scholarly journals Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma: Phase 3 Randomized, Open-Label IMbrave150 Study

Liver Cancer ◽  
2021 ◽  
pp. 1-13
Author(s):  
Shukui Qin ◽  
Zhenggang Ren ◽  
Yin-Hsun Feng ◽  
Thomas Yau ◽  
Baocheng Wang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Safety Data ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Extension Phase ◽  
Chinese Patients ◽  
Open Label ◽  
Phase 3 ◽  
Unresectable Hepatocellular Carcinoma ◽  
Grade 3

<b><i>Introduction:</i></b> Atezolizumab plus bevacizumab significantly improved overall survival (OS) and progression-free survival (PFS) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in IMbrave150. Efficacy and safety data from the Chinese subpopulation are reported. <b><i>Methods:</i></b> IMbrave150, a global, randomized, open-label, phase 3 study in patients with systemic treatment-naive unresectable HCC, included an extension phase that enrolled additional patients from mainland China. Patients were randomized (2:1) to receive intravenous atezolizumab 1,200 mg plus bevacizumab 15 mg/kg once every 3 weeks or sorafenib 400 mg twice a day until unacceptable toxicity or loss of clinical benefit. Co-primary endpoints were OS and independent review facility-assessed PFS per Response Evaluation Criteria in Solid Tumors version 1.1 in the intention-to-treat population. <b><i>Results:</i></b> Of 194 Chinese patients enrolled from April 16, 2018, to April 8, 2019 (137 in the global study and 57 in the China extension phase), 133 received atezolizumab plus bevacizumab and 61 received sorafenib. At the data cutoff (August 29, 2019), the stratified hazard ratio for OS was 0.44 (95% CI, 0.25–0.76) and for PFS was 0.60 (95% CI, 0.40–0.90). The respective median OS and PFS with atezolizumab plus bevacizumab were not reached (NR; 95% CI, 13.5 months to NR) and 5.7 months (95% CI, 4.2–8.3) versus 11.4 months (95% CI, 6.7 to NR) and 3.2 months (95% CI, 2.6–4.8) with sorafenib. Grade 3–4 adverse events (AEs) occurred in 78 of 132 (59.1%) atezolizumab plus bevacizumab-treated and 27 of 58 (46.6%) sorafenib-treated patients. The most common grade 3–4 AE with atezolizumab plus bevacizumab was hypertension, occurring in 15.2% of patients; however, other high-grade AEs were infrequent. <b><i>Conclusion:</i></b> Clinically meaningful improvements in OS and PFS observed with atezolizumab plus bevacizumab versus sorafenib suggest that atezolizumab plus bevacizumab may become a practice-changing treatment for Chinese patients with unresectable HCC.

scholarly journals An Expanded Treatment Protocol of Panobinostat Plus Bortezomib and Dexamethasone in Patients with Previously Treated Myeloma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3027-3027
Author(s):  
Vincent L Hansen ◽  
Morton Coleman ◽  
Stephanie Elkins ◽  
Jeffrey P. Letzer ◽  
Moshe Yair Levy ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Stable Disease ◽  
Safety Data ◽  
Treatment Protocol ◽  
Treatment Phase ◽  
Progression Free Survival ◽  
Open Label ◽  
Phase 3 ◽  
Advisory Committees ◽  
Grade 3

