"Cisplatin-Based Adjuvant Chemotherapy in Patients with Completely Resected Non-Small-Cell Lung Cancer".The New England Journal of Medicine. 2004. 350:351-360.PubMed•Full text•PDF

Contents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcome
8.2Secondary Outcomes
9Criticisms
10Funding
11Further Reading

Clinical Question

Does cisplatin-based adjuvant chemotherapy improve survival among patients with completely resected non-small-cell lung cancer?

Bottom Line

Cisplatin-based adjuvant chemotherapy provides a slight improvement in survival for patients with completely resected non-small-cell lung cancer.

Major Points

Guidelines

As of the knowledge cutoff date for this summary, guidelines regarding the use of adjuvant chemotherapy in non-small-cell lung cancer should be consulted for the most up-to-date recommendations.

Design

Multicenter, randomized, open-label, controlled trial

Population

A total of 1867 patients with completely resected non-small-cell lung cancer.

Inclusion Criteria
- Pathologically documented non-small-cell lung cancer of stage I, II, or III
- Complete surgical resection
- Age between 18 and 75 years
- No previous chemotherapy or radiotherapy
- No other previous cancers except nonmelanoma skin cancer or carcinoma in situ of the cervix

Exclusion Criteria
- Contraindications to chemotherapy
- Ineligibility as determined by other clinical factors

Baseline Characteristics
- The study population had stages I, II, or III non-small-cell lung cancer
- The median duration of follow-up was 56 months

Interventions

Randomly assigned to:
- Cisplatin-based chemotherapy (n=932) — three or four cycles
- Observation (n=935)

Outcomes

Primary Outcome
- Overall five-year survival rates: 44.5% in the chemotherapy group vs. 40.4% in the observation group (P<0.03)

Secondary Outcomes
- Disease-free survival rates at five years: 39.4% in the chemotherapy group vs. 34.3% in the observation group (P<0.003)
- No significant interactions with prespecified factors
- Chemotherapy-induced deaths: 0.8%

Criticisms

- Open-label design
- Selection of adjuvant therapy and radiotherapy was not uniform across centers
- Potential for confounding by differences in radiotherapy administration

Funding

Funded by unrestricted grants from various cancer research associations and institutions.

Further Reading