Top

International Journal of Clinical Oncology

Published in:

Open Access 10-08-2022 | Prostate Cancer | Original Article

Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study

Authors: Hiroji Uemura, Kazuki Kobayashi, Akira Yokomizo, Shiro Hinotsu, Shigeo Horie, Yoshiyuki Kakehi, Norio Nonomura, Osamu Ogawa, Mototsugu Oya, Kazuhiro Suzuki, Atsushi Saito, Keiko Asakawa, Satoshi Uno, Seiji Naito

Published in: International Journal of Clinical Oncology | Issue 10/2022

Abstract

Background

Patient-reported outcome (PRO) measures can provide valuable information in evaluating patients’ health-related quality of life (HRQoL). Post hoc analysis of the AFTERCAB study was conducted to evaluate the HRQoL benefit of enzalutamide plus androgen deprivation therapy (ADT) compared to flutamide plus ADT for the treatment of patients with castration-resistant prostate cancer (CRPC) in Japan.

Methods

The open-label AFTERCAB study was conducted from November 2016 to March 2020 in Japanese men aged ≥ 20 years with asymptomatic or mildly symptomatic CRPC. Patients received enzalutamide plus ADT or flutamide plus ADT, respectively, as first-line alternative androgen therapy (AAT). HRQoL was analyzed through the Functional Assessment of Cancer Therapy–Prostate, EuroQoL 5-Dimension 5-Level instruments, Brief Pain Inventory–Short Form, and Brief Fatigue Inventory. The longitudinal changes in HRQoL, HRQoL deterioration based on minimally important difference (MID), and time to HRQoL deterioration were evaluated for first-line AAT.

Results

Overall, HRQoL between the enzalutamide and flutamide groups was similar during first-line treatment. No statistically significant HRQoL difference in change from baseline to week 61 (least square mean difference; p value) was observed. Furthermore, proportions of pain progression, symptom worsening, and HRQoL deterioration based on MID, were not significantly different between groups.

Conclusions

The results were similar in all subscales of each PRO, demonstrating similar HRQoL deterioration based on MID criteria between the enzalutamide and flutamide groups.

Available only for authorised users

Sung H, Ferlay J, Siegel RL et al (2021) Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71(3):209–249. https://doi.org/10.3322/caac.21660CrossRefPubMed

National Cancer Center Japan (2021) Projected cancer incidence in 2021. https://ganjoho.jp/reg_stat/statistics/stat/short_pred_en.html. Accessed 24 Mar 2022

Crawford ED, Heidenreich A, Lawrentschuk N et al (2019) Androgen-targeted therapy in men with prostate cancer: evolving practice and future considerations. Prostate Cancer Prostatic Dis 22(1):24–38. https://doi.org/10.1038/s41391-018-0079-0CrossRefPubMed

Parker C, Castro E, Fizazi K et al (2020) Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 31(9):1119–1134. https://doi.org/10.1016/j.annonc.2020.06.011CrossRefPubMed

Kakehi Y, Sugimoto M, Taoka R, on behalf of the committee for establishment of the evidenced-based clinical practice guideline for prostate cancer of the Japanese Urological Association (2017) Evidenced-based clinical practice guideline for prostate cancer (summary: Japanese Urological Association, 2016 edition). Int J Urol 24(9):648–666. https://doi.org/10.1111/iju.13380CrossRefPubMed

Akaza H, Hinotsu S, Usami M et al (2009) Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, double-blind, randomized study for survival. Cancer 115(15):3437–3445. https://doi.org/10.1002/cncr.24395CrossRefPubMed

Onozawa M, Akaza H, Hinotsu S et al (2018) Combined androgen blockade achieved better oncological outcome in androgen deprivation therapy for prostate cancer: analysis of community-based multi-institutional database across Japan using propensity score matching. Cancer Med 7(10):4893–4902. https://doi.org/10.1002/cam4.1735CrossRefPubMedPubMedCentral

Tilki D, Evans CP (2014) The changing landscape of advanced and castration resistant prostate cancer: latest science and revised definitions. Can J Urol 21:7–13PubMed

The Japanese Urological Association (2012) Prostate cancer clinical practice guideline 2012 [In Japanese]. Kanehara & Co. Ltd, Tokyo

10.

