TY - JOUR
T1 - Escalated therapy for refractory urothelial tumors
T2 - Methotrexate- vinblastine-doxorubicin- cisplatin plus unglycosylated recombinant human granulocyte-macrophage colony-stimulating factor
AU - Logothetis, Christopher J.
AU - Dexeus, Francisco H.
AU - Sella, Avishay
AU - Amato, Robert J.
AU - Kilbourn, Robert G.
AU - Finn, Laury
AU - Gutterman, Jordan U.
PY - 1990/4/18
Y1 - 1990/4/18
N2 - Thirty-two assessable patients with metastatic urothelial tumors refractory to standard chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were treated with escalated doses of MVAC plus unglycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Results of this phase I trial revealed that escalated MVAC (30 mg of methotrexate/m2,4 mg of vinblastine/m2, 60 mg of doxorubicin/m2, and 100 mg of cisplatin/m2) can be tolerated by heavily pretreated patients. The side effects of rhGM-CSF are dose- and schedule-dependent. The maximum tolerated dose is 250 μg/m2 per day as a single dose administered subcutaneously (SC) for 10 consecutive days. This dose is well tolerated in outpatients, resulting in only modest fever and few side effects. The same dose delivered as a continuous infusion or a higher dose delivered either as a continuous infusion or SC caused significant side effects. For phase II trials, the starting dose of rhGM-CSF when combined with escalated MVAC is 120 μg/m2 per day SC for 10 consecutive days. Forty percent of the treated patients responded, seven (23%) with complete remission and five (17%) with partial remission. This response rate is higher than anticipated from such a modest dosage escalation in chemotherapy-refractory patients. ]J Natl Cancer Inst 82: 667-672,1990[
AB - Thirty-two assessable patients with metastatic urothelial tumors refractory to standard chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were treated with escalated doses of MVAC plus unglycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Results of this phase I trial revealed that escalated MVAC (30 mg of methotrexate/m2,4 mg of vinblastine/m2, 60 mg of doxorubicin/m2, and 100 mg of cisplatin/m2) can be tolerated by heavily pretreated patients. The side effects of rhGM-CSF are dose- and schedule-dependent. The maximum tolerated dose is 250 μg/m2 per day as a single dose administered subcutaneously (SC) for 10 consecutive days. This dose is well tolerated in outpatients, resulting in only modest fever and few side effects. The same dose delivered as a continuous infusion or a higher dose delivered either as a continuous infusion or SC caused significant side effects. For phase II trials, the starting dose of rhGM-CSF when combined with escalated MVAC is 120 μg/m2 per day SC for 10 consecutive days. Forty percent of the treated patients responded, seven (23%) with complete remission and five (17%) with partial remission. This response rate is higher than anticipated from such a modest dosage escalation in chemotherapy-refractory patients. ]J Natl Cancer Inst 82: 667-672,1990[
UR - http://www.scopus.com/inward/record.url?scp=0025237013&partnerID=8YFLogxK
U2 - 10.1093/jnci/82.8.667
DO - 10.1093/jnci/82.8.667
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C2 - 2181151
AN - SCOPUS:0025237013
SN - 0027-8874
VL - 82
SP - 667
EP - 672
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 8
ER -