National Economic Conditions May Impact the Financial Barriers to Travel for Cancer Operations.

Background: Better cancer-related outcomes are associated with physicians and hospitals with higher case volume. This serves as an incentive to refer patients requiring complex cancer operations to large referral centers, which may require increased travel for patients. However, barriers exist for patients to travel for cancer care, some of which may be aggravated or alleviated by factors relating to the health of the national economy. This impact may be reflected in variability of travel distances for cancer operations over time particularly for complex operation such as pancreatectomy and esophagectomy compared with less complex resections such as those for breast cancer or melanoma. Methods: We obtained the estimated travel distance for patients undergoing operations for cancer of the pancreas, esophagus, skin (melanoma), and breast from the National Cancer Database from 2004 to 2017 and correlated them with economic factors obtained from public sources. We then examined the impact of unemployment rates, gas prices, and inflation on travel distances regarding disadvantaged groups. Correlations were measured by the (rank-based, nonparametric) Spearman's correlation coefficient, and the corresponding P value is obtained by the asymptotic distribution of the coefficient. A P value of 0.05 equates to an absolute correlation value of 0.532. To adjust for multiple tests, a more restrictive P value of 0.01 was also assessed, which equates to correlation coefficients of absolute value greater than 0.661. Results: There were 4,222,380 cases in the dataset, of which 1,781,056 remained after exclusion. The economic factors that were associated most strongly with the distance patients traveled for all cancer operation types were the labor force participation rate, personal savings, consumer price index, and changes in gasoline prices. Inflation and rising gasoline prices were often inversely related with travel distance in lower-income and less well-educated regions and African American patients. Conclusions: Several macroeconomic factors correlate with the travel distance for operations, suggesting that the economic health of the nation may aggravate or alleviate the financial barriers to travel for cancer operations. Financially disadvantaged groups may be particularly vulnerable to changes in gasoline prices and inflation. Organizations serving these populations may need to increase patient support services during times of economic hardship to avoid the exacerbation of health care disparities.

Management of post-operative subcutaneous emphysema with the application of wound VAC therapy.

Extensive subcutaneous emphysema (SE) complicates between 1 and 6% of elective thoracic procedures. The management of SE is varied, and may include increasing the suction of chest tubes, placement of additional chest tubes, placement of subcutaneous drains and creation of releasing incisions. We present five patients with post-operative SE treated successfully with a subcutaneous infraclavicular incision and wound VAC therapy. A 5-cm incision was made 2 cm below the clavicle down and through the pectoralis major fascia. A VAC dressing was fitted to the wound and suction was applied to -125 mm Hg. Data were retrospectively collected and analyzed. VAC dressing was placed a median of 6 days after initial operation. All patients had improvement in symptoms and resolution of SE by VAC dressing therapy. Subcutaneous infraclavicular incision and VAC dressing placement is a viable treatment for patients with post-operative SE who fail conservative therapy.

Physician derived versus administrative data in identifying surgical complications. Fact versus Fiction.

BACKGROUND: Administrative data are widely used as determinants of surgical quality. We compared surgical complications identified in a structured surgical review to coding and billing data of over a 19-month period. METHODS: A retrospective review of monthly morbidity and mortality conference reports was compared to a report over the same time period generated from hospital coding and billing data. RESULTS: 807 sequential operative procedures were included. Physician derived data compared to administrative data identified a complication of any severity in 205 (25.4%) versus 111 (13.8%) cases (r = 0.39), and major complications in 68 (8.4%) versus 46 (5.7%) cases (r = 0.36). Review of the administrative data regarding major complications identified 80 false negatives, 52 false positives, and 38 true positive designations. Overall sensitivity, specificity, positive and negative predictive values, and accuracy for administrative data in identifying major complications was 0.32, 0.99, 0.42, 0.99, and 0.99. CONCLUSIONS: The correlation between physician determined and administrative data with regard to identifying surgical complications is poor. Administrative data are insensitive and lack positive predictive value.

Quality measurement affecting surgical practice: Utility versus utopia.

The Triple Aim: improving healthcare quality, cost and patient experience has resulted in massive healthcare "quality" measurement. For many surgeons the origins, intent and strengths of this measurement barrage seems nebulous-though their shortcomings are noticeable. This article reviews the major organizations and programs (namely the Centers for Medicare and Medicaid Services) driving the somewhat burdensome healthcare quality climate. The success of this top-down approach is mixed, and far from convincing. We contend that the current programs disproportionately reflect the definitions of quality from (and the interests of) the national payer perspective; rather than a more balanced representation of all stakeholders interests-most importantly, patients' beneficence. The result is an environment more like performance management than one of valid quality assessment. Suggestions for a more meaningful construction of surgical quality measurement are offered, as well as a strategy to describe surgical quality from all of the stakeholders' perspectives. Our hope is to entice surgeons to engage in institution level quality improvement initiatives that promise utility and are less utopian than what is currently present.

