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).
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.


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.


CONCLUSIONS
This combination merits further study in this group of patients.
Jatoi
A
A
Mayo Clinic Rochester, Rochester, MN. Electronic address: jatoi.aminah@mayo.edu.
Schild
S E
SE
Mayo Clinic Arizona, Scottsdale, AZ.
Foster
N
N
Mayo Clinic Rochester, Rochester, MN.
Henning
G T
GT
Michigan Cancer Consortium, Ann Arbor, MI.
Dornfeld
K J
KJ
Duluth City Clinical Oncology Program, Duluth, MN.
Flynn
P J
PJ
Metro-Minnesota Community Oncology Program, St Louis Park, MN.
Fitch
T R
TR
Mayo Clinic Arizona, Scottsdale, AZ.
Dakhil
S R
SR
Wichita Community Clinical Oncology Program, Wichita, KS.
Rowland
K M
KM
Carle Cancer Center City Clinical Oncology Program, Urbana, IL.
Stella
P J
PJ
Michigan Cancer Consortium, Ann Arbor, MI.
Soori
G S
GS
Missouri Valley Cancer Consortium, Omaha, NE.
Adjei
A A
AA
Roswell Park Cancer Institute, Buffalo, NY, USA.
D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000556:secondary / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000556:secondary / Q000628:therapy; D000068818:Cetuximab; D003131:Combined Modality Therapy; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000276:immunology / Q000378:metabolism; D005260:Female; D005500:Follow-Up Studies; D005720:Gamma Rays; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D066246:ErbB Receptors; D000068818:Cetuximab