Abstract
A phase II trial was performed to evaluate the efficacy and toxicity of a double modulation of 5-fluorouracil (5-FU) by methotrexate (MTX) and L- leucovorin (L-LV) in patients with advanced recurrent (inoperable) or metastatic colorectal carcinoma (ACC). Between July 1993 and October 1995, 41 patients with ACC received a regimen that consisted of MTX 150 mg/m2 i.v., infused over a 20-minute period at hour 0, followed 19 hours later by L-LV 250 mg/m2 in a 2-hour i.v. infusion. 5-FU, 900 mg/m2, was administered by i.v. push injection at hour 20. Beginning 24 hours after MTX administration, all patients received four doses of L-LV, 15 mg/m2 i.m., every 6 hours. Cycles were repeated every 15 days. Two patients were not assessable for response. Objective regression was observed in 11 of 39 (28%) patients, [95% confidence interval (CI), 14-42%]. One (2%) patient achieved complete response (CR) and 10 (26%) partial response (PR). No change was recorded in 15 (39%) patients and progressive disease was noted in 13 (33%) patients. The median time to treatment failure was 6 months and the median survival time was 10 months. Toxicity was within acceptable limits, but one therapy- related death due to severe leukopenia was observed. The dose-limiting toxicity was mucositis. Eight episodes of grade 3 or 4 stomatitis were observed, and were responsible for dosage modifications of MTX and 5-FU. In conclusion, further in experimental and clinical studies are clearly necessary in order to design the best modulatory strategy of 5-FU.
| Original language | English |
|---|---|
| Pages (from-to) | 94-98 |
| Number of pages | 5 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Feb 1998 |
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Keywords
- 5-FU
- Biomodulation
- Colorectal cancer
- L-leucovorin
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Double modulation of 5-fluorouracil by methotrexate and high-dose K- leucovorin in advanced colorectal cancer. / Romero, A. O.; Perez, J. E.; Cuevas, M. A.; Lacava, J. A.; Sabatini, C. L.; Dominguez, M. E.; Rodriguez, R.; Barbieri, M. R.; Ortiz, E. H.; Salvadori, M. A.; Romero Acuña, L. A.; Romero Acuña, J. M.; Langhi, M. J.; Amato, S.; Machiavelli, M. R.; Leone, B. A.; Vallejo, C. T.; Lorusso, V.; DeLena, M.
In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 21, No. 1, 02.1998, p. 94-98.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Double modulation of 5-fluorouracil by methotrexate and high-dose K- leucovorin in advanced colorectal cancer
AU - Romero, A. O.
AU - Perez, J. E.
AU - Cuevas, M. A.
AU - Lacava, J. A.
AU - Sabatini, C. L.
AU - Dominguez, M. E.
AU - Rodriguez, R.
AU - Barbieri, M. R.
AU - Ortiz, E. H.
AU - Salvadori, M. A.
AU - Romero Acuña, L. A.
AU - Romero Acuña, J. M.
AU - Langhi, M. J.
AU - Amato, S.
AU - Machiavelli, M. R.
AU - Leone, B. A.
AU - Vallejo, C. T.
AU - Lorusso, V.
AU - DeLena, M.
PY - 1998/2
Y1 - 1998/2
N2 - A phase II trial was performed to evaluate the efficacy and toxicity of a double modulation of 5-fluorouracil (5-FU) by methotrexate (MTX) and L- leucovorin (L-LV) in patients with advanced recurrent (inoperable) or metastatic colorectal carcinoma (ACC). Between July 1993 and October 1995, 41 patients with ACC received a regimen that consisted of MTX 150 mg/m2 i.v., infused over a 20-minute period at hour 0, followed 19 hours later by L-LV 250 mg/m2 in a 2-hour i.v. infusion. 5-FU, 900 mg/m2, was administered by i.v. push injection at hour 20. Beginning 24 hours after MTX administration, all patients received four doses of L-LV, 15 mg/m2 i.m., every 6 hours. Cycles were repeated every 15 days. Two patients were not assessable for response. Objective regression was observed in 11 of 39 (28%) patients, [95% confidence interval (CI), 14-42%]. One (2%) patient achieved complete response (CR) and 10 (26%) partial response (PR). No change was recorded in 15 (39%) patients and progressive disease was noted in 13 (33%) patients. The median time to treatment failure was 6 months and the median survival time was 10 months. Toxicity was within acceptable limits, but one therapy- related death due to severe leukopenia was observed. The dose-limiting toxicity was mucositis. Eight episodes of grade 3 or 4 stomatitis were observed, and were responsible for dosage modifications of MTX and 5-FU. In conclusion, further in experimental and clinical studies are clearly necessary in order to design the best modulatory strategy of 5-FU.
AB - A phase II trial was performed to evaluate the efficacy and toxicity of a double modulation of 5-fluorouracil (5-FU) by methotrexate (MTX) and L- leucovorin (L-LV) in patients with advanced recurrent (inoperable) or metastatic colorectal carcinoma (ACC). Between July 1993 and October 1995, 41 patients with ACC received a regimen that consisted of MTX 150 mg/m2 i.v., infused over a 20-minute period at hour 0, followed 19 hours later by L-LV 250 mg/m2 in a 2-hour i.v. infusion. 5-FU, 900 mg/m2, was administered by i.v. push injection at hour 20. Beginning 24 hours after MTX administration, all patients received four doses of L-LV, 15 mg/m2 i.m., every 6 hours. Cycles were repeated every 15 days. Two patients were not assessable for response. Objective regression was observed in 11 of 39 (28%) patients, [95% confidence interval (CI), 14-42%]. One (2%) patient achieved complete response (CR) and 10 (26%) partial response (PR). No change was recorded in 15 (39%) patients and progressive disease was noted in 13 (33%) patients. The median time to treatment failure was 6 months and the median survival time was 10 months. Toxicity was within acceptable limits, but one therapy- related death due to severe leukopenia was observed. The dose-limiting toxicity was mucositis. Eight episodes of grade 3 or 4 stomatitis were observed, and were responsible for dosage modifications of MTX and 5-FU. In conclusion, further in experimental and clinical studies are clearly necessary in order to design the best modulatory strategy of 5-FU.
KW - 5-FU
KW - Biomodulation
KW - Colorectal cancer
KW - L-leucovorin
UR - http://www.scopus.com/inward/record.url?scp=0031891542&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031891542&partnerID=8YFLogxK
U2 - 10.1097/00000421-199802000-00022
DO - 10.1097/00000421-199802000-00022
M3 - Article
C2 - 9499269
AN - SCOPUS:0031891542
VL - 21
SP - 94
EP - 98
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 1
ER -