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.

Frequency of side effects in outpatient cancer care and their influence on patient satisfaction--a prospective survey using the PASQOC questionnaire.

STUDY OBJECTIVES: The aims of the study were to examine the frequency of side effects and fatigue in ambulatory cancer patients and to analyse how these symptoms are reflected in patient satisfaction. SETTING: Private practices (N = 41) and day hospitals (N = 8) in Germany took part in the study. PARTICIPANTS: The respondents were 4,538 patients with cancer (response rate: 82%). The diagnoses were: 25% breast cancer, 21% colorectal cancer, 11% lymphomas and 12% haematological malignancies; mean age 63.5 years; 57% female. MEASUREMENTS: The 2004 PASQOC questionnaire contained 63 problem-oriented items which covered patient satisfaction for 15 dimensions of care. One item specifically assessed the prevalence of 17 different side effects. A score reflecting the severity of fatigue (fatigue index) was computed from three additional questions. For statistical analysis of patient satisfaction, the problem frequency was computed for each item. RESULTS: The most frequent single side effects were fatigue (60%), hair loss (54%), nausea (51%), sleep disturbance (42%), weight loss (36%), diarrhoea (32%) and mouth ulcerations (31%). The mean number of side effects was 5 per patient (range 0 to 17). The fatigue index revealed that 42% of subjects complained of moderate and 28% of severe fatigue. Both the total number of side effects and the fatigue score were negatively associated with patient satisfaction. CONCLUSIONS: Side effects and especially fatigue are frequent problems in cancer patients and are related to the patients' assessment of cancer care. Routine symptom assessment may identify patients who require more comprehensive supportive care.

An unusual case of Merkel cell carcinoma.

PURPOSE: Merkel cell carcinoma (MCC) is a rare aggressive neuroendocrine tumor of the skin mainly found in elderly white patients. Due to its poor prognosis with distant metastases in up to 33% and local recurrence in 25-33% and a 5 year disease-specific survival of 64% (1-2) its early diagnosis and appropriate treatment is mandatory. METHODS: The study is an exceptional clinical case of a patient with a large inoperable MCC unable to be treated according to treatment guidelines due to her old age. We review the literature addressing treatment options. RESULTS: The patient was treated with palliative definitive radiotherapy to her large MCC of the left lower leg. She showed a rapid clinical response to four palliative radiation doses of 7 Gy each, necrosis of tumor mass and persistent clearing at a follow-up of 32 weeks. Our patient was very unusual in terms of her extensive MCC and her rapid and complete response to palliative radiotherapy lasting for 6 months at present. CONCLUSIONS: As MCC is an aggressive tumor, best survival is achieved with early diagnosis in a localized stage and prompt adequate surgery and further stage-adjusted treatment. Thus, the differential diagnosis of MCC should not be dismissed in a reddish nodule on the leg, and every excision should be submitted to pathology. In accordance with the literature we demonstrate here that definitive radiotherapy is an effective treatment option for inoperable MCC, which in this individual patient produced necrosis of the extensive tumor mass after only four palliative doses.