scholarly journals Transarterial Chemoembolization Followed by Radiotherapy Versus Sandwich Treatment for Unresectable or Ablative Hepatocellular Carcinoma

2020 ◽  
Vol 19 ◽  
pp. 153303382098379
Author(s):  
Haimin Lin ◽  
Huiyong Wu ◽  
Ning Cong ◽  
Bo Liu ◽  
Chengxin Liu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Transarterial Chemoembolization ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Conformal Radiotherapy ◽  
Rank Test ◽  
Virus Reactivation ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3

Objective: Our objective is to assess whether the outcome of intrahepatic unresectable or ablative hepatocellular carcinoma (HCC) could be improved by supplemental transarterial chemoembolization (TACE) following initial treatment of TACE with 3-dimensional conformal radiotherapy (3DCRT), compared to TACE followed by 3DCRT alone. Methods: We retrospectively analyzed intrahepatic unresectable or ablative HCC patients who underwent TACE, followed by 3DCRT with or without additional TACE, from June 2010 to December 2016 at our institution. Survival was assessed using the Kaplan-Meier method and compared with the log-rank test. Cox regression analyses were used to identify factors that influenced prognosis. Toxicity profiles were evaluated using CTCAE 4.0. Results: 27 patients received TACE with 3DCRT (TR group) and 11 received additional TACE following TACE and 3DCRT (sandwich group), respectively. The median intrahepatic progression-free survival (IPFS), progression-free survival (PFS), and overall survival (OS) in the TR group and sandwich group were 5.4 months vs. 17 months (P = 0.018), 5.4 months vs. 17 months (P = 0.008), and 13.5 months vs. 29.2 months (P = 0.011), respectively. Multivariate Cox regression demonstrated that TACE followed by radiotherapy alone had a shorter IPFS (HR: 2.516, 95% CI (1.136-5.570), P = 0.023) and PFS (HR: 2.637, 95% CI (1.182-5.880), P = 0.018) compared with the sandwich treatment. Hepatitis B virus reactivation occurred in 1 patient in the sandwich group. Myleosuppresion was considered a grade 3/4 adverse event. Conclusion: Unresectable or ablative HCC patients possibly benefit from the combination of TACE and 3DCRT followed by additional TACE therapy, compared with TACE followed by 3DCRT alone.

scholarly journals Transarterial Chemoembolization Combined with Radiofrequency Ablation in the Treatment of Stage B1 Intermediate Hepatocellular Carcinoma

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Furong Liu ◽  
Minshan Chen ◽  
Jie Mei ◽  
Li Xu ◽  
Rongping Guo ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiofrequency Ablation ◽  
Transarterial Chemoembolization ◽  
Progression Free Survival ◽  
Intermediate Stage ◽  
Multivariate Regression Analysis ◽  
Rank Test ◽  
Free Survival ◽  
Kaplan Meier ◽  
Tace Group

Background. Due to the heterogeneity of patients with Barcelona clinic liver cancer (BCLC) intermediate-stage hepatocellular carcinoma (HCC), Bolondi criteria were proposed and patients were divided into four substages. The purpose of this study was to compare the survival of substage B1 patients who were initially treated with a combination of transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) (TACE-RFA) or TACE alone. Methods. 404 patients with stage B1 HCC were retrospectively analyzed from January 2005 to December 2012. 209 patients received TACE-RFA, and 195 received TACE alone as initial treatment. The overall survival (OS) and progression-free survival (PFS) rates were estimated by the Kaplan–Meier method and compared by the log-rank test. Results. 1-, 3-, and 5-year OS rates were 83.7%, 45.8%, and 24.8% in the TACE-RFA group and 80.7%, 26.4%, and 16.7% in the TACE group, respectively (P=0.003). The corresponding PFS rates were 71.8%, 26.6%, and 13.0% and 59.1%, 11.0%, and 2.2% in the TACE-RFA group and TACE group, respectively (P<0.001). Multivariate regression analysis indicated that tumor size (OS: hazard ratio (HR) = 0.683, P=0.001; PFS: HR = 0.761, P=0.013), along with treatment allocation (OS: HR = 0.701, P=0.003; PFS: HR = 0.620, P<0.001), was the independent prognostic factor for both OS and PFS. Conclusions. Combination TACE and RFA treatment yielded better survival than TACE alone for patients with stage B1 HCC according to the Bolondi criteria.

scholarly journals Response and Toxicity to the Second Course of 3 Cycles of 177Lu-PSMA Therapy Every 4 Weeks in Patients with Metastatic Castration-Resistant Prostate Cancer

Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2489
Author(s):  
Sazan Rasul ◽  
Tim Wollenweber ◽  
Lucia Zisser ◽  
Elisabeth Kretschmer-Chott ◽  
Bernhard Grubmüller ◽  
...  
Keyword(s):  
Response Rate ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Castration Resistant Prostate Cancer ◽  
Radioligand Therapy ◽  
Free Survival ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Node Metastases ◽  
Grade 3

Background: We investigated the response rate and degree of toxicity of a second course of three cycles of [177Lu]Lu-PSMA radioligand therapy (PSMA-RLT) every 4 weeks in mCRPC patients. Methods: Forty-three men (71.5 ± 6.6 years, median PSA 40.8 (0.87–1358 µg/L)) were studied. The response was based on the PSA level 4 weeks after the third cycle. The laboratory parameters before and one month after the last cycle were compared. Kaplan–Meier methods were used to estimate the progression-free survival (PFS) and overall survival (OS), and the Cox regression model was performed to find predictors of survival. Results: Twenty-six patients (60.5%) exhibited a PSA reduction (median PSA declined from 40.8 to 20.2, range 0.6–1926 µg/L, p = 0.002); 18 (42%) and 8 (19%) patients showed a PSA decline of ≥50% and ≥80%, respectively. The median OS and PFS were 136 and 31 weeks, respectively. The patients with only lymph node metastases survived longer (p = 0.02), whereas the patients with bone metastases had a shorter survival (p = 0.03). In the multivariate analysis, only the levels of PSA prior to the therapy remained significant for OS (p < 0.05, hazard ratio 2.43, 95% CI 1.01–5.87). The levels of hemoglobin (11.5 ± 1.7 g/dL vs. 11 ± 1.6 g/dL, p = 0.006) and platelets (208 ± 63 g/L vs. 185 ± 63 g/L, p = 0.002) significantly decreased one month after cycle three, though only two grade 3 anemia and one grade 3 thrombocytopenia were recorded. Conclusion: A further intensive PSMA-RLT course is well tolerated in mCRPC patients and associated with promising response rates and OS.

scholarly journals PD-L1 expression is a promising predictor of survival in patients with advanced lung adenocarcinoma undergoing pemetrexed maintenance therapy

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yi Qin ◽  
Lili Jiang ◽  
Min Yu ◽  
Yanying Li ◽  
Xiaojuan Zhou ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Lung Adenocarcinoma ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
Bivariate Correlation ◽  
Kaplan Meier ◽  
Alk Positive ◽  
Ecog Ps

Abstract This study aimed to identify potential predictive factors for the survival of advanced lung adenocarcinoma patients undergoing pemetrexed maintenance therapy. 122 advanced lung adenocarcinoma patients who received pemetrexed maintenance therapy were retrospectively analyzed. Kaplan–Meier method with Log-rank test was used for survival analysis. Univariate and multivariate Cox regression were performed to evaluate prognostic factors for overall survival (OS) and progression-free survival (PFS). Bivariate correlation analysis was used for exploratory purpose. For the whole cohort of 122 patients, median PFS was 11.97 months (95% CI 10.611–13.329) and estimated median OS was 45.07 months (95% CI 31.690–58.450). The mPFS of ALK-positive patients was superior to negative patients (18.27 vs. 11.90 months; P  = 0.039). Patients with ECOG PS 0 (14.4 vs. 11.1 months; p = 0.040) and patients with single-organ metastasis (19.0 vs. 11.0 months; p = 0.014) had prolonged median PFS. Compared with the low PD-L1 expression group, PFS of high PD-L1 expression group were improved (13.6 vs. 11.1 months, p = 0.104, at 1% cut-off; 17.5 vs. 11.1 months, p = 0.009, at 10% cut-off; and 27.5 vs. 11.4 months, p = 0.005, at 50% cut-off). No differences were found between EGFR positive and negative patients. PD-L1 expression was an independent prognostic factor for both PFS and OS times (PFS: HR, 0.175; P  = 0.001; OS: HR, 0.107; P  = 0.036). Bivariate correlation showed a significant positive correlation between PD-L1 expression and PFS (correlation coefficient R = 0.485, P  < 0.001). High PD-L1 expression could be a potential effective predictor for favorable survival of advanced lung adenocarcinoma patients undergoing pemetrexed maintenance therapy.

