5-year Tumor Recurrence Research Articles

Abstract OT2-03-01: Multicenter study to standardize and evaluate the efficacy of radiofrequency ablation therapy for early breast cancer (RAFAELO study)

Abstract Background: Early-stage breast cancer is increasingly detected by screening mammography, and we aim to establish radiofrequency ablation therapy (RFA) as a minimally invasive, cost-efficient, and cosmetically acceptable local treatment. In our Phase I study, localized tumors with a maximum diameter of 2 cm, preoperatively diagnosed by imaging and histopathology, were treated with RFA. A 90% complete ablation rate was confirmed histopathologically. Our phase II multicenter study of RFA without resection for early breast cancer will evaluate the long-term safety and efficacy of RFA as well as its cosmetic results, which are a perceived advantage of this technique. Trial design: This study is a Phase III, single-arm, multicenter study being conducted with the participation of 11 hospitals. In our experimental therapy, a radiofrequency electrode needle is inserted through the skin into the breast lesion under imaging guidance, followed by thermal ablation with radiofrequency waves. RFA will be conducted under general anesthesia. The Cool-tip™ RF Ablation Single Electrode Kit (Medtronic, CO, USA) will be used to standardize the evaluation of the ablation effect. After RFA, all patients will receive radiotherapy and systemic therapy according to the ER, HER2, tumor grade, and lymph node status of the primary tumor. Residual lesions after RFA will be assessed approximately 3 months after radiotherapy using imaging and pathological studies. All patients will undergo vacuum-assisted biopsy regardless of imaging results. If specimens show viable tumor tissue, additional excision will be performed. Follow-up evaluation for residual tumor, including clinical breast examination and diagnostic imaging (ultrasound, MRI, and mammography), will be performed yearly after RFA. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012429. Eligibility criteria: Early breast cancer patients, who are lack of prior treatment for breast cancer and histologically confirmed ductal carcinoma with a single localized tumor of 1.5 cm or less in the greatest dimension and clinically node negative on preoperative imaging. Specific Aims: The primary endpoint is 5-year ipsilateral breast tumor recurrence(IBTR) rate, and the secondary endpoints are residual lesion rate, overall survival, DFS, and adverse events of RFA. Statistical methods: The IBTR rate should be similar to that with standard treatment (BCS). However, the IBTR after RFA alone may be higher by up to 10% than in the NSABP-B06 study; therefore the 5-year IBTR rate is estimated to be 6.3%. We calculated the required sample size based on the following assumptions: a clinically acceptable 5-year local recurrence-free survival rate of 90%, a one-sided significance level of 5% (alpha = 0.1, 2-sided), and power of 80% (beta = 0.2). Taking into account a drop-out rate of 10%, approximately 372 patients will be enrolled in the study. Present accrual and target accrual: The trial was activated in August 2013, with a total of 372 patients enrolled by the end of June 2018. Citation Format: Kinosita T, Takahashi M, Fujisawa T, Yamamoto N, Doihara H, Ohtani S, Futamura M, Takahashi M, Aogi K, Hojo T, Yoshida M, Shiino S, Tsuda H. Multicenter study to standardize and evaluate the efficacy of radiofrequency ablation therapy for early breast cancer (RAFAELO study) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-03-01.

Long-term oncologic outcomes of a randomized controlled trial comparing laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer

BackgroundLaparoscopy-assisted gastrectomy is a feasible and safe procedure for treating advanced gastric cancer in terms of short-term outcomes. However, concern about long-term oncologic outcomes has limited the adoption of laparoscopy-assisted gastrectomy for advanced gastric cancer. MethodsWe launched a prospective randomized controlled trial comparing laparoscopic and open gastrectomy with D2 lymph node dissection for locally advanced gastric cancer to evaluate long-term oncologic feasibility. The 5-year overall survival, disease-free survival, and tumor recurrences have been determined on an intention-to-treat basis. ResultsBetween January 2010 and June 2012, a total of 328 patients with preoperative clinical stage T2-4aN0-3M0 gastric cancer were enrolled in the trial. We excluded 6 patients with unresected tumor, and the remaining 322 patients were randomized to the laparoscopic group (162 patients) or the open group (160 patients) for radical surgery. One patient in laparoscopy-assisted gastrectomy and 4 patients in open gastrectomy were lost to follow-up immediately after discharge, leaving 317 patients (161 in laparoscopy-assisted gastrectomy and 156 in open gastrectomy) eligible for long-term analysis. The 5-year overall survival rate was 49.0% in the laparoscopic group and 50.7% in the open group, and the 5-year disease-free survival rate was 47.2% and 49.6% in the 2 groups, respectively. Kaplan–Meier curves for overall survival and disease-free survival showed no differences between the 2 groups. There was no difference in the 5-year tumor recurrence rate between the 2 procedures. ConclusionLaparoscopy-assisted gastrectomy can provide comparable long-term survival without an increase in recurrence and metastasis in treating advanced gastric cancer.

Long-term postresection prognosis of primary neuroendocrine tumors of the liver.

