GIST-RISK study: Risk of recurrence in primary resectable GIST

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e21514-e21514
Author(s):  
A. Lopez-Pousa ◽  
V. Artigas Raventos ◽  
J. Lucena de la Poza ◽  
Á. Díaz de Liaño Arguelles ◽  
J. Fernández Hernández ◽  
...  

e21514 Background: Several risk classification scales have been proposed to estimate the risk of recurrence after surgery for primary GIST, identifying different factors: location, tumor biology, the patients (pts), and type of surgery. Methods: Between June 2007 and December 2008 we performed a retrospective study on primary GIST pts, to analyze potential prognostic factors for recurrence, according to the risk classifications proposed by Fletcher and Miettinen, and the impact of clinical and treatment variables. Results: As of October 2008 a total of 79 pts were enrolled. Pts characteristics: male 59.5%; median age 69 years (27–90). Symptoms: abdominal pain 33%; hematemesis 32%; abdominal mass 11%; anemia 10%; non-symptoms 20.3%. Two pts received preoperative imatinib. Laparotomy was performed in 69.7%, laparoscopic resection in 27.8% and both in 2.5% of pts (2 pts intraoperative tumor rupture). A R0 resection was performed in 74 pts (93.7%), R1 in 3 pts (3.8%) and R2 resection in 2 (2.5%) pts. Tumor location: 54 gastric, 25 non gastric. Median size 5.4 cm (range 0.5–35). Tumor size: <5cm 46%, 5–10cm 39% and >10cm 15% of pts. Mitotic index (per 50 HPF): ≤5 mitosis 69%, 6–10 mitosis 15% and >10 mitosis 16%. Histology: spindle-shaped 63%, epithelioid 6%, mixed cells 11%, not available 19%. Inmunohistochemistry: CD117 + 95%. Mutational analysis was obtained in 5 pts (four exon 11; one exon 18 mutation). Adjuvant imatinib was administered to 13 pts (16.5%). According to Fletcher: high-risk 31,1%, intermediate-risk 29,7%, low-risk 28,4%, very low-risk 10.8% of pts. According to Miettinen: high-risk 19.4%, moderate-risk 9.7%, low-risk 27.9%, very low-risk 20.8%, none risk 11.1%, insufficient data 11.1% of pts. Conclusions: Preliminary results shows a different risk of recurrence according to NIH consensus or Miettinen scales, with more than 60% versus 30% of pts with intermediate-high risk of recurrence. This study is still ongoing, additional data and follow-up will be provided. No significant financial relationships to disclose.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15139-e15139
Author(s):  
M. Piperdi ◽  
V. Velagapudi ◽  
G. Ayata ◽  
J. Simons ◽  
J. F. Tseng ◽  
...  

e15139 Background: Preop-CRT followed by surgical resection is the standard for LARC. LARC patients (pts) treated with preop-CRT have 60–70% 5-year survival. Several pathologic features including T stage (yT), lymph node (N) ratio (# of positive N (Np) / # of N examined (Ne)) and tumor regression grade (TRG) have been shown to be independent prognostic markers. We developed a prognostic score to determine pts with low risk of recurrence after preop-CRT. Methods: Our sample set consists of 20 pts treated on in house trial of preop-CRT with paclitaxel. All pts had R0 resections and received 4 months of 5-FU based adjuvant chemotherapy. All pathology slides were independently reviewed by GI pathologist. RPI scale of -4 to 14 was developed based on the formula: RPI = T (1–4) + (Np/Ne x 10) - TRG (0–4). The low, intermediate and high risk for recurrence were predefined as RPI (≤1), (>1 and <5), (≥5). Results: Between 1999–2003, 20 pts were treated on the trial and had R0 resection. The data is summarized in table 1 . The 5yr disease-free (DFS) and overall survival (OS) rate of all pts were 62 and 77%. Two pts (10%) achieved complete pathological response. Low, intermediate and high risk RPI was noted in 50, 35, and 15 % of pts. The 5yr DFS and OS for low, intermediate and high risk groups were 75, 42, 33 % and 86, 71 and 33% respectively.Conclusions: RPI can accurately predict a subset of pts with low risk of recurrence after preop-CRT. Majority of pts in this cohort have low risk RPI and have a favorable outcome (5yr survival rate of 86%). RPI could be very helpful in designing future trials tailoring adjuvant chemotherapy based on risk of recurrence. We are validating this data with a larger, independent group of LARC patients from our cancer registry (N=30) and this data will be available for presentation. Since RPI only requires the final pathology after CRT, it should be readily reproducible in future prospective studies across different institutions. [Table: see text] No significant financial relationships to disclose.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16762-e16762
Author(s):  
Hsu Wu ◽  
Jhe-Cyuan Guo ◽  
Shih-Hung Yang ◽  
Jen-Shi Chen ◽  
Ta-Sen Yeh

e16762 Background: Wide survival difference of pancreatic cancer in the same TNM stage had been demonstrated. Predictive nomogram for resected pancreatic cancer had been published before, but the impact of adjuvant chemotherapy was not incorporated, and the data of Asian people were lacking. We also evaluated the effect of adjuvant chemotherapy in different risk groups according to our nomogram. Methods: Pancreatic cancer patients who underwent curative surgery between 2000/1 and 2013/12 were collected from the Cancer Registry of NTUH as the training cohort. Another cohort from CGMH was studied as the validation cohort. Analyses were performed by IBM SPSS version 21.0. Age, gender, primary tumor location, tumor differentiation, LVI, PNI, T, N, AJCC 7th stage, section margin, and adjuvant chemotherapy were used for univariate and multivariate analysis. Nomogram was built and validated by software R 3.6.1. C-index was used to demonstrate the performance and discrimination ability of nomogram. Results: There were 319 and 245 patients in NTUH and CGMH cohorts. The R0 resection rates were 80.6 and 71.8%, and 24.5 and 63.7% of patients received adjuvant chemotherapy. Median OS were 16.9 and 15.7 months in NTUH and CGMH. AJCC 7th Stage, tumor differentiation, section margin, tumor location, LVI and receiving adjuvant chemotherapy were incorporated in the nomogram. C-index in NTUH cohort was 0.66 (95% CI: 0.62-0.70), which was higher then C-index of AJCC 7th Stage, 0.58 (95% CI: 0.54-0.61). The C-index in the CGMH was 0.65 (95% CI: 0.60-0.69). We grouped the two cohorts into low, medium, and high risk groups according to the nomogram score. In NTUH, there were 50, 208, and 48 patients in the low, medium, and high risk groups. In CGHM, there were 37, 156, and 45 patients in those groups. The Kaplan-Meier curves of OS separated nicely according to different risk groups (log rank p < 0.001). If excluding adjuvant chemotherapy in nomogram, C-index in NTUH was 0.63 (95% CI: 0.59-0.67) and 0.62 (95% CI: 0.58-0.66) in CGMH by the new nomogram. The relative survival hazard ratios of receiving adjuvant chemotherapy were 0.532, 0.626, and 0.358 in high, medium and low risk groups of NTUH and were 0.624, 0.798, and 0.788 in CGMH. Conclusions: The new nomogram with more clinical factors than TNM stage has better prognostic prediction. We add the impact of adjuvant chemotherapy into our predictive model. Adjuvant chemotherapy is important in resected pancreatic cancer, even in low risk population.


2021 ◽  
Vol 09 (03) ◽  
pp. E348-E355
Author(s):  
David L. Diehl ◽  
Harshit S. Khara ◽  
Nasir Akhtar ◽  
Rebecca J. Critchley-Thorne

Abstract Background and study aims The TissueCypher Barrett’s Esophagus Assay is a novel tissue biomarker test, and has been validated to predict progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with Barrett’s esophagus (BE). The aim of this study was to evaluate the impact of TissueCypher on clinical decision-making in the management of BE. Patients and methods TissueCypher was ordered for 60 patients with non-dysplastic (ND, n = 18) BE, indefinite for dysplasia (IND, n = 25), and low-grade dysplasia (LGD, n = 17). TissueCypher reports a risk class (low, intermediate or high) for progression to HGD or EAC within 5 years. The impact of the test results on BE management decisions was assessed. Results Fifty-two of 60 patients were male, mean age 65.2 ± 11.8, and 43 of 60 had long segment BE. TissueCypher results impacted 55.0 % of management decisions. In 21.7 % of patients, the test upstaged the management approach, resulting in endoscopic eradication therapy (EET) or shorter surveillance interval. The test downstaged the management approach in 33.4 % of patients, leading to surveillance rather than EET. In the subset of patients whose management plan was changed, upstaging was associated with a high-risk TissueCypher result, and downstaging was associated with a low-risk result (P < 0.0001). Conclusions TissueCypher was used as an adjunct to support a surveillance-only approach in 33.4 % of patients. Upstaging occurred in 21.7 % of patients, leading to therapeutic intervention or increased surveillance. These results indicate that the TissueCypher test may enable physicians to target EET for TissueCypher high-risk BE patients, while reducing unnecessary procedures in TissueCypher low-risk patients.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Satoshi Abiko ◽  
Soichiro Oda ◽  
Akimitsu Meno ◽  
Akane Shido ◽  
Sonoe Yoshida ◽  
...  

Abstract Background Methods have been developed for preventing delayed bleeding (DB) after gastric endoscopic submucosal dissection (GESD). However, none of the methods can completely prevent DB. We hypothesized that DB could be prevented by a modified search, coagulation, and clipping (MSCC) method for patients at low risk for DB and by combining the use of polyglycolic acid sheets and fibrin glue with the MSCC method (PMSCC method) for patients at high risk for DB (antibleeding [ABI] strategy). This study assessed the technical feasibility of this novel strategy. Method We investigated 123 lesions in 121 consecutive patients who underwent GESD in Kushiro Rosai Hospital between April 2018 and January 2020. The decision for continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment. Results Oral antithrombotic agents were administered to 28 patients (22.8%). The en bloc R0 resection rate was 98.4%. The MSCC method and the PMSCC method for preventing DB were performed in 114 and 9 lesions, respectively. The median time of the MSCC method was 16 min, and the median speed (the resection area divided by the time of method used) was 3.6 cm2/10 min. The median time of the PMSCC method was 59 min, and the median speed was 1.3 cm2/10 min. The only delayed procedural adverse event was DB in 1 (0.8%) of the 123 lesions. Conclusions The ABI strategy is feasible for preventing DB both in patients at low risk and in those at high risk for DB after GESD, whereas the PMSCC method may be necessary for reduction of time.


Author(s):  
Satish Sankaran ◽  
Jyoti Bajpai Dikshit ◽  
Chandra Prakash SV ◽  
SE Mallikarjuna ◽  
SP Somashekhar ◽  
...  

AbstractCanAssist Breast (CAB) has thus far been validated on a retrospective cohort of 1123 patients who are mostly Indians. Distant metastasis–free survival (DMFS) of more than 95% was observed with significant separation (P < 0.0001) between low-risk and high-risk groups. In this study, we demonstrate the usefulness of CAB in guiding physicians to assess risk of cancer recurrence and to make informed treatment decisions for patients. Of more than 500 patients who have undergone CAB test, detailed analysis of 455 patients who were treated based on CAB-based risk predictions by more than 140 doctors across India is presented here. Majority of patients tested had node negative, T2, and grade 2 disease. Age and luminal subtypes did not affect the performance of CAB. On comparison with Adjuvant! Online (AOL), CAB categorized twice the number of patients into low risk indicating potential of overtreatment by AOL-based risk categorization. We assessed the impact of CAB testing on treatment decisions for 254 patients and observed that 92% low-risk patients were not given chemotherapy. Overall, we observed that 88% patients were either given or not given chemotherapy based on whether they were stratified as high risk or low risk for distant recurrence respectively. Based on these results, we conclude that CAB has been accepted by physicians to make treatment planning and provides a cost-effective alternative to other similar multigene prognostic tests currently available.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5061-5061
Author(s):  
Matthew R. Cooperberg ◽  
Paul Brendel ◽  
Daniel J. Lee ◽  
Rahul Doraiswami ◽  
Hariesh Rajasekar ◽  
...  

5061 Background: We used data from a specialty-wide, community-based urology registry to determine trends in outpatient prostate cancer (PCa) care during the COVID-19 pandemic. Methods: 3,165 (̃ 25%) of US urology providers, representing 48 states and territories, participate in the American Urological Association Quality (AQUA) Registry, which collects data via automated extraction from electronic health record systems. We analyzed trends in PCa care delivery from 156 practices contributing data in 2019 and 2020. Risk stratification was based on prostate-specific antigen (PSA) at diagnosis, biopsy Gleason, and clinical T-stage, and we used a natural language processing algorithm to determine Gleason and T-stage from unstructured clinical notes. The primary outcome was mean weekly visit volume by PCa patients per practice (visits defined as all MD and mid-level visits, telehealth and face-to-face), and we compared each week in 2020 through week 44 (November 1) to the corresponding week in 2019. Results: There were 267,691 PCa patients in AQUA who received care between 2019 and 2020. From mid-March to early November, 2020 (week 10 – week 44) the magnitude of the decline and recovery varied by risk stratum, with the steepest drops for low-risk PCa (Table). For 2020, overall mean visits per day (averaged weekly) were similar to 2019 for the first 9 weeks (̃25). Visits declined to week 14 (18.19; a 31% drop from 2019), recovered to 2019 levels by week 23, and declined steadily to 11.89 (a 58% drop from 2019) as of week 44, the cut off of this analysis. Conclusions: Access to care for men with PCa was sharply curtailed by the COVID-19 pandemic, and while the impact was less for men with high-risk disease compared to those with low-risk disease, visits even for high-risk individuals were down nearly one-third and continued to fall through November. This study provides real-world evidence on the magnitude of decline in PCa care across risk groups. The impact of this decline on cancer outcomes should be followed closely.[Table: see text]


2021 ◽  
Vol 12 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  

BackgroundThe 21-gene assay recurrence score (RS) provides additional information on recurrence risk of breast cancer patients and prediction of chemotherapy benefit. Previous studies that examined the contribution of the individual genes and gene modules of RS were conducted mostly in postmenopausal patients. We aimed to evaluate the gene modules of RS in patients of different ages.MethodsA total of 1,078 estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients diagnosed between January 2009 and March 2017 from Shanghai Jiao Tong University Breast Cancer Data Base were included. All patients were divided into three subgroups: Group A, ≤40 years and premenopausal (n = 97); Group B, &gt;40 years and premenopausal (n = 284); Group C, postmenopausal (n = 697). The estrogen, proliferation, invasion, and HER2 module scores from RS were used to characterize the respective molecular features. Spearman correlation and analysis of the variance tests were conducted for RS and its constituent modules.ResultsIn patients &gt;40 years, RS had a strong negative correlation with its estrogen module (ρ = −0.76 and −0.79 in Groups B and C) and a weak positive correlation with its invasion module (ρ = 0.29 and 0.25 in Groups B and C). The proliferation module mostly contributed to the variance in young patients (37.3%) while the ER module contributed most in old patients (54.1% and 53.4% in Groups B and C). In the genetic high-risk (RS &gt;25) group, the proliferation module was the leading driver in all patients (ρ = 0.38, 0.53, and 0.52 in Groups A, B, and C) while the estrogen module had a weaker correlation with RS. The impact of ER module on RS was stronger in clinical low-risk patients while the effect of the proliferation module was stronger in clinical high-risk patients. The association between the RS and estrogen module was weaker among younger patients, especially in genetic low-risk patients.ConclusionsRS was primarily driven by the estrogen module regardless of age, but the proliferation module had a stronger impact on RS in younger patients. The impact of modules varied in patients with different genetic and clinical risks.


