Phase I Evaluation of Preirradiation Chemotherapy with Carmustine and Cisplatin and Accelerated Radiation Therapy in Patients with High-grade Gliomas

Phase I Evaluation of Preirradiation Chemotherapy with Carmustine and Cisplatin and Accelerated... AbstractOBJECTIVEA Phase I study was conducted to determine the safety, toxicity, and maximum tolerated dose of preirradiation chemotherapy using carmustine (BCNU) and cisplatin in the treatment of high-grade gliomas.METHODSPatients with newly diagnosed high-grade gliomas received BCNU and cisplatin after surgery, both before and during definitive radiation therapy. Preirradiation chemotherapy consisted of an administration of 40 mg/m2 BCNU on Days 1 through 3 and 30 mg/m2 cisplatin on Days 1 through 3 and 29 through 31 and repeated at 8 weeks to coincide with the start of radiation therapy. Postradiation chemotherapy consisted of an administration of 200 mg/m2 BCNU once every 8 weeks for four cycles. Radiation therapy consisted of 160-cGy fractions administered twice daily for 15 days, yielding a total dose of 4800 cGy. Dose escalation of BCNU was planned. If hematological toxicity was mild, the dose of cisplatin was to be held constant and BCNU dose escalated to 50 mg/m2 on Days 1 through 3.RESULTSEighteen patients were studied. The hematological toxicity was dose-limiting. Grade 3 or 4 leukopenia occurred in each of 10 patients (56%), and Grade 3 or 4 thrombocytopenia occurred in each of 9 patients (50%). Other toxicities included anorexia (94%), nausea (83%), emesis (33%), alopecia (94%), mild ototoxicity (50%), and, in one patient, death as a result of BCNU pulmonary toxicity. The median survival time was 14 months. Objective responses occurred in 45% of the patients evaluable for response. The maximum tolerated dose of this combination was 50 mg/m2 BCNU on Days 1 through 3 and 30 mg/m2 cisplatin on Days 1 through 3 and 29 through 31 before radiation and repeated in 8 weeks to coincide with the start of radiation.CONCLUSIONThis schedule of the preirradiation administration of BCNU and cisplatin with accelerated hyperfractionated radiation therapy for the treatment of high-grade gliomas provides a less toxic alternative to that of previous studies of preirradiation chemotherapy with these agents and merits further investigation. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Neurosurgery Oxford University Press

Phase I Evaluation of Preirradiation Chemotherapy with Carmustine and Cisplatin and Accelerated Radiation Therapy in Patients with High-grade Gliomas

Phase I Evaluation of Preirradiation Chemotherapy with Carmustine and Cisplatin and Accelerated Radiation Therapy in Patients with High-grade Gliomas

Phase I Evaluation of Preirradiation Chemotherapy with Carmustine and Cisplatin and Accelerated Radiation Therapy in Patients with High-grade Gliomas S. Vincent Rajkumar, M .D ., Jan C. Buckner, M .D ., Paula J. Schomberg, M .D ., Henry C. Pitot IV, M .D ., James N. Ingle, M .D ., Terrence L. Cascino, M .D. D iv isio n s of M ed ical O n co lo g y (SV R , JC B , H C P , JNI) and Radiation O n co lo g y (P)S) and the Departm ent of N eurology (T L C ), M ayo C lin ic and Foundation, Rochester, M innesota OBJECTIVE: A Phase I study was conducted to determine the safety, toxicity, and maximum tolerated dose of preirradiation chem otherapy using carmustine (B C N U ) and cisplatin in the treatment of high-grade gliomas. METHODS: Patients with newly diagnosed high-grade gliomas received B C N U and cisplatin after surgery, both before and during definitive radiation therapy. Preirradiation chemotherapy consisted of an administration of 40 mg/m2 B C N U on Days 1 through 3 and 30 mg/m2 cisplatin on Days 1 through 3 and 29 through 31 and repeated at 8 weeks to coincide with the start of radiation therapy. Postradiation chemotherapy consisted of an adm in­ istration of 200 mg/m2 B C N U once every 8 weeks for four cycles. Radiation therapy consisted of 1 6 0 -cG y fractions administered tw ice daily for 15 days, yielding a total dose of 4800 c G y . Dose escalation of B C N U was planned. If hematological toxicity was mild, the dose of cisplatin was to be held constant and B C N U dose escalated to 50 mg/m2 on Days 1 through 3. RESULTS: Eighteen patients w ere studied. The hematological toxicity was dose-limiting. G rade 3 or 4 leukopenia occurred in each of 10 patients (5 6 % ), and G rad e 3 or 4 thrombocytopenia occurred in each of 9 patients (5 0 % ). Other toxicities included anorexia (94% ), nausea (83% ), emesis (33% ), alopecia (94% ), mild ototoxicity (50% ), and, in one patient, death as a result of B C N U pulmonary toxicity. The median survival time was...
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Publisher
Congress of Neurological Surgeons
Copyright
© Published by Oxford University Press.
ISSN
0148-396X
eISSN
1524-4040
D.O.I.
10.1097/00006123-199901000-00036
Publisher site
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Abstract

AbstractOBJECTIVEA Phase I study was conducted to determine the safety, toxicity, and maximum tolerated dose of preirradiation chemotherapy using carmustine (BCNU) and cisplatin in the treatment of high-grade gliomas.METHODSPatients with newly diagnosed high-grade gliomas received BCNU and cisplatin after surgery, both before and during definitive radiation therapy. Preirradiation chemotherapy consisted of an administration of 40 mg/m2 BCNU on Days 1 through 3 and 30 mg/m2 cisplatin on Days 1 through 3 and 29 through 31 and repeated at 8 weeks to coincide with the start of radiation therapy. Postradiation chemotherapy consisted of an administration of 200 mg/m2 BCNU once every 8 weeks for four cycles. Radiation therapy consisted of 160-cGy fractions administered twice daily for 15 days, yielding a total dose of 4800 cGy. Dose escalation of BCNU was planned. If hematological toxicity was mild, the dose of cisplatin was to be held constant and BCNU dose escalated to 50 mg/m2 on Days 1 through 3.RESULTSEighteen patients were studied. The hematological toxicity was dose-limiting. Grade 3 or 4 leukopenia occurred in each of 10 patients (56%), and Grade 3 or 4 thrombocytopenia occurred in each of 9 patients (50%). Other toxicities included anorexia (94%), nausea (83%), emesis (33%), alopecia (94%), mild ototoxicity (50%), and, in one patient, death as a result of BCNU pulmonary toxicity. The median survival time was 14 months. Objective responses occurred in 45% of the patients evaluable for response. The maximum tolerated dose of this combination was 50 mg/m2 BCNU on Days 1 through 3 and 30 mg/m2 cisplatin on Days 1 through 3 and 29 through 31 before radiation and repeated in 8 weeks to coincide with the start of radiation.CONCLUSIONThis schedule of the preirradiation administration of BCNU and cisplatin with accelerated hyperfractionated radiation therapy for the treatment of high-grade gliomas provides a less toxic alternative to that of previous studies of preirradiation chemotherapy with these agents and merits further investigation.

Journal

NeurosurgeryOxford University Press

Published: Jan 1, 1999

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