A Randomized, Controlled Trial Evaluating Perioperative Risk-Stratification and Risk-Based, Protocol-Driven Management After Elective Major Cancer Surgery.

OBJECTIVE: We evaluated the efficacy of risk-based, protocol-driven management versus (vs) usual management after elective major cancer surgery to reduce 30-day rates of postoperative death or serious complications (DSC) . SUMMARY BACKGROUND DATA: Major cancer surgery is associated with significant perioperative risks which result in worse long-term outcomes. METHODS: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and co-management vs usual management. The primary study outcome was 30-day rate of DSC. Additional outcomes included complications, adverse events, health care utilization, health-related quality of life (HRQOL), and disease-free and overall survival (DFS and OS). RESULTS: Between August 2014 and June 2020, 1529 patients were enrolled and randomly allocated to the study arms; 738 patients in the Intervention Arm and 732 patients in the Control Arm were eligible for analysis. 30-day rate of DSC with the intervention was 15.0% (95% CI, 12.5-17.6%) vs 14.1%, (95% CI, 11.6-16.6%) with usual management (P=0.65). There were no differences in 30-day rates of complications or adverse events (including return to the operating room); postoperative length of stay; rate of discharge to home; or 30, 60, or 90-day HRQOL or rates of hospital readmission or receipt of anti-neoplastic therapy between the study arms. At median follow-up of 48 months, OS (P=0.57) and DFS (P=0.91) were similar. CONCLUSIONS: Risk-based, protocol-driven management did not reduce 30-day rate of DSC after elective major cancer surgery compared to usual management, nor improve postoperative health care utilization, HRQOL, or cancer outcomes. Trials are needed to identify cost-effective, tailored perioperative strategies to optimize outcomes after major cancer surgery.

The Addition of Chemoradiation to Adjuvant Chemotherapy is Associated With Improved Survival Following Upfront Surgical Resection for Pancreatic Cancer With Nodal Metastases.

BACKGROUND: It is unclear whether the addition of chemoradiation (CRT) to adjuvant chemotherapy (CT) following upfront resection of pancreatic ductal adenocarcinoma (PDAC) provides any benefit. While some studies have suggested a benefit to combined modality therapy (CMT) (adjuvant CT plus CRT), it is not clear if this benefit was related to increased CT usage in patients who received CMT. We sought to clarify the use of CMT in patients who underwent upfront resection of PDAC. METHODS: Patients with non-metastatic PDAC were retrospectively identified from the linked SEER-Medicare database. Those who underwent upfront resection were identified and divided into two cohorts - patients who received adjuvant CT and patients who received adjuvant CMT. Cohorts were compared. Univariate analysis described patient characteristics. Kaplan-Meier and multivariable Cox proportional hazards modeling were used to estimate overall survival (OS). RESULTS: 3555 patients were identified; 856 (24%) received CT and 573 (16%) received CMT. The median number of CT doses was 11 for both groups. Patients who received CMT were younger, diagnosed in the earlier time frame, and had fewer comorbidities. The median OS was 21 months and 18 months for those treated with CMT and CT (P < .0001), respectively, but when stratified by nodal status, the association with improved OS in the CMT cohort was only observed in node-positive patients. On multivariable analysis, receipt of CMT and removal of >15 lymph nodes decreased the risk of death (P < .05). DISCUSSION: Receipt of CMT following upfront resection for PDAC was associated with improved survival, which was confined to node-positive patients. The role of adjuvant CMT in PDAC with nodal metastases warrants further study.

Immunofluorescence in Robotic Colon and Rectal Surgery.

The indocyanine green fluorescence imaging system is a surgical tool with increasing applications in colon and rectal surgery that has received growing acceptance in various surgical disciplines as a potentially valid method to enhance surgical field visualization, improve lymph node retrieval, and decrease anastomotic leak. Small noncomparative prospective trials have shown that intraoperative fluorescence imaging is a safe and feasible method to assess anastomotic perfusion and that its use may impact anastomotic leak rates. However, larger prospective and randomized studies are required to validate its role and impact in colorectal surgery. The purpose of this article is to review the current status of the use of immunofluorescence in colon and rectal surgery, as well as new applications in robotic colon and rectal resections.

