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Jeffrey S Abrams

Publications and source records attributed to Jeffrey S Abrams.

15 recordsLinked to original sources
PubMed2006

Duration of letrozole treatment and outcomes in the placebo-controlled NCIC CTG MA.17 extended adjuvant therapy trial.

PURPOSE: MA.17 was a double-blind placebo-controlled trial involving 5187 postmenopausal women that established letrozole to be of value in reducing recurrence of breast cancer when given in the extended adjuvant therapy setting after about 5 years of tamoxifen. Analyses were conducted to examine the relationships between duration of treatment on MA.17 and outcomes. METHODS: The final MA.17 database that included all events up to the date of unblinding of the study was interrogated. A non-parametric kernel smoothing method was used to estimate the hazard rates for disease-free survival (DFS), distant DFS (DDFS) and overall survival (OS) at 6, 12, 24, 36 and 48 months of follow-up and the hazard ratios (HRs) of letrozole to placebo were determined. The trend in HRs over time was tested based on a Cox model with a time-dependent covariate. RESULTS: Considering all patients, HRs for events in DFS and DDFS progressively decreased over time, favoring letrozole, with the trend being significant (p < 0.0001 and p = 0.0013, respectively) whereas the trend for OS was not significant. Considering the 2360 patients with node-positive status, the HRs for DFS, DDFS and OS all decreased over time with tests for trend all showing significance (p = 0.0004, 0.0005 and 0.038, respectively). Considering the 2568 patients with node-negative status, the HRs for DFS decreased over time with the test for trend being significant (p = 0.027) whereas the HRs for DDFS and OS showed no significant change over time. CONCLUSION: These analyses suggest that, at least out to about 48 months, longer duration of letrozole treatment is associated with greater benefit in the extended adjuvant therapy setting.

Aged↗
PubMed2006

Arthroscopic approach to massive rotator cuff tears.

The treatment of a patient with a painful massive rotator cuff tear can be challenging. Massive tears exceed 5 cm in length and involve partial or complete tearing of three tendons. The arthroscopic approach provides a minimally invasive technique to evaluate the tear, mobilize and repair tendons, and improve symptoms without disruption of the deltoid. The arthroscopic technique can create a low-tension repair. The reduction of postoperative motion provides the best environment for tendon-to-bone reattachment. Procedures that have reduced rates of adhesion formation allow for this protection with a minimal risk of stiffness. Reduction of the boutonniere effect of superior head migration leads to improved arm elevation. Strength deficits are common and relate to muscle and tendon deterioration that may not be reversible, even with successful closure of the tear. Weakness caused by suprascapular neuropathy may improve after the position and length of the posterosuperior cuff tendons are reestablished. Arthroscopic options include rotator cuff repair, partial cuff repairs, xenografts, decompression, débridement, biceps tenotomy, tenodesis, and use in autografting.

Arthroscopy↗
PubMed2005

Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17.

BACKGROUND: Most recurrences in women with breast cancer receiving 5 years of adjuvant tamoxifen occur after 5 years. The MA.17 trial, which was designed to determine whether extended adjuvant therapy with the aromatase inhibitor letrozole after tamoxifen reduces the risk of such late recurrences, was stopped early after an interim analysis showed that letrozole improved disease-free survival. This report presents updated findings from the trial. METHODS: Postmenopausal women completing 5 years of tamoxifen treatment were randomly assigned to a planned 5 years of letrozole (n = 2593) or placebo (n = 2594). The primary endpoint was disease-free survival (DFS); secondary endpoints included distant disease-free survival, overall survival, incidence of contralateral tumors, and toxic effects. Survival was examined using Kaplan-Meier analysis and log-rank tests. Planned subgroup analyses included those by axillary lymph node status. All statistical tests were two-sided. RESULTS: After a median follow-up of 30 months (range = 1.5-61.4 months), women in the letrozole arm had statistically significantly better DFS and distant DFS than women in the placebo arm (DFS: hazard ratio [HR] for recurrence or contralateral breast cancer = 0.58, 95% confidence interval [CI] = 0.45 to 0.76; P < .001; distant DFS: HR = 0.60, 95% CI = 0.43 to 0.84; P = .002). Overall survival was the same in both arms (HR for death from any cause = 0.82, 95% CI = 0.57 to 1.19; P = .3). However, among lymph node-positive patients, overall survival was statistically significantly improved with letrozole (HR = 0.61, 95% CI = 0.38 to 0.98; P = .04). The incidence of contralateral breast cancer was lower in women receiving letrozole, but the difference was not statistically significant. Women receiving letrozole experienced more hormonally related side effects than those receiving placebo, but the incidences of bone fractures and cardiovascular events were the same. CONCLUSION: Letrozole after tamoxifen is well-tolerated and improves both disease-free and distant disease-free survival but not overall survival, except in node-positive patients.

Aged↗
PubMed2005

Preliminary data release for randomized clinical trials of noninferiority: a new proposal.

Noninferiority trials often require a long follow-up period for the data to reach the maturity needed for definitive analysis. A proposal is presented that allows for early release of outcome data from a carefully specified subset of noninferiority trials. This subset is defined so that the early release of the data will be potentially useful to patients who face a treatment decision but will not compromise the integrity of the trial or interfere with the completion of the trial to its definitive analysis. In particular, the release of the data will only occur after the last participant has been randomly assigned and is off treatment-arm-specific therapy and only if it is unlikely that subsequent treatment and/or follow-up practices will change based on the knowledge of released data. In contrast to standard interim monitoring, (1) the release of the data would be automatic and independent of the observed data, and (2) the trial would continue on to its planned final analysis and not be stopped. Examples are given demonstrating how the proposal would work, along with a discussion of possible objections to the proposal.

