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The profile and challenges of managing breast cancer in developing countries

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Title: The profile and challenges of managing breast cancer in developing countries


1
The profile and challenges of managing breast
cancer in developing countries
  • Dana Lucia Stanculeanu ,MD,PhD
  • Romania

2
ROMANIAin SE of Europe
3
Present
  • - In Romania are only two Oncology Institutes -
    Bucharest and Cluj- Napoca (south-east and west
    regions of the country).
  • Each of the 42 counties has an oncology network
    with Oncology offices and Oncology departments ,
    depending on economical potential of the region.
  • In 1998 it was created the National Insurance
    House supposed to support all expenses related
    by citizens health.
  • A National Oncology Program for prevention,
    diagnoses and treatment was validated by
    government .

4
Problem 1
  • National Cancer Registry
  • - existed till 1989
  • - since 1989 statistic data was collected
    through 2 sources National Statistic Center and
    Statistic Center of MoH
  • - there are many differences between the
    reality and the registered data

5
Problem 2
  • Romania a developing country ,with financial
    problems including the health system
  • The decrease of active population that can pay
    health insurance
  • Lack of consistent private alternative health
    insurance which can be in competition with
    National Insurance House thus resulting in a
    dysfunctional health system in Romania

6
Effects
  • Not enough funds for health and for Oncology
    Program because of
  • Economic alternatives
  • Under financing of real need of resources because
    errors in registration data for Oncology thus
    resulting in
  • Physicians being forced to focus on treatment of
    existing cases, most in advanced stages and
    diminishing possibility on early diagnosis and
    prevention

7
Breast cancer in Romaniaepidemiology
  • Cancer the second death cause after
    cardiovascular diseases
  • Breast cancer in Romania first death caused
    through cancer at women
  • Increasing incidence from 1981- 24,61/ooo
    inhabitants to 41,29ooo inhabitants in 1999.
  • In Romania most of cases are diagnosed in
    advanced stages
  • stage III - 41,32 stage IV - 17,16
  • In The Oncology Institute of Bucharest in 1998
    stage III was at 68,85 and stage IV was at
    8,48
  • The breast cancer mortality has grown in 1999
    being of 25,31ooo inhabitants in comparison
    with standard world mortality for breast cancer (
    11,52ooo inhabitants )and European standard
    mortality for breast cancer (16,00ooo
    inhabitants)

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Patient at first visit in Oncology Institute
Bucharest
13
Patient at first visit in Oncology Institute
Bucharest
14
Patient at first visit in Oncology Institute
Bucharest
15
Patient at first visit in Oncology Institute
Bucharest
16
Patient at first visit in Oncology Institute
Bucharest
17
Why in this stage?
  • Lack of educational programs for population
  • Difficult access to information
  • Lack of support from media channels in promoting
    screening programs with free access and promoting
    witch-doctors, healers
  • Errors in the health system operations
  • Low socio-economic level

18
Despite of these, patients are treated !
  • In Romania, therapeutic judgment is established
    by The Committee of therapeutic indication
    (Surgeon, Medical Oncologist , Radiotherapist,
    Pathologist)
  • The treatment choice is made in accordance with
    therapeutic guidelines , individualized for each
    patient.
  • The therapeutic guidelines are inspired by
    European guidelines (ESMO guidelines)
  • The main difficulty is created by an under
    financed program that may create the
    impossibility to make a treatment according with
    therapeutic guidelines.

