JCOG0505: trial | Bending the Curve: Trial by Trial

JCOG0505

Paclitaxel plus carboplatin versus paclitaxel plus cisplatin in metastatic or recurrent cervical cancer

Population

Metastatic or recurrent cervical cancer with no more than one previous platinum-containing treatment and no prior taxane; 253 patients enrolled between February 2006 and November 2009

Design

Open-label, randomised phase 3 non-inferiority trial. Paclitaxel 135 mg/m2 over 24 hours on day 1 plus cisplatin 50 mg/m2 on day 2 (TP) or paclitaxel 175 mg/m2 over 3 hours plus carboplatin AUC 5 on day 1 (TC), repeated every 3 weeks. Primary endpoint: overall survival; non-inferiority hazard-ratio threshold 1.29, planned sample 250.

Primary endpoint

Arms

Paclitaxel plus cisplatin (TP) (control): Paclitaxel 135 mg/m2 over 24 hours day 1 plus cisplatin 50 mg/m2 day 2 every 3 weeks
Paclitaxel plus carboplatin (TC) (experimental): Paclitaxel 175 mg/m2 over 3 hours plus carboplatin AUC 5 day 1 every 3 weeks

People

Kitagawa R, senior author Yoshikawa H

OSHR 0.994Δ median OS−0.8 monthsOSHR 1.571 (95% CI 1.06–2.32)Δ median OS−10.2 months

Show the numbers

Results reported for JCOG0505
Endpoint	Analysis	Paclitaxel plus carboplatin (TC)	Paclitaxel plus cisplatin (TP)	Effect
OSEnrolled patients (N = 253)	primaryKitagawa 2015	median 17.5 months	median 18.3 months	HR 0.994P=0.032 (non-inferiority)The abstract gives a 90% confidence interval of 0.79 to 1.25 for the hazard ratio, so no ci95 is entered. Stratified Cox regression; non-inferiority threshold hazard ratio 1.29.
OSPatients who had not received prior cisplatin	exploratoryKitagawa 2015	median 13 months	median 23.2 months	HR 1.571 (95% CI 1.06–2.32)Subgroup reported in the abstract; whether it was prespecified is not stated there. The abstract lists TC first (13.0) then TP (23.2).

Results reported for JCOG0505
Endpoint	Analysis	Paclitaxel plus carboplatin (TC)	Paclitaxel plus cisplatin (TP)	Effect
OSEnrolled patients (N = 253)	primaryKitagawa 2015	median 17.5 months	median 18.3 months	HR 0.994P=0.032 (non-inferiority)The abstract gives a 90% confidence interval of 0.79 to 1.25 for the hazard ratio, so no ci95 is entered. Stratified Cox regression; non-inferiority threshold hazard ratio 1.29.
OSPatients who had not received prior cisplatin	exploratoryKitagawa 2015	median 13 months	median 23.2 months	HR 1.571 (95% CI 1.06–2.32)Subgroup reported in the abstract; whether it was prespecified is not stated there. The abstract lists TC first (13.0) then TP (23.2).

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

Data table

Endpoint	HR	95% CI
OS	1.571	1.06–2.32

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

Show curves

Paclitaxel plus cisplatin (TP) (control)
Paclitaxel plus carboplatin (TC) (experimental)

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

Data table (modelled values)

Months	Paclitaxel plus cisplatin (TP)	Paclitaxel plus carboplatin (TC)
0	100.0%	100.0%
11	65.9%	64.7%
23	41.8%	40.2%
34	27.6%	26.0%
46	17.5%	16.2%

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

Show curves

Paclitaxel plus cisplatin (TP) (control)
Paclitaxel plus carboplatin (TC) (experimental)

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

Data table (modelled values)

Months	Paclitaxel plus cisplatin (TP)	Paclitaxel plus carboplatin (TC)
0	100.0%	100.0%
15	63.9%	44.9%
29	42.0%	21.3%
44	26.9%	9.6%
58	17.7%	4.5%

Appears in

2004 Cisplatin-paclitaxel and other platinum doublets for advanced disease

Sources

Kitagawa R, Katsumata N, Shibata T, Kamura T, Kasamatsu T, Nakanishi T, et al. Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial JCOG0505. J Clin Oncol. 2015;33(19):2129-35.
PubMed DOI