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

Abstract

Purpose

To assess quality of life (QOL) data from a double-blind Phase III study evaluating bicalutamide (Casodex™) 80 mg as part of maximum androgen blockade (MAB) in patients with previously untreated advanced prostate cancer.

Methods

Patients with untreated stage C/D prostate cancer were randomized to MAB with bicalutamide plus a luteinizing hormone-releasing hormone agonist (LHRHa) or LHRHa monotherapy. QOL was evaluated at baseline and at weeks 1, 5, and 24 using the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.

Results

A total of 203 patients were assessed for QOL. The MAB group had more rapid and greater improvements in “emotional well-being” and “prostate cancer-specific issues” domain scores than the monotherapy group. Further analysis of “prostate cancer-specific issues” revealed that, compared with monotherapy, MAB provided a greater improvement in “micturition disorder”-related QOL. Complete improvement rates for items related to “pain and micturition disorder” were also higher with MAB. Item scores of “pain and micturition disorder” did not correlate strongly with prostate-specific antigen levels or tumor size. Fewer patients who had deterioration in their “pain and micturition disorder” item scores at week 1 in the MAB group than the monotherapy group.

Conclusions

Maximum androgen blockade with bicalutamide plus LHRHa did not reduce the overall QOL of patients with previously untreated advanced prostate cancer. MAB was superior to monotherapy in achieving early improvement of QOL related to micturition disorder and pain.

Appendix

Question items in the FACT-P questionnaire (version 4A).

	Not at all	A little bit	Some-what	Quite a bit	Very much
Physical well-being
(1) I have a lack of energy	0	1	2	3	4
(2) I have nausea	0	1	2	3	4
(3) Because of my physical condition, I have trouble meeting the needs of my family	0	1	2	3	4
(4) I have pain	0	1	2	3	4
(5) I am bothered by side effects of treatment	0	1	2	3	4
(6) I feel ill	0	1	2	3	4
(7) I am forced to spend time in bed	0	1	2	3	4
Social/family well-being
(1) I feel close to my friends	0	1	2	3	4
(2) I feel close to my familya	0	1	2	3	4
(3) I get emotional support from my family	0	1	2	3	4
(4) I get support from my friends	0	1	2	3	4
(5) My family has accepted my illness	0	1	2	3	4
(6) I am satisfied with family communication about my illness	0	1	2	3	4
(7) Although I am ill, my family has a satisfactory lifea	0	1	2	3	4
(8) I feel close to my partner (or the person who is my main support)	0	1	2	3	4
Regardless of your current level of sexual activity, please answer the following question. If you prefer not to answer it, please check this box □ and go to the next section
(9) I am satisfied with my sex life	0	1	2	3	4
Emotional well-being
(1) I feel sad	0	1	2	3	4
(2) I am satisfied with how I am coping with my illness	0	1	2	3	4
(3) I am losing hope in the fight against my illness	0	1	2	3	4
(4) I feel nervous	0	1	2	3	4
(5) I worry about dying	0	1	2	3	4
(6) I worry that my condition will get worse	0	1	2	3	4
Functional well-being
(1) I am able to work (include work at home)	0	1	2	3	4
(2) My work (include work at home) is fulfilling	0	1	2	3	4
(3) I am able to enjoy life	0	1	2	3	4
(4) I have accepted my illness	0	1	2	3	4
(5) I am sleeping well	0	1	2	3	4
(6) I am enjoying the things I usually do for fun	0	1	2	3	4
(7) I am content with the quality of my life right now	0	1	2	3	4
Additional concernsb
(1) I am losing weight	0	1	2	3	4
(2) I have a good appetite	0	1	2	3	4
(3) I have aches and pains that bother me	0	1	2	3	4
(4) I have certain parts of my body where I experience significant pain	0	1	2	3	4
(5) My pain keeps me from doing things I want to do	0	1	2	3	4
(6) I am satisfied with my present comfort level	0	1	2	3	4
(7) I am able to feel like a man	0	1	2	3	4
(8) I have trouble moving my bowels	0	1	2	3	4
(9) I have difficulty urinating	0	1	2	3	4
(10) I urinate more frequently than usual	0	1	2	3	4
(11) My problems with urinating limit my activities	0	1	2	3	4
(12) I am able to have and maintain an erection	0	1	2	3	4

1. Above is a list of statements that other people with your illness have said are important. By circling one (1) number per line, please indicate how true each statement has been for you during the past 7 days. A higher FACT-P score indicated better quality of life. As the FACT-P questionnaire contains positive and negative items, the scores of the negative items (physical well-being items 1–7; emotional well-being items 1 and 3–6; additional concerns items 1, 3–5, 8–11) were reversed as part of the scoring calculation
2. FACT-P are owned and copyrighted by, and the intellectual property of, David Cella, PhD
3. ^aItems 2 and 7 of the social/family well-being domain were specific to the Japanese version of FACT-P
4. ^bProstate cancer-specific issues