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INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer.
Nick Pavlakis1,2, Kohei Shitara3, Katrin Sjoquist4,5
1Department of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia.
Regorafenib significantly improves overall survival for patients with advanced gastric and esophagogastric junction cancer (AGOC) refractory to prior treatments. This oral multikinase inhibitor offers a new therapeutic option, enhancing progression-free survival and quality of life.
Area of Science:
- Oncology
- Gastroenterology
- Clinical Trials
Background:
- Advanced gastric and esophagogastric junction cancer (AGOC) presents limited treatment options for refractory cases.
- Regorafenib, an oral multikinase inhibitor, previously demonstrated improved progression-free survival (PFS) in the INTEGRATE I trial.
Purpose of the Study:
- To evaluate the efficacy of regorafenib in improving overall survival (OS) in patients with refractory advanced gastric and esophagogastric junction cancer (AGOC).
Main Methods:
- A double-blind, placebo-controlled, randomized phase III trial (INTEGRATE IIa) compared regorafenib plus best supportive care (BSC) against placebo plus BSC.
- Participants had confirmed metastatic/advanced AGOC with at least two prior therapies.
- The primary endpoint was overall survival (OS), with secondary endpoints including PFS, objective response rate, safety, and quality of life (QoL).
Main Results:
- Regorafenib demonstrated a significant improvement in pooled overall survival (OS) (HR 0.70; P = .001) and in the INTEGRATE IIa cohort alone (HR 0.68; P = .006).
- Median OS was 4.5 months with regorafenib versus 4.0 months with placebo.
- Regorafenib also significantly improved progression-free survival (PFS) (HR 0.53; P < .0001) and delayed QoL deterioration.
Conclusions:
- Regorafenib offers a survival benefit compared to placebo for patients with refractory advanced gastric and esophagogastric junction cancer (AGOC).
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