The Prognostic Value of Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio in Patients with Hepatocellular Carcinoma Receiving Atezolizumab Plus Bevacizumab

Atezolizumab plus bevacizumab has been approved as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma (uHCC). This study was designed to assess the clinical impact of atezolizumab plus bevacizumab in uHCC patients. A total of 48 uHCC patients receiving atezolizumab plus bevacizumab were identified, including first-line, second-line, third-line, and later-line settings. In these patients, the median progression-free survival (PFS) was 5.0 months, including 5.0 months for the first-line treatment, not reached for the second-line treatment, and 2.5 months for the third line and later line treatment. The objective response rate and disease control rate to atezolizumab plus bevacizumab were 27.1% and 68.8%, respectively. The severity of most adverse events was predominantly grade 1–2, and most patients tolerated the toxicities. The ratios of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte (PLR) were used to predict PFS in these patients. The optimal cutoff values of NLR and PLR were 3 and 230, and NLR and PLR were independent prognostic factors for superior PFS in the univariate and multivariate analyses. Our study confirms the efficacy and safety of atezolizumab plus bevacizumab in uHCC patients in clinical practice and demonstrates the prognostic role of NLR and PLR for PFS in these patients.

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Clinical impact of lenvatinib in patients with unresectable hepatocellular carcinoma who received sorafenib

PeerJ ◽

10.7717/peerj.10382 ◽

2020 ◽

Vol 8 ◽

pp. e10382

Author(s):

Yen-Yang Chen ◽

Chih-Chi Wang ◽

Yueh-Wei Liu ◽

Wei-Feng Li ◽

Yen-Hao Chen

Keyword(s):

Hepatocellular Carcinoma ◽

Objective Response ◽

Evaluation Criteria ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

Efficacy And Safety ◽

Previous Response ◽

Unresectable Hepatocellular Carcinoma ◽

Third Line

Background Lenvatinib has been approved for use in the systemic treatment for unresectable hepatocellular carcinoma (HCC). This study aimed to investigate the efficacy and safety of lenvatinib in patients with unresectable HCC who received sorafenib. Methods A total of 40 patients who received lenvatinib after sorafenib were retrospectively identified: as second line in 20 patients, third line in 10 patients, and fourth line and later lines in 10 patients. The treatment response to lenvatinib was determined in accordance with the guidelines of the modified Response Evaluation Criteria in Solid Tumors (mRECIST) every 2–3 months after commencement of lenvatinib. Results Median progression-free survival (PFS) and median overall survival (OS) of the whole population were 3.3 and 9.8 months, respectively. The objective response rate was 27.5%. Univariate and multivariate analyses showed that alpha-fetoprotein level >400 ng/mL was an independent prognostic factor of worse PFS and OS. The clinical outcomes of lenvatinib therapy as second-line, third-line, or fourth line and later line treatment were similar, and previous response to sorafenib could predict the response to subsequent lenvatinib. Most adverse events were grades 1–2, and the majority of patients tolerated the side effects. Our study confirms the efficacy and safety of lenvatinib as second-line and later line treatment for patients with unresectable HCC who received sorafenib in clinical practice.

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Efficacy of weekly paclitaxel-bevacizumab combination in advanced nonsquamous non-small cell lung cancer (NSCLC): AVATAX, a retrospective multicentric study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e21086 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e21086-e21086

Author(s):

Geoffroy Bilger ◽

Anne-Claire Toffart ◽

Marie Darasson ◽

Michaël Duruisseaux ◽

Lucie Ulmer ◽

...

Keyword(s):

