Adjuvant concurrent chemoradiotherapy in extrahepatic cholangiocarcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4583-4583
Author(s):  
Walid Labib Shaib ◽  
Katerina Mary Zakka ◽  
Feng Tian ◽  
Zhengjia Chen ◽  
Pretesh R. Patel ◽  
...  

4583 Background: Resected cholangiocarcinomas are rare and have high relapse rates. Adjuvant chemotherapy is the standard of care (BiLCAP Trial). Adjuvant radiation therapy benefit is not well defined. This study aims to evaluate survival outcomes of the effect of adjuvant chemoradiotherapy compared to chemotherapy in extrahepatic cholangiocarcinoma (EHC) using the National Cancer Database (NCDB). Methods: Patients with resected EHC between 2004 and 2013 were identified from the NCDB using ICD-O-3 histology and topography codes: 8140, 8160, 8161, 8162 and C24.0. Patients with neoadjuvant therapy were excluded from this analysis. Univariate and multivariable analyses were conducted, and Kaplan-Meier Curves were used to compare overall survival (OS) based on treatment received. Results: A total of 236 EHC patients were identified. Males comprised 60.6% and 88.1% were Caucasian. Median age was 64 (range, 31-84) years. The majority were distal (72.0%, N = 157) followed by perihilar (20.6%, N = 45), hilar (6.4%, N = 14) and cystic (0.9%, N = 2). Distribution across stages I-III was 28.8% (N = 68), 56.8% (N = 134), and 14.4% (N = 34), consecutively. Adjuvant chemotherapy was given in 37.7% (N = 89) and adjuvant chemoradiotherapy in 62.3% (N = 147). The median dose of radiation was 50.4 Gy. Adjuvant chemoradiotherapy was mostly given in regional node positive disease (p = 0.016) and negative surgical margin (p = 0.002) compared to regional node negative disease and positive surgical margin, respectively. The use of adjuvant chemoradiotherapy was associated with improved OS compared to chemotherapy alone in univariate (HR 0.64; 95% CI 0.44-0.93; p = 0.019) and multivariable analysis (HR 0.65; 95% CI 0.44-0.96; p = 0.030). Median survival and 1 year-OS for patients that received chemoradiotherapy was 33.8 months (95% CI 28, NA) and 87.7% (80.9%, 92.1%) compared to chemotherapy alone which was 23.8 months (95% CI 18.9, 35.4) and 75.5% (64.9%, 83.3%). Conclusions: Adjuvant chemoradiotherapy was associated with improved survival in patients with resected EHC compared to chemotherapy alone. This conclusion warrants further prospective studies to confirm these results.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 330-330
Author(s):  
Aryavarta M. S. Kumar ◽  
Gavin Falk ◽  
Kevin L. Stephans ◽  
Matthew Walsh ◽  
Robert James Pelley ◽  
...  

