. Author manuscript; available in PMC: 2014 Sep 16.

Published in final edited form as: Cochrane Database Syst Rev. 2012 Mar 14;3:CD004706. doi: 10.1002/14651858.CD004706.pub4

Table 3.

Trials of adjuvant chemotherapy versus no further treatment

Study ID	Patients	Intervention	5-year survival	Survival/statistics	Adverse effects	Comments
ICON1 2003	447 FIGO I-III 93% FIGO stage 1	Immediate adjuvant platinum-based chemotherapy versus treatment on progression	OS 79% (adjuvant arm) versus70% ( no treatment)	Hazard ratios OS: HR 0.66; 95% CI 0.45 to 0.97; P = 0.03	Not reported	Survival improvement with adjuvant therapy
ACTION 2003	448 FIGO Ia-Ib grade II-III FIGO Ic-IIa FIGO I-IIa clear cell	Immediate adjuvant platinum-based chemotherapy versus treatment on progression Cisplatin dose = 75 mg/m² Carboplatin dose = 350 mg/m²	OS 85% (adjuvant arm) versus 78% (no treatment)	Hazard ratios OS: HR 0.69; 95% CI 0.44 to 1.08; P = 0.10 RFS: HR 0.63; 95% CI 0.43 to 0.92; P = 0.02	Not reported	Subgroup analysis showed that non-optimally staged patients in observation arm have significantly worse survival
Trope 2000	162 highrisk stage I 36% patients had low-volume residual disease	Carboplatin 6 cycles Q28/7 AUC = 7 versus chemo at progression	No difference between arms DFS 70% versus 71%, OS 86% versus 85%	Log rank test DFS P = 0.41 OS P = 0.43	Hazard ratios DFS: HR 0.98; 95% CI 0.52 to 1.83 DSS: HR 0.94; 95% CI 0.37 to 2.36	Not reported
Young 1990	48 treatment 44 observation	Melphalan versus no further treat	DFS 91% versus 98% OS 94% versus 98%	Log rank test DFS P = 0.41 OS P = 0.43	Melphalan: 16% had severe myelosuppression. 26% had gastrointestinal side effects. One death: myeloproliferative disorder aplastic anaemia 6 years after completing treatment	Trial under powered to show any real differences
Bolis 1995	85 FIGO (1976) I A-I B Grade 2 and 3	Cisplatin 50 mg/m² × 6 cycles Q28/7 versus no further treatment	DFS 83% versus 64% OS 88% versus 82%	Hazard ratios DFS: HR 0.50; 95% CI 0.21 to 1.19; P = 0.17 OS: HR 1.20; 95% CI 0.46 to 3.1; P = 0.71	Nausea and vomiting in more than two-thirds of patients in cisplatin arm. Severe in less than 10%. Leucopenia 14%; thrombocytopenia 8%; neurological toxicity 6%; renal toxicity 7%	There were patients with residual disease in both arms

CI = confidence interval; DFS = disease-free survival; OS = overall survival; RFS = recurrence-free survival; AUC = Area under the concentration curve