Presentation Authors: Hyun Sik Park*, Shin Hyun Shin, Seung Hyo Woo, Daejeon, Korea, Republic of, Seung Hyun Jeon, Seok Ho Kang, Dong Wook Shin, Seoul, Korea, Republic of, Jinsung Park, Daejeon, Korea, Republic of
Introduction: Both combined androgen blockade (CAB) and LHRH agonist alone is commonly used for androgen deprivation therapy (ADT) in prostate cancer (PC), while there are few studies investigating patient quality of life (QOL) following ADT. In this randomized clinical trial, we aimed to compare patients&[prime] QOL according to the ADT method.
Methods: 80 Patients who underwent primary ADT for newly diagnosed PC were randomly assigned to CAB group (Group 1, N=40) and LHRH agonist alone group (Group 2, N=40) from April 2014 to June 2018. Patients who were treated with prior ADT, neoadjuvant or salvage ADT were excluded. Leuprolide (Luphere depot 3.75mg) and antiandrogen (bicalutamide 50mg) were used to minimize confounding effect due to medication. Patients&[prime] QOL was evaluated at baseline, post-ADT 3 mo and 6 mo using the validated EORTC QLQ-C30, PR25 and depression questionnaire (patient health questionnaire [PHQ]-9). Difference of >10 points in the EORTC domain scores was defined as &[Prime]clinically significant&[Prime].
Results: In baseline clinicopathological characteristics and QOL, there was no significant difference between the two groups in both ITT and PP set. QOL following ADT in the PP set are summarized in Table 1. At 3 mo after ADT, Group 1 had significantly lower pain scores than Group 2 (mean Â± SD, ITT set: 4.76Â±9.54 vs. 16.18Â±19.46, p=0.003, PP set: 5.05Â±9.76 vs. 16.67Â±19.72, p=0.004), while such between-group difference was not observed at 6 months. Group 1 had poorer diarrhea symptom than Group 2 at 3 mo (PP set: 9.09Â±17.23 vs. 2.15Â±8.32, p=0.047) and Group 1 had better cognitive function than Group 2 at 6 mo (PP set: 86.87Â±11.61 vs. 78.49Â±20.72, p=0.049), but such differences were not clinically significant (difference < 10 points). No significant differences were observed in the other C30, PR25 domains and PHQ-9 at 3 months and 6 months.
Conclusions: There was no significant difference in PC patient&[prime]s QOL according to the ADT method, except that CAB was associated with significantly better pain relief than LHRH agonist alone at 3 months following ADT, which did not sustain thereafter. Our results suggest that benefit of prolonged (≥3mo) CAB is questionable in terms of patient QOL.
Source of Funding: This study was supported by DAEWOONG Pham, Co. Research Grant.