Impact of cranial stereotactic radiotherapy associated with immunotherapy with nivolumab and ipilimumab on overall survival in patients with melanoma brain metastases: a real-world evidence

PurposeTo evaluate the impact of cranial stereotactic radiotherapy (SRT) on overall survival (OS) of melanoma brain metastases (MBM) patients treated with combined nivolumab and ipilimumab (CNI) in a contemporary and real-world setting.Methods/patientsThe study was performed by using TriNetX, a global health network dataset of electronic medical records from patients in 49 healthcare organizations. We queried for patients with specific terms between January 2016 and December 2020 and run a propensity score matching (PSM) analysis. OS was estimated by Kaplan–Meier and log-rank test was applied.ResultsAfter initial query and PSM, 114 patients were selected in each cohort. Median OS was 327 days in CNI and not reached in the CNI + SRT cohort, with OS probability of 54.4 and 40.9%, respectively (log-rank P = .0057). CNI + SRT was associated with significantly decreased mortality (HR, 0.57; 95% CI 0.377-0.853; proportionality P = .0034).ConclusionsThis real-world analysis showed that CNI + SRT led to an improvement in OS compared to CNI. (AU)

Overall survival and prognostic factors in Stage I lung adenocarcinoma treated with curative intent: A real-life 19-year cohort study.

OBJECTIVES: Important differences in Stage I non-small-cell lung cancer (NSCLC) are related to the delay in the diagnosis to the treatment, hospitals' specialised status, comorbidities, tumour stage and histological type. METHODS: A 19-year retrospective cohort study was conducted, including 681 patients with NSCLC in clinical-stage IA-IB. The variables analysed were gender, age, schooling, type of health care provider, type of treatment, period of 5-year treatment, the time between first attendance to diagnosis and the time between diagnosis and treatment, and hospital's specialised status. RESULTS: Patients who underwent radiotherapy alone had three times more risk of death than those who underwent surgery alone (adjusted hazard ratio [adjHR] = 3.44; 95% confidence interval [CI]: 2.45-4.82; p <0.001). The independent risk of death factors was being treated in nonhigh complexity centres in oncology hospitals and having started the treatment more than 2 months after diagnosis (adjHR = 1.80; 95% CI: 1.26-2.56; p <0.001) and (adjHR = 2.00; 95% CI: 1.33-3.00; p <0.001), respectively. In addition, the patients diagnosed between 2011 and 2015 had a 40% lower risk of death when compared to those diagnosed between 2000 and 2005 (95% CI: 0.38-0.94; p = 0.027). CONCLUSION: The overall survival in curative intent Stage-I lung cancer patients' treatment was associated with the 5-year diagnosis group, the delayed time between diagnosis and treatment and the hospital qualification.

Impact of cranial stereotactic radiotherapy associated with immunotherapy with nivolumab and ipilimumab on overall survival in patients with melanoma brain metastases: a real-world evidence.

PURPOSE: To evaluate the impact of cranial stereotactic radiotherapy (SRT) on overall survival (OS) of melanoma brain metastases (MBM) patients treated with combined nivolumab and ipilimumab (CNI) in a contemporary and real-world setting. METHODS/PATIENTS: The study was performed by using TriNetX, a global health network dataset of electronic medical records from patients in 49 healthcare organizations. We queried for patients with specific terms between January 2016 and December 2020 and run a propensity score matching (PSM) analysis. OS was estimated by Kaplan-Meier and log-rank test was applied. RESULTS: After initial query and PSM, 114 patients were selected in each cohort. Median OS was 327 days in CNI and not reached in the CNI + SRT cohort, with OS probability of 54.4 and 40.9%, respectively (log-rank P = .0057). CNI + SRT was associated with significantly decreased mortality (HR, 0.57; 95% CI 0.377-0.853; proportionality P = .0034). CONCLUSIONS: This real-world analysis showed that CNI + SRT led to an improvement in OS compared to CNI.

