A phase II study of cetuximab and radiation in elderly and/or poor performance status patients with locally advanced non-small-cell lung cancer (N0422).

Abstract

BACKGROUND:

Non-small-cell lung cancer (NSCLC) is a disease of the elderly. Seeking a tolerable but effective regimen, we tested cetuximab + radiation in elderly and/or poor performance status patients with locally advanced NSCLC.

PATIENTS AND METHODS:

Older patients [≥ 65 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2] or younger patients (performance status of 2) received cetuximab 400 mg/m(2) i.v. on day 1 followed by weekly cetuximab 250 mg/m(2) i.v. with concomitant radiation of 6000 cGy in 30 fractions. The primary end point was the percentage who lived 11+ months.

RESULTS:

This 57-patient cohort had a median age (range) of 77 years (60-87), and 12 (21%) had a performance status of 2. Forty of 57 (70%) lived 11+ months, thus exceeding the anticipated survival rate of 50%. The median survival was 15.1 months [95% confidence interval (CI) 13.1-19.3 months], and the median time to cancer progression was 7.2 months (95% CI 5.8-8.6 months). No treatment-related deaths occurred, but 31 patients experienced grade 3+ adverse events, most commonly fatigue, anorexia, dyspnea, rash, and dysphagia, each of which occurred in <10% of patients.

CONCLUSION:

This combination merits further study in this group of patients.

• Authors: A Jatoi, S E Schild, N Foster, G T Henning, K J Dornfeld, P J Flynn, T R Fitch, S R Dakhil, K M Rowland, P J Stella, G S Soori, A A Adjei
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 21 Issue 10 Pg. 2040-2044 (Oct 2010) ISSN: 1569-8041 [Electronic] England
• PMID: 20570832 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• ErbB Receptors
• Cetuximab

Topics

• Adenocarcinoma (secondary, therapy)
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (secondary, therapy)
• Carcinoma, Squamous Cell (secondary, therapy)
• Cetuximab
• Combined Modality Therapy
• ErbB Receptors (antagonists & inhibitors, immunology, metabolism)
• Female
• Follow-Up Studies
• Gamma Rays
• Humans
• Lung Neoplasms (pathology, therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Radiotherapy Dosage
• Survival Rate
• Treatment Outcome