Abstract Introduction: Panobinostat (PAN) is a potent pan-deacetylase inhibitor that targets multiple myeloma (MM) cells via its effects on epigenetics and protein metabolism. In the PANORAMA 1 phase 3 trial, the combination of PAN, bortezomib (BTZ), and dexamethasone (Dex; PAN-BTZ-Dex) significantly increased progression-free survival compared with placebo plus BTZ and Dex, leading to US Food and Drug Administration approval of the combination for the treatment of patients with MM who have received ≥ 2 prior regimens including BTZ and an immunomodulatory agent. The "PANobinostat EXpansion treatment protocol" (PANEX) study was developed to provide access to PAN and gather additional safety data on the PAN-BTZ-Dex combination until PAN became commercially available. Methods: PANEX is a multicenter, open-label, expanded treatment protocol study of PAN-BTZ-Dex in adult patients with MM relapsed and/or refractory to ≥ 1 prior line of therapy. During treatment phase (TP) 1 of the study, patients received oral PAN (20 mg; days 1, 3, 5, 8, 10, and 12) plus intravenous (IV) or subcutaneous (SC) BTZ (1.3 mg/m2; days 1, 4, 8, and 11) for eight 21-day cycles. Patients with at least stable disease proceeded to TP2, with maintained PAN and less frequent BTZ dosing (days 1 and 8) for an additional 8 cycles. In both phases, oral Dex (20 mg) was administered on the days of and after BTZ treatment. Reduction to once-weekly BTZ was allowed before TP2 as a dose reduction strategy. Response assessments were completed per modified European Group for Blood and Marrow Transplantation criteria. Results: A total of 39 patients, with a median age of 70 years (range, 44-88 years), were enrolled in the study. Patients were heavily pretreated, with a median of 3 prior lines of therapy (range, 1-12; 21% ≥ 7 prior therapies), with nearly half of the patients (48.7%) having progressed on their most recent therapy. Most patients received SC BTZ (87.2% [n = 34] vs 12.8% [n = 5] IV BTZ), with a median treatment duration of 9.4 weeks (range, 2-34). A total of 21 patients achieved a partial response, leading to an overall response rate of 53.8%; an additional 17.9% achieved a minimal response, for a clinical benefit rate (≥ minimal response) of 71.8%, with 25.6% having stable disease. Notably, no patients in the current trial had a best response of progressive disease. The most common grade 3/4 hematologic laboratory abnormalities were thrombocytopenia (53.8%), anemia (17.9%), and neutropenia (17.9%). The most common nonhematologic grade 3/4 treatment-emergent adverse events (AEs) were dehydration (28.2%), fatigue (28.2%), diarrhea (17.9%), asthenia (10.3%), and pneumonia (10.3%). Common gastrointestinal treatment-emergent AEs of any grade included diarrhea (48.7%), nausea (25.6%), and vomiting (12.8%), and nearly all cases of dehydration were associated with these gastrointestinal events. Interestingly, in the patients receiving SC BTZ (n = 34), the rate of grade 3/4 diarrhea was 11.8%, approximately half the rate seen with IV BTZ administration in the phase 3 PANORAMA 1 trial (25%). Common serious AEs included dehydration (15.4%), diarrhea (12.8%), and pneumonia (10.3%). AEs led to PAN, BTZ, and Dex dose reductions in 59.0%, 59.0%, and 46.2% of patients, respectively. Conclusions: Overall, the results from PANEX, albeit in an older population of patients with more advanced MM, support those generated in PANORAMA 1. In the subgroup of patients receiving SC BTZ, the rate of diarrhea, an AE of interest with PAN-BTZ-Dex therapy, appeared to be reduced when compared with PANORAMA 1 data with IV BTZ administration. Further clinical experience with the use of SC BTZ in this combination will help to determine the potential impact of route of BTZ administration on tolerability. Disclosures Elkins: Pharmacyclics/Janssen: Speakers Bureau; Onyx Pharmaceuticals: Speakers Bureau. Letzer:Pharmacyclics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Honoraria, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Speakers Bureau. Levy:Takeda: Consultancy. Seneviratne:Novartis: Honoraria, Speakers Bureau. Rine:Novartis: Employment. White:Novartis: Employment. Kuriakose:Novartis: Employment, Equity Ownership.

