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Management of Stage IV Metastatic Breast Cancer in a Premenopausal Women

  • The recommended initial treatment regimen:
    • For premenopausal women with:
      • De novo stage IV ER-positive breast cancer is:
        • Endocrine therapy + ovarian ablation/suppression
  • With ovarian ablation / suppression:
    • The choice of endocrine therapy becomes similar to that of postmenopausal women and may include:
      • Tamoxifen or an aromatase inhibitor
  • New research focusing on the:
    • Cyclin-dependent kinase 4/6 inhibitors (CDK):
      • Is emerging in this setting as well:
        • And could be added to endocrine therapy with ovarian function suppression
  • Investigation began:
    • In the postmenopausal patient population
  • The PALOMA-1 trial:
    • Randomized postmenopausal women with advanced-stage, ER-positive, HER2-negative breast cancer to either:
      • Letrozole alone or letrozole in combination with palbociclib (CDKs 4 and 6 inhibitor):
        • Who had not received any systemic therapy
    • Median progression-free survival was:
      • 10.2 months versus 20.2 months:
        • In the letrozole group versus the palbociclib plus letrozole groups respectively:
          • p=0.0004
    • This phase 2 study:
      • Led to the FDA approval of palbociclib:
        • For treatment of postmenopausal women with ER-positive, HER2-negative:
          • Metastatic breast cancer
  • Phase 3 studies are ongoing:
    • However, the PALOMA-3 trial:
      • Randomized 521 women with ER-positive, HER2-negative metastatic breast cancer:
        • Who had progressed on prior endocrine therapy to:
          • Palbociclib plus fulvestrant or fulvestrant plus placebo
      • Median progression-free survival:
        • Was 9.5 months in those receiving fulvestrant plus palbociclib versus 4.6 months in those receiving fulvestrant plus placebo
          • p<0.0001
      • These data suggest an emerging role for CDK inhibitors:
        • In women with ER-positive, HER2-negative advanced disease
  • In the metastatic setting:
    • Neither radiation nor surgical resection of the primary tumor at diagnosis:
      • Have conclusively been shown to:
        • Improve overall survival
    • This question has been evaluated in several retrospective and large database series concluding optimistic results:
      • However:
        • These data are limited by significant selection bias
  • Two randomized controlled trials also address this question:
    • Badwe et al randomly assigned 350 patients with de novo stage IV breast cancer:
      • To receive locoregional therapy to the primary breast tumor and axilla or to no locoregional treatment
        • They stratified patients by:
          • Site of distant metastasis
          • Number of distant metastases
          • Hormone receptor status
      • Median overall survival was:
        • 19.2 months:
          • In those randomized to locoregional treatment and
        • 20.5 months:
          • In those in the no-locoregional treatment group
            • p=0.79
      • The investigators concluded:
        • There was no evidence that local treatment of the primary tumor:
          • Affects overall survival in patients with de novo stage IV disease who have responded chemotherapy
  • Second, Soran et al randomly assigned 274 women with treatment-naive stage IV breast cancer:
    • To local regional surgery plus systemic therapy versus systemic therapy alone
    • At a median follow-up of 40 months:
      • Overall survival was:
        • 46 months in the surgery group compared to only 36 months in the systemic therapy group
    • Unplanned subgroup analyses were performed:
      • And concluded overall survival was statistically higher in:
        • The surgery group than in the systemic therapy group in hormone receptor-positive, HER2-negative patients
          • HR: 0.64, p=0.01
        • In patients less than 55 years
          • HR 0.57, p = 0.006
        • In those with solitary bone-only metastasis
          • HR: 0.47, p = 0.04
    • The authors concluded:
      • There may be a benefit to locoregional surgery
  • In the US, E2108 is an ongoing randomized trial addressing this question as well
  • References:
    • Badwe R, Hawaldar R, Nair N, et al. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015;16(13):1380-1388.
    • National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines for Oncology: Breast Cancer. https://www.nccn.org/professionals/physician_gls/f_guidelines.asp Published January 2016. Accessed January 31, 2017.
    • Partridge AH, Rumble RB, Carey LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2014;32(29):3307-3329.
    • Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35.
    • Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425-439.
    • Atilla Soran, Vahit Ozmen, Serdar Ozbas, et al. A randomized controlled trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer: Turkish Study (Protocol MF07-01). J Clin Oncol. 2016;34(suppl; abstr 1005).

