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Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.

PURPOSE: The 21-gene recurrence score (RS) assay quantifies the likelihood of distant recurrence in women with estrogen receptor-positive, lymph node-negative breast cancer treated with adjuvant tamoxifen. The relationship between the RS and chemotherapy benefit is not known. METHODS: The RS was measured in tumors from the tamoxifen-treated and tamoxifen plus chemotherapy-treated patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B20 trial. Cox proportional hazards models were utilized to test for interaction between chemotherapy treatment and the RS. RESULTS: A total of 651 patients were assessable (227 randomly assigned to tamoxifen and 424 randomly assigned to tamoxifen plus chemotherapy). The test for interaction between chemotherapy treatment and RS was statistically significant (P = .038). Patients with high-RS (> or = 31) tumors (ie, high risk of recurrence) had a large benefit from chemotherapy (relative risk, 0.26; 95% CI, 0.13 to 0.53; absolute decrease in 10-year distant recurrence rate: mean, 27.6%; SE, 8.0%). Patients with low-RS (< 18) tumors derived minimal, if any, benefit from chemotherapy treatment (relative risk, 1.31; 95% CI, 0.46 to 3.78; absolute decrease in distant recurrence rate at 10 years: mean, -1.1%; SE, 2.2%). Patients with intermediate-RS tumors did not appear to have a large benefit, but the uncertainty in the estimate can not exclude a clinically important benefit. CONCLUSION: The RS assay not only quantifies the likelihood of breast cancer recurrence in women with node-negative, estrogen receptor-positive breast cancer, but also predicts the magnitude of chemotherapy benefit.

Adult↗

Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer.

OBJECTIVE: To appraise the economics of a recurrence score (RS), based on an assay that predicts distant recurrence-free survival in lymph-node-negative (LN-), estrogen-receptor-positive (ER+) patients with early-stage breast cancer receiving tamoxifen. STUDY DESIGN: Cost-utility analyses using a decision analytic model. METHODS: Using a Markov model, we forecast overall survival, costs, and cost effectiveness of using the RS in patients classified as having low or high risk of distant recurrence based on National Comprehensive Cancer Network (NCCN) clinical guidelines. Data from a large multicenter clinical trial (NSABP B-14) were analyzed to derive risk classification based on guideline criteria and RS assignments. Efficacy of adjuvant chemotherapy (CT) on distant recurrence-free survival (DRFS) was based on published meta-analyses of CT trials. The analysis took a societal perspective, considering survival, quality of life, and relevant costs. RESULTS: Fifty-three patients (8%) were classified as having low risk of distant recurrence by NCCN guidelines and the RS reclassified 15 of these patients (28%) to an intermediate/high-risk group. The remaining 615 patients (92%) were classified at high risk of distant recurrence by NCCN guidelines and the RS reclassified 300 of these patients (49%) to a low-risk group. Among a hypothetical cohort of 100 patients, RS is predicted on average to increase quality-adjusted survival by 8.6 years and reduce overall costs by $202 828. RS was cost saving in more than two-thirds of probabilistic simulations, with cost effectiveness most influenced by the propensity to administer CT based on RS results, and by the proportion of patients at low risk as defined by NCCN guidelines. CONCLUSIONS: The RS predicts more accurately than current guidelines recurrence risk in LN-, ER+ patients with early-stage breast cancer. If applied appropriately, the assay is predicted to increase quality-adjusted survival and save costs.

Breast Neoplasms↗

Recurrent rectal prolapse: what is the next good option?

