Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed: a Southwest Oncology Group study (SWOG 9235).
OBJECTIVE
To determine the efficacy and tolerability of bicalutamide in patients with advanced prostate cancer with progression after conventional hormonal therapy.


METHODS
Fifty-two patients received bicalutamide, 150 mg once daily, as second-line therapy after progressing following treatment with orchiectomy or luteinizing hormone-releasing hormone analogue or diethylstilbestrol, alone or in combination. Patients had measurable (n = 8) or assessable (n = 44) disease, a Southwest Oncology Group performance status of 0 to 2, and no prior antiandrogen therapy or chemotherapy. The objective response to treatment was assessed every 12 weeks; symptoms and pain were assessed monthly with questionnaires for 6 months.


RESULTS
There was evidence of palliation with three measures of pain and, to a lesser extent, with a measure of overall symptom status after 3 months of taking bicalutamide. No complete or partial responses occurred. However, 9 (20%) of 44 subjects with adequate prostate-specific antigen data had a 50% or higher decrease in their prostate-specific antigen levels, which did not correlate with symptom improvement. The median survival time was 15 months. The most common side effects were hot flashes (23%) and nausea (21%).


CONCLUSIONS
These data suggest that bicalutamide decreases pain and improves symptom status in patients with prostate cancer in whom first-line hormonal therapy failed.
Kucuk
O
O
Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
Fisher
E
E
Moinpour
C M
CM
Coleman
D
D
Hussain
M H
MH
Sartor
A O
AO
Chatta
G S
GS
Lowe
B A
BA
Eisenberger
M A
MA
Crawford
E D
ED
D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000813:Anilides / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004054:Diethylstilbestrol / Q000008:administration & dosage; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D009919:Orchiectomy; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010166:Palliative Care; D017430:Prostate-Specific Antigen / Q000032:analysis; D011471:Prostatic Neoplasms / Q000150:complications* / Q000188:drug therapy*; D011788:Quality of Life; D014105:Tosyl Compounds; D016896:Treatment Outcome
D000726:Androgen Antagonists; D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; D004054:Diethylstilbestrol; C053541:bicalutamide; D017430:Prostate-Specific Antigen