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Trastuzumab is a monoclonal antibody against HER2 (also known as ERBB2). The primary objective of the NRG Oncology/RTOG-1010 trial was to establish whether trastuzumab improves disease-free survival when combined with trimodality treatment (paclitaxel plus carboplatin and radiotherapy, followed by surgery) for patients with untreated HER2-overexpressing oesophageal adenocarcinoma. NRG Oncology/RTOG-1010 was an open label, randomised, phase 3 trial for which patients were accrued from 111 NRG-affiliated institutions in the USA. Eligible patients were adults (aged ≥18 years) with newly diagnosed pathologically confirmed oesophageal adenocarcinoma, American Joint Committee on Cancer 7th edition T1N1–2 or T2–3N0–2 stage disease, and a Zubrod performance status of 0–2. Patients were stratified by adenopathy (no vs yes [coeliac absent] vs yes [coeliac present ≤2 cm]) and randomly assigned (1:1) to receive weekly intravenous paclitaxel (50 mg/m2 intravenously over 1 h) and carboplatin (area under the curve 2, intravenously over 30–60 min) for 6 weeks with radiotherapy 50·4 Gy in 28 fractions (chemoradiotherapy) followed by surgery, with or without intravenous trastuzumab (4 mg/kg in week one, 2 mg/kg per week for 5 weeks during chemoradiotherapy, 6 mg/kg once presurgery, and 6 mg/kg every 3 weeks for 13 treatments starting 21–56 days after surgery). The primary endpoint, disease-free survival, was defined as the time from randomisation to death or first of locoregional disease persistence or recurrence, distant metastases, or second primary malignancy. Analyses were done by modified intention to treat. This study is registered with Clinicaltrials.gov, NCT01196390; it is now closed and in follow-up. 606 patients were entered for HER2 assessment from Dec 30, 2010 to Nov 10, 2015, and 203 eligible patients who were HER2-positive were enrolled and randomly assigned to chemoradiotherapy plus trastuzumab (n=102) or chemoradiotherapy alone (n=101). Median duration of follow-up was 2·8 years (IQR 1·4–5·7). Median disease-free survival was 19·6 months (95% CI 13·5–26·2) with chemoradiotherapy plus trastuzumab compared with 14·2 months (10·5–23·0) for chemoradiotherapy alone (hazard ratio 0·99 [95% CI 0·71–1·39], log-rank p=0·97). Grade 3 treatment-related adverse events occurred in 41 (43%) of 95 patients in the chemoradiotherapy plus trastuzumab group versus 52 (54%) of 96 in the chemoradiotherapy group and grade 4 events occurred in 20 (21%) versus 21 (22%). The most common grade 3 or worse treatment-related adverse events for both groups were haematological (53 [56%] of 95 patients in the chemoradiotherapy plus trastuzumab group vs 55 [57%] of 96 patients in the chemotherapy group) or gastrointestinal disorders (28 [29%] vs 20 [21 %]). 34 (36%) of 95 patients in the chemoradiotherapy plus trastuzumab group and 27 (28%) of 96 patients in the chemoradiotherapy only group had treatment-related serious adverse events. There were eight treatment-related deaths: five (5%) of 95 patients in the chemoradiotherapy plus trastuzumab group (bronchopleural fistula, oesophageal anastomotic leak, lung infection, sudden death, and death not otherwise specified), and three (3%) of 96 in the chemoradiotherapy group (two multiorgan failure and one sepsis). The addition of trastuzumab to neoadjuvant chemoradiotherapy for HER2-overexpressing oesophageal cancer was not effective. Trastuzumab did not lead to increased toxicities, suggesting that future studies combining it with or using other agents targeting HER2 in oesophageal cancer are warranted. National Cancer Institute and Genentech.