Surgical microwave ablation of otherwise non-resectable colorectal cancer liver metastases: Expanding opportunities for long term survival.

BACKGROUND: Colorectal liver metastases (CRLM) are the most common extra-lymphatic metastases in colorectal cancers, however, only 15-20% of these patients are candidates for resection. We reviewed our institutional experience with 135 surgical ablations for unresectable CRLM. METHODS: Retrospective review of surgically ablated CRLM from 2009 to 2018. Patient-specific variables were obtained from the medical record. Kaplan-Meier modeling was performed for survival analyses. RESULTS: We ablated 135 CRLM in 36 patients over 40 procedures. Median age was 52 years and 58% of patients were male. All patients received systemic chemotherapy. The ablation procedure was completed laparoscopically in 68% of procedures. Median number of ablated lesions per patient was 2 (range 1-15). Median maximum diameter of ablated lesions was 1.9 cm (range 0.5-12.2). Median follow up of the study was 28 months. In this time, median disease-free survival was not reached. Of the 135 lesions ablated, the per-lesion recurrence rate was 6/135 (4.4%). Median overall survival was 81 months. CONCLUSIONS: Surgical ablation of CRLM can provide excellent local control and long-term survival outcomes in patients who may otherwise not be candidates for other liver-directed therapies.

Adjuvant chemotherapy for intrahepatic cholangiocarcinoma: approaching clinical practice consensus?

BACKGROUND: Intrahepatic cholangiocarcinoma (ICC) is rare with limited evidence-based guidelines. This retrospective study evaluates the use of chemotherapy in patients with resected ICC. METHODS: The Surveillance Epidemiology and End Results (SEER) program database was used to identify patients with resected ICC. Patients were stratified by date of diagnosis (2000-2004, 2005-2009, 2010-2014), T, and N stage. Multivariable logistic regression models identified predictors of chemotherapy use. Kaplan-Meier and Cox proportional hazard models were used to identify survival trends. RESULTS: One thousand and two hundred twenty-three patients met inclusion criteria. Chemotherapy utilization increased over time (33% to 41%, P≤0.05). Chemotherapy use increased in lymph node (LN) positive patients [32% to 60% in 2010-2014; (P≤0.05) and T3/T4 disease (40% to 60% in 2010-2014; P≤0.01], but not in patients with LN negative or T1/T2 disease. LN positivity was associated with utilization of chemotherapy in 2005-2009 and 2010-2014. Overall survival increased from 32 to 41 months (P≤0.05). In LN positive patients, chemotherapy was associated with a decreased hazard ratio of death (P≤0.05) and T3/T4 disease was associated with an increased hazard ratio of death (P≤0.05). CONCLUSIONS: Adjuvant chemotherapy use in ICC has increased. More LN positive or patients with T3/T4 tumors are receiving chemotherapy, which may explain the improvement in overall survival.

Genomic expression assay testing among American Indian and Alaska Native women with breast cancer.

BACKGROUND: Breast cancer is one of the most common causes of cancer mortality for all women, including American Indian and Alaska Native (AI/AN) women. The use of the 21-gene recurrence score (RS) appears to be predictive of the benefit of chemotherapy for women with estrogen receptor (ER)-positive breast cancer. The objective of the current study was to compare RS testing between AI/AN and non-Hispanic White (NHW) women with breast cancer. METHODS: The Surveillance, Epidemiology, and End Results program was used to identify women with ER-positive breast cancer from 2004 through 2015. Multivariable logistic regression was used to evaluate factors associated with RS use, with high-risk RS, and with chemotherapy use among those with a high-risk RS. RESULTS: A total of 363,387 NHW patients and 1951 AI/AN patients with ER-positive breast cancer were identified. AI/AN women were found to be less likely to undergo RS testing and, when tested, were more likely to have a high-risk RS. In the multivariable logistic regression analysis, AI/AN women were found to be significantly more likely to have a high-risk RS (odds ratio,1.28; 95% confidence interval, 1.01-1.66). Among untested women, chemotherapy use was higher for AI/AN women; however, the use of chemotherapy was not found to be significantly different between the groups with a high-risk RS. Using Cox proportional hazards models, AI/AN race was found to be significantly associated with worse overall survival. CONCLUSIONS: AI/AN women were less likely to undergo RS testing compared with NHW women and were more likely to have a high-risk RS. Reversing the disparity in genomic expression assay testing is critical to ensure guideline-based breast cancer treatment and improve survival rates for AI/AN women with breast cancer.