Sorafenib-Regorafenib Sequential Therapy in Advanced Hepatocellular Carcinoma: A Single-Institute Experience

2017 ◽  
Vol 35 (6) ◽  
pp. 611-617 ◽  
Author(s):  
Kazuomi Ueshima ◽  
Naoshi Nishida ◽  
Masatoshi Kudo
Keyword(s):  
Hepatocellular Carcinoma ◽  
Objective Response ◽  
Progression Free Survival ◽  
Sequential Therapy ◽  
Advanced Hepatocellular Carcinoma ◽  
Open Label ◽  
Effective Treatment Option ◽  
Sorafenib Treatment ◽  
Advanced Hcc ◽  
Grade 3

Objectives: Previously, no therapeutic agent has been known to improve the overall survival compared with placebo in patients with hepatocellular carcinoma (HCC), who have progressed after sorafenib. In this patient population, regorafenib was first demonstrated to confer a survival benefit in the RESORCE trial, and subsequently it was approved as a second-line treatment for patients with advanced HCC. An open-label expanded access program (EAP) of regorafenib was implemented for compassionate use. We investigated the efficacy and safety of regorafenib based on our experience of the RESORCE trial and the EAP. Methods: Data from 5 patients from the RESORCE trial and 6 from the EAP were analyzed retrospectively. All patients had tolerated prior sorafenib and were progressing during sorafenib treatment. Results: The median progression-free survival was 9.2 months (95% CI 2.3-16.1). One patient achieved a partial response and 7 achieved stable disease. The objective response rate was 9.1%, and the disease control rate was 72.7%. No treatment-associated mortalities were observed. Grade 3 hypophosphatemia was observed in 2 patients, grade 2 anorexia was observed in 5 patients, and grade 3 neutropenia was observed in 2 patients. Grade 2 and grade 3 thrombocytopenia were observed in 2 and 3 patients, respectively. All treatment-related adverse events were improved by reduction or interruption of regorafenib. Five patients showed decreased serum albumin levels. Conclusion: Sorafenib and regorafenib sequential therapy presents a safe and effective treatment option for patients with advanced HCC.

Preliminary results of a phase II trial of FOLFOX4 regimen in Chinese patients with unresectable primary liver cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14065-14065 ◽  
Author(s):  
S. K. Qin ◽  
Y. J. Wang ◽  
Q. Wu ◽  
B. C. Xing
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cancer ◽  
Phase Ii ◽  
Primary Liver Cancer ◽  
Safety Data ◽  
Median Number ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Number Of Cycles

14065 Background: Primary liver cancer (PLC) is the 3rd most common cancer in whole China. Development of systemic chemotherapy for the patients not eligible for operation as well as TACE commonly have been required. Oxalipaltin (Eloxatin)+ 5-FU/LV, namely FOLFOX 4 regimen was tried to investigate its efficacy and safety in inoperable PLC. Methods: It was an open-label, single arm and multi-center phase II study to explore RR, DCR,TTP and MST. All the pts had pathologically confirmed inoperable PLC with/without distant metastasis. The pts were treated with the standard FOLFOX 4 regimen, that is OXA 85mg/m2 d1; LV 200mg/m2 IV 2hrs d1,2; 5-FU 400mg/m2 bolus, d1,2 and 5-FU 600mg/m2 CIV 22hrs d1,2; q2w upto 6 cycles or until progression. Tumor evaluation was done every 6 weeks using RECIST criteria. Neurotoxicity was evaluated by Eloxatin specific neurotoxicity criteria (Sanofi-Aventis Co.Ltd) and other toxicities by the NCI CTC AE version 2.0. Results: From July 2004 to Sep. 2005, 27 pts (21 male, 6 female) were recruited from the 4 cancer centers with average age of 56 ±13 years old. 25 patients (92.6%) had hepatocellular carcinoma, and 2 (7.4%) cholangiocellular carcinoma. 15 pts (55.6%) had metastatic disease. 1 pt received liver transplantation before inclusion. The median number of cycles was 4 per pt. 26 pts were evaluable for efficacy and safety. The RR was 19.2% (5/26; 1 CR and 4 PR), and DCR 57.7% (15/26; including 10 SD). 4 of the 5 responsive pts had hepatocellular carcinoma, and 1 had cholangiocarcinoma. Serum AFP level was significantly decreased (mean 131,890.4ug/dl at the baseline and 1,298.6ug/dl after 6 cycles) for the first 16 pts. The first 16 pts’ safety data were available in detail: 11 NCI grade 3/4 events were observed from a total of 76 cycles administered: including 5 neutropenia, 3 leucopenia, 1 thrombocytopenia, 1 infection and 1 liver dysfunction. Grade II & III neurotoxicity was found in 3 & 2 patients respectively. The TTP,MST and further safety data were under follow-up. Conclusions: The preliminary data of the FOLFOX 4 regimen for the advanced Chinese pts with inoperable PLC have shown encouraging results with the better efficacy and favorable safety profile. Further exploration in this area is warranted, especially in hepatocellular carcinoma. No significant financial relationships to disclose.