Liver resection for metastatic disease after y90 radioembolization: a case series with long-term follow-up.

INTRODUCTION: There are only few reports of liver resections for metastatic disease in patients previously treated with Y-90 radioembolization (RE), and long-term outcome data are sparse. We reviewed our center's experience in patients undergoing hepatectomy after hepatic RE. METHODS: A retrospective chart review of patients undergoing RE from 2004 to 2011 was performed. Demographic, clinicopathologic, operative, and long-term outcomes variables were collected. Independent pathologic review of tumor necrosis and normal liver tissue grading of fibrosis and inflammation after resection was performed. Data are expressed as medians and ranges. RESULTS: RE was delivered to 106 patients with primary and metastatic disease of the liver, of whom 9 patients (6 males, 3 females, median age 54 (47-76) years) with metastatic disease ultimately underwent resection. RE was previously administered to the right liver in five, the left liver in one, and to the whole liver in three. Two patients had a second RE performed before resection. Six of the nine patients had previously received several infusions of cytotoxic therapy. The operations occurred at a median of 115 (56-245) days after RE and included right lobectomy (n = 5), left lobectomy (n = 1), left-lateral sectionectomy (n = 1), and bilobar wedge resections (n = 2). Extrahepatic sites were resected in three patients. Median blood loss was 900 (range 250-3600) ml. Grade 3 or higher complications occurred in seven cases (78 %). Follow-up was complete all nine patients. Three patients (33 %) died within 30 days of resection. All those surviving the operative period had disease recurrence (time to recurrence: 202 [range 54-315] days), and all have since died (overall survival: 584 [range 127-1230] days). Review of resected specimens demonstrated median tumor necrosis of 70 % (range 20-90 %). In nontumor-bearing liver, fibrosis grade (0-4) and inflammation score (0-4) was 2 or less in all specimens. CONCLUSIONS: In this small cohort of highly selected and heavily pretreated patients, long-term survival in patients undergoing resection after RE appears possible, but the operations may carry substantial risks-highlighting the importance of careful patient selection for these resections. The etiology of morbidity and mortality is likely multifactorial and additional reports that include long-term outcomes will be necessary to identify more clearly the impact of RE on postoperative complications and death.

Voice outcomes after total thyroidectomy, partial thyroidectomy, or non-neck surgery using a prospective multifactorial assessment.

BACKGROUND: Voice alteration remains a significant complication of thyroid surgery. We present a comparison of voice outcomes between total thyroidectomy (TT), partial thyroidectomy (PT), and non-neck (NN) surgery using a multifactorial voice-outcomes classification tool. STUDY DESIGN: Patients with normal voice (n = 112) were enrolled between July 2004 and March 2009. The patients underwent TT (n = 54), PT (n = 35), or NN (n = 23) surgery under general endotracheal anesthesia as part of a prospective observational study involving serial multimodality voice evaluation preoperatively, and at 2 weeks, 3 months, and 6 months postoperatively. Patients with adverse voice outcomes were grouped into the negative voice outcomes (NegVO) category, including patients with objective (abnormality on videolaryngostroboscopy and substantial voice dysfunction) and subjective (normal videolaryngostroboscopy but with notable voice impairment) NegVO. Voice outcomes were compared among study groups. RESULTS: Negative voice outcomes occurred in 46% (95% CI, 34-59%) and 14% (95% CI, 6-30%) of TT and PT groups, respectively. No NegVOs were observed after NN surgery. Early NegVOs were more common in the TT group than in the NN or PT groups (p < 0.001). Most voice disturbances resolved by 6 months (TT 84%; PT 92%) with no difference in NegVO among all groups (p = 0.23). Black race and significant changes in certain voice outcomes measures at the 2-week follow-up visit were identified as predictors of late (3 to 6 months) NegVO. CONCLUSIONS: This comprehensive voice outcomes study revealed that the extent of thyroidectomy impacts voice outcomes in the early postoperative period, and identified risk factors for late NegVO in post-thyroidectomy patients who should be considered for early voice rehabilitation referral.

