Analysis of the effect of adjuvant therapy on overall survival for resected gallbladder adenocarcinoma using the National Cancer Database.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 360-360
Author(s):  
David G. Brauer ◽  
Kian-Huat Lim ◽  
Maria Majella Doyle ◽  
William G. Hawkins ◽  
William C. Chapman ◽  
...  

360 Background: The effect of adjuvant chemotherapy on survival after resection for gallbladder adenocarcinoma (GBC) is based on limited evidence. Since prospective trials are not generally practical for GBC, we sought to evaluate current best evidence to evaluate the role of adjuvant chemotherapy in multiple clinical scenarios by analyzing data from the U.S. National Cancer Database (NCDB). Methods: Patients who underwent resection for GBC diagnosed between 2004 and 2012 were identified in the NCDB. The effect of adjuvant therapy on overall survival (OS) was assessed using Kaplan-Meier analysis and Cox proportional hazards regression modeling. Results: 10,402 patients met inclusion criteria. Median follow-up was 14 months. Median survival was 16 months. One- and five-year OS were 57% and 23%, respectively. 3,509 patients (34%) received any modality of adjuvant therapy. Receipt of adjuvant therapy improved one-year OS (63% vs 55%, p < 0.01), but median OS was minimally changed (17 vs 15 months, NS). Adjuvant therapy was associated with improved one-year OS in T3 and T4N1 disease (Table 1). Only chemoradiation therapy was associated with improved one-year OS for T2 disease. Adjuvant chemotherapy was associated with worse one-year OS in T1N0 disease. Conclusions: Using data from the US NCDB, adjuvant therapy for resected gallbladder adenocarcinoma is associated with improved one-year overall survival with the exception of T1N0 disease. In the absence of prospective studies in this rare disease, retrospective data can provide insights into successful treatment strategies and guidelines for GBC. [Table: see text]

2019 ◽  
Vol 104 (12) ◽  
pp. 5948-5956 ◽  
Author(s):  
John F Tierney ◽  
Sitaram V Chivukula ◽  
Jennifer Poirier ◽  
Sam G Pappas ◽  
Erik Schadde ◽  
...  

Abstract Background Adrenocortical carcinoma (ACC) is a rare malignancy with a dismal prognosis. Two landmark trials published in 2007 and 2012 showed efficacy for adjuvant mitotane in resectable ACC and etoposide/doxorubicin/cisplatin plus mitotane for unresectable ACC, respectively. In this study, we used the National Cancer Database to examine whether treatment patterns and outcomes changed after these trials. Methods The National Cancer Database was used to examine treatment patterns and survival in patients diagnosed with ACC from 2006 to 2015. Treatment modalities were compared within that group and with a historical cohort (1985 to 2005). χ2 tests were performed, and Cox proportional hazards models were created. Results From 2006 to 2015, 2752 patients were included; 38% of patients (1042) underwent surgery alone, and 31% (859) underwent surgery with adjuvant therapy. Overall 5-year survival rates for all stages after resection were 43% (median, 41 months) in the contemporary cohort and 39% (median, 32 months) in the historical cohort. After 2007, patients who underwent surgery were more likely to receive adjuvant chemotherapy (P = 0.005), and 5-year survival with adjuvant chemotherapy improved (41% vs 25%; P = 0.02). However, survival did not improve in patients with unresectable tumors after 2011 compared with 2006 to 2011 (P = 0.79). Older age, tumor size ≥10 cm, distant metastases, and positive margins were associated with lower survival after resection (hazard ratio range: 1.39 to 3.09; P < 0.03). Conclusions Since 2007, adjuvant therapy has been used more frequently in patients with resected ACC, and survival for these patients has improved but remains low. More effective systemic therapies for patients with ACC, especially those in advanced stages, are desperately needed.


