Survival benefit of gastric resection in the setting of metastatic gastric cancer.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 166-166
Author(s):  
Trang Nguyen ◽  
Brooke Vuong ◽  
Mansen Wang ◽  
Trevan D Fischer ◽  
Melanie Goldfarb ◽  
...  

166 Background: Prognosis remains poor for metastatic gastric cancer. Gastrectomy in the setting of stage IV disease is typically reserved for palliation of symptoms such as bleeding or obstruction. The potential survival benefit of resection on survival is controversial. The objective of this study is to determine using the National Cancer Database (NCDB) whether there was an increase in overall survival in patients diagnosed with metastatic cancer who underwent a gastrectomy in addition to chemotherapy. Methods: The NCDB was queried between 2004-2014 for patients with metastatic gastric cancer (adenocarcinoma, mucinous adenocarcinoma, or signet ring carcinoma) who received chemotherapy. Kaplan-Meier analysis and multivariate Cox proportional hazards regression analysis was done using SAS software. Results: A total of 20,599 patients met inclusion criteria. A minority of these patients (2,508; 12.2%) underwent gastric resection in addition to chemotherapy. The median overall survival for those who underwent gastrectomy was 14.1 months compared to 8.6 months for chemotherapy alone (p < 0.0001). Other factors influencing survival included age, race, Charlson-Deyo co-morbidity index, year of diagnosis, primary tumor site, grade, and metastasis to multiple organs. Following multivariate analysis, patients who underwent gastrectomy and chemotherapy had a 36% lower risk of death compared to patients that had received chemotherapy alone (HR 0.64, 95% CI 0.48–0.80, P < 0.0001). Conclusions: In this population analysis, the addition of gastrectomy to chemotherapy was associated with improved overall survival for patients with stage IV gastric cancer and should be considered for patients that are surgical candidates. Patients who underwent gastrectomy had a 36% decreased risk of death compared to those who had chemotherapy alone. However, only a small proportion of patients in the United States received multimodality treatment.

2020 ◽  
Vol 28 (1) ◽  
pp. 138-151
Author(s):  
Kelly A. Stahl ◽  
Elizabeth J. Olecki ◽  
Matthew E. Dixon ◽  
June S. Peng ◽  
Madeline B. Torres ◽  
...  

Gastric cancer is the third most common cause of cancer deaths worldwide. Despite evidence-based recommendation for treatment, the current treatment patterns for all stages of gastric cancer remain largely unexplored. This study investigates trends in the treatments and survival of gastric cancer. The National Cancer Database was used to identify gastric adenocarcinoma patients from 2004–2016. Chi-square tests were used to examine subgroup differences between disease stages: Stage I, II/III and IV. Multivariate analyses identified factors associated with the receipt of guideline concordant care. The Kaplan–Meier method was used to assess three-year overall survival. The final cohort included 108,150 patients: 23,584 Stage I, 40,216 Stage II/III, and 44,350 Stage IV. Stage specific guideline concordant care was received in only 73% of patients with Stage I disease and 51% of patients with Stage II/III disease. Patients who received guideline consistent care had significantly improved survival compared to those who did not. Overall, we found only moderate improvement in guideline adherence and three-year overall survival during the 13-year study time period. This study showed underutilization of stage specific guideline concordant care for stage I and II/III disease.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 174-174
Author(s):  
Joshua Tseng ◽  
James Miller ◽  
Xiaoxi Feng ◽  
Alexandra Gangi ◽  
Jun Gong ◽  
...  