PURPOSE: The aim of this study was to assess the clinical and functional outcome of surgery for recurrent rectal prolapse and compare it with the outcome of patients who underwent primary operation for rectal prolapse. METHODS: All patients who underwent surgery for rectal prolapse were evaluated for age, gender, procedure, anorectal manometry and electromyography findings, and morbidity. The results for patients who underwent surgery for recurrent rectal prolapse were compared with a group of patients matched for age, gender, surgeon, and procedure who underwent primary operations for rectal prolapse. RESULTS: A total of 115 patients underwent surgery for rectal prolapse. Twenty-seven patients, 10 initially operated on at this institution and 17 operated on elsewhere, underwent surgery for recurrent rectal prolapse. These 27 patients were compared with 27 patients with primary rectal prolapse operated on in our department. In the recurrent rectal prolapse group, prior surgery included rectopexy in 7 patients, Delorme's procedure in 7 patients, perineal rectosigmoidectomy in 7 patients, anal encirclement procedure in 4 patients, and resection rectopexy in 2 patients. Operations performed for recurrence were perineal rectosigmoidectomy in 14 patients, resection rectopexy in 8 patients, rectopexy in 2 patients, pelvic floor repair in 2 patients, and Delorme's procedure in 1 patient. There were no statistically significant differences between the groups in preoperative incontinence score (recurrent rectal prolapse, 13.6 +/- 7.8 vs. rectal prolapse, 12.7 +/- 7.2; range, 0-20) or manometric or electromyography findings, and there were no significant differences in mortality (0 vs. 3.7 percent), mean hospital stay (5.4 +/- 2.5 vs. 6.9 +/- 2.8 days), anastomotic complications (anastomotic stricture (0 vs. 7.4 percent), anastomotic leak (3.7 vs. 3.7 percent) and wound infection (3.7 vs. 0 percent), postoperative incontinence score (2.8 +/- 4.8 vs. 1.5 +/- 2.7), or recurrence rate (14.8 vs. 11.1 percent) between the two groups at a mean follow-up of 23.9 (range, 6-68) and 22 (range, 5-55) months, respectively. The overall success rate for recurrent rectal prolapse was 85.2 percent. CONCLUSION: The outcome of surgery for rectal prolapse is similar in cases of primary or recurrent prolapse. The same surgical options are valid in both scenarios.

Adult↗

Kangal hot spring with fish and psoriasis treatment.

The effect of "Kangal Hot Spring with Fish" in the treatment of psoriasis is investigated. The study was carried out on 87 patients with psoriasis vulgaris and the patients were evaluated by a dermatologist for 21 days. The evaluation of the disease was performed using PASI (Psoriasis Area and Severity Index) scores. Recurrences were investigated in the patient population, who had been previously treated in the same hot spring. The first examination scores were significantly higher than the scores of the 3, 6, 9, 12, 15 and 21 days after treatment (p < 0.01). Longer remission periods, when compared to the topical corticosteroid treatment, expressed by the 35 patients previously treated in hot spring (p < 0.01). Spa therapy under observation of a dermatologist may be effective and useful for psoriasis vulgaris patients.

Adolescent↗

Dupuytren's contracture: an audit of the outcomes of surgery.

This multi-centre postal questionnaire study was conducted by the Audit Committee of the BSSH to assess the outcomes of surgery for Dupuytren's Contracture using subjective data provided by 1177 patients at a mean follow-up of 27 (SD 8) months after surgery. Surgery for Dupuytren's contracture achieved a high rate of full, or almost full, correction in 826 patients (75%) but had a high incidence of post-operative patient-reported complications of 46%. A higher complication rate was seen in those patients with worse initial deformities. The rate of contracture recurrence or persistence was 158 of 1037 (15%). The severity of contracture correlated with the final hand function measured using the PEM score. Recurrence was more common in patients with greater initial deformity. Recurrence was less common if good correction was achieved at surgery. The relevance and limitations of this data are discussed.

Dupuytren Contracture↗

Prediction of functional disability, recurrences, and chronicity after 1 year in 180 patients who required sick leave for acute low-back pain.

The aim of the study was to identify factors that predict low-back pain outcome at 12 months and thus to identify patients at risk for poor long-term outcomes. One hundred-eighty patients, all disabled by acute low-back pain, were included. Outcome (dependent) variables were Oswestry disability score, recurrences during the study year, and chronicity defined as 90 or more days off work for low-back pain during the study year, or a disease-specific sick-leave rate (a variable created by the authors) of more than 25%. Stepwise logistic regression analysis was performed. Thirty-three percent of the patients had an Oswestry score greater than 25, indicating moderate disability at the 1-year follow-up evaluation. Pain on coughing at study entry predicted a high likelihood of disability at 1 year, with a threefold risk. Many work days missed as a result of low-back pain in the past 2 years and lack of stimulating work tasks predicted recurrences during the year. A high Oswestry score assessed at study entry was the only factor that predicted chronicity. The factors revealed in the current study should help the clinician to identify patients at risk. The authors propose that the revealed predictors should be investigated extensively at the patient's first visit for acute low-back pain.

Adult↗

A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients.

INTRODUCTION: The Oncotype DX assay was recently reported to predict risk for distant recurrence among a clinical trial population of tamoxifen-treated patients with lymph node-negative, estrogen receptor (ER)-positive breast cancer. To confirm and extend these findings, we evaluated the performance of this 21-gene assay among node-negative patients from a community hospital setting. METHODS: A case-control study was conducted among 4,964 Kaiser Permanente patients diagnosed with node-negative invasive breast cancer from 1985 to 1994 and not treated with adjuvant chemotherapy. Cases (n = 220) were patients who died from breast cancer. Controls (n = 570) were breast cancer patients who were individually matched to cases with respect to age, race, adjuvant tamoxifen, medical facility and diagnosis year, and were alive at the date of death of their matched case. Using an RT-PCR assay, archived tumor tissues were analyzed for expression levels of 16 cancer-related and five reference genes, and a summary risk score (the Recurrence Score) was calculated for each patient. Conditional logistic regression methods were used to estimate the association between risk of breast cancer death and Recurrence Score. RESULTS: After adjusting for tumor size and grade, the Recurrence Score was associated with risk of breast cancer death in ER-positive, tamoxifen-treated and -untreated patients (P = 0.003 and P = 0.03, respectively). At 10 years, the risks for breast cancer death in ER-positive, tamoxifen-treated patients were 2.8% (95% confidence interval [CI] 1.7-3.9%), 10.7% (95% CI 6.3-14.9%), and 15.5% (95% CI 7.6-22.8%) for those in the low, intermediate and high risk Recurrence Score groups, respectively. They were 6.2% (95% CI 4.5-7.9%), 17.8% (95% CI 11.8-23.3%), and 19.9% (95% CI 14.2-25.2%) for ER-positive patients not treated with tamoxifen. In both the tamoxifen-treated and -untreated groups, approximately 50% of patients had low risk Recurrence Score values. CONCLUSION: In this large, population-based study of lymph node-negative patients not treated with chemotherapy, the Recurrence Score was strongly associated with risk of breast cancer death among ER-positive, tamoxifen-treated and -untreated patients.

Antineoplastic Agents, Hormonal↗

Development and Validation of a Multimodal Clinical, Pathologic, and Genomic Model for Breast Cancer Recurrence.

PURPOSE: To develop and validate a multimodal recurrence-risk model integrating histology, genomic testing, and clinical variables. METHODS: We developed AI-Path, a whole-slide image biomarker for recurrence prediction trained in CALGB 9344, and validated it in three independent cohorts: TAILORx, a multi-site Chicago cohort, and the MDX-BRCA cohort. We then integrated AI-Path with Oncotype DX Recurrence Score (RS), tumor size, and nodal status into a Cox model, PathClinRS, fit using 60% of cases from TAILORx, with the remaining 40% held out for validation. The primary end point was distant recurrence-free interval. Performance was assessed using Harrell's concordance index (C-index) and Kaplan-Meier analyses. RESULTS: A total of 12,418 patients were included. In TAILORx, AI-Path outperformed RS for distant recurrence (C-index, 0.682 vs 0.647; P = .038), driven by superior prediction of late recurrence (0.656 vs 0.567; P < .001). In node-negative disease, PathClinRS outperformed RSClin in the TAILORx fitting (0.72 vs 0.70; P = .016) and validation sets (0.74 vs 0.70; P = .004). In node-positive disease, PathClinRS outperformed RSClinN+ in Chicago (0.94 vs 0.74; P < .001) and MDX-BRCA (0.71 vs 0.66; P = .004) cohorts. Compared with NATALEE eligibility, PathClinRS identified nearly twice as many high-risk node-negative patients while maintaining a comparable 10-year distant recurrence risk (16.7% vs 16.6% per NATALEE eligibility in TAILORx fitting; 21.0% vs 19.4% in TAILORx validation). PathClinRS identified 68% of intermediate risk premenopausal patients as low-risk with no evidence of chemotherapy benefit, compared to only 36% identified as low risk by standard clinicopathologic criteria. CONCLUSION: Digital histopathology provides prognostic information complementary to genomic assays and has the potential to personalize therapy beyond existing clinicogenomic tools.

Journal Article↗

Bankart repair in traumatic anterior shoulder instability: open versus arthroscopic technique.

PURPOSE: The purpose of this study was to compare the results of open and arthroscopic Bankart repair using suture anchors in traumatic anterior glenohumeral instability. Variables measured were recurrence rate, range of motion, and return to preinjury activity. TYPE OF STUDY: Case control study. METHODS: Eighty-nine shoulders in 88 patients with traumatic unilateral anterior shoulder instability were evaluated using Rowe and University of California Los Angeles scores, recurrence, return to activity, and range of motion by an independent examiner at an average of 39 months after either an arthroscopic or open Bankart repair using suture anchors. The arthroscopic technique included a minimum of 3 anchors in most patients and a routine incorporation of capsular plication and proximal shift. Of the 89 shoulders, 30 shoulders (30 patients) underwent open Bankart repair and 59 shoulders (58 patients) underwent arthroscopic Bankart repair. RESULTS: Twenty-six shoulders (86.6%) in the open repair group showed excellent or good results, and 54 (91.5%) shoulders in the arthroscopic repair group showed excellent or good results. The arthroscopic group revealed slightly higher scores in the Rowe (P =.041) and UCLA scores (P =.026). Two patients (6.7%) in the open repair group and 2 (3.4%) in the arthroscopic repair group had experienced at least 1 episode of redislocation after the surgery. One patient (3.3%) in the open repair group and 4 (6.8%) in the arthroscopic repair group demonstrated mild apprehension. The overall residual instability was 10% in the open repair group and 10.2% in the arthroscopic repair group. There were no significant differences in the loss of external rotation and return to prior activity between the 2 groups (P >.05). Residual instability occurred more frequently in patients with fewer anchors. CONCLUSIONS: Arthroscopic suture anchor capsulorraphy showed similar results to the open Bankart procedure.

Adolescent↗

Quantitative evaluation of recurrent meningiomas.

Clinical, histological and karyometric parameters, nuclear DNA content and the number of nucleolar organizer regions were investigated in 9 recurrent meningiomas and 10 meningiomas which had not recurred within a 10-year period. There were no significant differences between the two groups as to age, sex, site of the tumours and most of the histological parameters scored. Recurrent tumours showed a higher number of mitotic figures and the nucleolus was visible in most of the cells. Cell density, nuclear area, perimeter and nuclear DNA content had values with no statistically significant differences between the two groups. However, significant differences were found in the distribution of the nuclei in the different ploidy regions. Most of the nuclei in the non recurrent cases were in the diploid range, whereas in recurrent tumours there was a reduction in the number of diploid cells associated with an increase in 2c--4c and 4c components. Recurrent tumours also showed a higher number of nucleolar organizer regions positively stained using an argyrophil method. The mitotic count and the nucleolar organizer regions appeared to be the best predictors for recurrence.

Adult↗

Complete rectal prolapse in young patients: psychiatric disease a risk factor of poor outcome.

OBJECTIVE: Complete rectal prolapse is rare before the age of 50. The aim of our study was to identify the risk factors of total rectal prolapse before this age and to determine the surgical outcome in this specific group of patients. PATIENTS AND METHODS: The charts of all patients, younger than 50 years old, treated for total rectal prolapse between June 1995 and December 2001 were reviewed. Associated conditions were noted and pre and postoperative functions were compared in regards of constipation and evacuations problems, anal continence (Wexner score), recurrent prolapse and overall satisfaction. All patients underwent an abdominal rectopexy according to the Orr-Loygue procedure. RESULTS: During the study period, 28 patients (21 females) with a mean age of 34 +/- 9 years were treated for a total rectal prolapse in our institution. Five patient (17.8%) had minor complications. After a mean follow up of 25 months, the global continence improved significantly (Wexner score: 4.9 vs 2; P = 0.014): 8 patients suffering from liquid stools incontinence before surgery were continent after rectopexy, while 2 continent patients became incontinent to liquid stools after surgery. Fourteen patients had chronic psychiatric disease requiring permanent treatment. These patients suffered more frequently from constipation (12/14 vs 5/14; P =0.006) and required more often a digital evacuation before surgery (6/14 vs 1/14; P = 0.07) than non psychiatric patients. They also suffered from more severe constipation and required more enemas after surgery (1/14 vs 6/12; P = 0.03) compared to patients without psychiatric disease. The only two patients, who had recurrence also had psychiatric disease. CONCLUSION: Chronic psychiatric disease requiring long-term medication is observed in 50% of patients with total rectal prolapse under the age of 50 years. Moreover, the medically induced constipation in these patients could represent a cause of poorer functional outcome. Therefore, we recommend the identification of this preoperative risk factor to assess the results of total rectal prolapse treatment in patients younger than 50 years of age.

