Lenalidomide monotherapy in chemotherapy-naive, castration-resistant prostate cancer patients: final results of a phase II study.
BACKGROUND
We investigated the activity of lenalidomide, which has antiangiogenic, antineoplastic, and immunomodulatory properties, in chemotherapy-naive, castration-resistant prostate cancer (CRPC) patients.


METHODS
Patients received 25 mg/d lenalidomide for 21 days in 28-day cycles, until disease progression or unacceptable toxicity developed. Endpoints included overall response rate and clinical benefit (overall response + stable disease), toxicity, time to radiographic progression, and time to prostate-specific antigen (PSA) progression, overall survival, and quality of life.


RESULTS
Thirty-two patients were enrolled in the study; of these, 77% (n = 25) had Gleason scores ≥ 7. The median age was 74 years (58-89 y), the median PSA level was 66 ng/mL (2-919 ng/mL), and 5 of 32 patients (17%) had liver or lung involvement. The median number of lenalidomide cycles was 3 (1-16 cycles). Stable disease was seen in 20 patients, for a clinical benefit rate of 63%. The median time to radiographic progression was 4 months (2-16 mo); the median overall survival was 20 months. Of 27 PSA-evaluable patients, 13 (48%) had a decline in PSA level; 3 (11%) had > 50% PSA decrease; the median time to PSA progression was 3 months (2-9 mo). Grade 3/4 hematologic toxicities were the most common adverse events without adverse impact on quality of life. Serious adverse events occurred in 14 patients (44%), including 1 patient (3%) with a rash definitely related to lenalidomide.


CONCLUSIONS
Lenalidomide monotherapy demonstrates modest activity in chemotherapy-naive CRPC.
Department of Medicine, Section of Hematology and Oncology, The University of Chicago, Chicago, IL. Electronic address: cnabhan@medicine.bsd.uchicago.edu.
Chadi
C
Nabhan
Department of Medicine, Advocate Lutheran General Hospital, Park Ridge, IL.
Anand
A
Patel
Department of Clinical Research, Advocate Illinois Masonic Hospital, Chicago, IL.
Dana
D
Villines
Oncology Specialists, S.C., Park Ridge, IL.
Kathy
K
Tolzien
Oncology Specialists, S.C., Park Ridge, IL.
Susan K
SK
Kelby
Oncology Specialists, S.C., Park Ridge, IL.
Timothy M
TM
Lestingi
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D017430:Prostate-Specific Antigen / Q000097:blood; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D020533:Angiogenesis Inhibitors; D013792:Thalidomide; D017430:Prostate-Specific Antigen; D000077269:Lenalidomide
Chemotherapy-naive; Hormone-refractory; Immunomodulatory therapy; Revlimid