174 Background: Racial disparities for gastric cancer are often identified in the literature. Although patients in Asia consistently demonstrate a survival benefit compared to those in the West, Asian patients in the US still retain this advantage, which suggests that tumor biology may be a major factor. The goal of our study is to identify racial differences in patient demographics, tumor biology and treatment for gastric cancer in the United States. Methods: The National Cancer Database was queried from 2006-2016 for patients with a diagnosis of gastric adenocarcinoma. Patient demographics, tumor characteristics, and treatment patterns were compared by patient ethnicity (White, Black, Hispanic, and Asian) with Kruskal-Wallis test and Pearson’s chi-squared test. Kaplan-Meier survival curves used to assess overall survival, and cox regression used to identify independent prognostic factors for survival. Results: 116,717 patients with gastric cancer identified; 78,066 were White, 17,486 were Black, 8,494 were Asian, and 12,671 were Hispanic. White patients were most likely to be older than 70 and have proximal tumors, and least likely to have diffuse type adenocarcinoma. Hispanic and Black patients were most likely to present with metastases. Asian patients were most likely to receive surgery and least likely to receive chemotherapy or radiotherapy. Stage for stage, Asians had the longest median survival, followed by Hispanic, Black, and White patients. Prognostic factors associated with a survival benefit include Asian ethnicity (HR 0.72, 95% CI 0.68-0.74), Hispanic ethnicity (HR 0.76, 95% CI 0.73-0.79), Black ethnicity (HR 0.95, 95% CI 0.93-0.98), private insurance (HR 0.91, 95% CI 0.87-0.96), higher income (HR 0.85, 95% CI 0.82-0.88), treatment at academic center (HR 0.87, 95% CI 0.83-0.91), higher-volume centers (HR 0.90, 95% CI 0.87-0.93), receiving surgery (HR 0.42, 95% CI 0.41-0.43), chemotherapy (HR 0.56, 95% CI 0.55-0.57), and radiation (HR 0.96, 95% CI 0.93-0.98). Conclusions: Treatment differences between Eastern and Western countries for gastric cancer persist between ethnic groups within the United States, with Asian patients retaining a survival benefit. Black and Hispanic patients present with aggressive disease and unfavorable socioeconomic factors that are detrimental to overall survival.


2020 ◽  
Vol 86 (4) ◽  
pp. 451-459
Author(s):  
Swan Lin ◽  
Naveed Shaik ◽  
Geoffrey Chan ◽  
Jorge E. Cortes ◽  
Ana Ruiz-Garcia

Abstract Purpose Glasdegib, an oral inhibitor of the Hedgehog signaling pathway, is approved in the United States in combination with low-dose cytarabine (LDAC) to treat patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive chemotherapy. This population pharmacokinetic/pharmacodynamic analysis characterized the time course of survival with glasdegib + LDAC relative to LDAC alone, and explored whether the differences in glasdegib exposure at the clinical dose of 100 mg once daily (QD) significantly affected overall survival (OS). Methods Data from the BRIGHT AML 1003 trial in patients with AML were included in treatment–response (glasdegib + LDAC, n = 78; LDAC alone, n = 38) and exposure–response (glasdegib + LDAC, n = 75) analyses. Results The analyses demonstrate that patients treated with glasdegib + LDAC (vs LDAC alone) at any time point during the study period were 58% less likely to die, translating to prolonging of median OS by ~ 5 months (hazard ratio 0.42 [95% confidence interval 0.28–0.66]). Variability in glasdegib exposures did not impact the risk of death. Additionally, potential covariates such as patient demographics, prior treatment with a hypomethylating agent, baseline safety laboratory values, and disease characteristics, did not impact the probability of OS. Conclusion Together these results confirm that glasdegib + LDAC treatment (vs. LDAC alone) is associated with a significant survival benefit in patients with newly diagnosed AML, and that variability in glasdegib doses (e.g., for dose reductions) and exposures do not compromise the survival benefit of glasdegib 100 mg QD. Clinical Trial number NCT01546038.


2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13054-e13054
Author(s):  
Lifen Cao ◽  
Jonathan T. Bliggenstorfer ◽  
Kavin Sugumar ◽  
Christopher W. Towe ◽  
Pamela Li ◽  
...  

