Objective
The purpose of this study was to identify factors associated with quality-of-life recovery after gastrectomy.
Methods
Patients anticipated to undergo gastric cancer resection were invited ...to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and STO22 surveys in the preoperative setting and at 0–1.5 months (early), > 1.5–6 months (intermediate), and > 6–18 months (late) following resection. Quality-of-life recovery was measured as paired differences between pre- and postoperative results. Multivariable linear regression identified factors associated with preoperative quality of life and degree of change following resection.
Results
Across 393 participants, response rates at the intermediate and late postoperative time points were 58% (
n
= 228) and 71% (
n
= 277), respectively. Relative to baseline, median global health scale decreased in the early (− 15.1 pts,
p
< 0.001) and intermediate (− 3.6 pts,
p
= 0.02) time points, but recovered by the late time point (+ 1.2 pts,
p
= 0.411). Relative to distal/subtotal gastrectomy, proximal/total gastrectomy was associated with worse recovery in both the early and late time points. Surgical complications were associated with worse early recovery. Patients who presented with locally advanced tumors (T3–T4) had lower preoperative quality-of-life scores, and more readily recovered to baseline after surgery. A minimally invasive approach was not associated with postoperative recovery.
Conclusions
Most patients recover to baseline within 1 year following major gastrectomy, and recovery is easier with more limited resections. Patients with locally advanced tumors tend to have poorer baseline quality of life, which may improve following resection.
IMPORTANCE: CDH1 variants are increasingly identified on commercially available multigene panel tests, calling for data to inform counseling of individuals without a family history of gastric cancer. ...OBJECTIVES: To assess association between CDH1 variant pathogenicity or family history of gastric or lobular breast cancer and identification of signet ring cell cancer and to describe outcomes of risk-reducing minimally invasive and open total gastrectomy. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was performed from January 1, 2006, to January 1, 2020, in 181 patients with CDH1 germline variants from a single institution. INTERVENTIONS: Genetic counseling, esophagogastroduodenoscopy, and possible total gastrectomy. MAIN OUTCOMES AND MEASURES: CDH1 variant classification, family cancer history, findings of signet ring cell carcinoma at esophagogastroduodenoscopy and surgery, postoperative events and weight changes, and follow-up. RESULTS: Of 181 individuals with CDH1 germline variants (mean SD age at time of testing, 44 15 years; 126 70% female), 165 harbored a pathogenic or likely pathogenic variant. Of these patients, 101 underwent open (n = 58) or minimally invasive (n = 43) total gastrectomy. Anastomotic leaks that required drainage were infrequent (n = 3), and median long-term weight loss was 20% (interquartile range IQR, 10%-23%). In those undergoing minimally invasive operations, more lymph nodes were retrieved (median, 28 IQR, 20-34 vs 15 IQR, 9-19; P < .001) and the hospital stay was 1 day shorter (median, 6 IQR, 5-7 vs 7 IQR, 6-7 days; P = .04). Signet ring cell cancer was identified in the surgical specimens of 85 of 95 patients (89%) with a family history of gastric cancer and 4 of 6 patients (67%) who lacked a family history. Among the latter 6 patients, 4 had a personal or family history of lobular breast cancer, including 2 with signet ring cell cancer. Of the 16 patients with pathogenic or likely pathogenic CDH1 variants who presented with locally advanced or metastatic gastric cancer, 3 (19%) had no family history of gastric cancer or personal or family history of lobular breast cancer. CONCLUSIONS AND RELEVANCE: Total gastrectomy may be warranted for patients with pathogenic or likely pathogenic CDH1 variants and a family history of gastric or lobular breast cancer and may be appropriate for those without a family history. A minimally invasive approach is feasible and may be preferred for selected patients.
To evaluate the efficacy of chemotherapy in patients with microsatellite instability (MSI)-high gastric cancer.
Although MSI-high gastric cancer is associated with a superior prognosis, recent ...studies question the benefit of perioperative chemotherapy in this population.
Locally advanced gastric adenocarcinoma patients who either underwent surgery alone or also received neoadjuvant, perioperative, or adjuvant chemotherapy between 2000 and 2018 were eligible. MSI status, determined by next-generation sequencing or mismatch repair protein immunohistochemistry, was determined in 535 patients. Associations among MSI status, chemotherapy administration, overall survival (OS), disease-specific survival, and disease-free survival were assessed.