scholarly journals Transarterial Chemoembolization of Hepatocellular Carcinoma with Oncozene Microspheres: An Initial, Short-Term Clinical Experience—A Retrospective, Matched, Comparison Study

Life ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 600
Author(s):  
Matthew L. Hung ◽  
Jerry Jiang ◽  
Harry Trieu ◽  
Frank Hao ◽  
Navid Eghbalieh ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Transarterial Chemoembolization ◽  
Tumor Response ◽  
Progression Free Survival ◽  
Embolic Agent ◽  
Rank Test ◽  
Fisher Exact Test ◽  
Short Term ◽  
Free Survival

Background: The purpose of this study is to describe a single institution’s experience using Oncozene (OZ) microspheres for transarterial chemoembolization (OZ-TACE) of hepatocellular carcinoma (HCC), and to compare tolerability, safety, short-term radiographic tumor response, progression-free survival (PFS), and overall survival (OS) of these procedures to TACE (LC-TACE) performed with LC beads (LC). Methods: A retrospective, matched cohort study of patients undergoing DEB-TACE (drug-eluting bead transarterial chemoembolization) with OZ or LC was performed. The cohort comprised 23 patients undergoing 29 TACE with 75 or 100 μm OZ and 24 patients undergoing 29 TACE with 100–300 μm LC. Outcome measures were changes in liver function tests, complications, treatment tolerability, short-term radiographic tumor response according to modified RECIST criteria for HCC, PFS, and 1-year OS. The Mann–Whitney U test, Fisher exact test, and log rank test were used to compare the groups. Results: The BCLC or Child–Pugh scores were similar between the OZ and LC group. However, the two groups differed with respect to the etiology of background cirrhosis (p = 0.02). All other initial demographic and tumor characteristics were similar between the two groups. OZ-TACE used less doxorubicin per treatment compared to LC-TACE (median 50 vs. 75 mg; p = 0.0005). Rates of pain, nausea, and postembolization syndrome were similar, irrespective of the embolic agent used. OZ-TACE resulted in an overall complication rate comparable to LC-TACE (20.7% vs. 10.3%; p = 0.47). LC-TACE resulted in a higher percent increase in total bilirubin on post-procedure day 1 (median 18.8 vs. 0%; p = 0.05), but this difference resolved at 1 month. Both OZ-TACE and LC-TACE resulted in similar complete (31% vs. 24%) and objective (66% vs. 79%) target lesion response rates on 1-month post-TACE imaging. Both OZ-TACE and LC-TACE had similar median progression-free survival (283 vs. 209 days; p = 0.14) and 1-year overall survival rates (85% vs. 76%; p = 0.30). Conclusion: With a significantly reduced dose of doxorubicin, TACE performed with Oncozene microspheres in a heterogeneous patient population is well-tolerated, safe, and produces a similar radiological response and survival rate when compared to LC Bead TACE.

scholarly journals Nomograms including the controlling nutritional status (CONUT) score in patients with hepatocellular carcinoma undergoing transarterial chemoembolization for prediction survival: A retrospective analysis

2021 ◽  
pp. 1-28
Author(s):  
Yi Chen ◽  
Wen-ji Xu ◽  
Yi Yang ◽  
Yu-Jing Xin ◽  
Xin-yuan Zhang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Nutritional Status ◽  
Transarterial Chemoembolization ◽  
Cox Regression ◽  
Multivariate Analyses ◽  
Intermediate Stage ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Conut Score

Abstract Objectives: This retrospective study investigated the predictive value of the Controlling Nutritional Status (CONUT) score in patients with intermediate-stage hepatocellular carcinoma (HCC) who received transarterial chemoembolization (TACE). Nomograms were developed to predict progression-free and overall survival (PFS, OS). Methods: The medical data of 228 patients with HCC and treated with TACE were collected. The patients were apportioned to 2 groups according to CONUT score: low or high (<4, ≥4). Univariate and multivariate analyses were performed using Cox regression for OS and PFS. OS and PFS were estimated by the Kaplan-Meier curve and compared with the log-rank test. Nomograms were constructed to predict patient OS and PFS. The nomograms were evaluated for accuracy, discrimination, and efficiency. Results: The cut-off value of CONUT score was 4. The higher the CONUT score, the worse the survival; Kaplan-Meier curves showed significant differences in OS and PFS between the low and high CONUT score groups (P = 0.033, 0.047). The nomograms including CONUT, based on the prognostic factors determined by the univariate and multivariate analyses, to predict survival in HCC after TACE were generated. Conclusions: The CONUT score is an important prognostic factor for both OS and PFS for patients with intermediate HCC who underwent TACE. The cut-off value of the CONUT score was 4. A high CONUT score suggests poor survival outcomes. Nomograms generated based on the CONUT score were good models to predict patient OS and PFS.