PurposePrimary hepatic neuroendocrine tumor (PHNET) is a very rare neoplasm, requiring strict exclusion of metastasis from possible extrahepatic primary sites for its diagnosis.MethodsWe reviewed our clinical experience of 13 patients with primary hepatic NET who underwent liver resection from January 1997 to December 2015.ResultsThe mean age of the 13 patients (8 males and 5 females) was 51.1 ± 12.8 years; the most common clinical manifestation was vague, nonspecific abdominal pain (n = 9). Of them, 11 patients underwent preoperative liver biopsy, 7 of which correctly diagnosed as neuroendocrine tumor (NET). Ten patients underwent R0 resection, and 3 underwent R1 resection. Diagnosis of PHNET was confirmed both immunohistochemically and by absence of extrahepatic primary sites. All tumors were single lesions, with a mean size of 9.6 ± 7.6 cm and a median size of 4.3 cm; all showed positive staining for synaptophysin and chromogranin. During a mean follow-up period of 95.1 ± 86.6 months, 7 patients died from tumor recurrence, whereas the other 6 remain alive to date, making the 5-year tumor recurrence rate 56.0% and the 5-year patient survival rate 61.5%. When confined to R0 resection, 5-year recurrence and survival rates were 42.9% and 70.0%, respectively. Univariate analysis showed that Ki-67 proliferative index was the only risk factor for tumor recurrence.ConclusionPHNET is a very rare tumor with no specific clinical features, and its final diagnosis depends primarily on pathology, immunohistochemistry, and exclusion of metastasis from other sites. Aggressive surgical treatment is highly recommended for PHNET because of acceptably favorable postresection outcomes.

AB095. Transurethral holmium laser bladder tumor submucosal dissection (HoL-BTSD) for non-muscle invasive bladder cancer

BackgroundTo compare the clinical efficacy of transurethral holmium laser bladder tumor submucosal dissection (HoL-BTSD) and transurethral bipolar plasma dissection of bladder tumor (TURBT) in the treatment of non-muscle invasive bladder cancer (NMIBC).MethodsFrom September 2012 to April 2016, 105 patients diagnosed with NMIBC were randomly divided into HoL-BTSD and TURBT group. A total 53 cases in HoL-BTSD and 52 cases in TURBT according to the operation method. The operation time, intraoperative bleeding, postoperative urinary catheter indwelling time, hospitalization time, main complication rate and 1 and 2 years recurrence rate were compared between two groups.ResultsBetween HoL-BTSD group and TURBT group, the mean operation time was 27.46±9.45 vs. 24.43±8.51 min (P>0.05). The mean intraoperative blood loss was 12.07±6.14 vs. 20.62±8.20 mL (P<0.05). The incidence of obturator reflex was 0% vs. 33.9% (P<0.05). The incidence of bladder perforation is 1.92% vs. 15.1% (P<0.05). The mean postoperative hospital stay was 6.10±1.62 vs. 7.66±1.79 days (P<0.05). The catheter retention time was 5.12 ±1.69 vs. 6.70±1.67 days (P<0.05). The incidence of postoperative bleeding was 0% vs. 11.3% (P<0.05). The incidence of urethral stricture was 3.85% vs. 7.55% (P>0.05). The rate of 1-year tumor recurrence was 5.8% vs. 18.9%. The rate of 2 years tumor recurrence was 13.5% vs. 35.8%.ConclusionsTransurethral holmium laser dissection of bladder tumor in the treatment of non-muscular infiltration of bladder cancer is effective with less complications, rapid recovery, early discharge, and low postoperative recurrence rate.

Effect of microvascular invasion on prognosis of patients with hepatocellular carcinoma after hepatectomy

Objective To investigate the effect of microvascular invasion (MVI) on tumor recurrence of hepatocellular carcinoma (HCC) patients after hepatectomy, the efficacy of sequential transcatheter arterial chemoembolization (TACE) on positive MVI patients after hepatectomy, and the effect of comprehensive treatment on the prognosis of patients with tumor recurrence. Methods The retrospective cross-sectional study was conducted. The clinicopathological data of 136 HCC patients who underwent hepatectomy in the First Affiliated Hospital of Air Force Medical University from February 2015 to December 2016 were collected. Patients were treated with TACE, radiofrequency ablation (RFA) and molecular-targeted drugs after hepatectomy, and patients with tumor recurrence selected 1 or 2 above treatments. The patient received postoperatively outpatient reexaminations every 3 months to detect tumor recurrence and survival. Follow-up was from the day of the surgery to death or December 2017. Observation indicators: (1) treatment after hepatectomy; (2) effect of MVI on tumor recurrence of HCC patients after hepatectomy: clinicopathological features and tumor recurrence rate between positive and negative MVI patients; (3) efficacy of TACE on positive MVI patients: clinicopathological features and tumor recurrence rate in positive MVI patients with or without TACE; (4) effect of comprehensive treatment on the prognosis of patients with tumor recurrence. Measurement data with normal distribution were represented as ±s and analyzed using the independent-samples t test. Comparisons of count data were analyzed using chi-square test or Fisher exact probalility. The tumor recurrence rate and survival rate were calculated by the Kaplan-Meier method, and Log-rank test was used for survival analysis. Results (1) Treatment after hepatectomy: of 136 patients undergoing hepatectomy, 117 underwent single hepatectomy and 19 combined sequential TACE; 59 had HCC recurrence, including 22 receiving comprehensive treatment. (2) Effect of MVI on tumor recurrence of HCC patients after hepatectomy: ① Clinicopathological features: of 117 patients undergoing single hepatectomy, positive MVI was detected in 49 patients, including 44 males and 5 females, with an age of (52±10)years old; 49 patients were in Child-Pugh grade A, including 36 combined with liver cirrhosis and 13 without liver cirrhosis; positive and negative alpha-fetoproteins (AFPs) were respectively detected in 34 and 15 patients. Negative MVI was detected in 68 patients, including 54 males and 14 females, with an age of (55±11)years old; 65 and 3 patients were respectively in Child-Pugh grade A and B, including 52 combined with liver cirrhosis and 16 without liver cirrhosis; positive and negative AFPs were respectively detected in 39 and 29 patients. There was no statistically significant difference in gender, age, Child-Pugh score of liver function, liver cirrhosis and comparison of AFP between positive and negative MVI patients (χ2=2.258, t=-1.626, χ2=0.804, 0.138, 1.758, P>0.05). ② Tumor recurrence rate: The 6-month and 1-year tumor recurrence rates after hepatectomy were respectively 30.77%, 30.61% in 117 patients undergoing single hepatectomy and 42.86%, 51.02% in 49 of 117 patients with positive MVI and 22.06%, 27.94% in 68 of 117 patients with negative MVI, showing statistically significant differences in 6-month and 1-year tumor recurrence rates between positive and negative MVI patients (χ2=5.738, 6.465, P 0.05). ② Tumor recurrence: the 6-month and 1-year tumor recurrence rates after hepatectomy were respectively 0, 28.57% in 7 positive MVI patients with sequential TACE and 42.86%, 51.02% in 49 positive MVI patients without sequential TACE, showing a statistically significant difference in 6-month tumor recurrence rate (χ2=4.800, P 0.05). (4) Effect of comprehensive treatment on the prognosis of patients with tumor recurrence: of 59 patients with tumor recurrence, 37 didn′t receive comprehensive treatment, 34 of 37 died within 1-year postoperatively, including 30 deaths within 6-month postoperatively, and 1-year survival rate was 8.10%; 22 received comprehensive treatment, including 4 deaths within 1-year postoperatively, and 1-year survival rate was 81.80%, showing a statistically significant difference in 1-year survival rate (χ2=32.698, P<0.05). Conclusions MVI is one of the important risk factors affecting HCC recurrence and metastasis after hepatectomy. The combined TACE after hepatectomy can reduce the HCC recurrence rate of MVI positive patients, and active comprehensive treatment after HCC recurrence can significantly prolong the survival time of patients. Key words: Hepatic neoplasms; Surgical resection; Microvascular invasion; Transcatheter arterial chemoembolization; Comprehensive treatment; Recurrence rate; Survival time

