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A phase II randomized four-regimen selection trial incorporating response for sequential chemotherapy in metastatic, unresectable urothelial cancer: Final results from the M. D. Anderson Cancer Center.

5071 Background: We developed a clinical trial incorporating response into the treatment algorithm. Patients meeting a certain threshold of response continued with the same treatment; those with insufficient response were switched to alternative chemotherapy. We now report on final results from this trial.


METHODS
Patients were randomly assigned to one of four regimens: ifosfamide, doxorubicin, gemcitabine; ifosfamide, paclitaxel, cisplatin; gemcitabine, cisplatin; or cisplatin, gemcitabine, and ifosfamide. To continue with chemotherapy, patients must have had at least a 40% response after the first 6-week interval, and a >90% response after the second 6 weeks. Otherwise, they were re-randomized to alternate chemotherapy. Overall success (OSX) was defined as patients with a >90% response with either front-line or second-line therapy. Surgical consolidation was offered to patients at the discretion of their treating physician.


RESULTS
Median overall survival (OS) for 120 patients was 19.1 mo. (3 and 5-yr survival: 33% and 20%). OSX was achieved in 41 patients (median OS: 51 mo.); the median OS in the other 79 patients was 15 mo. (p = 0.0001), with a 5-yr survival of 42% and 10% respectively. Surgical consolidation was performed in 35 patients: 23 with nodal metastases to pelvic and/or RPLN, 6 with cT4b tumors, and an additional 6 patients with distant metastases. Their median OS from surgery was 23.7 months, (5-yr survival: 31%). Surgical consolidation in the setting of OSX was associated with a 42% 5-yr survival as compared to 11% in those undergoing surgery in the absence of OSX. Visceral metastases and poor performance status were associated with a worse prognosis.


CONCLUSIONS
With sequential therapy, 34% of patients had a >90% response (OSX). A potential benefit in long-term survival was seen in patients who had surgical consolidation in the setting of OSX. This trial design provides a novel method for assessing the benefits of sequential chemotherapy, and enhancing the population of patients who may be offered surgical consolidation in the setting of initially unresectable, or metastatic urothelial cancer. No significant financial relationships to disclose.