scholarly journals Effectiveness of stereotactic ablative radiotherapy in patients with advanced hepatocellular carcinoma unsuitable for transarterial chemoembolization

2019 ◽  
Vol 11 ◽  
pp. 175883591988900
Author(s):  
Hsin-Lun Lee ◽  
Jo-Ting Tsai ◽  
Chun-You Chen ◽  
Ying-Chun Lin ◽  
Chin-Beng Ho ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Transarterial Chemoembolization ◽  
Linear Accelerator ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Tumor Control ◽  
Stereotactic Ablative Radiotherapy ◽  
Tumor Diameter ◽  
Advanced Hepatocellular Carcinoma ◽  
Free Survival

Background: Stereotactic ablative radiotherapy (SABR) can deliver tumoricidal doses and achieve long-term control in early hepatocellular carcinoma (HCC). However, limited studies have investigated the safety and effectiveness of SABR in patients with advanced diseases that is unsuitable for transarterial chemoembolization (TACE). Methods: In this observational study, we reviewed the medical records of patients with Barcelona Clinic Liver Cancer (BCLC) stage C disease treated with linear accelerator-based SABR between 2008 and 2016. Their tumors were either refractory to TACE or TACE was contraindicated. Overall survival (OS), in-field progression-free survival (IFPFS), and out-field progression-free survival were calculated using Kaplan–Meier analysis. The Cox regression model was used to examine the effects of variables. Treatment-related toxicities were scored according to the Common Terminology Criteria for Adverse Events (version 4.03) and whether patients developed radiation-induced liver disease (RILD) after SABR. Results: This study included 32 patients. The mean maximal tumor diameter and tumor volumes were 4.7 cm and 135.9 ml, respectively. Patients received linear accelerator-based SABR with a median prescribed dose of 48 Gy (30–60 Gy) in three to six fractions. Based on the assessment of treatment response by using the Response Evaluation Criteria in Solid Tumors (version 1.1), 19% of patients achieved a complete response and 53% achieved a partial response. After a median follow-up of 18.1 months (4.0–65.9 months), 10, 19, and 9 patients experienced in-field failure, out-field hepatic recurrence, and extrahepatic metastases, respectively. The estimated 2-year OS and IFPFS rates were 54.4% and 62.7%, respectively. In a multivariate analysis, a pretreatment Cancer of the Liver Italian Program (CLIP) score of ⩾2 ( p = 0.01) was a prognostic factor for shorter OS, and a biologically effective dose (BED) of < 85 Gy10 ( p = 0.011) and a Child–Pugh score of ⩾6 ( p = 0.014) were prognostic factors for inferior IFPFS. In this study five and eight patients developed classic and nonclassic RILD, respectively. Conclusions: SABR can serve as a salvage treatment for patients with HCC with BCLC stage C disease unsuitable for TACE, in particular, in those with a baseline CLIP score of ⩽1. A BED10 of ⩾85 Gy is an appropriate prescribed dose for tumor control. Because out-field relapse is the major cause of treatment failure, SABR in combination with novel systemic modalities should be investigated in future studies.

scholarly journals Development and Validation of a Predictive Model for Early Refractoriness of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

2021 ◽  
Vol 8 ◽  
Author(s):  
Tian-Cheng Wang ◽  
Tian-Zhi An ◽  
Jun-Xiang Li ◽  
Zi-Shu Zhang ◽  
Yu-Dong Xiao
Keyword(s):  
Hepatocellular Carcinoma ◽  
Logistic Regression ◽  
Predictive Model ◽  
Transarterial Chemoembolization ◽  
Progression Free Survival ◽  
Rank Test ◽  
Stepwise Logistic Regression ◽  
Kaplan Meier ◽  
Tumor Distribution ◽  
Validation Set

