Additional Surgical Resection Research Articles

Role of Resection Following Focal Progression with Standard Doses of Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors: Results of Propensity Score Analyses.

There are limited data on the clinical benefits of adding surgical resection in patients with focally progressive gastrointestinal stromal tumor (GIST). This study aims to compare the clinical outcomes of resection plus imatinib dose escalation or maintenance (S group) with imatinib dose escalation alone (NS group) in patients with advanced GIST following focal progression (FP) with standard doses of imatinib. A total of 90 patients with advanced GISTs who experienced FP with standard doses of imatinib were included in this retrospective analysis. The primary endpoints were time to imatinib treatment failure (TTF) and overall survival (OS). Compared with the NS group (n = 52), patients in the S group (n = 38) had a higher proportion of primary tumor site involvement and lower tumor burden at FP. With a median follow-up duration of 31.0 months, patients in the S group had significantly better TTF and OS than patients in the NS group (median TTF: 24.2 vs. 6.5 months, p < .01; median OS: 53.2 vs. 35.1 months, p = .009). Multivariate analysis showed that S group independently demonstrated better TTF (hazard ratio [HR], 0.29; p < .01) and OS (HR, 0.47; p = .01). Even after applying inverse probability of treatment-weighting adjustments, S group demonstrated significantly better TTF (HR, 0.36; p < .01) and OS (HR, 0.58; p = .049). Our results suggested that resection following FP with standard doses of imatinib in patients with advanced GIST provides additional benefits over imatinib dose escalation alone. This is the first study to compare the clinical outcomes of resection plus imatinib dose escalation or maintenance (S group) with imatinib dose escalation alone (NS group) in patients with advanced gastrointestinal stromal tumor (GIST) following focal progression (FP) with standard doses of imatinib. These findings suggest that resection can be safely performed following FP, and the addition of surgical resection provides further clinical benefit over imatinib dose escalation alone. Based on these results, the authors recommend resection following FP in patients with advanced GIST provided that an experienced multidisciplinary team is involved in the patient's treatment.

Qualitative and Quantitative Analysis of Posttreatment Strategy After Endoscopic Resection for Patients with T1 Colorectal Cancer at High Risk of Lymph Node Metastasis.

Although endoscopic resection is increasingly performed to treat submucosal invasive colorectal cancer (T1CRC), approximately 10% are at risk of lymph node metastasis. The Japanese Society for Cancer of the Colon and Rectum guideline indicates that the following risk factors should be considered when deciding whether to perform additional surgical resection with lymph node dissection: depth of T1 invasion, lymphovascular invasion, poor histological grade, and budding grade 2/3. However, there is little information about the prognosis of T1CRC patients, or factors to consider when deciding subsequent treatment of high-risk T1CRC. This retrospective mixed method study was conducted using electronic medical records at Kyoto University Hospital between February 2005 and February 2015. Participants were T1CRC patients at risk of lymph node metastasis with at least one of the above four risk factors. They were assigned either careful follow-up (FU) or additional surgery (AS) through shared decision-making. To identify factors affecting decision-making in the FU group, we performed qualitative content analysis of electronic medical records. The prognosis of the groups was compared using the Kaplan-Meier method and the log-rank test. Of 161 T1CRC patients, 18 were included in the FU group and 19 in the AS group. The median follow-up time was 39.5 (range 23-126)months for the FU group and 62 (range 22-141)months for the AS group. Factors considered in selecting FU were advanced age, comorbidities, the sole presence of the "depth" risk factor, and lower rectal cancer. For AS, the risk factors cited in the guideline were considered. There was one recurrent case in each group during the research period. There were no significant differences in overall survival, cause-specific survival, or recurrence-free survival between the groups. Age, comorbidities, and lower-rectal cancer location were considered in deciding posttreatment strategy among high-risk T1CRC patients, alongside with positive vertical margin, depth, lymphovascular invasion, poor histologic grade, and budding. During the research period, there was no prognostic difference between the FU and AS groups.

Long-term outcomes of superficial neoplasia at the esophagogastric junction treated via endoscopic submucosal dissection and endoscopic submucosal tunnel dissection: a cohort study of a single center from China.