Radiofrequency ablation combined with non-specific sequential immunotherapy for early hepatocellular carcinoma: a prospective study

Objective To investigate the clinical effect of radiofrequency ablation (RFA) combined with non-specific sequential immunotherapy (IM) for early hepatocellular carcinoma (HCC), and analyze the factors affecting prognosis of patients after RFA. Methods The prosepctive study was conducted. The clinicopathological data of 72 early HCC patients who were admitted to the People′s Hospital of Guangxi Zhuang Autonomous Region from January 2009 to October 2015 were collected. Patients were divided into 3 groups by random number table: patients in group A underwent single RFA therapy; patients in group B underwent RFA + non-specific sequential IM (1-3 times); patients in group C underwent RFA + non-specific sequential IM (≥4 times). RFA was performed by the same doctors team, and non-specific sequential IM planning included thymalfasin + interleukin-2 (IL-2). Observation indicators: (1) treatment situations; (2) follow-up and survival; (3) analysis of prognostic factors after RFA. Follow-up using outpatient examination was performed to detect tumor recurrence and overall survival up to December 2015. Measurement data with normal distribution were represented as ±s, and comparison among groups were evaluated with the ANOVA. Comparison of count data were analyzed using the chi-square test. The curve, rate and time of tumor recurrence after treatment, overall survival curve and time were respectively drawn and calculated by the Kaplan-Meier method, and the Log-rank test was used for survival analysis. The univariate analysis and multivariate analysis were respectively done using the COX proportional hazard regression model. Results Seventy-two patients were screened for eligibility, including 31 in group A, 22 in group B and 19 in group C. (1) Treatment situations: patients in 3 groups underwent RFA, and contrast-enhanced ultrasound showed complete tumors ablation at 5 days postoperatively. Patients in group B and C didn′t have significant adverse reactions after RFA during IM therapy. (2) Follow-up and survival: 72 patients were followed up for 2-66 months after treatment, with a median time of 34 months. The 1-year tumor recurrence rates after treatment in group A, B and C were respectively 19.4%, 13.6% and 10.5%, with no statistically significant difference (χ2=0.714, P>0.05). The median tumor recurrence times in group A, B and C were respectively 24.0 months, 30.0 months and 33.0 months, with no statistically significant difference (χ2=3.283, P>0.05). The median overall survival times in group A, B and C were respectively 46.0 months, 56.0 months and 57.0 months, with a statistically significant difference (χ2=7.079, P 0.05). (3) Analysis of prognostic factors after RFA: results of univariate analysis showed that initial tumor, tumor number, Barcelona clinic liver cancer (BCLC) staging and sequential IM after RFA were related factors affecting prognosis of early HCC patients [hazard ratio (HR)=2.636, 2.530, 0.145, 0.582, 95% confidence interval (CI): 1.218-5.703, 1.110-5.767, 0.041-0.517, 0.321-0.867, P 1, staging B of BCLC and without sequential IM after RFA were independent risk factors affecting prognosis of early HCC patients (HR=2.376, 2.683, 0.567, 95%CI: 1.080-5.229, 1.530-21.112, 0.335-0.962, P<0.05). Conclusions The non-specific sequential IM of thymalfasin + IL-2 can prolong survival time of early HCC patients after RFA. Tumor number > 1, staging B of BCLC and without sequential IM after RFA are independent risk factors affecting prognosis of early HCC patients. Key words: Liver neoplasms; Radiofrequency ablation; Immunotherapy; Thymalfasin; Interleukin-2

Multicystic mucinous adenocarcinoma of the uterine cervix compared with benign multicystic lesions: Multiparametric MR features.

