Treatment of Early Breast Cancer: A Report after Ten Years of a Clinical Trial

A controlled clinical trial has been carried out to compare radical mastectomy with wide excision (extended tylectomy) in the treatment of early breast cancer. Only patients aged 50 and over were included and 370 entered the trial during a period of 10 years. Postoperative radiotherapy was given in each case. In patients with clinically involved axillary nodes there was a significantly higher incidence of local and distant recurrence in those having a wide excision, and the survival of these patients was significantly less than those who had a radical mastectomy. In patients with clinically uninvolved nodes, although there was a significantly higher incidence of local recurrence in those having a wide excision, there was no increased incidence of distant recurrence and the survival rate was similar to those having a radical mastectomy.     

保乳手术治疗92 例早期乳腺癌的临床疗效观察

目的：观察保留乳房手术治疗早期乳腺癌的临床治疗效果及其安全性。方法：回顾性分析我院2008 年5 月—2010 年5 月间 收治的92 例行保乳手术的早期乳腺癌患者的临床资料,观察实施保乳手术并综合后的治疗疗效和患者生活质量变化。结果：全 部患者均顺利接受手术,近期乳房外形保持较好,美容效果好,手术并发症少。术后随访20～44 个月,1 例局部复发,1 例肝转移, 无死亡病例。结论：保乳手术治疗早期乳腺癌的美容效果好,并发症少,疗效显著;术前严格掌握手术适应症,术后规范的综合治 疗,是取得良好效果的基础。     

保乳手术治疗92例早期乳腺癌的临床疗效观察

目的：观察保留乳房手术治疗早期乳腺癌的临床治疗效果及其安全性。方法：回顾性分析我院2008年5月-2010年5月间收治的92例行保乳手术的早期乳腺癌患者的,临床资料,观察实施保乳手术并综合后的治疗疗效和患者生活质量变化。结果：全部患者均顺利接受手术,近期乳房外形保持较好,美容效果好,手术并发症少。术后随访20-44个月,1例局部复发,1例肝转移,无死亡病例。结论：保乳手术治疗早期乳腺癌的美容效果好,并发症少,疗效显著;术前严格掌握手术适应症,术后规范的综合治疗,是取得良好效果的基础。     

A Virtual Clinical Trial of FDG-PET Imaging of Breast Cancer: Effect of Variability on Response Assessment

INTRODUCTION: There is growing interest in using positron emission tomography (PET) standardized uptake values (SUVs) to assess tumor response to therapy. However, many error sources compromise the ability to detect SUV changes. We explore relationships between these errors and overall SUV variability. METHODS: We used simulations in a virtual clinical trial framework to study impacts of error sources from scanning and analysis effects on assessment of SUV changes. We varied tumor diameter, scan duration, pretherapy SUV, magnitude of change in SUV, image reconstruction filter, and SUV metric. Poisson noise was added to the raw data before image reconstruction. Variance from global sources of error, e.g., scanner calibration, was incorporated. Two thousand independent noisy sinograms per scenario were generated and reconstructed. We used SUVs to create receiver operating characteristic (ROC) curves to quantify ability to assess response. Integrating area under the ROC curve summarized ability to detect SUV changes. RESULTS: Scan duration and image reconstruction method had relatively little impact on ability to measure response. SUV_MAX is nearly as effective as SUV_MEAN, especially with increased image smoothing and despite size-matched region of interest placement. For an effective variability of 15%, we found the Positron Emission Tomography Response Criteria in Solid Tumors criteria for measuring response (±30%) similar to the European Organization for Research and Treatment of Cancer criteria (±25%). CONCLUSIONS: For typical PET variance levels, tumor response must be 30% to 40% to be reliably determined using SUVs. PET scan duration and image reconstruction method had relatively little effect.     

早期乳腺癌保乳术后放射治疗的临床研究

目的:通过对早期乳腺癌保乳术后放射治疗的研究,探讨其远期疗效及瘤床加量照射和放化疗顺序等问题。方法:84例早期乳腺癌患者行保乳手术,术后行三维适形放疗,50Gy/25次,1次/天,5次/周,瘤床局部加量10～16Gy/5～8次。化疗采用蒽环类为主的方案,65例肿瘤直径>1cm者先化疗3个周期后放疗,然后再化疗1～3周期,13例肿瘤直径≤1cm者在术后3～6周放疗,然后化疗4～6个周期。ER/PR阳性者均行内分泌治疗。结果:全组病人5年生存率100%,5年无瘤生存率91.4%。3例乳腺局部复发,3例分别出现肺、肝和骨转移,其中2例死于肿瘤转移。总复发率7.1%。瘤床加量组局部复发率低于未加量组(P=0.04)。放化疗顺序对肿瘤复发率无影响(P=0.15)。美容效果优良率94%,一般者3.6%,差者2.4%。结论:放射治疗是早期乳腺癌保乳治疗的重要组成部分,瘤床加量照射可降低局部复发率。放化疗顺序对于局部复发率影响不大。     

Calibration Test of PET Scanners in a Multi-Centre Clinical Trial on Breast Cancer Therapy Monitoring Using 18F-FLT

A multi-centre trial using PET requires the analysis of images acquired on different systems We designed a multi-centre trial to estimate the value of 18F-FLT-PET to predict response to neoadjuvant chemotherapy in patients with newly diagnosed breast cancer. A calibration check of each PET-CT and of its peripheral devices was performed to evaluate the reliability of the results.

Material and Methods

11 centres were investigated. Dose calibrators were assessed by repeated measurements of a 68Ge certified source. The differences between the clocks associated with the dose calibrators and inherent to the PET systems were registered. The calibration of PET-CT was assessed with an homogeneous cylindrical phantom by comparing the activities per unit of volume calculated from the dose calibrator measurements with that measured on 15 Regions of Interest (ROIs) drawn on 15 consecutive slices of reconstructed filtered back-projection (FBP) images. Both repeatability of activity concentration based upon the 15 ROIs (ANOVA-test) and its accuracy were evaluated.

