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Adding the immunotherapy durvalumab to chemotherapy before bladder removal, and continuing it afterwards, reduced relapse and death in muscle-invasive bladder cancer, the first improvement on neoadjuvant chemotherapy in two decades.
Open-label phase 3 trial of 1,063 patients with cisplatin-eligible muscle-invasive bladder cancer randomised to neoadjuvant gemcitabine-cisplatin with or without durvalumab, followed by radical cystectomy and, in the durvalumab arm, eight cycles of adjuvant durvalumab. Primary endpoints were event-free survival and pathological complete response.
24-month EFS was 67.8% vs 59.8% (HR 0.68) and 24-month OS 82.2% vs 75.2% (HR 0.75); pCR was 37.3% vs 27.5%. It made perioperative durvalumab a new standard for cisplatin-eligible patients and, following CheckMate 274 (adjuvant nivolumab), completed the move of checkpoint inhibitors into curative-intent bladder cancer treatment.
Patients fit enough for cisplatin whose bladder cancer has invaded the muscle wall should now be offered durvalumab with their pre-operative chemotherapy and for about a year after surgery, which improves the chance of cure without compromising the operation. The trial cannot say whether the adjuvant phase is necessary, or how to treat cisplatin-ineligible patients, for whom other trials are ongoing.
Shares Thomas Powles, Muscle-invasive and advanced bladder cancer, Neoadjuvant / adjuvant / perioperative, Durvalumab.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Thomas Powles, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative, PD-L1.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Durvalumab.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy, Neoadjuvant / adjuvant / perioperative, Durvalumab.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.