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Observational Study
. 2023 Dec;21(6):e438-e448.
doi: 10.1016/j.clgc.2023.05.008. Epub 2023 May 17.

Treatment Patterns and Efficacy of Chemotherapy After Pembrolizumab in Advanced Urothelial Cancer-a Real-World Study in the pre-Antibody-Drug Conjugate Era

Karin Holmsten  1 , Johanna Eknert  2 , Elisabeth Öfverholm  3 , Dimitrios Papantoniou  4 , Faith Jawdat  5 , Ingrida Verbiéné  6 , Anna Laurell  6 , Elin Jänes  7 , Johan Sandzén  8 , Elzbieta Wojtyna-Dziedzic  9 , Ida Lagstam  10 , Karin Söderkvist  11 , Fernanda Costa Svedman  5 , Fredrik Liedberg  12 , Martin Bruzelius  13 , Ann-Sofie Fransson  14 , Sofia Kjellström  15 , Lise Hoej Omland  16 , Helle Pappot  16 , Anders Ullén  5
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Free article
Observational Study

Treatment Patterns and Efficacy of Chemotherapy After Pembrolizumab in Advanced Urothelial Cancer-a Real-World Study in the pre-Antibody-Drug Conjugate Era

Karin Holmsten et al. Clin Genitourin Cancer. 2023 Dec.
Free article

Abstract

Background: Immune checkpoint inhibitors (ICIs) have been established as a routine treatment in patients with metastatic urothelial cancer (mUC). However, there has been no standard of care after progression on ICIs. We investigated real-world treatment patterns and efficacy of chemotherapy (CHT) after pembrolizumab, in the era before introduction of maintenance avelumab and antibody-drug conjugates (ADC).

Patients and methods: An observational, retrospective study was conducted at twelve Nordic centers. Patients with mUC were treated according to investigator´s choice of CHT after pembrolizumab. Primary endpoint was overall response (ORR) and disease control rate (DCR); secondary endpoints were progression-free (PFS) and overall survival (OS).

Results: In total, 102 patients were included whereof 23 patients received CHT after pembrolizumab as second line treatment (subcohort A) and 79 patients in third line (subcohort B). Platinum-gemcitabine combinations were the most common regimens in subcohort A, and vinflunine in subcohort B. The ORR and DCR were 36% and 47%, respectively. Presence of liver metastases was independently associated with lower ORR and DCR. The PFS and OS were 3.3 months and 7.7 months, respectively. Eastern Cooperative Oncology Group Performance Status (ECOG PS) and number of previous cycles of pembrolizumab were found to be independent prognostic factors associated with OS.

Conclusion: In a real-world setting, CHT showed clinically meaningful response rates and survival in mUC patients after progression with pembrolizumab. Clinical benefit may primarily be achieved in patients with favorable ECOG PS, in patients treated with > 6 cycles pembrolizumab as well as in patients without presence of liver metastases.

Keywords: Bladder cancer; Immune checkpoint inhibitors; Immunotherapy; Metastatic urothelial carcinoma; Palliative chemotherapy.

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Conflict of interest statement

Disclosure Anders Ullén: Research Funding: Bayer, the healthcare business of Merck KGaA, Darmstadt, Germany, Pierre Fabre. Consulting or Advisory Role: Astellas Pharma, Janssen-Cilag, Merck & Co, Kenilworth, NJ, Pierre Fabre, Pfizer, Roche, and the healthcare business of Merck KGaA, Darmstadt, Germany. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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