The addition of chemoradiation to adjuvant chemotherapy is associated with improved survival in lymph node-positive gastric cancer.

BACKGROUND: In the ARTIST trial, chemoradiation did not improve disease-free survival (DFS) in gastric cancer patients treated with curative-intent surgery and adjuvant chemotherapy. Subgroup analysis suggested chemoradiation improved DFS in patients with lymph node (LN) metastases, but the role of adjuvant chemoradiation remains uncertain. This study sought to determine the role of adjuvant chemoradiation using population-based methods. METHODS: Surveillance, Epidemiology and End Results-Medicare linked data from 2004 to 2013 was used to identify patients aged 66 and older with LN-positive gastric adenocarcinoma. Multivariable logistic regression evaluated factors associated with receipt of chemoradiation. The Kaplan-Meier method and Cox proportional hazards modeling were used to evaluate overall survival (OS). RESULTS: A total of 2409 patients with LN-positive gastric adenocarcinoma who underwent upfront surgical resection were identified; 309 (13%) received adjuvant chemotherapy and 407 (17%) received adjuvant chemotherapy and chemoradiation. Among all patients, median OS was 15 months. Median OS was 20 months for patients who received chemotherapy alone and 27 months for patients who received chemotherapy and chemoradiation (p < 0.05). Recent diagnosis, older age, tumor stage T3 or T4, and Charleston Comorbidity Index were associated with an increased hazard ratio for death (p < 0.05). Receipt of chemoradiation was associated with a decreased hazard ratio for death (p < 0.05). CONCLUSIONS: In patients with LN-positive gastric adenocarcinoma, the addition of chemoradiation to adjuvant chemotherapy after upfront surgical resection was associated with improved survival irrespective of the extent of lymphadenectomy. These data suggest chemoradiation should be considered in patients with LN-positive gastric adenocarcinoma.

Failure to administer multimodality therapy leads to sub-optimal outcomes for patients with node-positive biliary tract cancers in the United States.

BACKGROUND: Lymph node-positive biliary tract cancers have poor overall survival. Surgical resection followed by systemic chemotherapy is the mainstay of treatment. We sought to assess the delivery of multimodality therapy in the United States. METHODS: The Surveillance, Epidemiology, and End Results program database was used to identify patients with node-positive biliary tract cancers without distant metastases from 2000 to 2014. Patients were stratified by disease subtype (gallbladder cancer, intrahepatic, extrahepatic, or hilar cholangiocarcinoma) and treatment received (surgery alone, chemotherapy alone, or surgery + chemotherapy). Survival was analyzed using the Kaplan-Meier method and Cox proportional hazard modeling. RESULTS: A total of 3226 patients with node-positive biliary tract cancers were identified. Of 2837 patients who underwent surgical resection, 1386 (49%) received no systemic chemotherapy following surgery, while 1451 (51%) received surgery + chemotherapy. A total of 389 patients (12%) received chemotherapy alone. Median overall survival was longer for patients who underwent surgery + chemotherapy (19 months, p < 0.0001). There was no difference in survival for those who received surgery alone versus chemotherapy alone (10 months for both, p = NS). Receipt of surgery + chemotherapy was independently associated with survival on Cox proportional hazard ratio modeling compared to surgery alone (HR for mortality 1.71, 95% CI 1.56-1.87, p < 0.0001) or chemotherapy alone (HR 1.68, 95% CI 1.46-1.92, p < 0.0001). These trends were consistent across all disease subtypes. DISCUSSION: Optimal survival for node-positive biliary tract cancers depends on multimodality therapy. Following surgery, a substantial proportion of patients do not receive guideline recommended adjuvant therapy.

