Using real-world data to define a validated nomogram for advanced bladder cancer patients who respond to immunotherapy
Authors
Elumalai, ThiraviyamCroxford, William
Buijtenhuijs, B.
Conroy, Ruth
Sanderson, B.
Enting, D.
Aversa, C.
Doss, G.
Das, A.
Vasudev, N. S.
Kitetere, E.
Tolan, S.
Law, A.
Hoskin, P.
Mistry, H.
Choudhury, Ananya
Issue Date
2022
Metadata
Show full item recordAbstract
Aims Immune checkpoint inhibitors (ICIs) are used in incurable urothelial cancers, both in chemo-naïve and platinum-refractory patients. Efficacy and toxicity data published outside controlled clinical trials are limited. We report overall survival, progression-free survival and toxicities of ICIs in locally advanced (LABC) or metastatic bladder cancer (MBC). We aimed to develop and validate a prognostic model for these patients. Materials and methods A multicentre real-world individual patient-level data study (n = 272) evaluating ICIs in the first-line platinum-ineligible or platinum-refractory setting for LABC/MBC between March 2017 and February 2020 was undertaken. Cox regression analyses evaluated the association of prognostic factors with overall survival. Data were split to create a training (n = 208) and validation (n = 64) cohort. The backward elimination method with a P-value cut-off of 0.05 was used to develop a reduced prognostic model using the training data set. The concordance index and assessment of observed versus predicted survival probabilities were used to evaluate the final model. Results The median follow-up was 18.9 (15.8–21.5) months. The median overall survival and progression-free survival in the training cohort were 9.2 (95% confidence interval 7.4–10.5) and 4.5 months (3.5–5.7), respectively. The most common grade 1/2 adverse events recorded were fatigue (47.8%) and infection (19.9%). Five key prognostic factors found in the training set were low haemoglobin, high neutrophil count, choice of immunotherapy favouring pembrolizumab, presence of liver metastasis and steroid use within 30 days of treatment. The concordance index for the training and validation cohorts was 0.66 (standard error = 0.05) and 0.64 (standard error = 0.04), respectively, for the final model. A nomogram was developed to calculate the expected survival probabilities based on risk factors. Conclusions Real-world data were used to produce a validated prognostic model for overall survival in LABC/MBC treated with ICIs. This model could assist in patient stratification, interpreting and framing future trials incorporating PD-1/PD-L1 inhibitors in LABC/MBC.Citation
Elumalai T, Croxford W, Buijtenhuijs B, Conroy R, Sanderson B, Enting D, et al. Using Real-world Data to Define a Validated Nomogram for Advanced Bladder Cancer Patients Who Respond to Immunotherapy. Clin Oncol (R Coll Radiol). 2022.Journal
Clin Oncol (R Coll Radiol)DOI
10.1016/j.clon.2022.02.022PubMed ID
35282933Additional Links
https://dx.doi.org/10.1016/j.clon.2022.02.022Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.clon.2022.02.022
Scopus Count
Collections
Related articles
- A New Prognostic Model in Patients with Advanced Urothelial Carcinoma Treated with First-line Immune Checkpoint Inhibitors.
- Authors: Khaki AR, Li A, Diamantopoulos LN, Miller NJ, Carril-Ajuria L, Castellano D, De Kouchkovsky I, Koshkin V, Park J, Alva A, Bilen MA, Stewart T, Santos V, Agarwal N, Jain J, Zakharia Y, Morales-Barrera R, Devitt M, Nelson A, Hoimes CJ, Shreck E, Gartrell BA, Sankin A, Tripathi A, Zakopoulou R, Bamias A, Rodriguez-Vida A, Drakaki A, Liu S, Kumar V, Lythgoe MP, Pinato DJ, Murgic J, Fröbe A, Joshi M, Isaacsson Velho P, Hahn N, Alonso Buznego L, Duran I, Moses M, Barata P, Galsky MD, Sonpavde G, Yu EY, Shankaran V, Lyman GH, Grivas P
- Issue date: 2021 Jun
- Prognostic model in patients with metastatic urothelial carcinoma receiving immune checkpoint inhibitors after platinum failure.
- Authors: Park JH, Park I, Kim IH, Hur JY, Hwang I, Kim C, Kim HJ, Maeng CH, Park K, Lee MY, Lee HJ, Jung JY, Keam B, Park SH, Lee JL
- Issue date: 2022 Jun
- Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.
- Authors: Ferrara R, Imbimbo M, Malouf R, Paget-Bailly S, Calais F, Marchal C, Westeel V
- Issue date: 2021 Apr 30
- Single or combined immune checkpoint inhibitors compared to first-line platinum-based chemotherapy with or without bevacizumab for people with advanced non-small cell lung cancer.
- Authors: Ferrara R, Imbimbo M, Malouf R, Paget-Bailly S, Calais F, Marchal C, Westeel V
- Issue date: 2020 Dec 14
- Clinical Outcomes of Platinum-ineligible Patients with Advanced Urothelial Carcinoma Treated With First-line PD1/L1 Inhibitors.
- Authors: Pond GR, Agarwal A, Ornstein M, Garcia J, Gupta R, Grivas P, Drakaki A, Lee JL, Kanesvaran R, Lorenzo GD, Verolino P, Barata P, Bilen MA, Hussain SA, Curran C, Sonpavde G
- Issue date: 2021 Oct