Adult↗

A prospective arthroscopic study of acute first-time anterior shoulder dislocation in the young: a five-year follow-up study.

A prospective arthroscopic study was conducted on 31 patients with an acute first-time anterior shoulder dislocation (AFASD). The patients were aged between 16 and 39 years. The mean age was 24 years. None had a history of shoulder problems. All were evaluated after 1, 2, and 5 years. The Constant score, Rowe score, recurrence rate, and instability rate were evaluated, as well as patient satisfaction and sports participation. We conclude that after a prolonged follow-up, an increase in the instability rate in young patients with AFASD may become apparent. The overall instability rate was 55% (17/31) after 5-year follow-up. In patients aged younger than 18 years the instability rate was 71% (5/7). Age was the only predictive factor in shoulder instability. The mean Rowe score was 87 (range, 57-100; SD, 14). Three patients had undergone a stabilization operation at the 5-year follow-up. The intraarticular pathology found at arthroscopy was not predictive of shoulder instability. We could not find a correlation between sporting activities and shoulder instability. On the basis of our results, it appears unlikely that arthroscopic lavage reduces redislocation rates after AFASD in the young patient.

Adolescent↗

Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes.

PURPOSE: This study, along with two others, was done to develop the 21-gene Recurrence Score assay (Oncotype DX) that was validated in a subsequent independent study and is used to aid decision making about chemotherapy in estrogen receptor (ER)-positive, node-negative breast cancer patients. EXPERIMENTAL DESIGN: Patients with >or=10 nodes diagnosed from 1979 to 1999 were identified. RNA was extracted from paraffin blocks, and expression of 203 candidate genes was quantified using reverse transcription-PCR (RT-PCR). RESULTS: Seventy-eight patients were studied. As of August 2002, 77% of patients had distant recurrence or breast cancer death. Univariate Cox analysis of clinical and immunohistochemistry variables indicated that HER2/immunohistochemistry, number of involved nodes, progesterone receptor (PR)/immunohistochemistry (% cells), and ER/immunohistochemistry (% cells) were significantly associated with distant recurrence-free survival (DRFS). Univariate Cox analysis identified 22 genes associated with DRFS. Higher expression correlated with shorter DRFS for the HER2 adaptor GRB7 and the macrophage marker CD68. Higher expression correlated with longer DRFS for tumor protein p53-binding protein 2 (TP53BP2) and the ER axis genes PR and Bcl2. Multivariate methods, including stepwise variable selection and bootstrap resampling of the Cox proportional hazards regression model, identified several genes, including TP53BP2 and Bcl2, as significant predictors of DRFS. CONCLUSION: Tumor gene expression profiles of archival tissues, some more than 20 years old, provide significant information about risk of distant recurrence even among patients with 10 or more nodes.

Adult↗

Increased expression of prostate-specific G-protein-coupled receptor in human prostate intraepithelial neoplasia and prostate cancers.

The G-protein-coupled receptors and signal transduction pathways represent important specific targets for a variety of human diseases, ranging from the control of blood pressure, allergic response, hormonal disorders and neurologic diseases to tumorigenesis. Most recently, we and others have identified a novel human prostate-specific G-protein coupled receptor (PSGR). To investigate the potential roles of PSGR in human normal prostate and prostate cancers, we examined the expression level of PSGR in 146 human prostate samples with real-time quantitative reverse transcription-PCR and in situ hybridization method. We significantly extended previous studies and demonstrated that PSGR is specifically expressed in human prostate tissues, not in any other normal and tumor samples tested. Compared to normal and benign prostatic hyperplasia tissues, the expression of PSGR increased significantly in human prostate intraepithelial neoplasia (PIN) and prostate tumors (approximately 10-fold), especially in early prostate tumors, suggesting PSGR may play an important role in early prostate cancer development and progression. The sensitivity and specificity estimates for PSGR expression were calculated as the area under the receiver-operating characteristics curve (0.902), indicating high-level sensitivity and specificity for discriminating benign prostate tissues from malignant prostate tissues. The association of PSGR expression with clinical parameters (clinical stages, Gleason scores, recurrent status and metastasis) was also investigated in this study. Our data suggest that overexpression of PSGR in human PIN and prostate cancers have the potential for early prostate cancer detection and diagnosis.

