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Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

Carboplatin-based chemotherapy (C) versus immunotherapy (IO) in metastatic urothelial carcinoma (mUC).

Bladder Cancer

Genitourinary (Nonprostate) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr e16003)

Author(s): Emily Feld, Joanna Harton, Neal J. Meropol, Blythe J.S. Adamson, Ravi Bharat Parikh, Matt D. Galsky, Aaron B. Cohen, Vivek Narayan, John Paul Christodouleas, David J. Vaughn, Rebecca A. Hubbard, Ronac Mamtani; University of Pennsylvania, Philadelphia, PA; University of Pennsylvania Perelman School of Medicine, Department of Biostatistics and Epidemiology, Philadelphia, PA; Flatiron Health, New York, NY; Department of Medicine, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY; University of Pennsylvania, Department of Radiation Oncology, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

Abstract Disclosures


Background: There are limited data comparing first-line (1L) C versus IO in cisplatin-ineligible mUC patients. The primary evidence guiding treatment decisions was a May 2018 Food and Drug Administration (FDA) safety alert based on early review of two ongoing phase III trials, reporting shorter survival in PD-L1 negative patients receiving IO relative to chemotherapy. Final results from these trials are unknown and may not be applicable to a real-world cohort. Methods: We conducted a retrospective cohort study of mUC patients receiving 1L C or IO from January 1, 2011 to May 18, 2018 using the Flatiron Health electronic health record-derived database. The primary outcome was overall survival (OS) from start of 1L treatment to date of death. We compared 12- and 36-month OS, and hazard ratios before and after 12 months. Propensity score-based inverse probability of treatment weighting (IPTW) was used to address confounding in Kaplan-Meier (KM) and Cox multivariable regression model estimates of comparative-effectiveness. Results: Of 2,243 patients, 562 received IO and 1,681 received C. Baseline characteristics were balanced between groups, with few exceptions (Table). In the first 12 months, IO was associated with an increased hazard of death compared to C (HR 1.38, 95% CI 1.16-1.66). Among patients who survived one year, survival was improved with IO compared to C (HR 0.50, 95% CI 0.27-0.92). Conclusions: In routine clinical practice, 1L IO was associated with inferior 12-month OS relative to C, but superior OS beyond 12 months. Clinicians and patients should carefully consider how to balance the early benefit of C against the late benefit of IO. Currently pending trial results will contribute additional evidence to inform treatment decision making.

Baseline characteristics and OS results.

(n = 562)
(n = 1681)
Age, mean7676
Male (%)7373
Race white (%)7374
History of smoking (%)7472
PDL1 tested (%)86
ECOG ≥2 (%)2212
Elixhauser comorbidity score, mean2.281.07
OS, 12 months (%)40.746.4
OS, 36 months (%)29.113.7

Other Abstracts in this Sub-Category:


1. CALGB 90601 (Alliance): Randomized, double-blind, placebo-controlled phase III trial comparing gemcitabine and cisplatin with bevacizumab or placebo in patients with metastatic urothelial carcinoma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4503 First Author: Jonathan E. Rosenberg
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer


2. Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients (pts) with metastatic urothelial cancer (mUC): HCRN GU14-182.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4504 First Author: Matt D. Galsky
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer


3. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.

Meeting: 2019 ASCO Annual Meeting Abstract No: LBA4505 First Author: Daniel Peter Petrylak
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer