Real-world data on overall survival associated with biweekly versus weekly cetuximab among metastatic colorectal cancer (mCRC) patients in the United States.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 33-33
Author(s):  
Himani Agg ◽  
Yimei Han ◽  
Zhanglin Lin Cui
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Proportional Hazards ◽  
Stage Iv ◽  
The United States ◽  
Cox Proportional Hazards ◽  
Wild Type ◽  
Real World Data ◽  
Baseline Characteristics ◽  
Ecog Ps

33 Background: Cetuximab 250mg/m2 weekly (Q1W) after an initial dose of 400mg/m2 is approved for treatment of K-Ras wild-type mCRC. In real world 29% of patients received cetuximab 500mg/m2 biweekly (Q2W). In this study overall survival (OS) associated with Q2W vs Q1W dosing of cetuximab for mCRC in real world was compared. Methods: This study utilized Flatiron Health electronic health record-derived database to identify adult patients with stage IV or recurrent K-Ras wild-type mCRC who received cetuximab+FOLFIRI/FOLFOX/irinotecan, or cetuximab monotherapy in first, second or third-line therapy from 01/01/2013 to 12/31/2019. Patients were assigned to Q1W or Q2W cohort if they had 70% or more cetuximab infusions with a gap of 4-10 days or 11-18 days from previous infusion. Patients who did not fall into either cohort were excluded from analysis. Propensity score (PS) matching was used to balance cohorts on their baseline demographic, clinical and treatment characteristics. Kaplan-Meier methods and Cox proportional hazards regressions were used to compare OS. Results: Baseline characteristics for Q2W (N = 422) vs Q1W (N = 653) cohorts before PS matching- median age 62 vs 65 years, male 58.5% vs 59.3%, white 68.3% vs 66.5%, stage IV 56.6% vs 58.5%, ECOG PS 0/1 61.6% vs 52.1%, ECOG PS 2+ 9.2% vs 9.5%. After PS matching, baseline characteristics were balanced. Hazard ratios (HRs) comparing OS in PS-matched Q2W vs Q1W cohorts were not significant for overall or line of therapy populations (Table). Conclusions: Weekly and biweekly cetuximab had comparable effectiveness in this real-world study. [Table: see text]

Predictive value of fibroblast growth factor receptor (FGFR) mutations and gene fusions on anti-PD-(L)1 treatment outcomes in patients (pts) with advanced urothelial cancer (UC).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 419-419 ◽  
Author(s):  
Ademi E. Santiago-Walker ◽  
Fei Chen ◽  
Yohann Loriot ◽  
Arlene O. Siefker-Radtke ◽  
Libo Sun ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Predictive Value ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Growth Factor Receptor ◽  
Molecular Data ◽  
Cox Proportional Hazards ◽  
Real World Data ◽  
Treatment Information

419 Background: FGFR alterations have been shown to be associated with immunologically “cold” UC tumors with low immune marker expression and T cell infiltrate, a poorly receptive environment for immune checkpoint inhibitors. Using a real world matched clinical and genomic dataset of pts with advanced UC, we explored their predictive value in pts receiving anti-PD-(L)1 therapy. Methods: The Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) contained full clinical and treatment information and molecular data on a cohort of pts with confirmed advanced UC. The populations of interest are FGFR+ and FGFR- patients determined by the presence or absence of a prespecified panel of FGFR2/3 mutations and fusions. Overall survival (OS), measured from the start of anti-PD-(L)1 therapy, was analyzed using Kaplan-Meier estimation and Cox proportional hazards models adjusted for left truncation (delayed entry model). Results: 118 pts ( FGFR+ n = 26, FGFR- n = 92) treated with anti-PD-(L)1 therapy for advanced UC were assessed for OS. Median OS for FGFR+ pts who received any line of anti-PD-(L)1 therapy (n = 26) was 3.1 mo vs 6.1 mo for FGFR- pts (n = 92) (hazard ratio [HR] 1.33, 95% CI 0.78-2.26, p = 0.30). For first-line anti-PD-(L)1 therapy, median OS in FGFR+ pts (n = 12) was 4.7 mo vs 11.3 mo for FGFR- pts (n = 28) (HR 1.94, 95% CI: 0.78-4.82, p = 0.15); median OS in second-line were 3.1 mo (n = 12) vs 6.1 mo (n = 47), respectively (HR 1.17, 95% CI 0.53-2.59, p = 0.70). Per multivariate analysis, FGFR+ status appears to be associated with poorer OS in pts treated with any line of anti-PD-(L)1 therapy (HR 1.25, 95% CI 0.71-2.21, p = 0.43). Conclusions: These real-world data suggest that FGFR+ pts following anti-PD-(L)1 therapy for advanced UC may be associated with a trend in poorer overall survival outcome compared with FGFR- pts. These findings are in alignment with treatment history data from BLC2001 (Siefker-Radtke A, et al. ASCO-GU 2018), which showed low response rates to prior anti-PD-(L)1 therapies among FGFR+ pts.