Performance Status ◽

Objective Response ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

Multicentric Study ◽

Significant Difference ◽

Third Line ◽

And Performance ◽

Line Setting

e21086 Background: With the growing role of immunotherapy (ICI) as first-line setting for advanced NSCLC, strategies must be redefined after failure. The combination paclitaxel-bevacizumab showed in the ULTIMATE trial a significant superiority versus docetaxel as second or third-line treatment. Limited restropective studies has demonstrated unexpected efficacy of chemotherapy after prior progression on ICI. This combination could be use as salvage treatment following ICI. Methods: This multi-centric retrospective study identifies patients treated with the combination paclitaxel-bevacizumab in metastatic non-squamous NSCLC as second-line therapy or beyond. Main objectives were to describe safety and efficacy of this combination, with a special attention to the sub-group treated just after ICI. Results: From January 2010 to February 2020, 314 patients started the paclitaxel-bevacizumab combination : 55% male, with a median age of 60 years, 27% with a performance status ≥2, 45% with brain metastases. A majority of patients were treated in second (20%) and third-line (39%), and 28% were treated just after ICI failure (88/314). Objective response rate (ORR) was 40% and disease control rate was 77 %. Median progression-free survival (PFS) and overall survival (OS) were 5,7 months [IQ,3,2–9,6] and 10,8 months [IQ,5,3–19,6] respectively. All grades adverse events concerned 82% of patients, including 53% asthenia and 39% neurotoxicity, and 25% of patients continued a monotherapy alone due to toxicity. Median PFS for patients treated after ICI failure (ICI+) was significantly superior compare to those not previously treated with ICI (ICI-) : 7,0 months [IQ,4,2–11,0] vs 5,2 months [IQ,2,9–8,8] p (log-rank) = 0,01. There was not statistically significant difference in term of OS between this two groups. In multivariate analysis, factors associated with superior PFS were previous ICI treatment (ICI+) and performance status. Conclusions: This study confirms an acceptable toxicity profile associated with interesting efficacy of the combination paclitaxel-bevacizumab as second-line treatment or beyond for non–squamous NSCLC patients, particularly after progression with ICI.

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Efficacy and safety of lenvatinib in the real-world treatment of hepatocellular carcinoma: Results from a Canadian multicenter database (HCC CHORD).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.275 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 275-275

Author(s):

Carla Pires Amaro ◽

Michael J Allen ◽

Jennifer J. Knox ◽

Erica S Tsang ◽

Howard John Lim ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Real World ◽

Objective Response ◽

Progression Free Survival ◽

Drug Discontinuation ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

The Real ◽

First Line Therapy

275 Background: The REFLECT trial establishedlenvatinib (LEN) as a first-line treatment option for hepatocellular carcinoma (HCC). Compared to sorafenib (S), LEN has a higher objective response rate (ORR) and progression-free survival (PFS) with a slightly different toxicity profile. The aim of this study was to gather data regarding the efficacy and safety of LEN when used in the real-world treatment of HCC. To our knowledge, this is the first study to examine LEN use in HCC patients treated outside of Asia. Methods: HCC patients treated with LEN from 10 cancer centers in the Canadian provinces of British Columbia, Alberta, Ontario and Nova Scotia between July 2018 to July 2020 were included. Overall survival (OS), PFS, disease control rate (DCR) and ORR were retrospectively analyzed and compared across first- and second-to-fourth line use of LEN. ORR was determined radiographically according to the treating physician´s opinion in clinical notes and not RECIST 1.1 or mRECIST. Toxicities were also examined. Results: A total of 220 patients were included in this analysis. Median age was 67 years, 80% were men and 25.5% East Asian. The most frequent causes of liver disease were hepatitis C (37%) and B (26%). 62% of patients received any localized treatment before LEN, of those 26% had TACE, 15% TARE and 7.7% had liver transplant. Before starting LEN 29% of patients were ECOG 0 and 59% were ECOG 1. Most patients were Child-Pugh A (81%) and BCLC stage C (75.5%). Main portal vein invasion was present in 14% of the patients. Median follow-up was 4.5 months. A total of 173 patients (79%) received LEN as first line therapy and 47 patients (21%) were treated in second-to-fourth line. Of patients receiving LEN in first line, 22 (13%) started treatment with S, but switched to LEN before progression due to poor tolerance of S. ORR, DCR, PFS and OS are shown in the table. Toxicities occurred in 86% of patients and led to dose reductions in 76 (35%) patients and drug discontinuation in 53 (24%) patients. The most common side effects were fatigue (59%), hypertension (41%), decreased appetite (25%) and diarrhea (22%). Conclusions: Outcomes of HCC patients treated in Canada with LEN in the first line are comparable to those demonstrated in the REFLECT trial, despite the inclusion of Child-Pugh B and ECOG >1 patients. LEN use in second or later lines also showed similar outcomes, although more conclusions are difficult to draw due to the small numbers. LEN appears to be effective and safe in real world practice outside of Asia in first- and second-to-fourth line treatment of HCC. [Table: see text]

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Activity of new agents (NAs) as third-line treatment in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) showing a primary resistance (PRes) to NAs-based second line therapy after docetaxel (DOC): Preliminary results from a multicenter Italian study.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.216 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 216-216

Author(s):

Orazio Caffo ◽

Ugo De Giorgi ◽

Gaetano Facchini ◽

Lucia Fratino ◽

Donatello Gasparro ◽

...