Systemic therapy without radiation may be appropriate as neoadjuvant therapy for localized pancreas cancer.

BACKGROUND: The utility of neoadjuvant treatment for resectable pancreas cancer is yet to be determined, but has commonly included chemoradiation. We evaluated outcomes in patients with radiographically resectable pancreatic adenocarcinoma treated with neoadjuvant chemotherapy without chemoradiation. METHODS: A retrospective review of patients in our institutional pancreatic cancer registry was performed, which identified 36 patients who received neoadjuvant chemotherapy alone for resectable pancreatic adenocarcinoma between 2012 and 2016. RESULTS: Median age at diagnosis was 66.3 years. Chemotherapy regimens included gemcitabine (n=17), gemcitabine/nab-paclitaxel (n=8), or 5-FU/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) (n=11). Surgical resection was performed in 69% of patients (n=25), with an R0 resection rate of 92% (n=23 patients). During chemotherapy, distant disease became apparent in 19% of patients (n=7), while no patients had evidence of local progression. Resection rates were similar between chemotherapy regimens (single agent =59%, multiple agent =79%). Median overall survival for all patients who received neoadjuvant chemotherapy was 30.3 and 34.4 months for those who underwent surgical resection. There was no difference in median survival for patients treated with gemcitabine (31.3 months) or multi-agent chemotherapy (29.7 months). CONCLUSIONS: A short course of neoadjuvant chemotherapy without chemoradiation may improve patient selection prior to surgical resection for pancreas cancer. Further, local disease progression did not limit surgical resection in this small series.

Minimally invasive microwave ablation provides excellent long-term outcomes for otherwise inaccessible hepatocellular cancer.

BACKGROUND AND OBJECTIVES: Thermal ablation can be used as a bridge to transplant or with curative intent for hepatocellular carcinoma (HCC). We report our experience with laparoscopic ablation of HCC in patients deemed inaccessible by the percutaneous approach. METHODS: We performed a retrospective review of surgical ablations from 2009 to 2017. Patient demographics, disease and treatment characteristics, and outcomes were abstracted from the medical record. Kaplan-Meier modeling was performed for survival and recurrence. RESULTS: Thirty-three patients were included with a median age of 62 (interquartile range [IQR], 57-67). Most patients were male (76%) and Caucasian (70%). Ninety-seven percent had underlying cirrhosis. Median model for end stage liver disease-sodium was 9.5 (IQR, 8-12). The median maximal diameter of ablated lesions was 2.6 cm (IQR, 1.8-3.0). Thirty-nine lesions were ablated; 97% were completed laparoscopically. The median maximal diameter of the ablation zone was 4.8 cm (IQR, 3.8-5.7) with a median difference of ablation zone to the tumor of 2.0 cm (IQR, 1.5-2.75). Twelve patients received additional treatment. Median disease-free survival was 66.7 months and median follow-up 42.9 months. Disease recurrence occurred in 13 patients (39%)-systemic recurrence in 6%, intrahepatic recurrence in 27% and local recurrence in 6%. CONCLUSION: Laparoscopic thermal ablation of HCC is safe and provides good oncologic outcomes for otherwise inaccessible tumors.

Patterns of Treatment and Survival among American Indian and Alaska Native Women with Breast Cancer, 2000-2015.

We used data from the Surveillance, Epidemiology, and End Results Program to examine trends in breast cancer treatment and survival among a large sample of American Indian and Alaska Native women diagnosed from 2000-2015. Kaplan-Meier and Cox proportional hazard models were used to estimate survival. Alaska Natives were more likely to undergo mastectomy (48% compared with 39% of American Indians and 36% of non-Hispanic Whites) and were less likely to receive breast reconstruction following mastectomy (9% compared with 17% of American Indians and 28% of non-Hispanic Whites). Alaska Natives had both lower overall (HR: 1.40 95% CI: 1.19-1.65) and breast-cancer specific (HR: 1.29, 95% CI: 1.03, 1.63) survival compared with non-Hispanic Whites. Survival differences across the three racial groups varied significantly by age. Efforts to improve survival among American Indian and Alaska Native populations will need to address barriers to access among these vulnerable populations.

