Abstract
Twenty-two patients with metastatic colorectal cancer entered a Phase I- II trial to assess the maximum tolerable dose of alpha-2B-interferon administered intramuscularly three times per week in combination with fixed doses of 5-fluorouracil (450 mg/m2 IV for 5 days, and, from day 28, weekly) and folinic acid (200 mg/m2 IV before 5-fluorouracil) and the efficacy of this combination. Diarrhea and mucositis were the most frequent 5- fluorouracil-related toxicities and were ≥ECOG grade 3 in 23% and 18% of patients, respectively. Of 15 patients receiving interferon ≥9 x 106 IU, 10 required interferon dose reduction mostly because of severe fatigue, anorexia, and declining performance status. Among 19 patients evaluable for response, 3 achieved a partial response and 1 a complete response for an overall response rate of 21% (95% confidence interval, 6-46%). In conclusion, our study demonstrates that IFN-α2B at doses higher than 6 x 106 IU intramuscularly three times per week in the combination with 5-fluorouracil and folinic acid we used is too toxic for the majority of patients; this combination has moderate activity in metastatic colorectal cancer, although similar response rates have been reported, with less toxicity, with 5- fluorouracil plus folinic acid without IFN-α. A larger Phase III study would be required to determine the value of IFN-α in this combination.
| Original language | English |
|---|---|
| Pages (from-to) | 210-214 |
| Number of pages | 5 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 17 |
| Issue number | 3 |
| Publication status | Published - 1994 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Double 5-fluorouracil modulation with folinic acid and recombinant alpha- 2B-interferon : A Phase I-II study in metastatic colorectal cancer patients. / Brunetti, I.; Falcone, A.; Bertuccelli, M.; Cianci, C.; Ricci, S.; Conte, P. F.
In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 17, No. 3, 1994, p. 210-214.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Double 5-fluorouracil modulation with folinic acid and recombinant alpha- 2B-interferon
T2 - A Phase I-II study in metastatic colorectal cancer patients
AU - Brunetti, I.
AU - Falcone, A.
AU - Bertuccelli, M.
AU - Cianci, C.
AU - Ricci, S.
AU - Conte, P. F.
PY - 1994
Y1 - 1994
N2 - Twenty-two patients with metastatic colorectal cancer entered a Phase I- II trial to assess the maximum tolerable dose of alpha-2B-interferon administered intramuscularly three times per week in combination with fixed doses of 5-fluorouracil (450 mg/m2 IV for 5 days, and, from day 28, weekly) and folinic acid (200 mg/m2 IV before 5-fluorouracil) and the efficacy of this combination. Diarrhea and mucositis were the most frequent 5- fluorouracil-related toxicities and were ≥ECOG grade 3 in 23% and 18% of patients, respectively. Of 15 patients receiving interferon ≥9 x 106 IU, 10 required interferon dose reduction mostly because of severe fatigue, anorexia, and declining performance status. Among 19 patients evaluable for response, 3 achieved a partial response and 1 a complete response for an overall response rate of 21% (95% confidence interval, 6-46%). In conclusion, our study demonstrates that IFN-α2B at doses higher than 6 x 106 IU intramuscularly three times per week in the combination with 5-fluorouracil and folinic acid we used is too toxic for the majority of patients; this combination has moderate activity in metastatic colorectal cancer, although similar response rates have been reported, with less toxicity, with 5- fluorouracil plus folinic acid without IFN-α. A larger Phase III study would be required to determine the value of IFN-α in this combination.
AB - Twenty-two patients with metastatic colorectal cancer entered a Phase I- II trial to assess the maximum tolerable dose of alpha-2B-interferon administered intramuscularly three times per week in combination with fixed doses of 5-fluorouracil (450 mg/m2 IV for 5 days, and, from day 28, weekly) and folinic acid (200 mg/m2 IV before 5-fluorouracil) and the efficacy of this combination. Diarrhea and mucositis were the most frequent 5- fluorouracil-related toxicities and were ≥ECOG grade 3 in 23% and 18% of patients, respectively. Of 15 patients receiving interferon ≥9 x 106 IU, 10 required interferon dose reduction mostly because of severe fatigue, anorexia, and declining performance status. Among 19 patients evaluable for response, 3 achieved a partial response and 1 a complete response for an overall response rate of 21% (95% confidence interval, 6-46%). In conclusion, our study demonstrates that IFN-α2B at doses higher than 6 x 106 IU intramuscularly three times per week in the combination with 5-fluorouracil and folinic acid we used is too toxic for the majority of patients; this combination has moderate activity in metastatic colorectal cancer, although similar response rates have been reported, with less toxicity, with 5- fluorouracil plus folinic acid without IFN-α. A larger Phase III study would be required to determine the value of IFN-α in this combination.
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M3 - Article
VL - 17
SP - 210
EP - 214
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 3
ER -