Keyword(s):

Clinical Outcomes ◽

Objective Response ◽

Progression Free Survival ◽

Consecutive Series ◽

Line Treatment ◽

Second Line ◽

Castration Resistant Prostate Cancer ◽

Primary Resistance ◽

Third Line ◽

Third Line Treatment

216 Background: The androgen receptor machinery remains the ultimate target of NAs in mCRPC post-DOC, abiraterone acetate (AA), cabazitaxel (CAB), and enzalutamide (ENZ). It is postulated that some mechanisms of resistance may be common to all NAs. This may be crucial in planning their sequential use, mainly when a PRes to one of them is observed. The present study assessed the activity of NAs in pts who previously experienced a PRes to another NA administered after DOC. Methods: We collected data of pts who received sequentially two NAs after DOC in 32 Italian hospital. For each pt we recorded the clinical outcomes of all treatments received after DOC. For the study purpose, we consider with PRes all pts progressing within 3 months after second line NA start. All other pts were considered as without PRes. Results: A consecutive series of 271 mCRPC pts, median age 71 yrs (46-91), with bone (89%), nodal (56%) or visceral (19%) mets, was collected. All pts received NAs as second line after DOC (AA 54% – CAB 34%– ENZ 12%) and 54 (20%) showed a PRes. Among these, third line treatment [AA (31%), CAB (42%), and ENZ (27%)], produced a biochemical and an objective response rate of 11% in both cases, with a median progression free survival (PFS) and a median overall survival (OS) of 4 mos and 8 mos, respectively. No statistically significant differences were observed in terms of clinical outcomes on the basis of NA sequences (see Table). Conclusions: It appears from this preliminary data, that the activity of NAs in pts showing a PRes to second line NAs is very limited, regardless the NA is administered. [Table: see text]

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Real world outcomes in advanced urothelial cancer and the role of neutrophil to lymphocyte ratio.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e16020 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e16020-e16020

Author(s):

Steven Yip ◽

Jeenan Kaiser ◽

Haocheng Li ◽

Scott A. North ◽

Daniel Yick Chin Heng ◽

...

Keyword(s):

Real World ◽

Cox Regression ◽

Response Rates ◽

Neutrophil To Lymphocyte Ratio ◽

Second Line ◽

First Line ◽

Cox Regression Analysis ◽

Lymphocyte Ratio ◽

Line Setting

e16020 Background: Advanced urothelial carcinoma (UC) patients have a poor prognosis. In the first and second line UC treatment setting, we investigated real world outcomes and evaluated the prognostic role of the neutrophil to lymphocyte ratio (NLR). Methods: A retrospective analysis was performed on advanced UC patients treated with systemic therapy. Overall response rates (ORR), time to treatment failure (TTF) and overall survival (OS) were calculated. Cox regression analysis was performed to examine the association between baseline NLR (low NLR<3 vs high NLR≥3) and TTF and OS. Results: We evaluated 233 advanced UC patients. In the first line setting, the ORR was 25%. Median TTF and OS were 6.9 mo and 9 mo, respectively. Low baseline NLR was significantly associated with improved 8.3 mo median TTF, versus 5.8 mo for high NLR patients (p=0.05). Low NLR was significantly correlated with a longer median OS of 13.1 mo, in comparison to 8.2 mo in patients with high NLR (p=0.007). In the second line, an ORR of 22%, a median TTF of 4.1 mo and a median OS of 8 mo were observed. Low NLR in the second line was significantly associated with improved median TTF at 7.9 mo, versus 3.6 mo for patients with high NLR (p=0.03). Second line low NLR was also significantly associated with a longer median OS of 12.2 mo, in comparison to 6.8 mo in patients with high NLR (p=0.003). Conclusions: In this real world analysis of advanced UC patients, first line outcomes were lower than expected, while response rates in the second line compared favorably to the literature, suggesting a highly selected patient population actually receives second line treatment. A low baseline NLR in the first and second line is associated with improved TTF and OS and warrants further prospective evaluation. [Table: see text]

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Upfront or add-on combination therapeutic strategy exploration in unresectable hepatocellular carcinoma using sorafenib plus sintilimab: A retrospective analysis of real-world evidence.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e16135 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e16135-e16135

