PMID- 26543765
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20151106
LR  - 20220310
IS  - 2193-1801 (Print)
IS  - 2193-1801 (Electronic)
IS  - 2193-1801 (Linking)
VI  - 4
DP  - 2015
TI  - A phase I/II trial of epirubicin and docetaxel in locally advanced breast cancer 
      (LABC) on 2-weekly or 3-weekly schedules: NCIC CTG MA.22.
PG  - 631
LID - 10.1186/s40064-015-1392-x [doi]
LID - 631
AB  - This phase I/II neoadjuvant trial (ClinicalTrials.gov identifier NCT00066443) 
      determined maximally-tolerated doses (MTD), dose-limiting toxicities, 
      response-to-therapy, and explored the role of novel response biomarkers. MA.22 
      accrued T3N0, any N2 or N3, and T4 breast cancer patients. Treatment was 6 cycles 
      of 3-weekly (Schedule A; N = 47) or 8 cycles of 2-weekly (Schedule B; N = 46) 
      epirubicin/docetaxel chemotherapy in sequential phase I/II studies, with growth 
      factor support. In phase I of each schedule, MTDs were based on DLT. In phase II, 
      clinical responses (CR/PR) and pathologic complete responses (pCR) were assessed. 
      Tumor biopsy cores were obtained pre-, mid-, and post-treatment: 3 for pathologic 
      assessment; 3 for microarray studies. DLT for Schedule A was febrile neutropenia 
      at 105 mg/m(2) epirubicin and 75 mg/m(2) docetaxel; for schedule B, it was 
      fatigue at 75 mg/m(2) for both agents. Phase II doses were 90 mg/m(2) 
      epirubicin/75 mg/m(2) docetaxel for Schedule A and 60 mg/m(2) (both agents) for 
      Schedule B. Schedule A CR/PR and pCR rates were 90 and 10 %, with large 
      reductions in tumor RNA content and integrity following treatment; Schedule B 
      results were 93 and 0 %, with smaller reductions in RNA quality. Pre-treatment 
      expression of several genes was associated with clinical response, including 
      those within a likely amplicon at 17q12 (ERBB2, TCAP, GSDMB, and PNMT). The 
      combination regimens had acceptable toxicity, good clinical response, induction 
      of changes in tumor RNA content and integrity. Pre-treatment expression of 
      particular genes was associated with clinical responses, including several near 
      17q12, which with ERBB2, may better identify chemoresponsiveness.
FAU - Trudeau, Maureen Elizabeth
AU  - Trudeau ME
AD  - Sunnybrook Odette Cancer Centre, University of Toronto, 2075 Bayview Avenue, 
      Toronto, ON M4N 3M5 Canada.
FAU - Chapman, Judith-Anne W
AU  - Chapman JA
AD  - NCIC Clinical Trials Group, Queen's University, 10 Stuart Street, Kingston, ON 
      K7L 3N6 Canada.
FAU - Guo, Baoqing
AU  - Guo B
AD  - Advanced Medical Research Institute of Canada (AMRIC), 41 Ramsey Lake Road, 
      Sudbury, ON P3E 5J1 Canada.
FAU - Clemons, Mark J
AU  - Clemons MJ
AD  - The Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Ottawa, 
      ON K1H 8L6 Canada.
FAU - Dent, Rebecca A
AU  - Dent RA
AD  - Sunnybrook Odette Cancer Centre, University of Toronto, 2075 Bayview Avenue, 
      Toronto, ON M4N 3M5 Canada.
FAU - Jong, Roberta A
AU  - Jong RA
AD  - Sunnybrook Odette Cancer Centre, University of Toronto, 2075 Bayview Avenue, 
      Toronto, ON M4N 3M5 Canada.
FAU - Kahn, Harriette J
AU  - Kahn HJ
AD  - Sunnybrook Odette Cancer Centre, University of Toronto, 2075 Bayview Avenue, 
      Toronto, ON M4N 3M5 Canada.
FAU - Pritchard, Kathleen I
AU  - Pritchard KI
AD  - Sunnybrook Odette Cancer Centre, University of Toronto, 2075 Bayview Avenue, 
      Toronto, ON M4N 3M5 Canada.
FAU - Han, Lei
AU  - Han L
AD  - NCIC Clinical Trials Group, Queen's University, 10 Stuart Street, Kingston, ON 
      K7L 3N6 Canada.
FAU - O'Brien, Patti
AU  - O'Brien P
AD  - NCIC Clinical Trials Group, Queen's University, 10 Stuart Street, Kingston, ON 
      K7L 3N6 Canada.
FAU - Shepherd, Lois E
AU  - Shepherd LE
AD  - NCIC Clinical Trials Group, Queen's University, 10 Stuart Street, Kingston, ON 
      K7L 3N6 Canada.
FAU - Parissenti, Amadeo M
AU  - Parissenti AM
AD  - Advanced Medical Research Institute of Canada (AMRIC), 41 Ramsey Lake Road, 
      Sudbury, ON P3E 5J1 Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT00066443
PT  - Journal Article
DEP - 20151021
PL  - Switzerland
TA  - Springerplus
JT  - SpringerPlus
JID - 101597967
PMC - PMC4627986
OTO - NOTNLM
OT  - Docetaxel
OT  - Epirubicin
OT  - LABC
OT  - Microarray
OT  - Phase I/II
OT  - Response biomarkers
EDAT- 2015/11/07 06:00
MHDA- 2015/11/07 06:01
PMCR- 2015/10/21
CRDT- 2015/11/07 06:00
PHST- 2015/09/15 00:00 [received]
PHST- 2015/10/01 00:00 [accepted]
PHST- 2015/11/07 06:00 [entrez]
PHST- 2015/11/07 06:00 [pubmed]
PHST- 2015/11/07 06:01 [medline]
PHST- 2015/10/21 00:00 [pmc-release]
AID - 1392 [pii]
AID - 10.1186/s40064-015-1392-x [doi]
PST - epublish
SO  - Springerplus. 2015 Oct 21;4:631. doi: 10.1186/s40064-015-1392-x. eCollection 
      2015.