Survival outcomes of sipuleucel-T phase III studies: Impact of control-arm cross-over to salvage immunotherapy

Cancer Immunology Research

Volumn 3, Issue 9, 2015, Pages 1063-1069

  George, Daniel J ^a   Nabhan, Chadi ^b   Devries, Todd ^c   Whitmore, James B ^c   Gomella, Leonard G ^d  

^a DUKE UNIVERSITY   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c Dendreon   (United States)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; HEMOGLOBIN; LACTATE DEHYDROGENASE; SIPULEUCEL T; ANTINEOPLASTIC AGENT; CANCER VACCINE; TISSUE EXTRACT;

ARTICLE; BONE METASTASIS; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CRYOPRESERVATION; DISEASE COURSE; ELECTROCORTICOGRAPHY; HUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); SALVAGE THERAPY; ADULT; ADVERSE EFFECTS; AGED; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; IMMUNOTHERAPY; KAPLAN MEIER METHOD; MALE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PROCEDURES; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CANCER VACCINES; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; HUMANS; IMMUNOTHERAPY; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; SALVAGE THERAPY; TISSUE EXTRACTS; TREATMENT OUTCOME;

EID: 84961989851     PISSN: 23266066     EISSN: 23266074     Source Type: Journal    
DOI: 10.1158/2326-6066.CIR-15-0006     Document Type: Article

References (26)

1. PROVENGE (sipuleucel-T) suspension for intravenous infusion prescribing information. 2011. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf.
2. Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol 2006;24:3089-94.
3. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-22.
4. Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009;115:3670-9.
5. Sheikh NA, Jones LA. CD54 is a surrogate marker of antigen presenting cell activation. Cancer Immunol Immunother 2008;57:1381-90.
6. Branson M, Whitehead J. Estimating a treatment effect in survival studies in which patients switch treatment. Stat Med 2002;21:2449-63.
7. Robins JM, Tsiatis AA. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods 1991;20:2609-31.
8. Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MF, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology 2013;81:1297-302.
9. Hall SJ, Klotz L, Pantuck AJ, George DJ, Whitmore JB, Frohlich MW, et al. Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol 2011;186:877-81.
10. Sheikh NA, Petrylak D, Kantoff PW, Dela Rosa C, Stewart FP, Kuan LY, et al. Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castrationresistant prostate cancer. Cancer Immunol Immunother 2013;62:137-47.
11. Morden JP, Lambert PC, Latimer N, Abrams KR, Wailoo AJ. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med Res Methodol 2011;11:4.
12. Armstrong AJ, Garrett-Mayer ES, Yang YC, De Wit R, Tannock IF, Eisenberger M. A contemporary prognostic nomogram for men with hormonerefractorymetastatic prostate cancer: a TAX327 study analysis. Clin Cancer Res 2007;13:6396-403.
13. Tannock IF, De Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12.
14. Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513-20.
15. De Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castrationresistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54.
16. De Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
17. Scher HI, Fizazi K, Saad F, Taplin M-E, Sternberg CN, Miller K, et al. Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: results from the phase III AFFIRM study. ASCO Meeting Abstracts 2012;30(5 suppl): LBA1.
18. Parker C, Heinrich D, O'Sullivan JM, Fossa SD, Chodacki A, Demkow T, et al. Overall survival benefit and safety profile of radium-223 chloride, a first-in-class alpha-pharmaceutical: Results from a phase III randomized trial (ALSYMPCA) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. ASCO Meeting Abstracts 2012;30(5-suppl):8.
19. Sternberg CN, Petrylak DP, Sartor O, Witjes JA, Demkow T, Ferrero JM, et al. Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. J Clin Oncol 2009;27:5431-8.
20. Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, et al. Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in metastatic castrationresistant prostate cancer. J Clin Oncol 2010;28:1099-105.
21. Ibrahim A, Johnson J. FDA clinical briefing document for the oncologic drug advisory committee. Washington, DC: DHSS, PHS, FDA, Center for Drug Evaluation and Research. 2005.
22. FDA guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. 2007. Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. U. S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER).
23. Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology 2000;11:561-70.
24. Robins JM, Hernan MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology 2000;11:550-60.
25. Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the joint causal effect of nonrandomized treatments. J Am Stat Assoc 2001;96:9.
26. Robins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 2000;56:779-88.