Randomized, open-label, phase III study of pemetrexed plus carboplatin (PemC) followed by maintenance pemetrexed versus paclitaxel/carboplatin/bevacizumab (PCB) followed by maintenance bevacizumab in patients with advanced nonsquamous (NS) non-small cell lung cancer (NSCLC).

2013 ◽  
Vol 31 (18_suppl) ◽  
pp. LBA8003-LBA8003 ◽  
Author(s):  
Ralph Zinner ◽  
Helen J. Ross ◽  
Robert Weaver ◽  
Ramaswamy Govindan ◽  
Viran R. Holden ◽  
...  
Keyword(s):  
Safety Data ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Drug Regimen ◽  
Primary Objective ◽  
Phase Iii ◽  
Rank Test ◽  
Type I ◽  
Open Label ◽  
Grade 3

LBA8003 Background: PemC and PCB are regimens used for first-line treatment of advanced NS-NSCLC. The primary objective was to compare progression-free survival without Grade 4 toxicity (G4PFS) between two vs three drug regimen arms. Methods: Patients ≥18 years, Stage IV NS NSCLC, AJCC (v7.0), and ECOG PS 0/1 were enrolled. Patients were randomized (1:1); received 4 cycles of induction (PemC: Pem, 500 mg/m2 and C, AUC = 6; PCB: P, 200 mg/m2, C, AUC = 6, and B, 15 mg/kg) followed by Pem (PemC Arm) or B (PCB Arm) maintenance therapy in the absence of progressive disease or discontinuation. Secondary endpoints were PFS, overall survival (OS), overall response rate (ORR), and disease control rate (DCR). The study was powered for G4PFS; assuming hazard ratio (HR) of 0.75; there was 80% power to detect superiority of PemC over PCB with a 2-sided type I error of 0.10. Efficacy data were analyzed by intent-to-treat principle using the log-rank test for time-to-event variables, and an exact test for ORR and DCR. Safety data were evaluated using CTCAE v3 for patients who received ≥1 dose of study treatment. Results: Patients were randomized to PemC (N = 182) or PCB (N = 179). Baseline factors were balanced between arms: median age 66/66 years; % female 42/42; % PS=0, 47/47; % stage IV M1a 29/30; for PemC vs PCB, median G4PFS (months) was 3.91/2.86 (HR = 0.85, 90% CI 0.7, 1.04, p = 0.176); PFS and OS had HR = 1.06 (95% CI 0.84, 1.35), p = 0.610, and HR = 1.07 (95% CI 0.83, 1.36), p = 0.616, respectively. The ORR (%) 23.6/ 27.4 and DCR (%) 59.9/57.0 were for PemC vs PCB, respectively. Significantly more drug-related grade 3/4 anemia (18.7% vs 5.4%), and thrombocytopenia (24.0% vs 9.6%) were seen on PemC; significantly more grade 3/4 neutropenia (48.8% vs 24.6%) and grade 1/2 alopecia (28.3 % vs 8.2%) were seen on PCB. Conclusions: PemC was not superior to PCB in G4PFS; no difference in PFS or OS was observed for the two- vs three-drug regimens. There were no unexpected toxicities; the toxicity profiles demonstrated distinctions by arm, and both regimens demonstrated tolerability. Clinical trial information: NCT00948675.

