2001 Background: The GEINO-14-01 trial (NCT02209948) investigated the role of extending temozolomide (TMZ) for 6 cycles after the standard 6 cycles to improve 6m-PFS, SLP and OS in newly diagnosed glioblastoma (GBM) patients (p). Methods: Between 08/2014 and 11/2018, 166 p were screened and 159 randomized to extend (80p) or not (79p) TMZ treatment for 6 cycles after proving stable disease in the MRI performed before inclusion. Centralized review of histology and determination of MGMT status, if not previously available, were performed before randomizing patients. Two criteria of stratification were used: MGMT status and presence/absence of residual disease on the basal MRI (defined as a residual enhancement larger than 1cm in one). The primary endpoint was differences in 6mPFS, secondary endpoints were differences in PFS, OS, toxicity, between arms and per stratification factors. Results: Median age was 60.3 (range 29-83), 97p (61%) were methylated, basal MRI showed residual disease in 57p (35.8%). After a median follow up of 14.0 months, with 121 p(76.1%) already progressed and 81p (50.9%) already dead, median PFS is presented. Median (m) PFS is 8.0 months (95%CI: 5.7-10.2). There is no difference in mPFS between arms (adjusted HR = 0.98, 95% CI: 0.82-1.18, P = 0.907). Methylated tumors had longer mPFS (HR=0.57, 95% CI: 0.39-0.83, P=0.004) irrespectively to the study treatment. Conclusions: There is not apparent benefit of continuing TMZ treatment for more than 6 cycles. Data will be actualized for the congress.Supported by a Grant of the ISCIII: PI13/01751. Clinical trial information: NCT02209948.
BACKGROUND
Probable unresectable Glioblastomas (GB) diagnosed by imaging techniques withouth anatomo-pathological (ap) confirmation could be treated under standard treatment. We reported the outcomes from this strategy in our center after tumor board evaluation.
MATERIAL AND METHODS
From January/10 to September/16, 303 patients (pt) with GB were assessed by tumor board, during the same period 66 patients were consecutive analyzed with suspected GB by radiological criteria without histological diagnosis. We focus in the last group and analyzed the demographic/radiological data, non-biopsy causes, treatment type (concomitant Radio-Chemotherapy (RT/Ch), exclusive RT or Ch or Best supportive care (BSC)), Karnofsky index (KI) and degree of comorbidity (Charlson index (CI)).
RESULTS
Sixty six patients, 17.88% of the total GB cases (with/without ap). Average age: 77 years (33–91). Biopsy: non-diagnostic in 4pt. No biopsy: 62pt; due to non medical indication (71%), localization (22.7%), voluntary (4.5%). Treatment Type: Active: 43.93%, without biopsy due to non-medical indication (44.8%) and localization (41.37%). BSC: 53.03%, without biopsy due to non-medical indication 82.85%, localization 8.5%, voluntary 5.7%. Overall survival: 11.65 months in patients with active treatment and 4.8 months in BSC, greater benefit in <70 years and KI≥ 70 with statistical signification.
CONCLUSION
The diagnosis of GB by radiological criteria with the new imaging techniques has a good diagnostic-therapeutic correlation. In cases where surgical intervention is not possible, standard treatment offers good results. Age and KPS are variables that allow predicting a better evolution course. Although it was not possible to obtain a histological diagnosis, in this type of cases liquid biopsy could contribute to diagnosis this type of lesions inaccessible to biopsy.
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