"Cisplatin-Based Adjuvant Chemotherapy in Patients with Completely Resected Non-Small-Cell Lung Cancer".The New England Journal of Medicine. 2004. 350:351-360.
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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
Does cisplatin-based adjuvant chemotherapy improve survival among patients with completely resected non-small-cell lung cancer?
Cisplatin-based adjuvant chemotherapy provides a slight improvement in survival for patients with completely resected non-small-cell lung cancer.
Although complete surgical resection is recognized as an effective treatment for non-small-cell lung cancer, previous randomized trials had not conclusively shown a benefit from adjuvant chemotherapy. Building upon a previous meta-analysis suggesting a potential survival advantage with cisplatin-based chemotherapy, the International Adjuvant Lung Cancer Trial (IALT) was designed to compare the effects of adjuvant cisplatin-based chemotherapy to observation in patients with completely resected non-small-cell lung cancer.
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.
Multicenter, randomized, open-label, controlled trial
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
Randomly assigned to: - Cisplatin-based chemotherapy (n=932) — three or four cycles - Observation (n=935)
Primary Outcome - Overall five-year survival rates: 44.5% in the chemotherapy group vs. 40.4% in the observation group (P<0.03)
- 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%
- Open-label design - Selection of adjuvant therapy and radiotherapy was not uniform across centers - Potential for confounding by differences in radiotherapy administration
Funded by unrestricted grants from various cancer research associations and institutions.
The IALT Collaborative Group and author affiliations can be referenced for more details on the study.