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Lighting the way ahead: novel approaches to breast cancer treatment with Xeloda. Miguel Martin Hospital Universitario San Carlos Madrid, Spain. Novel treatment approaches with Xeloda. Metastatic breast cancer Sequential monotherapy All-oral regimens Novel schedules of administration

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Lighting the way ahead: novel approaches to breast cancer treatment with Xeloda

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Lighting the way ahead novel approaches to breast cancer treatment with xeloda
Lighting the way ahead:novel approaches to breast cancer treatment with Xeloda

Miguel Martin

Hospital Universitario San CarlosMadrid, Spain


Novel treatment approaches with xeloda
Novel treatment approaches with Xeloda

Metastatic breast cancer

  • Sequential monotherapy

  • All-oral regimens

  • Novel schedules of administration

    Adjuvant/neoadjuvant trials

  • Combined with taxanes and anthracyclines

  • Replacing anthracyclines in adjuvant treatment

  • Maintenance chemotherapy post adjuvant

  • Elderly patients


Mosg study design first line xeloda and taxanes in combination and sequence
MOSG study design: first-line Xeloda and taxanes in combination and sequence

RANDOMI

ZAT

ION

n=345

XT: Xeloda 825mg/m2 b.i.d., d1–14Taxotere 75mg/m2 on day 1, q21d (n=71)

XP: Xeloda 825mg/m2 b.i.d., d1–14paclitaxel 175mg/m2 on day 1, q21d (n=73)

docetaxel 100mg/m2q3w (n=21)

Xeloda1250mg/m2 b.i.d.d1–14, q21d (n=62)

PD

paclitaxel 175mg/m2q3w (n=4)

PD = disease progression

MOSG = Mexican Oncology Study Group

Torrecillas L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S200 (Abst 5048)


Patient characteristics baseline metastases
Patient characteristics: combination and sequencebaseline metastases

Torrecillas L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S200 (Abst 5048)


First line xeloda highly effective in combination and sequence with taxanes
First-line Xeloda: highly effective in combination and sequence with taxanes

*Includes only responses achieved after Xeloda monotherapy†Time to PD on Xeloda if no further treatment given or time to PD on sequential taxane treatment

Torrecillas L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S200 (Abst 5048)


Proposed cascade study evaluating xeloda in sequence with a taxane in first line mbc
Proposed CASCADE study evaluating Xeloda in sequence with a taxane in first-line MBC

3-weekly docetaxel 60–100mg/m2

or

weekly paclitaxel 80mg/m2

Xeloda1250mg/m2 b.i.d.d1–14, q21d

RANDO MIZATION

PD

n=700

1st-line MBC:

HER2-negative

³12 months, post adjuvant treatment

3-weekly docetaxel 100mg/m2

or

weekly paclitaxel 80mg/m2

Xeloda1250 or 1000mg/m2b.i.d., d1–14, q21d

PD

  • Primary endpoint: time to second-line treatment failure (PD, death, withdrawal for any reason)


All oral regimens
All-oral regimens taxane in first-line MBC


Phase i ii trials investigating xeloda in all oral combinations
Phase I/II trials investigating Xeloda taxane in first-line MBC in all-oral combinations

1Findlay MP et al. Proc Am Soc Clin Oncol 2002;21:85b (Abst 2151)

2Chan S-C et al. Proc Am Soc Clin Oncol 2002;21:53b (Abst 2023)

3Nole F. Eur J Cancer 2003;1(Suppl. 5):S174 (Abst 575)

4Delacambre C et al. Ann Oncol 2004;15(Suppl. 3):iii42 (Abst 158P)


Cyclox2 phase ii new zealand study evaluating xeloda plus oral cyclophosphamide in mbc
CYCLOX2: phase II New Zealand study evaluating taxane in first-line MBCXeloda plus oral cyclophosphamide in MBC

RANDO MI

ZATION

Xeloda 665mg/m2 b.i.d.continuously +

oral cyclophosphamide 100mg/m2d1–14, q28d

n=80

£1 prior regimen for advanced breast cancer

Prior adjuvant chemotherapy allowed

Xeloda 665mg/m2 b.i.d. continuously

  • Primary endpoint: response rate


Novel schedules of administration
Novel schedules of administration taxane in first-line MBC


Building upon experience in colorectal cancer with alternative schedules
Building upon experience in colorectal cancer with alternative schedules

  • Standard Xeloda dosing: 1250mg/m2 b.i.d. d1–14, q21d, selected over continuous administration

    • favorable safety and TTP1

    • small sample size (<40 patients in each arm)

    • applicable to breast cancer?