2021 ◽  
Vol 31 (7) ◽  
pp. 1075-1079
Author(s):  
Günter Emons ◽  
Jae-Weon Kim ◽  
Karin Weide ◽  
Nikolaus de Gregorio ◽  
Pauline Wimberger ◽  
...  

BackgroundThe impact of comprehensive pelvic and para-aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident.Primary ObjectiveEvaluation of the effect of comprehensive pelvic and para-aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence.Study HypothesisComprehensive pelvic and para-aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65.Trial DesignOpen label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo-oophorectomy is performed. In arm B, in addition, a systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended.Major Inclusion CriteriaPatients with histologically confirmed endometrial cancer stages pT1b–pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible.Exclusion CriteriaPatients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease.Primary EndpointOverall survival calculated from the date of randomization until death.Sample Size640 patients will be enrolled in the study.Estimated Dates for Completing Accrual and Presenting ResultsAt present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031.Trial RegistrationNCT03438474.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Lidoriki Irene ◽  
Schizas Dimitrios ◽  
Mpaili Efstratia ◽  
Mpoura Maria ◽  
Hasemaki Natasha ◽  
...  

Abstract Aim To investigate the impact of malnutrition on postoperative complications in esophageal cancer patients. Background and Methods Malnutrition is common in esophageal cancer patients due to the debilitating nature of their disease. Several methods of nutritional assessment have emerged as significant prognostic factors for short-and long-term outcomes in patients operated for esophageal cancer. The study sample consisted of 85 patients with esophageal (n=11) and gastroesophageal junction (n=74) cancer who were admitted for surgery in the First Department of Surgery, Laikon General Hospital, Athens, Greece, between September 2015 and March 2019. Out of them, 65 patients underwent esophagectomy, while 20 patients underwent total gastrectomy. The assessment of nutritional status included the Geriatric Nutritional Risk Index (GNRI), the Patient Generated Subjective Global Assessment (PG-SGA) and sarcopenia. GNRI was based on preoperative values of patients’ serum albumin and body weight. The preoperative assessment of sarcopenia was based on Skeletal Muscle Index (SMI) derived from analysis of CT scans using SliceOmatic® Software version 4.3 (Tomovision, Montreal, Canada). Postoperative complications were graded according to Clavien-Dindo classification. Minor complications included categories I-II, whereas major complications included categories III-V. Results Thirty nine patients (47.6%) developed postoperative complications. More specifically, 21 patients (24.7%) developed minor complications and 18 patients (21.2%) developed major complications, while anastomotic leakage occurred in 10 patients (11.8%). Eighty patients (94.1%) had a high-risk GNRI (<92), while 5 patients (5.9%) had a low-risk GNRI (≥92). Forty four patients (51.8%) were diagnosed with sarcopenia. The mean PG-SGA score was 8.82 ± 5.57. Patients with a high-risk GNRI demonstrated significantly higher rate of overall complications compared to low-risk GNRI patients (100% vs 44.2%, p<0.05 respectively). Moreover, the rate of anastomotic leakage was significantly higher in the sarcopenia group than in the non-sarcopenia group (29% vs 3.4%, p<0.05). Nonetheless, PG-SGA was not significantly associated with postoperative outcomes. Conclusion Higher-risk scores on the GNRI are associated with an increased risk for developing postoperative complications, while sarcopenia is associated with higher risk for anastomotic leakage among esophageal cancer patients. Preoperative assessment of GNRI and sarcopenia should be performed in all patients in order to detect patients who are at greater risk of postoperative morbidity.


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