Relationship between 6- and 9-month progression-free survival and overall survival in patients with metastatic urothelial cancer treated with first-line cisplatin-based chemotherapy

Matthew D. Galsky, Susan Krege, Chia Chi Lin, Noah Hahn, Thorsten Ecke, Erin Moshier, Guru Sonpavde, James Godbold, William K. Oh, Aristotle Bamias

Research output: Contribution to journalArticle

Abstract

BACKGROUND Use of progression-free survival (PFS) as a clinical trial endpoint in first-line treatment of patients with metastatic urothelial carcinoma (UC) is attractive, but would be enhanced by establishing a correlation between PFS and overall survival (OS). METHODS Data was pooled from 7 phase 2 and 3 trials evaluating cisplatin-based chemotherapy in metastatic UC. An independent cohort of patients enrolled on a phase 3 trial was used for external validation. Landmark analyses for progression at 6 and 9 months after treatment initiation were performed to minimize lead-time bias. A proportional hazards model was used to assess the utility of PFS for predicting OS. RESULTS A total of 364 patients were included in the initial cohort. The median PFS was 8.21 months (95% confidence interval = 7.43, 8.39) and the median OS was 13.50 months (95% confidence interval = 11.80, 15.67). In the landmark analysis, the median OS for patients who progressed at 6 months was 3.87 months compared with 15.06 months for those patients who did not progress (P

Original languageEnglish (US)
Pages (from-to)3020-3026
Number of pages7
JournalCancer
Volume119
Issue number16
DOIs
StatePublished - 2013
Externally publishedYes

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Cisplatin
Disease-Free Survival
Drug Therapy
Survival
Neoplasms
Confidence Intervals
Carcinoma
Proportional Hazards Models
Clinical Trials
Therapeutics

Keywords

  • bladder cancer
  • chemotherapy
  • cisplatin
  • clinical trials
  • overall survival
  • progression-free survival
  • urothelial cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Relationship between 6- and 9-month progression-free survival and overall survival in patients with metastatic urothelial cancer treated with first-line cisplatin-based chemotherapy. / Galsky, Matthew D.; Krege, Susan; Lin, Chia Chi; Hahn, Noah; Ecke, Thorsten; Moshier, Erin; Sonpavde, Guru; Godbold, James; Oh, William K.; Bamias, Aristotle.

In: Cancer, Vol. 119, No. 16, 2013, p. 3020-3026.

Research output: Contribution to journalArticle

Galsky, Matthew D. ; Krege, Susan ; Lin, Chia Chi ; Hahn, Noah ; Ecke, Thorsten ; Moshier, Erin ; Sonpavde, Guru ; Godbold, James ; Oh, William K. ; Bamias, Aristotle. / Relationship between 6- and 9-month progression-free survival and overall survival in patients with metastatic urothelial cancer treated with first-line cisplatin-based chemotherapy. In: Cancer. 2013 ; Vol. 119, No. 16. pp. 3020-3026.
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abstract = "BACKGROUND Use of progression-free survival (PFS) as a clinical trial endpoint in first-line treatment of patients with metastatic urothelial carcinoma (UC) is attractive, but would be enhanced by establishing a correlation between PFS and overall survival (OS). METHODS Data was pooled from 7 phase 2 and 3 trials evaluating cisplatin-based chemotherapy in metastatic UC. An independent cohort of patients enrolled on a phase 3 trial was used for external validation. Landmark analyses for progression at 6 and 9 months after treatment initiation were performed to minimize lead-time bias. A proportional hazards model was used to assess the utility of PFS for predicting OS. RESULTS A total of 364 patients were included in the initial cohort. The median PFS was 8.21 months (95{\%} confidence interval = 7.43, 8.39) and the median OS was 13.50 months (95{\%} confidence interval = 11.80, 15.67). In the landmark analysis, the median OS for patients who progressed at 6 months was 3.87 months compared with 15.06 months for those patients who did not progress (P",
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AU - Bamias, Aristotle

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N2 - BACKGROUND Use of progression-free survival (PFS) as a clinical trial endpoint in first-line treatment of patients with metastatic urothelial carcinoma (UC) is attractive, but would be enhanced by establishing a correlation between PFS and overall survival (OS). METHODS Data was pooled from 7 phase 2 and 3 trials evaluating cisplatin-based chemotherapy in metastatic UC. An independent cohort of patients enrolled on a phase 3 trial was used for external validation. Landmark analyses for progression at 6 and 9 months after treatment initiation were performed to minimize lead-time bias. A proportional hazards model was used to assess the utility of PFS for predicting OS. RESULTS A total of 364 patients were included in the initial cohort. The median PFS was 8.21 months (95% confidence interval = 7.43, 8.39) and the median OS was 13.50 months (95% confidence interval = 11.80, 15.67). In the landmark analysis, the median OS for patients who progressed at 6 months was 3.87 months compared with 15.06 months for those patients who did not progress (P

AB - BACKGROUND Use of progression-free survival (PFS) as a clinical trial endpoint in first-line treatment of patients with metastatic urothelial carcinoma (UC) is attractive, but would be enhanced by establishing a correlation between PFS and overall survival (OS). METHODS Data was pooled from 7 phase 2 and 3 trials evaluating cisplatin-based chemotherapy in metastatic UC. An independent cohort of patients enrolled on a phase 3 trial was used for external validation. Landmark analyses for progression at 6 and 9 months after treatment initiation were performed to minimize lead-time bias. A proportional hazards model was used to assess the utility of PFS for predicting OS. RESULTS A total of 364 patients were included in the initial cohort. The median PFS was 8.21 months (95% confidence interval = 7.43, 8.39) and the median OS was 13.50 months (95% confidence interval = 11.80, 15.67). In the landmark analysis, the median OS for patients who progressed at 6 months was 3.87 months compared with 15.06 months for those patients who did not progress (P

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