  • Alternative schedules evaluated in colorectal cancer

    • fixed daily dose of Xeloda (750 or 1000mg/m2 b.i.d., continuous administration) is feasible and well tolerated2

1Van Cutsem E et al. J Clin Oncol 2000;18:1337–45

2Lokich J et al. Cancer Invest 2004;22:713–7


Spanish phase ii trial continuous versus standard xeloda
Spanish phase II trial: alternative schedulescontinuous versus standard Xeloda

RANDO MIZATION

n=80

(initial phase)

Xeloda 1250mg/m2 b.i.d.

d1–14, q3w (standard arm)

MBC

HER-2 negative

up to 2 prior lines

Xeloda 800mg/m2 b.i.d.

d1–21, q3w (continuous arm)

  • Primary endpoint: incidence of HFS (H1: 50% vs 35%)

  • Secondary endpoints: RR, TTP

  • Similar dose intensities and cumulative doses



Intensive ongoing evaluation of xeloda as primary systemic therapy pst for bc
Intensive ongoing evaluation of Xeloda (N=21as primary systemic therapy (PST) for BC


Geparquattro german cooperative group neoadjuvant study
GEPARQUATTRO: German cooperative group neoadjuvant study (N=21

  • Primary endpoint: 5-year disease-free survival

  • Herceptin given concomitantly in HER-2 positive patients for eight or 12 cycles (and up to 1 year postoperatively)

n=1600

RANDO MIZATION

T100 x4

24 weeks

EC x4

24 weeks

T75/X1800x4

T75 x4

36 weeks

X1800 x4


Mindact optimizing decision making for adjuvant chemotherapy
MINDACT: optimizing decision-making (N=21for adjuvant chemotherapy

1st randomization

Assess clinical and genomic risk

Clinical and

genomic

BOTH HIGH RISK

DISCORDANTclinical and

genomic risks

Clinical and

genomic

BOTH LOW RISK

RANDOMIZE

decision-making

Use clinical risk

Use genomic risk

High risk

High risk

Low risk

Low risk

Chemotherapy

No chemotherapy

MINDACT = Microarray In Node Negative Disease May Avoid Chemotherapy


Adjuvant xt as a replacement for anthracycline based chemotherapy
Adjuvant XT as a replacement for anthracycline-based chemotherapy

2nd randomization

High-risk patients

RANDOMIZE

type of chemotherapy

Anthracycline based treatment

Xeloda/Taxotere (XT)


Geicam ciboma trial maintenance xeloda after adjuvant chemotherapy
GEICAM- chemotherapyCIBOMA trial: maintenance Xeloda after adjuvant chemotherapy

RANDO MIZATION

Xeloda

1000mg/m2 d1–14q3w x 8 cycles

n=3538

Operable breast cancer

Node+

ER/PR–

Completed six cycles

adjuvant anthracycline-based chemotherapy

Observation

  • Primary endpoint: 5-year disease-free survival (DFS); 14.18% relative increase (59.77–64.30%; HR 0.8582)


Ongoing trials evaluating xeloda as adjuvant treatment for elderly patients
Ongoing trials evaluating Xeloda as adjuvant treatment for elderly patients

XN = Xeloda plus vinorelbine


Xeloda improving the management of breast cancer through novel approaches
Xeloda: improving the management of breast cancer through novel approaches

  • As a highly effective and well-tolerated agent, Xeloda is enabling new treatment approaches for both metastatic and early breast cancer

  • Novel approaches under investigation will provide further options for tailoring treatment and improving outcomes


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