Phase II study of weekly docetaxel and capecitabine in patients with metastatic breast cancer.
OBJECTIVE
This phase II study evaluated the safety and efficacy of weekly docetaxel and capecitabine in patients with metastatic breast cancer.


METHODS
Thirty-nine patients with metastatic breast cancer received 30 mg/m2 of docetaxel on days 1, 8, and 15 in combination with capecitabine 800 mg/m2 twice daily on days 1-21, repeated every 28 days.


RESULTS
The median number of treatment cycles was 4 (range, 1-20 cycles). Grade 3 toxicities per patient were asthenia (n = 7; 18%), diarrhea (n = 7; 18%), nausea/vomiting (n = 5; 13%), stomatitis (n = 5; 13%), neutropenia (n = 5; 13%), and hand-foot syndrome (n = 4; 10%). There were only 2 grade 4 toxicities, febrile neutropenia and pulmonary embolism. The overall response rate was 44% (95% confidence interval (CI), 28%-60%), median duration of response was 9.1 months (95% CI, 6.2-12 months), and median time to progression was 5.5 months (95% CI, 3.7-7.3 months).


CONCLUSIONS
Weekly docetaxel with capecitabine was active with acceptable toxicities. Additional trials to define the optimal schedule of docetaxel and capecitabine are justified.
Mrozek
Ewa
E
Division of Hematology and Oncology, Comprehensive Cancer Center, Ohio State University Medical Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH, USA.
Ramaswamy
Bhuvaneswari
B
Young
Donn
D
Rhoades
Chris A
CA
Kendra
Kari
K
Allen
Joan
J
Moore
Tim
T
Hauger
Marsha
M
Watson
Holly
H
Merriman
Nancy
N
Nadella
Padma
P
Villalona-Calero
Miguel
M
Shapiro
Charles L
CL
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil