Alexandra W. Acher

Prognostic Performance of Different Lymph Node Staging Systems After Curative Intent Resection for Gastric Adenocarcinoma

Objective: To compare the prognostic performance of American Joint Committee on Cancer/International Union Against Cancer seventh N stage relative to lymph node ratio (LNR), log odds of metastatic lymph nodes (LODDS), and N score in gastric adenocarcinoma. Background: Metastatic disease to the regional LN basin is a strong predictor of worse long-term outcome following curative intent resection of gastric adenocarcinoma. Methods: A total of 804 patients who underwent surgical resection of gastric adenocarcinoma were identified from a multi-institutional database. The relative discriminative abilities of the different LN staging/scoring systems were assessed using the Akaikes Information Criterion (AIC) and the Harrells concordance index (c statistic). Results: Of the 804 patients, 333 (41.4%) had no lymph node metastasis, whereas 471 (58.6%) had lymph node metastasis. Patients with ≥N1 disease had an increased risk of death (hazards ratio = 2.09, 95% confidence interval: 1.68–2.61; P < 0.001]. When assessed using categorical cutoff values, LNR had a somewhat better prognostic performance (C index: 0.630; AIC: 4321.9) than the American Joint Committee on Cancer seventh edition (C index: 0.615; AIC: 4341.9), LODDS (C index: 0.615; AIC: 4323.4), or N score (C index: 0.620; AIC: 4324.6). When LN status was modeled as a continuous variable, the LODDS staging system (C index: 0.636; AIC: 4304.0) outperformed other staging/scoring systems including the N score (C index: 0.632; AIC: 4308.4) and LNR (C index: 0.631; AIC: 4225.8). Among patients with LNR scores of 0 or 1, there was a residual heterogeneity of outcomes that was better stratified and characterized by the LODDS. Conclusions: When assessed as a categorical variable, LNR was the most powerful manner to stratify patients on the basis of LN status. LODDS was a better predicator of survival when LN status was modeled as a continuous variable, especially among those patients with either very low or high LNR.

Effect of Perioperative Transfusion on Recurrence and Survival after Gastric Cancer Resection: A 7-Institution Analysis of 765 Patients from the US Gastric Cancer Collaborative

BACKGROUND The prognostic effect of perioperative blood transfusion on recurrence and survival in patients undergoing resection of gastric adenocarcinoma (GAC) remains controversial. STUDY DESIGN All patients who underwent resection for GAC from 2000 to 2012 at the 7 institutions of the US Gastric Cancer Collaborative were identified. The effect of transfusion on recurrence-free (RFS) and overall survival (OS) in the context of adverse clinicopathologic variables was examined by univariate and multivariate regression analyses. RESULTS Of 965 patients, 765 underwent curative intent R0 resection. Median follow-up was 44 months; 30-day mortalities were excluded. Median estimated blood loss (EBL) was 200 mL, and 168 patients (22%) received perioperative allogeneic blood transfusions. Transfused patients were less likely to receive adjuvant therapy (44% vs 56%; p = 0.01). Transfusion was associated with significantly decreased median RFS (13.5 vs 37.2 months, p < 0.001). Median OS was similarly decreased in patients receiving transfusions (18.6 vs 49.8 months, p < 0.001). On multivariate analysis, transfusion remained an independent risk factor for decreased RFS (hazard ratio [HR] 1.63; 95% CI 1.13 to 2.37; p = 0.010) and decreased OS (HR 1.79; 95% CI 1.21 to 2.67; p = 0.004), regardless of EBL or need for splenectomy. Timing (intraoperative vs postoperative) and volume of transfusion did not alter the negative prognostic effect of transfusion on survival. CONCLUSIONS Perioperative allogeneic blood transfusion is associated with decreased RFS and OS after resection of gastric cancer, independent of adverse clinicopathologic factors. This supports the judicious use of perioperative transfusion during resection of gastric cancer.

A nomogram to predict overall survival and disease-free survival after curative resection of gastric adenocarcinoma.

AbstractBackgroundThe American Cancer Society projects there will be over 22,000 new cases, resulting in nearly 11,000 deaths, related to gastric adenocarcinoma in the US in 2014. The aim of the current study was to find clinicopathologic variables associated with disease-free survival (DFS) and overall survival (OS) following curative resection of gastric adenocarcinoma, and create a nomogram for individual risk prediction.Methods A nomogram to predict DFS and OS following surgical resection of gastric adenocarcinoma was constructed using a multi-institutional cohort of patients who underwent surgery for primary gastric adenocarcinoma at seven major institutions in the US between January 2000 and August 2013. Discrimination and calibration of the nomogram were tested by C-statistic, Kaplan–Meier curves, and calibration plots.ResultsA total of 719 patients who underwent surgery for primary gastric adenocarcinoma were included in the study. Using the backward selection of clinically relevant variables with Akaike information criteria, age, sex, tumor site, depth of invasion, and lymph node ratio (LNR) were selected as factors predictive of OS, while age, tumor site, depth of invasion, and LNR were incorporated in the prediction of DFS. A nomogram was constructed to predict OS and DFS using these variables. Discrimination and calibration of the nomogram revealed good predictive abilities (C-index, DFS 0.711; OS 0.702).Conclusion Independent predictors of recurrence and death following surgery for primary gastric adenocarcinoma were used to create a nomogram to predict DFS and OS. The nomogram was able to stratify patients into prognostic groups, and performed well on internal validation.

Factors Associated With Recurrence and Survival in Lymph Node-negative Gastric Adenocarcinoma: A 7-Institution Study of the US Gastric Cancer Collaborative.

Objectives: To determine pathologic features associated with recurrence and survival in patients with lymph node–negative gastric adenocarcinoma. Study Design: Multi-institutional retrospective analysis. Background: Lymph node status is among the most important predictors of recurrence after gastrectomy for gastric adenocarcinoma. Pathologic features predictive of recurrence in patients with node-negative disease are less well established. Methods: Patients who underwent curative resection for gastric adenocarcinoma between 2000 and 2012 from 7 institutions of the US Gastric Cancer Collaborative were analyzed, excluding 30-day mortalities and stage IV disease. Competing risks regression and multivariate Cox regression were used to determine pathologic features associated with time to recurrence and overall survival. Differences in cumulative incidence of recurrence were assessed using the Gray method (for univariate nonparametric analyses) and the Fine and Gray method (for multivariate analyses) and shown as subhazard ratios (SHRs) and adjusted subhazard ratios (aSHRs), respectively. Results: Of 805 patients who met inclusion criteria, 317 (39%) had node-negative disease, of which 54 (17%) recurred. By 2 and 5 years, 66% and 88% of patients, respectively, experienced recurrence. On multivariate competing risks regression, only T-stage 3 or higher was associated with shorter time to recurrence [aSHR = 2.7; 95% confidence interval (CI), 1.5–5.2]. Multivariate Cox regression showed T-stage 3 or higher [hazard ratio (HR) = 1.8; 95% CI, 1.2–2.8], lymphovascular invasion (HR = 2.2; 95% CI, 1.4–3.4), and signet ring histology (HR = 2.1; 95% CI, 1.2–3.6) to be associated with decreased overall survival. Conclusions: Despite absence of lymph node involvement, patients with T-stage 3 or higher have a significantly shorter time to recurrence. These patients may benefit from more aggressive adjuvant therapy and postoperative surveillance regimens.

Using Human Factors and Systems Engineering to Evaluate Readmission after Complex Surgery.