The techniques and indications for endoscopic submucosal dissection (ESD) and endoscopic submucosal tunnel dissection (ESTD) to remove superficial neoplasia at the esophagogastric junction (EGJ) have been developed and expanded. However, the resection of superficial neoplasia at the EGJ by ESD remains challenging, and the long-term clinical outcomes of curative and non-curative resections based on histological criteria remain unclear. We conducted a retrospective analysis on the safety and efficacy of the ESD and ESTD procedure with these patients. The records of 209 consecutive patients at the Chinese PLA General Hospital who received ESD and ESTD to treat EGJ superficial neoplasia from November 2006 to December 2016 were reviewed for this retrospective cohort study. We divided patients into two groups (curative and non-curative resection). Of all 14 additional surgeries, 1 patient in the curative group and 13 in the non-curative group underwent surgical operation with residual tumor in 7 specimens. During a median follow-up period of 46.4months (range 12.2-142.3months), the 5-year survival rate was 98.6%. Two patients died 91months and 66months after surgery due to subarachnoid hemorrhage and lymphoma, respectively. One patient died of gastric cancer 1year after the surgery. The 5-year disease-specific survival rate was 99.5%. Local tumor recurrence was detected in 9 of 209 cases. In conclusion, ESD was shown to be a safe and effective treatment strategy for early EGJ neoplasia. Mucosal adhesion may increase the difficulty of piecemeal curative resection, but the superficial depth of such an invasion favors better clinical outcomes. Additional surgical resection is a good choice for non-curative ESD, and re-ESD is also an alternative, in conjunction with intensive follow-up.

Oral Sirolimus: An Option in the Management of Neonates with Life-Threatening Upper Airway Lymphatic Malformations.

Background: Mechanistic target of rapamycin (mTOR) inhibitors are being used off-label showing promising results in patients with vascular anomalies. Children with lymphatic malformations (LMs) involving the airway benefit from sirolimus therapy soon after birth, reducing the need of tracheostomy. Available information about efficacy and side effects in neonates remains poor. We present seven newborns with severe head and neck LM showing response to sirolimus with no significant toxicity. Methods and Results: We performed a retrospective review of neonates with head and neck LM who received sirolimus between January 2014 and May 2018 with upper airway involvement needing ventilatory support. We analyzed type of LM, involved anatomical area, symptoms and response to sirolimus, including dosage, blood levels, response, side effects, and complications. Seven neonates received primary treatment with sirolimus in the context of cervical LM. Sirolimus was started at the recommended dose of 0.8 mg/m2/12 h and adjusted to maintain blood levels between 4 and 12 ng/mL. Median follow-up was 32 months (4-43) with a median treatment duration of 12 months (3-43). One patient had complete resolution of the malformation, one had complete resolution of symptoms, and five had partial resolution of the malformation with significant improvement in their respiratory conditions. Two patients required additional subtotal surgical resection and one tracheostomy. Four patients remain under treatment. Toxicity was not observed. Conclusions: Sirolimus is a safe drug in neonates and can be considered the first therapeutical option in newborns at high risk of respiratory failure before sclerosis or surgery. Close follow-up is mandatory to identify side effects at long-term use.

Additional Surgical Resection After Endoscopic Resection for Patients With High-risk T1 Colorectal Cancer.

The purpose of this study was to reveal the safety and efficacy of additional surgical resection (ASR) for high-risk T1 colorectal cancer (CRC) after endoscopic resection (ER). We retrospectively analyzed 191 patients with high-risk T1 CRC after ER. The ASR was performed in 176 (92.1%) patients and 15 (7.9%) rejected ASR. All patients that underwent ASR experienced R0 resection; laparoscopic surgery was performed in 159 (90.3%) patients. Clavien-Dindo complications ≥grade II occurred in 33 patients (18.8%). Anastomotic leakage (8.5%) and ileus (5.7%) were the most frequent complications. The anus function was preserved in all patients. Metastatic lymph node was detected in 21 (11.9%) patients. There were no deaths or relapses in patients with ASR. One patient without ASR (6.7%) had a lymph node recurrence. ASR was safe and effective and is recommended for high-risk T1 CRC patients after ER. A satisfactory long-term outcome can be achieved.