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The 21-Gene Recurrence Score Assay (Oncotype DX)

  • The 21-gene recurrence score assay (Oncotype DX):
    • Is a reverse-transcriptase-polymerase-chain-reaction assay of:
      • 16 prospectively selected genes and 5 reference genes
  • Analysis is performed in:
    • Paraffin-embedded tumor tissue
  • This assay was developed from:
    • NSABP B-14 and validated with data and specimens from NSABP B-20
  • It estimates the 10-year risk of distant recurrence:
    • By categorizing results into:
      • Low-risk (RS<18) group
      • Intermediate-risk (RS 18-30) group
      • High-risk (RS>30) group
  • A low recurrence score:
    • Predicts little benefit of chemotherapy
  • The 21-gene recurrence score assay is proven to be prognostic for women with:
    • Node-negative
    • ER-positive breast cancer:
      • Treated with tamoxifen
  • Retrospective data obtained via optional tumor banking:
    • In accordance with the SWOG 8814 trial:
      • Which demonstrated postmenopausal women with node-positive ER-positive tumors achieved:
        • Superior survival when cyclophosphamide, doxorubicin, and fluorouracil was given before tamoxifen
    • The SWOG 8814 trial:
      • Allowed for retrospective assessment of recurrence score on DFS by treatment group
      • Analysis demonstrated the recurrence score results:
        • To be both prognostic and predictive of benefit to adjuvant chemotherapy:
          • As there was no added benefit to adjuvant systemic chemotherapy:
            • In women with low recurrence scores and
            • An improvement of DFS:
              • In those with high recurrence scores
  • These hypothesis-generating results serve as preliminary basis:
    • For the RxPonder trial:
      • Which is currently enrolling as a phase III trial:
        • Randomizing women with hormone receptor-positive and HER2-negative breast cancer involving 1 to 3 lymph nodes and a 21-gene assay recurrence score of 25 or less:
          • To endocrine therapy alone versus chemotherapy followed by endocrine therapy
  • The 21-gene recurrence score:
    • Is not used in patients with HER2-positive breast cancer

REFERENCES

  1. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-2826.
  2. Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726-3734.
  3. Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.
  4. Ramsey SD, Barlow WE, Gonzalez-Angulo AM, et al. Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes. Contemp Clin Trials. 2013;34(1):1-9.

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Metatastatic HER2 Postive Breast Cancer

  • In patients with metastatic HER2-positive breast cancer:
    • The addition of pertuzumab to trastuzumab and chemotherapy:
      • Improves progression-free survival
  • The Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) trial:
    • Randomized:
      • 808 women with HER2-positive metastatic breast cancer:
        • To trastuzumab and docetaxel plus pertuzumab versus placebo
      • Median 50-month follow-up
      • Results:
        • The trastuzumab, docetaxel, pertuzumab arm:
          • Was associated with a 15.7-month improvement:
            • In median overall survival
          • A 6.3-month improvement:
            • In median progression-free survival:
        • Compared to the trastuzumab, docetaxel, placebo arm:
          • Single-agent trastuzumab:
            • Results in reduced efficacy and should only be reserved for patients:
              • Who elect to avoid chemotherapy or
              • For those whom are poor candidates for chemotherapy
  • Trastuzumab plus anthracyclines (doxorubicin):
    • Are effective:
      • But there is higher cardiotoxicity with this combination
  • BCIRG 007:
    • Showed that multi-agent chemotherapy plus trastuzumab:
      • Paclitaxel, carboplatin, and trastuzumab:
        • Does not increase overall survival:
          • Compared to single-agent chemotherapy:
            • With docetaxel plus trastuzumab in patients with metastatic HER2-positive breast cancer
  • References:
    • Baselga J, Cortes J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109-119.
    • Swain SM, Kim SB, Cortes J, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013;14(6):461-471.
    • Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372(8):724-734.
    • Valero V, Forbes J, Pegram MD, et al. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens. J Clin Oncol. 2011;29(2):149-156.

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What is the goal of preoperative chemotherapy in inflammatory breast cancer?

  • The major determinant of overall survival:
    • In patients with inflammatory breast cancer:
      • Is the high risk of metastatic disease
  • Use of preoperative therapy in this setting:
    • Is to target any micrometastatic disease
    • To improve operability and surgical margins
    • To to evaluate response to chemotherapy
  • Neoadjuvant chemotherapy, surgery, and radiation therapy:
    • Remains the standard of care for this disease
  • A modified radical mastectomy without reconstruction:
    • Is the preferred treatment in this patient population:
      • Breast-conserving surgery:
        • Should not be offered:
          • Regardless of response to treatment
  • References:
    • Perez CA, Fields JN, Fracasso PM, et al. Management of locally advanced carcinoma of the breast. II. Inflammatory carcinoma. Cancer. 1994;74(1 Suppl):466-476.
    • Rueth NM, Lin HY, Bedrosian I, et al. Underuse of trimodality treatment affects survival for patients with inflammatory breast cancer: an analysis of treatment and survival trends from the National Cancer Database. J Clin Oncol. 2014;32(19):2018-2024.

