The median OS following standard temozolomide treatment concurrent with and adjuvant to radiotherapy given to (72.8% of) patients aged ≤70 years is consistent with findings reported from randomized phase III trials. The volume and expertise of the treatment center should be further investigated as a prognostic factor.
A clinical and epidemiological study on amyotrophic lateral sclerosis (ALS) was conducted in the province of Parma, Italy, from 1960–1990. A total of 121 cases were collected from hospital records. The average annual incidence was 0.98 per 100000 inhabitants, with a male/female ratio of 1.1. Age‐specific incidence was maximal in the age group 60–69 years. No difference between rural and urban areas was found. Prevalence on October 26th, 1981 was 2.5 per 100000. Mean age at onset was 60 years, with no significant sex difference. Mean duration of the disease was 30 (sd 21.4) months. Bulbar forms were significantly (p<0.05) shorter than conventional forms, with a mean duration of 23.4 (sd 21.4) months. Age at onset did not influence prognosis. A comparison of three decades was made, to verify whether possible variations of the disease had occurred with time. From our data a definite stability was found in such epidemiological parameters as incidence, prevalence, mean duration and mortality of ALS in the period.
2021 Background: The role of temozolomide concurrent with and adjuvant to radiotherapy (RT/TMZ) in elderly pts with GBM remains unclear. We therefore evaluated the efficacy of this approach in pts >70 years in the context of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), the first Italian prospective observational population-based study in neuro-oncology. Methods: The criteria for selecting pts enrolled in the PERNO study were: age >70 years; PS 0-3; histologically confirmed GBM; postoperative radiotherapy after surgery; residence in the Emilia Romagna region. Data were collected prospectively. Results: Pts accrual, started on January 1 2009, was closed, as planned, on December 31 2010. In the pts enrolled (n=53), median overall survival (mOS) was 11.1 months (95% CI: 8.8 - 13.5); survival rates at 1-, 2- and 3-years were 41.5% (95% CI: 28.2 – 54.8%), 15.2% (95% CI: 4.8 – 25.6%) and 6.1% (95%CI: 0 – 15.9%), respectively. Twenty-eight pts received RT/TMZ, and 25 pts RT alone. mOS was 11.6 months (95% CI: 8.6 – 14.6) following RT/TMZ and 9.3 months (95% CI: 8.1 – 10.6) following RT alone. mOS for pts with MGMT methylated status (n = 17) was 13.5 months (95% CI: 7.7 – 19.2), being 17.2 months (95% CI: 11.5 - 22.9) in those treated with RT/TMZ (n = 6) and 8.8 months (95% CI: 2 – 15.6) in those treated with RT alone (n = 11, p = 0.09). Elderly pts with MGMT unmethylated status (n = 25) had a mOS of 8.5 months (95% CI: 6 – 11, p = 0.014), being 8.5 months (95% CI: 2.3 – 14.7) in pts treated with RT/TMZ (n =10), and 8 months (95% CI: 3 – 12.9) in those treated with RT (n = 15, p = 0.55). Conclusions: RT/TMZ appears to be more effective in prolonging the mOS of elderly pts in those with MGMT methylation status (17.2 vs 8.5 months), and seem to perform better than TMZ alone, for which mOS was 9.7 months in the Nordic phase III trial. These findings underline the value of the ongoing randomized EORTC 26062-22061/NCIC CE.6 phase III comparing RT/TMZ with short course RT alone.
2057 Background: The role of temozolomide (TMZ) concurrent with and adjuvant to radiotherapy (RT) in the treatment of glioblastoma (GBM) has been demonstrated by the EORTC 22981/26981-NCIC CE.3 (EORTC/NCIC) randomized trial, and has been widely accepted as the standard treatment. The impact of RT/TMZ in the general patient population was assessed in the context of the Registry of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), that represents the first italian prospectic observational population-based study in neuro-oncology. Methods: Approvals from local Ethical Committees were obtained by 8 participating centres. Patients (pts) who met the following inclusion criteria were evaluated: age ≥18 years; PS 0-3; histologically confirmed GBM, no previous or concomitant non glial tumoral disease, resident in Emilia Romagna region. The data were prospectively collected. Results: From January 2009 to January 2011, 194 GBM pts were enrolled. The median age was 62.5, with 26% of pts over 70 years. After surgery pts received RT/TMZ (73%), RT alone (19%), TMZ alone (5%) or no further treatment (3%); 22% were included in clinical trials. Median overall survival (OS) was 12.9 months. Pts <70 years received RT/TMZ in 85% of cases. In this group of pts mOS was 17 months (95%CI: 15.4–18.6). Interestingly, pts <70 years included in experimental clinical trials showed a significant OS improvement (p=0.04). In multivariate analysis, only extent of surgery (p=0.047), KPS (p=0.01) and RT/TMZ (p<0.001) were associated with OS in pts <70 years. Conclusions: Our population data reproduces the beneficial effect of RT/TMZ from the EORTC/NCIC randomized trial, confirming how this successful approach as been widely incorporated in daily practice. Interestingly, our data suggest that the survival of GBM pts treated with RT/TMZ could be greater than patients treated with RT/TMZ in the EORTC/NCIC trial at the beginning of this century.
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