TY - JOUR
T1 - Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study
AU - Uemura, Hiroji
AU - Kobayashi, Kazuki
AU - Yokomizo, Akira
AU - Hinotsu, Shiro
AU - Horie, Shigeo
AU - Kakehi, Yoshiyuki
AU - Nonomura, Norio
AU - Ogawa, Osamu
AU - Oya, Mototsugu
AU - Suzuki, Kazuhiro
AU - Saito, Atsushi
AU - Asakawa, Keiko
AU - Uno, Satoshi
AU - Naito, Seiji
N1 - Funding Information:
HU, YK, and SN received personal fees from Astellas during the conduct of the study. KK and SHi served as study investigators during the conduct of the study. AY received honoraria from Astellas, Bayer, and Sanofi. SHo received personal fees from Astellas, honoraria from Astellas, Bayer, Kissel, Kyourin, Nihon Kayaku, Nippon Shinyaku, Pfizer, and Sanofi, and consulting fees from Astellas and Angfa. NN received honoraria from Astellas, AstraZeneca, Bayer, Janssen, Nippon Shinyaku, and Takeda. OO has no conflicts of interest to declare. MO received honoraria from Astellas, AstraZeneca, Bayer, Janssen, Merck, Sharp & Dohme, Sanofi, and Takeda, research funding from Astellas, and scholarship donations from Sanofi, Takeda, and Bayer. KS received honoraria from Astellas, AstraZeneca, Bayer, and Sanofi. AS is an employee and stockholder in Astellas. KA and SU are employees of Astellas.
Funding Information:
This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide. The authors would like to thank Hideyuki Akaza from the University of Tokyo for his valuable support during the conduct of the study. Medical writing support was provided by Vibha Dhamija, MS, and Jay Patel, PharmD, from IQVIA, and editorial assistance was provided by Mashal Hussain, PhD, and Jane Beck, MA, of Complete HealthVizion, all funded by the study sponsor.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - Androgen deprivation therapy
KW - CRPC in Japan
KW - Combined androgen blockade
KW - HRQoL
KW - Patient-reported outcome
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U2 - 10.1007/s10147-022-02221-w
DO - 10.1007/s10147-022-02221-w
M3 - Article
C2 - 35948732
AN - SCOPUS:85135836806
SN - 1341-9625
VL - 27
SP - 1632
EP - 1643
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 10
ER -
