Phase II trial of 10-EDAM in the treatment of metastatic breast cancer.
BACKGROUND
This phase II trial was conducted to assess the efficacy and safety of 10-Ethyl-10-Deaza-Aminopterin (10-EDAM), a folate antagonist, in metastatic breast cancer patients who had received no more than one prior chemotherapy regimen.


METHODS
Fifty-five patients were treated on an initial weekly dose 80 mg/m(2) of 10-EDAM. Patients who had received a prior chemotherapy regimen in the adjuvant setting (group 1) were considered separately from patients who had received a prior chemotherapy regimen in the metastatic setting (group 2).


RESULTS
The response rate for both groups combined was 18%, and median time to progression was 3 months. Median overall survival was 12 months. Treatment was associated with common chemotherapy-related toxicities, such as 25% grade three or four neutropenia and 20% grade three or four stomatitis.


CONCLUSIONS
In patients with metastatic breast cancer who had received one prior chemotherapy regimen, 10-EDAM was well tolerated. In general, while definite antitumor activity was documented, time to progression was brief.
Beinart
Garth A
GA
Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
Gonzalez-Angulo
Ana M
AM
Broglio
Kristine
K
Frye
Debbie
D
Walters
Ronald
R
Holmes
Frankie Ann
FA
Gunale
Shivaji
S
Booser
Daniel
D
Rosenthal
Julian
J
Dhingra
Kapil
K
Young
James A
JA
Hortobagyi
G N
GN
D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000505:Alopecia / Q000139:chemically induced; D000630:Aminopterin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents; C040210:edatrexate; D000630:Aminopterin