Effect of adjuvant therapy on resected gallbladder adenocarcinoma: A propensity score matched analysis of national data.

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.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 331-331
Author(s):  
Susanna W. L. de Geus ◽  
Sameer Hirji ◽  
Sing Chau Ng ◽  
Teviah E. Sachs ◽  
Jennifer F. Tseng

331 Background: Multiple randomized controlled trials have shown that both neoadjuvant chemotherapy (CT) and chemoradiation (CRT) convey survival benefit as compared to upfront surgery in patients with esophageal adenocarcinoma. However, international practice remains variable. Therefore, the present study compares the outcomes of first-line CT to CRT for patients with adenocarcinoma arising from the distal esophagus. Methods: Patients with clinical stage T2-T3, N0-N+ esophageal adenocarcinoma originating from the distal esophagus who received first-line CT or CRT were identified from the National Cancer Data Base (2006-2014). Propensity-score were created for the odds of receiving CRT. Patients were matched 1:1 based on propensity score. Subset analysis was performed in patients who underwent esophagectomy. Pathological complete response was defined as ypT0N0M0. Results: In total, 709 and 8,877 patients who received first-line CT and CRT were identified, respectively. CT was associated with stage cT2 (27.2% vs. 23.3%; p = 0.017), and treatment at a high-volume center (27.2% vs. 20.2%; p < 0.001). After matching, resection rates were comparable for patients who received first-line CT and CRT (62.2% vs. 63.7%; p = 0.545). However, median overall survival was slightly lower for patients who receive CT compared to CRT (23.7 vs. 28.4 months; p = 0.044). Among patients who underwent esophagectomy, time to surgery (135 vs. 134 days; p = 0.689) and median overall survival (37.0 vs. 40.5 months; p = 0.630) was similar between matched cohorts. However, complete response (15.8% vs. 25.8%; p < 0.001) and negative margin (94.3% vs. 88.9%; p = 0.004) rates were significantly lower after CT compared to CRT. Conclusions: In patients with esophageal adenocarcinoma, first-line CRT results in significantly higher pathological complete response rates, negative resection margins rates, and improved survival. These findings suggest that first-line CRT is preferable over CT when tolerated in patients with esophageal adenocarcinoma.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 378-378
Author(s):  
Jonathan J. Paly ◽  
Phillip John Gray ◽  
Chun Chieh Lin ◽  
Helmneh Sineshaw ◽  
Ahmedin Jemal ◽  
...  

378 Background: Testicular seminoma is the most common solid tumor seen in patients aged 15-35 and disease specific survival approaches 100% in controlled studies, even for those with node-positive disease. We sought to describe modern practice patterns as well as survival outcomes and factors associated with receipt of adjuvant therapy for patients presenting with initial clinical stage (CS) IIA/B disease. Methods: Data on patients diagnosed with CS IIA/B testicular seminoma from 1998-2011 were extracted from the National Cancer Data Base. Demographic, clinical, treatment, payer characteristics were evaluated using multivariate logistic regression to identify factors associated with receipt of chemotherapy or adjuvant radiation therapy (ART) within 6 months of orchiectomy. Five-year Kaplan-Meier overall survival (OS) by CS and treatment was calculated. Results: In total, 2,185 patients with CS II A/B were included. Management included orchiectomy alone (11.35%), adjuvant chemotherapy (27.46%), or ART (52.72%). In multivariate analysis, receipt of orchiectomy plus ART rather than adjuvant chemotherapy was more likely with CS IIA status (OR 2.4, p < 0.01), treatment outside of teaching or NCI network institution (OR 1.9-2.8, p < 0.02), or tumor size ≥4cm (OR 1.6, p < 0.01). Receipt of ART was less likely in Hispanic patients (OR 0.6, p=0.03) or in those diagnosed from 2006-2011 (OR 0.5, p < 0.01). Five-year OS for all patients was 97.2% for orchiectomy + ART, and 93.9% for orchiectomy + chemotherapy (log-rank p = 0.01). For CS IIA patients, 5-year OS was 98.3% for orchiectomy + ART versus 93.6% for orchiectomy + chemotherapy (log-rank p < 0.01). Differences in OS for CS IIB treated with chemotherapy or ART were not statistically significant. Conclusions: Consistent with national guideline recommendations, our analysis suggest that compared to chemotherapy, ART is associated with a survival advantage for CS IIA patients. Chemotherapy or ART showed no significant difference in effectiveness in patients with CS IIB. Disease bulk, race, treatment center type, and time period are associated with choice of adjuvant therapy. Longer follow-up and validation of these results is needed to account for late effects of treatment.


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]


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9071-9071
Author(s):  
Richard Lee O'Neal ◽  
OIga Vsevolozhskaya ◽  
Zhonglin Hao

9071 Background: Thymic Carcinoma is a rare malignancy with an aggressive clinical course. While the importance of surgery in the non-metastatic setting has been well defined, the optimal role of radiation and/or systemic therapy in this setting remains controversial. This study utilized the Surveillance, Epidemiology, and End Results (SEER) database to investigate the impact of adjuvant therapy on overall survival in patients with thymic carcinoma. Methods: We identified adults in the SEER database with thymic carcinoma diagnosed between 1989 to 2015 for analysis. As the primary treatment for non-metastatic thymic carcinoma is surgery, we excluded patients who did not have surgery as a component of their treatment Patients were categorized into Masaoka-Koga stage groups (I-IIa, IIb, III, and IV). Kaplan-Meier estimates of 10-year OS and multivariate Cox proportional hazards regression analyses were performed. Results: 515 patients met the inclusion criteria, of which 125 were stage I-IIa, 46 were stage IIb, 191 were stage III, and 143 were stage IV. A multivariate analysis was performed, adjusting for age, sex, race, and tumor size. When compared to surgery, no statistical improvement in survival was seen with adjuvant radiation or chemotherapy in stage I-IIa or IIb thymic carcinoma. In stage III disease, standard of care surgery was compared with adjuvant radiation (hazard ratio 0.69 (95% confidence interval 0.29 – 1.63], p = 0.39), adjuvant chemotherapy (hazard ratio [HR] 0.84 [95% confidence interval 0.28 – 2.53], p = 0.76), and adjuvant chemo-radiotherapy (HR 0.40 [0.18 – 0.93], p = 0.03). On Kaplan-Meier analysis, triple therapy (surgery + chemo-radiotherapy) was also associated with a marked improvement in 10-year overall survival at 55.3%, compared to 39.8%, 23.9%, and 20.8% (adjuvant radiation, adjuvant chemotherapy, and surgery alone, respectively). Conclusions: This study finds that in stage III thymic carcinoma, surgery followed by chemo-radiotherapy is associated with improved overall survival compared to single or dual-modality treatments. Because of the rarity of this disease, there are no large randomized studies evaluating the most appropriate treatment modalities, therefore this data may assist with clinical decision making in non-metastatic thymic carcinoma.


2020 ◽  
Author(s):  
Gerardo I. Magallanes-Garza ◽  
Sandra K. Santuario-Facio ◽  
Arlina F. Varela-Varela ◽  
Servando Cardona-Huerta ◽  
Pablo Ruiz-Flores ◽  
...  

Abstract Background: Studies of molecular changes occurring before and after neo-adjuvant chemotherapy (NCT) for breast cancer may unveil genetic biomarkers to predict therapy response. This study aimed at identifying genomic changes in breast primary tumors of patients under NCT. Gene expression changes were correlated with pathological response and survival.Methods: Gene expression profiles in tissue samples from pre and post NCT were obtained by a non-supervised classification analysis. Thirty-nine patients were classified according to their response to the chemotherapy as pathologic complete responders or non-responders (pCR and no-pCR, respectively). Overall survival was assessed by comparing gene expression values before NCT using the Log-rank (Mantel-Cox) test. Results: A signature constituted by 43 genes was obtained to stratify pCR and no-pCR patients after NCT (FC = + 3, FDR p -value < 0.0298). These genes were involved in regulation of the mitotic nuclear division and the anaphase-promoting complex-dependent catabolic process. Remarkably, over-expression of NUSAP1 and KIAA0101 were associated to poor overall survival. Conclusions: A new expression signature evaluating response for the neo-adjuvant chemotherapy stratified pathological response. The expression levels of NUSAP1 and KIAA0101 before and after the neo-adjuvant therapy may be useful to predict overall survival.