In 535 patients, 82 (15.3%) had an MSI-high tumor and ∼20% better OS, disease-specific survival, and disease-free survival. Grade 1 (90%-100%) pathological response to neoadjuvant chemotherapy was found in 0 of 40 (0%) MSI-high tumors versus 43 of 274 (16%) MSS. In the MSI-high group, the 3-year OS rate was 79% with chemotherapy versus 88% with surgery alone ( P =0.48). In the MSS group, this was 61% versus 59%, respectively ( P =0.96). After multivariable interaction analyses, patients with MSI-high tumors had superior survival compared with patients with MSS tumors whether given chemotherapy (hazard ratio=0.53, 95% confidence interval: 0.28-0.99) or treated with surgery alone (hazard ratio=0.15, 95% confidence interval: 0.02-1.17).
MSI-high locally advanced gastric cancer was associated with superior survival compared with MSS overall, despite worse pathological chemotherapy response. In patients with MSI-high gastric cancer who received chemotherapy, the survival rate was ∼9% worse compared with surgery alone, but chemotherapy was not significantly associated with survival.
We sought to define criteria associated with low lymph node metastasis risk in patients with submucosal (pT1b) gastric cancer from 3 Western and 3 Eastern countries.
Accurate prediction of lymph node ...metastasis risk is essential when determining the need for gastrectomy with lymph node dissection following endoscopic resection. Under present guidelines, endoscopic resection is considered definitive treatment if submucosal invasion is only superficial, but this is not routinely assessed.
Lymph node metastasis rates were determined for patient groups defined according to tumor pathological characteristics. Clinicopathological predictors of lymph node metastasis were determined by multivariable logistic regression and used to develop a nomogram in a randomly selected subset that was validated in the remainder. Overall survival was compared between Eastern and Western countries.
Lymph node metastasis was found in 701 of 3166 (22.1%) Eastern and 153 of 560 (27.3%) Western patients. Independent predictors of lymph node metastasis were female sex, tumor size, distal stomach location, lymphovascular invasion, and moderate or poor differentiation. Patients fulfilling the National Comprehensive Cancer Network guideline criteria, excluding the requirement that invasion not extend beyond the superficial submucosa, had a lymph node metastasis rate of 8.9% (53/594). Excluding moderately differentiated tumors lowered the rate to 3.4% (10/296). The nomogram's area under the curve was 0.690. Regardless of lymph node status, overall survival was better in Eastern patients.
The lymph node metastasis rate was lowest in patients with well differentiated tumors that were ≤3 cm and lacked lymphovascular invasion. These criteria may be useful in decisions regarding endoscopic resection as definitive treatment for pT1b gastric cancer.
To encourage implementation of the American College of Surgeons (ACS) NSQIP Risk Calculator for total gastrectomy for gastric cancer, its predictive performance for this specific procedure should be ...validated. We assessed its discriminatory accuracy and goodness of fit for predicting 12 adverse outcomes.
Data were collected on all patients with gastric cancer who underwent total gastrectomy with curative intent at Memorial Sloan Kettering Cancer Center between 2002 and 2017. Preoperative risk factors from the electronic medical record were manually inserted into the ACS-NSQIP Risk Calculator. Predictions for adverse outcomes were compared with observed outcomes by Brier scores, c-statistics, and Hosmer-Lemeshow p value.
In a total of 452 patients, the predicted rate of all complications (29%) was lower than the observed rate (45%). Brier scores varied between 0.017 for death and 0.272 for any complication. C-statistics were moderate (0.7–0.8) for death and renal failure, good (0.8–0.9) for cardiac complication, and excellent (≥0.9) for discharge to nursing or rehabilitation facility. Hosmer-Lemeshow p value found poor goodness of fit for pneumonia only.
For adverse outcomes after total gastrectomy with curative intent in gastric cancer patients, performance of the ACS-NSQIP Risk Calculator is variable. Its predictive performance is best for cardiac complications, renal failure, death, and discharge to nursing or rehabilitation facility.
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We sought to compare gastroesophageal junction (GEJ) cancer and gastric cancer (GC) and identify clinicopathological and oncological differences.
GEJ cancer and GC are frequently studied together. ...Although the treatment approach for each often differs, clinico-pathological and oncological differences between the 2 have not been fully evaluated.