Intraoperative inking is superior to suture marking for specimen orientation in breast cancer.

Margin status is an important indicator of residual disease after breast-conserving surgery (BCS). Intraoperatively, surgeons orient specimens to aid assessment of margins and guide re-excision of positive margins. We performed a retrospective review of BCS cases from 2013 to 2017 to compare the two specimen orientation methods: suture marking and intraoperative inking. Patients with ductal carcinoma in situ, T1/T2 invasive cancer treated with BCS were included. Rates of positive margins and residual disease at re-excision were evaluated. 189 patients underwent BCS; 83 had suture marking, 103 had intraoperative inking and 3 had un-oriented specimens. The incidence of positive margins was 29% (24 patients) in the suture marked group and 20% (21 patients) in the intraoperative inked group (P = .18). Among the 45 patients with positive margins, 60% of tumors were stage T1, 76% were node negative, 36% were palpable with median tumor size of 1.5 cm. Residual disease was identified on re-excision in 21% of the suture marked specimens and 57% of intraoperative inked specimens (P = .028). The incidence of residual cancer at re-excision for positive margins was higher for intraoperatively inked versus suture marked specimens. This finding suggests that intraoperative inking is more effective at guiding re-excision of positive margins.

Incidence and predictors of incisional hernia after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

Background and objectives: The incidence of incisional hernia (IH) after cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is largely unknown. Methods: We conducted a retrospective study to identify patients who underwent CRS/HIPEC from 2001 to 2016. Patients were followed postoperatively for a minimum of two years. The primary outcome was the occurrence of an IH identified either on CT scan or physical examination. Univariate and multivariable logistic regression models were used to test associations with IH. Results: We identified 155 patients who underwent CRS/HIPEC; 26 patients (17%) were diagnosed with an IH at a median time of 245 days (Interquartile range [IQR] 175 - 331 days). On multivariable analysis, older age [50-64 vs. 18-49 years: hazard ratio (HR) = 0.08; 95% confidence interval (CI), 0.01 to 0.64)], female gender (HR = 0.09; 95% CI, 0.01 to 0.75), and increased BMI (>30 vs. <25; HR = 0.03; 95% CI, 0.01 to 0.37) were significant independent predictors of IH. Conclusions: The incidence of IH in this high-risk patient population treated with CRS/HIPEC is similar to that after other abdominal cancer operations. Nevertheless, the occurrence of IH is an important patient outcome, so alternative closure techniques for reducing IH should be studied in this patient population. Synopsis In a single-institutional study, the incidence of incisional hernia was 17% after cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy. Independent risk factors of incisional hernia were older age, female gender and obesity.

Completion of Adjuvant Chemotherapy After Upfront Surgical Resection for Pancreatic Cancer Is Uncommon Yet Associated With Improved Survival.

BACKGROUND: Multiple trials have demonstrated a survival benefit for adjuvant chemotherapy after resection of pancreatic adenocarcinoma. This study aimed to identify the rate for completion of adjuvant chemotherapy, factors associated with completion, and its impact on survival after surgical resection. METHODS: The Surveillance Epidemiology and End Results Medicare-linked data was used to identify patients who underwent upfront resection for pancreatic adenocarcinoma from 2004 to 2013. Billing codes were used to quantify receipt and completion of chemotherapy. Factors associated with completion of chemotherapy were identified using multivariable regression. Kaplan-Meier and Cox proportional-hazards modeling were used to examine survival. RESULTS: The inclusion criteria were met by 2440 patients. Of these patients, 65% received no adjuvant chemotherapy, 28% received incomplete therapy, and 7% completed chemotherapy. The factors associated with chemotherapy completion were nodal metastases and treatment at a National Cancer Institute-designated cancer center (p ≤ 0.05). Comorbidities decreased the odds of completion (p ≤ 0.05). The median overall survival (OS) was 14 months for the patients who received no adjuvant chemotherapy, 17 months for those who received incomplete adjuvant chemotherapy, and 22 months for those who completed adjuvant chemotherapy (p ≤ 0.05). More recent diagnosis, comorbidities, T stage, nodal metastases, and no adjuvant chemotherapy were associated with an increased hazard ratio for death (p ≤ 0.05). Evaluation of 15 or more nodes and completion of chemotherapy decreased the hazard ratio for death (p ≤ 0.05). CONCLUSIONS: Only 7% of the Medicare patients who underwent upfront resection for pancreatic cancer completed adjuvant chemotherapy, yet completion of adjuvant chemotherapy was associated with improved OS. Completion of adjuvant chemotherapy should be the goal after upfront resection, but neoadjuvant chemotherapy may ensure that patients receive systemic chemotherapy.

