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

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

doi:10.1007/s10147-022-02221-w

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

Int J Clin Oncol. 2022 Oct;27(10):1632-1643. doi: 10.1007/s10147-022-02221-w. Epub 2022 Aug 10.

Authors

Hiroji Uemura¹, Kazuki Kobayashi², Akira Yokomizo³, Shiro Hinotsu⁴, Shigeo Horie⁵, Yoshiyuki Kakehi⁶, Norio Nonomura⁷, Osamu Ogawa⁸, Mototsugu Oya⁹, Kazuhiro Suzuki¹⁰, Atsushi Saito¹¹, Keiko Asakawa¹¹, Satoshi Uno¹², Seiji Naito³

Affiliations

¹ Department of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan. hu0428@yokohama-cu.ac.jp.
² Department of Urology, Yokosuka Kyosai Hospital, Yonegahamadori, Yokosuka, Kanagawa, 238-8558, Japan.
³ Department of Urology, Harasanshin Hospital, 1-8 Taihakumachi, Hakata-ku, Fukuoka, 812-0033, Japan.
⁴ Department of Biostatistics and Data Management, Sapporo Medical University, 17 Chome Minami 1 Jonishi, Chuo Ward, Sapporo, Hokkaido, 060-8556, Japan.
⁵ Department of Urology, Juntendo University, 2 Chome-1-1 Hongo, Bunkyo City, Tokyo, 113-8421, Japan.
⁶ Department of Medicine, Kagawa University, 1-1 Saiwaicho, Takamatsu, Kagawa, 760-0016, Japan.
⁷ Department of Urology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, 565-0871, Japan.
⁸ Department of Urology, Kyoto University, Yoshidahonmachi, Sakyo Ward, Kyoto, 606-8501, Japan.
⁹ Department of Urology, Keio University, 2 Chome-15-45 Mita, Minato City, Tokyo, 108-8345, Japan.
¹⁰ Department of Urology, Gunma University, Aramakimachi, Maebashi, Gunma, 371-8510, Japan.
¹¹ Medical Affairs Japan, Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.
¹² Data Science, Development, Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.

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.

Keywords: Androgen deprivation therapy; CRPC in Japan; Combined androgen blockade; HRQoL; Patient-reported outcome.

MeSH terms

Androgen Antagonists / therapeutic use
Androgens
Benzamides
Disease-Free Survival
Flutamide*
Humans
Male
Nitriles
Pain
Phenylthiohydantoin
Prostatic Neoplasms, Castration-Resistant* / drug therapy
Quality of Life

Substances

Androgen Antagonists
Androgens
Benzamides
Nitriles
Phenylthiohydantoin
Flutamide
enzalutamide