ASCO GI 2023 | INTEGRATE IIa: regorafenib in refractory advanced gastro-esophageal cancer
Regorafenib has demonstrated positive signals in patients with advanced gastroesophageal cancer. Nick Pavlakis, PhD, MBBS, FRACP, Royal North Shore Hospital, Sydney, Australia, discusses the results of INTEGRATE IIa (NCT02773524), a randomized, Phase III, double-blind trial of regorafenib versus placebo in refractory advanced gastroesophageal cancer. Regorafenib significantly improved overall survival in patients compared to placebo. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Gastrointestinal Cancers (GI) Symposium in San Francisco, CA.
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Transcript (edited for clarity)
The INTEGRATE study was a randomized double-blind, placebo controlled study evaluating regorafenib versus placebo in patients with refractory advanced stomach cancer, basically gastric and gastroesophageal cancer. It enrolled 251 patients and the pool results of the previous Phase II study and the INTEGRATE study demonstrated improvement in survival with regorafenib with the hazard ratio of 0...
The INTEGRATE study was a randomized double-blind, placebo controlled study evaluating regorafenib versus placebo in patients with refractory advanced stomach cancer, basically gastric and gastroesophageal cancer. It enrolled 251 patients and the pool results of the previous Phase II study and the INTEGRATE study demonstrated improvement in survival with regorafenib with the hazard ratio of 0.7 and in the INTEGRATE-IIa study as a standalone study, that hazard ratio was 0.68, both for statistically significant. And the one year survival was 19% versus 6% regorafenib versus placebo. And we think that best illustrates the value of the treatment in patients who have exhausted other therapies to now have this additional option. Also, the toxicity was as previously reported and manageable, and we delayed the deterioration in global quality of life, so allowing for whatever toxicity there was, patients did seem to benefit by having a delay in their deterioration and quality of life as well
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