330 Background: While surgery remains the only potential curative option for resectable pancreatic cancer, adjuvant therapy improves outcomes over surgery alone; however, adjuvant recommendations of chemotherapy vs chemoradiation remain controversial. We present outcomes comparing the two adjuvant treatments. Methods: In our single institution review, 343 patients (2000-2012) had pancreatoduodenectomy for pancreatic cancer. Medical oncology made adjuvant recommendations. Chemotherapy was gemcitabine or 5-FU and radiotherapy prescription was 45-54 Gy. Locoregional recurrences (LRR) were operative bed or regional nodal failures. Results: Median follow up and median survival (MS) for all patients was 17.5 and 19.5 mo respectively. 130 patients had resection alone (A), 84 had adjuvant chemotherapy (B), and 129 had adjuvant chemoradiation (C). MS for groups A, B, and C were 13, 23 and 26 mo respectively. Locoregional recurrence (LRR) was 60%, 63%, and 38% and distant failure was 64%, 65%, and 66% for groups A, B, and C respectively. Group C had significantly lower LRR compared to group B (p=0.01) however, survival between groups B and C was not statistically significant (p=0.23). Angiolymphatic invasion (ALI) and perineural invasion were correlated with LRR (p<0.01). Multivariable analysis showed LRR, laparoscopy, ALI, and the interaction term of LRR with surgical margin were significant predictors of survival (p<0.05). MS of patients with lymph node ratio (LNR) > 0.2 and LNR ≤ 0.2 was 18 and 27 mo respectively. Subgroup analysis showed survival advantages to adjuvant chemoradiation compared with adjuvant chemotherapy. R1 resections in groups B and C were 37% and 39% (p=ns) with MS of 16 vs 27 mo respectively (p=0.01). For patients with ≥ 8 LN dissected and LNR ≤ 0.2, MS was 24 vs 32 mo for groups B and C respectively (p=0.04). Conclusions: Adjuvant chemoradiation significantly decreases LRR in resected pancreatic cancer patients. Compared to adjuvant chemotherapy alone, adjuvant chemoradiation improved survival for patients with a 1) positive surgical margin and/or 2) LNR ≤ 0.2 with ≥ 8 LNs dissected.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16504-e16504
Author(s):  
Akshay G Reddy ◽  
Andrew D Sparks ◽  
Michael Joseph Whalen

e16504 Background: Given the rarity of bladder adenocarcinoma, there is a paucity of data examining the role of adjuvant chemotherapy (AC) in patients with regional lymph node positivity. This study aims to elucidate the oncologic and survival outcomes of patients with node-positive disease treated with or without AC. Methods: A retrospective cohort analysis of patients with node-positive primary bladder adenocarcinoma who had either received AC or did not receive AC after either radical (RC) or partial cystectomy (PC) was performed using the National Cancer Database from 2006 to 2016. Non-metastatic node-positive was defined as pT(any)N1-3 (pN+) disease. Demographic and clinicopathological variables were compared to adjust for confounding covariates in multivariable analysis to determine appropriate oncologic and surgical outcomes. Results: A total of 106 patients met inclusion criteria, of whom 38 received AC and 68 did not. Receipt of AC was significantly associated with improved survival relative to those who did not receive AC (overall survival: 29% vs 2.7%; adjusted hazards ratio = 0.43; p = 0.003) independent of extent of surgery. There was a trend toward higher receipt of adjuvant radiation along with AC, independent of surgical margin status. Receipt of AC additionally trended towards a significant association with decreased odds of 90-day mortality and 30-day unplanned readmission (Table). Conclusions: Based on the improved survival outcomes, positive nodal status may be a useful indicator of those who may benefit from AC, and potentially adjuvant radiation therapy, in bladder adenocarcinoma. Though compelling, larger studies will be required to make more conclusive statements regarding the most appropriate treatment course in these patients.[Table: see text]


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ching-Wei Yang ◽  
Hsiao-Hsien Wang ◽  
Mohamed Fayez Hassouna ◽  
Manish Chand ◽  
William J. S. Huang ◽  
...  

AbstractThe positive surgical margin (PSM) and biochemical recurrence (BCR) are two main factors associated with poor oncotherapeutic outcomes after prostatectomy. This is an Asian population study based on a single-surgeon experience to deeply investigate the predictors for PSM and BCR. We retrospectively included 419 robot-assisted radical prostatectomy cases. The number of PSM cases was 126 (30.1%), stratified as 22 (12.2%) in stage T2 and 103 (43.6%) in stage T3. Preoperative prostate-specific antigen (PSA) > 10 ng/mL (p = 0.047; odds ratio [OR] 1.712), intraoperative blood loss > 200 mL (p = 0.006; OR 4.01), and postoperative pT3 stage (p < 0.001; OR 6.901) were three independent predictors for PSM while PSA > 10 ng/mL (p < 0.015; hazard ratio [HR] 1.8), pT3 stage (p = 0.012; HR 2.264), International Society of Urological Pathology (ISUP) grade > 3 (p = 0.02; HR 1.964), and PSM (p = 0.027; HR 1.725) were four significant predictors for BCR in multivariable analysis. PSMs occurred mostly in the posterolateral regions (73.8%) which were associated with nerve-sparing procedures (p = 0.012) while apical PSMs were correlated intraoperative bleeding (p < 0.001). A high ratio of pT3 stage after RARP in our Asian population-based might surpass the influence of PSM on BCR. PSM was less significant than PSA and ISUP grade for predicting PSA recurrence in pT3 disease. Among PSM cases, unifocal and multifocal positive margins had a similar ratio of the BCR rate (p = 0.172) but ISUP grade > 3 (p = 0.002; HR 2.689) was a significant BCR predictor. These results indicate that PSA and pathological status are key factors influencing PSM and BCR.


BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e021341
Author(s):  
Cheng-I Hsieh ◽  
Raymond Nien-Chen Kuo ◽  
Chun-Chieh Liang ◽  
Hsin-Yun Tsai ◽  
Kuo-Piao Chung

ObjectivesOne feature unique to the Taiwanese healthcare system is the ability of physicians other than oncologists to prescribe systemic chemotherapy. This study investigated whether the care paths implemented by oncologists and non-oncologists differ with regard to patient outcomes.SettingData from the Taiwan Cancer Registry and National Health Insurance Database were linked to identify patients with colon cancer who underwent colectomy as first treatment within 3 months of diagnosis and adjuvant chemotherapy between 2005 and 2009.Participants and methodsPostoperative patients who underwent adjuvant chemotherapy were included in this study. The exclusion criteria included patients with stage IV disease, a positive surgical margin and early disease recurrence. Among the patients presenting with multiple primary cancers, we also excluded patients who were diagnosed with colon cancer but for whom this was not the first primary cancer. The variables included sex, age, comorbidities, disease stage, chemotherapy cycle and changes in treatment regimen as well as the specialty of treatment providers and their case volume. Cox regression models and Kaplan-Meier analysis were used to examine differences in outcomes in the matched cohorts.ResultsWe examined 3534 patients who were prescribed adjuvant chemotherapy by physicians from different disciplines. In terms of 5-year disease-free survival, no significant difference was observed between the groups of oncologists or surgeons among patients with stage II (90.02%vs88.99%) or stage III (77.64%vs79.99%) diseases. Patients who were subjected to changes in their chemotherapy regimens presented recurrence rates higher than those who were not.ConclusionsThe discipline of practitioners is seldom taken into account in most series. This is the first study to provide empirical evidence demonstrating that the outcomes of patients with colon cancer do not depend on the treatment path, as long as the selection criteria for adjuvant chemotherapy is appropriate. Further study will be required before making any further conclusions.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS228-TPS228 ◽  
Author(s):  
Se Hoon Park ◽  
Su Jin Lee ◽  
Seung Tae Kim ◽  
Jeeyun Lee ◽  
Joon Oh Park ◽  
...  

