The influence of chemotherapy induced nausea and vomiting (CINV) on survival: An individual participant data meta-analysis of the North-Eastern German Society of Gynecological Oncology (NOGGO) of 1213 recurrent ovarian cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17062-e17062
Author(s):  
Hannah Woopen ◽  
Rolf Richter ◽  
Guelhan Inci ◽  
Radoslav Chekerov ◽  
Gulten Oskay-Oezcelik ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cox Regression ◽  
Progression Free Survival ◽  
German Society ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Gynecological Oncology ◽  
The North ◽  
North Eastern ◽  
Grade Iii

e17062 Background: Nausea and vomiting are frequent side effects of chemotherapy and are the most feared toxicities of our patients. Aim of this study is to evaluate the potential influence of chemotherapy induced nausea and vomiting (CINV) on survival. Methods: Synthesized raw data of three phase II/III studies (“Tower”, “Topotecan phase III” and “Hector”) of the North-Eastern German Society of Gynecological Oncology (NOGGO) including 1213 patients were analyzed using logistic regression and cox regression analyses. Results: In this analysis 661 patients (54.5%) developed grade I/II and 44 patients (3.6%) grade III/IV nausea. 343 patients (28.3%) had grade I/II vomiting and 33 patients (2.7%) grade III/IV. There were no differences between severity of CINV regarding FIGO, grading, histology and amount of recurrences. Patients <65 years developed more frequently grade III/IV nausea than patients ≥ 65 years (p<0.001, OR 1.29, 95% CI 0.68-2.46). Polypharmacy was also associated with grade III/IV CINV (p<0.001 and p=0.002 respectively). Progression free survival was worse in patients with grade III/IV nausea (p=0.023, HR 1.58, 95% CI 1.14-2.20). Median overall survival (OAS) in patients without nausea was 19.0 months compared to patients with grade III/IV nausea with 11.0 months (p<0.001, HR for grade III/IV 2.35, 95% CI 1.64-3.37). Grade III/IV vomiting was also highly associated with worse OAS (median of 22.0 months in patients without vs. 5.9 months in patients with grade III/IV vomiting, p<0.001, HR for grade III/IV vomiting 3.4, 95% CI 2.32-5.00). However, dose reductions and prior discontinuation of chemotherapy were not more frequent in patients with nausea and vomiting. Conclusions: Patients with nausea and vomiting had a decreased progression and overall survival. This study underlines once again the importance of early best supportive care on survival.

scholarly journals History of Diabetes and Survival Outcome Among Participants 65 Years or Older in SWOG Clinical Trials

2017 ◽  
pp. 1-12 ◽  
Author(s):  
Dawn L. Hershman ◽  
Cathee Till ◽  
Jason D. Wright ◽  
Scott Ramsey ◽  
William E. Barlow ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Global Test ◽  
Free Survival ◽  
Medicare Claims ◽  
Patients With Diabetes ◽  
Clinical Records

Purpose Diabetes is common, increases with age, and may affect outcomes among people with cancer. Understanding the association between diabetes and cancer outcome is challenging, because patients with diabetes have increased all-cause mortality compared with patients without diabetes. Methods We systematically examined the phase III trial database of SWOG to identify patients enrolled in trials during the period from 1999 to 2011. We linked the SWOG clinical records to Medicare claims data according to Social Security number, sex, and date of birth. Medicare claims were used to identify diabetes with at least 6 months of continuous Medicare coverage immediately before registration. Multivariable Cox regression was used to compare survival outcomes between patients with and without diabetes for each of 10 tumor cohorts. The primary outcome was overall survival. We also examined progression-free survival and cancer-free survival. Results In total, 6,422 patients from 15 trials were ≥ 65.5 years of age, of whom 3,173 patients (49%) met the criteria for linkage to Medicare claims. Thirty percent (n = 952) had claims for diabetes before registration. Patients with diabetes were more likely to be black ( P < .001), but no other differences in demographic characteristics were observed. In multivariable Cox regression, no association was found between baseline diabetes and overall or progression-free survival; in one case, patients with diabetes had marginally worse cancer-free survival (advanced non–small-cell lung cancer; P = .05). A global test found that baseline diabetes was associated with worse overall survival ( P = .03) across the entire panel of analyses. Conclusion Diabetes is common among elderly patients enrolled in clinical trials. Unlike prior observational studies, among patients treated with uniform treatment regimens, and controlling for known prognostic factors, we did not observe an association between diabetes and progression-free or cancer-free survival.

scholarly journals 312 Female sex independently predicts adjuvant immunotherapeutic benefit from CTLA4 immune checkpoint inhibition

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A339-A339
Author(s):  
Ahmad Tarhini ◽  
Ni Kang ◽  
Sandra Lee ◽  
F Stephen Hodi ◽  
Gary Cohen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Treatment Efficacy ◽  
Significant Interaction ◽  
Cox Regression ◽  
Performance Status ◽  
Phase Iii ◽  
High Dose ◽  
List Type ◽  
Female Sex ◽  
Interaction Term

