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Poster display session

200P - Apalutamide (APA) plus androgen deprivation therapy (ADT) for metastatic castration-sensitive prostate cancer (mCSPC): Analysis of pain and fatigue in the TITAN study

Date

23 Nov 2019

Session

Poster display session

Topics

Tumour Site

Prostate Cancer

Presenters

Byung Ha Chung

Citation

Annals of Oncology (2019) 30 (suppl_9): ix68-ix70. 10.1093/annonc/mdz424

Authors

B.H. Chung1, K. McQuarrie2, A. Bjartell3, S. Chowdhury4, A.J. Pereira de Santana Gomes5, M. Özgüroğlu6, Á. Juárez Soto7, A.S. Merseburger8, H. Uemura9, D. Ye10, R. Given11, B. Miladinovic12, N. Li2, S. Hudgens13, L. Floden14, A. Lopez-Gitlitz15, K.N. Chi16, N. Agarwal17

Author affiliations

  • 1 Urinary Cancer, Yonsei University College of Medicine and Gangnam Severance Hospital, N/A - Seoul/KR
  • 2 Patient Reported Outcome Group, Janssen Research & Development, 19044 - Horsham/US
  • 3 Urological Cancer, Skåne University Hospital, Lund University, 214 21 - Malmö/SE
  • 4 Urological Cancer, Guy’s, King’s, and St Thomas’ Hospitals, and Sarah Cannon Research Institute, W1G 6AD - London/GB
  • 5 Oncology, Liga Norte Riograndense Contra O Cancer, 59075-740 - Natal/BR
  • 6 Oncology, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, 34096 - Istanbul/TR
  • 7 Oncology And Urology, Hospital Universitario de Jerez de la Frontera, 11407 - Cadiz/ES
  • 8 Urology, University Hospital Schleswig-Holstein, Campus Lübeck, 23562 - Lübeck/DE
  • 9 Medicine, Kindai University Faculty of Medicine, 589-0014 - Osaka/JP
  • 10 Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 11 Urology, Urology of Virginia, Eastern Virginia Medical School, 23462 - Norfolk/US
  • 12 Clinical Biostatistics, Janssen Research & Development, 92121 - San Diego/US
  • 13 Strategic Lead Regulatory & Access, Clinical Outcomes Solutions, 85718 - Tucson/US
  • 14 Biostatistics, Clinical Outcomes Solutions, 85718 - Tucson/US
  • 15 Clinical Oncology, Janssen Research & Development, 90024 - Los Angeles/US
  • 16 Oncology, BC Cancer and Vancouver Prostate Centre, V5Z 4E6 - Vancouver/CA
  • 17 Genitourinary Oncology, Huntsman Cancer Institute, University of Utah, 84112 - Salt Lake City/US

Resources

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Abstract 200P

Background

TITAN demonstrated that APA + ADT improves radiographic progression-free survival and overall survival over placebo (PBO) + ADT in patients (pts) with mCSPC, including those with low- and high-volume disease, previous docetaxel use, and prior treatment for localized disease (Chi KN N Engl J Med 2019). The likelihood of meaningful deterioration in pt-reported pain and fatigue in TITAN is explored.

Methods

mCSPC pts were randomized 1:1 to receive either APA (240 mg daily; n = 525) or PBO (n = 527), in addition to continuous ADT; each treatment cycle (C) was 28 days. Pain and fatigue were assessed using the Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory (BFI), at baseline and averaged over 7 consecutive days (D) (D -6 through D1 of each C). General estimating equations for logistic regression were used to estimate treatment-related differences in likelihood of worsening in pain or fatigue scores (worsening of ≥ 2 points in items from BPI-SF and BFI).Table:

200P

PainFatigue
BPI-SFBFI
ItemOR*pOR*p
Worst pain or fatigue, past 24 hr0.840.0871.050.693
Least pain, past 24 hr0.780.062NANA
Pain on average0.820.057NANA
Pain or fatigue right now0.840.1690.980.863
Average pain score0.800.068NANA
Pain or fatigue interference:
 General activity0.830.1511.020.849
 Mood0.730.0150.870.311
 Walking0.820.1290.930.549
 Normal work0.860.2321.000.976
 Relations0.780.0560.870.296
 Sleep0.770.044NANA
 Enjoyment of life0.810.1060.920.528
Overall interference score of pain or fatigue0.790.0320.950.640
Usual fatigue, past 24 hrNANA0.990.9044

hr, hours; NA, not on assessment; OR, adjusted odds ratio.

*

Data from all time points, including baseline patient-reported outcome score and stratification factors.

Nominal p-value, no adjustments of multiplicity.

