Back to Search
Start Over
Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma: a Gynecologic Oncology Group study.
- Source :
-
Gynecologic oncology [Gynecol Oncol] 2006 Sep; Vol. 102 (3), pp. 432-9. Date of Electronic Publication: 2006 Jul 24. - Publication Year :
- 2006
-
Abstract
- Objective: Compared to 3 cycles, to determine if 6 cycles of adjuvant carboplatin (C) and paclitaxel (P) significantly lower the rate of recurrence in surgically staged patients with stage IA grade 3, IB grade 3, clear cell, IC, and completely resected stage II epithelial ovarian cancer (EOC); and to compare toxicities.<br />Methods: Postoperatively, randomization was to either 3 or 6 cycles of chemotherapy consisting of P (175 mg/m2 over 3 h) and C (7.5 AUC over 30 min) every 21 days. Recurrence was any clinical or radiological evidence of new tumor.<br />Results: Of 457 patients, 427 (93%) were histologically and medically eligible. While thorough surgical staging was required, it was incomplete or inadequately documented in 29% of otherwise eligible patients. Median age was 55.5 years; 69% of patients had stage I disease. Median follow-up is 6.8 years for 344 women alive at last contact. Grade 3 or 4 neurotoxicity occurred in 4/211 (2%) and 24/212 (11%) treated patients on the 3- and 6-cycle regimens, respectively (p<0.01); 6 cycles also caused significantly more severe anemia and granulocytopenia. The recurrence rate for 6 cycles was 24% lower (hazard ratio [HR]: 0.761; 95% confidence interval [CI]: 0.51-1.13, p=0.18), and the estimated probability of recurrence within 5 years was 20.1% (6 cycles) versus 25.4% (3 cycles). The overall death rate was similar for these regimens (HR: 1.02; 95% CI: 0.662-1.57).<br />Conclusions: Compared to 3 cycles, 6 cycles of C and P do not significantly alter the recurrence rate in high risk early stage EOC but are associated with more toxicity.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma mortality
Chemotherapy, Adjuvant
Drug Administration Schedule
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
Ovarian Neoplasms mortality
Paclitaxel adverse effects
Proportional Hazards Models
Survival Analysis
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carboplatin administration & dosage
Carcinoma drug therapy
Ovarian Neoplasms drug therapy
Paclitaxel administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0090-8258
- Volume :
- 102
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Gynecologic oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16860852
- Full Text :
- https://doi.org/10.1016/j.ygyno.2006.06.013