Hypofractionated radiotherapy recommendations for localized prostate cancer in Brasil.

OBJECTIVE: Several prospective randomized trials have shown that hypofractionation has the same efficacy and safety as the conventional fractionation in the treatment of localized prostate cancer. There are many benefits of hypofractionation, including a more convenient schedule for the patients and better use of resources, which is especially important in low- and middle-income countries like Brasil. Based on these data, the Brazilian Society of Radiotherapy (Sociedade Brasileira de Radioterapia) organized this consensus to guide and support the use of hypofractionated radiotherapy for localized prostate cancer in Brasil. METHODS: The relevant literature regarding moderate hypofractionation (mHypo) and ultra-hypofractionation (uHypo) was reviewed and discussed by a group of experts from public and private centers of different parts of Brasil. Several key questions concerning clinical indications, outcomes and technological requirements for hypofractionation were discussed and voted. For each question, consensus was reached if there was an agreement of at least 75% of the panel members. RESULTS: The recommendations are described in this article. CONCLUSION: This initiative will assist Brazilian radiation oncologists and medical physicists to safely treat localized prostate cancer patients with hypofractionation.

Treatment of Localized and Locally Advanced, High-Risk Prostate Cancer: A Report From the First Prostate Cancer Consensus Conference for Developing Countries.

PURPOSE: To generate and present survey results on important issues relevant to treatment and follow-up of localized and locally advanced, high-risk prostate cancer (PCa) focusing on developing countries. METHODS: A panel of 99 PCa experts developed more than 300 survey questions of which 67 questions concern the main areas of interest of this article: treatment and follow-up of localized and locally advanced, high-risk PCa in developing countries. A larger panel of 99 international multidisciplinary cancer experts voted on these questions to create the recommendations for treatment and follow-up of localized and locally advanced, high-risk PCa in areas of limited resources discussed in this article. RESULTS: The panel voted publicly but anonymously on the predefined questions. Each question was deemed consensus if 75% or more of the full panel had selected a particular answer. These answers are based on panelist opinion and not on a literature review or meta-analysis. For questions that refer to an area of limited resources, the recommendations considered cost-effectiveness as well as the possible therapies with easier and greater access. Each question had five to seven relevant answers including two nonanswers. Results were tabulated in real time. CONCLUSION: The voting results and recommendations presented in this article can guide physicians managing localized and locally advanced, high-risk PCa in areas of limited resources. Individual clinical decision making should be supported by available data; however, as guidelines for treatment of localized and locally advanced, high-risk PCa in developing countries have not been defined, this article will serve as a point of reference when confronted with this disease.

Consensus on Screening, Diagnosis, and Staging Tools for Prostate Cancer in Developing Countries: A Report From the First Prostate Cancer Consensus Conference for Developing Countries (PCCCDC).

PURPOSE: To generate and present the survey results on critical issues relevant to screening, diagnosis, and staging tools for prostate cancer (PCa) focused on developing countries. METHODS: A total of 36 of 300 questions concern the main areas of interest of this paper: (1) screening, (2) diagnosis, and (3) staging for various risk levels of PCa in developing countries. A panel of 99 international multidisciplinary cancer experts voted on these questions to create recommendations for screening, diagnosing, and staging tools for PCa in areas of limited resources discussed in this manuscript. RESULTS: The panel voted publicly but anonymously on the predefined questions. Each question was deemed consensus if 75% or more of the full panel had selected a particular answer. These answers are based on panelist opinion not a literature review or meta-analysis. For questions that refer to an area of limited resources, the recommendations consider cost-effectiveness and the possible therapies with easier and greater access. Each question had five to seven relevant answers including two nonanswers. The results were tabulated in real time. CONCLUSION: The voting results and recommendations presented in this document can be used by physicians to support the screening, diagnosis, and staging of PCa in areas of limited resources. Individual clinical decision making should be supported by available data; however, as guidelines for screening, diagnosis, and staging of PCa in developing countries have not been developed, this document will serve as a point of reference when confronted with this disease.