Author(s):

Jiamin Cheng ◽

Yinyin Li ◽

Tong Wu ◽

Zhen Zhang ◽

Yan Chen ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Kinase Inhibitor ◽

Objective Response ◽

Progression Free Survival ◽

Second Line ◽

First Line ◽

First Line Therapy ◽

Treatment Naïve ◽

Inhibitor Regimen ◽

Grade 3

e16135 Background: Recently, tyrosine kinase inhibitor plus PD-1 inhibitor regimen has shown promising effects on hepatocellular carcinoma (HCC). So far, no study explored the effectiveness of upfront versus add-on combination therapy in patients with systemic treatment-naïve and treatment-experienced HCCThis study aimed to explore the effectiveness and safety of sintilimab combined sorafenib in patients with untreated or sorafenib monotherapy-refractory unresectable HCC. Methods: In this retrospective study, unresectable HCC patients received sintilimab plus sorafenib from January 2018 to December 2020 were enrolled. According to the prior treatment, patients were grouped as first-line and second-line (received sorafenib combined sintilimab after progression on sorafenib alone). Objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), safety, and the change of Child-Pugh score from baseline to progression were recorded. The PFS was defined as the time from first dosing of sintilimab until disease progressive or death. Results: A total of 31 patients were reviewed, including 19 patients in first-line group and 12 patients in second-line group. There were two patients with Barcelona Clinic Liver Cancer (BCLC) stage B and 17 patients with BCLC stage C in first-line group, and one patient with BCLC stage A and 11 patients with BCLC stage C in second-line group, respectively. The ORR and DCR were 27.8% and 77.8% in first-line group, and 16.7% and 75.0% in second-line group, respectively. Fourteen cases in first-line group and 10 cases in second-line group showed PD during the follow-up. The 6-month PFS rate of first-line group and second-line group were 47.1% and 64.8%, respectively. Thirteen and 9 patients experienced AE in two groups. Four and 2 grade 3 AEs occurred in two groups, respectively. The most frequency AE were hand-foot-skin reaction in both group (58.0% and 50.0%, respectively). One patient discontinued sintilimab due to AE in second-line group. Among PD patients, the Child-Pugh score improved in 2 cases, maintained in 5 cases, and deteriorated in 7 cases in the first-line group; and improved in 3 cases, miantained in 3 cases, and deteriorated in 4 cases in the second-line group. Conclusions: Sorafenib plus sintilimab showed potential anti-tumor effect and tolerance on unresectable HCC, either as first-line therapy or after progression with sorafenib monotherapy. Outcomes.[Table: see text]

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RAISE: A randomized, double-blind, multicenter phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab (RAM) or placebo (PBO) in patients (pts) with metastatic colorectal carcinoma (CRC) progressive during or following first-line combination therapy with bevacizumab (bev), oxaliplatin (ox), and a fluoropyrimidine (fp).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.512 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 512-512 ◽

Cited By ~ 7

Author(s):

Josep Tabernero ◽

Allen Lee Cohn ◽

Radka Obermannova ◽

Gyorgy Bodoky ◽

Rocio Garcia-Carbonero ◽

...

Keyword(s):

