Regorafenib improves outcomes in relapsed glioblastoma patients
medwireNews: The phase II REGOMA trial shows that patients with recurrent glioblastoma derive a significant overall survival (OS) and disease control benefit from treatment with regorafenib over lomustine.
In light of these “encouraging results” the efficacy of the oral multikinase inhibitor should be confirmed in a larger phase III study, presenting author Giuseppe Lombardi (Veneto Institute of Oncology IOV-IRCCS, Padua, Italy) said at the ESMO 2017 Congress, held in Madrid, Spain.
OS was a median of 6.5 months for the 59 patients with disease recurrence after treatment with radiation plus temozolomide who were randomly assigned to receive regorafenib 160 mg/day for 3 weeks followed by a 1 week break.
This compared with a median of 5.5 months for their 60 counterparts given the alkylating agent lomustine at a dose of 110 mg/m2 on the first day of each 6-week cycle, a statistically significant difference that translated into a 36% reduced risk for death in favor of regorafenib.
Lombardi pointed out that around three times as many patients in the regorafenib group as in the lomustine group were alive at the 12-month mark, with corresponding OS rates of 36.8% and 12.7%.
The secondary endpoints of progression-free survival and objective response rate did not differ significantly between the treatment arms. However, more regorafenib-treated patients achieved stable disease, resulting in a significantly higher disease control rate in the regorafenib than the lomustine arm, at 44.1% and 21.1%, respectively.
Regorafenib therapy allowed more patients to receive further treatment, with 67.9% of participants going on to receive third-line therapy compared with 43.9% of those in the lomustine study arm.
Fifty-six percent of participants given regorafenib experienced at least one treatment-related adverse event of grade 3–4, with increased lipase, hyperbilirubinemia, and hand–foot skin reaction the most common events, with each seen in 10.2% of patients.
But Lombardi noted that the toxicity profile was “manageable and expected,” adding that “in general, regorafenib was a well-tolerated treatment.”
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