CDDP), and epirubicin (EPIDX) administered every 3 weeks in patients with locally advanced or metastatic gastric cancer. Thirty-three patients received CDDP 60 mg/m2 over 30 minutes followed by 1-LV 250 mg/m2 over 2 hours followed by EPIDX 60 mg/m2 over 5 minutes (bolus) and followed by 5-FU 3,800 mg/m 2 as a 48-hour semiintermittent continuous infusion, with 67{\%} of total daily dose administered between 4 pm and midnight. Four patients had a locally advanced disease and 29 had metastatic disease. A total of 171 cycles were administered. Most relevant toxicities were stomatitis (grade III in 2{\%} of cycles and 12{\%} of patients) and neutropenia (grade III-IV in 8{\%} of cycles and 28{\%} of patients) with 3 (9{\%}) patients experiencing I episode of febrile neutropenia. No toxic deaths occurred. Thirty-one patients were evaluable for response. In 3 patients (9.6{\%}) a complete response and in 11 patients (35.4{\%}) a partial response was observed, for an objective response rate of 45{\%} (95{\%} C.I. 27-64{\%}). Median progression-free and overall survival were 5.9 and 9.8 months, respectively. In conclusion, this regimen is feasible in an outpatient setting with acceptable and manageable toxicities, and it is associated with promising antitumor activity, time to progression, and survival.",
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