2388P - Split-dose cisplatin plus gemcitabine use and associated clinical outcomes in the first-line (1L) treatment of locally advanced or metastatic urothelial cancer (la/mUC): Results of a retrospective observational study in Germany (CONVINCE)

Background

Platinum-based chemotherapy (PBC) followed by avelumab 1L maintenance in patients without progressive disease is standard 1L treatment for la/mUC. In patients ineligible for cisplatin at the standard dose schedule (C; 1 day per cycle), carboplatin (Cb) or a split-dose schedule of C (35 mg/m² on days 1 + 8) are alternative options. The effectiveness of these regimens compared with standard-dose C has not been extensively examined, especially in a real-world (rw) setting. In this study, we compared clinical outcomes to PBC in patients with la/mUC who received 1L gemcitabine (G) with split-dose C (CG-S) vs standard-dose CG or CbG regimens.

Methods

The CONVINCE study was initiated in Dec 2021 and enrolled 188 patients who received 1L PBC in 2019-2020 at 27 oncology or urology institutions (8 hospitals/19 office-based practices) across Germany. Objective response rates (ORRs) and rw progression-free survival (rwPFS) and overall survival (rwOS) were compared in the following subgroups: CG-S vs CG and CG-S vs CbG.

Results

Of 124 patients who received 1L PBC with G, 27 (21.8%) received CG-S, 75 (60.5%) CG, and 22 (17.7%) CbG. Median follow-up was 16.5 months. A Cox regression analysis including several characteristics (age, sex, Eastern Cooperative Oncology Group performance status [ECOG PS], comorbidities) showed no significant differences in rwPFS between CG-S vs CG and CG-S vs CbG subgroups.

Conclusions

This rw study provides valuable insights into the use of 1L CG-S in routine clinical practice in Germany, where C administered in split-dose schedule showed comparable outcomes to standard-dose C or Cb. The analysis suggests that CG-S can be a viable alternative for administering 1L PBC in patients with la/mUC for whom standard-dose C may be unsuitable, without compromising treatment effectiveness. Table: 2388P

Clinical trial identification

Editorial acknowledgement

Editorial support was provided by Jeremy Gardner on behalf of Clinical Thinking and was funded by Merck and Pfizer.

Legal entity responsible for the study

The authors.

Funding

This study was sponsored by Merck (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between Merck and Pfizer.

Disclosure

K. Schlack: Financial Interests, Institutional, Advisory Role: AAA, Amgen, Apogepha, Astellas, AstraZeneca, Bayer, BMS, Eisai, EUSA-Pharma, Fosanis, Ipsen, Janssen Cilag, Merck Healthcare, MSD, Novartis, Pfizer, Roche, Sanofi. S. Machtens: Financial Interests, Institutional, Advisory Role: Sanofi-Aventis, BD, Pfizer, Amgen, Bebig, Janssen-Cilag, Bayer, MSD, AstraZeneca; Financial Interests, Institutional, Speaker’s Bureau: Sanofi-Aventis, Amgen, Novartis, BD, Bebig, Janssen-Cilag, Pfizer, AstraZeneca, Ipsen, Apogepha, Takeda, Bayer, MSD, Merck. U. Osowski,S. Guenther, M. Kearney: Financial Interests, Institutional, Full or part-time Employment: Merck. R. Lipp: Financial Interests, Institutional, Advisory Role: Merck, AstraZeneca, Takeda, Janssen-Cilag, Sanofi, Gilead, Omnicare; Financial Interests, Institutional, Speaker’s Bureau: Merck; Financial Interests, Institutional, Other, Project Support: Merck, Pfizer, Janssen-Cilag, BMS, AstraZeneca, Gilead, AbbVie. All other authors have declared no conflicts of interest.