Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide

doi:10.1038/s41391-022-00592-9

Randomized Controlled Trial

. 2023 Mar;26(1):156-161.

doi: 10.1038/s41391-022-00592-9. Epub 2022 Oct 8.

Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide

YaoYao Pollock^{1

2}, Matthew R Smith³, Fred Saad⁴, Simon Chowdhury⁵, Stéphane Oudard⁶, Boris Hadaschik⁷, David Olmos⁸, Ji Youl Lee⁹, Hiroji Uemura¹⁰, Amitabha Bhaumik¹¹, Anil Londhe¹¹, Brendan Rooney¹², Sabine D Brookman-May^{13

14}, Peter De Porre¹⁵, Suneel D Mundle¹⁶, Eric J Small¹⁷

Affiliations

¹ The Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. yaoyao.pollock@gmail.com.
² St. Joseph Health Medical Group, Providence St. Joseph Health, Santa Rosa, CA, USA. yaoyao.pollock@gmail.com.
³ Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.
⁴ Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
⁵ Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London, UK.
⁶ Georges Pompidou Hospital, University de Paris, Paris, France.
⁷ University of Duisburg-Essen, Essen, and Ruprecht-Karls-University Heidelberg, Heidelberg, Germany.
⁸ Spanish National Cancer Research Centre (CNIO), Madrid and Biomedical Research Institute of Málaga (IBIMA), Málaga, Spain.
⁹ Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
¹⁰ Yokohama City University Medical Center, Yokohama, Japan.
¹¹ Janssen Research & Development, Titusville, NJ, USA.
¹² Janssen Research & Development, High Wycombe, UK.
¹³ Janssen Research & Development, Los Angeles, CA, USA.
¹⁴ Ludwig-Maximilians-University, Munich, Germany.
¹⁵ Janssen Research & Development, Beerse, Belgium.
¹⁶ Janssen Research & Development, Raritan, NJ, USA.
¹⁷ The Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.

PMID: 36209239
DOI: 10.1038/s41391-022-00592-9

Randomized Controlled Trial

Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide

YaoYao Pollock et al. Prostate Cancer Prostatic Dis. 2023 Mar.

. 2023 Mar;26(1):156-161.

doi: 10.1038/s41391-022-00592-9. Epub 2022 Oct 8.

Authors

Affiliations

¹ The Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. yaoyao.pollock@gmail.com.
² St. Joseph Health Medical Group, Providence St. Joseph Health, Santa Rosa, CA, USA. yaoyao.pollock@gmail.com.
³ Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.
⁴ Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada.
⁵ Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London, UK.
⁶ Georges Pompidou Hospital, University de Paris, Paris, France.
⁷ University of Duisburg-Essen, Essen, and Ruprecht-Karls-University Heidelberg, Heidelberg, Germany.
⁸ Spanish National Cancer Research Centre (CNIO), Madrid and Biomedical Research Institute of Málaga (IBIMA), Málaga, Spain.
⁹ Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
¹⁰ Yokohama City University Medical Center, Yokohama, Japan.
¹¹ Janssen Research & Development, Titusville, NJ, USA.
¹² Janssen Research & Development, High Wycombe, UK.
¹³ Janssen Research & Development, Los Angeles, CA, USA.
¹⁴ Ludwig-Maximilians-University, Munich, Germany.
¹⁵ Janssen Research & Development, Beerse, Belgium.
¹⁶ Janssen Research & Development, Raritan, NJ, USA.
¹⁷ The Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.

PMID: 36209239
DOI: 10.1038/s41391-022-00592-9

Erratum in

Correction to: Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide.
Pollock Y, Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik B, Olmos D, Lee JY, Uemura H, Bhaumik A, Londhe A, Rooney B, Brookman-May SD, De Porre P, Mundle SD, Small EJ. Pollock Y, et al. Prostate Cancer Prostatic Dis. 2023 Dec;26(4):813. doi: 10.1038/s41391-023-00683-1. Prostate Cancer Prostatic Dis. 2023. PMID: 37620428 No abstract available.

Abstract

Background: The phase III SPARTAN study demonstrated that apalutamide significantly improves metastasis-free survival and overall survival vs. placebo in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). However, patients receiving apalutamide experienced falls more frequently vs. those receiving placebo (15.6% vs. 9.0%).

Methods: 806 patients with nmCRPC randomized to apalutamide in SPARTAN and treated with apalutamide in addition to ongoing androgen deprivation therapy (ADT) were included in this post-hoc analysis investigating clinical variables associated with a subsequent fall. Time to a fall was assessed with Cox proportional-hazards models adjusted for baseline characteristics and time-varying factors. Statistical inference was based on final multivariable models.