Hypofractionated radiotherapy recommendations for localized prostate cancer in Brasil

SUMMARY OBJECTIVE: Several prospective randomized trials have shown that hypofractionation has the same efficacy and safety as the conventional fractionation in the treatment of localized prostate cancer. There are many benefits of hypofractionation, including a more convenient schedule for the patients and better use of resources, which is especially important in low- and middle-income countries like Brasil. Based on these data, the Brazilian Society of Radiotherapy (Sociedade Brasileira de Radioterapia) organized this consensus to guide and support the use of hypofractionated radiotherapy for localized prostate cancer in Brasil. METHODS: The relevant literature regarding moderate hypofractionation (mHypo) and ultra-hypofractionation (uHypo) was reviewed and discussed by a group of experts from public and private centers of different parts of Brasil. Several key questions concerning clinical indications, outcomes and technological requirements for hypofractionation were discussed and voted. For each question, consensus was reached if there was an agreement of at least 75% of the panel members. RESULTS: The recommendations are described in this article. CONCLUSION: This initiative will assist Brazilian radiation oncologists and medical physicists to safely treat localized prostate cancer patients with hypofractionation.

Antibiotics, cancer risk and oncologic treatment efficacy: a practical review of the literature.

Antibiotics have been extensively used to treat infectious diseases over the past century and have largely contributed to increased life expectancy over time. However, antibiotic use can impose profound and protracted changes to the diversity of the microbial ecosystem, affecting the composition of up to 30% of the bacterial species in the gut microbiome. By modifying human microbiota composition, antibiotics alter the action of several oncologic drugs, potentially leading to decreased efficacy and increased toxicities. Whether antibiotics interfere with cancer therapies or even increase the risk of cancer development has been under investigation, and no randomised trials have been conducted so far. The aim of the current review is to describe the possible effects of antibiotic therapies on different oncologic treatments, especially immunotherapies, and to explore the link between previous antibiotics use and the development of cancer.

Recommendations for hypofractionated whole-breast irradiation

SUMMARY This recommendation consensus for hypofractionated whole-breast radiotherapy (RT) was organized by the Brazilian Society of Radiotherapy (SBRT) considering the optimal scenario for indication and safety in the technology applied. All controversies and contraindication matters (hypofractionated RT in patients who underwent chemotherapy [CT], hypofractionated RT in lymphatic drainage, hypofractionated RT after mastectomy with or without immediate reconstruction, boost during surgery, hypofractionated RT in patients under 50 years old, hypofractionated RT in large breasts, hypofractionated RT in histology of carcinoma in situ [DCIS]) was discussed during a meeting in person, and a consensus was reached when there was an agreement of at least 75% among panel members. The grade for recommendation was also suggested according to the level of scientific evidence available, qualified as weak, medium, or strong. Thus, this consensus will aid Brazilian radiotherapy experts regarding indications and particularities of this technique as a viable and safe alternative for the national reality.

RESUMO Este consenso de recomendações para a radioterapia (RT) hipofracionada de toda a mama foi organizado pela Sociedade Brasileira de Radioterapia (SBRT) considerando o cenário ideal para indicação e segurança na tecnologia aplicada. Questões de controvérsias e contraindicações (RT hipofracionada em pacientes submetidas à quimioterapia [QT], RT hipofracionada nas drenagens linfáticas, RT hipofracionada após mastectomia com ou sem reconstrução imediata, a realização de reforço de dose em leito cirúrgico [ou boost], RT hipofracionada em pacientes com idade menor que 50 anos, RT hipofracionada em mamas volumosas, RT hipofracionada em histologia de carcinoma in situ [CDIS]) foram discutidas em encontro presencial, sendo o consenso atingido quando existisse concordância de pelo menos 75% dos panelistas. O grau de recomendação foi também sugerido de acordo com o nível de evidência científico disponível, qualificado entre fraco, médio ou forte. Assim, este consenso deverá servir para auxiliar os especialistas da radioterapia brasileira em relação às indicações e particularidades dessa técnica, como uma alternativa segura e viável para a realidade nacional.