The use of contralateral prophylactic mastectomy among elderly patients in the United States.

PURPOSE: Previous studies have reported increased rates of contralateral prophylactic mastectomy (CPM) in the United States among women with unilateral breast cancer. These trends have primarily focused on younger breast cancer patients. Given the growing aging population in the United States, we sought to determine whether CPM use is also increasing in elderly patients. METHODS: This population-based study identified patients in the surveillance epidemiology and end results (SEER) data. We determined the rate of CPM as a proportion of all surgically treated patients and as a proportion of all mastectomies. We compared the unadjusted CPM rates over the study period using the Cochrane-Armitage test for trend. We used a logistic regression model to test for the factors associated with CPM utilization. RESULTS: We identified 261,281 patients ≥ 65 years who underwent surgical treatment for breast cancer. For all patients treated with surgery for invasive breast cancer, the use of CPM increased from 1 in 2004 to 3% in 2014 (200% increase). Among mastectomy patients, the use of CPM increased from 3 in 2004 to 7% in 2014 (133% increase). Young age, non-Hispanic white race, lobular histology, higher grade, increased stage, negative lymph node status, and recent year of diagnosis were significantly associated with increased CPM rates. CONCLUSIONS: For elderly patients the use of CPM has continued to increase in the United States. These observations warrant concern in light of increasing evidence that CPM does not improve oncological outcomes and is associated with increased morbidity in older patients.

Trends in lobular carcinoma in situ management: endocrine therapy use in California and New Jersey.

PURPOSE: The diagnosis of lobular carcinoma in situ (LCIS) is a strong risk factor for breast cancer. Endocrine therapy (ET) for LCIS has been shown to decrease breast cancer risk substantially. The purpose of this study was to evaluate the trends of ET use for LCIS in two large geographic locations. PATIENTS AND METHODS: We identified women, ages 18 through 75, with a microscopic diagnosis of LCIS in California (CA) and New Jersey (NJ) from 2004 to 2014. We evaluated trends in unadjusted ET rates during the study period and used logistic regression to evaluate the relationship between patient, tumor, and treatment characteristics, and ET use. RESULTS: We identified 3,129 patients in CA and 2,965 patients in NJ. The overall use of ET during the study period was 14%. For the combined sample, women in NJ were significantly less likely to utilize ET then their counterparts in CA (OR 0.77, CI 0.66-0.90, NJ vs. CA). In addition, patients in the later year period (OR 1.27, CI 1.01-1.59, 2012-2014 vs. 2004-2005) and women who received an excisional biopsy (OR 2.35, CI 1.74-3.17), were more likely to utilize ET. Uninsured women were less likely to receive ET (OR 0.61, CI 0.44-0.84, non-insured vs. insured status). CONCLUSIONS: We observed that an increasing proportion of women are using ET for LCIS management, but geographical differences exist. Health insurance status played an important role in the underutilization of ET. Further research is needed to assess patient outcomes given the variations in management of LCIS.

21-Gene Recurrence Score Testing in HER2-positive Patients.

