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A nomogram including baseline prognostic factors to estimate the activity of second-line therapy for advanced urothelial carcinoma

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Pond, Gregory R., Agarwal, Neeraj, Bellmunt, Joaquim, Choueiri, Toni K., Qu, Angela, Fougeray, Ronan, Vaughn, David, James, Nicholas D., Salhi, Yacine, Albers, Peter et al.
(2014) A nomogram including baseline prognostic factors to estimate the activity of second-line therapy for advanced urothelial carcinoma. BJU International, 113 (5b). E137-E143. doi:10.1111/bju.12564

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Official URL: http://dx.doi.org/10.1111/bju.12564

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Abstract

Objective:
To study the impact of the prognostic factors liver metastasis (LM), anaemia (haemoglobin [Hb] <10 g/dL), Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥1 and time from previous chemotherapy (TFPC) on the activity of second-line therapy for advanced urothelial carcinoma (UC).

Patients and methods:
Twelve phase II trials evaluating second-line chemotherapy and/or biological characteristics (n = 748) in patients with progressive disease were pooled. Progression-free survival (PFS) was defined as tumour progression or death from any cause. The PFS rate at 6 months (PFS6) was defined from the date of registration and calculated using the Kaplan-Meier method. Response rate (RR) was defined using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0. A nomogram predicting PFS6 was constructed using the rms software package in R (http://www.r-project.org).

Results:
Data regarding progression, anaemia, LM, ECOG-PS and TFPC were available from 570 patients in nine phase II trials. The overall median PFS was 2.7 months, PFS6 was 22.2% (95% confidence interval 18.8-25.9) and the RR was 17.5% (95% CI: 14.5-20.9%). For every unit increase in risk group, the hazard of progression in 6 months increased by 41% and the odds of response decreased by 48%. A nomogram was constructed to predict PFS6 on an individual patient level. The model was internally validated and was shown to have acceptable calibration performance.

Conclusions:
The RR and PFS6 vary as a function of baseline prognostic factors in patients receiving second-line therapy for advanced UC. A nomogram incorporating prognostic factors facilitates the evaluation of outcomes across phase II trials enrolling heterogeneous populations and helps select suitable agents for phase III testing.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Urinary organs -- Cancer, Nomography (Mathematics)
Journal or Publication Title: BJU International
Publisher: Wiley-Blackwell Publishing Ltd.
ISSN: 1464-1603
Official Date: May 2014
Dates:
DateEvent
May 2014Published
23 April 2014Available
13 November 2013Accepted
Volume: 113
Number: 5b
Number of Pages: 7
Page Range: E137-E143
DOI: 10.1111/bju.12564
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Funder: Boehringer Ingelheim Pharmaceuticals, Celgene (Firm), Pierre Fabre Laboratories, AstraZeneca (Firm), British Mycological Society (BMS), GlaxoSmithKline

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