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Aggiornamenti scientifici di NAB-paclitaxel nel MBC in terapia di combinazione

Aggiornamenti scientifici di NAB-paclitaxel nel MBC in terapia di combinazione. Studi con Abraxane in combinazione con schedula settimanale: dati di efficacia e tollerabilità. Jackisch C et al., Breast Care (Basel). 2012 Apr;7(2):137-143.

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Aggiornamenti scientifici di NAB-paclitaxel nel MBC in terapia di combinazione

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  1. Aggiornamenti scientifici di NAB-paclitaxel nel MBC in terapia di combinazione

  2. Studi con Abraxane in combinazione con schedula settimanale: dati di efficacia e tollerabilità Jackisch C et al.,Breast Care (Basel). 2012 Apr;7(2):137-143

  3. Phase II Trial of Weekly NAB-paclitaxel in Combination With Gemcitabine in Patients With Metastatic Breast Cancer V. Roy, B. R. LaPlant, G. G. Gross, C. L. Bane, F. M. Palmieri, on behalf of the North Central Cancer Treatment Group Roy V et al. Ann Oncol. 2009;20(3):449-453.

  4. NAB-paclitaxel più gemcitabina: disegno dello studio This was an open-label, multicenter phase II study conducted through the North Central Cancer Treatment Group NAB-Paclitaxel 125 mg/m2Days 1 and 8 every 21 days Gemcitabine 1000 mg/m2Days 1 and 8 every 21 days IV, intravenous; MBC, metastatic breast cancer. Roy V et al. Ann Oncol. 2009;20(3):449-453.

  5. NAB-paclitaxel più gemcitabina: efficacia del trattamento di prima linea nelle donne con MBC a Overall confirmed response. CI, confidence interval;CR, complete response; MBC, metastatic breast cancer; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response. Roy V et al. Ann Oncol. 2009;20(3):449-453.

  6. Phase II Multicenter Trial of NAB-paclitaxel and Capecitabine in First-Line Treatment of Patients with Metastatic Breast Cancer Schwartzberg et al.Clin Breast Cancer. 2012 Apr;12(2):87-93

  7. NAB-paclitaxel e capecitabina: disegno dello studio Capecitabine 825 mg/m2 Orally bidDays 1-14 q3w NAB-paclitaxel 125 mg/m2 IV over 30 minDays 1 and 8 q3w without premedication Purpose: A single arm, multi-center phase II trial to determine efficacy of NAB-Paclitaxel + capecitabine as first line treatment of MBC patients (HER2-) • N = 50 • Patients with ECOG PS 0-2, HER2-, adequate organ function • Cycles of 21 days until disease progression or dose-limiting toxicity • Endpoints • Primary: ORR • Secondary: PFS, OS, safety bid, twice daily; IV, intravenous; MBC, metastatic breast cancer; q3w, every 3 weeks. Schwartzberg et al.Clin Breast Cancer. 2012 Apr;12(2):87-93

  8. NAB-paclitaxel e capecitabina: tassi di risposta CR, complete response; MBC, metastatic breast cancer; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease. Schwartzberg et al.Clin Breast Cancer. 2012 Apr;12(2):87-93

  9. NAB-paclitaxel e capecitabina: Progression Free Survival The red line indicates product limit estimate of survival curve and circles indicate a censored observation Schwartzberg et al.Clin Breast Cancer. 2012 Apr;12(2):87-93

  10. NAB-paclitaxel e capecitabina: Overall Survival The red line indicates product limit estimate of survival curve and circles indicate a censored observation

  11. NAB-paclitaxel e lapatinibnel MBC HER2+: risultati

  12. NAB-paclitaxel e lapatinib nel MBC HER2+: risultati

  13. STUDIO GOIM NAB-paclitaxel e Capecitabina in MBC

  14. Capecitabina 825 mg/m2 Orale 2 volte al giorno GG 1-14 q3w nab paclitaxel 150 mg/m2 IV in 30 minGG 1 e 8 q3w senza premedicazione STUDIO GOIM - NAB-paclitaxel e capecitabina in MBC - Disegnodello studio A MULTICENTER PHASE II TRIAL OF NAB-PACLITAXEL AND CAPECITABINE AS FIRST LINE TREATMENT IN HER-2 NEGATIVE METASTATIC BREAST CANCER (MBC) • N = fino a 94 • Pazienti con ECOG PS 0-1, HER2-, inclusi TN, adeguata funzionalità d’organo • 6 cicli (+ 2 a discrezione del clinico) • Endpoints • Primario: ORR, PFS • Secondari: OS, safety EUDRACT 000393-35 bid, twice daily; IV, intravenous; MBC, metastatic breast cancer; q3w, every 3 weeks.

  15. Phase II Trial of Weekly NAB-paclitaxel With Carboplatin and Trastuzumab as First-Line Therapy for Women With HER2-Overexpressing Metastatic Breast Cancer K. Conlin, A. D. Seidman, A. Bach, D. Lake, M. Dickler, G. D’Andrea, T. Traina, M. Danso, A. M. Brufsky, M. Saleh, A. Clawson, C. A. Hudis Conlin AK et al. Clin Breast Cancer. 2010;10(4):281-287.

  16. NAB-paclitaxel, carboplatino e trastuzumab nel MBC HER2+: schema terapeutico AUC, area under the curve; HER2, human epidermal growth factor receptor2; MBC, metastatic breast cancer; wk, week. Conlin AK et al. Clin Breast Cancer. 2010;10(4):281-287.

  17. NAB-paclitaxel, carboplatino e trastuzumab nel MBC HER2+: risultati di efficacia Median response duration: 17.8 months (95% CI, 15.9-37.0) Median PFS: 16.6 months (95% CI, 7.5-26.5) Thirty-two patients treated Seventeen treated solely on original regimen Three switched from original to revised regimen Twelve treated only on revised regimen CI, confidence interval; CR, complete response; HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; ORR, overall response rate; PR, partial response; SD, stable disease. Conlin AK et al. Clin Breast Cancer. 2010;10(4):281-287.

  18. Conclusioni • NAB-paclitaxel viene impiegato oggi con schedula trisettimanale (260 mg/m2), ma le evidenze attualmente disponibili giustificano il suo impiego anche in somministrazione settimanale (150, 125, 100 mg/m2 ) • La scelta della schedula deve essere guidata dalle terapie precedenti per la malattia metastatica, dalle condizioni generali della paziente e dall’eventuale combinazione con altri farmaci (chemioterapici e/o biologici)* • I dati clinici supportano il trattamento con NAB-paclitaxel in MBC dalla 1° linea in poi, anche per le pz pre-trattate con taxani in adiuvante, ricadute o refrattarie • La neuropatia sensoriale, che si manifesta in genere tardivamente nel corso del trattamento con NAB-paclitaxel, può essere gestita con riduzione/interruzione di dose e migliora rapidamente * Le linee-guida tedesche dell’AGO (Working Group on Breast Cancer) raccomandano la CT con singolo agente se il paziente progredisce lentamente e non soffre di sintomi considerevoli e di metastasi acute che ne minacciano la sopravvivenza

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