Coexisting DCIS and phyllodes breast tumors in Young Chinese women: Case series

IntroductionBreast cystosarcoma phyllodes tumors are rare and can be benign or malignant. All sub-divisions of phyllodes tumor—benign, borderline and malignant, can harbor carcinomas, although the incidence is extremely rare. Methods: We present two nonconsecutive cases of coexisting ductal carcinoma in situ (DCIS) and phyllodes breast tumors in young patients. Methods & Case PresentationRetrospective review of two patient’s medical record was performed. Case 130-year-old female underwent excisional biopsy for 3.48 cm mass found on ultrasound. Pathology revealed malignant phyllodes tumor with positive margin. On re-excision, patient was found to have 1.5 cm area of ductal carcinoma in situ (DCIS) with positive margin. Patient then underwent re-reexicision of DCIS with negative margin. Patient underwent chemotherapy and tamoxifen for three years without evidence of disease. Case 230-year-old female presented with 1.3 cm lesion found on ultrasound which core needle biopsy revealed a fibroepithelial tumor. Patient subsequently underwent excision biopsy which found 1.5 cm benign phyllodes tumor and 3.5 mm DCIS within the phyllodes tumor with negative margins. Patient declined additional chemotherapy or hormonal therapy and is currently considering mastectomy. ConclusionPhyllodes tumors are rare and ones with a coexisting carcinoma are even less frequently encountered. The treatment plan can change upon diagnosis of the carcinoma via the pathology. Treatment should be guided by the type and stage of carcinoma detected which may include additional surgical resection and lymph node sampling.

Retrospective Analyses of Systemic Chemotherapy and Cytoreductive Surgery for Patients with Ovarian Metastases from Colorectal Cancer: A Single-Center Experience

Background: Ovarian metastases from colorectal cancers are relatively rare. Since most ovarian metastases are associated with metastases at other sites, the prognosis is usually poor. Few reports exist that describe the clinical course of colorectal cancer patients with ovarian metastasis, including the chemotherapy response. Methods: We retrospectively reviewed the clinical data of patients with ovarian metastases from colorectal cancer treated at the National Cancer Center Hospital, Tokyo, between January 2006 and December 2015. Results: Thirty-seven patients with ovarian metastases received palliative chemotherapy as first-line treatment. The objective response rate for systemic chemotherapy of ovarian metastases was significantly lower than that for other metastatic sites (23.5 vs. 63.6% for first-line, respectively, p = 0.0047). Following chemotherapy, the additional surgical resection of ovarian metastases was positively associated with longer overall survival (OS) compared to no surgical resection (43.1 vs. 17.0 months, respectively, p = 0.0016). Furthermore, cytoreductive surgery was also positively associated with longer OS, especially when other metastatic sites were well controlled. Conclusions: Ovarian metastases are less responsive to systemic chemotherapy compared to extra-ovarian metastases in patients with relapsed or metastatic colorectal cancer. Multidisciplinary treatment strategy, including systemic chemotherapy and cytoreductive surgery, may contribute to the prolongation of OS.

Re-irradiation Using Intensity-modulated Radiotherapy for Recurrent and Second Primary Head and Neck Cancer.

Information on re-irradiation (re-RT) for recurrent and second primary head and neck cancer is limited. Herein, a description of our long-term experience of re-RT for previously irradiated head and neck cancer is provided. A retrospective review was performed for 73 consecutive patients re-irradiated for head and neck cancer between 2006 and 2015. Re-RT targets encompassed only the recurrent gross tumor and had tight margins (5-10 mm). Salvage surgery was performed on 28 (38%) patients before re-RT and 53 (73%) patients received chemotherapy concurrent with re-RT. The median interval between initial and re-RT was 31 months and the median cumulative dose of the two irradiations was 126 Gy (biologically equivalent to 2 Gy fractionation). With a median survival of 33 months, locoregional recurrence after re-RT developed in 37 patients (51%; 25 infield, 12 outfield). In multivariate analysis, higher re-RT dose (≥66 Gy), longer time interval (>2 years), and use of concurrent chemotherapy were associated with improved locoregional recurrence-free survival (all p<0.05). Additionally, performance status, additional surgical resection, and longer interval were associated with better overall survival (p=0.006, 0.021, 0.004, respectively). Clinically significant acute and late toxicities occurred in 14% and 22% of evaluable patients, but no grade 5 toxicity was observed. Moderate safety and acceptable toxicity was found after re-RT using tight margins, sufficient radiation dose, and daily image guidance. Encouraging local control and survival were obtained, similar to historical data using 1-2 cm margins.

Timing of re-irradiation in recurrent high-grade gliomas: a single institution study.