2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 408-408
Author(s):  
Albert Y. Lin ◽  
Natalia B. Kouzminova ◽  
Jonathan Pollack ◽  
Gerard Nuovo

408 Background: Fluoropyrimidine-based adjuvant chemotherapy is a standard treatment option for patients with high risk II or stage III CRC. It is, however, unclear if a subset of patients will benefit from chemotherapy more than others. MiR21, a small non-coding RNA, has been associated with promotion of tumor cell growth and metastasis. To assess the effect of miR21 on chemotherapy, we analyzed the association of miR21 expression with clinical outcomes and known prognostic factors. Methods: MicroRNA detection was performed by in situ hybridization on a CRC tissue microarray containing specimens from 130 cases (stage I, 21 patients; II: 44; III: 33; IV: 32). MiR21 expression was graded as negative (no staining in all tissue cores), low (0-10% staining), moderate (20-40%) and strong (50-100%), and was analyzed with stage, grade, expression of VEGF, Ki67, LEF1, OPN and MSH2 by immunohistochemistry. Cox proportional hazards regression analysis was performed to assess the association of miR21 expression with 10-year recurrence-free survival in the subgroup of 77 stage II or III patients. Results: In all, miR21 expression had moderate positive correlation with genes associated with tissue proliferation and invasion, including Ki67 (Spearman's r=0.42, p<0.001), VEGF (r=0.32, p<0.001) and OPN (r=0.32, p<0.001), and weak correlation with LEF1 (r=0.22, p=0.012) and MSH 2 (r=0.18, p=0.039). In the subgroup of 36 patients treated with adjuvant therapy, low or negative miR21 expression (≤10%, n=15) was associated with increased recurrence (HR =3.5; p=0.05). In the multivariate Cox regression model including stage, grade and LEF1 expression, the association of low or negative miR21 with cancer recurrence remained significant along with grade and LEF1. Ki67 was excluded from the multivariate model because of significant association with miR21 (r=0.44, p=0.007) in the analyzed group. Conclusions: Our results suggest that low miRNA21 expression is associated with increased risk for recurrence in CRC patients received adjuvant chemotherapy. Further investigation of miR21 in randomized studies is warranted to establish its role as a predictor for CRC in the setting of adjuvant therapy.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 111-111
Author(s):  
Christopher Duane Nevala-Plagemann ◽  
Samual Francis ◽  
Courtney Christine Cavalieri ◽  
Shane Lloyd ◽  
Ignacio Garrido-Laguna

111 Background: Neoadjuvant chemoradiation therapy (CRT) followed by esophagectomy is the current standard of care for patients with locally advanced esophageal cancer. The potential benefit of additional postoperative chemotherapy is still under investigation. In this study, we utilized the National Cancer Database to assess the effect of adjuvant chemotherapy in patients who were found to have node negative disease (pN0) following surgery. Methods: Patients with locally advanced esophageal cancer who received neoadjuvant CRT followed by esophagectomy from 2004 to 2014 were retrospectively identified using the National Cancer Database. Patients who were postoperatively staged as pN0 were then separated based on whether or not they received adjuvant chemotherapy. Using Kaplan-Meier estimation and a multivariate cox regression analysis, the overall survival of those who received adjuvant therapy was then compared to those who received neoadjuvant CRT alone. Results: 3,159 patients with locally advanced esophageal cancer underwent neoadjuvant CRT and were found to be pN0 following surgery. 119 of these patients received postoperative chemotherapy. The 1, 5, and 8-year overall survival in those receiving adjuvant therapy was 95.9%, 49.9%, and 47.7% compared to 85.8%, 44.6%, and 33.0% in those receiving neoadjuvant CRT alone, respectively (p = 0.019). Based on multivariate analysis, receiving adjuvant chemotherapy was independently associated with increased overall survival (p = 0.011; HR 0.658; 95% CI, 0.476 to 0.908). Conclusions: Adjuvant chemotherapy may improve survival in patients with locally advance esophageal cancer who have no evidence of local nodal metastases following surgery. Additional clinical trials are needed to further confirm which patients may benefit from adjuvant therapy and to determine the optimal postoperative therapeutic regimen.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16052-e16052
Author(s):  
Johannes Uhlig ◽  
Michael Cecchini ◽  
Stacey Stein ◽  
Jill Lacy ◽  
Kevin Kim

