title: Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance).
abstract: OBJECTIVE
  One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 × 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab.
  
  
  METHODS
  Patients (N = 443) with stage II to III TNBC received paclitaxel 80 mg/m(2) once per week (wP) for 12 weeks, followed by doxorubicin plus cyclophosphamide once every 2 weeks (ddAC) for four cycles, and were randomly assigned to concurrent carboplatin (area under curve 6) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles. Effects of adding these agents on pCR breast (ypT0/is), pCR breast/axilla (ypT0/isN0), treatment delivery, and toxicities were analyzed.
  
  
  RESULTS
  Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses, dose modification, or early discontinuation resulting from toxicity. Grade ≥ 3 neutropenia and thrombocytopenia were more common with carboplatin, as were hypertension, infection, thromboembolic events, bleeding, and postoperative complications with bevacizumab. Employing one-sided P values, addition of either carboplatin (60% v 44%; P = .0018) or bevacizumab (59% v 48%; P = .0089) significantly increased pCR breast, whereas only carboplatin (54% v 41%; P = .0029) significantly raised pCR breast/axilla. More-than-additive interactions between the two agents could not be demonstrated.
  
  
  CONCLUSIONS
  In stage II to III TNBC, addition of either carboplatin or bevacizumab to NACT increased pCR rates, but whether this will improve relapse-free or overall survival is unknown. Given results from recently reported adjuvant trials, further investigation of bevacizumab in this setting is unlikely, but the role of carboplatin could be evaluated in definitive studies, ideally limited to biologically defined patient subsets most likely to benefit from this agent.
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL. wsikov@wihri.org.
authors.forename: William M
authors.initials: WM
authors.lastname: Sikov
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Perou
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Baljit
authors.initials: B
authors.lastname: Singh
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Constance T
authors.initials: CT
authors.lastname: Cirrincione
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Sara M
authors.initials: SM
authors.lastname: Tolaney
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Kuzma
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Pluard
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: George
authors.initials: G
authors.lastname: Somlo
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Elisa R
authors.initials: ER
authors.lastname: Port
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Mehra
authors.initials: M
authors.lastname: Golshan
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Bellon
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Deborah
authors.initials: D
authors.lastname: Collyar
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Olwen M
authors.initials: OM
authors.lastname: Hahn
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Carey
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.affiliation: William M. Sikov, Miriam Hospital and Alpert Medical School of Brown University, Providence, RI; Donald A. Berry, University of Texas MD Anderson Cancer Center, Houston, TX; Charles M. Perou and Lisa A. Carey, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill; Constance T. Cirrincione, Alliance Statistical Center, Durham; Charles S. Kuzma, Southeast Cancer Control Consortium, Winston-Salem, NC; Baljit Singh, New York University Medical Center; Elisa R. Port, Mount Sinai Medical Center; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Sara M. Tolaney, Mehra Golshan, Jennifer R. Bellon, and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Timothy J. Pluard, Washington University-St Louis Medical Center, St Louis, MO; George Somlo, City of Hope Comprehensive Cancer Center, Duarte; Deborah Collyar, Patient Advocates in Research, Danville, CA; and Olwen M. Hahn, University of Chicago Medical Center, Chicago, IL.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D004317:Doxorubicin; D003520:Cyclophosphamide; D016190:Carboplatin; D017239:Paclitaxel
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