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A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Malate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer.
Symonds, Lynn; Jenkins, Isaac; Linden, Hannah M; Kurland, Brenda; Gralow, Julie R; Gadi, Vijayakrishna V K; Ellis, Georgiana K; Wu, Qian; Rodler, Eve; Chalasani, Pavani; Chai, Xiaoyu; Riedel, Jinny; Stopeck, Alison; Brown-Glaberman, Ursa; Specht, Jennifer M.
Afiliação
  • Symonds L; Medical Oncology, University of Washington, Seattle, WA.
  • Jenkins I; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
  • Linden HM; Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
  • Kurland B; eResearch Technologies, Inc., Pittsburgh, PA.
  • Gralow JR; Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
  • Gadi VVK; Medical Oncology, University of Illinois Cancer Center, Chicago, IL.
  • Ellis GK; Medical Oncology, University of Washington, Seattle, WA.
  • Wu Q; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
  • Rodler E; Hematology and Oncology, University of California Davis, Sacramento, CA.
  • Chalasani P; Hematology and Oncology, University of Arizona Cancer Center, Tucson, AZ.
  • Chai X; Microsoft, Redmond, WA.
  • Riedel J; Clinical Cancer Genetics, Duke Cancer Institute, Durham, NC.
  • Scca Network Investigators; Seattle Cancer Care Alliance Network, Seattle, WA.
  • Stopeck A; Hematology and Oncology, Stony Brook University, Stony Brook, NY.
  • Brown-Glaberman U; Hematology and Oncology, University of New Mexico, Albuquerque, NM.
  • Specht JM; Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: jspecht@uw.edu.
Clin Breast Cancer ; 22(1): 32-42, 2022 01.
Article em En | MEDLINE | ID: mdl-34158245
ABSTRACT

INTRODUCTION:

Neoadjuvant chemotherapy is standard treatment for locally advanced breast cancer (LABC) or inflammatory breast cancer (IBC). We hypothesized that adding sunitinib, a tyrosine kinase inhibitor with antitumor and antiangiogenic activity, to an anthracycline and taxane regimen would improve pathologic complete response (pCR) rates to a prespecified endpoint of 45% in patients with HER2-negative LABC or IBC.

METHODS:

We conducted a multicenter, phase II trial of neoadjuvant sunitinib with paclitaxel (S+T) followed by doxorubicin and cyclophosphamide plus G-CSF for patients with HER2-negative LABC or IBC. Patients received sunitinib 25 mg PO daily with paclitaxel 80 mg/m2 IV weekly ×12 followed by doxorubicin 24 mg/m2 IV weekly + cyclophosphamide 60 mg/m2 PO daily with G-CSF support. Response was evaluated using pCR in the breast and the CPS + EG score (clinical-pathologic scoring + estrogen receptor [ER] and grade).

RESULTS:

Seventy patients enrolled, and 66 were evaluable for efficacy. Eighteen patients (27%) had pCR in the breast (10 had ER+ disease and 8 had triple-negative disease). When defining response as pCR and/or CPS + EG score ≤2, 31 (47%) were responders. In pateints with ER positive disease, 23 (64%) were responders. The most common toxicities were cytopenias and fatigue.

CONCLUSIONS:

Neoadjuvant S+T followed by AC+G-CSF was safe and tolerable in LABC and IBC. The study did not meet the prespecified endpoint for pCR; however, 47% were responders using pCR and/or CPS + EG score ≤2. ER positive patients had the highest response rate (64%). The addition of sunitinib to neoadjuvant chemotherapy may provide promising incremental benefit for patients with ER positive LABC.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Fator Estimulador de Colônias de Granulócitos / Terapia Neoadjuvante / Neoplasias Inflamatórias Mamárias / Sunitinibe Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Fator Estimulador de Colônias de Granulócitos / Terapia Neoadjuvante / Neoplasias Inflamatórias Mamárias / Sunitinibe Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2022 Tipo de documento: Article