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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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Presentation Transcript
slide2

Recent CT evolutions of

Non Small Cell Lung Cancer

  • Arrival of new oralformulations
  • Development of multimodaltreatments
  • Development of chemotherapy for early stages
slide3

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

slide4

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

slide5

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

slide6

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

slide7

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

slide8

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

slide9

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

slide10

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

slide11

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