A non-computerised method of accurate prospective analysis of the quantitative aspects of the work of a general histopathology laboratory was devised. The method entails monitoring the progress of all biopsy and cytology specimens through the laboratory during selected monthly periods of study. The data collected include details of specimen type, block/section/stain details for each specimen, and information about the timed progress through technical, medical, and secretarial stages of specimen/report handling. The results give a detailed breakdown of the biopsy and cytology workload of this department. They give information about the rate of passage of specimens through the system and identify reasons for delay in the reporting of some cases. The method is easy to operate and will allow for the analysis of specific effects--for example, staff changes--on the efficiency of the department. The data will also provide some of the information required for the costing of histopathology laboratory services, and the type of information obtained will probably become a necessary requirement for laboratory accreditation.
ObjectivesAudit data consistently report around 60% of UK women aged ?80 years old do not have surgery fortheir breast cancer (compared with < 10% of younger women). However, previous studies have notadjusted for patient co-morbidity. We have therefore investigated the extent to which age-associateddifferences in breast cancer surgery rates, amongst women aged ?65 years, can be accounted for byco-morbidity.MethodsWomen with invasive breast cancer diagnosed between 1997- 2005 in the Northern & Yorkshire andWest Midlands regions were identified from cancer registration, along with whether surgery wasreceived. Linkage to Hospital Episode Statistics (HES) was used to estimate co-morbidity in thepreceding year. The Charlson co-morbidity score (range 0 [no co-morbidity] to 6 [greatest comorbidity])was derived from clinical coding within HES. In addition to co-morbidity, the impact oftumour stage, deprivation, year and region on treatment received were also examined.ResultsRecords were available for 23,038 women aged ?65 years. The proportion receiving surgery fell in thepresence of increasing co-morbidity (Charlson score 0= 74%, score 1= 66%, score 2= 52%, score3+=43%) However, after adjustment for co-morbidity and other covariates, older age continued topredict lack of surgery. Compared to 65-69 year olds, the odds of surgery decreased with age from0.74 (95% CI: 0.66-0.83) for 70-74 year olds to 0.13 (95% CI: 0.11-0.14) for women aged ?85 years.The proportion of women receiving surgery was significantly lower in more deprived areas, butincreased with each successive diagnosis year group.ConclusionsWhilst co-morbidity, as measured in administrative data, is associated with a reduced likelihood ofsurgery, it does not explain the apparent shortfall in surgery amongst older women in the UK. Futureresearch should consider the importance of patient preferences for treatment in addition toindividual-level measures of co-morbidity and frailty.
Abstract Background: The independent review of the UK National Health Service Breast Screening Programme reported (The Lancet, Volume 380, Issue 9855, Page 1778, 17 Nov 2012) on the benefits and harms of breast screening. It concluded that breast screening saves lives and acknowledged the existence of overtreatment. It encouraged randomized trials to elucidate the appropriate treatment of screen-detected DCIS to gain a better understanding of its natural history. The LORIS trial addresses the possible overtreatment of low and low/intermediate grade screen-detected (low risk) DCIS by randomizing patients to standard surgical treatment or active monitoring, each with long term follow up. Trial Design: LORIS is a phase III, multicentre, 2 arm study, with a built in 2 year Feasibility Phase, in patients confirmed to have low risk DCIS defined by strict criteria and determined by central pathology review. Patients will be randomized between standard surgery and active monitoring with annual mammography. Patients will be followed up for a minimum of 10 years. Eligibility Criteria: 1) Female, age ≥ 46 years 2) Screen-detected or incidental microcalcification (with no mass lesion clinically or on imaging) 3) Low risk DCIS on large volume vacuum-assisted biopsy, confirmed by central pathology review 4) Patient fit to undergo surgery 5) No previous breast cancer or ipsilateral DCIS diagnosis 6) Written informed consent Specific Aims: The LORIS Trial aims to establish whether patients with newly diagnosed low risk DCIS can safely avoid surgery without detriment to their wellbeing (psychological and physical) and whether those patients that do require surgery can be identified by pathological and radiological means. Primary endpoint: Ipsilateral invasive breast cancer free survival time Secondary endpoints: Overall survival; mastectomy rate; time to mastectomy; time to surgery; patient reported outcomes; health resource utilisation and assessment of predictive biomarkers. A digital image data repository and tissue bank will provide a prospective resource for both translational and imaging studies. Statistical Methods: A total of 932 patients will be randomized to a non-inferiority design to test the null hypothesis that active monitoring of women diagnosed with low risk DCIS is not non-inferior in terms of ipsilateral invasive breast cancer free survival (iiBCFS) time compared to treatment with surgery. The iiBCFS time will be compared across the two arms on a per protocol and intent-to-treat basis, using a 1-sided (α=0.05) log-rank test for non-inferiority. The iiBCFS rate is assumed to be 97.5% in the surgery arm at 5 years, utilizing 80% power to exclude a difference of more than 2.5% in the active monitoring arm. Present Accrual and Target Accrual: 32 UK centres are open for the Feasibility Phase of the trial which is nearing completion. The web-based central pathology review process is functioning efficiently, with a one week maximum turn around. Registrations and sites randomizing patients are on or above target. Randomizations are currently approximately 70% of target. A total of 60 centres will open in the main trial. Contact Information: For further information, please email the LORIS Trial Office LORIS@trials.bham.ac.uk. Citation Format: Francis A, Bartlett J, Billingham L, Bowden S, Brookes C, Dodwell D, Evans A, Fairbrother P, Fallowfield L, Gaunt C, Hanby A, Jenkins V, Matthews L, Pinder S, Pirrie S, Rea D, Reed M, Roberts T, Thomas J, Wallis M, Wilcox M, Young J. The UK LORIS trial: Randomizing patients with low or low intermediate grade ductal carcinoma in situ (DCIS) to surgery or active monitoring [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT1-03-01.