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 language | English |
|---|---|
| Pages (from-to) | 307-310 |
| Number of pages | 4 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 19 |
| Issue number | 3 |
| Publication status | Published - Jun 1996 |
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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 journal › Article
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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 -