A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: Final overall survival results and safety update

European Journal of Cancer

Volumn 49, Issue 6, 2013, Pages 1287-1296

  Sternberg, Cora N ^a   Hawkins, Robert E ^b   Wagstaff, John ^c   Salman, Pamela ^d   Mardiak, Jozef ^e   Barrios, Carlos H ^f   Zarba, Juan J ^g   Gladkov, Oleg A ^h   Lee, Eunsik ⁱ   Szczylik, Cezary ^j   McCann, Lauren ^k   Rubin, Stephen D ^k   Chen, Mei ^k   Davis, Ian D ^l  

^a SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c SINGLETON HOSPITAL   (United Kingdom)

^d Instituto Oncológico Fundación Arturo López Pérez   (Chile)

^e National Oncology Institute   (Slovakia)

^f PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^g Centro Médico San Roque   (Argentina)

^h Chelyabinsk Regional Clinical Oncology Dispensary   (Russian Federation)

ⁱ Seoul National University   (South Korea)

^j MILITARY INSTITUTE OF MEDICINE   (Poland)

^k GLAXOSMITHKLINE   (United States)

^l OLIVIA NEWTON JOHN CANCER RESEARCH INSTITUTE   (Australia)

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Author keywords

Inverse probability of censor weighting; Overall survival; Pazopanib; Rank preserving structural failure time model; Renal cell carcinoma

Indexed keywords

BEVACIZUMAB; EVEROLIMUS; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; PAZOPANIB; PLACEBO; SORAFENIB; SUNITINIB; TEMSIROLIMUS;

ADULT; ADVANCED CANCER; AGED; ARTERY THROMBOSIS; ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HAIR COLOR; HUMAN; HYPERTENSION; INTENTION TO TREAT ANALYSIS; KIDNEY METASTASIS; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; OVERALL SURVIVAL; POST HOC ANALYSIS; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SYSTEMIC THERAPY; TREATMENT DURATION;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; CARCINOMA, RENAL CELL; CROSS-OVER STUDIES; DIARRHEA; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYPERTENSION; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROGNOSIS; PYRIMIDINES; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; SULFONAMIDES; TREATMENT OUTCOME;

EID: 84875690904     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2012.12.010     Document Type: Article

References (32)