Real-world experience with sipuleucel-T (Sip-T) in Asian men with castrate-resistant prostate cancer (CRPC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17588-e17588
Author(s):  
Jingsong Zhang ◽  
Ming Liu ◽  
Jiahua Pan ◽  
Xiao X. Wei ◽  
Matthew Harmon ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Proportional Hazards ◽  
Specific Antigen ◽  
White Men ◽  
Cox Proportional Hazards ◽  
Real World Data ◽  
Significant Difference ◽  
The Difference ◽  
Castrate Resistant

e17588 Background: Clinical trials of sip-T predominately included white men (over 90%). Previously we explored outcomes with sip-T in white and black patients (pts) (Kantoff PW, NEJM 2010; Sartor AO, ASCO 2019, #5035). In this retrospective analysis of data from electronic medical record and practice management systems, we explored the hypothesis that Asian and white pts who receive sip-T for CRPC exhibit similar overall survival. Methods: Data came from > 100 US community urology practices, predominantly large urology group practice associations. White and Asian pts were matched based on 5 criteria: sip-T treatment year; treatment pattern for oral and sip-T; metastatic site (Bone v. Nodal v. Visceral); prostate-specific antigen (PSA) within 10%; and age at treatment. Parameters retrieved include those listed in the table. Overall survival (OS) was analyzed using Kaplan Meier (KM) methodology with Cox Proportional Hazards Modelling used to generate the hazard ratio (HR) with Asians as the reference. Descriptive summary statistics were generated for other parameters. Results: The analysis identified 102 white and 77 Asian pts; treatment ranged from 2012 to 2019 with 60% receiving sip-T after 2016, impacting the ability to examine long-term outcomes. Characteristics of the 2 groups were broadly similar, although more Asians had Gleason scores ≥8 than whites (Table). In the KM analysis, most pts were censored. While the KM survival curves separate around month 25, favoring Asian pts, the difference is not significant (HR, 0.69 [95% CI: 0.4, 1.4]; P = 0.277). Conclusions: These real-world data do not show a significant difference in OS between Asian and white men. Both groups exhibited relatively low median PSAs near 5 ng/mL, an observation correlated with longer OS in previous studies. [Table: see text]

Utilization and outcomes of primary tumor surgery for stage IV colon cancer in the United States: A population-based study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3542-3542
Author(s):  
Yvonne Sada ◽  
Zhigang Duan ◽  
Hashem El-Serag ◽  
Jessica Davila
Keyword(s):  
Colon Cancer ◽  
Logistic Regression ◽  
Primary Tumor ◽  
Proportional Hazards ◽  
Stage Iv ◽  
The United States ◽  
Cox Proportional Hazards ◽  
Tumor Surgery ◽  
Cancer Specific Survival ◽  
Co Morbidity

3542 Background: Stage IV colon cancer treatment may include resection of the primary tumor. Current use of primary tumor surgery (PTS) in clinical practice is unknown. This study examined utilization and determinants of PTS and evaluated its effect on survival. Methods: Using national Surveillance, Epidemiology, and End Results registry data, stage IV colon cancer patients diagnosed from 1998-2008 were identified. Data on demographics, PTS, and tumor features were collected. Temporal changes in receipt of PTS were examined over 3 periods (1998-2000, 2001-2004, 2005-2008). Multiple logistic regression was used to identify significant determinants of PTS. 1- and 3-year cancer-specific survival was calculated in PTS and non-PTS patients. Cox proportional hazards models examined the effect of PTS on mortality risk. Results: 16,029 patients were identified. Median age was 69 (IQR: 57-78), and 50% were male. Approximately 67% of patients received PTS. Receipt of PTS significantly declined from 72% in 1998-2000 to 68% in 2001-2004, and 63% in 2005-2008 (p<0.01). Results from the logistic regression analysis showed that patients who were younger, white, married, had right sided cancer and higher tumor grade were more likely to receive PTS (all p<0.01). The 1- and 3-year survival was higher in patients who received PTS compared with those who did not (1-year: 55% (95% CI: 54-56) vs. 24% (95% CI: 23-26); 3-year: 19% (95% CI: 19-20) vs. 4% (95%CI: 3.4-4.9)). Adjusted for demographics and tumor features, risk of mortality was 54% (HR=0.46; 95% CI: 0.44-0.48) lower in patients who received PTS than those without PTS. Recent year of diagnosis (HR=0.88; 95% CI: 0.75-0.80) and being married (HR=0.90, 95% CI: 0.86-0.95) were associated with lower mortality. Older age (HR=1.48; 95% CI: 1.39-1.56), black race (HR=1.09; 95% CI: 1.03-1.15), right sided cancer (HR=1.21; 95% CI: 1.17-1.26), and poorly differentiated tumors (HR= 1.62; 95% CI: 1.46-1.80) were associated with increased mortality. Conclusions: PTS utilization for stage IV colon cancer has significantly declined, yet survival was higher in patients who received PTS. However, these findings are limited by the absence of co-morbidity and chemotherapy data.

Real world eligibility of treatment-refractory stage IV colorectal cancer patients for palliative intent regorafenib monotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15007-e15007 ◽  
Author(s):  
Arkhjamil Angeles ◽  
Wayne Hung ◽  
Winson Y. Cheung
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Real World ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Stage Iv ◽  
Correct Trial ◽  
Eligibility Criteria ◽  
Ecog Ps

e15007 Background: The CORRECT trial demonstrated overall survival benefits of regorafenib monotherapy in patients with metastatic colorectal cancer (CRC) who were refractory to prior chemotherapy and biological therapy. However, stringent criteria used to determine treatment eligibility in the trial setting may limit its external validity in the real world. We aimed to examine treatment attrition rates and eligibility of regorafenib in routine clinical practice. Methods: All patients diagnosed with metastatic CRC between 2009 and 2014 who received 2 or more lines of systemic therapy at the British Columbia Cancer Agency were identified. During the study timeframe, cetuximab (cmab) and panitumumab (pmab) were only used in the chemo-refractory setting. Data on clinical factors, pathological variables and outcomes were ascertained and analyzed. Eligibility was defined based on criteria outlined in the CORRECT trial. Results: A total of 391 patients were included among whom only 39% were considered eligible for regorafenib. Median age was 61 (range 22-84) years. 247 (63%) were men, 305 (78%) were Caucasian, and 237 (60%) had a colonic primary. The disease burden at diagnosis was high: 267 (81%) had lymph node involvement, and 225 (59%) had distant metastases. In patients previously treated with cmab, main reasons for regorafenib ineligiblity were Eastern Cooperative Oncology Group performance status (ECOG PS) > 1 (26.9%), aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) (6.5%), and arterio-venous thrombotic or embolic events in the preceding 6 months (6.5%). In the group treated with pmab previously, main reasons for ineligibility were ECOG PS > 1 (46.6%), total bilirubin > 1.5 x ULN (14.1%), and thrombotic or embolic events in the past 6 months (5.7%). Additional analyses showed that regorafenib-eligible patients had increased median overall survival compared to ineligible patients (44.0 vs 37.1 months, P= 0.028). Conclusions: The strict trial eligibility criteria disqualified the majority of real world patients with metastatic CRC for regorfenib. As ineligibility predicts poorer outcomes, trials aimed at serving protocol-ineligible patients are warranted.

Value of precision medicine in advanced NSCLC: Real-world outcomes associated with the use of companion diagnostics.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20015-e20015
Author(s):  
Ani John ◽  
Roma Shah ◽  
William Bruce Wong ◽  
Charles Schneider ◽  
Hamid H. Gari ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Real World ◽  
Proportional Hazards ◽  
Survival Rates ◽  
Prognostic Index ◽  
Cox Proportional Hazards ◽  
Advanced Stage ◽  
Clinical Value ◽  
The Real