Results

There was no significant difference for dose calibrator measurements (median of difference −0.04%; min = −4.65%; max = +5.63%). Mismatches between the clocks were less than 2 min in all sites and thus did not require any correction, regarding the half life of 18F. For all the PET systems, ANOVA revealed no significant difference between the activity concentrations estimated from the 15 ROIs (median of difference −0.69%; min = −9.97%; max = +9.60%).

Conclusion

No major difference between the 11 centres with respect to calibration and cross-calibration was observed. The reliability of our 18F-FLT multi-centre clinical trial was therefore confirmed from the physical point of view. This type of procedure may be useful for any clinical trial involving different PET systems.     

基于药物临床试验项目管理系统的临床试验全程管理

我国药物临床试验机构经过多年的发展,临床试验的试验条件质量有了一定的改善,但与发达国家相比,还存在着很多不足,应用信息化管理有助于提高药物临床试验质量管理。文章对医院II～IV期药物临床试验项目管理系统的总体功能进行介绍,该系统从临床试验项目管理出发,结合药物临床试验运行特点及流程,实现临床试验项目及药物全过程化管理,并与医院信息管理系统（HIS）、实验室信息管理系统（LIS）、医学影像信息系统（PACS）接口,构建起机构办、药物管理部门、检验检查科室与研究者之间的公共信息平台,实现了数据共享。     

Management of Breast Cancer in Old Age

In a retrospective survey of 301 women aged over 70 with breast cancer the factors affectingfive-year survival are evaluated. The local disease is more advanced when the patient presents with it in old age than in younger women, possibly associated with a lesser degree of awareness or a long history of the primary tumour. It is not associated with a different average rate of tumour growth in old age, as measured by scar recurrences after surgery. Radical surgery may be followed by a high five-year survival rate in patients carefully selected on medical grounds, but in this unselected series the five-year survival rate was practically the same whether the local disease was limited or extensive at presentation and whatever the treatment given. The probability of five-year survival in a woman over 70 with breast cancer will depend mainly on her general health.     

Risk-Specific Optimal Cancer Screening Schedules: An Application to Breast Cancer Early Detection

The optimal schedules for breast cancer screening in terms of examination frequency and ages at examination are of practical interest. A decision-theoretic approach is explored to search for optimal cancer screening programs which should achieve maximum survival benefit while balancing the associated cost to the health care system. We propose a class of utility functions that account for costs associated with screening examinations and value of survival benefit under a non-stable disease model. We consider two different optimization criteria: optimize the number of screening examinations with equal screening intervals between exams but without a prefixed total cost; and optimize the ages at which screening should be given for a fixed total cost. We show that an optimal solution exists under each of the two frameworks. The proposed methods may consider women at different levels of risk for breast cancer so that the optimal screening strategies will be tailored according to a woman’s risk of developing the disease. Results of a numerical study are presented and the proposed models are illustrated with various data inputs. We also use the data inputs from the Health Insurance Plan of New York (HIP) and Canadian National Breast Screening Study (CNBSS) to illustrate the proposed models and to compare the utility values between the optimal schedules and the actual schedules in the HIP and CNBSS trials. Here, the utility is defined as the difference in cure rates between cases found at screening examinations and cases found between screening examinations while accounting for the cost of examinations, under a given screening schedule.     

早期乳腺癌的诊断及治疗进展

乳腺癌是全球女性最常见的恶性肿瘤。多年来早期乳腺癌是乳腺肿瘤学家积极关注的焦点之一。早期乳腺癌的长期治愈率达90%以上,其诊断率的提高将大大提高病人的生存率和生存年限,降低病死率。生活方式、环境因素、遗传基因等都是乳腺癌的危险因素。近年来早期乳腺癌发生率不断上升,并趋于年轻化,所以早期预防、早期发现、早期治疗成了治疗早期乳腺癌的关键。早期乳腺癌的治疗从传统的手术治疗发展到以手术为主,放化疗为辅的综合疗法。随着社会的进步和经济的发展,早期乳腺癌的治疗方案渐渐趋于完整。现对早期乳腺癌的诊断和治疗研究进展进行概述,以指导临床。     

Xeromammography in the Early Detection of Breast Cancer: Community Hospital Experience and Approach

Community hospitals can do much in the general effort toward earlier detection of breast cancer. Using xeromammography in the department of general radiology of one community hospital, 21 cases of occult carcinoma were detected in 2,392 patients in a two year period. Patients were both symptomatic and asymptomatic. This percentage is comparable to results in previously published series of similar patient populations, and can be expected to be slightly higher than screening populations of totally asymptomatic patients. In 24 percent of cases of occult carcinoma there was axillary node involvement, compared with 42 percent axillary node involvement in cases of nonoccult carcinoma.Early detection efforts are currently centered on improving thoroughness in physical examinations, stressing breast self-examination and identifying patients in high-risk categories. These, together with proper periodic use of mammograms, will yield the highest rate of early carcinoma detection until more sensitive biologic markers are developed.     

Anti-oestrogen Therapy for Breast Cancer: A Trial of Tamoxifen at Two Dose Levels

Tamoxifen (ICI 46474) was given by mouth to patients with advanced, recurrent, or metastatic breast carcinoma. At a dosage of 10 mg twice daily 60% of patients showed arrest or reversal of tumour growth. At a dosage of 20 mg twice daily 77% showed arrest or reversal of tumour growth. Side effects were usually trivial and their incidence was the same at both dose levels. No patients showed virilization of fluid retention.