Treatment Patterns and Outcomes of Women with Breast Cancer and Supraclavicular Nodal Metastases.

BACKGROUND: In 2002, breast cancer patients with supraclavicular nodal metastases (cN3c) were downstaged from AJCC stage IV to IIIc, prompting management with locoregional treatment. We sought to estimate the impact of multimodal therapy on overall survival (OS) in a contemporary cohort of cN3c patients. METHODS: Women ≥ 18 years with cT1-T4c/cN3c invasive breast cancer who underwent systemic therapy were identified from the 2004-2016 National Cancer Database. We compared three patient cohorts: (a) cN3c + multimodal therapy (systemic therapy, surgery, and radiation); (b) cN3c + non-standard therapy; and, (c) cM1. Logistic regression identified factors associated with receipt of multimodal therapy and Kaplan-Meier was used to estimate unadjusted OS. The Cox proportional hazards model estimated effects of diagnosis and treatment on OS after adjustment. RESULTS: Overall, 1827 (3.7%) patients with cN3c disease and 46,919 (96.3%) cM1 patients were identified. Of cN3c patients, 74.5% (n = 1362) received multimodal therapy and 25.5% (n = 465) received non-standard therapy; receipt of multimodal therapy was associated with improved 5-year OS (multimodal: 59% vs. M1: 28% vs. non-standard: 28%, log-rank p < 0.001). Adjusting for covariates, non-standard therapy was associated with an increased risk of death compared with receipt of multimodal therapy (HR 2.20, 95% CI 1.71-2.83, p < 0.001). Private insurance was the only patient characteristic associated with a greater likelihood of receiving multimodal therapy (OR 2.81; 95% CI, 1.64-4.82; p < 0.001). CONCLUSION: Women with cN3c breast cancer who received multimodal therapy demonstrated improved overall survival when compared with patients undergoing non-standard therapy and those with metastatic (M1) disease. Although selection bias may contribute to worse overall survival among cN3c patients undergoing non-standard therapy, national guidelines should encourage locoregional treatment in carefully selected patients.

Patient and physician views of shared decision making in cancer.

CONTEXT: Engaging patients in shared decision making involves patient knowledge of treatment options and physician elicitation of patient preferences. OBJECTIVE: Our aim was to explore patient and physician perceptions of shared decision making in clinical encounters for cancer care. DESIGN: Patients and physicians were asked open-ended questions regarding their perceptions of shared decision making throughout their cancer care. Transcripts of interviews were coded and analysed for shared decision-making themes. SETTING AND PARTICIPANTS: At an academic medical centre, 20 cancer patients with a range of cancer diagnoses, stages of cancer and time from diagnosis, and eight physicians involved in cancer care were individually interviewed. DISCUSSION AND CONCLUSIONS: Most physicians reported providing patients with written information. However, most patients reported that written information was too detailed and felt that the physicians did not assess the level of information they wished to receive. Most patients wanted to play an active role in the treatment decision, but also wanted the physician's recommendation, such as what their physician would choose for him/herself or a family member in a similar situation. While physicians stated that they incorporated patient autonomy in decision making, most provided data without making treatment recommendations in the format preferred by most patients. We identified several communication gaps in cancer care. While patients want to be involved in the decision-making process, they also want physicians to provide evidence-based recommendations in the context of their individual preferences. However, physicians often are reluctant to provide a recommendation that will bias the patient.

Relative impact of surgeon and hospital volume on operative mortality and complications following pancreatic resection in Medicare patients.

