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Stivarga improved survival and delayed disease progression in patients with refractory advanced gastric and esophagogastric junction cancer.
Among patients with refractory advanced gastric and esophagogastric junction cancer, Stivarga (regorafenib), an oral multikinase inhibitor, improved survival when administered with best supportive care compared with patients receiving placebo plus best supportive care, study findings demonstrate.
“The results of INTEGRATE IIa confirmed clinical benefit of [Stivarga] in patients with refractory [advanced gastric and esophagogastric junction cancer] by delaying disease progression and [quality of life] deterioration, leading to prolonged survival,” researchers wrote in the study published in Journal of Clinical Oncology.
After a median follow up of 48 months, patients treated with Stivarga demonstrated a 30% reduction in risk of death among both INTEGRATE I and INTEGRATE IIa cohorts. The INTEGRATE IIa group alone showed a similar reduction in risk of death of 32% and had a median overall survival of 4.5 months compared with four months in the placebo group.
In addition, the 12-month survival rates were 19% in those receiving Stivarga and 6% for those receiving a placebo, “which we believe is clinically important for participants seeking survival in this late stage of their illness; importantly, the survival gain was not offset by detriment in [quality of life],” study authors wrote.
Multikinase Inhibitor: a therapy that slows tumor growth by blocking multiple cell growth enzymes.
Overall Survival: the time from the start of treatment when a patient with cancer is still alive.
Vascular Endothelial Growth Factor Inhibitors: slows tumor growth by blocking blood vessel formation.
Progression-Free Survival: how long a person lives without their disease getting worse.
Objective Response Rate: the percentage of people whose disease shrunk or disappeared after treatment.
Patients in the treatment group were 47% less likely to experience disease progression or death compared to those on placebo. Patients receiving Stivarga also demonstrated delayed deterioration in quality-of-life. Results did not significantly vary based on prespecified subgroups.
There was no significant heterogeneity observed, suggesting, “that the overall results should be considered applicable to all participant subgroups,” study authors wrote.
The toxicity profile of Stivarga was consistent with that observed in previously conducted studies. In particular, side effects occurred in 95% of patients treated with Stivarga and 87% in those receiving placebo. Most side effects were mild to moderate (85%), followed by severe side effects (14%) and life-threatening side effects (1%).
These side effects included hand-foot syndrome (31% mild to moderate, 9% severe), mouth sores (20% mild to moderate, 1% severe), diarrhea (18% mild to moderate, 4% severe), high blood pressure (14% mild to moderate, 8% severe), liver damage (increased alanine transaminase: 12% mild to moderate, 5% severe; increased aspartate transaminase : 14% mild to moderate, 4% severe, 1% life-threatening) and constipation (12% mild to moderate, 1% severe). Among side effects, three resulted in death and one was a hepatic failure, both related to treatment. Unrelated to treatment, two cases of sepsis were recorded.
“Despite the toxicity, time to worsening of [quality of life] was delayed,” study authors wrote. “Since our study commenced, others recommend starting with a lower [Stivarga] dose and using dose escalation to reduce [side effects].”
A total of 251 patients were enrolled with 169 assigned to receive Stivarga and 82 assigned to receive placebo. Patients included those with metastatic/advanced gastric and esophagogastric junction cancer whose disease did not response to two or more prior therapies and prior vascular endothelial growth factor inhibitors.
As mentioned in the study, researchers are exploring the potential benefits of using Stivarga in combination with other drugs to improve treatment outcomes for patients with pretreated advanced gastric and esophagogastric junction cancer.
The primary focus of the study was overall survival, and the secondary focuses included progression-free survival, objective response rate, safety and quality-of-life.
“The pooled results of these two trials (INTEGRATE I phase II and INTEGRATE IIa) provide clear evidence of [overall survival] benefit of [Stivarga] in participants with [advanced gastric and esophagogastric junction cancer] who have failed previous chemotherapy, including a platinum and fluoropyrimidine analog,” study authors wrote.
Reference:
“INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer” by Dr. Nick Palvakis, et al., Journal of Clinical Oncology.
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