TPS228 Background: Treatment of gastric cancer (GC) has some notable differences between Asia and Western countries including the extent of surgery and the type of adjuvant therapy. In ARTIST trial comparing adjuvant chemotherapy involving capecitabine plus cisplatin with chemoradiotherapy, we reported comparable disease-free survival (DFS) in Korean patients with D2-resected GC. In subset analyses, patients with node-positive disease and intestinal type GC may have benefit with the addition of radiotherapy to adjuvant chemotherapy. Methods: ARTIST 2 (ClinicalTrials.gov, NCT0176146) is a 3-arm, multi-center, open-label phase III trial comparing adjuvant chemotherapy involving S-1 (40 mg/m2 bid 4-weeks-on/2-weeks-off) for one year (arm A) with S-1 plus oxaliplatin (SOX, S-1 40 mg/m2 bid 2-weeks-on/1-week-off plus oxaliplatin 130 mg/m2 iv on day 1) for 8 cycles (arm B) and chemoradiotherapy (arm C). Arm C patients receive SOX for 2 cycles, then concurrent chemoradiotherapy 45 Gy with S-1 40 mg bid daily, followed by additional SOX for 4 more cycles. Patients are randomized 1:1:1 with 3 strata: stage (II or III), type of surgery (subtotal or total gastrectomy) and Lauren classification (diffuse or intestinal type). Eligibility criteria include gastric or gastro-esophageal junction adenocarcinoma, D2 or higher surgery with no residual disease, pathologic stages 2 or 3, lymph node positive disease. Primary endpoint is DFS, and secondary endpoints include overall survival, safety, QOL and molecular biomarkers. To test if experimental arms (arm B or C) lower the hazard of recurrence by 50% (i.e., HR 1.5) compared to arm A, we need 900 patients (300 per arm) with 90% of overall statistical power. First patient entered onto the study in Feb 2013. As of Aug 2014, a total of 118 (13% of target) patients were recruited by 8 Korean tertiary centers. Clinical trial information: NCT0176146.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 80-80
Author(s):  
Arjun Sivaraman ◽  
Rafael Sanchez-Salas ◽  
Dominic Prapotnich ◽  
Kaixin Yu ◽  
Fabien Olivier ◽  
...  

80 Background: To evaluate the learning curve of Minimally Invasive Radical Prostatectomy (MIRP) in our institution and apply the cumulative summation (CUSUM) analytical technique to identify salient learning curve transition points in terms of oncological outcomes. Methods: Clinical, pathologic, and oncological outcome data were collected from our prospectively collected MIRP database to estimate Positive Surgical margin (PSM) and Biochemical Recurrence (BCR) trends during a 15 year period from 1998 to 2013. All the RPs (laparoscopic (LRP) / Robotic Assisted [RARP]) were performed by 9 surgeons. PSM was defined as presence of cancer cells at inked margins. BCR was defined as serum Prostate Specific Antigen (PSA) >0.2 ng/ml and rising or start of secondary therapy. Surgical learning curve was assessed with the application of Kaplan-Meier curves, Cox regression model, CUSUM and logistic model in order to define the “transition point” of surgical improvement. Results: We identified 5,547 patients with localized prostate cancer treated with MIRP (3,846 - LRP and 1,701 – RARP). Patient characteristics of LRP and RARP were similar. The overall risk of PSM in LRP was 25%, 20% and 17% for the first 50, 50 to 350 and >350 cases, respectively. For the same population, the 5-year BCR rate decreased from 21.5% to 16.7%. RARP started 3 years after the LRP program (after approximately 250 LRP). The PSM rate for RARP decreased from 21.8% to 20.4% and the corresponding 5-year BCR rate decreased from 17.6% to 7.9%. The CUSUM analysis showed significantly lower PSM and BCR at 2 years occurred at the transition point of 350 cases for LRP and 100 cases for RARP. In multivariable analysis, predictors of BCR were PSA, Gleason score, extra prostatic disease, seminal vesicle invasion and number of operations (p < 0.05). Patients harboring PSM showed higher BCR risk (23% vs. 8%, p < 0.05). Conclusions: Learning curve trends of MIRP in our large, single center experience showed significant reduction in PSM and BCR risk at 2 years are noted after the initial 350 cases and 100 cases of LRP and RARP, respectively.


2000 ◽  
pp. 1178-1182 ◽  
Author(s):  
BRADLEY C. LEIBOVICH ◽  
DONALD E. ENGEN ◽  
DAVID E. PATTERSON ◽  
THOMAS M. PISANSKY ◽  
ERIK E. ALEXANDER ◽  
...  

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 796-796
Author(s):  
Katerina Mary Zakka ◽  
Shayla Williamson ◽  
Renjian Jiang ◽  
Olatunji B. Alese ◽  
Walid Labib Shaib ◽  
...  

