Abstract
There is a paucity of chemotherapy options for patients with urothelial cancers who have relapsed following platinum based chemotherapy (CT). CAB-B1 was a single centre phase II randomised controlled trial of Cabazitaxel (CAB; 25mg/m2 q3 week for 6 cycles) versus best supportive care (BSC) in patients with histologically proven transitional cell carcinoma (TCC), locally advanced or metastatic, who had recurred after receiving platinum based treatment. Primary outcome was overall response rate (ORR) using RESIST. Secondary outcomes included Progression Free Survival (PFS) and Overall Survival (OS). Between January 2013 and October 2016, 20 patients were randomised (10 on each arm). BSC included paclitaxel CT for 9 patients and radiotherapy for 1 patient. 8 patients completed 6 cycles of CT (3 on CAB; 5 on BSC). 2 patients had an ORR on CAB and 1 patient on BSC. Median OS was 5.8 months (95% confidence interval (CI) 0.7-14.6) for CAB patients and 7.5 months (95% CI 1.0-10.8) for BSC patients. Median PFS was 4.8 months (95% CI 0.7-8.3) for CAB patients and 3.7 months (95% CI 1.0-7.0) for BSC patients. CAB-B1 successfully reached the efficacy target for 1st stage, showing that there could be a role for CAB in these patients.
Highlights
Bladder cancer is the 10th most common cause of cancer in the UK [1]
Patient characteristics were similar across trial arms (Table 1): 75% were males; median age 68 years; 65% had recurred within 6 months of previous CT
An interim analysis was performed after 20 patients in total were recruited into the first stage
Summary
Bladder cancer is the 10th most common cause of cancer in the UK [1]. The majority of bladder tumours occur in men, where it is the6th most common cause of cancer and 12th most common cause of cancer death in females [1]. Bladder cancer is the 10th most common cause of cancer in the UK [1]. The majority of bladder tumours occur in men, where it is the. 6th most common cause of cancer and 12th most common cause of cancer death in females [1]. The survival of untreated metastatic patients does not exceed 3 to 6 months, and systemic chemotherapy increases overall survival of patients with unresectable disease [2,3,4]. The overall survival (OS) of patients with advanced disease treated with chemotherapy remains short (about 14 months) and new agents are needed in this very poor prognosis disease. There was no standard of care for patients who relapsed after previously receiving neo-adjuvant chemotherapy and there was no standard second line chemotherapy at the time this study was planned.
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