Technical effects of adding 1 % lidocaine to technetium sulfur colloid for sentinel lymphatic mapping in early breast cancer: analysis of data from a double-blind randomized controlled trial.

BACKGROUND: A practice standard in sentinel lymph node (SLN) mapping in breast cancer is intradermal injection of technetium-99m sulfur colloid (Tc-99m), resulting in significant patient discomfort and pain. A previous randomized controlled trial showed that adding lidocaine to Tc-99m significantly reduced radioisotope injection-related pain. We tested whether 1 % lidocaine admixed with Tc-99m affects feasibility of SLN mapping. METHODS: Between January 2006 and April 2009, 140 patients with early breast cancer were randomly assigned (1:1:1:1) to receive standard topical 4 % lidocaine cream and intradermal Tc-99m (control) or to one of three other study groups: topical placebo cream and injection of Tc-99m containing sodium bicarbonate (NaHCO3), 1 % lidocaine, or both. All SLN data were collected prospectively. RESULTS: Study groups were comparable for clinicopathological parameters. As previously reported, the addition of 1 % lidocaine to the radioisotope solution significantly improved patient comfort. Overall SLN identification rate in the trial was 93 %. Technical aspects of SLN biopsy were similar for all groups, including time from injection to operation, first SLN (SLN 1) gamma probe counts, ex vivo counts for SLN 1 and SLN 2, and axillary bed counts. SLN identification rates were comparable statistically: control (96 %), lidocaine (90 %), sodium bicarbonate (97 %), and sodium bicarbonate-lidocaine (90 %). The control group had a significantly higher SLN 2/SLN 1 ex vivo count ratio, and the number of SLNs detected was significantly reduced in the lidocaine versus no-lidocaine groups (p < 0.05). CONCLUSIONS: Addition of 1 % lidocaine to standard radioisotope solution for SLN mapping in breast cancer is associated with fewer SLNs detected, but it does not appear to compromise SLN identification.

Utility of the voice handicap index as an indicator of postthyroidectomy voice dysfunction.

OBJECTIVES/HYPOTHESES: The Voice Handicap Index (VHI) is a simple, reliable, self-administered questionnaire that has been used to identify negative voice outcomes after thyroidectomy. This study provides an updated report of a multiyear study examining the predictive ability of the VHI to classify normal versus negative voice outcomes (VOs). STUDY DESIGN: Prospective observational, longitudinal study of the patient reported impact of voice changes after thyroidectomy using the VHI. Since the preliminary report, the sample size doubled and methods for classifying voice outcomes (VOs) were refined. METHODS: Ninety-one adults provided voice assessment data preoperatively (baseline) and at approximately 2 weeks postthyroidectomy. VO was defined according to endoscopic laryngeal examination, acoustic, auditory perceptual, and patient report parameters. The VHI was tested for its sensitivity and specificity for identifying VO. RESULTS: Twenty-two participants (24.2%) qualified as having adverse VOs during the early postoperative period. A change from baseline in VHI of 13-16 points had a diagnostic accuracy of 86% sensitivity and 88% specificity for classifying early VO and had 70% and 95% positive and negative predictive values, respectively. The Functional and Physical subscales of the VHI had higher predictive value than the Emotional subscale. Adjunctive analyses of a two-subscale version of the VHI and of the 10 items that comprises the VHI-10 also revealed high predictive value for differentiating groups by VO. CONCLUSIONS: Balanced sensitivity and specificity are achieved at a change in the total VHI score of 13-16. These results are generally consistent with several other studies examining voice problems over time. The VHI, as well as its alternate versions, appear to be useful and should be incorporated into the diagnostic process for identifying patients with voice problems after thyroidectomy.

Engaging in health behaviors to lower risk for breast cancer recurrence.

PURPOSE: While post-treatment breast cancer survivors face up to twice the cancer risk of the general population, modifiable health behaviors may somewhat reduce this risk. We sought to better understand health behaviors that early stage breast cancer survivors engage in to reduce recurrence risk. METHODS: Data came from a cross-sectional multi-site survey of 186 early-stage breast cancer survivors who received genomic testing for breast cancer recurrence risk (Oncotype DX) during their clinical care. Study outcomes were meeting health behavior recommendations (daily fruit and vegetable intake, regular physical activity, and having a healthy body mass index (BMI)). RESULTS: Approximately three-quarters of survivors we surveyed believed the 3 behaviors might reduce their cancer risk but many did not engage in these behaviors for this purpose: 62% for BMI, 36% for fruit and vegetable consumption, and 37% for physical activity. Survivors with higher recurrence risk, as indicated by their genomic test results, were no more likely to meet any of the three health behavior recommendations. Adherence to health behavior recommendations was higher for women who were white, college-educated, and had higher incomes. CONCLUSIONS: Many nonadherent breast cancer survivors wish to use these behavioral strategies to reduce their risk for recurrence, suggesting an important opportunity for intervention. Improving BMI, which has the largest association with cancer risk, is an especially promising target.