There is no standard treatment available for recurrent high-grade gliomas. This monoinstitutional retrospective analysis evaluates the differences in overall survival and progression-free survival in patients according to the timing of re-irradiation. Patients suffering from a glioblastoma who received re-irradiation for recurrence were evaluated retrospectively. The median overall survival (OS) and the median progression-free survival were compared with different treatment options and within various time periods. From January 2007 until March 2015, 41 patients suffering from recurrent high-grade gliomas received re-irradiation [median dose of 30.6Gy (range 20-40Gy) in median 4Gy fractions (range 1.8-5Gy)] in our institution after initial postoperative irradiation or combined radiochemotherapy. The OS in this population was 34 months, and the OS after recurrence (OS-R) was 13 months. After diagnosis of recurrence, patients underwent additional surgical resection after a median of 1.2 months, received a second-line systemic therapy after 2.2 months with or without re-irradiation after 5.7 months. Growth of the tumour was assessed 4.3 months after the start of re-irradiation. The OS after the second surgical resection was 12.2months, 11.7 months after the start of the second-line systemic therapy, and 6.7 months after the start of re-irradiation. The OS-R was not significantly correlated with the start of re-irradiation after a diagnosis of recurrence or the time period after the previous surgery. At this institution, re-irradiation was performed later compared to other treatment options. However, select patients could benefit from irradiation at an earlier time point. A precise time point should still be evaluated on an individual basis due to the patient's diverse conditions.

Inflammatory myofibroblastic tumor of the orbit: A clinico-pathological study of 25 cases

BackgroundInflammatory myofibroblastic tumor (IMT) is a rare entity characterized by the presence of myofibroblasts and inflammatory cells within a fibrous stroma, which typically occurs in children or young adults. The IMT is considered generally a benign lesion, although about 20% of cases may experience recurrence, and most rarely develop metastasis. Herein, we present the largest series of primary orbital IMT ever reported. Patients and methodsThe clinical records of 25 patients, collected between the 1995 and 2015, with biopsy-proven diagnosis of orbital IMT were retrospectively reviewed to determine demographic, clinical, radiologic and pathological features, management, and outcome. ResultsThe study included 13 females and 12 male patients, age ranged from 5 to 76 years. Disease onset was in all cases unilateral (25/25), with posterior location (10/25) or extending anterior to posterior (7/25). The most common signs and symptoms were: proptosis (19/25), ptosis (18/25), diplopia (10/25), periocular swelling (9/25), pain (8/25), redness (7/25). All patients underwent to incisional biopsy which included total or subtotal tumor resection avoiding arming of the adjacent structure, followed by systemic steroid therapy (22/25) or radiotherapy (3/25). The disease recurred in 6 (24%) patients who responded to the subsequent therapy. No one developed metastasis or died because of the disease. ConclusionIMT is a distinct entity which may occur in the orbit primarily. It should be considered in differential diagnosis in all orbital masses, particularly with onset of acute or subcronic inflammation. Surgical biopsy associated to a partial debulcking of the tumor, avoiding to damage adjacent vital structure may contribute to improve the outcome. Steroid therapy, seems to be the suitable as first line medical therapy, although, as reported in literature, not all cases respond to this treatment regimen. Radiotherapy, may be considered as an alternative therapy. Recurrences occurred in 24% of patients and may be treated with additional surgical resection and a new course of steroid or radiotherapy. No specific pathological features which may correlate with the prognosis have been found in this series.

Establishment of pathological quantitative method for determining undifferentiated component ratio in patients with differentiated/undifferentiated mixed-type early gastric cancer and clinical significance of this ratio.

The purpose of this study was to establish a pathological quantitative method for determining the undifferentiated components ratio (UCR) in patients with differentiated/undifferentiated mixed-type (Mixed-type) early gastric cancer (EGC) and to examine the clinical significance. The subjects were 410 patients who underwent surgical resection for EGC with the invasion limited to m or sm1. Analysis 1: In 12 randomly selected patients with Mixed-type cancer, we calculated the area ratio and the ratio of the length ratio using ImageJ and analyzed the correlation between them. Analysis 2: We generated ROC curves, and determined the cutoff UCR on the basis of the predictive risk factors for lymph node metastasis (LNM). Analysis 3: We analyzed the relationship between clinicopathological factors including UCR/length of undifferentiated component (LUC=maximum dimensions of tumor×UCR) and LNM. Analysis 1: The length ratio can be used as a substitute parameter for the UCR (r=0.996). Analysis 2: The cutoff UCR as a risk factor for LNM was 58% (sensitivity=1, 1-specificity=0.404). Analysis 3: Lymphovascular invasion (p<0.0001), UCR≥58% (p=0.023), and LUC≥25mm (p=0.005) were identified as significant risk factors for LNM. No LNM was observed in patients with invasion limited to m or sm1 and negativity for lymphovascular invasion and UCR<58% (0/215). In the patients with Mixed-type EGC, the length ratio of undifferentiated components can be a substitute parameter for the UCR. LNM rarely occurs in patients without lymphovascular invasion and with an UCR<58%. The analysis of the UCR has great significance in determining whether additional surgical resection is required after endoscopic resection.