PanCO: An open-label, single-arm pilot study of phosphorus-32 (P-32; Oncosil) microparticles in patients with unresectable locally advanced pancreatic adenocarcinoma (LAPC) in combination with FOLFIRINOX or gemcitabine + nab-paclitaxel (GNP) chemotherapies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4125-4125 ◽  
Author(s):  
Paul J. Ross ◽  
Daniel Croagh ◽  
Morteza Aghmesheh ◽  
Adnan Nagrial ◽  
Nam Nguyen ◽  
...  
Keyword(s):  
Pilot Study ◽  
Locally Advanced ◽  
Safety Data ◽  
Progression Free Survival ◽  
Tumour Volume ◽  
Current Standard ◽  
Open Label ◽  
Free Survival ◽  
Local Progression ◽  
Grade 3

4125 Background: LAPC is associated with a poor prognosis. Current standard treatment is limited to chemotherapy or chemo-radiotherapy. P-32 Microparticles is a brachytherapy device that implants a predetermined dose of P-32 into pancreatic tumours via endoscopic ultrasound (EUS) guidance. This reports the initial results of a pilot study in combination with chemotherapy. Methods: Eligible patients were permitted to receive either GNP or FOLFIRINOX. P-32 was implanted at week 4 or 5. The dose of P-32 was calculated from tumour volume to deliver an absorbed dose of 100 Gy. Diffusion pattern of the P-32 suspension was assessed by EUS and bremsstrahlung SPECT/CT imaging. Safety data was graded using CTCAE v4.0 criteria. Response was assessed according to RECIST 1.1 with CT scans every 8 weeks and FDG-PET scans at baseline and week 12. Results: 50 patients were enrolled (Intent-to-Treat population (ITT)) of which 42 were implanted with the device (Per Protocol population (PP)). 10 received FOLFIRINOX and 40 GNP. Median age was 65, 28 were male and all had a PS 0/1. 1070 adverse events (ITT) were reported; 153 (80% of patients) were ≥ Grade 3. The most common AEs of ≥ Grade 3 were haematological (39, 46%) and gastrointestinal disorders (30, 34%). No serious device- or radiation-related toxicities have been reported. PP Local Disease Control Rate at Week 16 was 90%; 95% CI: 77-97% and at Week 24 was 71%; 95% CI: 55-84%. Overall Response Rate (ORR) was 31%; 95% CI: 18-47%. Median change in tumour volume from Baseline to Week 16 and to Week 24 was -38% (range +89% to -90%) and -27.5% (range +139% to -79%). Ten (24%) patients underwent surgical resection following repeat staging. Eight patients had R0 margin. Conclusions: The use of EUS-guided implantation of P-32 is feasible, with an acceptable safety profile in combination with first-line chemotherapy for LAPC patients. Encouraging OR and DCR are observed. Further follow-up to inform results of local progression free survival and progression free survival is warranted. Acknowledgement: Nab-paclitaxel was supported by Specialised Therapeutics Australia Pty Ltd. Clinical trial information: NCT03003078.

scholarly journals REFLECT—a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset

2019 ◽  
Vol 55 (1) ◽  
pp. 113-122 ◽  
Author(s):  
Tatsuya Yamashita ◽  
Masatoshi Kudo ◽  
Kenji Ikeda ◽  
Namiki Izumi ◽  
Ryosuke Tateishi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Japanese Population ◽  
Objective Response ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Unresectable Hepatocellular Carcinoma

Abstract Background A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79–1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported. Methods The intent-to-treat population enrolled in Japan was analyzed. Results Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62–1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm. Conclusions The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. Trial registration ID ClinicalTrials.gov. No. NCT01761266.