BACKGROUND: Surgeon and hospital volume are both known to affect outcomes for patients undergoing pancreatic resection. The objective was to evaluate the relative effects of surgeon and hospital volume on 30-d mortality and 30-d complications after pancreatic resection among older patients. MATERIALS AND METHODS: The study used Texas Medicare data (2000-2012), identifying high-volume surgeons as those performing ≥4 pancreatic resections/year, and high-volume hospitals as those performing ≥11 pancreatic resections/year, on Medicare patients. Three-level hierarchical logistic regression models were used to evaluate the relative effects of surgeon and hospital volumes on mortality and complications, after adjusting for case mix differences. RESULTS: There were 2453 pancreatic resections performed by 490 surgeons operating in 138 hospitals. Of the total, 4.5% of surgeons and 6.5% of hospitals were high volume. The overall 30-d mortality was 9.0%, and the 30-d complication rate was 40.6%. Overall, 8.9% of the variance in 30-d mortality was attributed to surgeon factors and 9.8% to hospital factors. For 30-d complications, 4.7% of the variance was attributed to surgeon factors and 1.2% to hospital factors. After adjusting for patient, surgeon, and hospital characteristics, high surgeon volume (odds ratio [OR] = 0.54, 95% confidence interval [CI], 0.33-0.87) and high hospital volume (OR = 0.52; 95% CI, 0.30-0.92) were associated with lower risk of mortality; high surgeon volume (OR = 0.71, 95% CI, 0.55-0.93) was also associated lower risk of 30-d complications. CONCLUSIONS: Both hospital and surgeon factors contributed significantly to the observed variance in mortality, but only surgeon factors impacted complications.

Trends in Receipt and Timing of Multimodality Therapy in Early-Stage Pancreatic Cancer.

INTRODUCTION: Pancreatic cancer is considered a systemic disease at presentation. Therefore, multimodality therapy with surgical resection and chemotherapy is the standard of care for locoregional disease. We described treatment patterns and time trends with regard to age and treatment center in the receipt of multimodality therapy. METHODS: We used the National Cancer Data Base to identify patients ≥18 years old with stage I and II pancreatic adenocarcinoma. Treatment was defined as no treatment, resection only, chemotherapy only, or multimodality therapy, which consisted of both chemotherapy (neoadjuvant or adjuvant) and resection. Trends in the receipt and type of treatment were compared. RESULTS: Of 39,441 patients, 22.8% of patients received no treatment, 18.5% received chemotherapy only, 23.0% underwent surgical resection alone, and 35.8% of patients received multimodality therapy. Receipt of multimodality therapy increased from 31.3% in 2004 to 37.9% in 2011 (p < 0.0001). Patients >55 years were less likely to receive multimodality therapy (56-64 years: OR 0.83, 95% CI 0.78-0.89; 65-75: OR 0.60, 95% CI 0.55-0.65; ≥76: OR 0.17, 95% CI 0.16-0.19 compared to patients 18-55). Compared to community hospitals, patients treated at an NCI-designated center were more likely to receive multimodality therapy (OR 1.62, 95% CI 1.46-1.81) and, if they received multimodality therapy, delivery of chemotherapy in the neoadjuvant compared to adjuvant setting (OR 2.82, 95% CI 2.00-3.98). CONCLUSION: Despite increased use of multimodality therapy, it remains underutilized in all patients and especially in older patients. Receipt of multimodality therapy and neoadjuvant therapy is highly dependent on treatment at NCI-designated cancer centers.

Comparison of Comorbidity Scores in Predicting Surgical Outcomes.

