Improving breast cancer management with Xelodabased combinations

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Improving breast cancer management with
Xeloda-based combinations

• José Baselga
• Vall dHebron University HospitalBarcelona,
  Spain

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Xeloda combinations expanding options in the
management of breast cancer (BC)

• Xeloda is an essential component of BC treatment
• Phase III evidence in MBC shows that Xeloda
  extends survival in combination with Taxotere
  (XT)
• Xeloda is also an effective, well tolerated and
  convenient combination partner for
• paclitaxel (XP)
• vinorelbine (XN)
• Xeloda offers new options for tailored treatment
  in the metastatic and (neo)adjuvant settings

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XT is highly effective active management aids
tolerability
Patients ()
50 40 30 20 10 0
Grade 3 Grade 4 Grade 3 Grade 4
XT (n251)
Taxotere (n255)
Hand-foot syndrome
Fatigue/ asthenia
Diarrhoea
Stomatitis
Nausea
Neutropenic fever
OShaughnessy J et al. J Clin Oncol
200220281223
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Fewer grade 3/4 AEs after Taxotere and Xeloda
doses are both reduced
Cycles ()
20 16 12 8 4 0
Both full doses (670 cycles)X 1 250mg/m2 T
75mg/m2
Both reduced (405 cycles) X 1 000mg/m2 T 60mg/m2
Diarrhoea Stomatitis Hand-foot Neutropenic syn
drome fever
F. Hoffmann-La Roche, data on file
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XT dose reduction does not compromise efficacy
overall survival
Estimated probability
1.0 0.8 0.6 0.4 0.2 0.0
15.0
14.6
0 5 10 15 20 25 30 35 40 45 50
Months
F. Hoffmann-La Roche, data on file
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XP another front-line option for MBC
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XP consistently high activity in MBC
1Batista N et al. Br J Cancer 20049017406 2Gra
dishar W et al. J Clin Oncol 20042223217
CR complete response PR partial response
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Favourable safety profile of XP low incidence
of grade 3 / 4 AEs
Patients ()
60 50 40 30 20 10 0
Fatigue
Alopecia
Hand-footsyndrome
Peripheralneuropathy
Dyspnoea
Neutropenia
Paraesthesiae
1Batista N et al. Br J Cancer 200490174062Gra
dishar W et al. J Clin Oncol 20042223217
Not reported in European study
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XN another effective option for MBC
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XN consistently high activity in MBC
1Ghosn M et al. Proc Am Soc Clin Oncol 200322
(Abst 270)2Welt A et al. Breast Cancer Res Treat
200276S90 (Abst 336)3Stuart N et al. Proc Am
Soc Clin Oncol 20032246 (Abst 183) 4Ahn J et
al. Proc Am Soc Clin Oncol 20032254 (Abst
216)5Sambiasi D et al. Ann Oncol 200213(Suppl.
5)56 (Abst 200)6Schott A et al. Breast Cancer
Res Treat 200276S91 (Abst 338) 7Estevez L et
al. Ann Oncol 200415(Suppl. 3)iii44 (Abst 166P)
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XN favourable tolerability confirmed
Patients ()
80 60 40 20 0
Alopecia
Nausea/vomiting
Hand-footsyndrome
Diarrhoea
Mucositis
Peripheralneuropathy
Constipation
Stuart N et al. Proc Am Soc Clin Oncol 20032246
(Abst 183)
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Xeloda moving forward as treatment for early
breast cancer
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Phase III trial XT versus AC as primary therapy
for early BC
RANDO MIS ATION
SURGERY
AC x 4 (60/600)
n125/209 Eligibility criteriaECOG PS 1 Stage
II/III BC Axillary lymph node involvement No
prior treatment
XT x 4 (1000/75)
Adjuvant
Primary
AC x 4 (60/600)
XT x 4 (1000/75)
A doxorubicin C cyclophosphamide T
Taxotere X Xeloda
Ahn J-B et al. Ann Oncol 200415(Suppl. 3)iii57
(Abst 215PD)
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XT highly effective versus AC
Ahn J-B et al. Ann Oncol 200415(Suppl. 3)iii57
(Abst 215PD)
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Low incidence of grade 3/4 AEs with neoadjuvant
XT versus AC
Patients ()
100 80 60 40 20 0
Neutropenia Vomiting Hand-foot Stomatitis synd
rome
Ahn J-B et al. Ann Oncol 200415(Suppl. 3)iii57
(Abst 215PD)
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ECTO II neoadjuvant study in ER BC
RANDO MISATION
CMF x 4 Cel
AP x 4
SURGERY
n210 Operable, tumour gt2cm ER or PR
CMX x 4 Cel
AP x 4
XT x 4 Cel
AC x 4
A doxorubicin P paclitaxel C
cyclophosphamide M methotrexate F 5-FU X
Xeloda T Taxotere Cel celecoxib
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Phase III registration study adjuvant XT
RANDO MIS ATION
T x 4100
AC x 4 60/600
US Oncology n1 400/2 400 Eligibility
criteriaN12N0 tumour gt2cmN0 ER / PR
XT x 4 825/75
AC x 4 60/600
Patients with ER or PR tumours willreceive
tamoxifen or anastrozole for 5 years
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Xeloda a highly effective backbone for
combination regimens

• In MBC, Xeloda is a highly effective and well
  tolerated combination partner for
• taxanes
• vinorelbine
• The addition of Xeloda to Taxotere extends
  survival in MBC
• XT is also effective and well tolerated in the
  neoadjuvant setting
• Ongoing and planned trials are further evaluating
  these effective combinations
• in the metastatic setting
• as (neo)adjuvant treatment