Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer

被引:122
作者
Diéras, V
Fumoleau, P
Romieu, G
Tubiana-Hulin, M
Namer, M
Mauriac, L
Guastalla, JP
Pujade-Lauraine, E
Kerbrat, P
Maillart, P
Pénault-Llorca, F
Buyse, M
Pouillart, P
机构
[1] Inst Curie, Dept Med Oncol, F-75005 Paris, France
[2] Hop Hotel Dieu, Paris, France
[3] Ctr Rene Gauducheau, F-44035 Nantes, France
[4] Ctr Val Aurelle, Montpellier, France
[5] Ctr Rene Huguenin, St Cloud, France
[6] Ctr Antoine Lacassagne, F-06054 Nice, France
[7] Inst Bergonie, Bordeaux, France
[8] Ctr Leon Berard, F-69373 Lyon, France
[9] Ctr Eugene Marquis, Rennes, France
[10] Ctr Paul Papin, Angers, France
[11] Ctr Jean Perrin, Clermont Ferrand, France
[12] Int Inst Drug Dev, Brussels, Belgium
关键词
D O I
10.1200/JCO.2004.02.122
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This randomized, noncomparative, parallel-group study was designed to evaluate the pathologic complete response (pCR) rate of combined doxorubicin plus paclitaxel (AP) and doxorubicin plus cyclophosphamide (AC) as neoadjuvant chemotherapy in patients with previously untreated breast cancer who were unsuitable for conservative surgery. Patients and Methods A total of 200 patients with T2-3, N0-1, M0 disease were randomly assigned in a 2:1 ratio to receive preoperative chemotherapy with either doxorubicin 60 mg/m(2) plus paclitaxel 200 mg/m(2) as a 3-hour infusion (AP) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (AC) every 3 weeks for 4 courses followed by surgery. Results A pCR (eradication of invasive carcinoma in tumor and in axillary lymph nodes) was found in 16% and 10% of patients in the AP and AC arms, respectively, by study center pathologists, and in 8% and 6% of patients, respectively, by independent pathologists. Patients with pCRs tended to have unifocal disease, tumors with negative hormonal receptor status, and less differentiation (Scarff, Bloom, and Richardson scale grade 3). Breast-conserving surgery was performed in 58% and 45% of patients in the AP and AC arms, respectively. An objective clinical response was achieved in 89% of patients in the AP arm and 70% in the AC arm. At a median follow-up of 31 months, disease-free survival (DFS) was higher in patients who reached pCR versus those without pCR (91% v 70%). Conclusion The encouraging pathologic and clinical responses of patients with breast cancer after neoadjuvant chemotherapy with doxorubicin plus paclitaxel warrant additional investigation of paclitaxel in the neoadjuvant setting of breast cancer management.
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收藏
页码:4958 / 4965
页数:8
相关论文
共 30 条
  • [21] RAGAZ J, 1987, P AM ASSOC CANC RES, V28, P197
  • [22] PACLITAXEL AND RECOMBINANT HUMAN GRANULOCYTE-COLONY-STIMULATING FACTOR AS INITIAL CHEMOTHERAPY FOR METASTATIC BREAST-CANCER
    REICHMAN, BS
    SEIDMAN, AD
    CROWN, JPA
    HEELAN, R
    HAKES, TB
    LEBWOHL, DE
    GILEWSKI, TA
    SURBONE, A
    CURRIE, V
    HUDIS, CA
    YAO, TJ
    KLECKER, R
    JAMISDOW, C
    COLLINS, J
    QUINLIVAN, S
    BERKERY, R
    TOOMASI, F
    CANETTA, R
    FISHERMAN, J
    ARBUCK, S
    NORTON, L
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1993, 11 (10) : 1943 - 1951
  • [23] SATALOFF DM, 1995, J AM COLL SURGEONS, V180, P297
  • [24] SCHWARTZ GF, 1994, CANCER, V73, P362, DOI 10.1002/1097-0142(19940115)73:2<362::AID-CNCR2820730221>3.0.CO
  • [25] 2-L
  • [26] PACLITAXEL AS 2ND AND SUBSEQUENT THERAPY FOR METASTATIC BREAST-CANCER - ACTIVITY INDEPENDENT OF PRIOR ANTHRACYCLINE RESPONSE
    SEIDMAN, AD
    REICHMAN, BS
    CROWN, JPA
    YAO, TJ
    CURRIE, V
    HAKES, TB
    HUDIS, CA
    GILEWSKI, TA
    BASELGA, J
    FORSYTHE, P
    LEPORE, J
    MARKS, L
    FAIN, K
    SOUHRADA, M
    ONETTO, N
    ARBUCK, S
    NORTON, L
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (05) : 1152 - 1159
  • [27] Is there still a role for neoadjuvant therapy in breast cancer?
    Shannon, C
    Smith, I
    [J]. CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 2003, 45 (01) : 77 - 90
  • [28] SLEDGE GW, 1994, SEMIN ONCOL, V21, P15
  • [29] Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National surgical adjuvant breast and bowel project protocol B-26
    Smith, RE
    Brown, AM
    Mamounas, EP
    Anderson, SJ
    Lembersky, BC
    Atkins, JH
    Shibata, HR
    Baez, L
    DeFusco, PA
    Davila, E
    Tipping, SJ
    Bearden, JD
    Thirlwell, MP
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (11) : 3403 - 3411
  • [30] Teixeira MR, 1996, CANCER RES, V56, P855