North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer.
BACKGROUND
Docetaxel (T; Taxotere) with capecitabine (X) is active against metastatic breast cancer (MBC); bevacizumab (BV) has demonstrated efficacy with taxanes in the first-line setting. This study was conducted to assess the safety and efficacy of TX-BV in patients with MBC.


METHODS
In this single-arm, multicenter phase II study, patients received first-line bevacizumab 15 mg/kg and docetaxel 75 mg/m(2) on day 1 and capecitabine 825 mg/m(2) twice per day on days 1-14 every 21 days. Primary and secondary end points were tumor response rate (RR), overall survival (OS), progression-free survival (PFS), and toxicity.


RESULTS
A total of 45 assessable patients received TX-BV for a median of seven cycles. Two complete and 20 partial responses were observed (overall RR 49%); nine patients had stable disease >6 months, for a clinical benefit rate of 69%. Median response duration was 11.8 months. Median OS and PFS were 28.4 and 11.1 months, respectively. Grade 3/4 adverse events included hand-foot syndrome (29%), fatigue (20%), febrile neutropenia (18%), and diarrhea (18%). In cycles 3-10, median dose levels of docetaxel and capecitabine were 60 mg/m(2) and 660 mg/m(2), respectively.


CONCLUSIONS
TX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.
Perez
E A
EA
Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL. Electronic address: perez.edith@mayo.edu.
Hillman
D W
DW
Mayo Clinic, Rochester, MN.
Dentchev
T
T
Altru Health Systems, Grand Forks, ND.
Le-Lindqwister
N A
NA
Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL.
Geeraerts
L H
LH
Community Clinical Oncology Program, MeritCare Hospital, Fargo, ND.
Fitch
T R
TR
Mayo Clinic, Scottsdale, AZ.
Liu
H
H
Mayo Clinic, Rochester, MN.
Graham
D L
DL
Carle Cancer Center, Urbana, IL.
Kahanic
S P
SP
Siouxland Hematology-Oncology Associates, Sioux City, IA.
Gross
H M
HM
Hematology and Oncology of Dayton, Inc., Dayton, OH, USA.
Patel
T A
TA
Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL.
Palmieri
F M
FM
Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL.
Dueck
A C
AC
Mayo Clinic, Scottsdale, AZ.
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil