Background and Objective
This study aims to investigate the impact of sex on outcome measures stratified by histological subtype in patients with resectable gastric cancer (GC).
Methods
A post‐hoc ...analysis of the CRITICS‐trial, in which patients with resectable GC were treated with perioperative therapy, was performed. Histopathological characteristics and survival were evaluated for males and females stratified for histological subtype (intestinal/diffuse). Additionally, therapy‐related toxicity and compliance were compared.
Results
Data from 781 patients (523 males) were available for analyses. Female sex was associated with a distal tumor localization in intestinal (p = 0.014) and diffuse tumors (p < 0.001), and younger age in diffuse GC (p = 0.035). In diffuse GC, tumor‐positive resection margins were also more common in females than males (21% vs. 10%; p = 0.020), specifically at the duodenal margin. During preoperative chemotherapy, severe toxicity occurred in 327 (63%) males and 184 (71%) females (p = 0.015). Notwithstanding this, relative dose intensities were not significantly different between sexes.
Conclusions
Positive distal margin rates were higher in females with diffuse GC, predominantly at the duodenal site. Females also experience more toxicity, but this neither impacts dose intensities nor surgical resection rates. Clinicians should be aware of these different surgical outcomes when treating males and females with GC.
Objective:
To evaluate changes in treatment and outcomes of esophagogastric cancer surgery after introduction of the DUCA. In addition, the presence of risk-averse behavior was assessed.
Summary of ...Background Data:
Clinical auditing is seen as an important quality improvement tool; however, its long-term efficacy remains largely unknown. In addition, critics claim that enhancements result from risk-averse behavior rather than positive effects of auditing.
Methods:
DUCA data were used from registration start (1-1-2011) until 31-12-2018. Trends in patient, tumor, hospital and treatment characteristics were univariably assessed. Trends in short-term outcomes were investigated using multilevel multivariable logistic regression. Presence of risk aversion was described by the corrected proportion of patients undergoing surgery, using data from the Netherlands Cancer Registry. To evaluate the impact of centralization on time trends identified, the association between hospital volume and outcomes was investigated.
Results:
This study included 6172 patients with esophageal and 3,690 with gastric cancer who underwent surgery. Pathological outcomes (lymph node yield, radicality) improved and futile surgery decreased over the years. In-hospital/30-day mortality decreased for esophagectomy (4.2% to 2.5%) and for gastrectomy (7.1% to 4.3%). Reinterventions, (minor) complications and readmissions increased. Risk aversion appeared absent. Between 2011-2018, annual median hospital volumes increased from 38 to 53 for esophagectomy and from 14 to 29 for gastrectomy. Higher hospital volumes were associated with several improved outcomes measures.
Conclusions:
During 8 years of auditing, outcomes improved, with no signs of risk-averse behavior. These improvements occurred in parallel with centralization. Feedback on postoperative complications remains the focus of the DUCA.
OBJECTIVE:The aim of this study was to investigate the association between short-term outcome indicators and long-term survival after esophagogastric resections.
SUMMARY BACKGROUND DATA:Short-term ...outcome indicators are often used to compare performance between care providers. Some short-term outcome indicators concern the direct quality of care, that is, complications, others are used because they are expected to be associated with long-term outcomes.
METHOD:For this national cohort study, all patients who underwent esophagectomy or gastrectomy for cancer with curative intent between 2011 and 2016 and were registered in the Dutch Upper gastrointestinal Cancer Audit were included. Primary outcome was conditional survival (under the condition of surviving the first postoperative 30 days and hospital admission). Cox regression modeling was used to study the independent association between “textbook outcome” with survival. “Textbook outcome,” a composite quality indicator, was defined as a pathological complete resection with at least 15 retrieved lymph nodes, an uneventful postoperative course, and no hospital readmission.
RESULTS:In total, 4414 and 2943 patients with esophageal or gastric cancer, respectively, were included. The 1-, 2-, and 3-year overall survival rates were 76%, 62%, and 54%, and 71%, 56%, and 49% for esophageal and gastric cancer, respectively. Textbook outcome was achieved in 33% and 35% of patients respectively. “Textbook outcome” was independently associated with longer conditional survival hazard ratio0.75 (95% confidence interval, 0.68–0.84) and 0.69 (0.60–0.79), respectively.
CONCLUSION:This study showed that the short-term outcome indicator textbook outcome is associated with long-term overall survival and therefore may accentuate the importance of using these indicators in clinical audits.
Although radical surgery remains the cornerstone of cure in resectable gastric cancer, survival remains poor. Current evidence-based (neo)adjuvant strategies have shown to improve outcome, including ...perioperative chemotherapy, postoperative chemoradiotherapy and postoperative chemotherapy. However, these regimens suffer from poor patient compliance, particularly in the postoperative phase of treatment. The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens: (1) chemotherapy, (2) chemotherapy followed by chemoradiotherapy and (3) chemoradiotherapy.
In this multicentre phase II non-comparative study, patients with clinical stage IB-IIIC (TNM 8th edition) resectable gastric adenocarcinoma are randomised between: (1) 4 cycles of docetaxel+oxaliplatin+capecitabine (DOC), (2) 2 cycles of DOC followed by chemoradiotherapy (45Gy in combination with weekly paclitaxel and carboplatin) or (3) chemoradiotherapy. Primary endpoint is event-free survival, 1 year after randomisation (events are local and/or regional recurrence or progression, distant recurrence, or death from any cause). Secondary endpoints include: toxicity, surgical outcomes, percentage radical (R0) resections, pathological tumour response, disease recurrence, overall survival, and health related quality of life. Exploratory endpoints include translational studies on predictive and prognostic biomarkers.
The aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma. This treatment regimen will subsequently be compared with the standard therapy in a phase III trial.
clinicaltrials.gov NCT02931890 ; registered 13 October 2016. Date of first enrolment: 21 December 2017.
Background
This study aimed to describe the incidence of
failure to cure
(a composite outcome measure defined as surgery not meeting its initial aim), and the impact of hospital variation in the ...administration of neoadjuvant therapy on this outcome measure.
Methods
All patients in the Dutch Upper Gastrointestinal Cancer Audit undergoing curatively intended gastric cancer surgery in 2011–2019 were included.
Failure to cure
was defined as (1) ‘open-close’ surgery; (2) irradical surgery (R1/R2); or (3) 30-day/in-hospital mortality. Case-mix-corrected funnel plots, based on multivariable logistic regression analyses, investigated hospital variation. The impact of a hospital’s tendency to administer neoadjuvant chemotherapy on the heterogeneity in
failure to cure
between hospitals was assessed based on median odds ratios and multilevel logistic regression analyses.
Results
Some 3862 patients from 28 hospitals were included.
Failure to cure
was noted in 22.3% (hospital variation: 14.5–34.8%). After case-mix correction, two hospitals had significantly higher-than-expected
failure to cure
rates, and one hospital had a lower-than-expected rate. The
failure to cure
rate was significantly higher in hospitals with a low tendency to administer neoadjuvant chemotherapy. Approximately 29% of hospital variation in
failure to cure
could be attributed to different hospital policies regarding neoadjuvant therapy.
Conclusions
Failure to cure
has an incidence of 22% in patients undergoing gastric cancer surgery. Higher
failure to cure
rates were seen in centers administering less neoadjuvant chemotherapy, which confirms the Dutch guideline recommendation on the administration of neoadjuvant chemotherapy.
Failure to cure
provides short loop feedback and can be used as a quality indicator in surgical audits.
Abstract Introduction A significant number of transthoracic diagnostic biopsy procedures for lung lesions show indeterminate results. Such failures are potentially due to inadequate recognition of ...vital tumor tissue. The objective of this study was to evaluate whether optical spectroscopy at the tip of a biopsy needle device can improve the accuracy of transthoracic lung biopsies. Methods Ex vivo optical measurements were performed on lung tissue from 13 patients who underwent either lobectomy or segmental resection for primary non-small cell lung cancer or pulmonary metastases from various origins. From Diffuse Reflectance Spectroscopy (DRS) and Fluorescence Spectroscopy (FS) measurements, different parameters were derived such as tissue composition as well as physiological and metabolic characteristics. Subsequently, a classification and regression trees (CART) algorithm was used to classify the type of tissue based on the derived parameters. Histology analysis was used as gold standard to report sensitivity and specificity of the tissue classification based on the present optical method. Results Collective analysis of all DRS measurements showed an overall discrimination between lung parenchyma and tumor tissue with a sensitivity and specificity of 98 and 86%, respectively. When the data were analyzed per individual patient, eliminating inter-patient variation, 100% sensitivity and specificity was achieved. Furthermore, based on FS parameters, necrotic and non-necrotic tumor tissue could be distinguished with 91% sensitivity and specificity. Conclusion This study demonstrates that DRS provides accurate diagnosis of malignant lung lesions, whereas FS enables identification of necrotic tissue. When both optical techniques are combined within a biopsy device, the diagnostic performance and the quality of transthoracic biopsies could significantly be enhanced.
Abstract Introduction A worldwide increasing incidence is seen for oesophageal adenocarcinoma, but not for oesophageal squamous cell carcinoma (SCC) and gastric cardia adenocarcinoma. Purposes of the ...current study were to evaluate the changing incidence rates of oesophageal and gastric cardia cancer, and to assess survival trends. Patients and methods Patients diagnosed with oesophageal adenocarcinoma ( N = 12,195) or SCC ( N = 9046), or gastric cardia adenocarcinoma ( N = 9900) between 1989 and 2008 in the Netherlands were included. Changes in European Standard Population (ESP) and relative survival over time were evaluated. Results Incidence rates for oesophageal adenocarcinoma increased in males (+7.5%, P < 0.001) and females (+5.2%, P < 0.001), while the incidence for oesophageal SCC remained stable in males (−0.2%, P = 0.6) and slightly increased in females (+1.7%, P = 0.001). The incidence for gastric cardia cancer decreased in males (−1.2%, P < 0.006), and remained stable in females (−0.2%, P = 0.7). Five-year survival for both M0 and M1 oesophageal carcinoma doubled over the last 20 years. No significant changes in survival were found for M0 and M1 gastric cardia carcinoma. Discussion In the Netherlands, a rising incidence is seen for oesophageal adenocarcinoma, but not for gastric cardia adenocarcinoma. This finding most likely reflects true changes in disease burden, rather than being the result of changes in diagnosis or classification. The increased survival for oesophageal carcinoma can be attributed to centralisation of surgery, and an increased use of multimodality therapy, factors hardly acknowledged for gastric cancer.
This study compared extended transthoracic resection with limited transhiatal resection for adenocarcinoma of the esophagus or gastric cardia. The five-year survival rates in the two groups were not ...significantly different, but a nonsignificant trend in overall survival favored transthoracic resection in later years.
In this study of resection for adenocarcinoma, a trend in survival favored transthoracic resection.
Long-term survival after surgery with curative intent for adenocarcinoma of the distal esophagus and gastric cardia is only 20 percent.
1
,
2
Surgery is generally considered to offer the best chance for cure, but opinions differ on how to improve survival by surgery. One strategy aims at decreasing early postoperative risk by the use of limited cervicoabdominal (transhiatal) esophagectomy without formal lymphadenectomy. Another is intended to improve long-term survival by performing a combined cervicothoracoabdominal resection, with wide excision of the tumor and peritumoral tissues and extended lymph-node dissection in the posterior mediastinum and the upper abdomen (transthoracic esophagectomy with extended en . . .
Background and aims
In gastric cancer (GC), HER2 was the first biomarker for guided therapy registered for clinical use. Considering the recent approvals of immune check‐point blockade (ICB) in ...gastro‐oesophageal cancers, testing for mismatch repair deficiency (dMMR), Epstein–Barr virus (EBV) and PD‐L1 combined positive score (CPS) is becoming increasingly important. Here we describe a real‐world cohort on biomarker assessment in GC patients.