The impact of recurrent laryngeal neuromonitoring on multi-dimensional voice outcomes following thyroid surgery.

BACKGROUND: Voice changes after thyroidectomy are common but not always related to recurrent laryngeal nerve (RLN) injury. We evaluated if RLN neuromonitoring correlated with non-RLN injury-related changes in voice after thyroidectomy. METHODS: Prospective multi-dimensional voice assessment was conducted on patients undergoing thyroidectomy before, 1-4 weeks, and 6 months postoperatively. Voice outcome (VO) was determined as normal (NormVO) or negative (NegVO) based upon combinations of patient-reported symptoms, videolaryngoscopy, a composite of acoustic measurements, and clinician-perceived voice quality. Groups with and without neuromonitoring were compared for early and durable differences in VO. RESULTS: Ninety-one patients underwent thyroidectomy; 39 with RLN neuromonitoring and 52 without. The two study groups were similar with regard to baseline characteristics including voice assessment. There was no difference in NegVO between neuromonitored and non-monitored patients at 1-4 weeks (n = 89; 32% vs. 27%; P = 0.81) and 6 months (n = 71, 14% vs. 7%; P = 0.42) after thyroidectomy. Neuromonitoring was associated with a 48-min increase in median operative time, but this finding was not statistically significant in a multivariate model. CONCLUSION: In this study, recurrent laryngeal neuromonitoring did not appear to influence non-RLN injury related VO as measured by a comprehensive multidimensional voice assessment.

Giant Posterior Mediastinal Ancient Schwannoma Requiring Thoracoabdominal Resection: A Case Report and Literature Review.

Posterior mediastinal schwannomas are benign, slow growing nerve sheath tumors and rarely cause symptoms. We present a case of a 47-year-old man who presents with severe mid-back pain and dyspnea on exertion. Chest radiograph and computed topography revealed a large posterior mediastinum mass. Surgical resection required en bloc resection of a portion of the diaphragm, and wedge resection of the left lower lobe of the lung via left thoracoabdominal approach. Pathology was consistent with ancient schwannoma. This case is unique due to the location and size of the mass and the surgical approach required for complete resection.

Axillary sentinel lymph node biopsy after mastectomy: a case report.

BACKGROUND: Sentinel lymph node biopsy has been established as the preferred method for staging early breast cancer. A prior history of mastectomy is felt to be a contraindication. CASE PRESENTATION: A patient with recurrent breast cancer in her skin flap was discovered to have positive axillary sentinel nodes by sentinel lymph node biopsy five years after mastectomy for ductal carcinoma in situ. CONCLUSION: A prior history of mastectomy may not be an absolute contraindication to sentinel lymph node biopsy.

The role of listener experience on Consensus Auditory-perceptual Evaluation of Voice (CAPE-V) ratings of postthyroidectomy voice.

PURPOSE: To determine whether experienced and inexperienced listeners rate postthyroidectomy voice samples similarly using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). METHOD: Prospective observational study of voice quality ratings of randomized and blinded voice samples was performed. Twenty-one postthyroidectomy patients' voices, representing a wide range of severities, were rated using a custom-automated version of the CAPE-V. Ten male and 11 female voices were rated by 10 experienced and 10 inexperienced listeners. Experienced listeners consisted of 5 otolaryngologists (ENTs) and 5 speech-language pathologists (SLPs); inexperienced listeners were medical professionals with no formal training or experience in voice disorders. RESULTS: Inexperienced listeners rated voices as more severely impaired than experienced listeners for all CAPE-V parameters (p < or = .003). Those without experience in voice disorders had lower intra- and interrater reliability (e.g., r = .838 and .528, respectively, for overall severity) than those with experience in voice disorders (e.g., r = .911 and .722, respectively, for overall severity) for all parameters. Among experienced listeners, ENTs and SLPs rated voices similarly for most parameters. CONCLUSIONS: Experienced and inexperienced listeners judged voice quality differently given minimal training with the use of the CAPE-V. SLPs and ENTs rated postthyroidectomy voice quality similarly. These findings indicate that the CAPE-V can be used reliably and similarly by professionals who specialize in voice disorders.