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Cirugia De La Tiroides

SÍNTOMAS

Los procedimientos quirúrgicos de la tiroides se indican para pacientes con una variedad de afecciones tiroideas, incluyendo nódulos tiroideos cancerosos y benignos (no cancerosos), glándulas tiroides grandes (bocios) y glándulas hiperactivas. Existen varios tipos de operaciones de tiroides que un cirujano puede realizar, incluyendo

1) Biopsia o extracción de un bulto- quitar una pequeña parte de la glándula tiroides. 2)Lobectomía– sacar la mitad de la glándula tiroides; 3)Quitar casi toda la glándula tiroides (tiroidectomía subtotal– cuando se deja una pequeña cantidad de tejido tiroideo en ambos lados o tiroidectomía casi-total– cuando se deja aproximadamente un gramo o centímetro de tejido tiroideo en un lado); o 4) Tiroidectomía total, en la cual se elimina todo el tejido tiroideo identificable. Existen indicaciones específicas para cada una de estas operaciones. El principal riesgo de una operación de la tiroides incluye el posible daño a estructuras anatómicas cercanas a la misma, principalmente las glándulas paratiroides (que regulan los niveles de calcio) y los nervios de la laringe recurrentes y externos (que controlan las cuerdas vocales).

Cuando se recomienda cirugía de la tiroides, los pacientes deben hacer varias preguntas en relación con las operaciones de tiroides, incluyendo:

(1) ¿Por qué necesito una operación?
(2)¿Existen otras alternativas de tratamiento?
(3)¿Qué tipo de evaluación necesito antes de mi operación?
(4) ¿Cómo selecciono al cirujano?
(5) ¿Cuáles son los riesgos de la operación?
(6) ¿Qué porción de mi glándula tiroides se debe sacar?
(7) ¿Qué puedo esperar una vez que decida proceder con la cirugía?
(8) ¿Quedaré normal después de la cirugía? ¿Por qué necesito una operación?

El motivo más frecuente por el que los pacientes necesitan cirugía de la tiroides es después de la evaluación de un nódulo tiroideo, lo cual generalmente incluye una punción con aguja fina.

Puede recomendársele cirugía por cualquiera de los siguientes resultados de la punción:

(1) Cáncer (cáncer papilar);

(2) Posible cáncer (neoplasia folicular); o

(3) Benigno.

Se le puede recomendar cirugía por nódulos con punción benigna si el nódulo es grande, si continúa creciendo o si está causando síntomas (dolor, dificultad para tragar, etc). La cirugía también es una opción de tratamiento para el hipertiroidismo para bocios grandes y multinodulares y para cualquier bocio que este causando síntomas.

21-Gene Recurrence Score (Oncotype Dx)

  • Both tamoxifen and aromatase inhibitors:
    • Have been shown to:
      • Reduce recurrence rates and improve survival in postmenopausal women
  • Although chemotherapy has been shown to be beneficial in many patient subsets:
    • The 21-gene recurrence score was developed:
      • To help ascertain which patients with:
        • ER-positive, node-negative breast cancer:
          • Would be most likely to benefit from chemotherapy in addition to adjuvant tamoxifen
  • In patients with an intermediate recurrence score:
    • The benefit of chemotherapy is unclear
  • The Trial Assigning IndividuaLized Options for Treatment (Rx) [TAILORx] trial:
    • Is a randomized prospective trial:
      • That randomized women with ER-positive breast cancer:
        • With a score of 11 to 25 to:
          • Chemotherapy plus endocrine therapy to endocrine therapy alone
    • This trial is closed to accrual, and the results of this trial for this cohort are pending:
      • However:
        • Outcomes data from a subset of 1626 patients with a recurrence score of less than 10:
          • Were recently published
        • These patients were assigned to:
          • Receive endocrine therapy alone without chemotherapy
        • This study reported a 5-year local recurrence rate of:
          • 0.5% in women with a recurrence score of:
            • Less than 10
        • Furthermore:
          • At 5 years:
            • The invasive disease–free survival was:
              • 93.8%
            • The rate of freedom from recurrence of breast cancer at a distant site was:
              • 99.3%
            • At distant or local site was:
              • 98.7%
            • Overall survival rate of:
              • 98%
    • The authors concluded that a favorable gene expression profile:
      • Is associated with a very low rate of recurrence:
        • At 5 years with endocrine therapy alone
  • References:
    • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), Dowsett M, Forbes JF, et al. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001):1341-1352.
    • Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373(21):2005-2014.

