Monika Joshi, MD, on Findings on Chemoradiation With Durvalumab in Urothelial Carcinoma
Posted: Friday, July 8, 2022
Monika Joshi, MD, of Penn State Cancer Institute, discusses the ongoing phase II INSPIRE trial, which is investigating bladder-sparing chemoradiation with durvalumab as a new treatment strategy for stage III bladder cancer in the first prospective study designed for lymph node–positive disease alone. Dr. Joshi urges her colleagues to join the study.
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The main objective of this study is to compare the complete clinical response rate after chemo RT, with or without durvalumab between the two arms of the study. This is a randomized phase II study, where patients with NAT, N1 to N3, M0, so node-positive patients radiologically or pathologically would be randomized to chemo RT, with or without durvalumab. And then patients on the experimental arm, if they do get a good response, they will get six cycles of adjuvant durvalumab, whereas patients on the chemo RT arm who have good response would get surveillance. And of course, those who do have progression of disease would come off the study and be treated per their physician recommendation. We've made some changes in the study, so we are including patients N1 to N3, even if the node is less than one centimeter, but biopsy proven. We've also removed the mandate for necessary induction or neoadjuvant chemotherapy. So patients who are treatment naive or who are post-neoadjuvant chemotherapy, as long as the node positivity was diagnosed prior to being randomized to this study, as long as their neoadjuvant chemotherapy was given after the diagnosis of node positivity, they could be enrolled and they have not progressed on the chemotherapy. We have a stratification practice built to capture these, including receive of induction chemotherapy, or cisplatin-based versus non-cisplatin-based chemotherapy regimen during the chemo RT, as well as N1 versus N2 to N3, and extent of TURBT. The radiotherapy part is designed very similar to S1806, but also including the positive nodes, and has been designed by the NRG. Currently, the study is open to accrual and we would hope that everyone who's treating bladder cancer, or seeing node-positive patients, could join our study.