Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer

D. Khayat, P. Chollet, E. C. Antoine, S. Monfardini, G. Ambrosini, A. Benhammouda, M. F. Mazen, R. Sorio, O. Borg-Olivier, A. Riva, C. Ramazeilles, N. Azli

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Abstract

Purpose: To evaluate the feasibility and efficacy of a sequential administration of four cycles of docetaxel (100 mg/m2 every 3 weeks) followed by four cycles of doxorubicin and cyclophosphamide (AC; 60/600 mg/m2 every 3 weeks), with subsequent consolidation with docetaxel or AC, as first-line chemotherapy in patients with metastatic breast cancer (MBC). Patients and Methods: Forty-eight patients received 443 cycles of chemotherapy (median, 11 cycles/patient; range, 1 to 13 cycles). A total of 267 cycles of docetaxel (60.3%) and 176 of AC (39.7%) were given. Consolidation therapy was given to 33 patients (29 with docetaxel). Results: Grade 4 neutropenia was the most frequent toxicity (83% of patients). This was not cumulative and was rarely complicated by febrile neutropenia or severe infection. The nonhematologic safety profile was favorable: there were no grade 4 adverse events, and grade 3 episodes were infrequent. Docetaxel-specific toxicities were generally not severe. With a median cumulative doxorubicin dose of 397 mg/m2 (range, 150 to 543 mg/m2), two incidences of unrelated congestive heart failure after further treatment with anthracyclines and two of asymptomatic left ventricular ejection fraction decrease were observed. Among the 42 assessable patients, five (12%) had complete and 25 (60%) had partial responses, for an overall response rate of 71% (95% confidence interval, 55% to 84%). Median duration of response was 53 weeks (range, 12 to 72 weeks), and median time to progression was 46 weeks (range, 3 of 72 weeks). With a median follow-up of 40.4 months, median survival was 32 months (range, 2 to 55 months). Conclusion: This docetaxel-based sequential schedule is safe and effective in first-line therapy for MBC, without incurring cumulative toxicity, and provides a feasible chemotherapeutic option in this clinical setting.

Original languageEnglish
Pages (from-to)3367-3375
Number of pages9
JournalJournal of Clinical Oncology
Volume19
Issue number14
Publication statusPublished - Jul 15 2001

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docetaxel
Doxorubicin
Cyclophosphamide
Breast Neoplasms
Drug Therapy
Febrile Neutropenia
Anthracyclines
Neutropenia
Stroke Volume
Appointments and Schedules
Therapeutics
Heart Failure

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Khayat, D., Chollet, P., Antoine, E. C., Monfardini, S., Ambrosini, G., Benhammouda, A., ... Azli, N. (2001). Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer. Journal of Clinical Oncology, 19(14), 3367-3375.

Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer. / Khayat, D.; Chollet, P.; Antoine, E. C.; Monfardini, S.; Ambrosini, G.; Benhammouda, A.; Mazen, M. F.; Sorio, R.; Borg-Olivier, O.; Riva, A.; Ramazeilles, C.; Azli, N.

In: Journal of Clinical Oncology, Vol. 19, No. 14, 15.07.2001, p. 3367-3375.