e20015 Background: Five-year survival rates as low as 2.8% have been reported in patients with non-small cell lung cancer (NSCLC), highlighting the need for individualized diagnosis and treatment. Companion diagnostic testing (CDx) identifies patients with molecular targets likely to respond better to particular therapies; however, not all cancer patients receive CDx in the real-world setting. This study evaluated the clinical value of CDx in the real world with respect to overall survival among patients with non-squamous advanced (Stage IIIB/IV) NSCLC (aNSCLC). Methods: Patients were from the Flatiron Health electronic health-derived database, treated with systemic therapy, and diagnosed with aNSCLC between January 1, 2011 and May 31, 2018; those who received CDx with their first line of treatment were compared with those who did not. Logistic regression using components of the modified Lung Cancer Prognostic Index (LCPI; age, sex, stage, actionable mutation(s), smoking, respiratory comorbidity; Alexander et al. Br J Cancer. 2017) and other factors were used to predict characteristics associated with receiving CDx. Overall survival was evaluated using Kaplan-Meier analysis. Unadjusted and adjusted Cox proportional hazards regression models were used to evaluate the association between CDx and overall survival. Results: A total of 17,143 patients with aNSCLC (CDx, n = 14,389; no CDx, n = 2754) and a mean (SD) age at diagnosis of 67.2 (10.0) years (CDx, 67.1 [10.1]; no CDx, 67.5 [9.2]) were included. There were more nonsmokers in the CDx group (17.4%) than the no CDx group (5.5%). Patients who were female, diagnosed after 2014, receiving multiple lines of therapy or had advanced stage at diagnosis were more likely to receive CDx. Patients receiving CDx had decreased mortality risk (unadjusted HR [95% CI] = 0.54 [0.52-0.57]) and lived longer than those not receiving CDx (median survival = 14 vs 7 months). The significant reduction in mortality associated with CDx remained after adjusting for factors included in the modified LCPI (adjusted HR [95% CI] = 0.78 [0.75-0.82]) as well as a model without actionable mutations (adjusted HR [95% CI] = 0.70 [0.66-0.73]). Conclusions: Among patients with non-squamous aNSCLC, use of CDx was associated with reduced risk of mortality compared with no CDx.

scholarly journals Multiple immune-related adverse events and anti-tumor efficacy: real-world data on various solid tumors

2020 ◽  
Author(s):  
Keitaro Shimozaki ◽  
Yasutaka Sukawa ◽  
Noriko Beppu ◽  
Isao Kurihara ◽  
Shigeaki Suzuki ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
University Hospital ◽  
Real World Data

Abstract Background Immune checkpoint inhibitors have been approved for various types of cancer; however, they cause a broad spectrum of immune-related adverse events (irAEs). The association between the development of irAEs and the clinical benefit remains uncertain. We aimed to evaluate the association of irAEs and the treatment efficacy in the real-world practice. Methods We conducted a retrospective study on patients with recurrent or metastatic non-small cell lung cancer, melanoma, renal cell carcinoma, or gastric cancer who received anti-PD-1/PD-L1 antibodies (nivolumab, pembrolizumab, or atezolizumab) at the Keio University Hospital between September 2014 and January 2019. We recorded treatment-related AEs from medical records and graded them using the Common Terminology Criteria for Adverse Events version 4. We performed an overall survival (OS) analysis using a Cox proportional hazards model. Results Among 212 patients eligible for this study, 108 experienced irAEs and 42 developed multiple irAEs. OS in patients with multiple irAEs was significantly longer than that in patients with single irAE (42.3 months vs. 18.8 months; hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.25–0.93; P = 0.03). Moreover, OS from the development of a second irAE in those with multiple irAEs was longer than that from the development of the first irAE in patients with single irAEs (median OS, 26.9 months vs. 17.7 months, respectively; HR, 0.59; 95% CI, 0.30–1.14; P = 0.11). Conclusions Our single-center retrospective study revealed a remarkable tendency associating the development of multiple irAEs with favorable prognoses.

scholarly journals Prognostic Factors and a Nomogram Predicting Overall Survival in Patients with Limb Chondrosarcomas: A Population-Based Study

2021 ◽  
Vol 2021 ◽  
pp. 1-17
Author(s):  
Xinjie Wu ◽  
Yanlei Wang ◽  
Wei Sun ◽  
Mingsheng Tan
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Clinical Decision Making ◽  
Proportional Hazards ◽  
Cox Regression ◽  
Training Group ◽  
Clinical Decision ◽  
The United States ◽  
Cox Proportional Hazards ◽  
Predictive Values

