ABSTRACT
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.
Subject(s)
Antineoplastic Agents, Alkylating/therapeutic use , Brain Neoplasms/pathology , Brain Neoplasms/therapy , Dacarbazine/analogs & derivatives , Glioblastoma/pathology , Glioblastoma/therapy , Radiotherapy, Intensity-Modulated/methods , Adult , Aged , Antineoplastic Agents, Alkylating/administration & dosage , Antineoplastic Agents, Alkylating/adverse effects , Brain Neoplasms/mortality , Chemoradiotherapy , DNA Methylation , DNA Modification Methylases/genetics , DNA Repair Enzymes/genetics , Dacarbazine/administration & dosage , Dacarbazine/adverse effects , Dacarbazine/therapeutic use , Female , France , Glioblastoma/mortality , Humans , Male , Middle Aged , Radiotherapy, Intensity-Modulated/adverse effects , Temozolomide , Treatment Outcome , Tumor Burden , Tumor Suppressor Proteins/geneticsABSTRACT
INTRODUCTION: Getting a second opinion seems common in oncology, even though the management of these serious diseases results from a multidisciplinary approach. Our aim was to determine the incidence of requests for a second opinion in thoracic oncology at the university hospital of Nancy, since the establishment of the Cancer Plan in 2003. This plan formalized multidisciplinary staff meetings, which should help to reassure patients and therefore reduce the recourse to additional consultations. METHODS: A detailed and anonymous questionnaire was conducted on 77 patients suffering from lung cancer, followed-up over 2years in the respiratory department of the University Hospital of Nancy. The socio-economic characteristics were collected from the medical records. RESULTS: Recourse to a second practitioner was reported by 14 % of the patients suffering from lung cancer. It concerned more women than men and more patients with a higher educational level and socio-professional category. CONCLUSION: Requests for a second opinion by patients with lung cancer are not as frequent as expected. However, when they are made, it is more frequently by women and patients with a higher socio-economic status.
Subject(s)
Attitude to Health , Lung Neoplasms/diagnosis , Referral and Consultation/statistics & numerical data , Aged , Female , France/epidemiology , Humans , Incidence , Lung Neoplasms/epidemiology , Lung Neoplasms/psychology , Male , Middle Aged , Pilot Projects , Retrospective Studies , Surveys and QuestionnairesABSTRACT
PURPOSE: Fotemustine is a nitrosourea compound used for the treatment of malignant gliomas, especially in France. Recently, an EORTC-NCIC study has shown that a concomitant combination of radiotherapy plus temozolomide (an oral cytotoxic drug) improved survival in glioblastoma patients. We set out to test a concurrent combination of radiotherapy and fotemustine for newly malignant gliomas. METHODS: A prospective single-center phase II study opened for accrual in September 2004. Patients over 18 years of age able to give informed consent and with histologically proven, newly diagnosed supratentorial malignant gliomas were eligible. All patients were treated by a standard cranial irradiation (conformal irradiation, tumor bulk plus a margin of 2.5 cm) and concomitant daily administration of 10 mg/m(2) of fotemustine (5 days per week, 6 weeks, 1 h 30 min before radiation therapy). Adjuvant chemotherapy, fotemustine, was administered at tumor progression as standard and classic regimen. RESULTS: Twenty-two patients were enrolled, 16 men and 6 women, median age 56 years (range 32-74), median Karnofsky performance status 70 (range 60-90). Histology included 16 glioblastomas, 3 anaplastic astrocytomas, 2 anaplastic oligodendrogliomas and 1 mixed glioma. Eight patients underwent surgery (three total resections). Fourteen patients had a stereotactic biopsy. The concurrent radiotherapy-fotemustine combination was well tolerated: toxicity was mild and three hematologic toxicities grade 3-4 were observed. Median survival from the initial diagnosis was 9.9 months, two patients are currently alive. Median survival was 11 months for surgery and 9 months for stereotactic biopsy. CONCLUSIONS: Concomitant radiotherapy-fotemustine combination is safe and well tolerated. Overall survival of over 10 months for the whole population compares favorably with other reports.