We retrospectively identified patients with GEJ cancer or GC who underwent R0 resection at our center between January 2000 and December 2016. Clinicopathological characteristics, disease-specific survival (DSS), and site of first recurrence were compared.
In total, 2194 patients were analyzed: 1060 (48.3%) with GEJ cancer and 1134 (51.7%) with GC. Patients with GEJ cancer were younger (64 vs 66 years; P < 0.001), more often received neoadjuvant treatment (70.9% vs 30.2%; P < 0.001), and had lower pathological T and N status. Five-year DSS was 62.2% in patients with GEJ cancer and 74.6% in patients with GC ( P < 0.001). After adjustment for clinicopathological factors, DSS remained worse in patients with GEJ cancer (hazard ratio, 1.78; 95% confidence interval, 1.40-2.26; P < 0.001). The cumulative incidence of recurrence was approximately 10% higher in patients with GEJ cancer ( P < 0.001). The site of first recurrence was more likely to be hematogenous in patients with GEJ cancer (60.1% vs 31.4%; P < 0.001) and peritoneal in patients with GC (52.9% vs 12.5%; P < 0.001).
GEJ adenocarcinoma is more aggressive, with a higher incidence of recurrence and worse DSS, compared with gastric adenocarcinoma. Distinct differences between GEJ cancer and GC, especially in patterns of recurrence, may affect evaluation of optimal treatment strategies.
OBJECTIVE:To investigate the effect of second uterine curettage on the number of chemotherapy courses and relapse rate in low-risk postmolar gestational trophoblastic neoplasia.
METHODS:In a phase ...III trial, patients with low risk gestational trophoblastic neoplasia were randomised (1:1) to a second curettage or no curettage group before methotrexate treatment. Eligibility criteria were serum human chorionic gonadotropin (hCG) level 5,000 international units/L or less and fit for treatment with methotrexate. Exclusion criteria were previous uterine perforation and life-threatening bleeding. With a two-sided 5% significance level and a power of 99%, a sample size of 44 patients per group was necessary to detect a mean reduction in 2.3 chemotherapy courses. The primary outcome was the number of chemotherapy courses required for hCG normalization. Secondary outcomes were needed for second-line treatment, toxicity, relapse rates, and variables associated with number of chemotherapy courses.
RESULTS:From October 2011 through February 2016, 89 patients entered the study at the Mansoura Trophoblastic Clinic; in each group, 43 patients were included in the intention‐to‐treat analyses. Surgical complications did not occur. The mean number of chemotherapy courses required to reach hCG normalization was 4.4±2.2 SD in the control group vs 3.8±2.3 SD in the intervention group (P=.14). Groups were comparable in terms of second-line treatment needed to reach hCG normalization, and relapse within the first year. Only hCG levels related to the number of chemotherapy cycles required for hCG normalization.
CONCLUSION:Second uterine curettage did not reduce the number of chemotherapy courses required or affect relapse rate in patients with low-risk postmolar gestational trophoblastic neoplasia.
CLINICAL TRIALS REGISTRATION:Dutch Trial Registry, NTR3390.
A biologic, degradable extracellular matrix (ECM) has been shown to support esophageal tissue remodeling, which could reduce the risk of anastomotic leak following total gastrectomy and ...esophagectomy. We evaluated the safety and efficacy of reinforcing the anastomosis with ECM in reducing anastomotic leak as compared to a matched cohort.
In this single-center, nonrandomized phase II trial, gastric or esophageal adenocarcinoma patients undergoing total gastrectomy or esophagectomy were recruited from November 2013 through December 2018. ECM was surgically wrapped circumferentially around the anastomosis. Anastomotic leak was assessed clinically and by contrast study and defined as clinically significant if requiring invasive treatment (grade 3 or higher). Anastomotic stenosis, other adverse events, symptoms, and dysphagia score were collected by standardized forms at regular follow-up visits at approximately postoperative days (POD) 21 and 90. Patients receiving ECM were compared to a cohort matched for surgery type and age.
ECM placement was not feasible in 9 of 75 patients (12%), resulting in 66 patients receiving ECM. Total gastrectomy was performed in 50 patients (76%) and esophagectomy in 16 (24%). Clinically significant anastomotic leak was diagnosed in 6 of 66 patients (9.1%) (3/50 6.0% after gastrectomy, 3/16 18.8% after esophagectomy); this rate did not differ from that in the matched cohort (p = 0.57). Stenosis requiring invasive treatment occurred in 8 patients (12.5%), and 10 patients (15.6%) reported not being able to eat a normal diet at POD 90. No adverse events related to ECM were reported.