Functional voice outcomes after thyroidectomy: an assessment of the Dsyphonia Severity Index (DSI) after thyroidectomy.

BACKGROUND: The Dysphonia Severity Index (DSI) is an objective multiparametric acoustic calculation of vocal function; however, its changes after thyroidectomy have not yet been described. METHODS: Patient-reported symptoms, as well as auditory perceptual, acoustic, and videolaryngostroboscopic (VLS) data, were collected prospectively before and after thyroidectomy. Voice outcomes (normal versus negative voice outcome [NVO]) at 6 months after thyroidectomy were based on a combination of voice symptoms and objective findings. The DSI was assessed over the peri-operative course, and differences were determined with Wilcoxon signed rank tests. The DSI was compared between study groups (normal versus NVO) using t tests, analyses of variance (ANOVAs), or rank sum tests as appropriate. The predictive value of DSI for long-term voice dysfunction was assessed by an area under the receiver operating characteristics curve analysis. Correlations between DSI and Consensus Auditory Perceptual Ratings of Voice (CAPE-V) and the patient reported Voice Handicap Index (VHI) were determined with Pearson's correlation coefficients. RESULTS: In all, 62 patients were evaluated before, 1-4 weeks after, and 6 months after thyroidectomy. Eight (13%) patients were diagnosed with NVO at 6 months. The DSI was different postoperatively between NVO and normal voice (P=.005, repeated measures [RM]-ANOVA), with the NVO group demonstrating a lesser DSI value and greater change from pre-operative assessment at the first postoperative visit when compared with the normal group (P<.006 each). The DSI differed significantly for pre-operative and 6-month assessments according to sex, smoking status, and age. Short-term postoperative DSI (area under the curve [AUC]=0.795) and DSI change from baseline to 1-4 weeks (AUC=0.835) were highly predictive of 6-month NVO. DSI measurements over the post-thyroidectomy course were correlated poorly to moderately (maximum r = -0.62) with CAPE-V and VHI assessments for the same time points. CONCLUSION: The DSI is decreased in the early post-thyroidectomy period, mostly in persons who were ultimately found to have a long-term NVO. Early postoperative DSI and change of DSI from baseline at 1--4 weeks postoperation predict long-term post-thyroidectomy voice dysfunction. The modest correlations between the DSI and other vocal assessments point to the utility of DSI as an independent predictor of voice dysfunction after thyroidectomy, which can select patients who may benefit from voice therapy.

Development of a clinical decision model for thyroid nodules.

BACKGROUND: Thyroid nodules represent a common problem brought to medical attention. Four to seven percent of the United States adult population (10-18 million people) has a palpable thyroid nodule, however the majority (>95%) of thyroid nodules are benign. While, fine needle aspiration remains the most cost effective and accurate diagnostic tool for thyroid nodules in current practice, over 20% of patients undergoing FNA of a thyroid nodule have indeterminate cytology (follicular neoplasm) with associated malignancy risk prevalence of 20-30%. These patients require thyroid lobectomy/isthmusectomy purely for the purpose of attaining a definitive diagnosis. Given that the majority (70-80%) of these patients have benign surgical pathology, thyroidectomy in these patients is conducted principally with diagnostic intent. Clinical models predictive of malignancy risk are needed to support treatment decisions in patients with thyroid nodules in order to reduce morbidity associated with unnecessary diagnostic surgery. METHODS: Data were analyzed from a completed prospective cohort trial conducted over a 4-year period involving 216 patients with thyroid nodules undergoing ultrasound (US), electrical impedance scanning (EIS) and fine needle aspiration cytology (FNA) prior to thyroidectomy. A Bayesian model was designed to predict malignancy in thyroid nodules based on multivariate dependence relationships between independent covariates. Ten-fold cross-validation was performed to estimate classifier error wherein the data set was randomized into ten separate and unique train and test sets consisting of a training set (90% of records) and a test set (10% of records). A receiver-operating-characteristics (ROC) curve of these predictions and area under the curve (AUC) were calculated to determine model robustness for predicting malignancy in thyroid nodules. RESULTS: Thyroid nodule size, FNA cytology, US and EIS characteristics were highly predictive of malignancy. Cross validation of the model created with Bayesian Network Analysis effectively predicted malignancy [AUC = 0.88 (95%CI: 0.82-0.94)] in thyroid nodules. The positive and negative predictive values of the model are 83% (95%CI: 76%-91%) and 79% (95%CI: 72%-86%), respectively. CONCLUSION: An integrated predictive decision model using Bayesian inference incorporating readily obtainable thyroid nodule measures is clinically relevant, as it effectively predicts malignancy in thyroid nodules. This model warrants further validation testing in prospective clinical trials.

Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial.

BACKGROUND: Sentinel-lymph-node (SLN) mapping and biopsy maintains staging accuracy in early breast cancer and identifies patients for selective lymphadenectomy. SLN mapping requires injection of technetium-99m-sulfur colloid-an effective but sometimes painful method, for which better pain-management strategies are needed. In this randomised, double-blind trial, we compared degree of pain between standard radiocolloid injection and pH-adjusted and lidocaine-supplemented formulations for patients undergoing SLN mapping for breast cancer. METHODS: Between Jan 13, 2006, and April 30, 2009, 140 patients with early breast cancer were randomly assigned in a 1:1:1:1 fashion to receive the standard topical 4% lidocaine cream and injection of [(99m)Tc]Tc-sulfur colloid (n=35), or to one of three other study groups: topical placebo cream and injection of Tc-sulfur colloid containing either sodium bicarbonate (n=35), 1% lidocaine (n=35), or sodium bicarbonate and 1% lidocaine (n=35). The randomisation sequence was computer generated, and all patients and investigators were masked to treatment allocation. The primary endpoint was patient-reported breast pain immediately after radioisotope injection, using the Wong-Baker FACES pain rating scale and McGill pain questionnaire, analysed in the per-protocol population. This study is registered with ClinicalTrials.gov, number NCT00940199. FINDINGS: 19 of the 140 patients enrolled were excluded from analysis: nine declined study participation or sought care elsewhere, nine did not undergo SLN mapping because of disease extent or a technical problem, and one had unreliable data. There were no adverse events. Mean pain scores on the Wong-Baker scale (0-10) were: 6.0 (SD 2.6) for those who received standard of practice, 4.7 (3.0) for those who received radiocolloid plus bicarbonate, 1.6 (1.4) for those who received radiocolloid plus 1% lidocaine, and 1.6 (1.3) for those who received radiocolloid plus bicarbonate and 1% lidocaine (p<0.0001). Mean pain rating, according to the McGill questionnaire (0-78), was 17.5 (SD 11.8) for the standard-of-care group, 15.4 (14.4) for the sodium bicarbonate group, 4.6 (4.5) for the 1% lidocaine group, and 3.4 (5.1) for the sodium bicarbonate plus 1% lidocaine group (p<0.0001). SLN identification rates for each group were: 96% for the standard of care, 97% for sodium bicarbonate, 90% for 1% lidocaine, and 90% for sodium bicarbonate plus 1% lidocaine group (p=0.56). INTERPRETATION: For centres that use radiocolloid injections for SLN mapping in patients with early breast cancer, the addition of 1% lidocaine to the radioisotope solution can improve patient comfort, without compromising SLN identification. FUNDING: US Military Cancer Institute, the Clinical Breast Care Project, and the Army Regional Anesthesia and Pain Management Initiative.

The influence of a gene expression profile on breast cancer decisions.

PURPOSE: The Oncotype Dx Recurrence Score (RS), is often employed in patients with estrogen receptor-positive, node negative (ER+LN-) breast cancer. We investigated the impact of the RS on actual chemotherapy administration and the effect of the assay on a panel of breast oncology experts. PATIENTS AND METHODS: The prospective adjuvant chemotherapy recommendations (prior to RS) and actual adjuvant therapy (after RS) for consecutive patients with ER+LN- breast cancer were recorded. After 6 months and with the same information, a panel of five experts made adjuvant therapy recommendations with and without RS and rated the strength of their recommendations. Rates of panel consensus, recommendation changes, and changes in recommendation strength were compared. RESULTS: There were 29 patients (28 women). RS results altered the plan for chemotherapy in 9 patients (31%); 7 of 13 patients (54%) initially recommended for chemotherapy did not receive it, and 2 of 16 (13%) received chemotherapy following initial recommendations against it. RS results changed the panel's chemotherapy recommendation in 7 patients (24%): 5 of 12 (42%) recommendations for changed to against, and 2 of 17 (12%) recommendations against changed to for chemotherapy. RS increased consensus by the panel 10%, but did not increase the reported strength in chemotherapy recommendations. CONCLUSIONS: RS results were associated with real-world decision changes in 31% of patients and 24% of panel recommendations and increased panel consensus by 10%. However RS did not increase the strength of panelist's recommendations.