INTRODUCTION: The optimal methodology for assessing comorbidity to predict various surgical outcomes such as mortality, readmissions, complications, and failure to rescue (FTR) using claims data has not been established. OBJECTIVE: Compare diagnosis-based and prescription-based comorbidity scores for predicting surgical outcomes. METHODS: We used 100% Texas Medicare data (2006-2011) and included patients undergoing coronary artery bypass grafting, pulmonary lobectomy, endovascular repair of abdominal aortic aneurysm, open repair of abdominal aortic aneurysm, colectomy, and hip replacement (N=39,616). The ability of diagnosis-based [Charlson comorbidity score, Elixhauser comorbidity score, Combined Comorbidity Score, Centers for Medicare and Medicaid Services-Hierarchical Condition Categories (CMS-HCC)] versus prescription-based Chronic disease score in predicting 30-day mortality, 1-year mortality, 30-day readmission, complications, and FTR were compared using c-statistics (c) and integrated discrimination improvement (IDI). RESULTS: The overall 30-day mortality was 5.8%, 1-year mortality was 17.7%, 30-day readmission was 14.1%, complication rate was 39.7%, and FTR was 14.5%. CMS-HCC performed the best in predicting surgical outcomes (30-d mortality, c=0.797, IDI=4.59%; 1-y mortality, c=0.798, IDI=9.60%; 30-d readmission, c=0.630, IDI=1.27%; complications, c=0.766, IDI=9.37%; FTR, c=0.811, IDI=5.24%) followed by Elixhauser comorbidity index/disease categories (30-d mortality, c=0.750, IDI=2.37%; 1-y mortality, c=0.755, IDI=5.82%; 30-d readmission, c=0.629, IDI=1.43%; complications, c=0.730, IDI=3.99%; FTR, c=0.749, IDI=2.17%). Addition of prescription-based scores to diagnosis-based scores did not improve performance. CONCLUSIONS: The CMS-HCC had superior performance in predicting surgical outcomes. Prescription-based scores, alone or in addition to diagnosis-based scores, were not better than any diagnosis-based scoring system.

Laparoscopy decreases complications for obese patients undergoing elective rectal surgery.

INTRODUCTION: While there are many reported advantages to laparoscopic surgery compared to open surgery, the impact of a laparoscopic approach on postoperative morbidity in obese patients undergoing rectal surgery has not been studied. Our goal was to determine whether obese patients undergoing laparoscopic rectal surgery experienced the same benefits as non-obese patients. METHODS: We identified patients undergoing rectal resections using the National Surgical Quality Improvement Project Participant Use Data File. We performed multivariable analyses to determine the independent association between laparoscopy and postoperative complications. RESULTS: A total of 26,437 patients underwent rectal resection. The mean age was 58.5 years, 32.6 % were obese, and 47.2 % had cancer. Laparoscopic procedures were slightly less common in obese patients compared to non-obese patients (36.0 vs. 38.2 %, p = 0.0006). In unadjusted analyses, complications were lower with the laparoscopic approach in both obese (18.9 vs. 32.4 %, p < 0.0001) and non-obese (15.6 vs. 25.3 %, p < 0.0001) patients. In a multivariable analysis controlling for potential confounders, the risk of postoperative complications increased as the degree of obesity worsened. The likelihood of experiencing a postoperative complication increased by 25, 45, and 75 % for obese class I, obese class II, and obese class III patients, respectively. A laparoscopic approach was associated with a 40 % decreased odds of a postoperative complication for all patients (OR 0.60, 95 % CI 0.56-0.64). CONCLUSION: Laparoscopic rectal surgery is associated with fewer complications when compared to open rectal surgery in both obese and non-obese patients. Obesity was an independent risk factor for postoperative complications. In appropriately selected patients, rectal surgery outcomes may be improved with a minimally invasive approach.

Relative Contributions of Complications and Failure to Rescue on Mortality in Older Patients Undergoing Pancreatectomy.