BACKGROUND Our objective was to use a human factors and systems engineering approach to understand contributors to surgical readmissions from a patient and provider perspective. Previous studies on readmission have neglected the patient perspective. To address this gap and to better inform intervention design, we evaluated how transitions of care relate to and influence readmission from the patient and clinician perspective using the Systems Engineering Initiative for Patient Safety (SEIPS) model. STUDY DESIGN Patients readmitted within 30 days of discharge after complex abdominal surgery were interviewed. A focus group of inpatient clinician providers was conducted. Questions were guided by the SEIPS framework and content was analyzed. Data were collected concurrently from the medical record for a mixed-methods approach. RESULTS Readmission occurred a median of 8 days (range 1 to 25 days) after discharge. All patients had follow-up scheduled with their surgeon, but readmission occurred before this in 72% of patients. Primary readmission diagnoses included infection, gastrointestinal complications, and dehydration. Patients (n = 18) and clinician providers (n = 6) identified a number of factors during the transition of care that may have contributed to readmission, including poor patient and caregiver understanding; inadequate discharge preparation for home care; insufficient educational process and materials, negatively affected by electronic health record design; and inadequate care team communication. CONCLUSIONS This is the first study to use a human factors and systems engineering approach to evaluate the impact of the quality of the transition of care and its influence on readmission from the patient and clinician perspective. Important targets for future interventions include enhancing the discharge process, improving education materials, and increasing care team coordination, with the overarching theme that improved patient and caregiver understanding and engagement are essential to decrease readmission and postdischarge health care use.

Original scientific articleUsing Human Factors and Systems Engineering to Evaluate Readmission after Complex Surgery

BACKGROUND Our objective was to use a human factors and systems engineering approach to understand contributors to surgical readmissions from a patient and provider perspective. Previous studies on readmission have neglected the patient perspective. To address this gap and to better inform intervention design, we evaluated how transitions of care relate to and influence readmission from the patient and clinician perspective using the Systems Engineering Initiative for Patient Safety (SEIPS) model. STUDY DESIGN Patients readmitted within 30 days of discharge after complex abdominal surgery were interviewed. A focus group of inpatient clinician providers was conducted. Questions were guided by the SEIPS framework and content was analyzed. Data were collected concurrently from the medical record for a mixed-methods approach. RESULTS Readmission occurred a median of 8 days (range 1 to 25 days) after discharge. All patients had follow-up scheduled with their surgeon, but readmission occurred before this in 72% of patients. Primary readmission diagnoses included infection, gastrointestinal complications, and dehydration. Patients (n = 18) and clinician providers (n = 6) identified a number of factors during the transition of care that may have contributed to readmission, including poor patient and caregiver understanding; inadequate discharge preparation for home care; insufficient educational process and materials, negatively affected by electronic health record design; and inadequate care team communication. CONCLUSIONS This is the first study to use a human factors and systems engineering approach to evaluate the impact of the quality of the transition of care and its influence on readmission from the patient and clinician perspective. Important targets for future interventions include enhancing the discharge process, improving education materials, and increasing care team coordination, with the overarching theme that improved patient and caregiver understanding and engagement are essential to decrease readmission and postdischarge health care use.

An assessment of feeding jejunostomy tube placement at the time of resection for gastric adenocarcinoma: A seven‐institution analysis of 837 patients from the U.S. gastric cancer collaborative

Jejunostomy feeding tubes (J‐tubes) are often placed during resection for gastric adenocarcinoma (GAC). Their effect on postoperative complications and receipt of adjuvant therapy is unclear.

The importance of the proximal resection margin distance for proximal gastric adenocarcinoma: A multi-institutional study of the US Gastric Cancer Collaborative

A 5 cm margin is advocated for distal gastric adenocarcinoma (GAC). The optimal proximal resection margin (PM) length for proximal GAC is not established.