Background Anastomotic leak following esophagectomy is associated with significant morbidity and mortality. A major factor determining anastomotic success is an adequate blood supply to the conduit. The aim of this study was to determine the impact of intraoperative evaluation of the conduit’s vascular supply on anastomotic failure after esophagectomy. Methods We retrospectively analyzed data from 90 consecutive patients undergoing esophagectomy with gastric conduit reconstruction. A change in surgical practice occurred after 60 cases were completed, when we introduced the use of intraoperative indocyanine green fluorescence angiography and Doppler examination to evaluate blood supply and assist in construction of the conduit. The leak rates before and after implementation of conduit vascular evaluation were compared. Results After the introduction of intraoperative vascular evaluation of the gastric conduit, we noted a dramatic decrease in the rate of anastomotic leak from 20 % in the first 60 patients to 0 % in the succeeding 30 patients. Conclusions Intraoperative vascular evaluation with indocyanine green fluorescence imaging and Doppler examination of the gastric conduit used to assist reconstruction after esophagectomy allows for enhanced construction of the conduit that maximizes blood supply to the anastomosis. This change in practice was associated with a significant reduction in anastomotic leak rate.

Background In cancer, malnutrition is common and negatively impacts tolerance and outcomes of anti-tumor therapies. The aim of this study was to evaluate the prevalence of malnutrition risk and compare the clinicodemographic features between those with high malnutrition screening tool (MST) scores (i.e., ≥ 2 of 5 = high risk for malnutrition, H-MST) to low scores (L-MST). Methods A cohort of 3585 patients (May 2017 through December 2018), who completed the MST at least once at the time of diagnosis of any stage solid tumor, were analyzed. Logistic regression tested for associations between clinicodemographic factors, symptom scores, and H-MST prevalence. Results The median age was 64 years (25–75 IQR, 55–72), with 62% females and 81% White. Most common tumor primary sites were breast (28%), gastrointestinal (GI) (21%), and thoracic (13%). Most had non-metastatic disease (80%). H-MST was found in 28%—most commonly in upper (58%) and lower GI (42%), and thoracic (42%) tumors. L-MST was most common in breast (90%). Multivariable regression confirmed that Black race (OR 1.9, 95% CI 1.5–2.4, p  =  < 0.001), cancer primary site (OR 1.6–5.7, p  =  < 0.001), stage IV disease (OR 1.8, 95% CI 1.4–2.2, p  =  < 0.001), low BMI (OR 4.2, 95% CI 2.5–6.9 p  =  < 0.001), and higher symptom scores were all independently associated with H-MST. Conclusions Twenty-eight percent of solid tumor oncology patients at diagnosis were at high risk of malnutrition. Patients with breast cancer rarely had malnutrition risk at diagnosis. Significant variation was found in malnutrition risk by cancer site, stage, race, and presence of depression, distress, fatigue, and trouble eating/swallowing.

Background Pathologic complete response (pCR) of rectal cancer following neoadjuvant therapy is associated with decreased local recurrence and increased overall survival. This study utilizes a national dataset to identify predictors of pCR in patients with rectal cancer. Methods The National Cancer Database was queried for patients with nonmetastatic rectal cancer (2004–2014) who underwent neoadjuvant therapy and surgical resection. Unadjusted associations were assessed using rank-sum tests and χ 2 tests where appropriate. Backward elimination and forward selection multivariable logistic regression models were created to determine the relationship of annual surgical volume with pCR rate, adjusting for preoperative characteristics and radiation-surgery interval. Statistical tests were two-sided, with a significance level of p  ≤ 0.05. Analyses were performed using SAS version 9.4. Results A total of 27,532 patients from 1179 participating hospitals met the inclusion criteria. Generalized linear mixed models demonstrated that the odds of achieving pCR was independently associated with more recent diagnosis, female sex, private insurance, lower grade, lower clinical T classification, lower clinical N classification, increasing interval between the end of radiation and surgery, and treatment at higher-volume institutions. Conclusions pCR was associated with favorable tumor factors, insurance status, time between radiation and surgery, and institutional volume. It is not clear what is driving the higher rates of pCR at high-volume institutions. Research targeted at understanding processes that are associated with pCR in high-volume institutions is needed so that similar results can be achieved across the spectrum of facilities caring for patients in this population.

