Correlation of changes between 2-year disease-free survival and 5-year overall survival in adjuvant breast cancer trials from 1966 to 2006.

BACKGROUND: Although disease-free survival (DFS) is accepted as a valid end point in adjuvant breast cancer trials, improvement in 2-year DFS has never been formally established as an adequate correlate for 5-year overall survival (OS). We set out to ascertain if changes in 2-year DFS can be used to accurately predict 5-year OS changes. DESIGN: We conducted a systematic Medline search (1966-2006) for randomized adjuvant breast cancer trials of >100 patients per arm with 2-year DFS and 5-year OS data. A univariate regression model weighted by trial sample size was constructed to determine whether 2-year DFS differences between treatment arms within trials were predictive of 5-year OS differences. RESULTS: A total of 126 studies containing 149 treatment comparisons met the inclusion criteria. Difference in 2-year DFS was a significant predictor of difference in 5-year OS. For every 1% increase in 2-year DFS difference, the 5-year OS difference increased by 0.5%-0.55%. The proportion of variation explained ranged from 0.38 to 0.42, with a wide prediction interval. CONCLUSION: There is a statistically significant correlation, of moderate strength, between difference in 2-year DFS between treatment comparisons and difference in 5-year OS but the correlation is not strong enough to be used as a predictor.

A comparison of patient adherence and preference of packaging method for oral anticancer agents using conventional pill bottles versus daily pill boxes.

Adherence to medications is an important issue in oncology due to the increasing number of anticancer agents, such as targeted therapies, formulated for oral dosing. A prospective, crossover design was utilized in which patients on capecitabine were randomly assigned to one of two packaging methods for one cycle, and then switched over to the alternate packaging method in the subsequent cycle. Twenty-five patients were accrued to this study. Adherence rates were similar when using the daily pill boxes (17/21 = 81%) and when using the conventional pill bottles (18/21 = 86%). However, more patients were satisfied with the daily pill boxes (61% versus 11%, P = 0.027), preferred the daily pill boxes (61% versus 17%, P = 0.061), and thought the daily pill boxes were more helpful in reminding them to take their medications (50% versus 11%, P = 0.070). In conclusion, this small pilot study did not demonstrate that the use of daily pill boxes improved patient adherence with capecitabine, but patient satisfaction and preference for this packaging method were greater than for the conventional pill bottles. Further exploration of this intervention in a larger study is warranted.

Process water treatment at the Ranger uranium mine, Northern Australia.

The conceptual development and piloting of an innovative water treatment system for process water produced by a uranium mine mill is described. The process incorporates lime/CO2 softening (Stage 1), reverse osmosis (Stage 2) and biopolishing (Stage 3) to produce water of quality suitable for release to the receiving environment. Comprehensive performance data are presented for each stage. The unique features of the proposed process are: recycling of the lime/CO2 softening sludge to the uranium mill as a neutralant, the use of power station off-gas for carbonation, the use of residual ammonia as the pH buffer in carbonation; and the recovery and recycling of ammonia from the RO reject stream.

The ergonomic analysis of a trauma resuscitation room.

Ergonomics is the practical and scientific study of people in relation to their working environment. We describe its application to the operation of a trauma resuscitation room. We used specifically designed computer software. This methodology enables a unique and objective assessment of the design and operation of a clinical system. It may be particularly applicable to other hospital areas where the efficient interaction of staff, patients and equipment is crucial to the optimal clinical outcome.

Computed tomography of intraperitoneal malignancy.

