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Breast Cancer Guidelines 

Breast Cancer Screening

Guidelines on breast cancer screening have been issued by the following organizations:

 

  • American Cancer Society (ACS)
  • U.S. Preventive Services Task Force (USPSTF)
  • American College of Obstetricians and Gynecologists (ACOG)

The guidelines differ in their recommendations regarding breast self-examination and clinical breast examination, use of screening mammography in women 40-49 years old, age at which to discontinue screening mammography, and MRI mammography. All three guidelines recommend routine screening mammography in asymptomatic, average-risk women aged 50 to 74, but differ with regard to frequency of screening.

American Cancer Society screening guidelines

The ACS updated its guidelines for breast cancer screening in average-risk women in October 2015. [1] At this time, the ACS is in the process of updating the breast cancer screening guidelines for women at high risk, which were last updated in 2007. [2]

Breast examination

It is acceptable for women to choose not to do breast self-examination (BSE) or to do BSE regularly (monthly) or irregularly. Beginning in their early 20s, women should be told about the benefits and limitations of BSE. Whether a woman ever performs BSE, the importance of prompt reporting of any new breast symptoms to a health professional should be emphasized. Women who choose to do BSE should receive instruction and have their technique reviewed on the occasion of a periodic health examination

The ACS does not recommend clinical breast examination for breast cancer screening in average-risk women at any age

Mammography

ACS recommendations are as follows:

  • Women should begin regular screening mammography at age 45 years (strong recommendation)
  • Women aged 45-54 years should be screened annually (qualified recommendation)
  • Women 55 years and older should transition to biennial screening or have the opportunity to continue screening annually (qualified recommendation)
  • Women should have the opportunity to begin annual screening at 40-44 years  of age (qualified recommendation)
  • Women should continue screening mammography as long as their overall health is good and they have a life expectancy of 10 years or longer (qualified recommendation)

Breast MRI Screening as an Adjunct to Mammography

The ACS recommends annual MRI screening, based on evidence from nonrandomized screening trials and observational studies, in women with the following risk factors [3] :

  • BRCA mutation
  • First-degree relative of BRCA carrier, but untested
  • Lifetime risk ∼20–25% or greater, as defined by BRCAPRO or other models that are largely dependent on family history

The ACS recommends annual MRI screening, based on expert consensus opinion that considers evidence of lifetime risk for breast cancer, in women with the following risk factors [3] :

  • Radiation to chest between age 10 and 30 years
  • Li-Fraumeni syndrome and first-degree relatives
  • Cowden and Bannayan-Riley-Ruvalcaba syndromes and first-degree relatives with those syndromes

The ACS found insufficient evidence to recommend for or against MRI screening in women with the following risk factors:

  • Lifetime risk 15–20%, as defined by BRCAPRO or other models that are largely dependent on family history
  • Lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia (ALH)
  • Atypical ductal hyperplasia (ADH)
  • Heterogeneously or extremely dense breast on mammography
  • Personal history of breast cancer, including ductal carcinoma in situ (DCIS)

The ACS recommends against MRI screening (based on expert consensus opinion) in women at <15% lifetime risk.

Finally, the ACS advises that screening decisions should be made on a case-by-case basis, as there may be particular factors to support MRI. Payment should not be a barrier.

USPSTF screening guidelines

The USPSTF is in the process of updating its breast cancer screening recommendation. The current recommendations date from 2009. [4]

Breast examination recommendations are as follows:

  • No requirement for clinicians to teach women how to perform BSE (Grade D recommendation)
  • Insufficient current evidence to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older

Screening mammography recommendaitons are as follows:

  • No requirement for routine screening mammography in women aged 40 to 49 years (Grade C recommendation); the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient's values regarding specific benefits and harms
  • Biennial screening mammography for women between the ages of 50 and 74 years (Grade B recommendation)
  • Insufficient current evidence to assess the additional benefits and harms of screening mammography in women 75 years or older
  • Insufficient current evidence to assess the additional benefits and harms of either digital mammography or MRI instead of film mammography as a screening modality for breast cancer

BCRA-related cancer

In 2013, the USPSTF issued updated guidelines on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women. The current USPSTF recommendations are as follows [5] :

  • Women who have family members with breast, ovarian, tubal, or peritoneal cancer should be screened to identify a family history that may be associated with an increased risk for mutations in the breast cancer susceptibility genes BRCA1 or BRCA2
  • Women who have positive screening results should receive genetic counseling and then BRCA testing if warranted
  • Women without a family history associated with an increased risk for mutations should not receive routine genetic counseling or BRCA testing