19
The evolution of surgical treatment for breast
cancer
Conservative treatment
Modify radical mastectomy
Radical mastectomy (Halsted)
2001
20
The surgery of breast cancer today
  • The conservative treatment
  • Sentinel lymph node biopsy
  • Techniques of modify radical mastectomy
  • Breast reconstruction
  • Laparoscopic ovarian ablation

21
The conservative treatment in I and II stage
Limited surgery ? Radiotherapy
? Systemic treatment
or Radiotherapy ? Systemic treatment
or Systemic treatment ? Radiotherapy ? Limited
surgery
22
Because the most cases are advanced stage at
diagnosis in Romania ? mastectomy
  • Radical mastectomies( Halsted surgery) are
    not indicated and are replaced with modified
    radical mastectomy
  • Madden technique
  • Patey technique
  • Professor Chiricutas technique
  • IOB technique (Trestioreanu, Balanescu, Pitaru)

23
Radiotherapy after surgery
  • Radiotherapy after limited surgical resection
    gives additional problems for Radiotherapist
    compared with radiotherapy after radical
    mastectomy .
  • It is more difficult in case of radiotherapy
    after limited surgical resection because of young
    patients with small tumours , without lymph nodes
    who choose a more esthetic operation and this
    result must not be affected through irradiation.
  • The risk of local recurrence ,of excessive
    irradiation, of critical organs (heart, lung) and
    the risk of survival reduction is real when the
    the irradiation is not homogenous, under right
    dose or not appropriate to the clinical stage of
    the disease

24
Objectives followed
  • Identify the patients with high risk of heart
    toxicity(patients with left breast tumor)
  • Development of techniques which allow the
    improvement of local control through Radiotherapy
    and reducing side effects
  • Reducing risk of excessive irradiation of the
    heart through an homogenous and correct
    irradiation of the breast

25
Reason for using new irradiation technique
-advantages
  • The heart and lung irradiated volumes are reduces
    through
  • Three-dimensional planning usage, CT assisted
  • The calculation of absorbed dose in the volume
    not in plan, which provides an accurate image of
    the irradiation of critical organs

26
New irradiation techniques used in Romania
  • Radiotherapy modulated by intensity
  • - allows the tumour irradiation with a high and
    homogenous dose without irradiation of healthy
    organs near the tumour
  • Three-dimensional new method of stimulating the
    treatment plan (surface, CT assisted)
  • With CT assistance we can have the possibility
    to reconstruct a three-dimensional image starting
    from multiple two dimensional images

27
New irradiation techniques used in Romania
  • RT three-dimensional conformational
  • Which now allow Romanian Radiotherapists to use
    a bigger number of fascicules, fields with forms
    in accordance with target volume, fascicules
    which are not in the same plan.

28
RT an useful treatment way in association with
limited resection in early stage of the breast
cancer
  • RT- decreases the risk of mortality related to
    breast cancer (influenced by age and prognostic
    factors) overall benefit 0,8- 4,1 (EBCTCG)
  • - but increases with 0,8- 5,6 the risk of
    mortality by cardiologic cause

29
  • Using RMI ,the dose at heart level is
    significantly reduced ,without affecting the
    planned tumor volume .
  • Through RMI, the dose of collateral breast level
    can be maintained at an acceptable level .
  • Selection of cases which allow the reduction of
    dose at heart level in the moment of making
    treatment plan, depending on tumor localization,
    and the establishment of an accurate criteria
    for the application of this method .
  • These techniques are successfully used in The
    Oncology Institute of Bucharest .

30
The systemic treatment of breast cancer in
Romania
  • New treatment options with curative intention
    were identified, even for local advanced breast
    cancer.
  • The systemic therapy , neoadjuvant and adjuvant,
    with statistically proofs in favour of cure,
    free-disease survival and an overall survival are
    also used in Romania.
  • The systemic therapy is individualized for each
    patient depending on the prognostic factors.