Combination Therapy ◽

Statistical Significance ◽

Objective Response ◽

Progression Free Survival ◽

Phase Iii ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Double Blind ◽

Ecog Ps

512 Background: Angiogenesis is an important therapeutic target in CRC; VEGF plays a key role in angiogenesis. RAM is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2. The RAISE study evaluated the efficacy and safety of adding RAM to standard second-line treatment FOLFIRI. Methods: Eligible pts with mCRC who progressed on or after first-line combination therapy with bev, ox, and fp, had an ECOG PS of 0 or 1, and adequate organ function were randomized 1:1 (stratified by region, KRAS mutation status, and time to progressive disease [PD] after beginning first-line treatment) to receive RAM (8 mg/kg IV) plus FOLFIRI or PBO plus FOLFIRI every 2 weeks until PD, unacceptable toxicity, or death. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Planned sample size of 1,050 pts ensured 85% power to demonstrate statistical significance at an overall two-sided alpha of 0.05, assuming a hazard ratio (HR) of 0.8. Results: Between Dec 2010 and Aug 2013, 1,072 eligible pts were randomized (RAM 536; PBO 536). Baseline pt characteristics were similar between treatment arms. The OS HR was 0.84 (95% CI: 0.73, 0.98; log-rank p=0.0219). Median OS was 13.3months (m) for RAM vs 11.7m for PBO. The PFS HR was 0.79 (95% CI: 0.70, 0.90; log-rank p = 0.0005). Median PFS with RAM was 5.7m and 4.5m for PBO. ORR was 13.4% RAM; 12.5% PBO (p = 0.6336). Subgroup results were consistent with the OS and PFS results. Grade ≥3 adverse events (AEs) occurring in >5% of pts in RAM+FOLFIRI were: neutropenia (RAM 38.4% vs PBO 23.3% ), hypertension (11.2% vs 2.8%), diarrhea (10.8% vs 9.7%), and fatigue (11.5% vs 7.8%). Conclusions: RAISE met its primary end-point, demonstrating a statistically significant improvement in OS for RAM and FOLFIRI vs PBO and FOLFIRI in second-line mCRC pts. Benefits were similar across important clinical subgroups and no unexpected AEs were identified. Clinical trial information: NCT01183780.

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An exploratory study of sorafenib plus toripalimab for unresectable hepatocellular carcinoma with portal vein tumor thrombus.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.tps4658 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. TPS4658-TPS4658

Author(s):

Yu Yang ◽

Qiu Li

Keyword(s):

Hepatocellular Carcinoma ◽

Monoclonal Antibody ◽

Portal Vein ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Progression Free Survival ◽

Advanced Hepatocellular Carcinoma ◽

Line Treatment ◽

First Line ◽

First Line Treatment

TPS4658 Background: Portal vein tumor thrombosis (PVTT) is common among advanced hepatocellular carcinoma ( HCC), resulting in poor prognosis. As the standard first-line treatment, the efficacy of Sorafenib is not satisfactory in HCC with PVTT. Although immune checkpoint inhibitors have made a breakthrough in treatment of advanced HCC, objective response rate (ORR) of anti-PD-1 monoclonal antibody monotherapy is only 17-20%. Recently, PD-1/PD-L1 inhibitors combined with anti-angiogenesis therapy have shown good efficacy in the clinical studies. However, the data on immunotherapy for HCC with PVTT are still limited. Toripalimab is the first Chinese-produced anti-PD-1 monoclonal antibody marketed. We designed the study to evaluate the efficacy and safety of Sorafenib plus Toripalimab as the first-line treatment for unresectable HCC with PVTT. Methods: The study is a multicenter, single-arm, phase Ib/II trial. The primary objectives are 6-month progression-free survival (PFS) rate and safety. Secondary objectives include ORR, disease control rate, PFS, overall survival. The escalation stage includes two dose cohorts: Sorafenib 400 mg po qd or 400 mg bid combined with Toripalimab 240 mg iv d1 q3w. 6-12 patients are estimated to evaluate the dose-limiting toxicity within the first 42 days of administration. In the expansion stage, patients are treated with the recommended dose based on the escalation stage, until progressive disease or intolerable toxicity. Assuming Sorafenib plus Toripalimab can improve the 6-month PFS rate to 40% (Sorafenib:20%, β = 0.2, α = 0.05) and dropout is 10%, this stage need 39 patients. A total of 45-51 patients are enrolled. Major eligibility requirements include: unresectable HCC with diagnoses confirmed histologically or cytologically, or confirmed clinically in accordance with Chinese guideline for HCC diagnosis and treatment (v2017); radiographic evidence of PVTT; age ≥18 and < 75 years; at least one measurable lesion according to RECIST 1.1; a predicted life expectancy ≥ 3 months; ECOG PS≤1, Child-Pugh class A or B (≤7); no any prior systemic anti-cancer treatment; adequate organ function. Patients with hepatitis B treated with antiviral therapy (viral load < 100 IU/mL) or patients with chronic hepatitis C can be included. The study is open and actively enrolling at time of submission. Clinical trial information: NCT04069949 .

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Chemothery (pacitaxol or irinotecan), plus apatinib and sintilimab as second-/third-line treatment for advanced gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e16080 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e16080-e16080

Author(s):

Ting Deng ◽

Le Zhang ◽

Jingjing Duan ◽

Hongli Li ◽

Shaohua Ge ◽

...

