93314
document
Ten-year results of a randomised trial comparing cisplatin with cisplatin and cyclophosphamide in advanced , suboptimally debulked ovarian cancer . 176 eligible patients with advanced suboptimally operated ovarian carcinoma were randomly allocated to receive either cisplatin 75 mg/m2 or cisplatin 50 mg/m2 and cyclophosphamide 500 mg/m2 ( CP ) every 28 days for six courses . The overall clinical response rates ( complete response plus partial response ) were 52 and 63 % for CP and cisplatin , respectively ( non-significant ) . Including results obtained by second-look laparotomy , we did not observe a statistically significant difference in response rates in the two treatment groups . Median progression-free survival was 10 and 11.9 months for CP and cisplatin , respectively ( non-significant ) . No significant difference was observed in overall survival , with a median of 19.4 and 21.5 months for CP and cisplatin , respectively . Thirty-seven platinum-resistant and 27 platinum-sensitive tumours were treated with carboplatin or cisplatin as second-line therapy . Response rates to platinum second-line therapy were 6 and 50 % for resistant and sensitive tumours , respectively ( P < 0.001 ) . This difference in response rate was also confirmed by survival analysis . Patients with platinum-sensitive tumours survived longer when they were treated with platinum-containing chemotherapy ( P = 0.005 ) . Median survival was 22.8 and 8.5 months after initiation of second-line treatment for the platinum-containing and platinum-free regimens , respectively . In summary , we observed in suboptimally operated ovarian carcinoma patients similar response rates , progression-free interval , and overall survival for equitoxic cisplatin and CP . However , the doses of cisplatin and cyclophosphamide chosen were substantially lower than current standard doses of CP . Our study demonstrates , therefore , that a suboptimal dose of CP is as effective as optimal dose monotherapy cisplatin . Patients with recurrences considered as platinum-sensitive had a significantly higher response rate and improved survival when retreated with platinum-containing therapy .
93315
Intervention_Pharmacological
cisplatin
93316
Intervention_Pharmacological
cyclophosphamide
93317
Intervention_Pharmacological
cisplatin 75 mg/m2 or cisplatin 50 mg/m2 and cyclophosphamide 500 mg/m2
93318
Intervention_Pharmacological
CP and cisplatin
93319
Intervention_Pharmacological
CP and cisplatin
93320
Intervention_Pharmacological
CP and cisplatin
93321
Intervention_Pharmacological
carboplatin or cisplatin
93322
Intervention_Pharmacological
platinum-containing chemotherapy
93323
Intervention_Pharmacological
platinum-containing
93324
Intervention_Pharmacological
platinum-free
93325
Intervention_Pharmacological
cisplatin and CP
93326
Intervention_Pharmacological
cisplatin and cyclophosphamide
93327
Intervention_Pharmacological
CP
93328
Intervention_Pharmacological
cisplatin
93329
Intervention_Physical
platinum-containing therapy
93330
Outcome_Physical
overall clinical response rates
93331
Outcome_Physical
Median progression-free survival
93332
Outcome_Mortality
overall survival
93333
Outcome_Physical
Response rates
93334
Outcome_Physical
response rate
93335
Outcome_Mortality
Median survival
93336
Outcome_Physical
response rates
93337
Outcome_Mortality
progression-free interval
93338
Outcome_Mortality
overall survival
93339
Outcome_Physical
response rate
93340
Outcome_Mortality
survival