Recommendations for hypofractionated whole-breast irradiation.

This recommendation consensus for hypofractionated whole-breast radiotherapy (RT) was organized by the Brazilian Society of Radiotherapy (SBRT) considering the optimal scenario for indication and safety in the technology applied. All controversies and contraindication matters (hypofractionated RT in patients who underwent chemotherapy [CT], hypofractionated RT in lymphatic drainage, hypofractionated RT after mastectomy with or without immediate reconstruction, boost during surgery, hypofractionated RT in patients under 50 years old, hypofractionated RT in large breasts, hypofractionated RT in histology of carcinoma in situ [DCIS]) was discussed during a meeting in person, and a consensus was reached when there was an agreement of at least 75% among panel members. The grade for recommendation was also suggested according to the level of scientific evidence available, qualified as weak, medium, or strong. Thus, this consensus will aid Brazilian radiotherapy experts regarding indications and particularities of this technique as a viable and safe alternative for the national reality.

I BRAZILIAN CONSENSUS ON MULTIMODAL TREATMENT OF COLORECTAL LIVER METASTASES. MODULE 2: APPROACH TO RESECTABLE METASTASES.

BACKGROUND: Liver metastases of colorectal cancer are frequent and potentially fatal event in the evolution of patients. AIM: In the second module of this consensus, management of resectable liver metastases was discussed. METHOD: Concept of synchronous and metachronous metastases was determined, and both scenarius were discussed separately according its prognostic and therapeutic peculiarities. RESULTS: Special attention was given to the missing metastases due to systemic preoperative treatment response, with emphasis in strategies to avoid its reccurrence and how to manage disappeared lesions. CONCLUSION: Were presented validated ressectional strategies, to be taken into account in clinical practice.

I brazilian consensus on multimodal treatment of colorectal liver metastases. module 2: approach to resectable metastases / I consenso brasileiro de tratamento multidisciplinar de metástase hepática colorretais módulo 2: manejo das metástases ressecáveis

Background : Liver metastases of colorectal cancer are frequent and potentially fatal event in the evolution of patients. Aim : In the second module of this consensus, management of resectable liver metastases was discussed. Method : Concept of synchronous and metachronous metastases was determined, and both scenarius were discussed separately according its prognostic and therapeutic peculiarities. Results : Special attention was given to the missing metastases due to systemic preoperative treatment response, with emphasis in strategies to avoid its reccurrence and how to manage disappeared lesions. Conclusion : Were presented validated ressectional strategies, to be taken into account in clinical practice.

Racional: As metástases hepáticas de câncer colorretal são evento frequente e potencialmente fatal na evolução dos pacientes. Objetivo : No segundo módulo desse consenso, foi discutido o manejo de metástases hepáticas ressecáveis. Método : Foi definido o conceito de metástases síncrônicas e metacrônicas, e ambos os cenários foram discutidos separadamente de acordo com as suas peculiaridades prognósticas e terapêuticas. Resultados : Foi dada especial atenção às missing metástases em resposta ao tratamento pré-operatório sistêmico, com ênfase em estratégias para evitar sua recorrência e como gerenciar as lesões desaparecidas. Conclusão : Foram apresentadas e validadas estratégias de ressecção em várias circunstâncias, para serem aplicadas na prática clínica.

Ototoxicity evaluation in medulloblastoma patients treated with involved field boost using intensity-modulated radiation therapy (IMRT): a retrospective review.