31
A. Chemotherapy
  • Historic
  • 1950 first clinical trial (not utilized )
  • 1960 first modern clinical trial clinic
  • 1969 Cooper regime (CMFVP), first utilization
    with results in breast cancer resistant at
    hormonal therapy.
  • 1970 adjuvant chemotherapy become standard
    treatment in metastasis in breast cancer (MBC),
    N
  • 1976 Bonadonna regime recognized as standard for
    MBC, N
  • 1980 It is extended in breast cancer N-
    treatment
  • 1980 antracyclines introduced in the treatment
    regime
  • 1990 taxanes and vinorelbine start to be used
  • 1999 new molecules (Capecitabina, Trastuzumab)
  • 2000 very promising novel targeted therapy
    (e.g.Iressa)

32
  • Adjuvant chemotherapy in Romania
  • These regimes that used anthracyclines produced a
    significant improvement
  • of overall survival and decreasing of overall
    mortality especially at patients N (20-25
    reduction of mortality )
  • Most utilized regimens were CAF/CEF
  • Intensified dose and chemotherapy with high doses
  • Epirubicin seems to be the most appropriate
    anthracyclinic antibiotic for intensification
    and increasing dose .
  • Increasing dose of epiubicin permits the
    improvement of overall survival .
  • Chemotherapy with high doses and with stem cell
    support is exclusively reserved to clinical
    trials (not used yet in Romania).

33
  • Adjuvant chemotherapy
  • Taxanes use
  • Existent clinical data does not permit the
    establishment of final recommendation regarding
    their place in the improvement of survival at
    patients with breast cancer N.
  • For cases with breast cancer N- ,the taxanes
    are utilized only in clinical trials.
  • New direction in chemotherapy
  • The modality of integration of taxanes in
    adjuvant treatment.
  • Integration of the new drugs has shown efficacy
    in treatment of advanced breast cancer
    (Trastuzumab, Capecitabin)

34
Neoadjuvant Chemotherapy
  • Utilized at least with the same efficacy results
    as adjuvant chemotherapy , regarding overall
    survival and free-disease survival.
  • Main advantage potential reduction of size of
    primary tumour and increasing numbers of
    conservative treatments.
  • Can be a test of chemo-sensitivity in
    vivoallowing the individualization of the
    chemotherapy regimes after surgery.
  • The usage of taxanes in neoadjuvant treatment is
    under evaluation

35
Chemotherapy in metastatic breast cancer treatment
  • Even if it was introduced since 1950 ,
    chemotherapy in metastatic breast cancer
    treatment is a disputed subject in Romania as is
    in other countries.
  • There is a consensus regarding the modest value
    of this in increasing survival efficacy of
    salvation chemotherapy (2nd and 3rd lines)is low
    (RR 20, means overall survival lt10 months
    6-12 months).
  • For the most of the patients, the usage of more
    than 3 therapeutic lines is made with minimal
    benefits.
  • A whole serie of chemotherapy salvation regimes,
    in cases which resisted antrhaclynes, were tried,
    but none of them proved superior except the
    taxanes, especially Docetaxel

36
5. New molecules
  • Trastuzumab (Herceptin), first monoclonal
    antibody humanized recombined anti HER-2,proved a
    targeted action on the receptors HER-2,for
    HER2/neu, overexpressed in 25-36 of breast
    cancer .
  • It is under evaluation the combination
    TRASTUZUMAB TAXOTERE possible as adjuvant
    therapy for patients ER, HER2/neu (trial NSABP
    B31)
  • The effect of long term administration (1-2
    years) of TRASTUZUMAB after primary treatment
    (surgery and adjuvant chimiohormonotherapy ) is
    under evaluation -trial HERA
  • CAPECITABIN which has indication for breast
    cancer treatment chemo-resistant at taxanes and
    antracyclines
  • Expecting with maxim interest the clinical
    trials with a EGFR-TK inhibitor (IRESSA) ,knowing
    that EGFR are over expressed also in breast
    cancer tumours.

37
Romanian experience
  • In local advanced stages are used standard
    regimes, FEC/EC.
  • In selected cases are used regimes, with taxanes
    which in the majority of the cases lead to
    downstaging tumour and allow the surgery.
  • At patients with metastasis,especially hepatic
    metastasis, usage of taxanes represents first
    option when the budget allows this.
  • In Oncology Institut from Bucharest,only a small
    number of patients that fulfil the administration
    criteria beneficiated by Transtuzumab treatment
    ,with similar results reported by oncologycal
    publication.
  • Often , the Romanian Oncologist obtain incredible
    therapeutic results, taking into account that he
    can not assure constantly the same therapeutic
    regimes because of the budget limitations.

