Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer.
OBJECTIVE
To evaluate the efficacy and safety of erlotinib in advanced breast cancer. Experimental design Multicenter, phase II study of erlotinib (150 mg orally daily). Cohort 1: progression after anthracyclines, taxanes, and capecitabine (n = 47). Cohort 2: progression after >1 chemotherapy for advanced-stage disease (n = 22). Primary endpoint was response rate (World Health Organization criteria). Secondary endpoints were safety, time to progression, and survival.


RESULTS
One patient in each cohort (n = 2, 3.0%) had a partial response. Response duration was 17 weeks for the Cohort 1 patient and 32 weeks for the Cohort 2 patient. Median time to progression was 43 days for Cohort 1 (range 1-204) and 43 days for Cohort 2 (range 25-419). Common adverse events were diarrhea, rash, dry skin, asthenia, nausea, anorexia.


CONCLUSIONS
Erlotinib had minimal activity in unselected previously treated women with advanced breast cancer. Predictive factors are needed to identify breast cancer patients who may derive benefit from erlotinib treatment.
Dickler
Maura N
MN
Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. dicklerm@mskcc.org
Cobleigh
Melody A
MA
Miller
Kathy D
KD
Klein
Pamela M
PM
Winer
Eric P
EP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D015331:Cohort Studies; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D066246:ErbB Receptors / Q000378:metabolism; D000069347:Erlotinib Hydrochloride; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use*; D043823:Taxoids / Q000008:administration & dosage
D018943:Anthracyclines; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D043823:Taxoids; D003841:Deoxycytidine; D000069287:Capecitabine; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D005472:Fluorouracil