A concurrent ultra-fractionated radiation therapy and temozolomide treatment: A promising therapy for newly diagnosed, inoperable glioblastoma.
We report on a phase II clinical trial to determine the effect of a concurrent ultra-fractionated radiotherapy and temozolomide treatment in inoperable glioblastoma patients. A phase II study opened; patients over 18 years of age who were able to give informed consent and had histologically proven, newly diagnosed inoperable diagnosed and supratentorial glioblastoma were eligible. Three doses of 0.75 Gy spaced apart by at least 4 hr were delivered daily, 5 days a week for six consecutive weeks for a total of 67.5 Gy. Chemotherapy was administered during the same period, which consisted of temozolomide given at a dose of 75 mg/m(2) for 7 days a week. After a 4-week break, chemotherapy was resumed for up to six cycles of adjuvant temozolomide treatment, given every 28 days, according to the standard 5-day regimen. Tolerance and toxicity were the primary endpoints; survival and progression-free survival were the secondary endpoints. In total, 40 patients were enrolled in this study, 29 men and 11 women. The median age was 58 years, and the median Karnofsky performance status was 80. The concomitant ultra-fractionated radiotherapy and temozolomide treatment was well tolerated. Complete responses were seen in four patients, and partial responses were reported in seven patients. The median survival from the initial diagnosis was 16 months. Several long-term survivors were noted. Concurrent ultra-fractionated radiation therapy and temozolomide treatment are well accepted by the patients. The results showed encouraging survival rates for these unfavorable patients.
Service de Neuro-Oncologie, CHU De Nancy, Nancy, France.
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Beauchesne
Departement de Biologie, Centre E Marquis, Rennes, France.|CNRS, UMR 6290, Universite Rennes 1, Rennes, France.
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Quillien
Centre Private de Radiothérapie, Centre C Bernard, Metz, France.
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Faure
Departement de Radiathérapie, Institut De Cancérologie Lorrain, Vandoeuvre, France.
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Bernier
Departement de Radiothérapie, Centre P Strauss, Strasbourg, France.
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Noel
Departement de Radiothérapie, CHR Metz Mercy, France.
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Quetin
EORTC Data Center, Bruxelles, Belgique.
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Gorlia
Service de Neuro-Oncologie, CHU De Nancy, Nancy, France.
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Carnin
INSERM U917, Rennes, France.|INSERM ER440-OSS, Centre Eugène Marquis, Rennes, France.
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Pedeux
D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy; D019175:DNA Methylation; D015254:DNA Modification Methylases / Q000235:genetics; D045643:DNA Repair Enzymes / Q000235:genetics; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005602:France; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D000077204:Temozolomide; D016896:Treatment Outcome; D047368:Tumor Burden; D025521:Tumor Suppressor Proteins / Q000235:genetics
D018906:Antineoplastic Agents, Alkylating; D025521:Tumor Suppressor Proteins; D003606:Dacarbazine; D015254:DNA Modification Methylases; C515491:MGMT protein, human; D045643:DNA Repair Enzymes; D000077204:Temozolomide
glioblastoma-inoperable; low doses-radiation therapy; ultra-fractionated regimen