Methods
Patients diagnosed with GC between 2017 and 2021 were included. Biomarker results were retrieved from electronic patient files. PD‐L1 CPS was determined retrospectively on dMMR and EBV‐positive (EBV+) tumours. Data on genomic sequencing were analysed separately.
Results
Of 363 patients identified, 45% had metastatic disease. In 335 patients (92%) at least one biomarker was tested. The prevalence of HER2+, dMMR and EBV+ tumours was 10% (32 of 319), 7% (20 of 294) and 1% (three of 235), respectively. Of the dMMR and EBV+ tumours, 95% had a PD‐L1 CPS ≥ 5. Therapeutic strategy was adjusted in 31 of 55 patients and consisted of anti‐HER2 therapies as well as ICB in clinical trials. Genomic alterations were found in 44 of 60 tested patients. TP53 (73%) and PIK3CA (20%) mutations were most common, followed by KRAS mutations (11%) and amplifications (11%).
Conclusions
In this real‐world cohort, testing for HER2, dMMR and EBV status affected treatment decisions in 56% of the patients. Although most dMMR and EBV+ tumours had a PD‐L1 CPS ≥ 5, not all patients with a high probability of treatment response are identified. Based on these results, a stepwise diagnostic strategy is proposed.
In this real‐world cohort, testing for HER2, dMMR and EBV status affected treatment decisions in 56% of the patients. Although most dMMR and EBV+ tumors had a PD‐L1 CPS≥5, not all patients with a high probability of response are identified. Based on these results, we propose a stepwise diagnostic strategy.
IMPORTANCE: The optimal staging for gastric cancer remains a matter of debate. OBJECTIVE: To evaluate the value of 18F-fludeoxyglucose–positron emission tomography with computed tomography ...(FDG-PET/CT) and staging laparoscopy (SL) in addition to initial staging by means of gastroscopy and CT in patients with locally advanced gastric cancer. DESIGN, SETTING, AND PARTICIPANTS: This multicenter prospective, observational cohort study included 394 patients with locally advanced, clinically curable gastric adenocarcinoma (≥cT3 and/or N+, M0 category based on CT) between August 1, 2017, and February 1, 2020. EXPOSURES: All patients underwent an FDG-PET/CT and/or SL in addition to initial staging. MAIN OUTCOMES AND MEASURES: The primary outcome was the number of patients in whom the intent of treatment changed based on the results of these 2 investigations. Secondary outcomes included diagnostic performance, number of incidental findings on FDG-PET/CT, morbidity and mortality after SL, and diagnostic delay. RESULTS: Of the 394 patients included, 256 (65%) were men and mean (SD) age was 67.6 (10.7) years. A total of 382 patients underwent FDG-PET/CT and 357 underwent SL. Treatment intent changed from curative to palliative in 65 patients (16%) based on the additional FDG-PET/CT and SL findings. FDG-PET/CT detected distant metastases in 12 patients (3%), and SL detected peritoneal or locally nonresectable disease in 73 patients (19%), with an overlap of 7 patients (2%). FDG-PET/CT had a sensitivity of 33% (95% CI, 17%-53%) and specificity of 97% (95% CI, 94%-99%) in detecting distant metastases. Secondary findings on FDG/PET were found in 83 of 382 patients (22%), which led to additional examinations in 65 of 394 patients (16%). Staging laparoscopy resulted in a complication requiring reintervention in 3 patients (0.8%) without postoperative mortality. The mean (SD) diagnostic delay was 19 (14) days. CONCLUSIONS AND RELEVANCE: This study’s findings suggest an apparently limited additional value of FDG-PET/CT; however, SL added considerably to the staging process of locally advanced gastric cancer by detection of peritoneal and nonresectable disease. Therefore, it may be useful to include SL in guidelines for staging advanced gastric cancer, but not FDG-PET/CT.
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