RESUMO
PURPOSE: To determine the 12-year risk of developing an ipsilateral breast event (IBE) for women with ductal carcinoma in situ (DCIS) of the breast treated with surgical excision (lumpectomy) without radiation. PATIENTS AND METHODS: A prospective clinical trial was performed for women with DCIS who were selected for low-risk clinical and pathologic characteristics. Patients were enrolled onto one of two study cohorts (not randomly assigned): cohort 1: low- or intermediate-grade DCIS, tumor size 2.5 cm or smaller (n = 561); or cohort 2: high-grade DCIS, tumor size 1 cm or smaller (n = 104). Protocol specifications included excision of the DCIS tumor with a minimum negative margin width of at least 3 mm. Tamoxifen (not randomly assigned) was given to 30% of the patients. An IBE was defined as local recurrence of DCIS or invasive carcinoma in the treated breast. Median follow-up time was 12.3 years. RESULTS: There were 99 IBEs, of which 51 (52%) were invasive. The IBE and invasive IBE rates increased over time in both cohorts. The 12-year rates of developing an IBE were 14.4% for cohort 1 and 24.6% for cohort 2 (P = .003). The 12-year rates of developing an invasive IBE were 7.5% and 13.4%, respectively (P = .08). On multivariable analysis, study cohort and tumor size were both significantly associated with developing an IBE (P = .009 and P = .03, respectively). CONCLUSION: For patients with DCIS selected for favorable clinical and pathologic characteristics and treated with excision without radiation, the risks of developing an IBE and an invasive IBE increased through 12 years of follow-up, without plateau. These data help inform the treatment decision-making process for patients and their physicians.
Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Carcinoma Intraductal não Infiltrante/patologia , Carcinoma Intraductal não Infiltrante/cirurgia , Mastectomia Segmentar/métodos , Recidiva Local de Neoplasia/patologia , Adulto , Idoso , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Carcinoma Intraductal não Infiltrante/tratamento farmacológico , Carcinoma Intraductal não Infiltrante/mortalidade , Feminino , Seguimentos , Humanos , Imuno-Histoquímica , Estimativa de Kaplan-Meier , Mastectomia Segmentar/efeitos adversos , Pessoa de Meia-Idade , Análise Multivariada , Invasividade Neoplásica/patologia , Recidiva Local de Neoplasia/epidemiologia , Estadiamento de Neoplasias , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Taxa de Sobrevida , Tamoxifeno/administração & dosagem , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. METHODS: The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. RESULTS: There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). CONCLUSIONS: The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.
Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/metabolismo , Carcinoma Intraductal não Infiltrante/diagnóstico , Carcinoma Intraductal não Infiltrante/metabolismo , Perfilação da Expressão Gênica , Recidiva Local de Neoplasia/diagnóstico , Adulto , Idoso , Biomarcadores Tumorais/análise , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Carcinoma Ductal de Mama/metabolismo , Carcinoma Intraductal não Infiltrante/patologia , Feminino , Regulação Neoplásica da Expressão Gênica , Humanos , Estimativa de Kaplan-Meier , Mastectomia Segmentar , Pessoa de Meia-Idade , Gradação de Tumores , Recidiva Local de Neoplasia/metabolismo , Estadiamento de Neoplasias , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de RiscoRESUMO
PURPOSE: A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast brachytherapy catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. METHODS AND MATERIALS: CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34Gy in 3.4Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. RESULTS: The C-MLB was placed more frequently in patients with closer skin spacing (<7mm) and rib spacing (<7mm) than in MS patients (45.5% vs. 12.1%, p=0.0057 and 57.6 vs. 33.3, p=0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p=0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p=0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p=0.0024). CONCLUSION: The C-MLB catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.
Assuntos
Neoplasias da Mama/radioterapia , Catéteres , Braquiterapia/instrumentação , Braquiterapia/métodos , Feminino , Humanos , Lesões por Radiação/prevenção & controle , Dosagem Radioterapêutica , Pele/efeitos da radiaçãoRESUMO
PURPOSE: To determine the risk of ipsilateral breast events in patients with ductal carcinoma in situ (DCIS) treated with local excision without irradiation. PATIENTS AND METHODS: Patients with either low- or intermediate-grade DCIS measuring 2.5 cm or smaller, or high-grade DCIS measuring 1 cm or smaller who had microscopic margin widths of 3 mm or wider and no residual calcifications on postoperative mammograms were eligible for a prospective trial conducted from 1997 to 2002 by the Eastern Cooperative Oncology Group and North Central Cancer Treatment Group. Patients entered in 2000 and later could take tamoxifen if they wished. Median age at last surgery for the entire population was 60 years (range, 28 to 88 years), and median tumor sizes in the two strata were 6 mm and 5 mm, respectively. RESULTS: With a median follow-up of 6.2 years, the 5-year rate of ipsilateral breast events in the 565 eligible patients in the low/intermediate grade stratum was 6.1% (95% CI, 4.1% to 8.2%). With a median follow-up of 6.7 years, this incidence for the 105 eligible patients in the high-grade stratum was 15.3% (95% CI, 8.2% to 22.5%). CONCLUSION: Rigorously evaluated and selected patients with low- to intermediate-grade DCIS with margins 3 mm or wider had an acceptably low rate of ipsilateral breast events at 5 years after excision without irradiation. Patients with high-grade lesions had a much higher rate, suggesting that excision alone is inadequate treatment. Further follow-up is necessary to document long-term results.