ACOG screening guidelines

The ACOG released its current guidelines in 2011. [3]

Breast examination

Breast self-awareness should be encouraged and can include breast self-examination; women should report any changes in their breasts to their health care providers

  • For women aged 20–39 years, clinical breast examinations are recommended every 1–3 years.
  • For women aged 40 years and older, clinical breast examination should be performed annually

Mammography

Women should be educated on the predictive value of screening mammography and the potential for false-positive results and false-negative results; women should be informed of the potential for additional imaging or biopsies that may be recommended based on screening results

  • Women aged 40 years and older be offered screening mammography annually
  • Biennial screening may be a more appropriate or acceptable strategy to some women, and recommends the screening strategy should therefore be determined based on the patient's individual risk and values.
  • Breast magnetic resonance imaging (MRI) is not recommended for screening women at average risk of developing breast cancer
  • Women who are estimated to have a lifetime risk of breast cancer of 20% or greater, based on risk models that rely largely on family history (such as BRCAPRO, BODACEA, or Claus), but who are either untested or test negative for BRCA gene mutations, can be offered enhanced screening
  • For women who test positive for BRCA1 and BRCA2 mutations, enhanced screening should be recommended and risk reduction methods discussed

Pharmacologic Interventions for Breast Cancer Risk Reduction

Guidelines for pharmacologic intervention in women who are at increased risk for breast cancer, but do not have a personal history of breast cancer, have been issued by the American Society of Clinical Oncology (ASCO) [6] and the U.S. Preventive Services Task Force (USPSTF). [7] The guidelines differ in their classification of increased risk and in their inclusion of women with lobular carcinoma in situ (LCIS).

American Society of Clinical Oncology

ASCO has updated its practice guidelines regarding pharmacologic intervention (eg, tamoxifen, raloxifene, and aromatase inhibitors) for breast cancer risk reduction. [6]

ASCO guidelines recommend the following [6] :

  • For premenopausal or postmenopausal women with increased risk for breast cancer, offer tamoxifen (20 mg/day for 5 years) to reduce the risk of invasive ER-positive breast cancer
  • In postmenopausal women, raloxifene (60 mg/day for 5 years) may also be considered
  • Off-label use of exemestane (25 mg/day for 5 years) should be discussed as an alternative to reduce the risk in postmenopausal women
  • All three agents should be discussed (including risks and benefits) with women aged 35 years or older without a personal history of breast cancer who are at increased risk of developing invasive breast cancer

ASCO guidelines recommend that discussions with patients and health care providers should include both the risks and benefits of pharmacologic breast cancer risk reduction in the preventive setting.

Tamoxifen

ASCO guidelines recommend that use of tamoxifen, 20 mg per day orally for 5 years, should be discussed as an option to reduce the risk of invasive breast cancer (BC), specifically ER-positive BC, in women 35 years of age or older who are premenopausal or postmenopausal and have a 5-year projected absolute breast cancer risk ≥ 1.66% or with LCIS. Risk reduction benefit continues for at least 10 years.

ASCO guidelines advise that tamoxifen not be used in the following cases:

  • In women with a history of deep vein thrombosis, pulmonary embolus, stroke, or transient ischemic attack or during prolonged immobilization
  • In combination with hormone therapy
  • In women who are pregnant, may become pregnant, or are nursing mothers

Raloxifene

ASCO guidelines recommend that raloxifene should be discussed as an option to reduce the risk of invasive BC, specifically ER-positive BC, in postmenopausal women who are age ≥ 35 years with a 5-year projected absolute BC risk ≥ 1.66% or with LCIS. Raloxifene is given in a dosage of 60 mg/ day orally for 5 years; it can be used for longer than 5 years in women with osteoporosis, in whom BC risk reduction is a secondary benefit.

ASCO guidelines advise that raloxifene not be used in the following cases:

  • For BC risk reduction in premenopausal women
  • In women with a history of deep vein thrombosis, pulmonary embolus, stroke, or transient ischemic attack or during prolonged immobilization

Exemestane

Exemestane is not FDA approved for breast cancer risk reduction. However, ASCO guidelines recommend that it should be discussed as an alternative to tamoxifen and/or raloxifene to reduce the risk of invasive BC, specifically ER-positive BC, in postmenopausal women age ≥ 35 years with a 5-year projected absolute BC risk ≥ 1.66% or with LCIS or atypical hyperplasia. It should not be used for BC risk reduction in premenopausal women. Exemestane is given in a dosage of 25 mg per day orally for 5 years.