Multicystic mucinous adenocarcinoma is rarely recognized and has a high misdiagnosis rate. To distinguish malignant multicystic mucinous adenocarcinomas from benign multicystic lesions in the uterine cervix using multiparametric MR. Retrospective. Forty patients with seven cystic mucinous adenocarcinomas and 33 benign multicystic lesions. 3.0T. Diffusion-weighted images (DWI) and dynamic contrast-enhanced (DCE) images. Lesion size, intracystic hemorrhage, solid component, and heterogeneous enhancement were subjectively assessed, and apparent diffusion coefficient (ADC) values, Ktrans , Kep , and Ve parameters were compared. Student's t-test was used to compare age, tumor size, ADC values, and DCE parameters. Pearson's chi-square test was used to compare intracystic hemorrhage, solid component, and heterogeneous enhancement. Receiver-operating-characteristic (ROC) analysis of ADC values, tumor size, and Ktrans were performed. The size of mucinous adenocarcinomas was larger than benign multicystic lesions (4.09 ± 2.09 vs. 2.23 ± 0.58 cm, P < 0.001); the area under the curve (AUC) for tumor size was 0.859 with a sensitivity of 71.4% and specificity of 90.9%. Stromal ADC value was lower for mucinous adenocarcinomas (1.19 ± 0.22 vs. 1.68 ± 0.22 × 10-3 mm2 /s, P < 0.001); AUC for stromal ADC value was 0.970, with a sensitivity of 86.4% and specificity of 100.0%. Among quantitative DCE parameters, only ktrans offered a discriminative value (1.72 ± 1.42 vs. 0.69 ± 0.30 min-1 , P = 0.031); the AUC for ktrans was 0.831 with a sensitivity of 71.4% and specificity of 97.0%. Intracystic hemorrhage (3/7), solid component (5/7), and heterogeneous enhancement (4/7) were only found in mucinous adenocarcinomas. Five patients (71.4%) had lymphovascular space invasion and three (42.9%) had lymph node metastasis. The 1-year tumor recurrence or metastasis rate was 28.5% (2/7). Awareness of multiparametric MR features can assist in the differentiation of mucinous adenocarcinomas from benign multicystic lesions. 4 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018;47:1336-1343.

Abstract OT2-01-04: Freezing instead of resection of small breast tumors (FROST): A study of cryoablation in the management of early stage breast cancer

Abstract Background/Objective: ACOSOG Z1072 demonstrated complete target tumor ablation in 92% of stage I invasive breast cancers treated with cryoablation prior to resection. We hypothesize that cryoablation can achieve complete tumor ablation and adequate local control in a selected population of women with early stage invasive breast cancer managed with cryoablation alone, without planned surgical resection. Methods: The trial is a phase II, single-arm, multicenter study open to women age 50 and older with core needle biopsy-proven clinical stage I, T1, clinically node negative (N0), unifocal, hormone receptor positive, HER2/neu-negative invasive ductal carcinoma measuring ≤1.5 cm by mammography (MG), ultrasound (US), and MRI. Once registered, subjects will undergo US-guided cryoablation followed 6 months later by an US-guided core biopsy of the cryoablated lesion to confirm the absence of residual viable disease. Following cryoablation, subjects will also begin a minimum 5-year course of adjuvant endocrine therapy and serial MG, US, and MRI. Whole breast radiotherapy (WBRT) is optional for subjects age 70+ (stratum I) and mandatory for women age 50-69 (stratum 2). Sentinel node biopsy (SNBx) is optional in both cohorts. All subjects found to have residual or recurrent disease will undergo standard surgical resection. Study SchemaRegistrationCryoablation6 MonthsSemiannualAnnualResectionAge 50+, tumor size ≤ 1.5 cm, unifocal, N0, biopsy proven invasive breast cancerFollowed by endocrine therapy (all patients); WBRT (Stratum 2); SNBx (optional)MG, US, MRI, needle biopsy; resection of residual cancer or serial follow up if absentUnilateral US or MG X 3 yearsBilateral MG and MRIRecurrent/residual breast or axillary cancer The trial was activated in June 2016. The study is currently open at 6 sites with up to 30 sites planned. A total of 110 eligible subjects will be enrolled in each stratum for total accrual goal of 220. Enrollment is planned over 3 years followed by 5 years of follow-up. Results: The primary endpoint of the study will be to determine the rate of complete tumor ablation in patients treated with cryoablation, defined as absence of residual viable carcinoma detected by core needle biopsy of the ablation site performed 6-months post-cryoablation. The secondary endpoint will be to determine the 5-year ipsilateral breast tumor recurrence rate in patients treated with cryoablation without subsequent resection. Local recurrence will be defined as recurrence of cancer within the index quadrant confirmed histologically by needle biopsy. Breast cosmesis (assessed by BCCT.core) and adverse events will also be evaluated. Conclusions: If the FROST Trial is successful at achieving complete ablation in ≥ 80% of study subjects, the trial will provide an important foundation for establishing cryoablation as an alternative to conventional therapy in selected women with early stage invasive breast cancer. If interested, please contact Pam Ellis, clinical coordinator, at (925)460-6080 or pellis@sanarus.com. Citation Format: Coronado GM, Ho ET, Holmes DR. Freezing instead of resection of small breast tumors (FROST): A study of cryoablation in the management of early stage breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT2-01-04.

Implementing complete mesocolic excision for colon cancer - mission completed?

