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Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States.

Publication ,  Journal Article
Wong, MK; Jonasch, E; Pal, SK; Signorovitch, JE; Lin, PL; Wang, X; Liu, Z; Culver, K; Scott, JA; George, DJ; Vogelzang, NJ
Published in: Expert Opin Pharmacother
April 2015

OBJECTIVE: Comparing prognostic factors for overall survival (OS) in community-practice metastatic renal cell carcinoma (mRCC) patients receiving second-line everolimus with those previously reported in clinical trials. RESEARCH DESIGN AND METHODS: Two separate chart sets (2009 - 2012) were used to develop and validate a prognostic model for patients initiating second-line everolimus after first-line tyrosine kinase inhibitor (TKI). MAIN OUTCOME MEASURES: Prognostic factors for OS have been identified and validated in separate samples. RESULTS: One-year OS probabilities in the study (n = 220) and validation (n = 97) samples were 68 and 67%; median OS was 19 and 23 months - higher than the 1-year OS of 60% and median OS of 14.8 months of RECORD-1. Karnofsky performance score < 80%, duration of mRCC < 1 year, progression on first-line TKI, liver metastasis and clear cell histology were significant prognostic factors for shorter survival. One-year OS estimates were 84% for validation sample patients with 0 - 2 risk factors, 63% for 3 risk factors and 22% for 4 - 5 risk factors (log-rank p < 0.001). CONCLUSION: Real-world prognostic factors for OS following second-line everolimus for mRCC were largely consistent with those previously identified in trial data; however, OS was longer in the practice setting than in clinical trials and was not associated with type of first-line TKI.

Duke Scholars

Published In

Expert Opin Pharmacother

DOI

EISSN

1744-7666

Publication Date

April 2015

Volume

16

Issue

6

Start / End Page

805 / 819

Location

England

Related Subject Headings

  • United States
  • Sirolimus
  • Protein Kinase Inhibitors
  • Prognosis
  • Pharmacology & Pharmacy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Humans
  • Female
 

Citation

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Wong, M. K., Jonasch, E., Pal, S. K., Signorovitch, J. E., Lin, P. L., Wang, X., … Vogelzang, N. J. (2015). Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States. Expert Opin Pharmacother, 16(6), 805–819. https://doi.org/10.1517/14656566.2015.1020298
Wong, Michael K., Eric Jonasch, Sumanta K. Pal, James E. Signorovitch, Peggy L. Lin, Xufang Wang, Zhimei Liu, et al. “Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States.Expert Opin Pharmacother 16, no. 6 (April 2015): 805–19. https://doi.org/10.1517/14656566.2015.1020298.
Wong, Michael K., et al. “Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States.Expert Opin Pharmacother, vol. 16, no. 6, Apr. 2015, pp. 805–19. Pubmed, doi:10.1517/14656566.2015.1020298.
Wong MK, Jonasch E, Pal SK, Signorovitch JE, Lin PL, Wang X, Liu Z, Culver K, Scott JA, George DJ, Vogelzang NJ. Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States. Expert Opin Pharmacother. 2015 Apr;16(6):805–819.

Published In

Expert Opin Pharmacother

DOI

EISSN

1744-7666

Publication Date

April 2015

Volume

16

Issue

6

Start / End Page

805 / 819

Location

England

Related Subject Headings

  • United States
  • Sirolimus
  • Protein Kinase Inhibitors
  • Prognosis
  • Pharmacology & Pharmacy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Humans
  • Female