Aged↗

Long-term follow-up after autologous hematopoietic stem cell transplantation for low-grade non-Hodgkin lymphoma.

Autologous hematopoietic stem cell transplantation (AHSCT) in low-grade non-Hodgkin lymphoma (NHL) can result in a prolonged remission, although most patients eventually relapse and die of their disease. We report long-term outcomes of AHSCT for patients with relapsed low-grade NHL. Between May 1983 and 2001, 67 patients with relapsed or refractory stage III and IV low-grade NHL received an AHSCT at the University of Minnesota at a median of 2.3 years (range, 0.4-15.2 years) after diagnosis. At transplantation, 62 patients (92%) were in complete remission (CR) (6%) or partial remission (PR) (86%); 5 (8%) had resistant disease; and 9 (14%) had transformed to a higher-grade NHL. After AHSCT, 32 (49%) of 65 evaluable patients achieved CR, and 26 (40%) achieved PR. Overall survival (OS) was 50% (95% confidence interval [CI], 38%-62%) at 4 years and 33% (95% CI, 20%-46%) at both 10 and 18 years, whereas progression-free survival (PFS) was 28% (95% CI, 17%-39%) at 4 years, 18% (95% CI, 8%-28%) at 10 years, and 14% (95% CI, 4%-25%) at 18 years. Transplant-related mortality in the first 100 days was 3% (95% CI, 0%-7%). Relapse occurred in 62% (95% CI, 48%-75%) at 4 years and 72% (95% CI, 56%-87%) at 10 years. Eleven patients (16%) developed myelodysplastic syndrome/acute myeloid leukemia 1 to 8 years after AHSCT, and 3 (5%) developed solid tumors. In multiple regression analysis, the International Prognostic Index (IPI) score at transplantation was the most significant predictor for both OS and PFS. The median OS has not been reached in patients with an IPI score of 0 or 1 at transplantation (20 of 35 survive 2 to 18 years after AHSCT), whereas it was 2.3 and 1.6 years for IPI scores of 2 and 3, respectively ( P = .002). A good response (CR/PR) to AHSCT (relative risk [RR], 0.4; 95% CI, 0.2-0.9; P = .04) and age <50 years (RR, 0.5; 95% CI, 0.2-0.8; P = .01) were also independently significant predictors of good OS and PFS. We present mature follow-up data (median follow-up, 8 years; range, 2-18 years) of patients undergoing AHSCT for relapsed low-grade NHL and demonstrate extended OS and PFS. Very long-term remissions were seen in nearly 20% of patients. AHSCT remains promising, especially for patients with sensitive relapse and lower IPI scores. Recurrent lymphoma after AHSCT remains the major problem, and prolonged survival is further tempered by a significant risk of post-transplantation second malignancies, including myelodysplastic syndrome/acute myeloid leukemia and solid tumors.

Adult↗

Oncotype DX-guided vs physician-directed chemotherapy and survival in HR+/HER2- breast cancer.

