Residual metastatic axillary lymph nodes following neoadjuvant chemotherapy predict disease-free survival in patients with locally advanced breast cancer

BACKGROUND: This study was performed to validate the prognostic significance of residual axillary lymph node metastases in patients with locally advanced breast cancer (LABC) treated with neoadjuvant chemotherapy and to analyze other clinicopathologic factors that might be independent predictors of disease-free survival (DFS) in an attempt to identify patients in whom axillary dissection might be omitted. METHODS: One hundred sixty-five assessable patients with LABC were treated in a prospective trial of neoadjuvant chemotherapy utilizing four cycles of 5-fluorouracil, doxorubicin, and cyclophosphamide. Responding patients were treated with segmental mastectomy and axillary dissection or modified radical mastectomy. Patients subsequently received additional chemotherapy followed by irradiation of the breast or chest wall and draining lymphatics. The median follow-up was 35 months. RESULTS: Clinical tumor response to neoadjuvant chemotherapy (P = 0.046) and the number of residual metastatic axillary lymph nodes found at axillary dissection (P = 0.05) were the only independent predictors of DFS. Patients with a complete clinical response had a predictably excellent DFS and those with no change or progressive disease had a poor DFS. In patients with a partial response, the number of residual metastatic lymph nodes further stratified patients with respect to DFS (P = 0.006). CONCLUSIONS: Clinical response and residual metastatic axillary lymph nodes following neoadjuvant chemotherapy are important predictors of DFS. Patients with a clinically positive axilla following neoadjuvant chemotherapy should undergo axillary dissection to ensure local control. However, the benefit of axillary dissection in patients with a clinically negative axilla may be minimal if the axilla will be irradiated, and histologic staging does not affect subsequent systemic treatment. A prospective randomized trial of axillary dissection versus axillary radiotherapy in patients with a clinically negative axilla following neoadjuvant chemotherapy is presently under way to evaluate this hypothesis.     

Efficacy of ceftriaxone versus cefazolin in the prophylactic management of extra-articular cortical violation of bone due to low-velocity gunshot wounds

One hundred patients sustained gunshot wounds involving bone but not joint with a low-velocity bullet. Soft-tissue involvement was less than 1 cm at its greatest diameter. All patients were free from artery or nerve damage. No formal fixation of fracture was required. The results of the study suggest that patients need not be hospitalized longer than 2 days after an extra-articular, low-velocity gunshot wound that violates the cortex. In addition, through the use of long half-life antibiotics, such as ceftriaxone, the length of hospitalization may further be reduced to a day, while the potential for morbidity from infection is not increased.     

Place of transvaginal sonography in the evaluation of reproductive endocrinology

A high frequency vaginal probe with improved resolution offers a remarkable sharp clear image of pelvic organs. This is possible because of its closed proximity with target organ and non-intervention by gut or omentum. Study of ovarian follicular dynamics (folliculometry), identification of proliferative, secretory and decidual changes of endometrium (endometrial dating) in different phases of menstrual cycle and imaging of mucus secretion in the cervical canal (cervical mucus study) in the pre-ovulatory phase is possible by transvaginal probe. It is non-invasive, acceptable to patients, and thus can be repeated any number of times. A close serial monitoring offers immense wealth of information about the anatomical as well as reproductive endocrinal status of the patient. Ovulation can be predicted in advance. The case of dysovulation can be identified in first cycle of study; corrective therapy can be started in another two or three cycles, aiming at achieving perfect folliculogenesis. Once well tuned synchronised cycle is restored, the pregnancy outcome is remarkable. Thus transvaginal sonography offers one of the best reproductive endocrinology evaluation in the hand of a modern gynaecological sonologist and infertility specialist.     

The cost-effectiveness of mammographic screening strategies

OBJECTIVE: To compare and analyze the cost-effectiveness of different mammographic screening strategies. DESIGN: A computer simulation model was developed to compare mammographic screening with observation without screening. Cost-effectiveness was expressed as marginal cost per year of life saved (MCYLS) and was calculated for the following mammographic screening strategies: (1) annual for ages 40 to 79 years; (2) annual for ages 50 to 79 years; (3) biennial for ages 50 to 79 years; (4) annual for ages 40 to 49 years with biennial for ages 50 to 79 years; (5) annual for ages 40 to 64 years with biennial for ages 65 to 79 years; (6) biennial for ages 40 to 49 years with annual for ages 50 to 79 years; and (7) annual for high-risk and biennial for normal-risk women aged 40 to 49 years with annual for ages 50 to 79 years. DATA SOURCES: The probability and cost of all outcomes were established from previously published data or community experience. RESULTS: The most cost-effective screening strategy is biennial mammography for women aged 50 to 79 years, with an MCYLS of $16,000. Adding annual mammography for women aged 40 to 49 years increases the MCYLS to $20,200, but is more cost-effective than other tested protocols that included women in their 40s; annual mammography for ages 40 to 49 years with biennial for ages 50 to 79 years is also more cost-effective than annual mammography for ages 50 to 79 years. CONCLUSION: Screening programs that include women in their 40s can be as cost-effective as some that exclude such women. Choice of a screening strategy depends on financial resources and desired effectiveness.     

Sequential monitoring of survival data with the Wilcoxon statistic

When a spending function is used in sequential data monitoring of a clinical trial, it is important to know the information fraction at the times of interim analysis. In a maximum duration designed study, the information fraction is unknown when data are monitored, and it has to be estimated. The modified Wilcoxon statistic developed by Peto and Peto and modified by Prentice is often used to compare two survival curves in a clinical trial. We give guidelines for estimating the information fraction in a maximum duration trial when this statistic is employed. When there is a relatively low event rate or the survival time is approximately exponential, the information fraction for the Peto-Peto-Prentice Wilcoxon statistic is very close to that of the popular logrank statistic. In other cases, it would be helpful to estimate the information fraction as a function of elapsed calendar time. We discuss both group sequential and continuous monitoring.