BackgroundSex differences in tumor immunity and response to immunotherapy were shown in murine models and descriptive analyses from recent clinical trials. Female sex hormones have been implicated in melanoma development and response to systemic therapy. We hypothesized a gender difference in response to adjuvant immunotherapy with ipilimumab (3 or 10 mg/kg; ipi3 or ipi10) versus high dose IFNα (HDI) as tested in the E1609 trial.MethodsE1609 demonstrated significant overall survival (OS) benefit with ipi3 versus HDI.1 We investigated treatment efficacy between ipi and HDI in the subgroups by sex (female, male), age (< 55 or ≥55), stage at study entry (IIIB, IIIC, M1a/1b), ECOG performance status (PS 0, 1), ulceration (yes, no), primary tumor (known, unknown), number of lymph nodes involved (0, 1, 2–3, 4+). Forest plots were created to compare OS and RFS with ipi3 vs. HDI and ipi10 vs. HDI using the concurrently randomized ITT populations. For the estimated HRs, 95% confidence intervals were created for all subgroups.ResultsThe subgroups of female, stage IIIC, PS=1, ulcerated, in-transit without lymph node involvement demonstrated significant improvement in overall survival (OS) and/or relapse free survival (RFS) with ipi3 versus HDI as summarized in table 1. Female sex was significant for both OS and RFS and was further explored. In investigating RFS with ipi3 versus HDI, a multivariate Cox regression model including sex, treatment and interaction term of sex*treatment, indicated a significant interaction between sex and treatment (P = 0.026). Including sex, PS (0 vs. 1), age (<55 vs. 55+), ulceration (yes vs. no), stage (IIIB, IIIC, M1a, M1b), treatment and interaction term of sex*treatment, indicated a significant interaction between sex and treatment (P = 0.024). While similar trends were seen, no significant interactions between sex and treatment effect were found in the OS multivariate analysis or in the comparison of ipi10 versus HDI. When exploring age, in the univariate analyses in the ipi3 versus HDI comparison older women appeared to drive most of the difference (age ≥55: OS, P=0.02 and RFS, P=0.08; differences non-significant for women <55). Table 1.Abstract 312 Table 1Treatment efficacy between ipi3 and HDI by subgroupConclusionsFemale sex was independently associated with RFS adjuvant immunotherapeutic benefit from ipi3, supporting a potentially important role for female related factors in the immune response against melanoma, and these warrant further investigation.Trial RegistrationNCT01274338Ethics ApprovalThe study protocol was approved by the institutional review board (IRB) of each participating institution and conducted in accordance with Good Clinical Practice guidelines as defined by the International Conference on Harmonisation. This study was monitored by the ECOG-ACRIN DataSafety Monitoring Committee and the NCI.ConsentAll patients provided IRB-approved written informed consent.ReferenceTarhini AA, Lee SJ, Hodi FS, Rao UNM, Cohen GI, Hamid O, Hutchins LF, Sosman JA, Kluger HM, Eroglu Z, Koon HB, Lawrence DP, Kendra KL, Minor DR, Lee CB, Albertini MR, Flaherty LE, Petrella TM, Streicher H, Sondak VK, Kirkwood JM. Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609. J Clin Oncol. 2020 Feb 20;38(6):567–575. PMID: 31880964.

Hyaluronan heterogeneity in pancreatic ductal adenocarcinoma, primary tumors, and sites of metastasis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16231-e16231
Author(s):  
Veronica Placencio-Hickok ◽  
Marie Lauzon ◽  
Natalie Moshayedi ◽  
Michelle Guan ◽  
Sungjin Kim ◽  
...  
Keyword(s):  
Overall Survival ◽  
Liver Metastasis ◽  
Regression Model ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Ductal Adenocarcinoma ◽  
High Status ◽  
Free Survival ◽  
Pdac Tissue ◽  
Treatment Naïve

e16231 Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive cancers with an estimated five-year survival rate of 10%. The dense desmoplastic stroma in PDAC contributes to its aggressive nature and treatment resistance. Among the components comprising the stroma, hyaluronan (HA) has been demonstrated to play a critical role in tumor progression and survival. Previous preliminary studies have suggested differences in HA expression in primary and metastatic foci in PDAC. However, the effects of treatment and location of HA expression as well as the role of CD44, a known receptor for HA, on HA as a biomarker signature remain unknown. Thus, we investigated the potential of HA as a biomarker in primary PDAC and metastases. Methods: PDAC tissue from primary (n = 43) and metastatic (n = 66) sites were obtained from Cedars-Sinai Medical Center along with associated clinical data. Tissue slides were stained with H&E, HA using a histochemical assay, and CD44 by immunohistochemistry. HA staining was scored according to the proportion of stromal staining at an intensity greater than the background stroma. HA status was defined as ≥ 50% staining being HA high and < 50% as being HA low. CD44 staining was recorded as an H-score (percentage of tumor cells staining multiplied by intensity of staining on a scale from 0 to 3). Associations between HA levels and the requested variables were examined with t-test, Wilcoxon rank-sum test, Chi-squared test, Fisher’s exact test, or Cox regression model where appropriate. Kaplan-Meier curves were created to assess progression free survival and overall survival. Analyses were performed using SAS 9.4 with two-sided tests and a significance level of 0.05. Results: HA score was significantly higher in primary PDAC tissue compared to sites of metastases (p = 0.0148). Within the metastases, HA score was significantly higher in liver metastasis compared to other sites of metastasis (p = 0.0478). In the liver metastasis tissue, HA score trended lower in patients with previously treated tissue compared to treatment naïve tissue (p = 0.0622). In the treatment naive liver metastasis cohort, patients with HA high status had decreased progression free survival and overall survival compared to patients with HA low status (p = 0.0032 and p = 0.0478, respectively). Using HA score and CD44 in a Cox regression model demonstrated that for every one unit increase in HA score, the risk for recurrence/progression increased by 4.4% at any fixed point in time, adjusting for CD44 score (p = 0.0049). Conclusions: HA score is variable between primary PDAC, PDAC metastatic to the liver, and PDAC metastatic to other sites. Within liver metastases, patients with HA high status had decreased progression free survival and overall survival compared to patients with HA low status. HA levels can serve as a potential biomarker to guide pancreatic cancer treatments and trial design for agents targeting the stroma.

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