USPSTF guidelines

The USPSTF updated its guidelines for primary breast cancer risk reduction in 2013. [7] The USPSTF recommends that clinicians engage in shared, informed decision making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene.

The USPSTF concluded that women with an estimated 5-year risk of 3% or greater are, on the basis of model estimates (specifically, the Freedman risk-benefit tables for women aged 50 years or older), more likely to benefit from tamoxifen or raloxifene.

Lymph Node Biopsy and Dissection

Guidelines for sentinel lymph node biopsy and axillary lymph node dissection (ALND) have been issued by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).

American Society of Clinical Oncology

A 2014 update on sentinel lymph node biopsy for patients with early-stage breast cancer by ASCO advises that sentinel lymph node biopsy may be offered to the following patients [8] :

  • Women with operable breast cancer and multicentric tumors
  • Women with DCIS who will be undergoing mastectomy
  • Women who previously underwent breast and/or axillary surgery
  • Women who received preoperative/neoadjuvant systemic therapy

According to the ASCO guidelines, sentinel lymph node biopsy should not be performed in patients with any of the following:

  • Large or locally advanced invasive breast cancer (tumor size T3/T4)
  • Inflammatory breast cancer
  • DCIS (when breast-conserving surgery is planned)
  • Pregnancy

ASCO recommendations regarding ALND in patients who have undergone sentinel lymph node biopsy are as follows:

  • ALND should not be performed in women with no sentinel lymph node (SLN) metastases
  • In most cases, ALND should not be performed in women with one to two metastatic SLNs who are planning to undergo breast-conserving surgery with whole-breast radiotherapy
  • ALND should be offered to women with SLN metastases who will be undergoing mastectomy

National Comprehensive Cancer Network

The 2016 NCCN guidelines recommend that SLNB should be performed and is the preferred method of axillary lymph node staging if the patient is an appropriate candidate for SLNB. [9] Candidates include patients with clinical stage I, IIA, IIB, and IIIA T3, N1, M0 who are clinically node negative at the time of diagnosis, as well as those who are clinically node positive but have negative results on fine needle aspiration or core biopsy.

The NCCN recommends axillary dissection level I/II if the sentinel node is not identified or if the sentinel node is positive but the patient fails to meet all the following criteria:

  • T1 or T2 tumor
  • Only one or two positive sentinel lymph nodes
  • Breast-conserving therapy
  • Whole-breast radiation therapy planned
  • No preoperative chemotherapy

If the patient does meet all those criteria, the NCCN recommends against further axillary surgery. In addition, no further axillary surgery is a category 1 recommendation for patients with a negative sentinal lymph node. The NCCN guidelines also state that lymph node dissection is optional in the following cases:

  • Strongly favorable tumors
  • When no result would affect the choice of adjuvant systemic therapy
  • Elderly patients
  • Patients with comorbid conditions

Finally, for patients with clinically negative axillae who are undergoing mastectomy and for whom radiation therapy is planned, the NCCN states that axillary radiation may replace axillary dissection level I/II for regional control of disease. [9]

Lumpectomy Margins

The following consensus guideline, released by the Society of Surgical Oncology and the American Society for Radiation Oncology, addresses margins for breast-conserving surgery with whole-breast irradiation (WBI) in stages I and II invasive breast cancer [10] :

  • Positive margins are associated with at least a two-fold increase in ipsilateral breast tumor recurrence (IBTR)
  • Negative margins optimize IBTR; this risk is not significantly lowered by wider margin widths
  • IBTR rates are reduced with the use of systemic therapy; in patients who do not receive adjuvant systemic therapy, margins wider than no ink on tumor are not needed
  • Biologic subtypes do not indicate the need for margins wider than no ink on tumor
  • Margin width should not determine the choice of WBI delivery technique, fractionation, and boost dose
  • Wider negative margins than no ink on tumor are not indicated for patients with invasive lobular cancer; classic lobular carcinoma in situ (LCIS) at the margin is not an indication for reexcision; the significance of pleomorphic LCIS at the margin is not clear
  • Young age is associated with an increased risk for IBTR after breast-conserving therapy, an increased risk for local relapse on the chest wall after mastectomy, and adverse biologic and pathologic features; an increased margin width does not nullify the increased risk for IBTR in young patients
  • An extensive intraductal component (EIC) identifies patients who may have a large residual ductal carcinoma in situ (DCIS) burden after lumpectomy; when margins are negative, there is no evidence of an association between an increased risk for IBTR and EIC

Radical Mastectomy

According to National Comprehensive Cancer Network (NCCN) guidelines, mastectomy with level I/II axillary lymph node dissection is the recommended procedure in patients who respond to neoadjuvant chemotherapy. Other NCCN indications for mastectomy include the following [9] :