2017 ◽  
Vol 35 (5) ◽  
pp. 515-522 ◽  
Author(s):  
Ali A. Mokdad ◽  
Rebecca M. Minter ◽  
Hong Zhu ◽  
Mathew M. Augustine ◽  
Matthew R. Porembka ◽  
...  

Purpose To compare overall survival between patients who received neoadjuvant therapy (NAT) followed by resection and those who received upfront resection (UR)—as well as a subgroup of UR patients who also received adjuvant therapy—for early-stage resectable pancreatic adenocarcinoma. Patients and Methods Adult patients with resected, clinical stage I or II adenocarcinoma of the head of the pancreas were identified in the National Cancer Database from 2006 to 2012. Patients who underwent NAT followed by curative-intent resection were matched by propensity score with patients whose tumors were resected upfront. Overall survival was compared by using a Cox proportional hazards regression model. Early postoperative and oncologic outcomes were evaluated. Results We identified 15,237 patients with clinical stage I or II resected pancreatic head adenocarcinoma. From the NAT group, 2,005 patients (95%) were matched with 6,015 patients who underwent UR. The NAT group was associated with improved survival compared with UR (median survival, 26 months v 21 months, respectively; stratified log-rank P < .01; hazard ratio, 0.72; 95% CI, 0.68 to 0.78). Patients in the UR group had higher pathologic T stage (pT3 and T4: 86% v 73%; P < .01), higher positive lymph nodes (73% v 48%; P < .01), and higher positive resection margin (24% v 17%; P < .01). Compared with a subset of UR patients who received adjuvant therapy, NAT patients had a better survival (adjusted hazard ratio, 0.83; 95% CI, 0.73 to 0.89). Conclusion NAT followed by resection has a significant survival benefit compared with UR in early-stage, resected pancreatic head adenocarcinoma. These findings support the use of NAT, particularly as a patient selection tool, in the management of resectable pancreatic adenocarcinoma.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 181-181
Author(s):  
Chun-Xia Du ◽  
Xiao-Yan Liu ◽  
Hong-Gang Zhang ◽  
Ai-Ping Zhou

181 Background: To compare the efficacy of docetaxel plus FOLFOX4 to FOLFOX4 as adjuvant chemotherapy for gastric cancer patients. Methods: 320 patients with stage IB-IV (M0) gastric cancer were enrolled into the retrospective study. All patients received a total or subtotal gastrectomy with at least D1 lymph nodes dissection. 193 patients received FOLFOX4 as adjuvant chemotherapy. 127 patients received biweekly docetaxel plus FOLFOX4 (DOF regimen) as adjuvant chemotherapy. Docetaxel was administered at 40 mg/m2 on day 1, followed by FOLFOX4 regimen. Both of the regimens were repeated every 2 weeks for a maximum of 12 cycles. Results: In comparison with patients in FOLFOX4 group, patients in DOF group were relatively younger (p=.001), with more advanced disease in pN stage (p=.035) and pTNM stage (p=.031), received more cycles of adjuvant chemotherapy (p=.004), and had a higher percentage of adjuvant radiation (p =.002). After adjustment of unbalanced variables as mentioned above, no statistical difference was observed between DOF group and FOLFOX4 group in terms of 3-year disease-free survival (54% vs 69%, p = 0.100, HR 1.362, 95% CI (0.943-1.967)) and 3-year overall survival(70% vs 72%, p = 0.810, HR 1.049, 95% CI (0.711-1.548)). Stratified analysis according to clinicopathologic characters showed that there were almost no statistical differences of 3-year overall survival rates between two groups, except the primary site (middle 1/3) (p =.025) and pTNM stage (IIb stage) (p =.035) in favor of FOLFOX4 group. The incidences of grade 3/4 adverse events were obviously higher in DOF group than in FOLFOX4 group,including decreased appetite (18.1% V 10.4%, P = 0.046), diarrhea (4.7% V 0%, p=0.004 ), hypersensitivity reactions to oxaliplatin (3.1% V 0%, p=0.024) and neutropenia (47.3% V 31.6%, p=0.004). Conclusions: Compared to FOLFOX4 regimen, adjuvant docetaxel plus FOLFOX4 did not show significant survival advantages in gastric cancer patients. However, a more serious toxicity profile was observed in docetaxel plus FOLFOX4 arm. Further studies are needed to decide whether triplet regimen is appropriate as adjuvant chemotherapy of gastric cancer.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 716-716
Author(s):  
Danish Shahab ◽  
Emmanuel M. Gabriel ◽  
Kristopher Attwood ◽  
Valerie Francescutti ◽  
Wen Wee Ma ◽  
...  