BACKGROUND: Ototoxicity is a known side effect of combined radiation therapy and cisplatin chemotherapy for the treatment of medulloblastoma. The delivery of an involved field boost by intensity modulated radiation therapy (IMRT) may reduce the dose to the inner ear when compared with conventional radiotherapy. The dose of cisplatin may also affect the risk of ototoxicity. A retrospective study was performed to evaluate the impact of involved field boost using IMRT and cisplatin dose on the rate of ototoxicity. METHODS: Data from 41 medulloblastoma patients treated with IMRT were collected. Overall and disease-free survival rates were calculated by Kaplan-Meier method Hearing function was graded according to toxicity criteria of Pediatric Oncology Group (POG). Doses to inner ear and total cisplatin dose were correlated with hearing function by univariate and multivariate data analysis. RESULTS: After a mean follow-up of 44 months (range: 14 to 72 months), 37 patients remained alive, with two recurrences, both in spine with CSF involvement, resulting in a disease free-survival and overall survival of 85.2% and 90.2%, respectively.Seven patients (17%) experienced POG Grade 3 or 4 toxicity. Cisplatin dose was a significant factor for hearing loss in univariate analysis (p < 0.03). In multivariate analysis, median dose to inner ear was significantly associated with hearing loss (p < 0.01). POG grade 3 and 4 toxicity were uncommon with median doses to the inner ear bellow 42 Gy (p < 0.05) and total cisplatin dose of less than 375 mg/m2 (p < 0.01). CONCLUSIONS: IMRT leads to a low rate of severe ototoxicity. Median radiation dose to auditory apparatus should be kept below 42 Gy. Cisplatin doses should not exceed 375 mg/m2.

Radioterapia intraoperatória como protocolo de tratamento do câncer de mama inicial / Intraoperative radiotherapy as a protocol for the treatment of initial breast cancer

OBJETIVO: Avaliar a experiência inicial de implementação e aplicação de radioterapia única e intraoperatória com feixe de elétrons em pacientes selecionadas com diagnóstico de câncer de mama em estágio inicial. Avaliar também a recorrência local e os eventos adversos (complicações locais). MÉTODOS: Foram avaliadas 50 pacientes com câncer de mama, pós-menopausadas, com tumores de <2,5cm e linfonodos axilares clinicamente não palpáveis, que se submeteram a uma ressecção segmentar e biópsia de linfonodo sentinela e técnica de radioterapia intraoperatória. Essas pacientes foram seguidas por um período médio de 52,1 meses. RESULTADOS: A idade média dos pacientes foi de 65,5 anos de idade. O diâmetro médio do tumor foi de 1,41cm 82% tinham tumores com receptor hormonal positivo e HER-2 negativo. A dose de radiação empregada foi de 21 Gy em todas as pacientes, com um tempo médio de irradiação intraoperatória de 8,97 minutos. O seguimento médio dessas pacientes foi de 52,1 meses. Foram evidenciados três casos com recorrência local durante esse período, sendo que nenhuma dessas pacientes tinha metástases à distância no momento do diagnóstico da recidiva. O diagnóstico patológico dessas três pacientes foi idêntico ao do tumor primário. Nesta casuística, não se registrou infecção pós-operatória ou formação de seroma. No entanto, em 35 pacientes (70%), foi observada uma fibrose local como sequela de pós-operatório. Esta, quando presente, diminuiu gradualmente e desapareceu completamente em um período médio de 18 meses. CONCLUSÃO: A radioterapia parcial é uma técnica viável e promissora, mas que deve ser indicada em casos selecionados, pelo menos até que tenhamos um maior tempo de seguimento que proporcione maior segurança para indicá-la em nossa rotina, como fazemos com a radioterapia convencional.