Tran C, Ouk S, Clegg NJ et al (2009) Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 324(5928):787–790. https://doi.org/10.1126/science.1168175CrossRefPubMedPubMedCentral

11.

Beer TM, Armstrong AJ, Rathkopf DE et al (2014) Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 371(5):424–433. https://doi.org/10.1056/NEJMoa1405095CrossRefPubMedPubMedCentral

12.

Scher HI, Fizazi K, Saad F et al (2012) Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 367(13):1187–1197. https://doi.org/10.1056/NEJMoa1207506CrossRefPubMed

13.

Sternberg CN, Fizazi K, Saad F et al (2020) Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med 382(23):2197–2206. https://doi.org/10.1056/NEJMoa2003892CrossRefPubMed

14.

Stenzl A, Dunshee C, De Giorgi U et al (2020) Effect of enzalutamide plus androgen deprivation therapy on health-related quality of life in patients with metastatic hormone-sensitive prostate cancer: an analysis of the ARCHES randomised, placebo-controlled, phase 3 study. Eur Urol 78(4):603–614. https://doi.org/10.1016/j.eururo.2020.03.019CrossRefPubMed

15.

Armstrong AJ, Szmulewitz RZ, Petrylak DP et al (2019) ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol 37(32):2974–2986. https://doi.org/10.1200/jco.19.00799CrossRefPubMedPubMedCentral

16.

Astellas Pharma Inc (2014) Astellas announces marketing approval in Japan for XTANDI® (enzalutamide) capsules, an advanced prostate cancer treatment. Published March 26, 2014. https://www.fiercepharma.com/marketing/astellas-announces-marketing-approval-japan-for-xtandi%C2%AE-enzalutamide-capsules-an-advanced. Accessed 24 Mar 2022

17.

Davis ID, Martin AJ, Stockler MR et al (2019) Enzalutamide with standard first-line therapy in metastatic prostate cancer. N Engl J Med 381:121–131. https://doi.org/10.1056/NEJMoa1903835CrossRefPubMed

18.

Penson DF, Feng Z, Kuniyuki A et al (2003) General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study. J Clin Oncol 21(6):1147–1154. https://doi.org/10.1200/jco.2003.07.139CrossRefPubMed

19.

Baguley BJ, Bolam KA, Wright ORL et al (2017) The effect of nutrition therapy and exercise on cancer-related fatigue and quality of life in men with prostate cancer: a systematic review. Nutrients 9(9):1003. https://doi.org/10.3390/nu9091003CrossRefPubMedCentral

20.

Langston B, Armes J, Levy A et al (2013) The prevalence and severity of fatigue in men with prostate cancer: a systematic review of the literature. Support Care Cancer 21(6):1761–1771. https://doi.org/10.1007/s00520-013-1751-5CrossRefPubMed

21.

Larkin D, Lopez V, Aromataris E (2014) Managing cancer-related fatigue in men with prostate cancer: a systematic review of non-pharmacological interventions. Int J Nurs Pract 20(5):549–560. https://doi.org/10.1111/ijn.12211CrossRefPubMed

22.

Storey DJ, McLaren DB, Atkinson MA et al (2012) Clinically relevant fatigue in men with hormone-sensitive prostate cancer on long-term androgen deprivation therapy. Ann Oncol 23(6):1542–1549. https://doi.org/10.1093/annonc/mdr447CrossRefPubMed

23.

Erim DO, Bennett AV, Gaynes BN et al (2020) Associations between prostate cancer-related anxiety and health-related quality of life. Cancer Med 9(12):4467–4473. https://doi.org/10.1002/cam4.3069CrossRefPubMedPubMedCentral

24.