Results: Falls were reported for 125/803 (15.6%) patients treated with apalutamide and ADT. Most falls were grade 1 or 2 and did not require hospitalization. Median time from randomization to first fall was 9.2 months (range 0.1-25.3 months). In the final multivariable model of both baseline and after-baseline covariates, baseline patient characteristics (older age, poor Eastern Cooperative Oncology Group performance status, history of neuropathy, and α-blocker use before study treatment) remained significantly associated with fall; after-baseline clinical characteristics significantly associated with time to fall were development of neuropathy, arthralgia, and weight loss before fall.

Conclusions: This analysis identified risk factors for fall among nmCRPC patients treated with apalutamide. Clinical management can minimize these identified risks while enhancing patient outcomes. Preventive interventions should be considered when the identified baseline conditions and post-treatment neuropathy, arthralgia, or weight decrease are present, to reduce risk of fall.

Trial registration: ClinicalTrials.gov: NCT01946204.

PubMed Disclaimer

Cited by

Falls among geriatric cancer patients: a systematic review and meta-analysis of prevalence and risk across cancer types.
Lingamaiah D, Bushi G, Gaidhane S, Balaraman AK, Padmapriya G, Kaur I, Lal M, Iqbal S, Prasad GVS, Pramanik A, Vishwakarma T, Malik P, Sharma P, Singh MP, Punia A, Jagga M, Shabil M, Mehta R, Sah S, Zahiruddin QS. Lingamaiah D, et al. BMC Geriatr. 2025 Mar 15;25(1):179. doi: 10.1186/s12877-025-05722-1. BMC Geriatr. 2025. PMID: 40089681 Free PMC article.
Intensive sampling of the umbra and penumbra improves clinically significant prostate cancer detection and reduces risk of grade group upgrading at radical prostatectomy.
Lee AYM, Chen K, Cheng CWS, Ho HSS, Yuen JSP, Ngo NT, Law YM, Tay KJ. Lee AYM, et al. World J Urol. 2023 Aug;41(8):2265-2271. doi: 10.1007/s00345-023-04499-5. Epub 2023 Jul 3. World J Urol. 2023. PMID: 37395756
Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN.
Shen J, Chowdhury S, Agarwal N, Karsh LI, Oudard S, Gartrell BA, Feyerabend S, Saad F, Pieczonka CM, Chi KN, Brookman-May SD, Rooney B, Bhaumik A, McCarthy SA, Bevans KB, Mundle SD, Small EJ, Smith MR, Graff JN. Shen J, et al. Br J Cancer. 2024 Jan;130(1):73-81. doi: 10.1038/s41416-023-02492-8. Epub 2023 Nov 11. Br J Cancer. 2024. PMID: 37951974 Free PMC article.

References

1. ERLEADA (apalutamide) [prescribing information]. Janssen Pharmaceutical Companies, Horsham, PA; 2020.
1. ERLEADA (apalutamide). [Summary of Product Characteristics]. The electronic Medicines Compendium (eMC) Web site ( https://www.ema.europa.eu/en/documents/product-information/erleada-epar-... ) and https://www.ema.europa.eu/en/medicines/human/EPAR/erleada .
1. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79:150–8. - DOI - PubMed
1. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N. Engl J Med. 2018;378:1408–18. - DOI - PubMed
1. Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19:1404–16. - DOI - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- Nature Publishing Group
Medical
- ClinicalTrials.gov

[1] ERLEADA (apalutamide) [prescribing information]. Janssen Pharmaceutical Companies, Horsham, PA; 2020.

[2] ERLEADA (apalutamide) [prescribing information]. Janssen Pharmaceutical Companies, Horsham, PA; 2020.

[3] ERLEADA (apalutamide). [Summary of Product Characteristics]. The electronic Medicines Compendium (eMC) Web site ( https://www.ema.europa.eu/en/documents/product-information/erleada-epar-... ) and https://www.ema.europa.eu/en/medicines/human/EPAR/erleada .

[4] ERLEADA (apalutamide). [Summary of Product Characteristics]. The electronic Medicines Compendium (eMC) Web site ( https://www.ema.europa.eu/en/documents/product-information/erleada-epar-... ) and https://www.ema.europa.eu/en/medicines/human/EPAR/erleada .

[5] Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79:150–8. - DOI - PubMed

[6] Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79:150–8. - DOI - PubMed

[7] Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N. Engl J Med. 2018;378:1408–18. - DOI - PubMed

[8] Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N. Engl J Med. 2018;378:1408–18. - DOI - PubMed

[9] Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19:1404–16. - DOI - PubMed

[10] Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19:1404–16. - DOI - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide

Affiliations

Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide

Authors

Affiliations

Erratum in

Abstract

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical

Erratum in

Abstract

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Associated data

Related information

LinkOut - more resources

Full Text Sources

Medical