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NON SMALL CELL LUNG CANCER

NON SMALL CELL LUNG CANCER. Recent CT evolutions of Non Small Cell Lung Cancer. Arrival of new oral formulations Development of multimodal treatments Development of chemotherapy for early stages. Role of chemotherapy in Non Small Cell Lung Cancer. STAGE III:

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NON SMALL CELL LUNG CANCER

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  1. NON SMALL CELL LUNG CANCER

  2. Recent CT evolutions of Non Small Cell Lung Cancer • Arrival of new oralformulations • Development of multimodaltreatments • Development of chemotherapy for early stages

  3. Role of chemotherapy in Non Small Cell Lung Cancer • STAGE III: • Induction CT to optimize local radical treatment • preoperative CT • chemoradiation STAGE I, II: Adjuvant CT after complete resection STAGE IV: Palliative CT to enlarge survival and preserve QOL

  4. Which CT in metastatic Non Small Cell Lung Cancer? Patients’ population: Stage IV PS Comorbidities Need for QOL Age Fit for polyCT Fit for monoCT With CDDP Without CDDP Elderly pts

  5. NAVELBINE + CDDP Phase III studies * Comparator Reference NVB-CDDPVDS-CDDPLeChevalier NVB-CDDPCDDPWozniak TXL-CBDCANVB-CDDPKelly NVB-IFO-CDDPNVB-CDDPSouquet TXL-CBDCANVB-CDDPScagliotti GEM-CDDPNVB-CDDPScagliotti TXT-CDDPNVB-CDDPFossella GEM-CDDPNVB-CDDPGebbia GEM-CDDPNVB-CDDPMartoni 1994 1998 2001 2002 2002 2002 2003 2003 2003 * Endpoint: Median survival >: Significant improvement >: No significant improvement Le Chevalier, JCO 94; Wozniak, JCO 98 ; Kelly, JCO 01; Fossella, JCO 03 Scagliotti, JCO 02; Souquet, Annals 02; Gebbia, Lung Cancer 03 ; Martoni, ASCO 2003

  6. NVB weekly + CDDP Regimen OR MS Wozniak(n= 206) NVB25-CDDP100 26% 8 m 1-YS 36% LeChevalier(n= 206) NVB30-CDDP120 30% 9.3 m 33% Souquet(n= 133) NVB30-CDDP80 35% 10.3 m 38% Kelly(n= 202) NVB25-CDDP100 28% 8.1 m 36% Scagliotti(n= 201) NVB25-CDDP100 30% 9.5 m 37% Fossella(n= 404) NVB25-CDDP100 25% 10.1 m 41% Gebbia(n= 100) NVB25-CDDP100 34% - - NAVELBINE + CDDP Phase III studies Pujol(n= 156) NVB30-CDDP100 - 9.8 m 43% The reproducible efficacy of a never exceeded reference Wozniak, JCO 98; Le Chevalier, JCO 94; Souquet, Annals 02; Kelly, JCO 01; Scagliotti, JCO 02; Fossella, JCO 03 Gebbia, Lung Cancer 03 ; Pujol, IASLC 03

  7. NAVELBINE + CDDP: a new schedule Phase III studies NVB D1,D8 + CDDP Regimen OR MS 1-YS Kakolyris(n= 162) NVB30-CDDP80 38% 11.5 m 45% NVB30-CDDP80 32% - - Gebbia (n = 100) Martoni(n= 137) NVB25-CDDP75 31% 9 m - NAVELBINE D1,D8 + CDDP D1 every 3 weeks: The convenience of a new schedule with the efficacy of the reference. Kakolyris ASCO 02; Gebbia Lung Cancer 03; Martoni, ASCO 03

  8. TXT + GEM (n= 167) 32% 7 m 9 m 34.4% NAVELBINE + CDDP: a new schedule NAVELBINE30 mg/m2 D1, D8 CDDP80 mg/m2 D8 (+ G-CSF) Phase III study every 3 weeks Dose intensity: 90% (NVB) - 89% (CDDP) NVB + CDDP (n= 146) OR 38% ns TTP 8 m MS 11.5 m ns 1-YS 45.4% NAVELBINE + CDDP 3-week schedule: all the efficacy of NAVELBINE + CDDP Kakolyris, Poster ASCO 02

  9. NAVELBINE + CDDP: a new schedule IASLC 2003 NVB 25 weekly + CDDP 100 Q4w NVB 30 D1-D8 + CDDP 80 Q3w VS Phase III study n= 100 pts(study ongoing) Gebbia, Oral communication IASLC 03

  10. NAVELBINE + CDDP: a new schedule IASLC 2003 (p= 0.0058) (p= 0.047) NVB D1-D8 Q3w is an effective regimen and better tolerated than the weekly NVB-CDDP schedule Gebbia, Oral communication IASLC 03

  11. 4-week schedule 3-week schedule 25 - 35% 8 - 10.3 m 33 - 43% 31 - 38% 9 - 11.5 m 45% NAVELBINE + CDDP Phase III results OR MS 1-YS Optimal efficacy + Manageable tolerance profile + No cumulative toxicity Therapeutic benefit can be prolonged with NAVELBINE Le Chevalier, JCO 94; Wozniak, JCO 98; Kelly, JCO 01; Souquet, Ann. Oncol 02; Fossella, JCO 03; Scagliotti, JCO 02; Pujol, IASLC 03 3 week schedule: Martoni, ASCO 03; Kakolyris, ASCO 02; Gebbia, IASLC 03

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