INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG).

BACKGROUND: Advanced gastro-oesophageal cancer (AGOC) carries a poor prognosis. No standard of care treatment options are available after first and second-line therapies. Regorafenib is an oral multi-targeted tyrosine kinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases. Regorafenib 160 mg daily prolonged progression free survival compared to placebo (INTEGRATE, phase 2). Regorafenib 80 mg daily in combination with nivolumab 3 mg/kg showed promising objective response rates (REGONIVO). METHODS/DESIGN: INTEGRATE II (INTEGRATE IIa and IIb) platform comprises two international phase III randomised controlled trials (RCT) with 2:1 randomisation in favor of experimental intervention. INTEGRATE IIa (double-blind) compares regorafenib 160 mg daily on days 1 to 21 of each 28-day cycle to placebo. INTEGRATE IIb (open label) compares REGONIVO, regorafenib 90 mg days 1 to 21 in combination with intravenous nivolumab 240 mg days 1 and 15 each 28-day cycle with investigator's choice of chemotherapy (control). Treatment continues until disease progression or intolerable adverse events as per protocol. Eligible participants include adults with AGOC who have failed two or more lines of treatment. Stratification is by location of tumour (INTEGRATE IIa only), geographic region, prior VEGF inhibitor and prior immunotherapy use (INTEGRATE IIb only). Primary endpoint is overall survival. Secondary endpoints are progression free survival, objective response rate, quality of life, and safety. Tertiary/correlative objectives include biomarker and pharmacokinetic evaluation. DISCUSSION: INTEGRATE II provides a platform to evaluate the clinical utility of regorafenib alone, as well as regorafenib in combination with nivolumab in treatment of participants with refractory AGOC. TRIAL REGISTRATION: INTEGRATE IIa prospectively registered 1 April 2016 Australia New Zealand Clinical Trial Registry: ACTRN12616000420448 (ClinicalTrials.gov NCT02773524). INTEGRATE IIb prospectively registered 10 May 2021 ClinicalTrials.gov: NCT04879368.

Experiences and Satisfaction With Telehealth During the COVID-19 Pandemic: The Perspectives of Patients With Cancer in Australia.

PURPOSE: There has been a significant rise in telehealth consultations across Australia since COVID-19 was declared a worldwide pandemic. We aimed to obtain patient feedback on telehealth, identify key strengths and weaknesses, and assess the feasibility of telehealth beyond the pandemic. METHODS: A survey was developed to obtain patient feedback on telehealth. Patients attending medical oncology clinics at St George Hospital and Sutherland Hospital from April 1, 2020, to May 31, 2020, were identified. Patients who were reviewed via phone or videoconference were included in this study. Eligible patients were texted or emailed a survey link within a week of their telehealth consultation. Surveys were anonymous and completion of the survey implied informed consent. Patients who did not have a mobile number or e-mail were excluded from this study. RESULTS: One thousand fifty-nine patients were reviewed during the study period, of whom 644 (60%) were reviewed via telehealth. The survey response rate was 36.3% (230 patients responded of 634 surveys sent). Ten telehealth patients did not have a mobile number or email and were excluded. Sixty-seven percent of telehealth consults were for active surveillance, 31% for prechemotherapy/treatment reviews, 1.6% for best supportive care, and 0.5% for new consults. Seventy percent of patients were satisfied that their medical needs were met via telehealth. Ninety percent wanted another telehealth consult, and 73% wanted telehealth to continue post resolution of the pandemic. Minimizing risk of exposure to COVID-19 and patient convenience were identified as key strengths of telehealth while absence of physical examination was the main disadvantage. CONCLUSION: Majority of the patients surveyed were satisfied that telehealth safely met their medical needs. There is a considerable demand for telehealth to continue beyond the pandemic.