INTRODUCTION: The 21-gene recurrence score (RS) has been extensively studied and validated in patients with estrogen receptor-positive (ER+), human epidermal growth factor 2 (HER2)-negative breast cancer; however, RS testing is not routinely performed in patients with HER2-positive (HER2+) disease. We sought to determine patterns of RS testing, to characterize RS distributions, and to determine the impact of RS results on clinical decision-making for patients with ER+, HER2+ breast cancer. MATERIALS AND METHODS: Using the Surveillance and Epidemiology End Results program database, we identified women with ER+, HER2+ breast cancer. We stratified patients using TAILORx RS cutoffs and evaluated treatment characteristics across patients. Multivariable logistic regression was performed to determine factors associated with RS testing and receipt of a high-risk RS. RESULTS: Overall, 5% of patients with ER+, HER2+, early stage breast cancer underwent RS testing. The distribution of RS testing by TAILORx cutoffs were: high-risk, 17%; intermediate-risk, 49%; and low-risk, 34%. Chemotherapy utilization among those not tested was 66%. Among those tested, utilization was significantly associated with RS results: 67% of high-risk, 30% of intermediate-risk, and 19% of low-risk patients received chemotherapy. Progesterone receptor-negative status, larger tumor size, and high tumor grade were significantly associated with high-risk RS. CONCLUSIONS: RS testing is used sparingly among patients with HER2+ early-stage breast cancer; however, test results appear to impact clinician's decision-making on chemotherapy use.

Surgical resection of lymph node positive intrahepatic cholangiocarcinoma may not improve survival.

BACKGROUND: Nodal positivity is a predictor of poor survival following resection for intrahepatic cholangiocarcinoma (ICC). The aim of this study was to evaluate the impact of surgical resection on survival in patients with lymph node (LN) positive ICC. METHODS: An augmented version of the Surveillance, Epidemiology, and End Results program database was utilized to identify patients with LN-positive ICC without distant metastases from 2000 to 2014. Patients were stratified by treatment: chemotherapy alone or surgical resection with/without chemotherapy. Survival was evaluated using Kaplan-Meier and Cox proportional hazard models. RESULTS: 169 patients who underwent treatment for LN-positive ICC were identified. 88% underwent surgical resection and 12% underwent chemotherapy alone. The median survival for patients who underwent surgical resection was not different from patients treated with chemotherapy alone (19 months 95% Confidence Interval (CI) 17-33 versus 20 months CI 10-27, p = 0.323). A cox-proportional hazard ratio model demonstrated that black race was associated with worse survival (p < 0.05), while surgical resection was not independently associated with survival. CONCLUSION: Surgical resection for patients with LN-positive ICC may not improve survival compared to chemotherapy alone. Pathologic LN evaluation should be performed prior to surgical resection, to improve patient selection and ensure receipt of optimal therapy.

21-gene recurrence score testing in the older population with estrogen receptor-positive breast cancer.

INTRODUCTION: The 21-gene recurrence score (RS) (Oncotype Dx, Genomic Health, Redwood City Ca) has not been validated in an older cohort with estrogen receptor (ER)-positive breast cancer. The objective of this study was to evaluate RS validity in a group of older women with ER-positive breast cancer. METHODS: Utilizing the Surveillance, Epidemiology, and End Results Program (SEER) database with available RS, we evaluated women with ER-positive breast cancer aged 18-69 and those 70 years of age and older from 2004 to 2014. We utilized multivariable logistic regression models to evaluate factors associated with RS testing as well as a high-risk categorization for those who underwent testing. Survival was analyzed using Kaplan Meier curves and Cox proportional hazard models. RESULTS: We identified 363,876 women aged 18-69 years and 147,107 women aged 70 years and older. A smaller proportion of patients in the older group (8%) underwent RS testing than in the younger group (18%). Of the patients who underwent testing, distribution of RS was similar between groups. High-risk categorization independently predicted a higher likelihood of death for older patients (hazard ratio 1.47, 95% confidence interval 1.15-1.90). Among patients with high-risk RS, chemotherapy was associated with a decreased risk of death in the younger group, but not in the older group. CONCLUSION: Older women are less likely to receive RS testing, but when tested, older patients have a similar distribution of RS as compared to younger patients. While high-risk categorization in the older cohort was prognostic, chemotherapy was not associated with improved survival.