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Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma : a retrospective analysis of pooled, prospective phase 2 trials

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Sonpavde, Guru, Pond, Gregory R., Fougeray, Ronan, Choueiri, Toni K. , Qu, Angela, Vaughn, David, Niegisch, Günter, Albers, Peter, James, Nicholas D., Wong, Yu-Ning et al.
(2013) Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma : a retrospective analysis of pooled, prospective phase 2 trials. European Urology, 63 (4). pp. 717-723. doi:10.1016/j.eururo.2012.11.042

Research output not available from this repository, contact author.
Official URL: http://dx.doi.org/10.1016/j.eururo.2012.11.042

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Abstract

Background:

Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM).

Objectives:

The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors.

Design, setting, and participants:

Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n = 570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n = 352).

Outcome measurements and statistical analysis:

Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures.

Results and limitations:

ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic = 0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable.

Conclusions:

Shorter TFPC enhances prognostic classification independent of ECOG-PS >0, Hb <10 g/dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Chemotherapy, Kidneys -- Cancer
Journal or Publication Title: European Urology
Publisher: Elsevier BV
ISSN: 0302-2838
Official Date: April 2013
Dates:
DateEvent
April 2013Published
26 November 2012Available
18 November 2012Accepted
Volume: 63
Number: 4
Number of Pages: 7
Page Range: pp. 717-723
DOI: 10.1016/j.eururo.2012.11.042
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: Boehringer Ingelheim Pharmaceuticals, AstraZeneca (Firm), British Mycological Society (BMS), GlaxoSmithKline

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