High-Dose Folinic Acid and Fluorouracil with or Without Ifosfamide Is an Inactive Combination in Advanced Pancreatic Cancer

A Randomized Phase II Study of the Italian Oncology Group for Clinical Research (G.O.I.R.C.)

F. Di Costanzo, M. Tagliaventi, P. Carlini, S. Zironi, B. Mazzocchi, M. Bella, D. Donati, L. Acito, P. Maggian, S. Angiona

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

The Italian Oncology Group for Clinical Research (GOIRC) randomized 55 naive patients with advanced pancreatic cancer (APC) between intravenous fluorouracil (5FU) 400 mg/m2, days 1-5 and folinic acid (FA) 200 mg/m2, days 1-5 alone, using Machover's schedule, or with FU, FA, and ifosfamide (IFO) 5 g/m2, day 1 and Mesna. In both arms, treatment was repeated every 28 days. Fifty-one patients were evaluable for response. The overall response rate was 6% (3 out of 51), 1 out of 29 (3%) complete response (CR) in the arm with FU plus FA, and 2 out of 22 (9%) partial responses (PR) in the arm with IFO. The duration of response rate was 39, 55, and 74 weeks, respectively. Median survival time was 21 weeks (range, 4-83 weeks) for 5FU/FA and 16 weeks (range, 3-106 weeks) for the FU/FA/IFO arm. Diarrhea, mucositis, and vomiting occurred in the majority of patients. One patient died due to toxicity. The combination of 5FU plus FA failed to demonstrate therapeutic activity in patients with APC and was associated with moderate to severe toxicity that could lower the quality of life of these patients. Ifosfamide did not potentiate the activity of this combination. Neither of these combinations should be considered for treatment of patients with APC.

Original languageEnglish
Pages (from-to)307-310
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume19
Issue number3
Publication statusPublished - Jun 1996

Fingerprint

Ifosfamide
Medical Oncology
Leucovorin
Pancreatic Neoplasms
Fluorouracil
Research
Mesna
Mucositis
Vomiting
Diarrhea
Appointments and Schedules
Therapeutics
Quality of Life
Survival

Keywords

  • 5FU
  • Chemotherapy
  • Folinic acid
  • Ifosfamide
  • Pancreatic carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

High-Dose Folinic Acid and Fluorouracil with or Without Ifosfamide Is an Inactive Combination in Advanced Pancreatic Cancer : A Randomized Phase II Study of the Italian Oncology Group for Clinical Research (G.O.I.R.C.). / Di Costanzo, F.; Tagliaventi, M.; Carlini, P.; Zironi, S.; Mazzocchi, B.; Bella, M.; Donati, D.; Acito, L.; Maggian, P.; Angiona, S.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 19, No. 3, 06.1996, p. 307-310.

Research output: Contribution to journalArticle

@article{d347e5697fda4552af269b7632ba4862,
title = "High-Dose Folinic Acid and Fluorouracil with or Without Ifosfamide Is an Inactive Combination in Advanced Pancreatic Cancer: A Randomized Phase II Study of the Italian Oncology Group for Clinical Research (G.O.I.R.C.)",
abstract = "The Italian Oncology Group for Clinical Research (GOIRC) randomized 55 naive patients with advanced pancreatic cancer (APC) between intravenous fluorouracil (5FU) 400 mg/m2, days 1-5 and folinic acid (FA) 200 mg/m2, days 1-5 alone, using Machover's schedule, or with FU, FA, and ifosfamide (IFO) 5 g/m2, day 1 and Mesna. In both arms, treatment was repeated every 28 days. Fifty-one patients were evaluable for response. The overall response rate was 6{\%} (3 out of 51), 1 out of 29 (3{\%}) complete response (CR) in the arm with FU plus FA, and 2 out of 22 (9{\%}) partial responses (PR) in the arm with IFO. The duration of response rate was 39, 55, and 74 weeks, respectively. Median survival time was 21 weeks (range, 4-83 weeks) for 5FU/FA and 16 weeks (range, 3-106 weeks) for the FU/FA/IFO arm. Diarrhea, mucositis, and vomiting occurred in the majority of patients. One patient died due to toxicity. The combination of 5FU plus FA failed to demonstrate therapeutic activity in patients with APC and was associated with moderate to severe toxicity that could lower the quality of life of these patients. Ifosfamide did not potentiate the activity of this combination. Neither of these combinations should be considered for treatment of patients with APC.",
keywords = "5FU, Chemotherapy, Folinic acid, Ifosfamide, Pancreatic carcinoma",
author = "{Di Costanzo}, F. and M. Tagliaventi and P. Carlini and S. Zironi and B. Mazzocchi and M. Bella and D. Donati and L. Acito and P. Maggian and S. Angiona",
year = "1996",
month = "6",
language = "English",
volume = "19",
pages = "307--310",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - High-Dose Folinic Acid and Fluorouracil with or Without Ifosfamide Is an Inactive Combination in Advanced Pancreatic Cancer