Assuntos
Neoplasias da Mama/cirurgia , Carcinoma Intraductal não Infiltrante/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Carcinoma Intraductal não Infiltrante/tratamento farmacológico , Carcinoma Intraductal não Infiltrante/mortalidade , Terapia Combinada , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Análise de Sobrevida , Taxa de Sobrevida , Tamoxifeno/uso terapêutico , Resultado do TratamentoAssuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Antineoplásicos Hormonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biópsia por Agulha , Neoplasias da Mama/economia , Carcinoma Intraductal não Infiltrante/diagnóstico , Carcinoma Intraductal não Infiltrante/terapia , Feminino , Humanos , Cooperação Internacional , Imageamento por Ressonância Magnética , Mamoplastia , Mastectomia , Procedimentos Cirúrgicos Minimamente Invasivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Biópsia de Linfonodo Sentinela , Tamoxifeno/uso terapêuticoRESUMO
BACKGROUND: In 1994, the Eastern Cooperative Oncology Group (ECOG) initiated for the Breast Intergroup a randomized clinical trial (E3193) in premenopausal patients with early-stage breast carcinoma (lymph node-negative and receptor-positive, with tumors measuring < or = 3 cm) comparing tamoxifen as adjuvant systemic therapy with tamoxifen and ovarian ablation by one of three different methods. Ovarian ablation could be accomplished either via radiotherapy (RT) (20 Gray [Gy]/10 fractions to a modified pelvic volume), surgical oophorectomy, or goserelin/leuprolide injections as per patient/physician choice. In the current study, we report the efficacy of pelvic RT with this dose-fractionation scheme in the induction of ovarian ablation. METHODS: Twenty-two of 174 patients (13%) who were randomized to treatment with tamoxifen and ovarian ablation received RT for ovarian ablation. RT quality assurance was performed. Of the 22 patients, 19 were treated per protocol, 1 patient had a minor violation (20 elapsed days for 10 RT fractions), and 2 patients had major violations (1 patient who was treated with RT as per protocol but who was treated at a non-Intergroup center, and 1 patient who was treated at a dose of 15 Gy/5 fractions). RESULTS: No acute Grade 3 or 4 (according to the Common Toxicity Criteria of the National Cancer Institute) toxicities were reported during RT. Of the 22 patients receiving RT, evaluable follow-up data were available for 20 patients. Based on postmenopausal levels of estradiol or follicle-stimulating hormone at varying intervals after the completion of RT, 15 of 20 patients (75%) achieved successful ovarian ablation with RT. At a median follow-up of 54 months (range, 21-66 months), no Grade 3 or 4 complications from RT were observed. CONCLUSIONS: Ovarian ablation by RT as performed in the current trial (given at a dose of 20 Gy in 10 fractions to a modified pelvic treatment volume) was found to be effective for ovarian ablation in the majority of patients, but may take some months to be complete. Consequently, patients should be evaluated to ascertain that ablation has been accomplished.
Assuntos
Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/radioterapia , Ovariectomia , Pré-Menopausa , Tamoxifeno/uso terapêutico , Adulto , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Terapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
Since its inception, the AJCC staging system for breast cancer has been in an almost constant state of evolution, striving with each revision to reflect the most up-to-date clinical research as well as the widespread consensus among physicians about appropriate diagnostic and treatment standards. To date, these revisions have essentially represented a "fine-tuning" of the initial judgment that tumor size, lymph node status, and presence of distant metastases are the most significant prognostic factors for breast cancer. With the problems of standardization and reproducibility being resolved, it is likely that histologic grade will join this group of independent markers and be incorporated into the AJCC staging system in the near future. Over the last 15 years. considerable attention has been focused on the discovery of new markers visualized with immunohistochemistry and RT-PCR that may be validated as independent prognostic indicators (reviewed by Mirza et al). To date, the usefulness of many of these markers has been limited by lack of standardization in measurement techniques, but several show great promise for the future. By increasing the number of prognostic markers that can give independent information about patient outcome, physicians will be better able to determine optimal treatment approaches for individual patients.
Assuntos
Comitês Consultivos/normas , Neoplasias da Mama/patologia , Manuais como Assunto/normas , Estadiamento de Neoplasias/normas , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Feminino , Humanos , Estados UnidosRESUMO
PURPOSE: To revise the American Joint Committee on Cancer staging system for breast carcinoma. MATERIALS AND METHODS: A Breast Task Force submitted recommended changes and additions to the existing staging system that were (1) evidence-based and/or consistent with widespread clinical consensus about appropriate diagnostic and treatment standards and (2) useful for the uniform accrual of outcome information in national databases. RESULTS: Major changes included the following: size-based discrimination between micrometastases and isolated tumor cells; identifiers to indicate usage of innovative technical approaches; classification of lymph node status by number of involved axillary lymph nodes; and new classifications for metastasis to the infraclavicular, internal mammary, and supraclavicular lymph nodes. CONCLUSION: This revised staging system will be officially adopted for use in tumor registries in January 2003.