Introduction. We aimed to develop and validate a nomogram for predicting the overall survival of patients with limb chondrosarcomas. Methods. The Surveillance, Epidemiology, and End Results (SEER) program database was used to identify patients diagnosed with chondrosarcomas, from which data was extracted from 18 registries in the United States between 1973 and 2016. A total of 813 patients were selected from the database. Univariate and multivariate analyses were performed using Cox proportional hazards regression models on the training group to identify independent prognostic factors and construct a nomogram to predict the 3- and 5-year survival probability of patients with limb chondrosarcomas. The predictive values were compared using concordance indexes ( C -indexes) and calibration plots. Results. All 813 patients were randomly divided into a training group ( n = 572 ) and a validation group ( n = 241 ). After univariate and multivariate Cox regression, a nomogram was constructed based on a new model containing the predictive variables of age, site, grade, tumor size, histology, stage, and use of surgery, radiotherapy, or chemotherapy. The prediction model provided excellent C -indexes (0.86 and 0.77 in the training and validation groups, respectively). The good discrimination and calibration of the nomograms were demonstrated for both the training and validation groups. Conclusions. The nomograms precisely and individually predict the overall survival of patients with limb chondrosarcomas and could assist personalized prognostic evaluation and individualized clinical decision-making.

Progression-free and overall survival analysis in patients with metastatic melanoma undergoing first- versus second-line therapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9078-9078
Author(s):  
J. B. Allred ◽  
V. Suman
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Metastatic Melanoma ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Stage Iv ◽  
Cox Proportional Hazards ◽  
Line Therapy ◽  
The Relationship ◽  
Stage Iv Melanoma

9078 Background: A frequently discussed topic at meetings of oncologists is the question of expected clinical outcomes for patients with metastatic melanoma undergoing 1st vs 2nd line systemic therapy. Differing outcomes in these two patient populations could affect interpretation of non-randomized clinical trials involving both patient populations. Some have suggested superior clinical outcome in patients undergoing 2nd line therapy. As there is little data addressing this issue, we sought to answer the question by comparing the clinical outcomes of patients with metastatic melanoma treated on 1st vs 2nd line therapy across clinical trials conducted at our institution. Methods: Data were collected from 10 phase II clinical trials for patients with stage IV melanoma for which Mayo Clinic was the data center. The 10 trials included three categories of treatments: cytotoxic chemotherapy (4), cancer vaccines (4), and biologic agents (2). In all studies, eligibility criteria required: stage IV melanoma, life expectancy >3 months, reasonable hematology and serum chemistry laboratory results, and an ECOG performance status of ≤2. Cox proportional hazards models were fit to assess the relationship between patients' “therapy” status (1st vs 2nd line) and time to events, both overall survival (OS) and progression free survival (PFS), for each treatment category. Results: We identified 318 unique eligible patients across 10 trials. Removed from the analysis were 55 patients (ocular melanoma and/or metastases involving the central nervous system) leaving 263. Cox proportional hazards results demonstrated no differences in PFS or OS for 1st vs 2nd line patients for either “chemotherapy” or “vaccine” treatment regimens. However, patient treated on “biologic” trials as 1st line therapy appeared to demonstrate a PFS advantage over 2nd line treatments (HR=1.98, p-value=0.02). There was a suggestion of an OS benefit for 1st line patients in this category, however, the relationship was not significant (HR=1.77, p=0.07). Conclusions: The presented data suggest that there is no PFS/OS difference in stage IV melanoma patients receiving 1st vs 2nd line therapy (no PFS/OS advantage to patients treated in 2nd line vs. 1st line). No significant financial relationships to disclose.

Does up-front definitive surgical resection with delayed chemotherapy in patients with stage IV rectal cancer compromise overall survival?

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 586-586
Author(s):  
Bindu V. Manyam ◽  
Shlomo A. Koyfman ◽  
Davendra Sohal ◽  
Ismail Mallick ◽  
Chandana A. Reddy ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Surgical Resection ◽  
Proportional Hazards ◽  
Performance Status ◽  
Rectal Adenocarcinoma ◽  
Stage Iv ◽  
Cox Proportional Hazards ◽  
Significant Difference ◽  
Poorly Differentiated