Keyword(s):

Adverse Events ◽

Objective Response ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Elevated Alkaline Phosphatase ◽

Second Line Chemotherapy ◽

Third Line ◽

Line Chemotherapy ◽

Third Line Treatment

e16080 Background: Patients with advanced gastric or gastro-esophageal junction cancer have poor prognosis after progression on first-line chemotherapy. We investigated to combine second-line chemotherpy with third-line drugs, apatinib and anti-PD-1 antibody in these patients. Methods: This study is a single center, exploratory study in China. Eligible patients are adults with histologically confirmed advanced gastric or GEJ adenocancinoma, who were failure of first-line or second-line chemotherapy. Subjects receive chemotherapy, pacitaxol or iritecan (investigator choice), apatinib 250mg po qd, sintilimab 200mg ivd q3w. Response was assessed every 6 weeks. (RECIST version1.1) Primary endpoint was progression free survival (PFS). Results: Between May 30, 2019 and November 5, 2020, a total of 26 patients were enrolled in this study, and 4 (15.4%) patients were failure of second-line chemotherapy. There were 21 males and 5 females, and the median age was 61. The total number of treatment cycles was 140 and the median number was 5.5. Among 24 patients who were evaluated, partial response (PR) was obtained in 12 cases, stable disease (SD) in 8 cases and progressive disease (PD) in 4 cases. Objective response rate was 50.0%，and disease control rate was 83.3%. The median PFS was 7.06 months (95% CI 5.52-8.60), and the median overal survival has not yet been reached. The most common adverse events (AE) were leukopenia (61.5%), anemia (57.7%), neutropenia (53.8%), proteinuria (42.3%), alopecia (42.3%), hypothyroidism (38.5%), elevated alanine aminotransferase (34.6%), elevated aspartate aminotransferase (34.6%) and elevated alkaline phosphatase (34.6%), but most of them were grade 1 or 2, and the most common grade 3 or 4 treatment-related adverse events was neutropenia (11.5%). Conclusions: Chemotherapy, plus apatinib and sintilimab demonstrated promising activity and manageable safety profile as second- even third-line treatment in advanced gastric or GEJ cancer. Demographics and baseline characteristics.[Table: see text]

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Regorafenib Combined With Sintilimab Versus Regorafenib as Second-line Treatment for Advanced Hepatocellular Carcinoma

10.21203/rs.3.rs-872090/v1 ◽

2021 ◽

Author(s):

Jingjun Huang ◽

Yongjian Guo ◽

Wensou Huang ◽

Zining Xu ◽

Liteng Lin ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Adverse Events ◽

Objective Response ◽

Progression Free Survival ◽

Advanced Hepatocellular Carcinoma ◽

Line Treatment ◽

Second Line ◽

Free Survival ◽

Advanced Hcc ◽

Grade 3

Abstract Purpose: To evaluate the safety and efficacy of regorafenib combined with immune checkpoint inhibitor sintilimab (rego-sintilimab) as second-line treatment for advanced hepatocellular carcinoma (HCC) patients who failed prior sorafenib or lenvatinib.Methods: This retrospective study evaluated consecutive patients with advanced HCC who received rego-sintilimab (rego-sintilimab group) or regorafenib alone (regorafenib group) as second-line treatment from January 2019 to December 2020. Adverse events, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared between the two groups. Results: Eighty-three patients were included: 48 received rego-sintilimab and 35 received regorafenib. Rego-sintilimab group had higher ORR (33.3% vs 14.3%, P =.049), longer PFS (median, 5.1 vs 3.0 months; P =.001), and better OS (median, 13.3 vs 9.1 months; P =.001) than regorafenib group. Regorafenib alone, Child-Pugh B, and neutrophil-to-lymphocyte ratio (NLR) >3.5 were independent prognostic factors for poor OS in uni- and multi-variable analyses. Subgroup analyses showed that, in patients with Child-Pugh A (16.4 vs 11.5 months; P =.005), Child-Pugh B (8.8 vs 6.4 months; P =.032), or NLR ≤3.5 (16.3 vs 11.5 months; P =.012), rego-sintilimab group had significantly better median OS than regorafenib group, whereas median OS was not significantly different between the two groups in patients with NLR >3.5 (8.4 vs 7.0 months; P =.288). The incidences of grade 3/4 adverse events were similar between the two groups (39.4% vs 34.1%; P =.445).Conclusion: Rego-sintilimab was tolerable and led to better OS than regorafenib as second-line treatment for advanced HCC patients, especially in those with NLR ≤3.5.

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