JBR.10: trial | Bending the Curve: Trial by Trial

JBR.10

Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer

Population

Patients with completely resected stage IB (45%) or stage II (55%) non-small-cell lung cancer.

Design

Randomised comparison of adjuvant vinorelbine plus cisplatin versus observation after complete resection. Primary end point overall survival; principal secondary end points recurrence-free survival and toxicity and safety. 482 patients randomised (242 and 240); median age 61 years in both groups, 65% men, 53% adenocarcinoma; all with ECOG performance status 0 or 1.

Primary endpoint

Arms

Observation (control, n = 240): Observation after complete resection
Vinorelbine plus cisplatin (experimental, n = 242): Adjuvant vinorelbine plus cisplatin

People

Winton T, National Cancer Institute of Canada Clinical Trials Group and National Cancer Institute of the United States Intergroup JBR.10 Trial Investigators

OSHR 0.69Δ median OS+21 monthsΔ 60-month OS+15 pointsRFSHR 0.6

Show the numbers

Results reported for JBR.10
Endpoint	Analysis	Vinorelbine plus cisplatin	Observation	Effect
OSRandomised patients (482)	primaryWinton 2005	median 94 months; 69% at 5 y	median 73 months; 54% at 5 y	HR 0.69P=0.04Median survival 94 versus 73 months (P=0.04 for overall survival); 5-year survival 69% versus 54% (P=0.03). No confidence interval is given for the hazard ratio in the abstract.
RFSRandomised patients (482)	primaryWinton 2005	—	median 46.7 months	HR 0.6P<0.001Hazard ratio for recurrence 0.60. Median relapse-free survival with vinorelbine plus cisplatin was not reached, so only the observation median is entered. A principal secondary end point. No confidence interval is given in the abstract.
Toxic death rateChemotherapy group (denominator not stated in the abstract)	primaryWinton 2005	0.8%	—	Two patients died from toxic effects of chemotherapy.

Results reported for JBR.10
Endpoint	Analysis	Vinorelbine plus cisplatin	Observation	Effect
OSRandomised patients (482)	primaryWinton 2005	median 94 months; 69% at 5 y	median 73 months; 54% at 5 y	HR 0.69P=0.04Median survival 94 versus 73 months (P=0.04 for overall survival); 5-year survival 69% versus 54% (P=0.03). No confidence interval is given for the hazard ratio in the abstract.
RFSRandomised patients (482)	primaryWinton 2005	—	median 46.7 months	HR 0.6P<0.001Hazard ratio for recurrence 0.60. Median relapse-free survival with vinorelbine plus cisplatin was not reached, so only the observation median is entered. A principal secondary end point. No confidence interval is given in the abstract.
Toxic death rateChemotherapy group (denominator not stated in the abstract)	primaryWinton 2005	0.8%	—	Two patients died from toxic effects of chemotherapy.

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

Show curves

Vinorelbine plus cisplatin (experimental)
Observation (control)

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

Data table (modelled values)

Months	Vinorelbine plus cisplatin	Observation
0	100.0%	100.0%
59	64.7%	57.1%
118	41.9%	32.6%
176	27.3%	18.8%
235	17.7%	10.7%

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

Show curves

Observation (control)

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

Data table (modelled values)

Months	Observation
0	100.0%
29	65.0%
58	42.3%
88	27.1%
117	17.6%

Appears in

2004 Adjuvant cisplatin after resection: IALT, JBR.10 and LACE

Sources

Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med. 2005;352(25):2589-97.
PubMed DOI