scholarly journals Therapeutic effectiveness and safety of sintilimab-dominated triple therapy in unresectable hepatocellular carcinoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lei Dai ◽  
Xingchen Cai ◽  
Joseph Mugaanyi ◽  
Yelei Liu ◽  
Shuqi Mao ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Disease Control ◽  
Triple Therapy ◽  
Transcatheter Arterial Chemoembolization ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Free Survival ◽  
Unresectable Hepatocellular Carcinoma ◽  
Arterial Chemoembolization

AbstractImmune checkpoint inhibitor therapy has shown promising results in patients with unresectable hepatocellular carcinoma. This study aimed to evaluate the effectiveness and safety of sintilimab, a programmed cell death protein-1 (PD-1) blockade, combined with sorafenib and transhepatic arterial chemotherapy and embolization in this patient population, compared with sintilimab monotherapy and sintilimab-sorafenib duotherapy. This was a 22 months single center retrospective cohort study in China. 80 patients with unresectable hepatocellular carcinoma were included, with diagnosis confirmed by either histologic, cytologic or diagnostic imaging analysis. The patients were divided into three groups based on therapeutic regimen: sintilimab monotherapy (sintilimab group, n = 22), sintilimab-sorafenib duotherapy (duplex group, n = 23), sintilimab-sorafenib and transcatheter arterial chemoembolization combined therapy (triple group, n = 35). The principal evaluation criteria were overall survival and progression free survival in the population, assessed according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1). Secondary evaluation criteria were safety, objective response rate and disease control rate. From March 1st, 2019 to December 31, 2020, 80 patients with unresectable hepatocellular carcinoma were included and divided into three treatment groups (22 received sintilimab monotherapy, 23 received sintilimab-sorafenib duotherapy, and 35 received sintilimab-sorafenib combined with transcatheter arterial chemoembolization). The median overall survival of all patients was 11.0 months (95% CI 7.7–14.3). Median overall survival was 13.0 months (95% CI NE–NE), 9.0 months(95% CI 6.3–11.7)and 3.0 months (95% CI 1.9–4.1, p < 0.0001) in the triple therapy, duplex and sintilimab groups respectively, while the corresponding median progression-free survival were 5.0 months (95% CI 2.9–7.1, p < 0.001), 4.0 months (95% CI 2.8–5.2) and 2.0 months (95% CI 1.7–2.3). Disease control and clinical benefits rates were higher in the triple therapy group (80%, 95% CI 63.1–91.6, p < 0.001; 54.3%, 95% CI 36.6–71.2, p < 0.01) compared to the sintilimab group. Median duration of disease control was 4.0 months (95% CI NE–NE, p < 0.01) in the triple therapy group, longer than that of the duplex group (2.0 months, 95% CI 0.9–3.1) and sintilimab group (2.0 months, 95% CI 0.8–3.2). Grade 3 or 4 treatment-related adverse events occurred in 26.3% of 80 patients with hypertension was the most common event observed (38, 47.5%), however, other severe toxic effects were infrequent. Sintilimab combined with sorafenib and transcatheter arterial chemoembolization might have more beneficial effects on overall and progression-free survival and on the duration of disease control outcomes than both sintilimab monotherapy and sintilimab-sorafenib duotherapy in patients with unresectable hepatocellular carcinoma. This triple therapy model might represent an innovative and effective option for inoperable liver cancer.

Evaluation of transcatheter arterial chemoembolization (TACE) plus sorafenib in Chinese patients with unresectable hepatocellular carcinoma: A subgroup analysis of START trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14605-e14605
Author(s):  
Guohong Han ◽  
Jijin Yang ◽  
Guoliang Shao ◽  
Gaojun Teng ◽  
Maoqiang Wang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Subgroup Analysis ◽  
Performance Status ◽  
Safety Data ◽  
Complete Response ◽  
Chinese Patients ◽  
Ecog Performance Status ◽  
Efficacy Analysis ◽  
Unresectable Hepatocellular Carcinoma ◽  
Start Trial

