Dosage of capecitabine and cyclophosphamide combination therapy in patients with metastatic breast cancer.
BACKGROUND
Capecitabine is a highly effective and well-tolerated treatment for metastatic breast cancer (MBC) and extends survival when combined with docetaxel. Capecitabine and cyclophosphamide are orally administered and have preclinical synergy and non-overlapping toxicities.


METHODS
Sixteen pretreated MBC patients received escalating doses of oral capecitabine 628 to 829 mg/m2 twice daily (bid) plus oral cyclophosphamide 33 to 50 mg/m2 bid, on days 1 to 14 every 21 days.


RESULTS
Among the ten patients receiving capecitabine/cyclophosphamide 829/33 mg/m2 bid on days 1 to 14, two experienced dose-limiting toxicities (DLT, treatment delay > 1 week due to grade 2 leukopenia). Because neither patient developed further grade > 1 toxicity and none of the patients experienced grade 3/4 toxicities or further DLTs, this dose level is the recommended regimen, producing partial responses in two of five evaluable patients.


CONCLUSIONS
The recommended all oral capecitabine/cyclophosphamide combination regimen is well tolerated and active in MBC, and is being evaluated in a phase II study in anthracycline-pretreated MBC.
Ohno
Shinji
S
Department of Breast Oncology, National Kyushu Cancer Center Hospital, 3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan. sohno@nk-cc.go.jp
Mitsuyama
Shoshu
S
Tamura
Kazuo
K
Nishimura
Reiki
R
Tanaka
Maki
M
Hamada
Yuzo
Y
Kuroki
Shoji
S
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004357:Drug Synergism; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis
D003841:Deoxycytidine; D000069287:Capecitabine; D003520:Cyclophosphamide; D005472:Fluorouracil