Objectives: To develop and validate a predictive model for early refractoriness of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).Methods: In this multicenter retrospective study, a total of 204 consecutive patients who initially underwent TACE were included. Early TACE refractoriness was defined as patients presented with TACE refractoriness after initial two consecutive TACE procedures. Of all patients, 147 patients (approximately 70%) were assigned to a training set, and the remaining 57 patients (approximately 30%) were assigned to a validation set. Predictive model was established using forward stepwise logistic regression and nomogram. Based on factors selected by logistic regression, a one-to-one propensity score matching (PSM) was conducted to compare progression-free survival (PFS) between patients who were present or absent of early TACE refractoriness. PFS curve was estimated by Kaplan-Meier method and compared by log-rank test.Results: Logistic regression revealed that bilobar tumor distribution (p = 0.002), more than three tumors (p = 0.005) and beyond up-to-seven criteria (p = 0.001) were significantly related to early TACE refractoriness. The discriminative abilities, as determined by the area under the receiver operating characteristic (ROC) curve, were 0.788 in the training cohort and 0.706 in the validation cohort. After PSM, the result showed that patients who were absent of early TACE refractoriness had a significantly higher PFS rate than those of patients who were present (p &lt; 0.001).Conclusion: This study presents a predictive model with moderate accuracy to identify patients with high risk of early TACE refractoriness, and patients with early TACE refractoriness may have a poor prognosis.

scholarly journals High Visceral Adipose Tissue Density Correlates With Unfavorable Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization

2021 ◽  
Vol 9 ◽  
Author(s):  
Qiang Li ◽  
Lei Zhang ◽  
Zhong-Heng Hou ◽  
Dong-Xu Zhao ◽  
Jian-Bin Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Body Composition ◽  
Adipose Tissue ◽  
Transarterial Chemoembolization ◽  
Cox Regression ◽  
Intermediate Stage ◽  
Rank Test ◽  
Muscle Area ◽  
Cox Regression Analysis ◽  
Kaplan Meier

Objectives: This study aimed to evaluate the association between different body composition features with prognostic outcomes of intermediate stage hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).Methods: The areas and density of skeletal muscle area (SM) and adipose tissue [subcutaneous (SAT); visceral (VAT)] were calculated on the pre-TACE CT scans. Overall survival (OS) and progression-free survival (PFS) curves were calculated using the Kaplan–Meier method and compared with log-rank test. The discrimination and performance of body composition features were measured by area under time-dependent receiver operating characteristic (ROC) curve. Univariate and multivariate Cox proportional hazard analyses were applied to identify the association between body composition parameters and outcomes.Results: A significant prolonged OS and PFS was displayed by Kaplan–Meier curve analysis for HCC patients with VAT HU below −89.1 (25.1 months, 95% CI: 18.1–32.1 vs. 17.6 months, 95% CI: 16.3–18.8, p &lt; 0.0001, 15.4 months, 95% CI: 10.6–20.2 vs. 6.6 months, 95% CI: 4.9–8.3, p &lt; 0.0001, respectively). The 1-, 2-, 3-, and 5-year OS area under the curve (AUC) values of the VAT HU were higher than the other body composition parameters. Meanwhile, it is also found that 3-, 6-, 9-, and 12-month PFS AUC values of VAT HU were the highest among all the parameters. Univariate and multivariate Cox-regression analysis suggested a significant association between VAT density and outcomes (OS, HR: 1.015, 95% CI: 1.004–1.025, p = 0.005, PFS, HR: 1.026, 95% CI: 1.016–1.036, p &lt; 0.0001, respectively).Conclusion: The VAT density could provide prognostic prediction value and may be helpful to stratify the intermediate stage HCC patients.

Pomalidomide (Pom) in Relapsed and Refractory Multiple Myeloma (RRMM) - theUARK Compassionate Use Protocol,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3995-3995
Author(s):  
Saad Usmani ◽  
Sarah Waheed ◽  
Jackie Szymonifka ◽  
Susan Panozzo ◽  
Nathan M Petty ◽  
...  
Keyword(s):  
Research Funding ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Compassionate Use ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3