Research output: Contribution to journalArticle

Khayat, D, Chollet, P, Antoine, EC, Monfardini, S, Ambrosini, G, Benhammouda, A, Mazen, MF, Sorio, R, Borg-Olivier, O, Riva, A, Ramazeilles, C & Azli, N 2001, 'Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer', Journal of Clinical Oncology, vol. 19, no. 14, pp. 3367-3375.
Khayat, D. ; Chollet, P. ; Antoine, E. C. ; Monfardini, S. ; Ambrosini, G. ; Benhammouda, A. ; Mazen, M. F. ; Sorio, R. ; Borg-Olivier, O. ; Riva, A. ; Ramazeilles, C. ; Azli, N. / Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer. In: Journal of Clinical Oncology. 2001 ; Vol. 19, No. 14. pp. 3367-3375.
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abstract = "Purpose: To evaluate the feasibility and efficacy of a sequential administration of four cycles of docetaxel (100 mg/m2 every 3 weeks) followed by four cycles of doxorubicin and cyclophosphamide (AC; 60/600 mg/m2 every 3 weeks), with subsequent consolidation with docetaxel or AC, as first-line chemotherapy in patients with metastatic breast cancer (MBC). Patients and Methods: Forty-eight patients received 443 cycles of chemotherapy (median, 11 cycles/patient; range, 1 to 13 cycles). A total of 267 cycles of docetaxel (60.3{\%}) and 176 of AC (39.7{\%}) were given. Consolidation therapy was given to 33 patients (29 with docetaxel). Results: Grade 4 neutropenia was the most frequent toxicity (83{\%} of patients). This was not cumulative and was rarely complicated by febrile neutropenia or severe infection. The nonhematologic safety profile was favorable: there were no grade 4 adverse events, and grade 3 episodes were infrequent. Docetaxel-specific toxicities were generally not severe. With a median cumulative doxorubicin dose of 397 mg/m2 (range, 150 to 543 mg/m2), two incidences of unrelated congestive heart failure after further treatment with anthracyclines and two of asymptomatic left ventricular ejection fraction decrease were observed. Among the 42 assessable patients, five (12{\%}) had complete and 25 (60{\%}) had partial responses, for an overall response rate of 71{\%} (95{\%} confidence interval, 55{\%} to 84{\%}). Median duration of response was 53 weeks (range, 12 to 72 weeks), and median time to progression was 46 weeks (range, 3 of 72 weeks). With a median follow-up of 40.4 months, median survival was 32 months (range, 2 to 55 months). Conclusion: This docetaxel-based sequential schedule is safe and effective in first-line therapy for MBC, without incurring cumulative toxicity, and provides a feasible chemotherapeutic option in this clinical setting.",
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T1 - Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer

AU - Khayat, D.

AU - Chollet, P.

AU - Antoine, E. C.

AU - Monfardini, S.

AU - Ambrosini, G.

AU - Benhammouda, A.

AU - Mazen, M. F.

AU - Sorio, R.

AU - Borg-Olivier, O.

AU - Riva, A.

AU - Ramazeilles, C.

AU - Azli, N.

PY - 2001/7/15

Y1 - 2001/7/15

N2 - Purpose: To evaluate the feasibility and efficacy of a sequential administration of four cycles of docetaxel (100 mg/m2 every 3 weeks) followed by four cycles of doxorubicin and cyclophosphamide (AC; 60/600 mg/m2 every 3 weeks), with subsequent consolidation with docetaxel or AC, as first-line chemotherapy in patients with metastatic breast cancer (MBC). Patients and Methods: Forty-eight patients received 443 cycles of chemotherapy (median, 11 cycles/patient; range, 1 to 13 cycles). A total of 267 cycles of docetaxel (60.3%) and 176 of AC (39.7%) were given. Consolidation therapy was given to 33 patients (29 with docetaxel). Results: Grade 4 neutropenia was the most frequent toxicity (83% of patients). This was not cumulative and was rarely complicated by febrile neutropenia or severe infection. The nonhematologic safety profile was favorable: there were no grade 4 adverse events, and grade 3 episodes were infrequent. Docetaxel-specific toxicities were generally not severe. With a median cumulative doxorubicin dose of 397 mg/m2 (range, 150 to 543 mg/m2), two incidences of unrelated congestive heart failure after further treatment with anthracyclines and two of asymptomatic left ventricular ejection fraction decrease were observed. Among the 42 assessable patients, five (12%) had complete and 25 (60%) had partial responses, for an overall response rate of 71% (95% confidence interval, 55% to 84%). Median duration of response was 53 weeks (range, 12 to 72 weeks), and median time to progression was 46 weeks (range, 3 of 72 weeks). With a median follow-up of 40.4 months, median survival was 32 months (range, 2 to 55 months). Conclusion: This docetaxel-based sequential schedule is safe and effective in first-line therapy for MBC, without incurring cumulative toxicity, and provides a feasible chemotherapeutic option in this clinical setting.

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