e13054 Background: Conflicting data exist regarding benefit of surgery of the primary site for stage IV breast cancer, in which systemic therapy is standard of care and patient characteristics may bias treatment decisions. Metastatic triple negative breast cancer (TNBC) is an aggressive subtype with limited therapy options and poor prognosis. Our aim was to assess whether surgery for the primary tumor in stage IV TNBC provides a survival advantage over systemic therapy alone. Methods: The National Cancer Database was queried for patients with de-novo stage IV TNBC who received systemic therapy alone or systemic therapy and surgery of the primary breast site 2004-2016. Patients receiving surgery for metastatic tumor sites or with incomplete follow up data were excluded. 1:1 propensity matching was performed for demographics, comorbidities, clinical T and N stage, and metastatic sites to minimize confounding factors. Survival outcomes were analyzed using a stratified log-rank test and Cox proportional hazard regression analysis. Results: Of 2989 patients, 782 (26.21%) underwent surgery plus systemic therapy and 2207 (73.84%) were treated with systemic therapy alone. The majority of all patients were aged 51-70 with low co-morbidity, and treated in metropolitan areas. Patients treated at academic facilities (OR = 0.67, p = 0.025), with multiple metastatic sites (OR = 0.59, p < 0.001), or advanced clinical N stage (OR = 0.55, p < 0.001) were less likely to undergo surgery. Of those who completed surgery, 58% had unilateral mastectomy, and 63% had axillary lymph node dissection. Propensity matching identified 507 ‘paired’ patients with similar characteristics in the surgery and systemic therapy alone groups. After multivariable adjustment, surgery was associated with superior overall survival compared with systemic therapy alone (HR 0.73, P < 0.001). Older age (HR = 1.47, p < 0.001), greater comorbidity (HR = 1.28, p < 0.001) and multiple metastatic sites (HR = 1.53, p < 0.001) significantly decreased overall survival in the matched cohort. Median survival was shortest in the systemic therapy alone group (12.8 months, 95% CI 11.3-14.5) and longest in those undergoing systemic therapy plus simple mastectomy (18 months, 95% CI 14.3-21.2), though approximately 4 months of median survival was added for all patients undergoing any surgery vs. systemic therapy alone (p = 0.0001). Conclusions: In stage IV TNBC, surgical resection of the primary tumor site in addition to systemic therapy may provide a survival benefit in selected patients. Though in this retrospective study the sequence of treatment was unknown, surgery could be considered for low disease burden as in other malignancies with oligometastatic disease. Additional research is needed to determine if these findings persist in prospective studies and for other hormone-receptor subtypes.


2008 ◽  
Vol 26 (30) ◽  
pp. 4891-4898 ◽  
Author(s):  
Shaheenah Dawood ◽  
Kristine Broglio ◽  
Ana M. Gonzalez-Angulo ◽  
Aman U. Buzdar ◽  
Gabriel N. Hortobagyi ◽  
...  

Purpose Overall, breast cancer mortality has been declining in the United States, but survival studies of patients with stage IV disease are limited. The aim of this study was to evaluate trends in and factors affecting survival in a large population-based cohort of patients with newly diagnosed stage IV breast cancer. Patients and Methods We searched the Surveillance, Epidemiology, and End Results registry to identify female patients with stage IV breast cancer diagnosed between 1988 and 2003. Patients were divided into three groups according to year of diagnosis (1988 to 1993, 1994 to 1998, and 1999 to 2003). Survival outcomes were estimated by the Kaplan-Meier method, and Cox models were fit to determine the characteristics independently associated with survival. Results We identified 15,438 patients. Median age was 62 years. Median follow-up was 16 months, 18 months, and 11 months in periods 1988 to 1993, 1994 to 1998, and 1999 to 2003, respectively. Median breast cancer–specific survival was 23 months. In the multivariate model, earlier year of diagnosis, grade 3 disease, increasing age, being unmarried, hormone receptor–negative disease, and no surgery were all independently associated with worse overall and breast cancer–specific survival. With each successive year of diagnosis, black patients had an increasingly greater risk of death compared with white patients (hazard ratio, 1.03; 95% CI, 1.00 to 1.06; P = .031). Conclusion The survival of patients with newly diagnosed stage IV breast cancer has modestly improved over time, but these data suggest that the disparity in survival between black and white patients has increased.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18566-e18566
Author(s):  
Diana Saravia ◽  
Leah Elson ◽  
Hong Liang ◽  
Nadeem Bilani ◽  
Elizabeth Blessing Elimimian ◽  
...  

