دورية أكاديمية

Phase I study pilot arms of radiotherapy and carmustine with temozolomide for anaplastic astrocytoma (Radiation Therapy Oncology Group 9813): implications for studies testing initial treatment of brain tumors.

التفاصيل البيبلوغرافية
العنوان: Phase I study pilot arms of radiotherapy and carmustine with temozolomide for anaplastic astrocytoma (Radiation Therapy Oncology Group 9813): implications for studies testing initial treatment of brain tumors.
المؤلفون: Chang SM; Department of Neurological Surgery, University of California San Francisco, School of Medicine, 400 Parnassus Avenue A808, San Francisco, CA 94143, USA. changs@neurosurg.ucsf.edu, Seiferheld W, Curran W, Share R, Atkins J, Choucair A, Kresl J, Thoron L, Cairncross G, Gilbert M, Bahary JP, Dolinskas C, Louis DN, Bushunow P, Buckner J, Barger G, Mehta M
المصدر: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2004 Jul 15; Vol. 59 (4), pp. 1122-6.
نوع المنشور: Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, U.S. Gov't, P.H.S.
اللغة: English
بيانات الدورية: Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print Cited Medium: Print ISSN: 0360-3016 (Print) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE
أسماء مطبوعة: Publication: New York, NY : Elsevier, Inc
Original Publication: Elmsford, N. Y., Pergamon Press.
مواضيع طبية MeSH: Antineoplastic Combined Chemotherapy Protocols/*adverse effects , Astrocytoma/*drug therapy , Astrocytoma/*radiotherapy , Brain Neoplasms/*drug therapy , Brain Neoplasms/*radiotherapy , Dacarbazine/*analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Carmustine/administration & dosage ; Carmustine/adverse effects ; Dacarbazine/administration & dosage ; Dacarbazine/adverse effects ; Female ; Humans ; Male ; Middle Aged ; Pilot Projects ; Temozolomide
مستخلص: Purpose: To determine the safety and toxicity of carmustine (BCNU) and temozolomide (TMZ) with radiotherapy (RT) in newly diagnosed anaplastic astrocytoma.
Methods and Materials: Patients >18 years old with anaplastic astrocytoma, a Karnofsky performance status score of > or =60, and adequate pulmonary function were eligible. All patients provided informed consent. Standard RT started within 5 weeks of diagnosis. In both arms, 150 mg/m(2) of TMZ was given on Days 1-5 of RT. In Arm 1, 200 mg/m(2) of carmustine was given on Day 1 of RT. In Arm 2, 150 mg/m(2) of carmustine was given on Day 5 of RT. After RT, TMZ and carmustine were repeated for a total of six cycles.
Results: A total of 15 and 14 patients were enrolled in the two pilot arms. Because of hematologic and pulmonary toxicities, dose reductions by the second cycle of therapy occurred in >70% of the patients in Arm 1 and >50% in Arm 2 despite a reduction in the carmustine dose.
Conclusion: The results of these pilot studies have implications for the design of studies testing the initial treatment of brain tumors. Because of the poor tolerance of the combination, the multicooperative group Phase III study consists of two randomized arms of single-agent carmustine vs. single-agent TMZ.
معلومات مُعتمدة: U10 CA 21661 United States CA NCI NIH HHS; U10 CA 32115 United States CA NCI NIH HHS; U10 CA 37422 United States CA NCI NIH HHS
المشرفين على المادة: 7GR28W0FJI (Dacarbazine)
U68WG3173Y (Carmustine)
YF1K15M17Y (Temozolomide)
تواريخ الأحداث: Date Created: 20040706 Date Completed: 20040826 Latest Revision: 20181130
رمز التحديث: 20231215
DOI: 10.1016/j.ijrobp.2004.01.002
PMID: 15234047
قاعدة البيانات: MEDLINE
الوصف
تدمد:0360-3016
DOI:10.1016/j.ijrobp.2004.01.002