Abstract
Purpose: This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC). Patients and Methods: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m 2 plus docetaxel 75 mg/m2 (n = 214) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (n = 215) on day 1, every 3 weeks for up to eight cycles. Results: Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank p = .014; median TTF, 25.6 v 23.7 weeks; log-rank P = .048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P = .009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P = .01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%). Conclusion: AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.
| Original language | English |
|---|---|
| Pages (from-to) | 968-975 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 21 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Mar 15 2003 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer : Results of a randomized, multicenter, phase III trial. / Nabholtz, Jean Marc; Falkson, Carla; Campos, Daniel; Szántó, J.; Martin, Miguel; Chan, Stephen; Pienkowski, Tadeuz; Zaluski, Jerzy; Pintér, T.; Krzakowski, Maciej; Vorobiof, Daniel; Leonard, Robert; Kennedy, Ian; Azli, Nacer; Murawsky, Michael; Riva, Alessandro; Pouillart, Pierre.
In: Journal of Clinical Oncology, Vol. 21, No. 6, 15.03.2003, p. 968-975.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer
T2 - Results of a randomized, multicenter, phase III trial
AU - Nabholtz, Jean Marc
AU - Falkson, Carla
AU - Campos, Daniel
AU - Szántó, J.
AU - Martin, Miguel
AU - Chan, Stephen
AU - Pienkowski, Tadeuz
AU - Zaluski, Jerzy
AU - Pintér, T.
AU - Krzakowski, Maciej
AU - Vorobiof, Daniel
AU - Leonard, Robert
AU - Kennedy, Ian
AU - Azli, Nacer
AU - Murawsky, Michael
AU - Riva, Alessandro
AU - Pouillart, Pierre
PY - 2003/3/15
Y1 - 2003/3/15
N2 - Purpose: This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC). Patients and Methods: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m 2 plus docetaxel 75 mg/m2 (n = 214) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (n = 215) on day 1, every 3 weeks for up to eight cycles. Results: Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank p = .014; median TTF, 25.6 v 23.7 weeks; log-rank P = .048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P = .009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P = .01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%). Conclusion: AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.
AB - Purpose: This randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC). Patients and Methods: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m 2 plus docetaxel 75 mg/m2 (n = 214) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (n = 215) on day 1, every 3 weeks for up to eight cycles. Results: Time to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank p = .014; median TTF, 25.6 v 23.7 weeks; log-rank P = .048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P = .009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P = .01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%). Conclusion: AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.
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U2 - 10.1200/JCO.2003.04.040
DO - 10.1200/JCO.2003.04.040
M3 - Article
VL - 21
SP - 968
EP - 975
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 6
ER -