586 Background: Definitive resection of the primary is frequently part of the management of patients (pts) with stage IV rectal cancer with good performance status and low volume of systemic metastases. It is unclear whether delaying systemic therapy for up front surgical management of the primary compromises overall survival (OS). Methods: Pts with metastatic rectal adenocarcinoma who received definitive surgical resection between 1998-2011 were identified in an IRB approved registry. The sequencing of CT and surgery, and the use of perioperative radiation therapy (RT), was at the discretion of treating physicians. Preoperative chemotherapy (Pre-CT) regimens included 5-fluorouracil (5-FU) +/- leukovorin (LV), capecitabine, 5-FU/LV/oxaliplatin +/- avastin, or 5-FU/LV/irinocetan. RT dose was typically 50.4 Gy. OS was measured from the date of diagnosis. Baseline variables were compared using the Chi-square and unpaired t-tests. OS was calculated using the Kaplan Meier method. Univariate (UVA) and multivariate analysis (MVA) were performed using Cox proportional hazards regression to identify variables associated with OS. Results: In this study of 115 pts, 75 (65%) were treated with pre-CT, while 40 (35%) were treated with up front surgery. Of the pts who received surgery up front, 3 (8%) received RT and of the pts who received pre-CT, 62 (83%) received RT. The cohort was predominantly male (70%) with a median age of 57, median KPS of 80, and median follow-up of 24.1 months. 94% of pts had T3/T4 tumors, 80% had N+ disease, and 33% had poorly differentiated tumors. Liver directed therapy (LDT) was performed in 61% of pts. There was no significant difference in OS (32.3 vs. 32 months; p = 0.24) between pts treated with pre-CT and those who received surgery up front, respectively. UVA demonstrated that pre-CT was not associated with OS (HR 1.26; p = 0.544). MVA demonstrated that pts with poorly differentiated tumors (HR 2.04; p = 0.007) and those that did not undergo LDT (HR 2.45; p = 0.001) had inferior survival. Conclusions: Delaying systemic chemotherapy in order to achieve local control with surgical resection up front does not appear to impact OS in pts with stage IV rectal cancer.

A tertiary cancer center experience with yttrium-90 radioembolization in hepatocellular carcinoma.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 443-443
Author(s):  
Kerry Schaffer ◽  
Marcus Smith Noel ◽  
Aram F. Hezel ◽  
Alan W. Katz ◽  
Ashwani Sharma ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Proportional Hazards ◽  
Cox Model ◽  
The United States ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Bridge To Transplant ◽  
Kaplan Meier ◽  
Pugh Class

443 Background: Local-regional radioembolization with Yitrium-90 (Y-90) has become standard practice for patients with hepatocellular carcinoma (HCC) either as a bridge to transplant, or for local disease control. Outcomes data in the United States are limited and here we review our institutional experience with Y-90 radioembolization. Methods: We retrospectively reviewed charts from 70 patients with HCC who were treated with Y-90 from May 2010- January 2014. Clinical variables including Child-Pugh class and CLIP score were extracted from patient records. The Cox proportional hazards model was used to determine prognostic factors, and Kaplan-Meier curves were used to determine PFS and OS. Results: Median age was 61 (range 43-82), 79% Caucasian, 84% male, and 79% Child-Pugh class A. Median progression free survival (PFS) was 8.4 months (95% CI 6-10.7) and overall survival (OS) was 14.2 months (95% CI 9.7-21). Overall survival significantly differed by Child -Pugh score (p= 0.009), CLIP score (p=0.003), and presence of portal vein thrombosis (PVT) (p=0.0384), based on the log-rank test comparing Kaplan-Meier curves. Using univariate Cox proportional hazards models, both elevated baseline AFP, measured on a log scale (HR 1.79, 95% CI 1.32-2.43, p=0.0002) and post Y-90 treatment with sorafenib (HR=2.30, 95% CI 1.07-4.95, p=0.03) were associated with worse mortality. Elevated AFP (HR 2.45, 95% CI 1.73-3.47, p<0.0001) and Child-Pugh score of B (HR 4.83, 95% CI 2.23-10.43, p<0.0001) were associated with worse mortality in a multivariate Cox model adjusting for age and ethnicity. Furthermore, AFP values were significantly higher in the 10 patients who died within 4 months of Y-90 (p=0.001), and significantly lower in 7 patients who eventually received a liver transplant (p=0.0002). Conclusions: In patients undergoing treatment with Y-90 radioembolization, Child-Pugh class, CLIP score, presence of PVT, baseline AFP, and sorafenib post Y-90 were significantly associated with overall survival. Median PFS and OS data in this institutional cohort are encouraging. Further prospective studies on Y-90 treatment for HCC are warranted.

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