Esper P, Mo F, Chodak G et al (1997) Measuring quality of life in men with prostate cancer using the Functional Assessment of Cancer Therapy-Prostate instrument. Urology 50(6):920–928. https://doi.org/10.1016/S0090-4295(97)00459-7CrossRefPubMed

25.

EuroQol Research Foundation (2022) EQ-5D Instruments; EQ-5D-5L. https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/. Accessed 24 Mar 2022

26.

Cleeland CS (2009) The Brief Pain Inventory user guide. https://www.mdanderson.org/documents/Departments-and-Divisions/Symptom-Research/BPI_UserGuide.pdf. Accessed 24 Mar 2022

27.

Mendoza TR, Wang XS, Cleeland CS et al (1999) The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer 85(5):1186–1196. https://doi.org/10.1002/(sici)1097-0142(19990301)85:5%3c1186::aid-cncr24%3e3.0.co;2-nCrossRefPubMed

28.

Scher HI, Halabi S, Tannock I et al (2008) Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the prostate cancer clinical trials working group. J Clin Oncol 26(7):1148–1159. https://doi.org/10.1200/JCO.2007.12.4487CrossRefPubMed

29.

Arai Y, Akaza H, Deguchi T et al (2008) Evaluation of quality of life in patients with previously untreated advanced prostate cancer receiving maximum androgen blockade therapy or LHRHa monotherapy: a multicenter, randomized, double-blind, comparative study. J Cancer Res Clin Oncol 134(12):1385–1396. https://doi.org/10.1007/s00432-008-0409-zCrossRefPubMed

30.

Cella D, Ivanescu C, Holmstrom S et al (2015) Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol 26(1):179–185. https://doi.org/10.1093/annonc/mdu510CrossRefPubMed

31.

Fizazi K, Scher HI, Miller K et al (2014) Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol 15(10):1147–1156. https://doi.org/10.1016/S1470-2045(14)70303-1CrossRefPubMed

32.

Loriot Y, Miller K, Sternberg CN et al (2015) Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol 16(5):509–521. https://doi.org/10.1016/S1470-2045(15)70113-0CrossRefPubMed

33.

Tombal B, Saad F, Penson D et al (2019) Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol 20(4):556–569. https://doi.org/10.1016/s1470-2045(18)30898-2CrossRefPubMed

34.

Iguchi T, Tamada S, Kato M et al (2020) Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study. Int J Clin Oncol 25(3):486–494. https://doi.org/10.1007/s10147-019-01554-3CrossRefPubMed

Title: Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study
Authors: Hiroji Uemura
Kazuki Kobayashi
Akira Yokomizo
Shiro Hinotsu
Shigeo Horie
Yoshiyuki Kakehi
Norio Nonomura
Osamu Ogawa
Mototsugu Oya
Kazuhiro Suzuki
Atsushi Saito
Keiko Asakawa
Satoshi Uno
Seiji Naito
Publication date: 10-08-2022
Publisher: Springer Nature Singapore
Keywords: Prostate Cancer
Prostate Cancer
Flutamide
Enzalutamide
Androgens
Published in: International Journal of Clinical Oncology / Issue 10/2022
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-022-02221-w

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 10/2022

The tumor suppressor function of hsa_circ_0006282 in gastric cancer through PTEN/AKT pathway

Fusobacterium nucleatum load in MSI colorectal cancer subtypes

Prevalence of pathogenic germline variants in the circulating tumor DNA testing

Percutaneous cryoablation combined with prior transcatheter arterial embolization for renal cell carcinomas of 3 cm or larger: a prospective study

Real-world efficacy and safety of nivolumab plus ipilimumab in untreated metastatic renal cell carcinoma, and the impact of previous nephrectomy on clinical outcome: Japanese multi-institutional retrospective study

Surgical and functional outcomes of robot-assisted laparoscopic partial nephrectomy for renal cell carcinoma in adolescents and young adults: a propensity score matching study

Keynote webinar | Spotlight on antibody–drug conjugates in cancer