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. 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:baseline 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


Phase i ii trials investigating xeloda in all oral combinations

Phase I/II trials investigating Xeloda 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 Xeloda 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


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:continuous 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 evaluation in the adjuvant treatment of early bc n 21 244

Intensive evaluation in the adjuvant treatment of early BC (N=21244)


Intensive ongoing evaluation of xeloda as primary systemic therapy pst for bc

Intensive ongoing evaluation of Xeloda as primary systemic therapy (PST) for BC


Geparquattro german cooperative group neoadjuvant study

GEPARQUATTRO: German cooperative group neoadjuvant study

  • 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 for 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-CIBOMA 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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