1072P - Experience of patients treated with sipuleucel-T in an academic setting

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cancer Immunology and Immunotherapy
Presenter Nrupen Bhavsar
Citation Annals of Oncology (2014) 25 (suppl_4): iv361-iv372. 10.1093/annonc/mdu342
Authors N.A. Bhavsar1, M.R. Harrison2, L.J. Howie2, A.J. Armstrong3, K. Davis3, Q. Chen4, M.R. Pupa4, A. Abernethy4, D.J. George5, B.R. Hirsch4
  • 1Center On Learning Healthcare, Duke Clinical Research Institute 8481, 27705 - Durham/US
  • 2Medicine, Duke Cancer Institute, Durham/US
  • 3Medicine, Duke University Medical Center, Durham/US
  • 4Center For Learning Healthcare, Duke Clinical Research Institute, Durham/US
  • 5Surgery, Duke University Medical Center, Durham/US

Abstract

Aim

Sipuleucel–T (ST) is an autologous active cellular immununotherapy for men with metastatic castration-resistant prostate cancer. The role of ST in controlled trial settings has been reported. However, its use in routine clinical care is less well defined. What is the pattern of ST utilization and patient experience in an academic cancer center that was an early provider of ST therapy?

Methods

A retrospective registry was generated including all patients with metastatic, castrate resistant prostate cancer treated with ST at the Duke Cancer Institute between 5/2010-10/2012. Data were aggregated from the electronic health record and tumor registry, supplemented by manual abstraction from clinical notes. Data were collected on demographics, treatment patterns, labs, symptoms and clinical endpoints. Findings were compared to those seen in the landmark trial (LT) by Kantoff et al.

Results

94 patients initiated treatment with ST, with 91 completing therapy. Baseline data in the Table compare registry and LT patients. Median PSA prior to therapy was 11.0 ng/mL (n = 82, range: 0.1-1111.2 ng/mL) vs 26.7 ng/mL (n = 77, range: 0.3-3225.6 ng/mL) within 2 months of treatment completion. Median PSA at initiation of therapy in the LT was 51.7 ng/mL. ST was the first agent received post castration resistance in 66% of patients, 2nd line for 15%, 3rd line or greater for 19%. Rigors and chills were documented in 5% and 9% of patients. Median time to next therapy was 89.5 days (range: 9-988). Opiates were used by 16% prior to ST vs 33% within 2 months of completion. The most common symptoms documented within 3 months of ST completion included fatigue (21%), pain (16%), nausea (8%), anorexia (7%), constipation (5%), and anxiety (5%). All grade symptoms in the LT included fatigue (39%), back pain (34%), nausea (28%) and anorexia (7%).

Conclusions

Patients treated in the academic setting were largely reflective of those seen in the approval trial, although they appeared healthier at baseline and tolerated therapy relatively well. Endpoints in this patient cohort will mature over time.

Disclosure

M.R. Harrison: Grant support: Bristol-Myers Squibb, Argos, Dendreon, Pfizer, Exelixix, Janssen; paid consultant to Exelixis, AVEO, Novartis, Dendreon; speaker honoraria: Novartis, Prometheus, Dendreon; paid to prepare educational presentations: Novartis, Sanofi-Aventis; A.J. Armstrong: Research funding: Medivation, Janssen, Sanofi-Aventis, Dendreon Prostate Cancer Foundation, Department of Defense; Speaker: Dendreon; consultant -Bayer-Algeta, Medivation, Janssen, Sanofi-Aventis, Dendreon; A. Abernethy: Research: NINR, NCI, AHRQ, DARA, Glaxo Smith Kline, Celgene, Helsinn, Dendreon, Kanglaite, Bristol Myers Squibb, Pfizer; consulting - Bristol Myers Squibb, ACORN Research; corporate leadership athenahealth, Orange Leaf Associates; D.J. George: Grant support from Pfizer, Novartis, Genentech/Roche, Glaxo Smith Kline; and is a paid consultant to Pfizer, Novartis, Aveo, Astellas, Bayer, Genentech/Roche; B.R. Hirsch: Grant support from Pfizer, Dendreon, Bristol-Myers Squibb, Glaxo Smith Kline, Agency for Healthcare Research and Quality. All other authors have declared no conflicts of interest.