T2 - A Randomized Phase II Study of the Italian Oncology Group for Clinical Research (G.O.I.R.C.)

AU - Di Costanzo, F.

AU - Tagliaventi, M.

AU - Carlini, P.

AU - Zironi, S.

AU - Mazzocchi, B.

AU - Bella, M.

AU - Donati, D.

AU - Acito, L.

AU - Maggian, P.

AU - Angiona, S.

PY - 1996/6

Y1 - 1996/6

N2 - The Italian Oncology Group for Clinical Research (GOIRC) randomized 55 naive patients with advanced pancreatic cancer (APC) between intravenous fluorouracil (5FU) 400 mg/m2, days 1-5 and folinic acid (FA) 200 mg/m2, days 1-5 alone, using Machover's schedule, or with FU, FA, and ifosfamide (IFO) 5 g/m2, day 1 and Mesna. In both arms, treatment was repeated every 28 days. Fifty-one patients were evaluable for response. The overall response rate was 6% (3 out of 51), 1 out of 29 (3%) complete response (CR) in the arm with FU plus FA, and 2 out of 22 (9%) partial responses (PR) in the arm with IFO. The duration of response rate was 39, 55, and 74 weeks, respectively. Median survival time was 21 weeks (range, 4-83 weeks) for 5FU/FA and 16 weeks (range, 3-106 weeks) for the FU/FA/IFO arm. Diarrhea, mucositis, and vomiting occurred in the majority of patients. One patient died due to toxicity. The combination of 5FU plus FA failed to demonstrate therapeutic activity in patients with APC and was associated with moderate to severe toxicity that could lower the quality of life of these patients. Ifosfamide did not potentiate the activity of this combination. Neither of these combinations should be considered for treatment of patients with APC.

AB - The Italian Oncology Group for Clinical Research (GOIRC) randomized 55 naive patients with advanced pancreatic cancer (APC) between intravenous fluorouracil (5FU) 400 mg/m2, days 1-5 and folinic acid (FA) 200 mg/m2, days 1-5 alone, using Machover's schedule, or with FU, FA, and ifosfamide (IFO) 5 g/m2, day 1 and Mesna. In both arms, treatment was repeated every 28 days. Fifty-one patients were evaluable for response. The overall response rate was 6% (3 out of 51), 1 out of 29 (3%) complete response (CR) in the arm with FU plus FA, and 2 out of 22 (9%) partial responses (PR) in the arm with IFO. The duration of response rate was 39, 55, and 74 weeks, respectively. Median survival time was 21 weeks (range, 4-83 weeks) for 5FU/FA and 16 weeks (range, 3-106 weeks) for the FU/FA/IFO arm. Diarrhea, mucositis, and vomiting occurred in the majority of patients. One patient died due to toxicity. The combination of 5FU plus FA failed to demonstrate therapeutic activity in patients with APC and was associated with moderate to severe toxicity that could lower the quality of life of these patients. Ifosfamide did not potentiate the activity of this combination. Neither of these combinations should be considered for treatment of patients with APC.

KW - 5FU

KW - Chemotherapy

KW - Folinic acid

KW - Ifosfamide

KW - Pancreatic carcinoma

UR - http://www.scopus.com/inward/record.url?scp=0029975668&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029975668&partnerID=8YFLogxK

M3 - Article

VL - 19

SP - 307

EP - 310

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 3

ER -