Sunitinib malate for metastatic castration-resistant prostate cancer following docetaxel-based chemotherapy.
BACKGROUND
Systemic therapy options are limited for metastatic castration-resistant prostate cancer (CRPC) patients who progress following docetaxel (Taxotere). This phase II trial evaluated sunitinib malate in patients with progressing metastatic CRPC following prior docetaxel.


METHODS
Patients with metastatic CRPC progressing following one to two chemotherapy regimens including docetaxel were included. The primary end point was progression-free survival (PFS) per radiographic and clinical evaluations. Oral sunitinib was administered 50 mg/day 4-weeks on followed by 2-weeks off per cycle up to a maximum of eight cycles or until clinical progression or intolerable toxicity.


RESULTS
Thirty-six patients with a median age of 69.5 years were accrued. The median PFS was 19.4 weeks with a 12-week PFS of 75.8%. Four patients (12.1%) had a > or =50% prostate-specific antigen (PSA) decline and seven (21.2%) had a > or =30% PSA decline. Two of 18 patients (11.1%) with measurable disease demonstrated 30% declines by RECIST and eight (44.4%) displayed some shrinkage. A decline in pain score > or =2 points occurred in 13.6% of 22 assessable patients. Drug discontinuation due to toxic effects occurred in 52.8% of patients.


CONCLUSIONS
Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel.
Sonpavde
G
G
US Oncology Research, Inc., Houston, TX; Texas Oncology PA, Webster, TX. Electronic address: Guru.Sonpavde@USOncology.com.
Periman
P O
PO
US Oncology Research, Inc., Houston, TX; Texas Oncology PA, Amarillo, TX.
Bernold
D
D
US Oncology Research, Inc., Houston, TX; Interlakes Oncology Hematology, Rochester, NY.
Weckstein
D
D
US Oncology Research, Inc., Houston, TX; New Hampshire Hematology-Oncology, P.A., Hooksett, NH.
Fleming
M T
MT
US Oncology Research, Inc., Houston, TX; Virginia Oncology Associates, Hampton, VA.
Galsky
M D
MD
US Oncology Research, Inc., Houston, TX; Comprehensive Cancer Centers of Nevada, Las Vegas, NV.
Berry
W R
WR
US Oncology Research, Inc., Houston, TX; Cancer Centers of North Carolina, Raleigh, NC.
Zhan
F
F
US Oncology Research, Inc., Houston, TX.
Boehm
K A
KA
US Oncology Research, Inc., Houston, TX.
Asmar
L
L
US Oncology Research, Inc., Houston, TX.
Hutson
T E
TE
US Oncology Research, Inc., Houston, TX; Baylor Sammons Cancer Center, Dallas, TX, USA.
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002369:Castration; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D000077143:Docetaxel; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D000077210:Sunitinib; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D017211:Treatment Failure
D020533:Angiogenesis Inhibitors; D007211:Indoles; D011758:Pyrroles; D043823:Taxoids; D000077143:Docetaxel; D000077210:Sunitinib