TY - JOUR
T1 - Phase II study of dose-dense sequential doxorubicin and docetaxel for patients with advanced operable and inoperable breast cancer
AU - Cooper, Brenda W.
AU - Radivoyevitch, Tomas
AU - Overmoyer, Beth A.
AU - Shenk, Robert R.
AU - Pham, Huong T.
AU - Samuels, Judith R.
AU - Parry, Margaret P.
AU - Silverman, Paula
N1 - Funding Information:
Supported, in part, by NIH Grant P30 CA43703, Case Comprehensive Cancer Center, Aventis Pharmaceuticals.
PY - 2006/6
Y1 - 2006/6
N2 - Rapid sequential delivery of doxorubicin 75 mg/m2 q 2 weeks×3 cycles followed by docetaxel 100 mg/m2 q 2 weeks×3 cycles, with filgrastim support was evaluated in patients with inoperable and large operable breast cancers who were not initially candidates for breast conservation therapy. Postoperative CMF chemotherapy and/or radiation were administered based on surgical findings. Median age of the 39 enrolled patients was 47 (range 27-59), stage IIA (6 patients), IIB (14 patients), IIIA (10 patients), IIIB (9 patients), and 23 patients (59%) had clinical nodal involvement. The average bidimensional tumor size before treatment was 30 cm2. Clinical responses included 13 (33%) complete responses, 23 (59%) partial responses, 1 stable disease, and 2 progressive disease, for an overall response rate of 92%. Clinical response rate was 11/13(85%) in HER2/neu positive patients compared to 25/26 (96%) in tumors that did not express HER2/neu. Twenty patients (51%) underwent breast conservation surgery. Pathologic tumor response at the time of definitive surgery included 4 pathologic CR (pCR, 10%), 4 microscopic invasion (pINV), and 14 (36%) pathologically negative axillary nodes. pCR was not observed in any HER2/neu positive patients. 5/39 patients were unable to complete all cycles of docetaxel and 8 patients required dose reduction of docetaxel due to development of grade 3-4 mucositis and hand-foot syndrome. This observation prompted a protocol change requiring 3 weeks between doxorubicin and docetaxel. Primary chemotherapy with dose-dense doxorubicin and docetaxel given sequentially is well tolerated and allows a high rate of breast sparing in patients with large breast cancers.
AB - Rapid sequential delivery of doxorubicin 75 mg/m2 q 2 weeks×3 cycles followed by docetaxel 100 mg/m2 q 2 weeks×3 cycles, with filgrastim support was evaluated in patients with inoperable and large operable breast cancers who were not initially candidates for breast conservation therapy. Postoperative CMF chemotherapy and/or radiation were administered based on surgical findings. Median age of the 39 enrolled patients was 47 (range 27-59), stage IIA (6 patients), IIB (14 patients), IIIA (10 patients), IIIB (9 patients), and 23 patients (59%) had clinical nodal involvement. The average bidimensional tumor size before treatment was 30 cm2. Clinical responses included 13 (33%) complete responses, 23 (59%) partial responses, 1 stable disease, and 2 progressive disease, for an overall response rate of 92%. Clinical response rate was 11/13(85%) in HER2/neu positive patients compared to 25/26 (96%) in tumors that did not express HER2/neu. Twenty patients (51%) underwent breast conservation surgery. Pathologic tumor response at the time of definitive surgery included 4 pathologic CR (pCR, 10%), 4 microscopic invasion (pINV), and 14 (36%) pathologically negative axillary nodes. pCR was not observed in any HER2/neu positive patients. 5/39 patients were unable to complete all cycles of docetaxel and 8 patients required dose reduction of docetaxel due to development of grade 3-4 mucositis and hand-foot syndrome. This observation prompted a protocol change requiring 3 weeks between doxorubicin and docetaxel. Primary chemotherapy with dose-dense doxorubicin and docetaxel given sequentially is well tolerated and allows a high rate of breast sparing in patients with large breast cancers.
KW - Breast conservation
KW - Her2/neu expression
KW - Primary chemotherapy
UR - http://www.scopus.com/inward/record.url?scp=33745468587&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33745468587&partnerID=8YFLogxK
U2 - 10.1007/s10549-005-9125-4
DO - 10.1007/s10549-005-9125-4
M3 - Article
C2 - 16344915
AN - SCOPUS:33745468587
VL - 97
SP - 311
EP - 318
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 3
ER -