The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction \u2013 a phase III trial of the German AIO/CAO-V/CAOGI

BackgroundHistorical data indicate that surgical resection may benefit select patients with metastatic gastric and gastroesophageal junction cancer. However, randomized clinical trials are lacking. The current RENAISSANCE trial addresses the potential benefits of surgical intervention in gastric and gastroesophageal junction cancer with limited metastases.MethodsThis is a prospective, multicenter, randomized, investigator-initiated phase III trial. Previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) receive 4 cycles of FLOT chemotherapy alone or with trastuzumab if Her2+. Patients without disease progression after 4 cycles are randomized 1:1 to receive additional chemotherapy cycles or surgical resection of primary and metastases followed by subsequent chemotherapy. 271 patients are to be allocated to the trial, of which at least 176 patients will proceed to randomization. The primary endpoint is overall survival; main secondary endpoints are quality of life assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 22 patients have been enrolled.DiscussionIf the RENAISSANCE concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, patients with gastric or GEJ cancer and metastases will no longer be considered candidates for surgical intervention.Trial registrationThe article reports of a health care intervention on human participants and is registered on October 12, 2015 under ClinicalTrials.gov Identifier: NCT02578368; EudraCT: 2014–002665-30.

Amputation neuroma mimicking lymph node metastasis of remnant gastric cancer: a case report

BackgroundAmputation neuromas (ANs) are reactive hyperplasia of nerve tissues that occur after a trauma or surgery involving the peripheral nerves. Only two previous reports of ANs occurring around the stomach and post gastrectomy have been reported. We report the case of a patient with AN near the remnant stomach who underwent distal gastrectomy for gastric cancer.Case presentationA 76-year-old man underwent distal gastrectomy, D1+ lymphadenectomy, and Billroth-I reconstruction for early gastric cancer in another hospital at 63 years of age. A regular gastrointestinal endoscopic follow-up examination after gastrectomy revealed an ulcerative lesion on the lesser curvature of the remnant stomach, which was diagnosed as remnant gastric cancer based on the histopathological examination. Then, he was transferred to our hospital. An upper gastrointestinal series and endoscopy revealed an 18-mm Type 0-IIc lesion on the lesser curvature of the remnant stomach with an estimated depth within the mucosa (T1a). An abdominal contrast-enhanced computed tomography (CT) failed to detect the primary lesion; however, a slightly enhanced 13 × 10-mm nodule was detected near the lesser curvature of the remnant stomach. An endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of the nodule showed no cancer cell; thus, endoscopic submucosal dissection (ESD) for the remnant gastric cancer was performed. Histopathological examination revealed noncurative resection due to T1b2 and UL (+). We planned an additional surgical resection. Before the resection, CT was performed, which had a 3-month interval with a previous CT, showing an enlargement of the nodule to 16 × 12 mm. We diagnosed the nodule as a lymph node metastasis and performed resection of the remnant stomach, D2 lymphadenectomy, splenectomy, and Roux-en-Y reconstruction. The nodule was later diagnosed as AN based on the histopathological examination. There was no residual cancer in the resected specimen.ConclusionsWe report AN mimicking lymph node metastasis near the remnant stomach of a patient with remnant gastric cancer. When nodules appear in the previous operative field, the possibility of ANs should be considered, although the incidence may be quite low.

Lymph node metastasis can be determined by just tumor depth and lymphovascular invasion in early gastric cancer patients after endoscopic submucosal dissection.

