Randomized phase II trial of carboplatin versus paclitaxel and carboplatin in platinum-sensitive recurrent advanced ovarian carcinoma: a GEICO (Grupo Espanol de Investigacion en Cancer de Ovario) study.
BACKGROUND
The aim of this study was to determine whether the response rate for the paclitaxel-carboplatin combination is superior to carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma.


METHODS
Patients with recurrent ovarian carcinoma, 6 months after treatment with a platinum-based regimen and with no more than two previous chemotherapy lines, were randomized to receive carboplatin area under the curve (AUC) 5 (arm A) or paclitaxel 175 mg/m(2) + carboplatin AUC 5 (arm B). The primary end point was objective response, following a 'pick up the winner' design. Secondary end points included time to progression (TTP), overall survival, tolerability and quality of life (QoL).


RESULTS
Eighty-one patients were randomized and included in the intention-to-treat analysis. The response rate in arm B was 75.6% [26.8% complete response (CR) + 48.8% partial response (PR)] [95% confidence interval (CI) 59.7% to 87.6%] and 50% in arm A (20% CR + 30% PR) (95% CI 33.8% to 66.2%). No significant differences were observed in grade 3-4 hematological toxicity. Conversely, mucositis, myalgia/arthralgia and peripheral neurophaty were more frequent in arm B. Median TTP was 49.1 weeks in arm B (95% CI 36.9-61.3) and 33.7 weeks in arm A (95% CI 25.8-41.5). No significant differences were found in the QoL analysis.


CONCLUSIONS
Paclitaxel-carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.
González-Martín
A J
AJ
Medical Oncology Service, Hospital Universitario Ramón y Cajal, Madrid, Spain. agonzalezm@seom.org
Calvo
E
E
Bover
I
I
Rubio
M J
MJ
Arcusa
A
A
Casado
A
A
Ojeda
B
B
Balañá
C
C
Martínez
E
E
Herrero
A
A
Pardo
B
B
Adrover
E
E
Rifá
J
J
Godes
M J
MJ
Moyano
A
A
Cervantes
A
A
D000328:Adult; D000368:Aged; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy; D010052:Ovariectomy / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010166:Palliative Care; D011336:Probability; D011379:Prognosis; D011788:Quality of Life; D018570:Risk Assessment; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome
D016190:Carboplatin; D017239:Paclitaxel