1. E. Arai, and Y. Kanai Genetic and epigenetic alterations during renal carcinogenesis Int J Clin Exp Pathol 4 1 2010 58 73
2. E.C. Nelson, C.P. Evans, and P.N. Lara Jr. Renal cell carcinoma: current status and emerging therapies Cancer Treat Rev 33 3 2007 299 313
3. J.I. Diaz, L.B. Mora, and A. Hakam The Mainz classification of renal cell tumors Cancer Control 6 6 1999 571 579
4. A. Jemal, R. Siegel, J. Xu, and E. Ward Cancer statistics, 2010 CA Cancer J Clin 60 5 2010 277 300
5. J. Ferlay, D.M. Parkin, and E. Steliarova-Foucher Estimates of cancer incidence and mortality in Europe in 2008 Eur J Cancer 46 4 2010 765 781
6. B. Ljungberg, N.C. Cowan, and D.C. Hanbury EAU guidelines on renal cell carcinoma: the 2010 update Eur Urol 58 3 2010 398 406
7. Motzer RJ, Agarwal N, Beard C, et al. NCCN clinical practice guidelines in oncology: kidney cancer, version 2.2011. < http://www.nccn.org/ professionals/physician-gls/pdf/kidney.pdf >; 2011 [accessed September 4, 2012].
8. G. Sonpavde, and T.E. Hutson Pazopanib: a novel multitargeted tyrosine kinase inhibitor Curr Oncol Rep 9 2 2007 115 119
9. US Department of Health and Human Services Food & Drug Administration. Pazopanib [approval notice]. < http://www.fda.gov/AboutFDA/ CentersOffices/CDER/ucm187509.htm >; 2009 [accessed September 4, 2012].
10. European Medicines Agency. Votrient (pazopanib) authorisation details. < http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/001141/human-med-001337.jsp&murl=menus/medicines/medicines. jsp&mid=WC0b01ac058001d124&jsenabled=true >; 2010 [accessed September 4, 2012].
11. C.N. Sternberg, I.D. Davis, and J. Mardiak Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial J Clin Oncol 28 6 2010 1061 1068
12. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 3 2000 205 216
13. National Cancer Institute Cancer Therapy Evaluation Program. Common terminology criteria for adverse events v3.0 (CTCAE). < http://ctep.cancer. gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf >; 2006 [accessed September 4, 2012].
14. Robins JM. Information recovery and bias adjustment in proportional hazards regression analysis of randomized trials using surrogate markers. Proceedings of the Biopharmaceutical Section, American Statistical Association 1993:24-33.
15. J.M. Robins, and D.M. Finkelstein Correcting for noncompliance and dependent censoring in an AIDS Clinical Trial with inverse probability of censoring weighted (IPCW) log-rank tests Biometrics 56 3 2000 779 788
16. A. Rotnitzky, and J.M. Robins Inverse probability weighted estimation in survival analysis P. Armitage, T. Colton, Encyclopedia of biostatistics 2nd ed. 2005 John Wiley & Sons 2619 2625
17. J.M. Robins, and A.A. Tsiatis Correcting for non-compliance in randomized trials using rank preserving structural failure time models Commun Stat Theory Methods 20 8 1991 2609 2631
18. I.R. White, A.G. Babiker, S. Walker, and J.H. Darbyshire Randomization-based methods for correcting for treatment changes: examples from the Concorde trial Stat Med 18 19 1999 2617 2634
19. B. Escudier, J. Bellmunt, and S. Negrier Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival J Clin Oncol 28 13 2010 2144 2150
20. B. Escudier, T. Eisen, and W.M. Stadler Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial J Clin Oncol 27 20 2009 3312 3318
21. R.J. Motzer, B. Escudier, and S. Oudard Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors Cancer 116 18 2010 4256 4265
22. R.J. Motzer, T.E. Hutson, and P. Tomczak Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma J Clin Oncol 27 22 2009 3584 3590
23. B.I. Rini, S. Halabi, and J.E. Rosenberg Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206 J Clin Oncol 28 13 2010 2137 2143
24. R.J. Motzer, M. Mazumdar, J. Bacik, P. Russo, W.J. Berg, and E.M. Metz Effect of cytokine therapy on survival for patients with advanced renal cell carcinoma J Clin Oncol 18 9 2000 1928 1935
25. S. Negrier, B. Escudier, and C. Lasset Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie N Engl J Med 338 18 1998 1272 1278
26. L.M. Minasian, R.J. Motzer, L. Gluck, M. Mazumdar, V. Vlamis, and S.E. Krown Interferon alfa-2a in advanced renal cell carcinoma: treatment results and survival in 159 patients with long-term follow-up J Clin Oncol 11 7 1993 1368 1375
27. R.J. Motzer, J. Bacik, B.A. Murphy, P. Russo, and M. Mazumdar Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma J Clin Oncol 20 1 2002 289 296
28. G.D. Demetri, X. Huang, and C.R. Garrett Novel statistical analysis of long-term survival to account for crossover in a phase III trial of sunitinib (SU) vs. placebo (PL) in advanced GIST after imatinib (IM) failure J Clin Oncol 26 Suppl. 2008 [abstract 10524]
29. P. Korhonen, E. Malangone, and S. Sherman Overall survival (OS) of metastatic renal cell carcinoma (mRCC) patients corrected for crossover using inverse probability of censoring weights (IPCW) and rank preserving structural failure time (RPSFT) models: Two analyses from the RECORD-1 trial J Clin Oncol 28 15s 2010 [abstract 4595]
30. M. Colleoni, A. Giobbie-Hurder, and M.M. Regan Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study J Clin Oncol 29 9 2011 1117 1124
31. C.J. Howe, S.R. Cole, J.S. Chmiel, and A. Munoz Limitation of inverse probability-of-censoring weights in estimating survival in the presence of strong selection bias Am J Epidemiol 173 5 2011 569 577
32. Motzer RJ, Hutson TE, Reeves J, et al. Randomized, open-label, phase III trial of pazopanib versus sunitinib in first-line treatment of patients with metastatic renal cell carcinoma (MRCC): results of the COMPARZ trial. Presented at ESMO 2012, September 28-October 2, 2012, Vienna, Austria [abstract 8 LBA].