e16052 Background: To assess microsatellite instability (MSI) and KRAS mutation prevalence, discrepancies and their impact on outcome in AJCC stage IV colorectal adenocarcinoma (colorectal cancer; CRC). Methods: The 2010-2016 United States National Cancer Database was queried for stage IV CRC patients > 18yo and information on MSI and KRAS mutation. Microsatellite status was stratified as stable microsatellites (MSS, including low instability) and microsatellite instability high (MSI-H). KRAS status was stratified as mutation and wildtype. Prevalence and discrepancies were evaluated according to patient demographics, US geography and CRC factors. Overall survival (OS) was assessed using Cox proportional hazards models adjusting for age, gender, race, comorbidities, metastatic burden, CRC treatment, treatment center type, and year of CRC diagnosis. A priori, a statistical interaction test between microsatellite status, KRAS status and primary CRC site was planned. Results: Microsatellite/KRAS status was available for n = 10,844/n = 25,712 patients, respectively. OS was assessed in n = 5,904 patients with data on both microsatellite and KRAS status, and follow-up. Overall prevalence of MSI-H was 3.1% and KRAS mutation 42.4%. Microsatellite and KRAS status varied according to primary CR site, as presented in Table. Further variation was evident according to US-geography, with MSI-H rates ranging from 1.6% to 4.1%, and KRAS mutation rates ranging from 41.1% to 44%. On multivariable analyses, longer OS was observed in patients with KRAS wildtype versus mutation (HR = 0.91, 95% CI: 0.85-0.97 p = 0.004), MSS versus MSI-H (HR = 0.75, 95% CI: 0.62-0.9, p = 0.003), and left-sided versus right-sided CRC (HR = 0.65, 95% CI: 0.6-0.7, p < 0.001). The effect of KRAS mutation further varied with CRC site and microsatellite status (interaction p = 0.002). Conclusions: Depending on its primary site and US geography, stage IV CRC shows distinct mutational behavior. KRAS mutation, MSI-H, MSI-H and primary CRC sidedness independently affect overall survival and interact with distinct prognostic profiles. Generically classifying adenocarcinomas of different site as “CRC” might deprecate this diversity. [Table: see text]


Author(s):  
Sivesh K. Kamarajah ◽  
Filip Bednar ◽  
Clifford S. Cho ◽  
Hari Nathan

Abstract Background The benefit of adjuvant chemotherapy (AC) after pancreatoduodenectomy (PD) for ampullary adenocarcinoma is uncertain. We aimed to evaluate the association of AC with survival in patients with resected ampullary adenocarcinoma. Methods Using the National Cancer Database (NCDB) data from 2004 to 2016, patients with non-metastatic ampullary adenocarcinoma who underwent PD were identified. Patients with neoadjuvant radiotherapy and chemotherapy and survival < 6 months were excluded. Propensity score matching was used to account for treatment selection bias. A multivariable Cox proportional hazards model was then used to analyze the association of AC with survival. Results Of 3186 (43%) AC and 4172 (57%) no AC (noAC) patients, 1720 AC and 1720 noAC patients remained in the cohort after matching. Clinicopathologic variables were well balanced after matching. After matching, AC was associated with improved survival (median 47.5 vs 39.6 months, p = 0.003), which remained after multivariable adjustment (HR: 0.83, CI95%: 0.76–0.91, p < 0.001). Multivariable interaction analyses showed that this benefit was seen irrespective of nodal status: N0 (HR: 0.81, CI95%: 0.68–0.97, p < 0.001), N1 (HR: 0.65, CI95%: 0.61–0.70, p < 0.001), N2 (HR: 0.73, CI95%: 0.59–0.90, p = 0.003), N3 (HR: 0.59, CI95%: 0.44–0.78, p < 0.001); and margin status: R0 (HR: 0.85, CI95%: 0.77–0.94, p < 0.001), R1 (HR: 0.69, CI95%: 0.48–1.00, p < 0.001). Stratified analyses by nodal and margin status demonstrated consistent results. Conclusion In this large retrospective cohort study, AC after resected ampullary adenocarcinoma was associated with a survival benefit in patients, including patients with node-negative and margin-negative disease.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15669-e15669
Author(s):  
Gyulnara G. Kasumova ◽  
Omidreza Tabatabaie ◽  
Rebecca A. Miksad ◽  
Sing Chau Ng ◽  
Manuel M. Hidalgo ◽  
...  