PurposeEndoscopic submucosal dissection (ESD) is a minimally invasive treatment for early gastric cancer (EGC) with negligible risk of lymph node metastasis (LNM). When a patient is determined to have noncurative resection after ESD, additional surgical resection with lymph node dissection is recommended. Previous studies report that LNM is found in about 10% of these patients. It may be possible to avoid unnecessary surgical resection by selecting patients properly. We aimed to clarify the risk factors associated with LNM in EGC patients who underwent ESD and to develop a highly accurate diagnostic algorithm for LNM.Patients and methodsAmong 1005 patients with EGC who underwent ESD, 423 patients who could be followed up for more than 3 years after treatment or who underwent additional surgical resection were examined. We used the leave-one-out method to explore the combination of predictive factors of LNM and differentiated LNM by a unique classifier.ResultsCurative resection was achieved in 322 patients, whereas noncurative resection was achieved in 101 patients. In the noncurative resection group, LNM occurred in eight patients with additional surgical resection and one patient during follow-up. The combination of depth of invasion, lymphatic, and venous invasion showed the highest diagnostic performance and could differentiate LNM with 100% sensitivity, 86% specificity, and 86% diagnostic accuracy.ConclusionMore than 500 μm submucosal invasion and lymphatic and venous invasion will be useful in assessing LNM after ESD for patients with EGC. When these three factors are not observed, follow-up alone might be appropriate and it may be possible to reduce unnecessary surgical resection.

Clinical Usefulness of Double Biomarkers 18F-Flurodeoxyglucose-Positron Emission Tomography and Carbohydrate Antigen 19-9 for Survival Prediction in Locally Advanced Pancreatic Cancer Patients Treated with Chemoradiation Therapy

To investigate the clinical significance of 18F-Flurodeoxyglucose-positron emission tomography (FDG-PET) parameters and carbohydrate antigen 19-9 (CA 19-9) levels in stratifying prognostic groups in patients with locally advanced pancreatic cancer after concurrent chemoradiotherapy (CRT) From our institutional database, we selected 257 patients with locally advanced pancreatic cancer who underwent both pretreatment 18F-FDG PET and CA 19-9 test, and received concurrent CRT between January 2004 and December 2011. The maximum standardized uptake value (SUVmax) was calculated at regions of primary tumors from pre-CRT and post-CRT FDG-PETs. SUV parameters (pre- and post-CRT SUVmax), SUV decline rate (%), CA 19-9 levels (pre- and post-CRT CA 19-9), and CA 19-9 decline rate (%) were analyzed for comparing radiologic response and survival outcomes (progression-free survival (PFS), overall survival (OS)). Median OS and PFS were 14.6 months and 8.8 months from the date of first diagnosis, respectively, at a median follow-up time of 14.2 months (range, 2.3-133.8 months). Radiologic responses after CRT (complete or partial response) were firstly obtained in 17% of the patients (n=43). Of the 164 patients with recurrences after CRT, distant metastasis (DM) was the most common (n=141, 86%), followed by local recurrence (LR) (n=12, 7%), and LR+DM (n=11, 7%). Additional surgical resection, maintenance chemotherapy, post-CRT CA 19-9 <66, and CA 19-9 decline ratio ≥91.2% were independent predictors of favorable PFS (p=<0.001, <0.001, 0.001, and 0.003), and pre-CRT CA 19-9 <760, CA 19-9 decline ratio ≥91.2% were independent predictors of favorable OS (p=0.017, <0.001) in multivariate analysis. For the PET parameters, SUV decline ≥63% was the most significant prognostic factor (p=0.029 for PFS, 0.017 for OS). Patients with SUV decline ≥63% were included in the responder group more than in the non-responder group (12% vs. 2%, p=0.057). We also divided patients into 4 risk groups according to the number of positive favorable factors (SUV decline ratio ≥63%, pre-CRT CA 19-9 <760 (for OS groups) or post-CRT CA 19-9 <66 (for PFS groups), and CA 19-9 decline ratio ≥91.2%) (0: high-risk, 1: intermediate high-risk, 2: intermediate low-risk, 3: low risk). The low-risk group showed significantly favorable PFS than other groups (median 59.4 months, p=0.001, 0.014, and 0.005, respectively). The low-risk group also showed the most favorable OS than others (median 85.4 months, p=0.020, 0.043, and 0.109, respectively). In patients with locally advanced pancreatic cancer, the use of a combination of double biomarkers, SUVmax and CA 19-9, appears useful in predicting survival outcomes after CRT. In other words, three prognostic factors such as SUV decline ratio, pre or post-CRT CA 19-9, and CA 19-9 decline ratio seem to have substantial advantages over single-parameter by facilitating better treatment selection for locally advanced pancreatic tumors.

