scholarly journals Axitinib plus immune checkpoint inhibitor: evidence- and expert-based consensus recommendation for treatment optimisation and management of related adverse events

2020 ◽  
Vol 123 (6) ◽  
pp. 898-904 ◽  
Author(s):  
Viktor Grünwald ◽  
Martin H. Voss ◽  
Brian I. Rini ◽  
Thomas Powles ◽  
Laurence Albiges ◽  
...  

Abstract With the recent approval of the combinations of axitinib with the immune checkpoint inhibitor (ICI) pembrolizumab or avelumab for first-line treatment of advanced renal cell carcinoma, guidance on how to distinguish between immune-related adverse events (AEs) caused by ICI versus axitinib-related AEs is necessary to optimise therapy with axitinib–ICI combinations. The recommendations here are based on (1) systematic review of published evidence, (2) discussion among experts in the field and (3) a survey to obtain expert consensus on specific measures for therapy management with the combinations axitinib/avelumab and axitinib/pembrolizumab. The experts identified areas of AEs requiring unique management during treatment with axitinib–ICI combinations that were not covered by current recommendations. Diarrhoea, hepatic toxicity, fatigue and cardiovascular AEs were found to be applicable to such specialised management. Triage between immune-suppressive and supportive measures is a key component in therapy management. Clinical monitoring and experience with both classes of agents are necessary to manage this novel therapeutic approach. We focused on AEs with an overlap between axitinib and ICI therapy. Our recommendations address AE management of axitinib–ICI combinations with the aim to improve the safety of these therapies.

Author(s):  
Antoine N. Saliba ◽  
Zhuoer Xie ◽  
Alexandra S. Higgins ◽  
Xavier A. Andrade‐Gonzalez ◽  
Harry E. Fuentes‐Bayne ◽  
...  

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A660-A660
Author(s):  
Petros Grivas ◽  
Phani Veeranki ◽  
Kevin Chiu ◽  
Vivek Pawar ◽  
Jane Chang ◽  
...  

BackgroundAvelumab, a PD-L1 immune checkpoint inhibitor (ICI), was recently approved as first-line (1L) maintenance therapy for locally advanced/unresectable or metastatic urothelial carcinoma (aUC) after disease control with platinum-based chemotherapy.1 Given the evolving treatment landscape, the study aim was to gain real-world insights into clinical decision-making among oncologists for patients with aUC.MethodsIn March 2021, a cross-sectional web-based survey was administered to a sample of US oncologists treating patients with aUC. Oncologists' demographics, practice characteristics, and treatment patterns were obtained; descriptive statistics were used.ResultsThe study included 151 medical oncologists, who reported that 54% and 31% of their patients, on average, would be classified as cisplatin or carboplatin eligible for their 1L treatment, respectively. Approximately 78% of oncologists (n=118) considered using ICI maintenance in ≥40% of their patients following disease control with platinum chemotherapy and were categorized as the “high-consideration” group, for further exploratory analysis; the rest (22%) were in the low-consideration group (See table 1). Approximately, 31% and 27% of oncologists in the high- and low-consideration groups reported administering ICI maintenance with a 2–3-week gap after chemotherapy, while 45% and 46% reported administering it with a 4–6-week gap after chemotherapy, respectively.ConclusionsSurveyed oncologists reported that 85% of patients with aUC in US may be eligible for platinum-based chemotherapy. Further, 78% of the surveyed oncologists would consider 1L ICI maintenance therapy after disease control with platinum-based chemotherapy for over 40% of their patients. Future studies are warranted to evaluate real-world treatment patterns, barriers, and utilization of ICI maintenance therapy as the new 1L standard of care.AcknowledgementsThe authors would like to acknowledge all physicians at who participated and completed the survey for the study.ReferencePowles T, et al. N Engl J Med 2020;383(13):1218–1230.Ethics ApprovalThe study was reviewed and determined to be exempt by Advarra IRB.ConsentAll survey participated signed a consent form.Abstract 630 Table 1Oncologists characteristics and considerations for 1L ICI maintenance therapy


Medicina ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 1151
Author(s):  
Shinsuke Suzuki ◽  
Satoshi Toyoma ◽  
Yohei Kawasaki ◽  
Koh Koizumi ◽  
Nobuko Iikawa ◽  
...  