e15669 Background: There is a paucity of data and no consensus regarding administration of adjuvant therapy after resection of gallbladder cancer. In the absence of a completed clinical trial, we retrospectively reviewed US cancer data. Methods: National Cancer Data Base was queried for patients diagnosed with gallbladder adenocarcinoma between 2004-2014 who underwent definitive resection for non-metastatic disease (pT1b, pT2, pT3, pN0, pN1, pNX) and had R0 and R1 resection margins. One-to-one propensity score matching was used to account for potential selection bias in patient and tumor characteristics. Kaplan-Meier method was used to compare overall survival. Results: Of 4830 patients identified, 1489 (30.8%) received adjuvant chemotherapy. Patients who received adjuvant chemotherapy were more likely to be younger, have private insurance or Medicare, have no comorbidities, higher T stage, and moderately to poorly differentiated tumors (all p-values < 0.0001). The majority of patients who received adjuvant chemotherapy also received adjuvant radiation (58.0%). On unadjusted analysis, patients who received adjuvant chemotherapy had no difference in median overall survival compared to those who did not (25.8 vs 29.0 mo; p = 0.3060). After matching for sex, age, race, insurance, comorbidity, facility type, pT stage, lymph node status, resection margins (R0 vs R1), adjuvant radiation, and tumor grade no difference in median overall survival remained between patients who did (21.8 mo) and did not (22.6 mo) receive adjuvant chemo (p = 0.6843). However, after matching on the propensity to receive adjuvant radiation in addition to the above covariates, receipt of adjuvant radiation resulted in a persistently significant increase in median overall survival (27.8 vs 22.2 mo; p = 0.0005). Conclusions: After matching for potential confounders, there is no difference in overall survival for patients who did and did not receive adjuvant chemotherapy after R0/R1 resection for pT1b, pT2, and pT3 gallbladder adenocarcinoma; however, adjuvant radiation does appear to confer a survival advantage. These results support the current treatment guidelines until evidence from RCTs becomes available.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18038-e18038
Author(s):  
David Deng ◽  
Winson Y. Cheung

e18038 Background: Timeliness of adjuvant chemotherapy is an important predictor of survival for patients with breast and colorectal cancer whereby long delays has been shown to detrimentally impact outcomes. The effects of adjuvant treatment timing remain largely unknown for early pancreatic cancer. This study aims to identify independent predictors of treatment timeliness and overall survival in this patient population. Methods: We conducted a retrospective, population-based analysis of 179 patients with resected pancreatic cancer who subsequently started adjuvant chemotherapy between 2008 and 2014 at any 1 of 6 cancer centers across British Columbia, Canada. Logistic regression was used to identify predictive factors for adjuvant chemotherapy timing. Prognostic factors for survival were ascertained using multivariate Cox proportional hazards models. Results: Our study cohort included 91 men (51%) and 88 women (49%). At time of diagnosis, 145 patients (81%) had nodal involvement and 107 patients (60%) had good ECOG performance status (ECOG 0-1). The median age of diagnosis was 67 (range 37-85) years. The median interval between surgery and start of adjuvant chemotherapy was 70 (range 19-46) days. Abnormal bilirubin was the only factor significantly correlated with delayed chemotherapy (OR, 3.89; 95% CI, 1.55-9.73; P = 0.004). Median overall survival was 468 days following resection (95% CI, 425-538). Multivariate survival analysis showed that high CA 19-9 levels (HR, 2.44, 95% CI: 1.36-4.40, P = 0.003) and abnormal bilirubin (HR, 0.40; 95% CI, 0.22-0.73; P = 0.003) were prognostic factors for overall survival. Median survival for patients who waited up to 35, 70 or 105 days for chemotherapy following resection were 588 days (95% CI, 270-776), 490 days (95% CI, 360-688) and 466 days (95% CI, 432-538) respectively. Overall, timeliness was not predictive of survival (HR, 1.12; 95% CI, 0.64-1.97; P= 0.70). Conclusions: Patients with hyperbilirubinema experienced delays in adjuvant chemotherapy, likely due to the need for relief of biliary obstruction and subsequent recovery. However, timeliness of adjuvant chemotherapy did not influence outcomes, suggesting that treatment should still be considered irrespective of timing.


2011 ◽  
Vol 29 (25) ◽  
pp. 3381-3388 ◽  
Author(s):  
Erin S. O'Connor ◽  
David Yu Greenblatt ◽  
Noelle K. LoConte ◽  
Ronald E. Gangnon ◽  
Jinn-Ing Liou ◽  
...  

