Your browser doesn't support javascript.
loading
Randomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance).
Sideras, Kostandinos; Hillman, David W; Giridhar, Karthik; Ginos, Brenda F; Tenglin, Richard C; Liu, Heshan; Chen, Beiyun; Tan, Winston; Gross, Gerald G; Mowat, Rex B; Dueck, Amylou C; Perez, Edith A; Moreno-Aspitia, Alvaro.
Afiliación
  • Sideras K; Mayo Clinic, Jacksonville, FL, USA.
  • Hillman DW; Mayo Clinic, Rochester, MN, USA.
  • Giridhar K; Mayo Clinic, Rochester, MN, USA.
  • Ginos BF; Mayo Clinic, Rochester, MN, USA.
  • Tenglin RC; Rapid City Regional Hospital, Rapid City, SD, USA.
  • Liu H; Mayo Clinic, Rochester, MN, USA.
  • Chen B; Mayo Clinic, Rochester, MN, USA.
  • Tan W; Mayo Clinic, Jacksonville, FL, USA.
  • Gross GG; Roger Maris Cancer Center, Fargo, ND, USA.
  • Mowat RB; Toledo Community Hospital Oncology Program, Toledo, OH, USA.
  • Dueck AC; Mayo Clinic, Rochester, MN, USA.
  • Perez EA; Mayo Clinic, Jacksonville, FL, USA.
  • Moreno-Aspitia A; Mayo Clinic, Jacksonville, FL, USA.
Oncologist ; 2022 Apr 21.
Article en En | MEDLINE | ID: mdl-35445723
BACKGROUND: Anthracycline use in metastatic breast cancer (MBC) is hindered by cumulative exposure limits and risk of cardiotoxicity. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone and anthracyclines, is theorized to exhibit less cardiotoxicity, mainly due to lack of iron binding. We conducted a randomized phase II study to evaluate the efficacy and safety of 2 dosing schedules of pixantrone in patients with refractory HER2-negative MBC. METHODS: Intravenous pixantrone was administered at 180 mg/m2 every 3 weeks (group A) versus 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle (group B). Primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), median 6-month PFS, overall survival (OS), safety, quality of life, and serial assessment of circulating tumor cells. A 20% ORR was targeted as sufficient for further testing of pixantrone in this patient population. RESULTS: Forty-five patients were evaluable, with 2 confirmed partial responses in group A and 1 in group B. The trial was terminated due to insufficient activity. Overall median PFS and OS were 2.8 (95% confidence interval [CI]: 2.0-4.1) and 16.8 (95% CI: 8.9-21.6) months, respectively. Notable overall grade 3-4 adverse events were the following: neutrophil count decrease (62%), fatigue (16%), and decrease in ejection fraction (EF) (4%). CONCLUSION: Pixantrone has insufficient activity in the second- and third-line MBC setting. It appears, however, to have limited cardiotoxicity. (ClinicalTrials.gov ID: NCT01086605).
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Aspecto: Patient_preference Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Aspecto: Patient_preference Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido