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ObjectiveTo assess the long-term safety of no axillary clearance in elderly patients with breast cancer and nonpalpable axillary nodes.BackgroundLymph node evaluation in elderly patients with early breast cancer and clinically negative axillary nodes is controversial. Our randomized trial with 5-year follow-up showed no breast cancer mortality advantage for axillary clearance compared with observation in older patients with T1N0 disease.MethodsWe further investigated axillary treatment in a retrospective analysis of 671 consecutive patients, aged ≥70 years, with operable breast cancer and a clinically clear axilla, treated between 1987 and 1992; 172 received and 499 did not receive axillary dissection; 20 mg/day tamoxifen was prescribed for at least 2 years. We used multivariable analysis to take account of the lack of randomization.ResultsAfter median follow-up of 15 years (interquartile range 14–17 years) there was no significant difference in breast cancer mortality between the axillary and no axillary clearance groups. Crude cumulative 15-year incidence of axillary disease in the no axillary dissection group was low: 5.8% overall and 3.7% for pT1 patients.ConclusionsElderly patients with early breast cancer and clinically negative nodes did not benefit in terms of breast cancer mortality from immediate axillary dissection in this nonrandomized study. Sentinel node biopsy could also be foregone due to the very low cumulative incidence of axillary disease in this age group. Axillary dissection should be restricted to the small number of patients who later develop overt axillary disease.

Older patients with T1N0 breast cancer can be treated by conservative breast surgery and no axillary dissection without adversely affecting breast cancer mortality or overall survival. The very low cumulative incidence of axillary events suggests that even sentinel node biopsy is unnecessary in these patients. Axillary dissection should be reserved for the small proportion of patients who later develop overt axillary disease.

Older patients with early breast cancer and a clinically clear axilla treated by conservative surgery, postoperative radiotherapy, and adjuvant tamoxifen do not benefit from axillary dissection. This study was registered at clinicaltrials.gov (ID NCT00002720).

Abstract Background Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. Methods We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. Results For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77–1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). Conclusions In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

The utility of fine needle aspiration (FNA) and physical examination for selecting patients with palpable thyroid nodules for surgery was evaluated in 795 consecutive cases. Surgery was performed in 216 patients based upon the cytological diagnosis and clinical criteria. Excluding 42 patients who were lost to follow-up, the remaining 537 were regularly followed up (range, 2-10 years). Cytological findings were classified as malignant, histologic control recommended (suspicious), follicular tumor, benign, and unsatisfactory. Thirty-six aspiration biopsies were positive for malignancy and the diagnosis was confirmed histologically in 34 of them. In 65 patients with final histological diagnosis of malignancy, cytology was positive in 34, suspicious in 20, benign in 3 cases, and unsatisfactory in 8. All patients with cytological diagnosis of follicular tumor had a benign lesion at histology. There were two false positive and three false negative cytological results among the 216 histologically confirmed cases. Excluding unsatisfactory specimen sensitivity, specificity and the predictive value for a positive and a negative result were respectively 95%, 97.5%, 94.5%, and 97%. We conclude that FNA is a very reliable diagnostic test in the evaluation of thyroid nodules and is the best guidance in addition to clinical criteria for selecting patients to be submitted to surgery.

BACKGROUND: Although axillary surgery is still considered to be a fundamental part of the management of early breast cancer, it may no longer be necessary either as treatment or as a guide to adjuvant treatment. The authors conducted a single-center randomized trial (INT09/98) to determine the impact of avoiding axillary surgery in patients with T1N0 breast cancer and planning chemotherapy based on biological factors of the primary tumor on long-term disease control. METHODS: From June 1998 to June 2003, 565 patients aged 30 years to 65 years with T1N0 breast cancer were randomized to either quadrantectomy with (QUAD) or without (QU) axillary lymph node dissection; a total of 517 patients finally were evaluated. All patients received radiotherapy to the residual breast only. Chemotherapy for patients in the QUAD treatment arm was determined based on lymph node status, estrogen receptor status, and tumor grade. Chemotherapy for patients in the QU treatment arm was based on estrogen receptor status, tumor grade, and human epidermal growth factor receptor 2 and laminin receptor status. Overall survival (OS) was the primary endpoint. Disease-free survival (DFS) and rate and time of axillary lymph node recurrence in the QU treatment arm were the secondary endpoints. RESULTS: After a median follow-up of >10 years, the estimated adjusted hazards ratio of the QUAD versus QU treatment arms for OS was 1.09 (95% confidence interval, 0.59-2.00; P 5.783) and was 1.04 (95% confidence interval, 0.56-1.94; P 5.898) for DFS. Of the 245 patients in the QU treatment arm, 22 (9.0%) experienced axillary lymph node recurrence. The median time to axillary lymph node recurrence from breast surgery was 30.0 months (interquartile range, 24.2 months-73.4 months). CONCLUSIONS: Patients with T1N0 breast cancer did not appear to benefit in terms of DFS and OS from immediate axillary lymph node dissection in the current randomized trial. The biological characteristics of the primary tumor appear adequate for guiding adjuvant treatment. Cancer 2014;120:885-93.

The clinical-radiologic-cytologic triplet was used for diagnostic evaluation in 1708 women over 30 years old with a breast lump. All the lumps were subjected to surgery except for 258 cases in which clinical resolution took place within 1-2 months. Seven-hundred and ninety-three out of 1450 nodules removed were cancers. Sensitivity of the clinical, mammographic and cytologic examinations was 82%, 73% and 68%, respectively. It increased to 95% when they were associated. Specificity was 63%, 80% and 97%, respectively. The predictive value of positive results of the triple test was 100%. No patient with malignant cytology was subsequently shown to have benign disease. The systematic use of the triple test in solid breast lumps for the early detection of cancer is recommended as a routine procedure. However, participation of experienced radiologists and pathologists as well as physicians skilled in fine needle puncture is required.