ICON3: trial | Bending the Curve: Trial by Trial

ICON3

Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial

N = 2,074

Population

Women with ovarian cancer requiring first-line chemotherapy

Design

International randomised trial. Between February 1995 and October 1998, 2074 patients from 130 centres in eight countries were randomly assigned to paclitaxel plus carboplatin or to control. The control, CAP (cyclophosphamide, doxorubicin, cisplatin) or single-agent carboplatin, was chosen by the patient and clinician before randomisation. Primary outcome overall survival; secondary outcomes progression-free survival and toxicity; intention-to-treat analysis (Lancet abstract).

Primary endpoint

Arms

Control: CAP or single-agent carboplatin (control): Cyclophosphamide, doxorubicin and cisplatin (CAP) or single-agent carboplatin, chosen before randomisation (doses not given in the abstract)
Paclitaxel plus carboplatin (experimental): Paclitaxel plus carboplatin (doses not given in the abstract)

People

International Collaborative Ovarian Neoplasm Group, International Collaborative Ovarian Neoplasm Group

OSHR 0.98 (95% CI 0.87–1.10)Δ median OS+0.7 monthsPFSHR 0.93 (95% CI 0.84–1.03)Δ median PFS+1.2 months

Show the numbers

Results reported for ICON3
Endpoint	Analysis	Paclitaxel plus carboplatin	Control: CAP or single-agent carboplatin	Effect
OS	primarymedian follow-up 51 monthsInternational 2002	median 36.1 months	median 35.4 months	HR 0.98 (95% CI 0.87–1.10)P=0.741265 patients had died at the analysis. The abstract gives the difference in median OS as 0.7 months (95% CI -3.6 to 4.7).
PFS	primarymedian follow-up 51 monthsInternational 2002	median 17.3 months	median 16.1 months	HR 0.93 (95% CI 0.84–1.03)P=0.161538 patients had progressive disease or died. The abstract gives the difference in median PFS as 1.2 months (95% CI -0.5 to 2.8); secondary outcome.

Results reported for ICON3
Endpoint	Analysis	Paclitaxel plus carboplatin	Control: CAP or single-agent carboplatin	Effect
OS	primarymedian follow-up 51 monthsInternational 2002	median 36.1 months	median 35.4 months	HR 0.98 (95% CI 0.87–1.10)P=0.741265 patients had died at the analysis. The abstract gives the difference in median OS as 0.7 months (95% CI -3.6 to 4.7).
PFS	primarymedian follow-up 51 monthsInternational 2002	median 17.3 months	median 16.1 months	HR 0.93 (95% CI 0.84–1.03)P=0.161538 patients had progressive disease or died. The abstract gives the difference in median PFS as 1.2 months (95% CI -0.5 to 2.8); secondary outcome.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
OS	0.98	0.87–1.1
PFS	0.93	0.84–1.03

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Paclitaxel plus carboplatin (experimental)
Control: CAP or single-agent carboplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Paclitaxel plus carboplatin	Control: CAP or single-agent carboplatin
0	100.0%	100.0%
23	64.3%	63.7%
45	42.1%	41.4%
68	27.1%	26.4%
90	17.8%	17.2%

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Paclitaxel plus carboplatin (experimental)
Control: CAP or single-agent carboplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Paclitaxel plus carboplatin	Control: CAP or single-agent carboplatin
0	100.0%	100.0%
11	64.4%	62.3%
22	41.4%	38.8%
32	27.7%	25.2%
43	17.9%	15.7%

Appears in

1996 Paclitaxel with platinum in first line: GOG-111, OV-10, ICON3

Sources

International Collaborative Ovarian Neoplasm Group. Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial. Lancet. 2002;360(9332):505-15.
PubMed DOI