Purpose Adjuvant chemotherapy is typically considered for patients with stage II colon cancer characterized by poor prognostic features, including obstruction, perforation, emergent admission, T4 stage, resection of fewer than 12 lymph nodes, and poor histology. Despite frequent use, the survival advantage conferred on patients with stage II disease by chemotherapy is yet unproven. We sought to determine the overall survival benefit of chemotherapy among patients with stage II colon cancer having poor prognostic features. Patients and Methods A total of 43,032 Medicare beneficiaries who underwent colectomy for stage II and III primary colon adenocarcinoma diagnosed from 1992 to 2005 were identified from the Surveillance, Epidemiology, and End Results (SEER) –Medicare database. χ2 and two-way analysis of variance were used to assess differences in patient- and disease-related characteristics. Five-year overall survival was examined using Kaplan-Meier survival analysis and Cox proportional hazards regression with propensity score weighting. Results Of the 24,847 patients with stage II cancer, 75% had one or more poor prognostic features. Adjuvant chemotherapy was received by 20% of patients with stage II disease and 57% of patients with stage III disease. After adjustment, 5-year survival benefit from chemotherapy was observed only for patients with stage III disease (hazard ratio[HR], 0.64; 95% CI, 0.60 to 0.67). No survival benefit was observed for patients with stage II cancer with no poor prognostic features (HR, 1.02; 95% CI, 0.84 to 1.25) or stage II cancer with any poor prognostic features (HR, 1.03; 95% CI, 0.94 to 1.13). Conclusion Among Medicare patients identified with stage II colon cancer, either with or without poor prognostic features, adjuvant chemotherapy did not substantially improve overall survival. This lack of benefit must be considered in treatment decisions for similar older adults with colon cancer.


2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Xiao-Li Yu ◽  
Jin Yang ◽  
Ting Chen ◽  
Yi-min Liu ◽  
Wei-ping Xue ◽  
...  

Background. The prognostic values of weight loss and body mass index (BMI) in esophageal carcinoma remain controversial. This study aimed to evaluate the impacts of weight loss on the survival of patients undergoing radical surgery and adjuvant chemotherapy. Methods. The medical records of 189 consecutive patients with nonmetastatic esophageal carcinoma treated in our hospital between January 2012 and December 2013 were reviewed, and 121 patients were included for analysis. Results. Kaplan-Meier analysis revealed that the 3-year overall survival rate was significantly higher in the low pretreatment weight loss (pre-LWL) group than in the high pretreatment weight loss (pre-HWL) group (P<0.001). In addition, the 3-year overall survival rate of normal weight group was higher than that of overweight and underweight groups (P=0.007). Multivariate Cox proportional hazards analysis showed that pre-LWL group had a significantly better 3-year overall survival than pre-HWL group (P=0.027, HR = 1.89, and 95% CI = 1.07–3.32). pN stage and age were also the survival prognostic factors. Conclusions. Our study showed that low pretreatment weight loss predicted a better survival outcome in the esophageal carcinoma patients with radical surgery and adjuvant chemotherapy. However, BMI and weight loss during treatment had no impact on the survival outcome.


2020 ◽  
Vol 163 (5) ◽  
pp. 986-991
Author(s):  
Jordan I. Teitelbaum ◽  
Khalil Issa ◽  
Ian R. Barak ◽  
Feras Y. Ackall ◽  
Sin-Ho Jung ◽  
...  

Objective To determine whether treatment of sinonasal squamous cell carcinoma (SCC) at a high-volume facility affects survival. Study Design Retrospective database analysis. Setting National Cancer Database (2004-2014). Subjects and Methods The National Cancer Database was queried for sinonasal SCC from 2004 to 2014. Patient demographics, tumor characteristics and classification, resection margins, treatment regimen, and facility case-specific volume—averaged per year and grouped in tertiles as low (0%-33%), medium (34%-66%), and high (67%-100%)—were compared. Overall survival was compared with Cox proportional hazards regression analysis. Results A total of 3835 patients treated for sinonasal SCC between 2004 and 2014 were identified. Therapeutic options included surgery alone (18.6%), radiotherapy (RT) alone (29.1%), definitive chemoradiation (15.4%), surgery with adjuvant RT (22.8%), and combinations (14.1%) of the aforementioned treatments. Patients who underwent surgery with adjuvant RT had better overall survival (hazard ratio [HR], 0.74; P < .001; 95% CI, 0.63-0.86). As for treatment volume per facility, 7.4% of patients were treated at a low-volume center, 17.5% at a medium-volume center, and 75.1% at a high-volume center. Univariate analysis showed that treatment at a high-volume facility conferred a significantly better overall survival (HR, 0.77; P = .002). Multivariable Cox proportional hazards regression analysis, adjusting for age, sex, tumor classification, and treatment regimen, demonstrated that patients who underwent treatment at a high-volume facility (HR, 0.81; P < .001) had significantly improved survival. Conclusion This study shows a better overall survival for sinonasal SCC treated at high-volume centers. Further study may be needed to understand the effect of case volume on the paradigms of sinonasal SCC management.


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