OBJECTIVE: To report on preliminary outcomes of single-dose intraoperative radiotherapy for early-stage breast cancer based on local recurrence rates and complications. METHODS: Fifty postmenopausal women with <2.5cm breast tumors and clinically normal axillary lymph nodes were submitted to quadrantectomy, sentinel lymph node biopsy and intraoperative radiotherapy and studied. Mean follow-up time was 52.1 months. RESULTS: Mean patient age was 65.5 years; mean tumor diameter was 1.41cm 82% of nodules were hormonal receptor positive and HER-2 negative. All patients received a 21 Gy radiation dose for a mean time of 8.97 minutes. Distant metastases were not observed. Local recurrence was documented in three cases, with identical histological diagnosis as the primary tumors. Thirty-five (70%) patients had local fibrosis, with gradual improvement and complete resolution over 18 months. Postoperative infection and seroma formation were not observed. CONCLUSION: Partial radiotherapy is a potentially feasible and promising technique. Careful patient selection is recommended before a longer follow-up period has elapsed to confirm intraoperative radiotherapy safety and efficacy.

Intraoperative radiotherapy as a protocol for the treatment of initial breast cancer.

OBJECTIVE: To report on preliminary outcomes of single-dose intraoperative radiotherapy for early-stage breast cancer based on local recurrence rates and complications. METHODS: Fifty postmenopausal women with <2.5cm breast tumors and clinically normal axillary lymph nodes were submitted to quadrantectomy, sentinel lymph node biopsy and intraoperative radiotherapy and studied. Mean follow-up time was 52.1 months. RESULTS: Mean patient age was 65.5 years; mean tumor diameter was 1.41cm 82% of nodules were hormonal receptor positive and HER-2 negative. All patients received a 21 Gy radiation dose for a mean time of 8.97 minutes. Distant metastases were not observed. Local recurrence was documented in three cases, with identical histological diagnosis as the primary tumors. Thirty-five (70%) patients had local fibrosis, with gradual improvement and complete resolution over 18 months. Postoperative infection and seroma formation were not observed. CONCLUSION: Partial radiotherapy is a potentially feasible and promising technique. Careful patient selection is recommended before a longer follow-up period has elapsed to confirm intraoperative radiotherapy safety and efficacy.

Impacto da adição da temozolamida à radioterapia no tratamento de crianças portadoras de tumor de tronco cerebral / Impact of the addition of temozolomide to radiotherapy in the treatment of children with brain stem tumors

OBJETIVO: Analisar o impacto da adição da temozolamida à radioterapia em tumores de tronco cerebral em crianças. MATERIAL E MÉTODO: Entre 2000 e 2005 foram analisadas, retrospectivamente, 64 crianças com tumor do tronco cerebral. Dessas crianças, 32 receberam temozolamida(grupo 1) e 32 não a receberam (grupo 2). RESULTADOS: A idade mediana no grupo 1 foi de 8,2 anos e no grupo 2 foi de 7,5 anos. A localização tumoral era predominantemente difusa (53%) emambos os grupos. Todos os pacientes receberam radioterapia com doses superiores a 50 Gy. No grupo1 foram ministrados nove ciclos, em média, de quimioterapia (3û14 ciclos). O tempo de progressão de doença foi de 7,9 meses no grupo 2 versus 13,8 meses no grupo 1. A sobrevida global foi de 8,8 meses (0,3û30,9 meses) no grupo 1 e de 14,6 meses (4,3û33 meses) no grupo 2. CONCLUSÃO: A utilização da temozolamida após a radioterapia proporcionou aumento da sobrevida, deseis meses em média, nos pacientes pediátricos com tumor do tronco cerebral.

OBJECTIVE: To analyze the impact of adding temozolomide to radiotherapyin pediatric brain stem tumors. MATERIAL AND METHOD: Between 2000 and 2005, 64 children with brain stem tumor were analyzed: 32 received temozolomide (group 1) and 32 did not(group 2). RESULTS: The median age of patients in group 1 was 8.2 year-old and in group 2 was 7.5 year-old. The predominant tumoral localization was diffuse (53%) in both groups. All of the patients were submitted to radiotherapy. In group 1, the median number of temozolomide cycles was 9 (3û14 cycles). Time of disease progression was 7.9 months in group 2 versus 13.8 months in group 1. Overall survival was 8.8 months (0.3û30.9 months) in group 1 and 14.6 months (4.3û33 months) in group 2. CONCLUSION: In our institution,adding temozolomide to radiotherapy increased the overall survival in approximately six months in brain stem pediatric tumors.

