Clinical outcomes of patients with breast cancer in a phase I clinic: the M. D. Anderson cancer center experience.
OBJECTIVE
Patients with metastatic breast cancer (MBC) refractory to standard therapy have a poor prognosis. We assessed prognostic factors and clinical outcomes for patients with MBC referred to a phase I clinic focused primarily on targeted agents.


METHODS
We reviewed the medical records of sequential patients with MBC who presented to our phase I clinic between September 2004 and May 2008 to assess baseline patient characteristics, overall survival (OS), and clinical benefit.


RESULTS
A total of 92 patients were identified, with a median age of 53 years (range, 28-83 years). The median number of previous therapies was 5 (range, 1-16 therapies). Of 92 patients, 78 were eligible for and offered > or = 1 phase I clinical trial. With a median follow-up of 7.4 months, the median OS was 6.7 months (95% CI, 5.2-9.7). In multivariate analysis, independent factors predicting shorter survival were > or = 10 previous treatments (vs. < 10 previous treatments; hazard ratio [HR], 3.27; 95% CI, 1.37-7.81; P = .008), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2/3 (vs. 0/1; HR, 2.92; 95% CI, 1.28-6.66; P = .01), and albumin level < 3.5 g/dL (vs. > 3.5 g/dL; HR, 2.88; 95% CI, 1.41-5.89; P = .004).


CONCLUSIONS
Patients with locally advanced or metastatic breast cancer referred for our phase I studies had a median survival of 6.7 months. Heavily pretreated disease, poor ECOG PS, and/or low albumin levels were associated with significantly shorter survival in a multivariate analysis.
Department of Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1402, USA. jjwheler@mdanderson.com
Jennifer
J
Wheler
Apostolia M
AM
Tsimberidou
Stacy
S
Moulder
Massimo
M
Cristofanilli
David
D
Hong
Aung
A
Naing
Raminder
R
Pathak
Suyu
S
Liu
Lei
L
Feng
Razelle
R
Kurzrock
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018567:Breast Neoplasms, Male / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D002173:Cancer Care Facilities / Q000706:statistics & numerical data*; D017321:Clinical Trials, Phase I as Topic; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016879:Salvage Therapy / Q000379:methods
D000970:Antineoplastic Agents