The definition of complete mesocolic excision (CME) for colon carcinomas revolutionized the way of colon surgery. This technique conquered the world starting from Erlangen. Nevertheless, currently new developments especially in minimally invasive surgery challenge CME to become settled as a standard of care. To understand the evolution of CME, anatomical details occurring during embryogenesis and their variations have to be considered. This knowledge is indispensable to transfer CME from an open to a minimally invasive setting. Conventional surgery for colon cancer (non-CME) has a morbidity of 12.1–28.5% and a 3.7% mortality risk vs. 12–36.4% morbidity and 2.1–3% mortality for open CME. The morbidity of laparoscopic CME is between 4 and 31% with a mortality of 0.5–0.9%. In robotic assisted surgery, morbidity between 10 and 25% with a mortality of 1% was published. The cancer-related survival after 3 and 5 years for open CME is respectively 91.3–95% and 90% vs. 87% and 74% for non-CME. For laparoscopic CME the 3- and 5-year cancer-related survival is 87.8–97% and 79.5–80.2%. In stage UICC III the 3- and 5-year cancer-related survival is 83.9% and 80.8% in the Erlangen data of open technique vs. 75.4% and 65.5–71.7% for laparoscopic surgery. For stage UICC III the 3- and 5-year local tumor recurrence is 3.8%. The published data and the results from Erlangen demonstrate that CME is safe in experienced hands with no increased morbidity. It offers an obvious survival benefit for the patients which can be achieved solely by surgery. Teaching programs are needed for minimally invasive CME to facilitate this technique in the same quality compared to open surgery. Passing these challenges CME will become the standard of care for patients with colon carcinomas offering all benefits of minimally invasive surgery and oncological outcome.

Outcomes by molecular subtype after accelerated partial breast irradiation using single-entry catheters

PurposeTumor biology is being recognized as an important indicator of prognosis and risk of locoregional recurrence. Here, we determine actuarial recurrence rates by approximated molecular subtype for women treated with single-entry catheter accelerated partial breast irradiation (sAPBI). Methods and MaterialsOne thousand four hundred eighty-six women with invasive cancer having known ER, PR, and Her2 status and at least 1-year of followup were treated using MammoSite, Contura, or SAVI sAPBI from 2002 to 2014 at our institution. Actuarial recurrence rates were determined for the following four approximated molecular subtypes using the Kaplan–Meier method: luminal A (n = 1081), luminal B (n = 164), Her2 (n = 123), and triple-negative breast cancer (TNBC; n = 118). ResultsWith a median followup time of 3.3 years (range 1–13.6 years), the 5-year in-breast tumor recurrence rate was 2.6% overall, 2.1% for luminal A, 1.5% for luminal B, 4.9% for Her2, and 5.4% for TNBC. Luminal A and B subtypes, as compared with the more aggressive Her2 and TNBC subtypes combined, demonstrated lower 5-year in-breast tumor recurrence (2.1% vs. 5.1%, p = 0.021). The 5-year regional nodal recurrence rate was 1.4% overall, 1.4% for luminal A, 0% for luminal B, 1% for Her2, and 4.2% for TNBC. The 5-year locoregional control is 97.3% for luminal breast cancers and 93.8% for the more aggressive Her2 and TNBC subtypes collectively. ConclusionsLuminal cancers demonstrated excellent 5-year locoregional control with sAPBI. Although caution should be used when treating patients with the more aggressive Her2 and TNBC subtypes, these subtypes have demonstrated higher LRR with mastectomy and whole-breast irradiation. Further randomized comparisons are needed to determine the optimal treatment for these higher risk patients.

Comparison of the effect of spinal anesthesia and general anesthesia on 5-year tumor recurrence rates after transurethral resection of bladder tumors.

Non-muscle invasive bladder tumors are early-stage tumors with high recurrence rates. Transurethral resection of bladder tumor (TURB) is performed under spinal or general anesthesia; however, the effect of the two anesthetic techniques on non-muscle invasive bladder tumor recurrence is unknown. Thus, we compared their effects on tumor recurrence rates five years after TURB. Data from 876 patients who underwent TURB from 2000 to 2007 was reviewed. Patients received spinal or general anesthesia based on their choice or the clinician's preference. Tumor recurrence five years after TURB was assessed using multivariate Cox regression model, propensity score analysis (matching and inverse probability of treatment weighting), and Kaplan–Meier method. The five-year tumor recurrence rate after TURB was 42% and 53% for spinal and general anesthesia groups, respectively (P = 0.013). Hazard ratios for tumor recurrence in the spinal anesthesia group compared to that in the general anesthesia group were 0.619 (P <0.001), 0.642 (P = 0.001), and 0.636 (P <0.001) in the Cox regression model, Cox regression model with propensity score matching, and adjusted analysis with inverse probability of treatment weighting, respectively. The five-year tumor recurrence rate was significantly lower in the spinal anesthesia group than in the general anesthesia group in both the unadjusted (P = 0.002) and adjusted Kaplan–Meier curves (P <0.001). Therefore, spinal anesthesia for non-muscle invasive bladder tumor resection was associated with a lower five-year tumor recurrence rate than general anesthesia. This finding provides useful information for an appropriate selection of anesthetic technique for TURB.

Prognostic effect of transarterial chemoembolization-induced complete pathological response in patients undergoing liver resection and transplantation for hepatocellular carcinoma.

Transarterial chemoembolization (TACE)-induced complete pathological response (CPR) is known to improve postresection outcomes of hepatocellular carcinoma (HCC). We aimed to assess the prognostic effects of CPR after preoperative TACE for HCC in patients who underwent hepatic resection (HR) or liver transplantation (LT). The clinical outcomes of patients showing CPR after HR (n = 110) or LT (n = 233) were analyzed. The control groups comprised patients with minimal recurrence risk as naïve single HCC ≤ 2 cm for HR (n = 476), and 1 or 2 HCCs ≤ 2 cm for LT (n = 184). Among HR study patients, 1-, 3-, and 5-year tumor recurrence rates were 18.5%, 50.6%, and 58.7% respectively, which were higher than those of controls (P < 0.001). The 1-, 3-, and 5-year patient survival rates were 97.8%, 82.0%, and 69.1%, respectively, which were lower than those of controls (P < 0.001). Among LT study patients, 1-, 3-, and 5-year tumor recurrence rates were 4.1%, 7.9%, and 7.9%, respectively, which were higher than those of controls (P = 0.019). The 1-, 3-, and 5-year patient survival rates were 92.7%, 89.2%, and 86.9%, respectively, which were not different than those of controls (P = 0.11). LT recipients had lower recurrence and higher survival rates compared with HR patients (P < 0.001). The tumor recurrence site was mainly intrahepatic in HR patients. There was no difference between the incidences of extrahepatic recurrence in the HR study group and all-site recurrence in the LT study group (P = 0.61). We concluded that the prognostic effect of TACE-induced CPR for HCC patients appears to be limited to downstaging. LT recipients benefited more from CPR than HR patients. Liver Transplantation 23 781-790 2017 AASLD.

