PMID- 14581269
OWN - NLM
STAT- MEDLINE
DCOM- 20040422
LR  - 20200203
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 14
IP  - 11
DP  - 2003 Nov
TI  - Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in 
      patients with operable breast cancer.
PG  - 1623-8
AB  - BACKGROUND: This study was conducted to assess the antitumour activity of 
      docetaxel in combination with doxorubicin for neoadjuvant therapy of patients 
      with breast cancer. PATIENTS AND METHODS: Forty-eight women were treated with 
      intravenous doxorubicin 50 mg/m(2) over 15 min followed by a 1-h infusion of 
      docetaxel 75 mg/m(2) every 3 weeks for six cycles. Dexamethasone or prednisolone 
      premedication was allowed. Granulocyte colony-stimulating factor was not allowed 
      as primary prophylaxis. The primary end point was the pathologically documented 
      complete response rate (pathological response). RESULTS: The mean relative dose 
      intensity calculated for four or more cycles was 0.99 for doxorubicin and 0.99 
      for docetaxel. Overall, the pathological response rate was 13%. There were 11 
      complete and 29 partial clinical responses for an overall response rate of 85% 
      [95% confidence interval (CI) 75% to 95%] in the evaluable population (n = 47). 
      Disease-free and overall survival rates were 85% (95% CI 71% to 94%) and 96% (95% 
      CI 85% to 99%), respectively, after a median follow-up of 36.6 months. Grade 3/4 
      neutropenia was observed in 65% of patients and 17% reported grade 4 febrile 
      neutropenia. CONCLUSIONS: Docetaxel and doxorubicin is an effective and 
      well-tolerated combination in the neoadjuvant therapy of breast cancer. Future 
      controlled trials are warranted to investigate the best schedules and to 
      correlate response with biological factors.
FAU - Ganem, G
AU  - Ganem G
AD  - Centre Jean Bernard, Le Mans, France. gganem@noos.fr
FAU - Tubiana-Hulin, M
AU  - Tubiana-Hulin M
FAU - Fumoleau, P
AU  - Fumoleau P
FAU - Combe, M
AU  - Combe M
FAU - Misset, J-L
AU  - Misset JL
FAU - Vannetzel, J-M
AU  - Vannetzel JM
FAU - Bachelot, T
AU  - Bachelot T
FAU - De Ybarlucea, L R
AU  - De Ybarlucea LR
FAU - Lotz, V
AU  - Lotz V
FAU - Bendahmane, B
AU  - Bendahmane B
FAU - Dieras, V
AU  - Dieras V
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - 80168379AG (Doxorubicin)
SB  - IM
MH  - Adult
MH  - Antibiotics, Antineoplastic/administration & dosage
MH  - Antineoplastic Agents, Phytogenic/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/pathology/surgery
MH  - Carcinoma, Ductal, Breast/*drug therapy/surgery
MH  - Chemotherapy, Adjuvant
MH  - Docetaxel
MH  - Dose-Response Relationship, Drug
MH  - Doxorubicin/administration & dosage
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Survival Analysis
MH  - Taxoids/administration & dosage
MH  - Treatment Outcome
EDAT- 2003/10/29 05:00
MHDA- 2004/04/23 05:00
CRDT- 2003/10/29 05:00
PHST- 2003/10/29 05:00 [pubmed]
PHST- 2004/04/23 05:00 [medline]
PHST- 2003/10/29 05:00 [entrez]
AID - S0923-7534(19)64212-2 [pii]
AID - 10.1093/annonc/mdg449 [doi]
PST - ppublish
SO  - Ann Oncol. 2003 Nov;14(11):1623-8. doi: 10.1093/annonc/mdg449.