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Non-Small Cell Lung Cancer · Medical

JBR.10

After complete resection of stage IB–II NSCLC, does cisplatin–vinorelbine improve survival compared with observation?

Population
482 patients with completely resected stage IB (T2N0) or stage II (T1–2N1) NSCLC.
Intervention vs comparator
Four cycles of cisplatin plus vinorelbine versus observation.
Sample size
482
Primary endpoint
Overall survival

Reported outcome visualization

Key results

At 9.3 years' median follow-up, OS favoured chemotherapy (HR 0.78, 95% CI 0.61–0.99; P=.04). The stage II subgroup had HR 0.68 (95% CI 0.50–0.92; P=.01); stage IB did not show benefit (HR 1.03, 95% CI 0.70–1.52; P=.87). The earlier 5-year analysis reported survival 69% vs 54%.

Absolute Effect

At the earlier 5-year landmark, absolute OS difference was about 15 percentage points; descriptive NNT ≈7 to prevent one death by 5 years. The updated report supports a stage-dependent effect; do not apply the 15-point estimate uniformly to stage IB.

NNT: ≈7 at 5 years for the earlier pooled 5-year OS estimate; stage-specific applicability is limited.

NNH: Not quantifiable from the verified fixed-time toxicity data used in this summary; see toxicity and treatment burden below.

Time-to-event interpretation: Hazard ratios and median survival are relative/time-to-event measures; they are not converted into NNT unless a fixed-time absolute event estimate is available.

Toxicity and treatment burden

Cisplatin/vinorelbine causes clinically important myelosuppression, nausea, fatigue, renal and neurologic toxicity; the regimen has substantial treatment burden. Do not derive NNH without a prespecified, comparable fixed-time toxicity rate.

Follow-up, limitations and maturity

Follow-up: Median follow-up 9.3 years.

Open-label trial conducted before current TNM staging and adjuvant targeted/immunotherapy. Stage IB subgroup did not benefit; the pooled estimate should not erase stage-specific uncertainty.

Clinical interpretation

Adjuvant cisplatin-based chemotherapy produces a durable survival benefit after resection, most clearly for node-positive stage II disease.

Primary publication and sources

Winton T, et al. N Engl J Med. 2005; updated analysis: Butts CA, et al. J Clin Oncol. 2010.

Primary publication / PubMed ↗

Additional authoritative source / follow-up ↗

Current-practice context · reviewed 15 October 2026

Adjuvant cisplatin-based chemotherapy is established after resection for stage IIA–IIIA NSCLC in fit patients. It is not routinely recommended for every stage IB tumour; tumour size, pathologic risk and actionable biomarkers matter. Modern adjuvant targeted and immune therapies are supported by separate trials and should not be attributed to JBR.10.

ASCO rapid recommendation update for adjuvant therapy in resected NSCLC ↗