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Which endocrine therapy regimen would result in highest (or best) disease-free survival in a 32 year old women one year out from a pT2, pN1, ER positive, HER2 negative invasive ductal carcinoma of the right breast?

  • The Tamoxifen and Exemestane Trial (TEXT) and the Suppression of Ovarian Function Trial (SOFT):
    • Investigated adjuvant endocrine therapies:
      • For premenopausal women:
        • With hormone receptor-positive breast cancer
  • Randomizing women to:
    • Exemestane plus ovarian function suppression (OFS)
    • Tamoxifen plus OFS
    • Tamoxifen alone:
      • For 5 years
  • The studies were combined for primary analysis:
    • After enrolling:
      • 4690 patients
    • After a median follow-up of:
      • 68 months:
        • DFS was:
          • 91.1% in the exemestane-ovarian suppression arm versus
          • 87.3% in the tamoxifen-ovarian suppression arm
            • p<0.001
    • Overall survival:
      • Did not differ between the groups
    • Adverse events were reported for:
      • 30.6% of exemestane-ovarian suppression patients and
      • 29.4% of tamoxifen-ovarian suppression group
  • Women on an aromatase inhibitor or who experience ovarian failure secondary to treatment:
    • Should have monitoring of bone health:
      • With a bone mineral density scan:
        • At baseline and periodically thereafter
  • The use of estrogen, progesterone, or selective ER modulators:
    • To treat osteoporosis or osteopenia in women with breast cancer:
      • Is discouraged
    • The use of a bisphosphonate:
    • Is generally the preferred intervention:
      • To improve bone mineral density
        • Optimal duration of bisphosphonate therapy:
          • Has not been established:
            • Factors to consider for duration of anti-osteoporosis therapy include:
              • Bone mineral density
              • Response to therapy
              • Risk factors for continued bone loss or fracture
    • Women treated with a bisphosphonate:
      • Should undergo a dental examination with preventive dentistry prior to the initiation of therapy, and
      • Should take supplemental calcium and vitamin D
  • References:
    • Pagani O, Regan MM, Walley BA, et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014;371(2):107-118.
    • Wilkinson GS, Kuo Y-F, Freeman JL, Goodwin JS. Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: a population-based analysis. J Natl Cancer Inst. 2007;99(13):1016-1024.
    • Regan MM, Francis PA, Pagani O, et al. Absolute benefit of adjuvant endocrine therapies for premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer: TEXT and SOFT Trials. J Clin Oncol. 2016;34(19):2221-2231.

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Pathologic Complete Response to Preoperative Systemic Therapy in Triple Negative Breast Cancer

  • Pathologic complete response to preoperative systemic therapy:
    • Is associated with a favorable:
      • Disease-free survival:
        • Particularly in situations in which all treatment:
          • Is given preoperatively
  • The collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) group:
    • Reviewed 12 international trials:
      • With 11,955 patients:
        • To evaluate the rates of pCR among patients receiving neoadjuvant chemotherapy:
          • According to their tumor subtype
    • Patients with hormone receptor positive, HER2 negative tumors:
      • Experienced pCR:
        • In only 7.5% of cases
    • While the greatest rate of pCR:
      • Was seen in those with HER2 positive tumors:
        • Receiving anti-HER2 therapy:
          • pCR of 50%
    • Pathologic complete response:
      • Occurred in 34% women:
        • With triple negative cancers
  • Unfortunately:
    • The achievement of pCR in locally advanced TNBC:
      • Is not a reliable predictor:
        • Of better overall survival
  • The triple negative phenotype:
    • Is more likely to be associated with BRCA1 mutations and therefore:
      • Current NCCN guidelines recommend:
        • Genetic testing:
          • For women younger than 60 who have triple negative breast cancer
    • There are no compelling data at present:
      • That the triple negative phenotype precludes breast-conserving therapy:
        • In fact, one recent study:
          • Found the 5-year rate of locoregional recurrence (LRR) to be similar:
            • Among those having:
              • Breast conserving surgery (4.2%) and
              • Mastectomy (5.4%)
    • Further, the authors found no significant difference:
      • In LRR, distant metastasis, overall recurrence, disease-free survival, or overall survival
  • The accuracy of clinical examinations, mammogram, ultrasound, and MRI:
    • Can be used to predict the presence of disease on final pathology:
      • But none are able to reliably predict a pCR
  • References:
    • von Minckwitz G, Untch M, Blohmer JU, et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012;30(15):1796-1804.
    • Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164-172.
    • Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008;26(8):1275-1281.
    • Symmans WF, Peintinger F, Hatzis C, et al. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol. 2007;25(28):4414-4422.
    • Zumsteg ZS, Morrow M, Arnold B, et al. Breast-conserving therapy achieves locoregional outcomes comparable to mastectomy in women with T1-2N0 triple-negative breast cancer. Ann Surg Oncol. 2013;20(11):3469-3476.