e18566 Background: We previously elucidated sociodemographic factors associated with risk-of-death, in a subgroup of patients with Stage IV human epidermal growth factor 2 (HER)+ breast cancer. To further understand determinants of disparities in all subgroups of stage IV breast cancer, this study sought to evaluate factors which are predictive of overall survival (OS) in a cohort of patients with metastatic breast cancer (MBC), according to the following subtypes: 1) estrogen receptor (ER)+ or progesterone receptor (PR)+ and (HER)-, (2) (ER+ or PR+) and HER+, (3) (ER- and PR-) and HER-, or (4) (ER- and PR-) and HER+. Methods: Study population included patients with MBC, extracted from the National Cancer Database, treated between 2010 and 2016. Descriptive statistics were used to summarize patient characteristics, and chi-square tests were performed to compare patient characteristics, by ethnic group (white, black, Hispanic, Asian, and other). Multivariate Cox regression models with backward elimination (using significance level of p<0.05) were utilized to compare overall survival among patient cohorts. In addition, Kaplan-Meier survival curves of patient cohort were also produced. Statistics were performed using SAS. Results: Records from n= 47,032 patients were included, the majority were 50 years or older, white, and treated with hormonal therapy. With a median follow-up time of 2.3 years, disparities in OS were observed; black patients were more likely to suffer death (HR=1.12 (1.08-1.16), p<0.0001), compared to white patients. Additional factors contributing to risk of death in MBC included: being male (HR=1.12, (1.02-1.23), p=0.019), having visceral involvement compared to bone only (HR=1.52, (1.05-1.28), p<0.0001), income < $38,000 (HR=1.13 (1.09-1.17), p<0.0001), being on government insurance (HR=1.24, (1.20-1.27), p<0.0001, and having Triple Negative Breast Cancer (ER- and PR-) and HER- status (HR=1.68 (1.60-1.75) p<0.0001). Patients who receive chemotherapy, not hormonal therapy (HR=1.25 (1.2 – 1.3), p<0.0001), were found to have worse prognosis possibly reflecting biology of disease at presentation and lack of specific targeted therapy. Conclusions: This study confirms that sociodemographic disparities exist in OS among patients within the same stage of MBC, and regardless of receptor status subtypes. Clinical practice should focus on closing disparities gaps for those with advanced and MBC, especially among Black, impoverished, and male patients. Better treatment approaches should be sought for patients with visceral metastasis and those diagnosed with triple negative receptor status, who continue to suffer from worse outcomes.


ESMO Open ◽  
2019 ◽  
Vol 4 (3) ◽  
pp. e000488 ◽  
Author(s):  
Masahiko Aoki ◽  
Hirokazu Shoji ◽  
Kengo Nagashima ◽  
Hiroshi Imazeki ◽  
Takahiro Miyamoto ◽  
...  

BackgroundNivolumab showed a survival benefit for advanced gastric cancer (AGC). However, an acceleration of tumour growth during immunotherapy, (hyperprogressive disease, HPD) has been reported in various cancers. This study reviewed the HPD in patients with AGC treated with nivolumab or irinotecan.MethodsThe subjects of this retrospective study were patients with AGC with measurable lesions, and their tumour growth rates (TGR) during nivolumab or irinotecan were compared with those during prior therapy. HPD was defined as an increase in TGR more than twofold.Results34 and 66 patients received nivolumab and irinotecan in third or later line between June 2009 and September 2018 at our hospital; 22 patients receiving nivolumab had prior treatment with irinotecan, and one patient received irinotecan after nivolumab. Nivolumab and irinotecan showed no differences in disease control rates (38.2% and 34.8%) and in progression-free survival (PFS) (HR 1.1, 95% CI 0.7 to 1.6, p=0.802). The incidence of HPD was slightly higher after nivolumab (29.4%) than after irinotecan (13.5%) (p=0.0656), showing no differences in background between the patients with and without HPD. Compared between HPD and PD other than HPD after nivolumab, the HRs for PFS and overall survival (OS) were 1.1 (95% CI 0.5 to 2.7; p=0.756), and 2.1 (95% CI 0.7 to 5.8; p=0.168), but such clear difference in OS was not observed after irinotecan.ConclusionsHPD was observed more frequently after nivolumab compared with irinotecan, which was associated with a poor prognosis after nivolumab but not so clearly after irinotecan.


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