Intensity modulated radiotherapy for localized prostate cancer: rigid compliance to dose-volume constraints as a warranty of acceptable toxicity?

BACKGROUND: To report the toxicity after intensity modulated radiotherapy (IMRT) for patients with localized prostate cancer, as a sole treatment or after radical prostatectomy. METHODS: Between August 2001 and December 2003, 132 patients with prostate cancer were treated with IMRT and 125 were evaluable to acute and late toxicity analysis, after a minimum follow-up time of one year. Clinical and treatment data, including normal tissue dose-volume histogram (DVH) constraints, were reviewed. Gastro-intestinal (GI) and genito-urinary (GU) signs and symptoms were evaluated according to the Radiation Therapy Oncology Group (RTOG) toxicity scales. Median prescribed dose was 76 Gy. Median follow-up time was of 26.1 months. RESULTS: From the 125 patients, 73 (58.4%) presented acute Grade 1 or Grade 2 GI and 97 (77.2%) presented acute Grade 1 or Grade 2 GU toxicity. Grade 3 GI acute toxicity occurred in only 2 patients (1.6%) and Grade 3 GU acute toxicity in only 3 patients (2.4%). Regarding Grade 1 and 2 late toxicity, 26 patients (20.8%) and 21 patients (16.8%) presented GI and GU toxicity, respectively. Grade 2 GI late toxicity occurred in 6 patients (4.8%) and Grade 2 GU late toxicity in 4 patients (3.2%). None patient presented any Grade 3 or higher late toxicity. Non-conformity to DVH constraints occurred in only 11.2% of treatment plans. On univariate analysis, no significant risk factor was identified for Grade 2 GI late toxicity, but mean dose delivered to the PTV was associated to higher Grade 2 GU late toxicity (p = 0.042). CONCLUSION: IMRT is a well tolerable technique for routine treatment of localized prostate cancer, with short and medium-term acceptable toxicity profiles. According to the data presented here, rigid compliance to DHV constraints might prevent higher incidences of normal tissue complication.

Validando o SIR: um melhor índice prognóstico para pacientes com metástases cerebraistratados com cirurgia estereotática / Validating the SIR: a better prognostic score index for patients with brain metastases treated with stereotactic radiosurgery

Objetivo: Validar o SIR (score index for survival in patients with brain metastasis treated with stereotatic radiosurgery) [índice de escore paraavaliar a sobrevida de pacientes com metástases cerebrais tratadoscom radiocirurgia estereotática], uma classificação elaborada paramelhor prever o prognóstico de pacientes com metástases cerebraistratados com radiocirurgia, reavaliar a sobrevida dos pacientes e revisara literatura médica. Métodos: Foram analisados dados de 100 pacientes com metástases cerebrais tratados com radiocirurgia estereotática um uma única instituição, entre julho de 1993 e fevereiro de 2002. Os fatores prognósticos e índices estudados foram: idade, índice de desempenho de Karnofsky, estado da doença extracraniana, número de lesões cerebrais, volume da maior lesão, tipode tumor primário, tratado ou não tratado com radioterapia cerebral total,SIR e RPA (Recursive Partitioning Analysis – classificação por análiserecursiva fragmentada). As curvas atuariais de sobrevida de Kaplan-Meier foram calculadas e comparadas. Os modelos Cox – completo e de eliminação retrógrada – foram utilizados para identificar os fatores prognósticos e índices, associados à sobrevida. Resultados: Ao analisar as curvas de sobrevida de Kaplan-Meier, o índice de desempenho de Karnofsky, o estado da doença extracraniana, o volume da maior lesão cerebral, a RPA e o SIR mostraram correlação significativa com o prognóstico. Aplicando os modelos de Cox, observou-se significância para índice de desempenho de Karnofsky (p < 0,0001) e volume da maior lesão (p = 0,0182), assim como para o SIR e paraa RPA, quando testados individualmente (p < 0,0001 e p = 0,0002). Contudo, testando SIR e RPA conjuntamente, só o SIR alcançou significância estatística independente (p < 0,0001). Conclusão: Ao reavaliar nossa casuística, a classificação SIR mostrou maior precisão do que a RPA para prever o tempo de sobrevida de pacientes com metástases cerebrais tratados com radiocirurgia.