BACKGROUND: For pancreatectomy patients, mortality increases with increasing age. Our study evaluated the relative contribution of overall postoperative complications and failure to rescue rates on the observed increased mortality in older patients undergoing pancreatic resection at specialized centers. METHODS: We identified 2694 patients who underwent pancreatic resection from the American College of Surgeons' National Surgical Quality Improvement Pancreatectomy Demonstration Project at 37 high-volume centers. Overall morbidity and in-hospital mortality were determined in patients younger than 80 years (N = 2496) and 80 years or older (N = 198). Failure to rescue was the number of deaths in patients with complications divided by the total number of patients with postoperative complications. RESULTS: No significant differences were observed between patients younger than 80 years and those 80 years or older in the rates of overall complications (41.4% vs 39.4%, P = 0.58). In-hospital mortality increased in patients 80 years or older compared to patients younger than 80 years (3.0% vs 1.1%, P = 0.02). Failures to rescue rates were higher in patients 80 years or older (7.7% vs 2.7%, P = 0.01). Across 37 high-volume centers, unadjusted complication rates ranged from 25.0% to 72.2% and failure to rescue rates ranged from 0.0% to 25.0%. Among patients with postoperative complications, comorbidities associated with failure to rescue were ascites, chronic obstructive pulmonary disease, and diabetes. Complications associated with failure to rescue included acute renal failure, septic shock, and postoperative pulmonary complications. CONCLUSIONS: In experienced hands, the rates of complications after pancreatectomy in patients 80 years or older compared to patients younger than 80 years were similar. However, when complications occurred, older patients were more likely to die. Interventions to identify and aggressively treat complications are necessary to decrease mortality in vulnerable older patients.

The risk paradox: use of elective cholecystectomy in older patients is independent of their risk of developing complications.

BACKGROUND: We recently developed and validated a prognostic model that accurately predicts the 2-year risk of emergent gallstone-related hospitalization in older patients presenting with symptomatic gallstones. STUDY DESIGN: We used 100% Texas Medicare data (2000 to 2011) to identify patients aged 66 years and older with an initial episode of symptomatic gallstones not requiring emergency hospitalization. At presentation, we calculated each patient's risk of 2-year gallstone-related emergent hospitalization using the previously validated model. Patients were placed into the following risk groups based on model estimates: <30%, 30% to <60%, and ≥ 60%. Within each risk group, we calculated the percent of elective cholecystectomies (≤ 2.5 months from initial episode) performed. RESULTS: In all, 161,568 patients had an episode of symptomatic gallstones. Mean age was 76.5 ± 7.3 years and 59.9% were female. The 2-year risk of gallstone-related hospitalizations increased from 15.9% to 41.5% to 65.2% across risk groups. For the overall cohort, 22.3% in the low-risk group, 20.9% in the moderate-risk group, and 23.2% in the high-risk group underwent elective cholecystectomy in the 2.5 months after the initial symptomatic episode. In patients with no comorbidities, elective cholecystectomy rates decreased from 34.2% in the low-risk group to 26.7% in the high-risk group. Of patients who did not undergo cholecystectomy, only 9.5% were seen by a surgeon in the 2.5 months after the initial episode. CONCLUSIONS: The risk of recurrent acute biliary symptoms requiring hospitalization has no influence, or even a paradoxical negative influence, on the decision to perform elective cholecystectomy after an initial symptomatic episode. Translation of the risk prediction model into clinical practice can better align treatment with risk and improve outcomes in older patients with symptomatic gallstones.

PREOP-Gallstones: A Prognostic Nomogram for the Management of Symptomatic Cholelithiasis in Older Patients.

OBJECTIVE AND BACKGROUND: The decision regarding elective cholecystectomy in older patients with symptomatic cholelithiasis is complicated. We developed and validated a prognostic nomogram to guide shared decision making for these patients. METHODS: We used Medicare claims (1996-2005) to identify the first episode of symptomatic cholelithiasis in patients older than 65 years who did not undergo hospitalization or elective cholecystectomy within 2.5 months of the episode. We described current patterns of care and modeled their risk of emergent gallstone-related hospitalization or cholecystectomy at 2 years. Model discrimination and calibration were assessed using a random split sample of patients. RESULTS: We identified 92,436 patients who presented to the emergency department (8.3%) or physician's office (91.7%) and who were not immediately admitted. The diagnosis for the initial episode was biliary colic/dyskinesia (65.3%), acute cholecystitis (26.6%), choledocholithiasis (5.7%), or gallstone pancreatitis (2.4%). The 2-year emergent gallstone-related hospitalization rate was 11.1%, with associated in-hospital morbidity and mortality rates of 56.5% and 6.5%. Factors associated with gallstone-related acute hospitalization included male sex, increased age, fewer comorbid conditions, complicated biliary disease on initial presentation, and initial presentation to the emergency department. Our model was well calibrated and identified 51% of patients with a risk less than 10% for 2-year complications and 5.4% with a risk more than 40% (C statistic, 0.69; 95% confidence interval, 0.63-0.75). CONCLUSIONS: Surgeons can use this prognostic nomogram to accurately provide patients with their 2-year risk of developing gallstone-related complications, allowing patients and physicians to make informed decisions in the context of their symptom severity and its impact on their quality of life.