Clinical Trials Data Monitoring Committees↗
PubMed2003

A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer.

BACKGROUND: In hormone-dependent breast cancer, five years of postoperative tamoxifen therapy--but not tamoxifen therapy of longer duration--prolongs disease-free and overall survival. The aromatase inhibitor letrozole, by suppressing estrogen production, might improve the outcome after the discontinuation of tamoxifen therapy. METHODS: We conducted a double-blind, placebo-controlled trial to test the effectiveness of five years of letrozole therapy in postmenopausal women with breast cancer who have completed five years of tamoxifen therapy. The primary end point was disease-free survival. RESULTS: A total of 5187 women were enrolled (median follow-up, 2.4 years). At the first interim analysis, there were 207 local or metastatic recurrences of breast cancer or new primary cancers in the contralateral breast--75 in the letrozole group and 132 in the placebo group--with estimated four-year disease-free survival rates of 93 percent and 87 percent, respectively, in the two groups (P< or =0.001 for the comparison of disease-free survival). A total of 42 women in the placebo group and 31 women in the letrozole group died (P=0.25 for the comparison of overall survival). Low-grade hot flashes, arthritis, arthralgia, and myalgia were more frequent in the letrozole group, but vaginal bleeding was less frequent. There were new diagnoses of osteoporosis in 5.8 percent of the women in the letrozole group and 4.5 percent of the women in the placebo group (P=0.07); the rates of fracture were similar. After the first interim analysis, the independent data and safety monitoring committee recommended termination of the trial and prompt communication of the results to the participants. CONCLUSIONS: As compared with placebo, letrozole therapy after the completion of standard tamoxifen treatment significantly improves disease-free survival.

Adult↗
PubMed2003

Arthroscopic repair of posterior instability and reverse humeral glenohumeral ligament avulsion lesions.

Posterior glenohumeral subluxation is not as uncommon as once believed. Unidirectional instability as a result of a traumatic event or the primary direction of multidirectional instability as a result of overuse can lead to recurrent involuntary subluxations. Failure of the posterior restraints can occur at the glenoid labral attachment, mid-capsule, and laterally, as in a RHAGL avulsion. Soft tissue reattachment to bone is by way of suture anchors. This may occur at the glenoid medially or laterally along the humeral head insertion (RHAGL lesion). Capsular plication and superior shift can obliterate the capsular pouch. Additional labral lesions superiorly and anteriorly are repaired to centralize the humeral head and reduce the possibility of subcoracoid and subacromial impingement. Recurrence rates are reduced with symmetric repairs that address multiple lesions that are not always seen with a unidirectional open approach. Capsular tears, detachments, and the rotator capsular interval are reduced with minimal alterations in range of motion. Immobilization is combined with intermittent range of motion exercises. Protective scapular and rotator strengthening is a prerequisite before return to strenuous activities. Surgical repair followed by a well monitored rehabilitation protocol can return most individuals back to sport and vocation.

Arthroscopy↗
PubMed2002

Complications associated with arthroscopic shoulder surgery.

We review the literature on complication of arthroscopic shoulder surgery and their management. Computer data based searches were used to identify articles regarding complications of shoulder arthroscopy, as well as hand searches of Arthroscopy and Journal of Shoulder and Elbow Surgery over the last decade. Arthroscopic shoulder surgery has become a popular therapeutic and diagnostic procedure during the past two decades. As with all interventions complications can occur which require recognition and management by the orthopedic surgeon. While the literature is helpful with identifying types of complications, establishing the rate of these complications remains elusive. These complications can be divided into general complications, complications generic to all shoulder procedures, and complications specific to the type of procedure performed. General complications such as infection and anesthesia problems continue to show low incidences. Shoulder arthroscopy presents increased risk of complications over knee arthroscopy in regard to vascular and neurologic injury, fluid extravasation, stiffness, iatrogenic tendon injury, and equipment failure. New techniques of increased complexity for subacromial surgery, rotator cuff repair, and arthroscopic instability present new problems related to implant failure, nerve injury, iatrogenic fracture, and capsular necrosis. While the rate of complications especially with newer procedures remain elusive, most studies suggest that the rate is low, 5.8-9.5% in all recent review studies published. Underreporting complications makes assessment of incidence rates of complication difficult. Proper patient selection, attention to operative detail, and careful post-operative monitoring can minimize the morbidity associated with these complications.

Arthroscopy↗
PubMedDate not supplied

Arthroscopic Bankart reconstruction with a bioabsorbable anchor.

This study evaluated the clinical effectiveness of a poly-l-lactic acid biodegradable suture anchor for arthroscopic Bankart reconstruction with a prospective multicenter study. Inclusion criteria were one or more episodes of traumatic dislocation or multiple posttraumatic subluxations as a manifestation of unidirectional anterior instability. Exclusion criteria were significant glenoid bone deficiency, large Hill-Sachs lesions, rotator cuff tears, multidirectional instability, posterior labrum tears, or biceps ruptures. Fifty-seven patients were followed up for a mean of 24 months. Postoperative apprehension tests were negative in all but two. Motion improved from 155 degrees preoperatively to a mean of 175 degrees postoperatively. Four patients had postoperative instability symptoms (two dislocators and two with subluxations). Postoperative radiographs demonstrated no lytic or resorptive bone changes from the suture anchors. The mean postoperative Rowe score was 93. The biodegradable suture anchor achieved good clinical results when used for arthroscopic Bankart reconstruction with no material-related adverse events.

Absorbable Implants↗