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Medical oncologists are administering an anti-cancer drug, regorafenib, to improve the overall survival of patients with metastatic colorectal cancer who have stopped responding to standard therapy (called refractory mCRC). However, some of the side effects badociated with the use of this drug often limit its use in clinical practice. A study reported at the 2018 ESMO World Congress on Gastrointestinal Cancer suggests the utility of a more flexible dosage, which improves the quality of life of patients without compromising the effectiveness .
This international trial, led by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), included 299 patients from a dozen hospitals in Spain, Italy and France. The average age of participants was 64 years and they had received an average of four treatment lines prior to inclusion in the trial with regorafenib between July 2016 and September 2017.
"Regorafenib has been approved since 2013 for patients with metastatic colorectal cancer (mCRC) who have evolved to standard treatments," said Dr. Guillem Argiles, author of the study, Medical Oncologist and Clinical Investigator, Group of gastrointestinal and endocrine tumors, Vall d'Hebron University Hospital and Institute of Oncology Vall d'Hebron (VHIO), Barcelona, Spain.
"Its adverse toxicity profile often limits its use in routine clinical practice, and this clinical trial has attempted to demonstrate the utility of different dosing strategies to improve its safety and quality of life in patients who may benefit from the drug. the context of an advanced disease. " . "
In the trial, patients were randomized 1: 1: 1: standard dose to 160 mg / day for three weeks followed by a week of rest; reduced dose of 120 mg / day for three weeks followed by one week off (reduced dose group); or an intermittent dose of 160 mg / day / week, followed by a week off (intermittent group). Patients in the last two groups (reduced dose or intermittent dose) were switched to the standard dose if, after the first treatment cycle, no limiting toxicity prevented continuing to participate in the trial. "We reduced the dose during the first cycle, and then increased, because it was shown that the toxicity is higher during the first and second months of treatment," explained Argiles.
The researchers observed that the flexible dose showed a numerical improvement on several parameters improving tolerance, such as fatigue, hypertension or hand-foot syndrome (reaction due to redness, swelling and pain in the palms ), although REARRANGE has not achieved its primary objective: to improve the overall safety of regorafenib in the reduced and intermittent dose groups. The mean duration of treatment was 3.2 months in the standard group; 3.7 in the reduced dose group; and 3.8 alternating weeks. Median progression-free survival was not different from one group to another (approximately 2 months).
"Although the statistical significance has not been reached, we have observed a numerical reduction of some side effects that can be very embarrbading for patients," explained Argiles. "These findings, interpreted in the context of other trials, such as the US ReDOS study, indicate that more flexible doses of regorafenib provide an effective alternative to improve the quality of life of patients with severe pain. refractory metastatic colorectal cancer. "
Professor Eric Van Cutsem, from the University of Leuven, Belgium, commented on the results: "This study will modify clinical practice regarding the use of regorafenib in patients with metastatic colorectal cancer because it demonstrates and supports something that many clinicians have already observed and practice in regular clinical practice. " In his opinion, the trial shows that this reduction in the initial dose of regorafenib limits the toxicity of the drug while maintaining its efficacy.
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Material provided by European Society of Medical Oncology. Note: Content can be changed for style and length.
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