796 Background: Goblet cell tumors (GCT) of the appendix are very rare tumors constituting 2.5%-5% of all primary appendiceal neoplasms. Role of adjuvant chemotherapy (AC) is not established for GCT. This study aims to evaluate the impact of AC in stage II-III appendiceal GCT. Methods: Patients with pathological stage II and III GCT who underwent surgical resection between 2006 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8243/3, 8245/3 and C18.1. Patients treated with neoadjuvant systemic and/or radiation therapy and adjuvant radiation were excluded. Univariate and multivariable analyses were conducted, and Kaplan-Meier Curves were used to compare overall survival (OS) based on treatment received with Log-rank test. Results: A total of 1,046 patients were identified. 53.7% males and 89.0% Caucasian; median age 56 (range, 20-90) years. Distribution across pathological stages II-III was 83.6% (N = 874) and 16.4% (N = 172) consecutively. 8.3% (N = 73) of stage II and 50.6% (N = 87) of stage III patients received AC. In the total cohort, AC was not associated with better OS compared to no AC in univariate analysis (HR 1.84; 95% CI 1.26-2.67; p = 0.001) or multivariable analysis (HR 0.94; 95% CI 0.57-1.52; p = 0.790). For stage II patients, AC was not associated with better OS in univariate (HR 1.24; 95% CI 0.60-2.57; p = 0.562) or multivariable analyses (HR 1.67; 95% CI 0.76-3.64; p = 0.199). Similarly, in stage III patients, AC was not associated with better OS in univariate (HR 0.78; 95% CI 0.48-1.29; p = 0.340) or multivariable analyses (HR 0.55; 95% CI 0.28-1.04; p = 0.067). In the entire cohort 5-year OS for patients that received AC was 83.9% (80.3%, 86.9%) versus 70.7% (60.9%, 78.5%) (p = 0.001) with no AC. For stage II patients, 5-year OS was 77.3% with AC vs. 87.7% with no AC (p = 0.562). For stage III patients, 5-year OS was 64.8% with AC vs. 54.4% with no AC (p = 0.340). Conclusions: AC was not associated with improved 5-year OS in patients with pathological stage II and III GCT compared to no AC.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 455-455
Author(s):  
Amir A. Rahnemai-Azar ◽  
Sean Ronnekleiv-Kelly ◽  
Daniel Abbott ◽  
Cecilia Grace Ethun ◽  
George A. Poultsides ◽  
...  

455 Background: Surgical resection is required for curative treatment of patients with extra-hepatic cholangiocarcinoma (EH-CCA). The objective of this study was to determine if the distance of surgical margin was associated with outcome. Methods: Patients who underwent curative-intent resection for EH-CCA between 2000 and 2015 at 10 hepatobiliary centers across the U.S. were evaluated using prospectively collected data. Cox proportional hazard model was utilized to evaluate the influence of the extent of the margin on outcome. Results: 538 patients with EH-CCA who underwent curative-intent resection were included: 383 (71%) undergoing R0 resection, 153 (28%) undergoing R1 resection, and 2 with R2 resection. A negative surgical margin (R0) was associated with improved recurrence-free (RFS) and overall survival (OS) (RFS: 10.5% vs. 3.6% (R1) and OS: 25.8% vs. 9.3% (R1). Subsequently, further analysis on 161 patients with complete data on distance of resection margin, all undergoing R0 resection, was performed to assess the impact of extent of margin on outcome. On multi-variable analysis, the resection margin distance, analyzed as a continuous variable, was not associated with either improved RFS (RR 1.00, 95% CI 0.96-1.05; p 0.71) or OS (RR 0.99, 95% CI 0.96-1.01; p 0.49). Increasing age, increased tumor size, and LN metastasis were identified as independent predictors of OS; while RFS were mainly dependent on tumor size and LN metastasis (Table). Conclusions: Achieving R0 resection is acceptable for EH-CCA tumors, and obtaining additional margin does not confer a benefit on overall survival. Increasing age, tumor size, and LN metastasis are independent predictors of RFS and OS, but increased margin width is not associated with improvement in either. Multivariable analysis of factors affecting OS of patients with extra-hepatic CCA who underwent surgical resection, with significant factors noted in bold. [Table: see text]


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