38
B. Hormonal therapy in Romania
  • Most utilized as first line therapy
    antiestrogens Tamoxifen, accessible from
    financial point of view, with good results
  • For patients with ER breast cancer,administratio
    n of this treatment is not depending by age or
    menopausal status,lymph nodes invasion , size of
    tumour.
  • Patients with ER- tumours dont beneficiate by
    this treatment,in this case they are not
    protected against risk of collateral breast
    cancer treatment.
  • For a more small number of postmenopausal
    patients with advanced breast cancer are used
    aromatase inhibitors as first line therapy
    (e.g.Anastrozole, Letrozol ),this being only
    financial restricted

39
Hormonal therapy in Romania
  • Postmenopausal patients with locally advance or
    metastatic breast cancer, ER receptor
  • - For an more small number of
    postmenopausal patients with advanced breast
    cancer are used non-steroidal aromatase
    inhibitors as first line therapy
    (e.g.Anastrozole, Letrozol),this being only
    financial restricted.
  • - For second line hormonal treatment first
    option are also the aromatase inhibitors
    (e.g.Anastrozole, Letrozole, Exemestane)

40
Ovarian ablation
  • Significant improvement of survival in
    premenopausal patients with breast cancer,
    independent of lymph node affecting status .
  • Ovarian suppression with LHRH analog (Goserelin)
    at premenopausal patients ER has similar
    benefits with chemotherapy in patients with not
    sever prognostic factors. In addition, this
    option if treatment is not associated with severe
    side effects of chemotherapy (alopecia, nausea,
    infection )
  • It is used at this type of patients in
    combination LHRHa Tamoxifen, with good results.
  • The clasic ovarian ablation has associated some
    disadvantages for patients
  • - Oophorectomy is associated with
    increased morbidity .The procedure is
    irreversible, even if the patient does or does
    not obtain any clinical benefit.It can be made
    laparoscopic with better results as classical
    techniques

41
  • New direction in hormonal therapy of breast
    cancer
  • Will be adopted and utilized in Romania also
    based on latest evidence data of important
    clinical trials for evaluation of
  • a) Adjuvant treatment
  • ATAC Anastrozole vs Tx vs Anastrozole Tx
  • FEMTA Femara vs Tx
  • TEAM Exemestane vs Tx
  • b)replacement of Tamoxifen
  • ARNO Tx 2 years 3 years Anastrozole vs Tx 5
    years
  • IBCSG 1898 2years Tx 3 years Letrozole vs 2
    years Letrozole 3years Tx
  • c)secvential treatment after 5 years of Tamoxifen
    treatment
  • USI 5 years Tx 5 years Letrozole vs placebo
    5 years
  • NSABP B-33

42
The most difficult problem in Romania in the
treatment of breast cancer hormonal therapy
  • -Often, for Oncologist, the testing of ER status
    is a real problem and the hormonal choice is
    forced limited only at Tamoxifen.
  • The economic barriers do not always allow to
    assure the continuity of the best option
    treatment .
  • For this reason , the clinician can be forced
    sometime to use some less efficient option (e.g.
    aminogluthetimide, progestatives)

43
Conclusions
  • The systemic therapy, neoadjuvant and adjuvant,
    individualized for each patient offer benefits
    regarding the overall survival.
  • Expected evaluation of new molecules , new
    associations
  • Hormonal therapy remains the key treatment of
    breast cancer.

44
Conclusions
  • Romanias integration in clinical trials can
    offer benefits for patients with breast cancer
  • The according of consultancy in prevention and
    screening will be helpful for the implication of
    non-government organizations
  • The possibility of Romanias including in UE can
    be a chance for economic re-launch and for a
    solid and efficient health system
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