A Prospective Study of Stent Covered With Triamcinolone-Soaked Polyglycolic Acid Sheet in Preventing Stricture Formation After Large Esophageal ESD

Introduction: Stricture occurs almost 100% in circumferential lesions after endoscopic submucosal dissections (ESD), which leads to a low quality of life. As an intermediate-acting steroid, triamcinolone is easily absorbed into the submucosal layer and durable in inhibiting inflammation, while locoregional injections may cause delayed perforation and bleeding and oral prednisolone have systemic adverse effects. Polyglycolic acid(PGA) sheet outside of stent serves a scaffold for cell adhesion and proliferation, which can be gradually biodegradated in 30 days. We evaluate the safety and efficacy of a new method(stent covered with triamcinolone-soaked PGA sheet) for preventing stricture formation after large esophageal ESD. Methods: Form June 2016 to December 2016, 16 patients of large esophageal superficial cancer(≥3/4 of the esophageal circumference) were prospectively enrolled to perform ESD. Randomized to two groups(Group A: triamcinolone-soaked PGA sheet, n=8; Group B: PGA sheet, n=8). All stents were placed immediately after ESD and were removed 4 weeks post-ESD, The primary outcome was the incidence of stricture formation. The secondary outcome was the number of endoscopic balloon dilatation (EBD) sessions required. Results: No adverse events occurred in both groups. One patient required additional surgical resection in group A was excluded. Mean length of the resection in two groups have no statistical significance(9.00±3.37 cm vs 7.38±2.26 cm, P=0.287). Three patients(42.9%) in group A and 5(62.5%) in group B developed stricture(P=0.619). No stricture was found in post-operation with non-circumference resection in both groups. The stricture rate of circumferential lesions was 50%(3/6Symboland the medium diameter of stricture was 5mm(range 2-9mm) in group A, while 100%(5/5) and 3mm(range 2-4mm) in group B(stricture rate: P=0.182; diameter: P=0.216). All strictures were found in the middle of the defects in both groups(8/8). The medium numbres of EBD in group A was 3 (range 3-4) after a followed-up of 7.5 months(range 5-11months), and the number was 5 in group B(range 3-11) with followed-up of 8.0 months(range 5-11months)(P=0.122).SymbolConclusion: Triamcinolone-soaked PGA sheet is safe and radically decreases the incidence of esophageal stricture and the number of EBD sessions. Triamcinolone exposed to the surgical wound by saturating PGA sheet is a novel administration, which distinguishes from traditional oral prednisolone and locoregional steroid injections.Figure: Study flow chart.Table: Table. The incidence of stricture formation and the number of EBD dilatation

Androgen Deprivation Therapy (ADT) and Radiation Therapy (RT) Alone As Compared With Trimodality Therapy With ADT, RT, and Surgery in Men With High Risk, Nonmetastatic Adenocarcinoma of the Prostate

Radiation therapy (RT) combined with long-term androgen deprivation therapy (ADT) represents a current standard of care for high risk prostate cancer patients. Despite this, men with high risk prostate cancer often undergo surgical resection before RT and ADT. It remains unknown if the addition of surgery to RT and ADT improves outcomes for men with high risk disease. Given the added cost and morbidity associated with the addition of surgical resection, the potential benefits of surgery seem prudent to explore. We conducted an analysis of men with high risk prostate cancer intended to examine the benefit, if any, to trimodality therapy consisting of surgery, RT, and ADT in high risk patients. The National Cancer Database was queried for men with adenocarcinoma of the prostate, treated from the years of 2004 to 2010, with one high risk feature (PSA>20, >=T3a, or Gleason score of 8-10). Patients were included if they received dose escalated RT (>=75.6 Gy) with ADT, or trimodality therapy consisting of surgery, RT, and ADT. Propensity scores were determined for patients receiving RT and ADT, and patients receiving surgery, RT and ADT. Patient characteristics were compared using t-tests, Wilcoxon Rank-Sum test, and Chi-square tests. Propensity score matching was used to balance between baseline characteristics. Overall survival (OS) was measured beginning at a landmark time of 10 months from diagnosis. OS was assessed with multivariable proportional hazards regression, propensity weighted for average treatment effect for the treated. A total of 25,035 patients met inclusion criteria for this analysis. A total of 24,062 men were treated with RT and ADT alone, and 973 men were treated with surgery, RT, and ADT. The mean age was 69.8 years in the whole cohort. Patients who received trimodality therapy, including RT, ADT, and surgical resection, were more likely to be younger (mean age of 61.5 years in the ADT, RT and Surgery groups versus 70.2 years in ADT and RT alone cohort, P <0.001). On propensity weighted multivariate analysis non-white race, increasing age, higher Charlson-Deyo comorbidity index, and increasing PSA were all associated with worse overall survival. As compared with a reference group of dose escalated RT and ADT, the patients treated with surgery, RT and ADT had no statistically significant improvement in OS, HR 0.866 (95% CI, 0.743 – 1.009, P = 0.066). No statistically significant OS benefit was seen for the use of trimodality therapy including surgery, RT and ADT when compared with dose escalated RT and ADT alone in men with high risk prostate cancer. It remains unknown if more narrowly defined subsets of high risk patients selectively benefit from trimodality therapy. Given the added cost and morbidity of surgery, men who are likely to require RT and ADT after surgery may be best suited by treatment with dose escalated RT and ADT alone.