Abstract Abstract 3995 Background: Pom is a third generation immunomodulatory drug (IMiD) which has demonstrated safety and efficacy in RRMM with prior exposure/resistant to other IMiDs and bortezomib. This is the first report on the UARK Pom compassionate use experience in RRMM. Methods: First cycle Pom was given at 4mg orally Days 1–21 every 28 days; dexamethasone (DEX) was given to 9/23 patients at doses varying from 12 to 40 mg on schedules ranging from Days 1–4, weekly, twice a week, or three times a week. In the absence of at least PR, Pom dose was escalated to 5mg. 1patient also received bortezomib and 1 patient received bortezomib and cytoxan. Cox regression modeling was employed for univariate and multivariate analyses, whereas Kaplan-Meier curves were used for overall survival (OS) and progression free survival (PFS). Results: 23 patients with RRMM were enrolled. Baseline characteristics included age >=65yr in 43%, ISS stage >=II was seen in 78% of patients, cytogenetic abnormalities (CA) within 6 months in 80%, and GEP-defined high risk in 41% of patients. 22/23 patients (96%) had prior autologous stem cell transplant. 19/23 patients (83%) had at least 2 transplants. All 23 patients had disease progression after having received regimens containing bortezomib, thalidomide, lenalidomide, melphalan and steroids. At least 1 cycle of treatment was administered to all 23 patients enrolled, 52% of patients received >1 cycle of treatment and only 13% received =>5 cycles. 10 patients (43%) discontinued therapy primarily due to progression or death. 5/23 (22%) patients achieved PR, 57% had stable disease. A trend towards PFS benefit was observed in patients receiving cycle 2 (HR=0.30, p=0.215) on univariate analysis and multivariate analysis (HR=0.40, p=0.48) after adjusting for GEP-defined risk status (HR=2.69, p=0.16). Most common toxicities, counting all toxicities (>=grade 3) were: thrombocytopenia (70%), leukopenia (61%), anemia (43%), hypophosphatemia (35%) and hypokalemia (26%). Overall and progression- free survival at 12 months were 52% and 30%, respectively. Conclusions: Pom demonstrates anti-myeloma activity in this advanced RRM population, especially in a sub-population with GEP-defined low-risk disease. Disclosures: Barlogie: Celgene: Consultancy, Honoraria, Research Funding; IMF: Consultancy, Honoraria; MMRF: Consultancy; Millennium: Consultancy, Honoraria, Research Funding; Genzyme: Consultancy; Novartis: Research Funding; NCI: Research Funding; Johnson & Johnson: Research Funding; Centocor: Research Funding; Onyx: Research Funding; Icon: Research Funding.

Retrospective analysis of ipilimumab-induced diarrhea and/or colitis: A single centre review.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21064-e21064 ◽  
Author(s):  
Marco Adelmo James Iafolla ◽  
Gregory Russell Pond ◽  
Elaine McWhirter
Keyword(s):  
Cox Regression ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Published Data ◽  
Free Survival ◽  
Severe Diarrhea ◽  
Patient Demographics ◽  
Kaplan Meier ◽  
Melanoma Patients ◽  
Grade 3

e21064 Background: Ipilimumab is an effective medication in advanced melanoma but can cause severe diarrhea and colitis. This study identified the rate of ipilimumab-induced diarrhea/colitis at the Juravinski Cancer Centre (JCC), its associated factors for development, overall survival (OS) and progression free survival (PFS). Methods: The Ontario Patient Information System was used to retrospectively identify all melanoma patients at the JCC who were treated with ipilimumab 3 mg/kg IV every 3 weeks (September 2012 to June 2016). Patient demographics, medical history, prior melanoma treatments, diagnosis of ipilimumab-induced diarrhea/colitis, interventions to treat the diarrhea/colitis, and OS and PFS were collected. Descriptive statistics summarized characteristics and outcomes. Kaplan-Meier methods estimated time to event outcomes. Cox regression evaluated whether markers were prognostic for time to diarrhea/colitis diagnosis. Results: 71 patients were treated with ipilimumab at the JCC, of which 22 patients (31%) developed diarrhea/colitis of any Grade; 4 patients developed Grade 1, 5 patients Grade 2, 6 patients Grade 3, 3 patients Grade 4, and 4 patients had unclear Grade. 11 patients required prednisone 1-2 mg/kg and 2 patients required anti-TNF treatment to treat their diarrhea/colitis; 1 patient required colectomy due to perforation. 10 patients required treatment discontinuation due to diarrhea/colitis. Whole cohort median OS and PFS was 340 days (95% CI 205, 519) and 110 days (95% CI 91, 138), respectively. Univariate analysis showed that only inadequate hematologic function at time of first ipilimumab application was prognostic of diarrhea/colitis (HR = 6.42, 95% CI 1.44, 28.62; p = 0.015). Conclusions: Our OS, PFS, and rate of all grade ipilimumab-induced diarrhea/colitis are similar to published data, however our rate of Grade > 2 is larger. Additional work is needed to identify risk factors for the development of this immune related adverse event.

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