Omitting re-excision for focally positive margins after breast-conserving surgery does not impair disease-free and overall survival

PurposeIn contrast to other countries, the Dutch breast cancer guideline does not recommend re-excision for focally positive margins after breast-conserving surgery (BCS) in invasive tumor and does recommend whole-breast irradiation including boost. We investigated whether omitting re-excision as compared to performing re-excision affects prognosis with a retrospective population-based cohort study.MethodsThe total cohort included 32,119 women with primary BCS for T1–T3 breast cancer diagnosed between 2003 and 2008 from the nationwide Netherlands cancer registry. The subcohort included 10,433 patients in whom the resection margins were registered. Outcome measures were 5-year ipsilateral breast tumor recurrence (IBTR) rate, 5-year disease-free survival (DFS) rate, and 10-year overall survival (OS) rate.ResultsIn the total cohort, 25,878 (80.6%) did not have re-excision, 2368 (7.4%) had re-excision by BCS, and 3873 (12.1%) had re-excision by mastectomy. Five-year IBTR rates were 2.1, 2.8, and 2.9%, respectively (p = 0.001). In the subcohort, 7820 (75.0%) had negative margins without re-excision, 492 (4.7%) had focally positive margins without re-excision, 586 (5.6%) had focally positive margins and underwent re-excision, and 1535 (14.7%) had extensively positive margins and underwent re-excision. Five-year IBTR rate was 2.3, 2.9, 1.1, and 2.9%, respectively (p = 0.099). Compared to omitting re-excision, performing re-excision for focally positive margins was associated with lower risk of IBTR (adjusted HR 0.30, 95% CI 0.11–0.82), but not with DFS (adjusted HR 0.83 95% CI 0.59–1.17) nor with OS (adjusted HR 1.17 95% CI 0.87–1.59).ConclusionOmitting re-excision in breast cancer patients for focally positive margins after BCS does not impair DFS and OS, provided that whole-breast irradiation including boost is given.

Prognosis of Intrahepatic Cholangiocarcinomas with HBV Infection is Better than Those with Hepatolithiasis After R0 Liver Resection: A Propensity Score Matching Analysis.

The impact of different causative factors of intrahepatic cholangiocarcinoma (ICC) on disease outcome remains largely unknown. This study aimed to evaluate the prognosis of ICC patients with different pathogenic factors after hepatectomy. Data of 731 consecutive patients undergoing R0 liver resection for ICC at The Eastern Hepatobiliary Surgery Hospital between 2004 and 2010 were analyzed. These patients were divided into the hepatitis B virus-related (HBV-ICC, n=519), hepatolithiasis-related (stone-ICC, n=87), HBV plus hepatolithiasis-related (HBV/stone-ICC, n=45), and other etiologies-related (other-ICC, n=80) ICC groups. Propensity score matching (PSM) was used to eliminate the baseline differences between these groups. In these four groups, the 5-year tumor recurrence and overall survival (OS) rates were 75.4, 90.3, 83.0 and 81.9%, and 32.7, 16.3, 17.7 and 22.6%, respectively. The significant differences in recurrence and OS were identified between the HBV- and stone-ICC groups (both p<0.001). In these two groups, most of the independent prognostic predictors were similar, but tumor diameter >5cm was demonstrated as a risk factor in the HBV-ICC patients only, and surgical margin <1cm and human epidermal growth factor receptor 2-positive were demonstrated as risk factors in the stone-ICC patients only. With PSM, 75 patients in each of the HBV- and stone-ICC cohorts were created, and the 5-year recurrence and OS rates were 69.9 versus 88.6, and 34.6 versus 19.2%, respectively (p=0.017, 0.027). Patients with HBV-ICC achieved better outcomes than those with stone-ICC. This prognostic difference was probably associated with biological malignant invasiveness rather than tumor stage.

Natural course and prognosis of anaplastic gangliogliomas: a multicenter retrospective study of 43 cases from the French Brain Tumor Database.

Anaplastic gangliogliomas (GGGs) are rare tumors whose natural history is poorly documented. We aimed to define their clinical and imaging features and to identify prognostic factors. Consecutive cases of anaplastic GGGs in adults prospectively entered into the French Brain Tumor Database between March 2004 and April 2014 were screened. After diagnosis was confirmed by pathological review, clinical, imaging, therapeutic, and outcome data were collected retrospectively. Forty-three patients with anaplastic GGG (median age, 49.4 y) from 18 centers were included. Presenting symptoms were neurological deficit (37.2%), epileptic seizure (37.2%), or increased intracranial pressure (25.6%). Typical imaging findings were unifocal location (94.7%), contrast enhancement (88.1%), central necrosis (43.2%), and mass effect (47.6%). Therapeutic strategy included surgical resection (95.3%), adjuvant radiochemotherapy (48.8%), or radiotherapy alone (27.9%). Median progression-free survival (PFS) and overall survival (OS) were 8.0 and 24.7 months, respectively. Three- and 5-year tumor recurrence rates were 69% and 100%, respectively. The 5-year survival rate was 24.9%. Considering unadjusted significant prognostic factors, tumor midline crossing and frontal location were associated with shorter OS. Temporal and parietal locations were associated with longer and shorter PFS, respectively. None of these factors remained statistically significant in multivariate analysis. We report a large series providing clinical, imaging, therapeutic, and prognostic features of adult patients treated for an intracerebral anaplastic GGG. Our results show that pathological diagnosis is difficult, that survivals are only slightly better than for glioblastomas, and that complete surgical resection followed with adjuvant chemoradiotherapy offers longer survival.

