Currently, there is no global standard of care for treatment of patients with metastatic urothelial cancer (mUC) who progress despite platinum-based chemotherapy. Practice guidelines recommend varied approaches from supportive care alone to single-agent chemotherapy based largely on the results of small single-arm trials that demonstrated modest activity. The treatment and outcomes of real-world patients with mUC treated with second-line (2L) systemic therapies remains underexplored.
Pts diagnosed with stage IV transitional cell carcinoma of the bladder from 1/2004 to 12/2011 were identified in the US SEER-Medicare database. Other criteria included ≥ 66 y of age at diagnosis (1 y after Medicare eligibility), with no prior cancer diagnosis and enrolled in Medicare Parts A and B. 2L chemotherapy regimens were defined as any change in 1L chemotherapy or start of new treatment upon completion of 1L. Kaplan-Meier methods were used to assess survival by 2L treatment approach (follow up through 12/2013).
240 mUC pts treated with 2L chemotherapy were included. Median age at diagnosis was 75 y (IQR 71-79 y), and 81% of pts were aged ≥ 70 y; 74% were male and 93% were white. Most pts (199/240, 83%) received cisplatin- or carboplatin-based prior 1L therapies. The most common comorbidities included diabetes (16%) and chronic obstructive pulmonary disease (10%). Among pts receiving 2L chemotherapy, 40% (97/240) received single agents. The majority of pts who received single-agents had taxanes (paclitaxel 37/97, 38%; docetaxel 20/97, 21%), followed by gemcitabine (19/97, 20%) and other single agents (21/97, 21%). The median overall survival (OS) in pts receiving any single-agent 2L chemotherapy was 6.4 mo (95% CI, 4.4,-8.5 mo), with a 24-mo OS rate of 13%. The median OS in pts receiving single-agent taxanes was 5.2 mo (95% CI, 3.5-8.6 mo), with a 24-mo OS rate of 8%.
In this real-world mUC population, pts received a wide variety of therapies in the 2L setting. Regardless of the treatment approach, outcomes were generally poor with a low likelihood of durable disease control. These results may serve as a benchmark for the effectiveness of novel therapies currently being developed for the treatment of mUC.
Clinical trial identification
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
F. Hoffmann-La Roche Ltd.
M.D. Galsky: Advisory Board: Genentech, Merck, Astellas, Novartis, Consulting: BioMotiv. Research funding: Novartis, NMS, Celgene. S-W. Lin, S. Ogale, C. Derleth: Employee of Genentech, Inc. M. Zivkovic: Employee of Genesis Research. J. Simpson: Employee of Genentech, Inc. All other authors have declared no conflicts of interest.