Objective: The aim of this paper is to validate the score index forsurvival in patients treated with stereotactic radiosurgery, using aclassification prepared to better evaluate the prognosis of patientswith brain metastasis submitted to stereotactic surgery, re-evaluatingsurvival of patients and reviewing the medical literature. Methods:Data from 100 patients with brain metastases treated with stereotacticradiosurgery at a single institution, between July 1993 and February2000, were retrospectively analyzed. The prognostic factors andscores studied were age, Karnofsky performance status, extracranialdisease status, number of brain lesions, volume of the largest lesion,primary tumor type, treated or not with whole brain radiation therapy,SIR, and RPA. Kaplan-Meier actuarial survival curves for subsets werecalculated and compared by log-rank test. Complete and backwardelimination Cox models were utilized to identify the prognostic factorsand scores independently associated with survival. Results: Karnofskyperformance status, extracranial disease status, volume of the largestbrain lesion, RPA, and SIR were significantly correlated with prognosisin Kaplan-Meier survival analysis. Applying Cox models, significancewas observed for KPS and volume of the largest lesion (p < 0.0001and p = 0.0182, respectively), as well as for SIR and RPA when testedindividually (p < 0.0001 and p = 0.0002, respectively). However, whentesting SIR and RPA together, only SIR reached independent statisticalsignificance (p < 0.0001). Conclusion: SIR classification demonstrateda better accuracy in predicting survival time than RPA. SIR was testedin other centers, showing superior accuracy and applicability than theRPA, thus validating this score.

Uso da radioterapia intra-operatória (IORT) como protocolo de investigação no tratamento do câncerde mama inicial: resultados parciais do Hospital Israelita Albert Einstein / An investigational protocol of intraoperative radiotherapy in the tratment of early-stage breast cancer: partial results from the Hospital Israelita Albert Einstein

Objetivo: Descrever e avaliar a experiência inicial do uso da radioterapia intra-operatória no tratamento do câncer de mama inicial no Hospital Israelita Albert Einstein. Métodos: Foram estudadas 22 pacientes com carcinoma de mama invasivo, idade ≥ 45 anos, tumor ≤ 2,5 cm e axila clinicamente negativa à avaliação intra-operatória, submetidas a cirurgia conservadora com exérese do linfonodo sentinela e radioterapiaintra-operatória. As pacientes foram avaliadas quanto às características clínicas, anatomopatológicas e técnicas da radioterapia intra-operatória. Resultados: A média de idade das pacientes foi de 60,4 anos, sendo 90,9%pós-menopausadas. O diâmetro tumoral médio foi 1,5 cm, sendo 81% dostumores do tipo ductal invasivo. Em 89%, os receptores estrogênicos e/ou progestagênicos foram positivos e o Her-2/neu foi negativo. O estadiamento clínico das pacientes era I em 86,4%. O linfonodo sentinela estava livre de neoplasia em 81,8%. A dose de radiação foi de 21 Gy em todas aspacientes, com tempo médio de irradiação de 9,65 minutos, tempo médiode cirurgia de 234 minutos e profundidade média de tecido irradiado de 1,72 cm. Conclusão: Nossos dados iniciais são semelhantes aos daliteratura, demonstrando que a radioterapia intra-operatória é uma técnica factível em nosso meio, segura e com potencial equivalente à radioterapia externa convencional, com benefícios radiobiológicos, técnicos, clínicos,psicológicos e econômicos.