  • Prior radiation therapy to the breast or chest wall
  • Radiation therapy contraindicated by pregnancy (except patients in the third trimester who can receive radiation postpartum)
  • Inflammatory breast cancer
  • Diffuse suspicious or malignant-appearing microcalcifications
  • Widespread disease that is multicentric, located in more than one quadrant, and cannot be removed through a single incision with negative margins
  • A positive pathologic margin after repeat re-excision and suboptimal cosmetic outcome

Relative indications for mastectomy include the following:

  • Active connective tissue disease involving skin (eg, scleroderma, lupus)
  • Tumors greater than 5 cm in diameter
  • Focally positive margin

Patients who are younger than 35 years of age or premenopausal with known BRCA1/2 mutations have an increased risk of local recurrence. Prophylactic bilateral mastectomy may be considered for risk reduction.

Postmastectomy Radiation Therapy

Clinical practice guidelines developed by the American Society of Clinical Oncology (ASCO), recommend that postmastectomy radiation therapy be performed according to the following criteria [11] :

  • Positive postmastectomy margins
  • Primary tumors >5 cm
  • Involvement of ≥4 lymph nodes

Patients with more than four positive lymph nodes should also undergo prophylactic nodal radiation therapy at doses of 45-50 Gy to the axillary and supraclavicular regions. For patients in whom ALND shows no node involvement, axillary radiation therapy is not recommended.

Treatment of HER2-Positive Breast Cancer

Evidence-based guidelines from the American Society of Clinical Oncology (ASCO) for treatment of HER2-positive breast cancer, which are largely adapted from the 2015 Cancer Care Ontario (CCO) clinical practice guidelines, are as follows [12, 13, 14] :

  • Trastuzumab plus chemotherapy is recommended for all patients with HER2-positive, node-positive breast cancer and for patients with HER2-positive, node-negative breast cancer with tumors >1 cm
  • Trastuzumab plus chemotherapy may be considered in small (≤1 cm), node-negative tumors in patients with HER2-positive T1a-b N0 disease
  • In high-risk HER2-positive disease, the recommended regimen is sequential anthracycline and taxanes given concurrently with trastuzumab; or docetaxel, carboplatin, and trastuzumab for six cycles
  • For lower-risk node-negative HER2-positive disease, an alternative regimen is paclitaxel and trastuzumab in combination once weekly for 12 weeks, with trastuzumab then given for 1 year
  • In patients with high-risk disease and when a taxane is contraindicated, the optimal dose of an anthracycline three-drug regimen that contains cyclophosphamide is recommended, with a cumulative dose of doxorubicin ≥240 mg/m² or epirubicin ≥600 mg/m², but no higher than 720 mg/m²; the cumulative dose of doxorubicin in two-drug regimens should not exceed 240 mg/m²
  • Docetaxel and cyclophosphamide for four cycles is an acceptable non-anthracycline regimen
  • For patients in whom anthracycline-taxane is contraindicated, cyclophosphamide-methotrexate-fluorouracil (with oral cyclophosphamide) is an acceptable chemotherapy alternative to doxorubicin-cyclophosphamide
  • Concurrent administration of trastuzumab with the anthracycline component of a chemotherapy regimen is not recommended because of the potential for increased cardiotoxicity, but trastuzumab should be preferentially administered concurrently (not sequentially) with a non-anthracycline chemotherapy regimen
  • Second-line treatment, for patients whose disease progresses during or after first-line treatment with HER2-targeted agents, is with ado-trastuzumab emtansine (T-DM1)
  • T-DM1 can be used as third-line treatment if the cancer progresses during or after second-line treatment, in patients who have not previously received the drug

Hormonal Adjuvant Therapy

The American Society of Clinical Oncology (ASCO) has issued an updated clinical practice guideline on adjuvant endocrine therapy for women with hormone receptor–positive breast cancer. The guideline includes the recommendation that women with stage I to III disease consider taking tamoxifen for 10 years. [15, 16]

For pre- or perimenopausal patients, ASCO recommends offering adjuvant endocrine therapy with tamoxifen for 5 years, after which the patient should receive additional therapy based on her menopausal status. If the patient is premenopausal, she should be offered continued tamoxifen for a total duration of 10 years. If the patient is postmenopausal, she should be offered continued tamoxifen for a total duration of 10 years or an aromatase inhibitor for a total duration of up to 10 years of adjuvant endocrine therapy. [15, 16]

