Improvements in clinical benefit with vinorelbine in the treatment of hormone-refractory prostate cancer: a phase II trial.
BACKGROUND
Clinical activity is difficult to assess by traditional response endpoints in patients with advanced prostate cancer. We used clinical benefit response to assess the activity of vinorelbine (Navelbine) in patients with hormone-refractory prostate cancer.


METHODS
Forty-nine men with hormone-refractory prostate cancer received vinorelbine weekly for eight weeks followed by every-other-week dosing. Clinical benefit response was defined by improvement in 1 of the following categories for at least 12 weeks and stable response or better in the other 2: pain index (analgesic consumption and pain intensity), Karnofsky performance status, and tumor status.


RESULTS
Of 37 evaluable patients, 14 (39%) achieved clinical benefit for a median duration of 6 months (range 3-24 months). Toxicities consisted primarily of brief neutropenia and mild nausea.


CONCLUSIONS
These findings indicate that vinorelbine is well tolerated in men with hormone-refractory prostate cancer and produces durable clinical benefit as defined by improvement in pain index and performance status.
Fields-Jones
S
S
Cancer Therapy and Research Center, Brooke Army Medical Center, San Antonio, TX, USA.
Koletsky
A
A
Wilding
G
G
O'Rourke
M
M
O'Rourke
T
T
Eckardt
J
J
Yates
B
B
McGuirt
C
C
Burris
H A
HA
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D016001:Confidence Intervals; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D006728:Hormones; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D017430:Prostate-Specific Antigen / Q000032:analysis / Q000187:drug effects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D012720:Severity of Illness Index; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000972:Antineoplastic Agents, Phytogenic; D006728:Hormones; D014747:Vinblastine; D017430:Prostate-Specific Antigen; D000077235:Vinorelbine