Esophageal anastomotic reinforcement after total gastrectomy or esophagectomy with a biologic, degradable ECM was mostly feasible and safe, but was not associated with a statistically significant decrease in anastomotic leak.
Abstract Aim To investigate the overall survival of invasive breast cancer patients with primary breast conserving surgery (BCS) followed by re-excision compared to those with primary BCS only. The ...Dutch re-excision indications are less stringent compared to other European and Northern American countries (Society of Surgical Oncology-American Society for Radiation Oncology (SSO/ASTRO) guideline). Methods Retrospective analyses in women <75 years with breast cancer stage pT1–T3 treated by BCS and radiotherapy between 1999 and 2012 from a population-based database. The national guideline recommends to reserve re-excision for invasive tumours showing ‘more than focally positive’ margin since 2002. Patients were divided into ‘primary BCS only’, ‘re-excision by BCS’, and ‘re-excision by mastectomy’. Multivariable Cox regression analysis was adjusted for patient and systemic treatment characteristics. Results A total of 11,695 patients were included of which 2156 (18.4%) underwent re-excision. Median time of follow-up was 61 months (interquartile range (IQR) 26–101). The 5-year overall survival rates in the ‘primary BCS only’, ‘re-excision by BCS’ and ‘re-excision by mastectomy’ group were 92%, 95% and 91%, respectively. The 10-year overall survival rates were 81%, 82% and 79%, respectively ( P = 0.20). After multivariable analyses no significant association was observed between use of and type of re-excision and overall survival. Conclusions The overall survival of breast cancer patients with a re-excision did not significantly differ from the survival of women who underwent primary BCS only. Advising re-excision only for those tumours showing ‘more than focally positive’ resection margin appears safe, supposing the long-term safety of the recent SSO/ASTRO guideline that more cautiously recommended re-excision for tumours showing ‘ink on tumour’.
Prophylactic skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) both are associated with major risk reduction in women with high breast cancer risk. Skin-sparing mastectomy followed by ...nipple-areola complex (NAC) reconstruction is standard of care, but NSM is increasingly being performed. Preservation of the NAC in NSM may increase patient satisfaction. Therefore, we measured NAC sensitivity after NSM and compared patient satisfaction as well as body image after SSM with NSM.
Women who underwent prophylactic bilateral SSM or NSM and immediate implant breast reconstruction between 2002 and 2012 were eligible. Patient satisfaction was assessed using the Breast-Q reconstruction questionnaire, body image using Hopwood's body image scale (BIS), and satisfaction with the (reconstructed) NAC using a study-specific questionnaire. In the NSM group, NAC sensitivity was assessed using Semmes Weinstein monofilaments with a 5-point scale and compared with NAC sensitivity in a nonoperated control group.
The SSM group comprised 25 women (50 SSMs) and the NSM group 20 women (39 NSMs). Median follow-up was 65 months in the SSM group compared with 27 months in the NSM group (P < 0.01). In univariable analyses, Breast-Q scores were favorable in the SSM group compared with the NSM group with trends for higher "satisfaction with breasts" (66.2 vs 56.6; P = 0.06) and "satisfaction with outcome" (76.1 vs 61.5; P = 0.09). Mean BIS score of 7.1/30 in the SSM group and 9.3/30 in the NSM group (P = 0.35). Adjusted for follow-up, there were no significant differences in Breast-Q scores, nor in BIS scores. Interestingly, satisfaction with the (reconstructed) NAC was similar after SSM and NSM. Nipple-areola complex sensitivity was lower in the NSM group (mean score, 1.9; 95% confidence interval, 1.5-2.3) compared with the control group (mean score, 4.7; 95% confidence interval, 4.6-4.9; P < 0.01).
Breast-Q scores regarding satisfaction with breasts and overall outcome were in favor of the SSM group. Residual NAC sensitivity after NSM was low. This suggests that SSM followed by NAC reconstruction is a balanced alternative to NSM. We observed no significant differences in body image and NAC-specific satisfaction between the NSM and SSM groups.
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