Postmenopausal patients should be offered adjuvant endocrine therapy with one of the following treatments [15, 16] :

  • Tamoxifen for 10 years
  • An aromatase inhibitor for 5 years
  • Tamoxifen for 5 years, then switching to an aromatase inhibitor for up to 5 years
  • Tamoxifen for 2-3 years, then switching to an aromatase inhibitor for up to 5 years

Postmenopausal patients who are intolerant of either tamoxifen or an aromatase inhibitor should be offered an alternative adjuvant endocrine therapy. Patients who have received an aromatase inhibitor but discontinued treatment at less than 5 years may be offered tamoxifen for a total of 5 years. Patients who have received tamoxifen for 2-3 years should be offered an aromatase inhibitor for up to 5 years, for a total duration of up to 7-8 years of adjuvant endocrine therapy. [15, 16]

Follow up for Breast Cancer Survivors

The National Comprehensive Cancer Network (NCCN) [9] and the American Society of Clinical Oncology (ASCO) [17] have issued guidelines on followup care for breast cancer survivors. The guidelines differ principally in the timing of care. See the table below.

Table Follow-up Recommendations for Breast Cancer Survivors (Open Table in a new window)

 

NCCN

ASCO

History and physical examination

Year 1, every 3-4 mo



Year 2, every 4 mo



Year 3-5, every 6 mo



Year 6+, annually

Year 1-3, every 3-6 mo



Year 4-5, every 6-12 mo



Year 6+, annually

Breast self-examination

No recommendation

Counseled to perform monthly breast self-examination

Mammography

6 mo after post-BCS radiation therapy



Annually thereafter

6 mo after definitive radiation therapy



Every 6-12 mo for surveillance of abnormalities



Annually if stability of abnormalities is achieved

Pelvic examination

Annually, for women on tamoxifen



Annual exam if uterus present

Regular gynecologic follow-up



Patients on tamoxifen should be advised to report any vaginal bleeding

Routine blood tests

Not recommended

Not recommended

Imaging studies

Not recommended

Not recommended

Tumor marker testing

Not recommended

Not recommended

Use of Biomarkers to Guide Adjuvant Systemic Therapy

A guideline from the American Society of Clinical Oncology (ASCO) advises that the only biomarkers that can guide choices of specific treatment regimens in breast cancer are as follows:

  • Estrogen receptor (ER)
  • Progesterone receptor (PR)
  • Human epidermal growth factor receptor 2 (HER2)

ASCO recommendations regarding further biomarker use include the following:

  • The Oncotype DX 21-gene recurrence score may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with HER2-positive or triple-negative (ER,PR, HER2 negative) breast cancer
  • The EndoPredict 12-gene risk score may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The MammaPrint (Agendia) 70-gene assay should not be used in patients with triple-negative breast cancer; in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer; or in patients with HER2-positive breast cancer
  • PAM50 risk of recurrence score may be used, in combination with other clinicopathologic variables, in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The Breast Cancer Index may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The Mammostrat (Clarient) five-protein assay should not be used in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer or in patients with HER2-positive or triple-negative breast cancer.
  • Immunohistochemistry 4 may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with HER2-positive or triple-negative breast cancer
  • Urokinase plasminogen activator and plasminogen activator inhibitor type 1 may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, they should not be used in patients with HER2-positive breast cancer or triple-negative breast cancer
  • Circulating tumor cells should not be used to guide decisions on adjuvant systemic therapy
  • Tumor-infiltrating lymphocytes should not be used in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • Protein encoded by the MKI67 gene should not be used to guide the selection of adjuvant chemotherapy
  • CYP2D6 polymorphisms or p27 expression determined by immunohistochemistry should not be used to guide the selection of adjuvant tamoxifen
  • Protein encoded by the immunohistochemistry MKI67 gene labeling index should not be used to guide the selection of adjuvant aromatase inhibitors
  • For patients with ER/PR-positive, HER2-negative (node-negative) breast cancer who have had 5 yr of endocrine therapy without evidence of recurrence, clinicians should not use multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, or immunohistochemistry 4) to guide decisions on extended endocrine therapy
  • Clinicians should not use microtubule-associated protein Tau messenger (m)RNA expression or mRNA expression determined by immunohistochemistry or HER1/epidermal growth-factor receptor expression by immunohistochemistry to guide the selection of adjuvant taxanes
  • Clinicians should not use TOP2A gene amplification or TOP2A protein expression determined by immunohistochemistry and should not use HER2 and TOP2A gene coamplification, CEP17 duplication, TIMP-1, FOXP3, or p53 to guide the selection of adjuvant anthracyclines
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