Background and Objectives: In recent years, the effectiveness of chemotherapy after immune checkpoint inhibitor administration has attracted attention in various cancers, including head and neck cancers. However, individual assessments of the administered chemotherapy regimens are insufficient. This study aimed to evaluate the efficacy and safety of chemotherapy after immune checkpoint inhibitor administration in recurrent metastatic head and neck cancer by focusing on a single regimen. Materials and Methods: We retrospectively reviewed clinical and radiological data from the medical records of 18 patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who received systemic chemotherapy with weekly cetuximab and paclitaxel (Cmab + PTX) after progression following immune checkpoint inhibitor (ICI) therapy. The objective response rate (ORR) and disease control rate (DCR) were assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. Adverse events (AEs) were recorded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Results: In all patients, the ORR, DCR, median PFS, and median OS were 44.4%, 72.2%, 3.8 months, and 9.6 months, respectively. Regarding AEs, three patients developed grade 3 neutropenia. Grade 3 anemia, paronychia, asthenia, and peripheral neuropathy were observed in one patient each. There were no treatment-related deaths. Conclusions: Cmab + PTX was shown to maintain high efficacy and acceptable safety for R/M HNSCC that progressed after ICI therapy. Further research is needed to establish optimal treatment sequences and drug combinations for recurrent R/M HNSCC.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16194-e16194
Author(s):  
Osama Diab ◽  
Maloree Khan ◽  
Saqib Abbasi ◽  
Anwaar Saeed ◽  
Anup Kasi ◽  
...  

e16194 Background: Hepatocholangiocarcinoma (HCC-CC) is a rare form of cancer with a poor prognosis. Of all primary liver cancers, the incidence of HCC-CC ranges from 0.4 to 14.2%. HCC-CC is a mixed carcinoma with findings of both hepatocellular carcinoma and cholangiocarcinoma. Immune checkpoint inhibitors are a potent first line treatment in hepatocellular carcinoma with multiple clinical trial showing effectiveness in cholangiocarcinoma. HCC-CC has limited proven treatment options as patients are generally excluded from clinical trials. In this study we reviewed outcomes of patients with HCC-CC who received immune checkpoint inhibitor in a single center. Methods: Records of patients who had a pathological confirmed HCC-CC by a subspecialized hepatic pathologist at the University of Kansas medical center were reviewed. We identified 6 patients with locally advanced unresectable or metastatic HCC-CC that received immune checkpoint inhibitor between February 2017 and January 2021. Baseline characteristics were obtained, as well as best response, line of therapy, and duration of response. Results: Of the six patients 4 (66%) received PD-1 inhibitor alone and 2 (34%) received combination therapy with CTLA-4 inhibitor for the treatment of HCC-CC. There were 3 (50%) females and 6 (100%) with prior hepatitis C infection. four (66%) patients had metastatic disease and 2 had locally unresectable advanced disease. Objective response rate was 83.3%. One patient achieved complete response and had a treatment holiday after receiving treatment for 2 years, and restarted immunotherapy upon relapse. Four patients had a partial response, of which two passed away after disease progression. One patient had stable disease on 2 different lines of immunotherapy then progressed. Of those who responded, one patient received immunotherapy, 3 (50%) received liver directed therapy and two received chemotherapy or Lenvatinib as first line treatment (Table). Conclusions: Immune checkpoint inhibitors demonstrate potential activity in patients with HCC-CC without unexpected side effect in this unmet need high-risk population. Larger studies are needed to confirm activity and efficacy in this setting.[Table: see text]


Dermatitis ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Alexandria M. Brown ◽  
Wylie Masterson ◽  
Jonathan Lo ◽  
Anisha B. Patel

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