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Comprehensive Review of Navelbine,Navelbine,Oral navelbine vs. IV Navelbine Efficacy Quality of life Convenience Adjuvant chemotherapy with Navelbine Lace meta-analysis Navelbine in first line Histology Navelbine in maintenance therapy Navelbine in elderly Monotherapy,NAVELBINE ORAL,I.V. versus ORAL,25 mg/m I.V. versus 60 mg/m ORAL,30 mg/m I.V. versus 80 mg/m ORAL,Equivalent AUCs: I.V. ORAL 30 mg/m 80 mg/m 25 mg/m 60 mg/m,Marty, Ann. Oncol. 2001,NAVELBINE ORAL: for an improved convenience of treatment,1,10,100,1000,10000,0,12,24,36,Time (h),Blood Conc (ng/ml),1,10,100,1000,10000,0,12,24,36,Time (h),Blood Conc (ng/ml),NVB Oral: 60 mg/m/w x3 then 80 mg/m/w versus NVB I.V.: 30 mg/m/w Stage IIIB-IV PS 0-1 No history of malabsorption,Jassem, Ann Oncol 2001,NAVELBINE I.V. versus ORAL,RANDOMISED PHASE II STUDY,NAVELBINE I.V. versus ORAL,Jassem, Ann Oncol 2001,Single agent,NON-SMALL CELL LUNG CANCER - Single Agent Vinorelbine vs Supportive Care - - In Patients Age 70: A Prospective Randomized Trial -,Gridelli et al JNCI 1999, p = 0.04,NON-SMALL CELL LUNG CANCER - SWOG 95-09 Randomized Trial in 410 Patients -,Kelly J Clin Oncol 2001; Survival: 1 YR 36%/38%, 2 YR 15%/16%; Resp Rate: 28%/25%,NON-SMALL CELL LUNG CANCER - SWOG Randomized Trial: Quality of Life -,Kelly J Clin Oncol 2001. (N = 410). Baseline Compared with Week 25 (Using FACT-L),Evaluation of the impact on nursing and pharmacy staff resource and patient waiting time of a switch from IV to oral chemotherapy: a time and motion audit,Dr Henry Taylor Kent Oncology Centre,9,Cancer Services Collaborative, 31st October 2005,Capacity Planning,For each patient given IV chemotherapy: 4 patients could have been given oral chemotherapy by nursing staff 3 patients could have had their oral chemotherapy prepared by pharmacy,Unit: minute,Adjuvant Chemotherapy in NSCLC:,A new standard of care?,New Engl J Med 2004;350:351-60,4%,ASCO 2005 ANITA : OS,Adjuvant Chemotherapy Standard of Care,Good performance status patients with “R0” Anatomic Resection - Stages IIA-B - IIIA NSCLC - Maybe Larger IB ?,JCO 2008: LACE meta-analysis JTO 2010: LACE NAVELBINE meta-analysis,*LACE=Lung Adjuvant Cisplatin Evaluation *PORT= post-operative RT,Pignon, JCO 2008, Douillard, JTO 2010,Activity of a CDDP-based doublet in an adjuvant treatment,Specific input of NAVELBINE in a CDDP-based adjuvant treatment,NAVELBINE + cisplatin is the new standard of care as adjuvant treatment for NSCLC,Resectable NSCLC: Contribution of NVB I.V. + CDDP Should adjuvant CT be NVB+CDDP?,6,Survival (%),+5.3% with CDDP-based,+8.9% with NVB+CDDP,LACE Navelbine,Pignon, JCO 2008, Douillard, JTO 2010,Navelbine as first line in NSCLC,MEDIAN SURVIVAL (months),NAVELBINE I.V./ORAL - Cisplatin Experience,(n=118),(n=206),(n=206),(n=202),(n=201),(n=140),(n=250),(n=204),(n=404),(n=137),(n=190),Phase III trials - n 2000 patients,Le Chevalier Wozniak Kelly Scagliotti Fossella Gebbia Gebbia Georgoulias Martoni Douillard Ohe Tan 1994 1998 2001 2002 2003 2003 2005 2005 2005 2005 2007 2007,(n=145),NVB I.V./ORAL,1st line metastatic NSCLC NVB IV/Oral + Carbo experience,n= 912,(n=61),(n=75),(n=77),(n=83),(n=52),(n=150),(n=158),(n=156),MS (m),NVB IV/Oral,(n=44),(n=56),Parente Santomaggio Bretti Cremonesi Maguire Tan Helbekkmo Jensen* OBrien* Reck* 1997 1998 2001 2003 2003 2005 2007 2007 2004 2006,* Phase II trials,MS: 8m 12.3m,Phase III trial,Histology Matter of Navelbine,GLOB 3: Patients characteristics,Tan, Ann Oncol 2009,23,GLOB 3: Survival,NAVELBINE + CDDP versus docetaxel + CDDP: Similar OS,NVB TXT P-value MS (m) 9.92 9.82 0.668 95% CI 8.61 11.6 8.80 11.5 HAZARD RATIO 0.948 0.744 1.209,Tan, Ann Oncol 2009,Histology highlights in metastatic setting,GLOB 3: Adenocarcinoma outcome is improved by chemotherapies.,Tan, Ann Oncol 2009,CONCLUSION,Safety profile of Oral vinorelbine was qualitatively comparable to IV regimen. Oral vinorelbine (Navelbine) offers the convenience of an oral administration without interfering with the efficacy and the safety of the well-established IV vinorelbine Histology matter in Navelbine ?,Navelbine in Maintenance Therapy,27,1st line metastatic NSCLC - NAVELBINE Oral + CBDCA (1/2 - Reck),*after testing myelosensitivity at 60 mg/m/week at the first 3 administrations,High efficacy of NAVELBINE Oral reproducing NVB I.V. data,Reck, Lung Cancer 2009,28,NAVELBINE Oral + CBDCA (2/2 - Reck),The combination of NVB Oral + CBDCA “offers an active and safe regimen for patients with unresectable localized or metastatic NSCLC, for whom palliation coupled with optimal safety is the main end point.”,Reck, Lung Cancer 2009,Treatment of Special Populations: Elderly and PS2 patients,Randomized Trials in Elderly NSCLC,Trial Group Comment V vs BSC ELVIS Completed GV vs V SICOG Completed G vs V vs GV ITA-MILES Completed,Chemotherapy in Elderly Patients with Advanced NSCLC,13%,4.5,76 15%,Vinorelbine,30%*,7,76 22%,Gemcitabine + Vinorelbine,Frasci,14%,4.9,76 -,BSC,32%*,6.5,78 20%,Vinorelbine,Gridelli*,1 YR,MS (mo),N Response,Regimen,Author,*Gridelli, J Natl Cancer Inst 1999; 85:365-376. Frasci et al, Proc ASCO 2001, 19:A1895,* p0.05,The MILES Phase III Trial: Gemcitabine + Vinorelbine vs Vinorelbine and vs Gemcitabine in Elderly Advanced NSCLC Patients,NSCLC 70+ years old Chemotherapy nave Stage IIIB (N3 or pleural effusion) or IV PS 0-2,RANDOMI ZE,Gridellii et al.ASCO 2001 Abstract 1230,Vinorelbine 30 mg/m2 d1,8 Q 3 weeks,Gemcitabine 1000 mg/m2 d1,8 Vinorelbine 25 mg/m2 d1,8 Q 3 weeks,Gemcitabine 1200 mg/m2 d1,8 Q 3 weeks,Single Agent Chemotherapy in Elderly Patients with Advanced NSCLC,*Gridelli, J Natl Cancer Inst 1999; 85:365-