Abstract 3410: Downregulation of let 7a 5p predicts lymph node metastasis and prognosis in colorectal cancer: implications for chemotherapy

Abstract Background. Colorectal cancer guidelines recommend adjuvant chemotherapy is based on the number of lymph nodes metastasis. Let-7a-5p is a microRNA which could inhibits migration, invasion and epithelial-mesenchymal transition by targeting HMGA2. The aim of this study was to investigate the role of let-7a-5p in clinical impact of colorectal cancer (CRC). Methods. One hundred ninety-two CRC patients were enrolled. The expression of let-7a-5p and HMGA2 in serums and tumor tissues were analyzed by real-time PCR and immunohistochemistry. Univariate (Kaplan-Meier) analysis was used to analyze primary outcomes included 5-year overall survival and tumor recurrence. Results. The expression of let-7a-5p in tumor tissues was significantly negative correlated with tumor size, stage, and lymph node metastasis in CRC patients (p = 0.024 for tumor size, p = &amp;lt;0.0001 for stage, and p&amp;lt;0.0001 for lymph node metastasis). There was a negative correlation between levels of let-7a-5p and the HMGA2 gene (p &amp;lt;0.0001), especially in CRC patients with wildtype APC gene. Patients with let-7a-5p low / HMGA2 high had poorer overall survival (OS) and disease-free survival (DFS) rates than those with let-7a-5p high / HMGA2 high, let-7a-5p high / HMGA2 low, and let-7a-5p low /HMGA2 low groups. In addition, the expression levels of let-7a-5p in PBMCs were positive correlated with in tumor tissues of CRC patients. Conclusion. We suggest that down-regulation of let-7a-5p in PBMCs and tumor tissues patients could be used to predicts lymph node metastasis and prognosis impact on chemotherapy of colorectal cancer Citation Format: Ya-Wen Cheng, Tsang-Pai Liu, Po-Li Wei, Huei Lee. Downregulation of let 7a 5p predicts lymph node metastasis and prognosis in colorectal cancer: implications for chemotherapy. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 3410.

PD11-04 TRANSURETHRAL ENDOSCOPIC SUBMUCOSAL EN BLOT DISSECTION FOR NON-MUSCLE INVASIVE BLADDER TUMOR: A PROSPECTIVE COMPARISON STUDY OF HYBRIDKNIFE ASSISTED VERSUS CONVENTIONAL DISSECTION TECHNIQUE

INTRODUCTION AND OBJECTIVES: Endoscopic submucosal dissection (ESD), an emerging new technology, had been reported to safely, effectively and en blot dissection method for gastrointestinal epithelial tumors treatment, which maybe a better en blot desection approach for NMIBC treatment. The present study is to compare the efficacy and safety of bladder tumor-endoscopic submucosal dissection (BT-ESD) and conventional transurethral resection of bladder cancer (TURBT) in patients with non-muscle invasive bladder tumor (NMIBC). METHODS: A prospective trial was carried out in Shaanxi Provincial People’s Hospital (Shaanxi, China), 75 patients eligible suspicious NMIBC, between November 2013 and Oct 2014, were constructively enrolled in and randomized to use of either the BT-ESD (ESD Group, 38 cases) or the TURBT treatment (TURBT group, 37 cases). The operation time, blood loss, postoperative bladder irrigation time, catheter indwelling time, hospital stay, complications and 1-year tumor recurrence rate were compared between 2 groups. RESULTS: A total of 75 patients with comparable characteristics between groups were included. The ESD group showed increased average operation time than TURBT group (30.2 9.2 min v.s 15.08 6.1 min, p< 0.05), respectively, no significant difference were found in the smaller tumor (0-2cm). The postoperative bladder irrigation time, catheter indwelling time and hospital stay in BT-ESD group were significantly shorter than TURBT group (8.3 2.8h, 2.3 0.9d and 3.0 1.3d for ESD group;16.7 3.6h, 4.8 1.3d and 6.5 1.8d for TURBT group). In addition, the BT-ESD group showed decreased overall incidence of complications (7.9% v.s 18.9%, p<0.05) and 1-year tumor recurrence rate (5.3% v.s 21.6%, p < 0.05). CONCLUSIONS: We conclude that BT-ESD as a novel approach used for NMIBT appears to be a feasibly safe and applicable. Compared with conventional TURBT, BT-ESD applies an en bloc resection technique following the principles of oncologic surgery by using HybirdHnife to facilitate histopathologic assessment more accurate and reach a R0 resection. This is much critical for planning strategy of intravesical instillation, assessing prognosis and determining the protocol of follow-up, with respective potential advantages in decreasing rates of tumor recurrence and progression, and reducing socioeconomic costs. Clearly, BT-ESD appears to benefit the patients and is worth popularizing application in clinic.