Efficacy of Additional Surgical Resection After Endoscopic Submucosal Dissection for Superficial Esophageal Cancer.

This study aimed to investigate the efficacy of additional surgical resection (ASR) after endoscopic submucosal dissection (ESD) for superficial esophageal cancer (SEC). Clinicopathological features and prognoses were analyzed in esophageal cancer (EC) cases with the indication for additional treatments (AT) after ESD (37 cases) and in cases that underwent primary resection (13 cases). Sixteen out of 37 cases underwent ASR. The remaining 21 cases underwent other treatments or observation. Although all ASR cases are alive without recurrence, recurrence developed in 2 non-ASR cases. Residual tumors were detected in 2 ASR cases. All 4 cases were T1b and positive for lymph vessel invasion (ly+). No significant difference was observed in surgical outcomes between ASR and primary surgical resection (PSR) cases. AT need to be considered for T1b and ly+ cases, and ASR is one of the effective AT. The safety of ASR was similar to PSR for SEC.

The “RENAISSANCE” Trial: Effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction—A phase III trial of the German AIO/CAO-V/CAOGI.

TPS4140 Background: Recent data indicates that surgical resection may bring a benefit for select patients with metastatic gastric / esophagogastric junction cancer. However, no data obtained in randomized trials is available up to now. The current RENAISSANCE trial investigates this long-lasting question about the role of surgical intervention in limited-metastatic gastric / esophagogastric junction cancer. Methods: This is a prospective, multicenter, randomized, investigator initiated phase III trial. In this study, previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) will receive 4 cycles of FLOT (docetaxel 50 mg/m²; oxaliplatin 85 mg/m²; leucovorin 200 mg/m²; 5-FU 2,600 mg/m²), and if Her2+ with trastuzumab. Patients without disease progression after 4 cycles are randomized 1:1 to receive additional chemotherapy cycles or surgical resection of primary and metastases followed by subsequent chemotherapy. 271 patients are to be allocated to the trial, of which at least 176 patients will be randomized. The primary endpoint is overall survival; main secondary endpoints are quality of life parameters as assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 21 patients have been enrolled. EudraCT: 2014-002665-30. Clinical trial information: NCT02578368.

Long-term outcomes after treatment for T1 colorectal carcinoma: a multicenter retrospective cohort study of Hiroshima GI Endoscopy Research Group

We aimed to clarify the long-term outcomes of patients with T1 colorectal carcinoma (CRC) after endoscopic resection (ER) and surgical resection. We examined T1 CRC patients treated during 1992-2008 and who had ≥5years of follow-up. Patients who did not meet the curative criteria after ER according to the Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines were defined as "non-endoscopically curable" and classified into three groups: ER alone (Group A: 121 patients), additional surgery after ER (Group B: 238 patients), and surgical resection alone (Group C: 342 patients). Long-term outcomes and predictors of recurrence were analyzed. Of the 882 patients with T1 CRC, 701 were non-endoscopically curable. Among these patients, recurrence and 5-year overall survival (OS) rates were 0.6 and 91.1%, respectively. In Groups A, B, and C, recurrence rates were 5.0, 5.5, and 3.8%, OS rates were 79.3, 92.4, and 91.5% (p<0.01), and 5-year disease-free survival (DFS) rates were 98.1, 97.9, and 98.5%, respectively. Thirty-two patients experienced local recurrence or distant/lymph node metastasis (Group A: 6; Group B: 13; Group C: 13) and 14 patients died of primary CRC (Group A: 3; Group B: 7; Group C: 4). Age ≥65years, protruded gross type, positive lymphatic invasion, and high budding grade were significant predictors of recurrence in non-endoscopically curable patients. Our findings supported the JSCCR criteria for endoscopically curable T1 CRC. ER for T1 CRC did not worsen the clinical outcomes of patients who required additional surgical resection.