Surgeon and Facility Variation in the Use of Minimally Invasive Breast Biopsy in Texas.

OBJECTIVE AND BACKGROUND: Minimally invasive breast biopsy (MIBB) rates remain well below guideline recommendations of more than 90% and vary across geographic areas. Our aim was to determine the variation in use attributable to the surgeon and facility and determine the patient, surgeon, and facility characteristics associated with the use of MIBB. METHODS: We used 100% Texas Medicare claims data (2000-2008) to identify women older than 66 years with a breast biopsy (open or minimally invasive) and subsequent breast cancer diagnosis/operation within 1 year. The percentage of patients undergoing MIBB as the first diagnostic modality was estimated for each surgeon and facility. Three-level hierarchical generalized linear models (patients clustered within surgeons within facilities) were used to evaluate variation in MIBB use. RESULTS: A total of 22,711 patients underwent a breast cancer operation by 1226 surgeons at 525 facilities. MIBB was the initial diagnostic modality in 62.4% of cases. Only 7.0% of facilities and 12.9% of surgeons used MIBB for more than 90% of patients. In 3-level models adjusted for patient characteristics, the percentage of patients who received MIBB ranged from 7.5% to 96.0% across facilities (mean = 50.1%, median = 49.2%) and from 8.0% to 87.0% across surgeons (mean = 50.3%, median = 50.9%). The variance in MIBB use was attributable to facility (8.8%) and surgeon (15.4%) characteristics. Lower surgeon and facility volume, longer surgeon years in practice, and smaller facility bed size were associated with lower rates of MIBB use. CONCLUSIONS: Identification of surgeon and facility characteristics associated with low use of MIBB provides potential targets for interventions to improve MIBB rates and decrease variation in use. TYPE OF STUDY: Retrospective cohort.

Impact of liver-directed therapy in colorectal cancer liver metastases.

BACKGROUND: There is a paucity of data on the current management and outcomes of liver-directed therapy (LDT) in older patients presenting with stage IV colorectal cancer (CRC). The aim of the study was to evaluate treatment patterns and outcomes in use of LDT in the setting of improved chemotherapy. METHODS: We used Cancer Registry and linked Medicare claims to identify patients aged ≥66 y undergoing surgical resection of the primary tumor and chemotherapy after presenting with stage IV CRC (2001-2007). LDT was defined as liver resection and/or ablation-embolization. RESULTS: We identified 5500 patients. LDT was used in 34.9% of patients; liver resection was performed in 1686 patients (30.7%), and ablation-embolization in 554 patients (10.1%), with 322 patients having both resection and ablation-embolization. Use of LDT was negatively associated with increasing year of diagnosis (odds ratio [OR] = 0.96, 95% confidence interval [CI] 0.93-0.99), age >85 y (OR = 0.61, 95% CI 0.45-0.82), and poor tumor differentiation (OR = 0.73, 95% CI 0.64-0.83). LDT was associated with improved survival (median 28.4 versus 21.1 mo, P < 0.0001); however, survival improved for all patients over time. We found a significant interaction between LDT and period of diagnosis and noted a greater survival improvement with LDT for those diagnosed in the late (2005-2007) period. CONCLUSIONS: Older patients with stage IV CRC are experiencing improved survival over time, independent of age, comorbidity, and use of LDT. However, many older patients deemed to be appropriate candidates for resection of the primary tumor and receipt of systemic chemotherapy did not receive LDT. Our data suggest that improved patient selection may be positively impacting outcomes. Early referral and optimal selection of patients for LDT has the potential to further improve survival in older patients presenting with advanced colorectal cancer.

