Abstract
The purpose of the study was to establish the maximum tolerated dose of ifosfamide, administered over 72 hr, in metastatic breast cancer patients, pretreated with chemotherapy. Ifosfamide and mesna were given at the same dose, in the same solution, using a portable Pharmacia CADD-1 pump connected to a central venous access, at three dose levels: 7.5 g/m2 (6 patients), 9 g/m2 (8 patients), 10.5 g/m2 (3 patients); the courses were repeated every 3 weeks. Seventeen patients with a median age of 55 years (range, 34-68) and median performance status of 0 (range, 0-2) were treated. The patients were pretreated with a median of 2 (range, 1-3) prior regimens including anthracyclines in 14 patients and paclitaxel in 9. Dose-limiting toxicity was defined as the occurrence of any of the following events in ≤ 2/6 patients: absolute neutrophil count 7 days or 3 days; febrile neutropenia; grade 4 thrombocytopenia; any grade ≤ 3 nonhematologic toxicity. The dose-limiting toxicities were febrile neutropenia and grade 4 thrombocytopenia in 2/3 patients treated at 10.5 g/m2. Seven patients achieved an objective response (response rate 41%; 95% Cl, 18% to 67%). We conclude that 72-hr infusion of ifosfamide is feasible in ambulatory patients. The recommended dose for phase II studies is 9 g/m2, with courses repeated every 21 days.
| Original language | English |
|---|---|
| Pages (from-to) | 826-828 |
| Number of pages | 3 |
| Journal | Tumori |
| Volume | 83 |
| Issue number | 5 |
| Publication status | Published - Sep 1997 |
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Keywords
- Breast cancer
- Ifosfamide
ASJC Scopus subject areas
- Cancer Research
Cite this
A dose-finding study of ifosfamide by three-day continuous infusion in pretreated, advanced breast cancer patients. / Michelotti, Andrea; Salvadori, Barbara; Donati, Sara; Tognoni, Alessandra; Tibaldi, Carmelo; Conte, Pier Franco.
In: Tumori, Vol. 83, No. 5, 09.1997, p. 826-828.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A dose-finding study of ifosfamide by three-day continuous infusion in pretreated, advanced breast cancer patients
AU - Michelotti, Andrea
AU - Salvadori, Barbara
AU - Donati, Sara
AU - Tognoni, Alessandra
AU - Tibaldi, Carmelo
AU - Conte, Pier Franco
PY - 1997/9
Y1 - 1997/9
N2 - The purpose of the study was to establish the maximum tolerated dose of ifosfamide, administered over 72 hr, in metastatic breast cancer patients, pretreated with chemotherapy. Ifosfamide and mesna were given at the same dose, in the same solution, using a portable Pharmacia CADD-1 pump connected to a central venous access, at three dose levels: 7.5 g/m2 (6 patients), 9 g/m2 (8 patients), 10.5 g/m2 (3 patients); the courses were repeated every 3 weeks. Seventeen patients with a median age of 55 years (range, 34-68) and median performance status of 0 (range, 0-2) were treated. The patients were pretreated with a median of 2 (range, 1-3) prior regimens including anthracyclines in 14 patients and paclitaxel in 9. Dose-limiting toxicity was defined as the occurrence of any of the following events in ≤ 2/6 patients: absolute neutrophil count 7 days or 3 days; febrile neutropenia; grade 4 thrombocytopenia; any grade ≤ 3 nonhematologic toxicity. The dose-limiting toxicities were febrile neutropenia and grade 4 thrombocytopenia in 2/3 patients treated at 10.5 g/m2. Seven patients achieved an objective response (response rate 41%; 95% Cl, 18% to 67%). We conclude that 72-hr infusion of ifosfamide is feasible in ambulatory patients. The recommended dose for phase II studies is 9 g/m2, with courses repeated every 21 days.
AB - The purpose of the study was to establish the maximum tolerated dose of ifosfamide, administered over 72 hr, in metastatic breast cancer patients, pretreated with chemotherapy. Ifosfamide and mesna were given at the same dose, in the same solution, using a portable Pharmacia CADD-1 pump connected to a central venous access, at three dose levels: 7.5 g/m2 (6 patients), 9 g/m2 (8 patients), 10.5 g/m2 (3 patients); the courses were repeated every 3 weeks. Seventeen patients with a median age of 55 years (range, 34-68) and median performance status of 0 (range, 0-2) were treated. The patients were pretreated with a median of 2 (range, 1-3) prior regimens including anthracyclines in 14 patients and paclitaxel in 9. Dose-limiting toxicity was defined as the occurrence of any of the following events in ≤ 2/6 patients: absolute neutrophil count 7 days or 3 days; febrile neutropenia; grade 4 thrombocytopenia; any grade ≤ 3 nonhematologic toxicity. The dose-limiting toxicities were febrile neutropenia and grade 4 thrombocytopenia in 2/3 patients treated at 10.5 g/m2. Seven patients achieved an objective response (response rate 41%; 95% Cl, 18% to 67%). We conclude that 72-hr infusion of ifosfamide is feasible in ambulatory patients. The recommended dose for phase II studies is 9 g/m2, with courses repeated every 21 days.
KW - Breast cancer
KW - Ifosfamide
UR - http://www.scopus.com/inward/record.url?scp=0031408347&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031408347&partnerID=8YFLogxK
M3 - Article
C2 - 9428916
AN - SCOPUS:0031408347
VL - 83
SP - 826
EP - 828
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 5
ER -