e14605 Background: The therapeutic effect of TACE plus Sorafenib (Sor) for unresectable hepatocellular carcinoma (uHCC) was evaluated in the START (Study in Asia of the Combination of TACE with Sor in Patients with Hepatocellular Carcinoma) trial. The preliminary results presented at ILCA 2011 showed encouraging safety and efficacy profiles of TACE plus Sor in HCC, with a median time to progression (TTP) of 9.3 months and median overall survival (OS) not reached. Here we present results of a subgroup analysis of Chinese patients with more updated data. Methods: Patients with uHCC and candidates for TACE were enrolled. TACE with lipiodol and doxorubicin (30-60 mg) was performed every 6 to 8 weeks. Sor (400mg bid) was administrated 4 days after first TACE, and then continuously with interruption 3 days before and after the TACE procedure. Tumors were assessed 4 weeks after every TACE, and every 3 months thereafter if no TACE was indicated. Patients who do not require TACE due to complete response or intolerability continued to receive Sor until disease progression (PD) or unacceptable toxicity. This analysis was conducted to evaluate the efficacy of TACE plus Sor on TTP based on modified RECIST criteria, OS and response rate (RR) in Chinese patients with uHCC. Cut-off date for the efficacy analysis is Sep 30th, 2011. Because no new or unexpected side effects were noted during this study period, safety data were not collected in this subgroup analysis. Results: A total of 64 patients enrolled from Sep. 2009 to Apr. 2010, were evaluated. The median age was 62 yr (range, 31-75) and all patients were ECOG Performance Status 0-1. The main etiology for HCC was hepatitis B in 94.9% of patients. The mean dose of Sor in this group of patients is 787.63mg.The median treatment duration was 6.4 months. The median TTP was 10.6 months, and the median OS was 16.5 months. The objective RR was 44.3%, and 11.5% of patients had PD. Conclusions: This subgroup analysis suggests that Chinese patients with uHCC may benefit from TACE and Sor combination therapy, with better improvement of TTP, compared to the interim analysis results of the overall population from the START trial.

scholarly journals Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3405
Author(s):  
Thierry de Baere ◽  
Boris Guiu ◽  
Maxime Ronot ◽  
Patrick Chevallier ◽  
Géraldine Sergent ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Tumor Response ◽  
Objective Response ◽  
Survival Rates ◽  
Evaluation Criteria ◽  
Real Life ◽  
Progression Free Survival ◽  
Mri Scans ◽  
Drug Eluting ◽  
Grade 3

Background and aim: Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B hepatocellular carcinoma (HCC) and stage 0-A unsuitable for curative treatments. We assessed efficacy and safety along with hepatobiliary toxicities (HBT) of DEM-TACE using a novel microsphere, LifePearlTM, loaded with anthracyclines. Materials and methods: 97 patients diagnosed with HCC were prospectively enrolled and treated using LifePearlTM loaded with doxorubicin (77%) or idarubicin (23%). Safety and tolerability were assessed using CTCAE, HBT by CT/MRI scans, and tumor response by applying modified Response Evaluation Criteria in Solid Tumors (mRECIST). Follow-up was after 2 years. Results: Adverse events (AE) were reported in 73.2% of patients, majority being Grade 1–2. Grade ≥ 3 AE reported in 13.4% of patients were mainly related to postembolization syndrome. HBT were observed after 15.5% (29/187) of the DEM-TACEs. Objective response and disease control rates were 81% and 99%, respectively, as the best responses. Survival rates at one and two years were 81% and 66%, respectively, while the median overall survival (OS) was not reached. Median progression free survival was 13.7 months (95% CI: 11.3; 15.6) and median time to TACE untreatable progression was 16.7 months (95% CI: 12.7; not estimable (n.e.)). Conclusions: DEM-TACE using LifePearlTM provides a high tumor response rate in HCC patients. HBT rates within or below previously reported results for cTACE and DEM-TACE indicate a good safety profile for LifePearlTM. The trial was registered in National Library of Medicine (ID: NCT03053596).

Sign in / Sign up

Export Citation Format

Share Document