Improving Patient-Centered Transitional Care after Complex Abdominal Surgery

BACKGROUND Poor-quality transitions of care from hospital to home contribute to high rates of readmission after complex abdominal surgery. The Coordinated Transitional Care (C-TraC) program improved readmission rates in medical patients, but evidence-based surgical transitional care protocols are lacking. This pilot study evaluated the feasibility and preliminary effectiveness of an adapted surgical C-TraC protocol. STUDY DESIGN The intervention includes in-person enrollment of patients. Follow-up protocolized phone calls by specially trained surgical C-TraC nurses addressed medication management, clinic appointments, operation-specific concerns, and identification of red-flag symptoms. Enrollment criteria included pancreatectomy, gastrectomy, operative small bowel obstruction or perforation, ostomy, discharge with a drain, in-hospital complication, and clinician discretion. Engaged patients participated in the first phone call, which was within 48 to 72 hours of discharge and continued every 3 to 4 days. Patients completed the program once they and surgical C-TraC nurse agreed that no additional follow-up was needed or the patient was readmitted. RESULTS Two hundred and twelve patients were enrolled, October 2015 through April 2016, with a mean age of 56 years (range 19 to 89 years); 33% of patients were 65 years or older. Surgery sites included colon (46%), small bowel (16%), pancreas (12%), multivisceral (9%), liver (4.5%), retroperitoneum/soft tissue (4.5%), gastric (4%), biliary (2%), and appendix (1.5%). Refusal rate was 1% and engagement was 95%. At initial call, 47% of patients had at least 1 medication discrepancy (range 0 to 6). Mean number of calls from provider to patient was 3.2 (range 0 to 20, median 3). CONCLUSIONS A phone-based transitional care protocol for surgical patients is feasible, with <1% refusals and 95% engagement. Medication management is a prominent issue. Future studies are needed to assess the impact of surgical C-TraC on post-discharge healthcare use.

Impact of lymph node ratio in selecting patients with resected gastric cancer for adjuvant therapy

Background. The impact of adjuvant chemotherapy and chemo‐radiation therapy in the treatment of resectable gastric cancer remains varied. We sought to define the clinical impact of lymph node ratio on the relative benefit of adjuvant chemotherapy or chemo‐radiation therapy among patients having undergone curative‐intent resection for gastric cancer. Methods. Using the multi‐institutional US Gastric Cancer Collaborative database, 719 patients with gastric adenocarcinoma who underwent curative‐intent resection between 2000 and 2013 were identified. Patients with metastasis or an R2 margin were excluded. The impact of lymph node ratio on overall survival among patients who received chemotherapy or chemo‐radiation therapy was evaluated. Results. Median patient age was 65 years, and the majority of patients were male (56.2%). The majority of patients underwent either subtotal (40.6%) or total gastrectomy (41.0%), with the remainder undergoing distal gastrectomy or wedge resection (18.4%). On pathology, median tumor size was 4 cm; most patients had a T3 (33.0%) or T4 (27.9%) lesion with lymph node metastasis (59.7%). Margin status was R0 in 92.5% of patients. A total of 325 (45.2%) patients underwent resection alone, 253 (35.2%) patients received 5‐FU or capecitabine‐based chemo‐radiation therapy, whereas the remaining 141 (19.6%) received chemotherapy. Median overall survival was 40.9 months, and 5‐year overall survival was 40.3%. According to lymph node ratio categories, 5‐year overall survival for patients with a lymph node ratio of 0, 0.01–0.10, >0.10–0.25, >0.25 were 54.1%, 53.1 %, 49.1 % and 19.8 %, respectively. Factors associated with worse overall survival included involvement of the gastroesophageal junction (hazard ratio 1.8), T‐stage (3–4: hazard ratio 2.1), lymphovascular invasion (hazard ratio 1.4), and lymph node ratio (>0.25: hazard ratio 2.3; all P < .05). In contrast, receipt of adjuvant chemo‐radiation therapy was associated with an improved overall survival in the multivariable model (versus resection alone: hazard ratio 0.40; versus chemotherapy: hazard ratio 0.45, both P < .001). The benefit of chemo‐radiation therapy for resected gastric cancer was noted only among patients with lymph node ratio >0.25 (versus resection alone: hazard ratio R 0.34; versus chemotherapy: hazard ratio 0.45, both P < .001). In contrast, there was no noted overall survival benefit of chemotherapy or chemo‐radiation therapy among patients with lymph node ratio ≤0.25 (all P > .05). Conclusion. Adjuvant chemotherapy or chemo‐radiation therapy was utilized in more than one‐half of patients undergoing curative‐intent resection for gastric cancer. Lymph node ratio may be a useful tool to select patients for adjuvant chemo‐radiation therapy, because the benefit of chemo‐radiation therapy was isolated to patients with greater degrees of lymphatic spread (ie, lymph node ratio >0.25).