A review of 205 abdominal computed tomographic (CT) scans in 83 patients with gastric or ovarian neoplasms was performed in order to assess their contribution to management. Assessment of scan accuracy was based on results of invasive procedures, clinical data, and double-blind re-reporting. Scans appeared to be of greater value in patients with ovarian rather than gastric neoplasms (p less than 0.001), and in patients undergoing clinically-indicated rather than routine scans (p less than 0.001). No clinical benefit accrued from the use of pre-treatment scans. Overall accuracy of scanning was judged to be significantly greater for the ovarian than the gastric group (p less than 0.001), while concordance of scan reports with re-reporting was also greater in the ovarian group (p less than 0.001). The data indicate the inherent limitations of the CT scan and the high degree of subjectivity in its interpretation, particularly when used in the follow-up of patients with known or suspected recurrent gastric cancer. CT scanning remains a potentially useful adjunct to clinical assessment of patients with intraperitoneal malignancy, but should not be regarded as obviating the need for clinical judgement in management decisions.

Percutaneous biopsy of retroperitoneal lymph nodes. A multicentric study.

Percutaneous transperitoneal biopsy of retroperitoneal lymph nodes is a fast and well tolerated procedure to improve the diagnosis of metastasis for staging primary tumours and general lymphatic disease. In 303 patients examined by lymphography and biopsy, cytology disclosed metastases in almost twice as many patients as lymphography alone. By combining both examinations, staging operations can be omitted in many patients.

Periureteral thin-needle aspiration biopsy.

The relatively common occurrence of ureteral obstruction in patients with known malignancy elsewhere presents an interesting clinical problem. In those who have undergone abdominal surgery or radiation therapy for malignancy, it is difficult to determine whether ureteral obstruction is the complication of therapy or of recurrent metastatic carcinoma. Transperitoneal thin-needle aspiration biopsy provides an acceptable alternative in determining the true cause of the obstruction. This procedure is competitive with explorative surgery and laparoscopy and is much more specific than CT, excretory urography, and other imaging modalities. In our series of 32 patients, biopsy revealed metastatic tumor in 18 patients, thus altering their clinical management.

Technical considerations of interventional radiology. Unit design and coordination of diagnostic pathology services.

With close cooperation between the clinician, radiologist, and pathologist, and with exacting attention to detail, the combined techniques of interventional radiology and diagnostic cytopathology can provide a definitive diagnosis in a large variety of clinical situations. Undoubtedly, the increasing interest in utilization of these methods will expand the number of patients who can benefit from these rapid, safe, relatively inexpensive, and highly accurate diagnostic techniques.

Percutaneous transperitoneal lymph-node biopsy as a means of improving lymphographic diagnosis.

Percutaneous transperitoneal fine-needle lymph-node biopsy was performed in 52 patients to establish a diagnosis of metastatic disease in nodal defects detected during lymphography. The procedure was found to be highly accurate, with few false-negatives and no false-positives.

Fine needle aspiration cytopathology of retroperitoneal lymph nodes in the evaluation of metastatic disease.

Fine needle aspiration biopsy of retroperitoneal lymph nodes was performed in 47 patients with abnormal lymphograms during the course of evaluation for metastatic disease. The biopsies were positive for malignant tumor in 11 patients. Utilizing established cytopathologic criteria a definitive diagnosis could be established. Fine needle aspiration of abnormal lymph nodes detected by lymphography is an easily performed, accurate diagnostic technique.

Ultrasonic detection of myocardial infarction by amplitude analysis.

Myocardial infarctions were produced in dogs by occluding the left anterior descending artery; the dogs were killed at varying times, from 30 minutes to 8 days. Prior to sacrifice, Thioflavin S was injected intravenously. The excised heart was scanned by a B-scanner interfaced with a computer that permitted quantification of signal amplitude. The heart was sectioned, photographed, and studied pathologically. Infarcted myocardium showed high ultrasonic reflectivity with average amplitudes 1.4--2.6 times that of normal muscle. Perfusion-histomorphologic evidence of infarction correlated best in infarcts of 24 hours or less; older infarcts were generally underestimated. Tissue changes, sources of false-positive and false-negative findings, signal processing, and potential clinical utility are discussed.

A needle biopsy would be quickest.

A case of a benign intrathoracic thyroid adenoma which was biopsied percutaneously is described. Except for a routine posterior-anterior (PA) and lateral chest X-ray examination, no preliminary investigations were performed. This resulted in several unnecessary procedures.