Absence of Benefit of Transcatheter Arterial Chemoembolization (TACE) in Patients with Resectable Solitary Hepatocellular Carcinoma

This study aimed to assess the prognostic impact of preoperative transcatheter arterial chemoembolization (TACE) on long-term survival outcomes in patients undergoing resection of small solitary hepatocellular carcinoma (HCC). Enrolled patients had undergone macroscopic curative resection of solitary 2-5 cm HCC with (n = 105) or without (n = 830; control group) preoperative TACE. TACE group was divided into subgroups A (n = 68, 1-2 TACEs within 12 months), B (n = 23, ≥ 3 TACEs within 12 months), and C (n = 14, TACE prior to 12 months). The number of TACE sessions was 1.8 ± 1.6. In TACE A-C subgroups, pathological response of tumor necrosis >50 % at median post-TACE period after final TACE was observed in 41 (60.3 %) at 1.9 months, 10 (43.5 %) at 2.1 months, and 2 (14.3 %) at 18.9 months, respectively. The 5-year tumor recurrence and patient survival rates were 62.8 and 70.4 % in TACE group and 51.4 and 83.4 % in control group, respectively (p ≤ 0.003). Median periods of postoperative tumor recurrence in TACE A-C subgroups and control group were 35, 13, 14, and 55 months, respectively (p < 0.001); and postoperative survival periods at 75 % survival rate were 51, 38, 51, and 98 months, respectively (p = 0.003). TACE-induced extensive tumor necrosis did not improve postoperative prognosis in TACE A subgroup (p ≥ 0.053). Postoperative prognosis after preoperative sequential TACE and portal vein embolization was comparable to that of the control group (p ≥ 0.052). Preoperative TACE for small solitary HCCs may adversely affect post-resection prognosis, irrespective of pathological responses. Preoperative TACE should be avoided for patients with resectable small HCCs.

Perioperative Allogenenic Blood Transfusion is Associated With Worse Clinical Outcome for Patients Undergoing Gastric Carcinoma Surgery: A Meta-Analysis.

Whether perioperative allogenic blood transfusion (ABT) has adverse effect on patients with gastric carcinoma (GC) surgery or not, that is controversial. Our study evaluated the association between ABT and some clinical outcomes of GC surgery patients.Data of relevant studies were based on PubMed, EMBASE, and the Cochrane Library search. The relative risk (RR) of 5-year survival rates, tumor recurrence, and postoperative complications were performed; subgroup analyses included district, transfusion rates, age, participants, sex, and tumor stage.The study was approved by the ethics committee of the First People's Hospital of Shunde.In total, 9189 participants from 16 studies were included in the meta-analysis. The 5-year survival rate was decreased for the GC patients with ABT (RR = 0.74, 95% confidence interval [CI] = 0.69–0.79), the risk of tumor recurrence was significantly higher for ABT patients (RR = 1.82, 95% CI = 1.32–2.51), and postoperative complications increased in ABT patients (RR = 1.36, 95% CI = 1.02–1.81), respectively; in subgroup analyses, 5-year survival rates were not associated with the transfusion rates (χ2 = 0.37, P = 0.54).Transfusion for patients undergoing GC surgery, even low transfusion rates, would reduce the 5-year survival rates, and elevated the risk of tumor recurrence and postoperative complication.

Efficacy of three dimensional visualization technique assisted hepatectomy for the treatment of primary liver cancer

To study the clinical efficacy of three dimensional visualization technique assisted hepatectomy for the treatment of primary liver cancer. A total of 108 primary liver cancer patients who had been admitted to Zhujiang Hospital of Southern Medical University from September 2013 to December 2014 were assigned to three dimensional visualization technique assisted hepatectomy group (n = 55) and routine hepatectomy group (n = 53) according to different methods of hepatectomy. The observed variable in two groups as fellow: the operative time, intraoperative blood loss, intraoperative blood transfusion, the change of postoperative liver function and biochemical indicators in 1, 3, 5 days, postoperative complication. The patients were followed up via-return visit or telephone.A student's t test was used to compare continuous parametric variables, and the Mann-Whitney U test was used to compare non-parametric or discrete variables, as appropriate. Categorical data were compared using the Chi-square test or Fisher's exact test. In 3D group and routine hepatectomy group, the patients' intraoperative blood transfusion volume were 300 ml (200-600 ml) and 400 ml (300-700 ml) (χ² = -2.609, P = 0.009) respectively, intraoperative blood loss volume were 400 ml (250-600 ml) and 550 ml (400-800 ml) (χ² = -2.277, P = 0.023), the operative time were (247 ± 57) min and (262 ± 53) min (χ² = -1.787, P = 0.074), the deterioration of the mainly liver function indicators peak in routine hepatectomy group were higher than that in 3D group (P < 0.05). The ALT, AST, TBIL in 3D group were lower than that in routine group on postoperative day 1, 3, 5, respectively (χ² = -5.740- -0.692, all P < 0.05). The ALB in 3D group was higher than that in routine group on postoperative day 3, 5 ((33.0 ± 5.6) g/L vs. (31.2 ± 4.1) g/L, (36.7 ± 4.4) g/L vs. (34.7 ± 4.2) g/L) (t = 1.922-2.573, both P < 0.05). In 3D group and routine hepatectomy group, the incidence of postoperative complications were 10.9% and 30.1% (χ² = 6.185, P = 0.013), the length of postoperative hospital day were (12.6 ± 3.6) days and (14.4 ± 3.5) days (χ² = -3.384, P = 0.031), the positive rate of resection margin were 0 and 9.4% respectively (Fisher test: P = 0.026), the 1-year tumor recurrence rate were 22.2% and 37.5% (P > 0.05), 1-year survival rate was 82.2% and 77.5% (P > 0.05). No perioperative mortality was occured in the two groups. Three dimensional visualization technique assisted hepatectomy for the treatment of primary liver cancer could reduce surgical injury, lower the rate of postoperative complications, improve the safety and the efficacy of the operation and achieve a good prognosis.