Cost-effectiveness of elective laparoscopic cholecystectomy versus observation in older patients presenting with mild biliary disease.

Our objective was to determine the probability threshold for recurrent symptoms at which elective cholecystectomy compared to observation in older patients with symptomatic cholelithiasis is the more effective and cost-effective option. We built a decision model of elective cholecystectomy versus observation in patients >65 presenting with initial episodes of symptomatic cholelithiasis that did not require initial hospitalization or cholecystectomy. Probabilities for subsequent hospitalization, emergency cholecystectomy, and perioperative complications were based on previously published probabilities from a 5 % national sample of Medicare patients. Costs were estimated from Medicare reimbursements and from the Healthcare Cost and Utilization Project. Utilities (quality-adjusted life years, QALYs) were obtained from established literature estimates. Elective cholecystectomy compared to observation in all patients was associated with lower effectiveness (-0.10 QALYs) and had an increased cost of $3,422.83 per patient at 2-year follow-up. Elective cholecystectomy became the more effective option when the likelihood for continued symptoms exceeded 45.3 %. Elective cholecystectomy was both more effective and less costly when the probability for continued symptoms exceeded 82.7 %. An individualized shared decision-making strategy based on these data can increase elective cholecystectomy rates in patients at high risk for recurrent symptoms and minimize unnecessary cholecystectomy for patients unlikely to benefit.

Trajectory of care and use of multimodality therapy in older patients with pancreatic adenocarcinoma.

INTRODUCTION: Multimodality therapy with chemotherapy and operative resection is recommended for patients with locoregional pancreatic cancer but is not received by many patients. OBJECTIVE: To evaluate patterns in the use and timing of chemotherapy and resection and factors associated with receipt of multimodality therapy in older patients with locoregional pancreatic cancer. METHODS: We used Surveillance, Epidemiology, and End Results-linked Medicare data (1992-2007) to identify patients with locoregional pancreatic adenocarcinoma. Multimodality therapy was defined as receipt of both chemotherapy and pancreatic resection. Logistic regression was used to determine factors independently associated with receipt of multimodality therapy. Log-rank tests were used to identify differences in survival for patients stratified by type and timing of treatment. RESULTS: We identified 10,505 patients with pancreatic adenocarcinoma. 5,358 patients (51.0%) received either chemotherapy or surgery, with 1,166 patients (11.1%) receiving both modalities. Resection alone was performed in 1,138 patients (10.8%), and chemotherapy alone was given to 3,054 (29.1%) patients. In patients undergoing resection as the initial treatment modality, 49.4% never received chemotherapy; 97.4% of patients who underwent chemotherapy as the initial treatment modality never underwent resection. The use of multimodality therapy increased from 7.4% of patients in 1992-1995 to 13.8% of patients in 2004-2007 (P < .0001). The 2-year survival was 41.0% for patients receiving multimodality therapy, 25.1% with resection alone, and 12.5% with chemotherapy alone (P < .0001). Of the patients receiving multimodality therapy, chemotherapy was delivered in the adjuvant setting in 93.1% and in the neoadjuvant setting in 6.9%, with similar 2-year survival with either approach (neoadjuvant vs adjuvant, 46.9% vs 40.6%; P = .16). Year of diagnosis, white race, less comorbidity, and no vascular invasion were independently associated with receipt of multimodality therapy. CONCLUSION: Only half of older patients with locoregional pancreatic cancer receive any treatment, and fewer than one quarter of treated patients receive multimodality therapy. Nearly all patients receiving chemotherapy as the initial treatment modality did not undergo resection, whereas half of those undergoing resection first received chemotherapy. When multimodality therapy is used, the vast majority of patients had chemotherapy in the adjuvant setting with a similar survival, regardless of approach.