Background In the treatment of rectal cancer, a longer radiation-surgery interval from the end of neoadjuvant radiation therapy to surgery has been associated with higher rates of complete pathologic response (pCR), but the optimal interval with respect to survival has not been established. Data from the National Cancer Database (NCDB) was used to evaluate the impact of radiation-surgery interval on oncologic outcomes. Methods The NCDB was searched for patients diagnosed with nonmetastatic rectal cancer who underwent preoperative radiation followed by radical surgical resection. A Cox proportional hazards model was constructed to examine the influence of radiation-surgery interval while controlling for potential confounding factors. Sensitivity analysis was used to confirm the results of the model. Results A cohort of 6397 patients meeting all inclusion and exclusion criteria from 2004–2006 was identified, and the pCR rate for this cohort was 6.9 %. Of those who experienced a pCR, 76.2 % had done so by 60 days. Intervals greater than 60 days were associated with higher rates of positive surgical margins (6.7 vs. 4.8 %, p  = 0.009) and lower rates of sphincter-preserving surgery (64.9 vs. 68.9 %, p  = 0.007). An interval greater than 60 days was associated with significantly shorter survival (hazard ratio (HR), 1.314; 95 % CI 1.191–1.449; p  < 0.001). Conclusions Radiation-surgery interval beyond 60 days is associated with increased rate of positive surgical margins, decreased rate of sphincter-preserving surgery, and decreased survival. Delay of surgery for rectal cancer beyond 60 days after the completion of neoadjuvant therapy should be done with caution.

Background Current National Comprehensive Cancer Network guidelines for resectable small bowel neuroendocrine tumors (NETs) recommend regional lymphadenectomy. However, no consensus exists on the optimal nodal harvest. Methods The National Cancer Database was queried for patients with resectable small bowel NETs (1998–2013). Patients with metastatic disease and missing lymph node harvest data were excluded. We performed logistic regression of factors determining nodal positivity and multivariable survival analyses. Results Of 11,852 patients, 81.8% underwent lymphadenectomy. 79.3% were node positive (N+) and 46.9% of patients had tumors < 1 cm. Independent predictors of N+ were large tumor size, ileal location, and neuroendocrine carcinoma histology. Logistic regression found no difference between observed and expected proportions of N+ patients with lymphadenectomy greater than or equal to eight nodes. Lower metastatic node ratio predicted improved survival on multivariable analysis and is associated with high-volume institutions. Conclusion Small bowel NETs have high rates of nodal metastasis, even in patients with small tumors, and many patients do not undergo lymphadenectomy despite the clear benefit. Lymphadenectomy of eight nodes is optimal to identify N+ patients. Additionally, minimizing metastatic node ratio with complete regional lymphadenectomy is associated with improved survival in these patients.

Background Optimal nutrition after esophagectomy is challenging due to alterations in eating, both from the tumor and during surgical recovery. Enteral nutrition via feeding tube is commonly used. The impact of feeding tubes on post-esophagectomy outcomes was examined in a large national data set. Methods Patients with esophageal cancer (1998–2013) undergoing esophagectomy were extracted from the Surveillance Epidemiology and End Results-Medicare database. Chi-square and t tests were used to compare categorical and continuous variables. Time trend analyses were performed with Cochran–Armitage survival using log-rank and multivariable analysis with generalized linear modeling. Results The study examined 2495 patients. The majority had enteral feeding access (71%, n  = 1794) during the perioperative period. Mortality among the patients with feeding tubes was lower at 30 days (5.4% vs 8.4%), 60 days (9.0% vs 13.0%), and 90 days (12.2% vs 15.8%). In the multivariable analysis, the patients with feeding tubes had improved short-term survival at 30 days (odds ratio [OR], 0.65, 95% confidence interval [CI], 0.46–0.93), 60 days (OR, 0.64; 95% CI, 0.49–0.85), and 90 days (OR, 0.70; 95% CI, 0.54–0.90). The hospital stay was shorter for the patients undergoing enteral feeding tube placement (17.9 vs 19.5 days; p  = 0.04). Discharge destination (home vs health care facility) showed no difference. Conclusions Feeding tubes in patients undergoing esophagectomy were associated with an increase in short-term survival up to 90 days after surgery. Feeding tube placement was not associated with higher rates of non-home discharges and did not prolong the hospital stay.