BACKGROUND: Oncotype DX testing guides adjuvant chemotherapy decisions in early-stage hormone receptor-positive/HER2-negative breast cancer, but testing is not universally performed, and outcomes associated with genomic-informed versus clinicopathologic-based chemotherapy decision pathways remain unclear. METHODS: Using the 2022 National Cancer Database Breast Participant User File, we identified women diagnosed from 2010 to 2022 with pathologic T1b-T2, node-negative, hormone receptor-positive/HER2-negative invasive breast cancer who received adjuvant chemotherapy and endocrine therapy. Patients were classified into an Oncotype-guided group, defined by Oncotype DX testing with a recurrence score of 26 or higher, and a physician-directed group, defined by receipt of chemotherapy without genomic testing. The primary outcome was overall survival. Analyses used multivariable Cox models, logistic-IPTW and MLP-IPTW, restricted mean survival time analysis, and a Bayesian latent confounding survival model. RESULTS: Among 56,625 women, 27,278 were in the Oncotype-guided group and 29,347 in the physician-directed group. Median ages were 59 and 56 years, respectively. The Oncotype-guided group had more favorable overall survival than the physician-directed group in multivariable Cox analysis (HR, 0.906; 95% CI, 0.856-0.959; P&#x202f;<&#x202f;0.001), with similar findings in IPTW analyses. The association was concentrated among patients aged 56 years or older (HR, 0.866; 95% CI, 0.809-0.927; P&#x202f;<&#x202f;0.001). The Bayesian model showed no strong residual confounding signal. CONCLUSIONS: Among chemotherapy-treated women, an Oncotype-guided pathway was associated with more favorable overall survival than a physician-directed pathway, particularly among older patients, which indicating prognostic heterogeneity selected using genomic versus conventional clinicopathologic information.

Humans↗

The role of radical prostatectomy in patients with pretreatment prostate-specific antigen > or = 40 ng/mL.

OBJECTIVE: To assess the efficacy of radical prostatectomy (RP) in men presenting with markedly elevated prostate-specific antigen (PSA) levels, the records of 17 patients presenting with serum PSA values > or = 40 ng/mL, who underwent RP at Walter Reed Army Medical Center (WRAMC) between 1990 and 1995, were reviewed. METHODS: Pathologic and clinical data (staging, Gleason score, recurrences, adjuvant and neo-adjuvant treatment, most recent PSA value, urinary continence, and sexual function) for each patient was examined. The Kaplan-Meier method was used to analyze the disease-free survival (DFS) for PSA and clinical recurrence. Urinary continence and potency were also assessed. RESULTS: With a mean follow-up of 6.21 years (median 5.28 y), all 17 patients are alive. Five patients have no evidence of disease (NED), and 12 are alive with prostate cancer. Fifteen patients have PSA values between 0.1 and 3.0 ng/mL, and two patients have PSA values that have returned to pretreatment levels. Eleven patients received neo-adjuvant and/or adjuvant therapy. Fourteen men (82.3%) are continent and seven (41.1%) are potent. Survival analysis demonstrates a PSA DFS of 52.9% at five years and 26.5% at nine years; while, clinical DFS was 92.3% at five years and 58.0% at nine years. CONCLUSIONS: This study suggests a possible surgical role in treating patients presenting with significantly elevated PSA values. While surgery alone is unlikely to cure prostate cancer in these patients, surgery in conjunction with hormonal or radiation therapy may prolong survival with acceptable effects on urinary continence and potency.

Aged↗

Stroke unit versus general medical wards, II: neurological deficits and activities of daily living: a quasi-randomized controlled trial.

BACKGROUND AND PURPOSE: The efficacy of stroke units has been extensively examined. It is unknown, however, whether the superiority of the stroke unit will remain after the increased focus on stroke treatment in general medicine. This study of patients admitted to the hospital early and with a short length of stay determines the effect and identifies certain important components of a stroke unit. METHODS: Five hundred fifty patients aged 60 years or older with acute stroke were allocated by a quasi-randomized design to a stroke unit or a general medical ward based on date of birth in the month. Patients admitted within 24 hours of onset were enrolled. Outcomes after 7 months were death, proportion needing long-term care, and change in neurological and functional state assessed by the Scandinavian Stroke Scale and Barthel Index. RESULTS: Seven months after admission there was a trend in favor of the stroke unit in all outcome measures, but no significant differences in clinical outcomes were found except for change in the Scandinavian Stroke Scale score. Recurrent stroke during hospitalization occurred more often in the general medical ward (P = .03). The stroke unit was significantly more aggressive in mobilization out of bed (P<.01) and use of parenteral fluid (P<.0001), aspirin (P<.0001), antipyretics (P<.0001), and antibiotics (P<.0001). CONCLUSIONS: Our study confirms the benefit of the stroke unit, but the effects on the most reliable clinical outcomes were modest and insignificant. Treatment in this stroke unit hastened recovery. More aggressive rehabilitation and use of parenteral fluid, aspirin, antipyretics, and antibiotics appeared in the stroke unit.

Activities of Daily Living↗