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Hypofractionated Whole Breast Irradiation (WBI) in Breast Conserving Surgery

  • Hypofractionated WBI continues to increase in its utilization with several regimens available including:
    • The Canadian regimen (42.5 Gy/16 fractions) and 
    • Various UK regimens
  • Ten-year data are now available:
    • With a local recurrence rate of 7% from the Canadian regimen 
    • And no difference in local recurrence or toxicity:
      • Compared with standard fractionation
  • Similar results have been seen with the:
    • UK Standardisation of Breast Radiotherapy (START) A and B trials:
      • Which have found no difference in local recurrence:
        • With fewer treatments and higher doses per treatment compared to standard fractionation
      • The START-B trial:
        • Randomized 2215 women to 40 Gy in 15 fractions or standard 50 Gy in 25 fractions:
        • The 10-year local-regional relapse rate:
          • Was 4.3% for the 40 Gy group and 5.5% for the 50 Gy group
        • Breast shrinkage, telangiectasia, and breast edema:
          • Were significantly less common in the 40 Gy group than in the 50 Gy group
  • In the Canadian trials:
    • 24% of patients were younger than age 50 years
    • 31% had tumors greater than 3 cm
    • 26% were ER-negative
    • 18% had high-grade tumors
    • 42% received tamoxifen
    • 11% received adjuvant systemic therapy of:
      • Cyclophosphamide, methotrexate, and fluorouracil as the standard chemotherapy
  • In the START-A trial:
    • 51% had tumors less than 2 cm
    • 29% of patients had positive lymph nodes
    • Only 35% of patients in this trial received adjuvant systemic therapy
  • Collectively, the hypofractionation trials represent:
    • A more diverse, higher-risk patient population in an era without the benefits of modern systemic therapy
    • This may explain the relatively higher rates of local failure when compared to the accelerated partial breast irradiation group
  • References:
    • Haviland JS, Owen JR, Dewar JA, et al; START Trialists’ Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment early stage breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013;14:1086-1094.
    • Whelan TJ, Pignol JP, Levine MN, et al. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010;362:513-520.

Canadian Trial

  • A multi-institution, prospective randomized trial:
    • From participating Cancer Care Ontario centers:
      • Was performed from 1993 to 1996
  • The aim of the study sought to determine:
    • Whether accelerated, hypofractionation whole-breast irradiation (WBI) was as effective as the traditional 5-week schedule
  • Included in the study were women:
    • Who received (BCS) for invasive breast cancer with clear surgical margins and negative axillary nodes
  • Participants were randomly assigned:
    • To receive WBI either at the standard dose:
      • Of 50.0 Gy in 25 fractions over 35 days (control group), or
    • At a dose of 42.5 Gy in 16 fractions over 22 days (hypofractionated-radiation group)
  • The control group included 612 patients and the hypofractionation group had 622 patients
  • Results from this study:
    • Indicated that the Canadian regimen:
      • Was not inferior to the standard 5-week treatment regimen for women who received BCS for invasive breast cancer with clear surgical margins and negative axillary nodes
    • The risk of local recurrence at 10 years was:
      • 6.7% in the control group and 6.2% in the hypofractionated group
    • Cosmesis at 10 years was found to be:
      • Comparable between the two groups:
        • With good or excellent outcomes:
          • For 71.3% of women in the control group and 69.8% in the hypofractionated-radiation group
    • There was also no difference between the two groups in:
      • OS and no increase in cardiac-related deaths was seen in the hypofractionated group

REFERENCES

  1. Whelan TJ, Pignol J-P, Levine MN, et al. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010;362:513-520.

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