Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease.
OBJECTIVE
The aim of the study was to evaluate the activity of vinorelbine (VNLB) in a population of advanced ovarian cancer patients, with particular attention to defining its role in platinum-resistant disease.


METHODS
Thirty-three patients were recruited and treated with VNLB 25 mg/m2 intravenously (IV) weekly. the median age was 53 years, performance status 0 to 2, and number of previous chemotherapy regimens two (range, one to five). Twenty-four patients were platinum-resistant; the remaining nine either were platinum-sensitive (four cases) or had undetermined sensitivity (five cases).


RESULTS
The mean delivered dose-intensity of VNLB was 67% of the planned level, because 60% of the cycles were delayed due to neutropenia or anemia. Four partial responses (PRs) and one complete response (CR) were observed, for an overall response rate of 15% (95% exact confidence interval, 5.1% to 31.9%). All the responses occurred in the subgroup of 24 platinum-resistant cases, in whom the response rate was 21% (95% exact confidence interval, 7.1% to 42.1%). Seven patients became stabilized on VNLB, and 27% of the cases showed a reduction in serum cancer antigen 125 (CA 125) levels. G3/G4 side effects consisted of neutropenia, anemia, and worsening of preexisting peripheral neuropathy. No treatment-related deaths occurred.


CONCLUSIONS
VNLB led to a 21% response rate in the population of heavily pretreated and platinum-resistant ovarian cancer patients. Further studies of VNLB alone or in combination with taxanes are warranted in patients with less pretreatment.
Bajetta
E
E
Division of Medical Oncology B, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Italy.
Di Leo
A
A
Biganzoli
L
L
Mariani
L
L
Cappuzzo
F
F
Di Bartolomeo
M
M
Zilembo
N
N
Artale
S
S
Magnani
E
E
Celio
L
L
Buzzoni
R
R
Carnaghi
C
C
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000032:analysis; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use*; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
D000970:Antineoplastic Agents; D018394:CA-125 Antigen; D017671:Platinum Compounds; D014747:Vinblastine; D000077235:Vinorelbine