Results

Median scores for pain (APA, 1.14; PBO, 1.00) and fatigue (APA, 1.29; PBO 1.43) on 0-10 severity scales indicated all pts were relatively asymptomatic at baseline. Pts treated with APA vs PBO consistently scored favorably in all BPI-SF pain severity– and pain interference–related questions, and had significantly lower risk of worsening pain interference with mood (p = 0.015), sleep (p = 0.044), and overall pain interference (p = 0.032; Table). Reduced risk of overall pain interference was observed by C18. In general, pt experience with fatigue was similar with APA and PBO (Table).

Conclusions

In a broad population of pts with mCSPC in TITAN, no additional pt-reported fatigue was observed with the addition of APA or PBO to ADT. Pts reported consistently favorable pain scores and less interference from pain in their daily lives with APA.

Clinical trial identification

NCT02489318.

Editorial acknowledgement

Editorial assistance was provided by Patricia McChesney, PhD, CMPP, of Parexel (Hackensack, NJ), and was funded by Janssen Research & Development.

Legal entity responsible for the study

Janssen Research & Development.

Funding

Janssen Research & Development.

Disclosure

B.H. Chung: Research grant / Funding (self), Travel / Accommodation / Expenses: Janssen (USA & Korea); Research grant / Funding (self): Bayer (Germany); Research grant / Funding (self): Pfizer (USA); Research grant / Funding (self): AstraZeneca (UK); Research grant / Funding (self): Roche (Switzerland); Research grant / Funding (self): Myovant Sciences GmbH (Australia); Travel / Accommodation / Expenses: Astellas (Korea); Travel / Accommodation / Expenses: Ipsen (Korea); Travel / Accommodation / Expenses: JW Pharma (Korea); Travel / Accommodation / Expenses: Takeda (Korea); Travel / Accommodation / Expenses: Handok (Korea); Travel / Accommodation / Expenses: Amgen (Korea). K. McQuarrie: Full / Part-time employment: Janssen Research & Development; Shareholder / Stockholder / Stock options: Johnson & Johnson. A. Bjartell: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Janssen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Incyte; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Ferring; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: IPSEN; Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Officer / Board of Directors: LIDDS Pharma; Research grant / Funding (self), Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Officer / Board of Directors, Non-remunerated activity/ies: Glactone Pharma/Development ; Shareholder / Stockholder / Stock options: WntResearch. S. Chowdhury: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Johnson & Johnson; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Clovis. Á. Juárez Soto: Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies, Publication Steering Committee TITAN & IP Clinical Trial SPARTAN: Janssen. A.S. Merseburger: Travel / Accommodation / Expenses, Non-remunerated activity/ies, support for clinical trial conduct: Janssen Cilag; Travel / Accommodation / Expenses, Non-remunerated activity/ies, support for clinical trial conduct: Astellas Pharma; Travel / Accommodation / Expenses, Non-remunerated activity/ies, support for clinical trial conduct: Roche. H. Uemura: Speaker Bureau / Expert testimony, Research grant / Funding (self): Janssen; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Takeda; Research grant / Funding (self): Astellas; Speaker Bureau / Expert testimony, Research grant / Funding (self): Ono/BMS; Research grant / Funding (self): Taiho; Speaker Bureau / Expert testimony: Pfizer; Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Novartis. R. Given: Speaker Bureau / Expert testimony: Janssen. B. Miladinovic: Full / Part-time employment: Janssen Research & Development; Shareholder / Stockholder / Stock options: Johnson & Johnson. N. Li: Full / Part-time employment: Janssen Research & Development; Shareholder / Stockholder / Stock options: Johnson & Johnson. S. Hudgens: Full / Part-time employment: Clinical Outcomes Solutions; Travel / Accommodation / Expenses: Janssen Research & Development. L. Floden: Full / Part-time employment: Clinical Outcomes Solutions; Travel / Accommodation / Expenses: Janssen Research & Development. A. Lopez-Gitlitz: Full / Part-time employment: Janssen Research & Development; Shareholder / Stockholder / Stock options: Johnson & Johnson. K.N. Chi: Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: Janssen; Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: Astellas; Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: Essa ; Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: Sanofi; Travel / Accommodation / Expenses, Institutional: Bayer; Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: Roche; Research grant / Funding (institution), Travel / Accommodation / Expenses, Institutional: AstraZeneca. N. Agarwal: Advisory / Consultancy: Astellas; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Argos; Advisory / Consultancy: Bristol Myers Squibb; Advisory / Consultancy: Bayer; Advisory / Consultancy: Clovis; Advisory / Consultancy: Eisai; Advisory / Consultancy: Exelixis; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Ely Lilly; Advisory / Consultancy: Foundation One; Advisory / Consultancy: Genentech; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy: Merck; Advisory / Consultancy: Medivation; Advisory / Consultancy: Novartis; Advisory / Consultancy: Nektar; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Pharmacyclics. All other authors have declared no conflicts of interest.

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