Life-Threatening Sepsis Associated With Adjuvant Doxorubicin Plus Docetaxel for Intermediate-Risk Breast Cancer

摘要: ContextAdjuvant chemotherapy with new cytotoxic agents for breast cancer must be properly assessed toxicity.ObjectiveTo describe adverse events associated adjuvant for breast cancer, which led to premature termination of a clinical trial.Design, Setting, and PatientsWe conducted prospective randomized multicenter study (Reposant sur des Arguments Pronostiques et Predictifs [RAPP]-01) compare the effectiveness 2 regimens. Patients (women aged 18-70 years) had primary unilateral either moderate number positive axillary lymph nodes (≤3) or no positive axillary (N0), but were at high risk relapse. were treated 11 French cancer referral centers from June 1999 through January 2003. Primary prophylaxis for febrile neutropenia was not recommended in the protocol.InterventionsDoxorubicin, 50 mg/m2, plus docetaxel, 75 mg/m2, or doxorubicin, 60 cyclophosphamide, 600 given postoperatively 4 courses.Main Outcome MeasuresThe main end point disease-free survival rate 5 years, as estimated using Kaplan-Meier product limit method. Secondary points included safety, is focus this article, overall survival.ResultsA total 627 women enrolled. Median follow-up currently too short (24 months) analyze point. The trial terminated prematurely when deaths related drug toxicity 1 case perforative peritonitis occurred among patients neutropenia, all doxorubicin-docetaxel group. incidence significantly higher with the doxorubicin-docetaxel regimen (40.8%) than doxorubicin-cyclophosphamide regimen (7.1%) (P<.001).ConclusionsA life-threatening complications doxorubicin-docetaxel regimen found open-label controlled trial. doxorubicin-docetaxel combination should be considered as an alternative outside carefully designed studies that include neutropenia.