716 Background: 15-20% of patients with locally advanced rectal adenocarcinoma (LARC) achieve a pathologic complete response (pCR) following neoadjuvant chemoradiation (nCRT). The role of adjuvant chemotherapy has been questioned. Methods: Patients with rectal cancer receiving nCRT in the National Cancer Data Base (NCDB) 2006-2013 data set were evaluated. The primary outcome was overall survival (OS). The association between OS and patient characteristics were examined using multivariable Cox regression models. Results: 2,903 patients were identified who achieved a pCR. The median follow up was 43.2 months. 2,102 received nCRT and 789 received nCRT + adjuvant chemotherapy. Factors significantly associated with OS included age (p<0.001), gender (p=0.011), Charlson-Deyo comorbidity score (CDI) (p<0.001), grade (p=0.029), clinical T stage (p=0.030), and CEA negativity (p=0.002), but not nodal status. The 3-year OS rate was 94% in the adjuvant therapy group as compared to 84% in the nCRT alone group (p<0.001). In considering clinical N-stage, the benefit was comparable for both N+ and N- tumors. Adjuvant chemotherapy was more likely to be given for younger patients (age < 60), lower comorbidity score, higher grade, positive CEA status, higher clinical T stage, and higher clinical N stage. When stratifying by these factors, similar benefits in OS were observed in the adjuvant cohort. Conclusions: Following nCRT and achievement of a pCR, the receipt of adjuvant chemotherapy is associated with improved OS. Patients receiving adjuvant therapy were more likely to be younger and have a low CDI, but have more advanced stage disease. Thus, a selection bias may be present. Nonetheless, in the setting of the already excellent outcome associated with pCR, the additional benefit of adjuvant chemotherapy should be weighed against toxicity.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16716-e16716
Author(s):  
Syed Mohammad Ali Kazmi ◽  
Suleyman Yasin Goksu ◽  
Muhammet Ozer ◽  
Nina Niu Sanford ◽  
Matthew R. Porembka ◽  
...  

e16716 Background: Gallbladder cancer (GBC) is an uncommon but highly fatal malignancy. Surgery remains the only potentially curative treatment for GBC. The role of neoadjuvant chemotherapy in patients with locally advanced GBC undergoing surgery is unknown. We studied the association of neoadjuvant chemotherapy on survival in locally advanced GBC patients who underwent resection. Methods: We identified adult patients with locally advanced (stage III-IV) GBC who underwent definitive surgery between 2004 and 2016 using the National Cancer Database. Treatment was categorized as neoadjuvant chemotherapy plus surgery (NAT), surgery plus adjuvant therapy (AT), and surgery alone (SA). Categorical variables were compared using the chi-square test with Bonferroni correction. Kaplan-Meier and Cox regression were used for survival analyses. We used 1:3 nearest neighbor propensity score matching based on NAT for each group. Results: Out of a total of 5,962 patients, 122 (2.2%) received NAT, 2934 (53.6%) AT, and 2421 (44.2%) SA. NAT was associated with private insurance and treatment at an academic/research facility (all p < .001) while SA patients were older, Hispanic, had government insurance, and higher comorbidities (all p < .001). Although all groups had similar lymph node assessment (NAT: 45%, AT: 46%, SA: 37%, p < .001), NAT was associated with lymph node negative disease (NAT 23%, AT 13.2%, SA 13.2%, p < .001). Median overall survival was higher in NAT compared to AT or SA (21 vs. 14 vs. 6 months, p < .001) which persisted after propensity score matching (21 vs. 15 vs. 9 months, p < .001) and multivariable regression analysis (Table). In node positive GBC, NAT was associated with improved median overall survival (NAT 24, AT 18, SA 8 months, p < .001). Conclusions: NAT is infrequently used in patients with locally advanced GBC. NAT is associated with improved median overall survival compared to AT and SA, and appears to be most beneficial in node positive disease. Prospective studies are needed to evaluate the role of neoadjuvant chemotherapy in locally advanced GB. [Table: see text]


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