Background: Although concurrent radio-chemotherapy and adjuvant temozolomide (TMZ) treatment for six cycles has been established as a standard of care for newly diagnosed glioblastoma multiforme (GBM) patients, the recommended duration of adjuvant TMZ remains a matter of debate. Methods: We conducted this historical cohort study to evaluate the survival benefit and toxicity profile of administration of 12 cycles of adjuvant TMZ in patients with newly diagnosed histologically confirmed GBM and compared this data with that of patients who completed the standard 6 cycles without disease progression. After concurrent radio-chemotherapy, TMZ was administered for 6 cycles (group 1) and for 12 cycles (group 2). Univariate and multivariate analysis (using the Cox proportional hazards model) were performed to identify factors affecting progression free survival (PFS) and overall survival (OS). Results: Between June 2016 and February 2018, 55 patients were eligible. Patients in Group 1 (n=29) had a median PFS of 15 months (95% CI: 10.215-19.785), while those in Group 2 (n=26) had a median PFS of 18 months (95% CI: 16.611-19.389). After a median follow up duration of 20 months (range: 12-41), the median OS was 18 months (95% CI: 13.420-22.580) in Group 1 and 22 months (95% CI: 18.777-25.223) in Group 2. There was no statistically significant correlation between the number of chemotherapy cycles and PFS (P = 0.513) or OS (P = 0.867). The extent of surgical resection was the only independent prognostic factor for both PFS (P = 0.015) and OS (P = 0.028) by multivariate analysis. Three grade ≥3 hematologic toxicity were encountered in three patients. One in the six-cycle group (neutropenia), and two in the 12-cycle group (one had neutropenia and the other one developed thrombocytopenia). No statistically significant difference in the toxicity profile between both groups.Conclusions: Although extending adjuvant TMZ to 12 cycles was not associated with increased toxicities, it did not significantly improve PFS or OS. So we do not recommend any modifications in the six months protocol until further studies are performed. It should be weighed against the compromised quality of life and the cost to the health care system.
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