Randomized study of postoperative radiotherapy and simultaneous temozolomide without adjuvant chemotherapy for glioblastoma.

PURPOSE: To evaluate the efficacy of simultaneous postoperative temozolomide radiochemotherapy in glioblastoma patients. PATIENTS AND METHODS: From February 2002 to July 2004, n = 65 patients from 11 German centers with macroscopic complete tumor resection were randomized to receive either postoperative radiotherapy alone (RT, n = 35) or postoperative radiotherapy with simultaneous temozolomide (RT + TMZ, n = 30). Patients were stratified according to age (< or =/>50 years) and WHO performance score (0-1 vs. 2). RT consisted of 60 Gy in 30 fractions. In the RT + TMZ arm, oral TMZ was administered daily at a dose of 75 mg/m(2) including weekends (40-42 doses). Adjuvant treatment was not given, but in both arms, patients with recurrent tumors and in good condition (WHO 0-2) were scheduled for salvage chemotherapy with TMZ. RESULTS: The trial was stopped early due to the results of EORTC-study 26981-22981 that showed a survival benefit for the combination of concomitant and adjuvant TMZ compared to radiotherapy alone. In total, 62/65 patients were evaluable. Stratification variables were well balanced (< or = 50 years 26% vs. 20%, WHO 0-1 91% vs. 100%). Neither overall survival (median 17 vs. 15 months) nor progression-free survival (median 7 vs. 6 months) differed significantly between the two arms. In the RT (RT + TMZ) arm, 76% (62%) of the progressing patients received salvage chemotherapy with TMZ, 36% (50%) had a second resection. There was a time-constant trend for increased general quality of life (EORTC questionnaire QLQ C30) and brain-specific quality of life (EORTC questionnaire B20) in the combined arm. Lymphopenia G3-4 was more frequent (33 vs. 6%) in the RT + TMZ arm. CONCLUSION: After early closure of this trial, a benefit for progression-free survival for simultaneous TMZ radiochemotherapy alone could not be demonstrated. In both arms, salvage therapies were frequently used and probably had a major effect on overall survival.

[Craniospinal irradiation -- patient positioning and verification with portal films]. / Kraniospinale Bestrahlung -- Patientenlagerung und Verifikation.

BACKGROUND: Implementation of an important step for quality assurance in irradiation of the craniospinal axis was made through changes in the irradiation technique. Crucial improvements in patient positioning and the possibility of taking portal films of the field junctions are described. MATERIAL AND METHODS: A box for the positioning of the head of the patient in has been developed. In combination with vacuum cushions, it is a cheap method for the individual and secure positioning of the patient in prone position. Furthermore, a method for taking portal films of the field junctions between the lateral cranial and the upper dorsal spinal field as well as between the two dorsal spinal fields is described. DISCUSSION: The use of the "Bonner Box" improves the patient positioning with respect to reproducibility, setup time and comfort. The documentation of the field junctions in craniospinal irradiation, which is described for the first time, is an important tool for quality assurance.