Immunotherapy releated cardiomyopathy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14601-e14601
Author(s):  
Ozlem Sonmez ◽  
Ozlem Nuray Sever ◽  
Basak Oyan ◽  
Osman Gokhan Demir
Keyword(s):  
Side Effects ◽  
Checkpoint Inhibitors ◽  
Rare Complication ◽  
Single Agent ◽  
Tnf Alpha ◽  
Oncology Practice ◽  
And Control ◽  
Chemotherapy Agents ◽  
As Effects ◽  
Cessation Of Treatment

e14601 Background: Side effects of immunotherapies also differ from classical cytoxic chemotherapy agents such as effects. Cardiomyopathy is a relatively rare complication. Studies have shown that the risk of developing myocarditis is higher when the ipilimumab / nivolumab combination is used than when the single agent nivolumab is used. ImmunoCheckpoint inhibitors are associated with an increase in immunologic response and immunosuppressives such as corticosteroids, TNF-alpha antagonists and mycophenolate acetate are used in treatment.In this study, we aimed to report cardiac toxicity in patients who treated with immune checkpoint inhibitors. Methods: Forty patients who were treated with immunocheckpoint inhibitors were screened retrospectively at two centers in Turkey between August 2015 and January 2017 . Results: Twenty-eight of the patients were male (70%), 12 were female (30%); The median age was 61 (32-81) years. 23 (57.5%) patients received nivolumab and 16 (40 %) patients received pembrolizumab and 1(2.5%) patient received pembrolizumab/ipilimumab combination. Seven of the cases had immuno-related side effects (17.5%).In two of our patients, after the second cure of the treatment, diffuse edema and shortness of breath due to heart failure was detected. Echocardiography revealed a low ejection fraction. Methylprednisolone was started by cessation of treatment. One week after the symptoms improved rapidly and control ejection fractions normalized. One of these patients was diagnosed with malignant melanoma and the other with RCC , they using pembrolizumab and nivolumab respectively. Conclusions: In conclusion, side effects that may occur may lead to fatal outcomes, while immunotherapy, which is increasingly used in oncology practice, may result in satisfactory success in treatment. Patients and their relatives should be adequately informed about side effects caused by these agents, complaints should be carefully evaluated and treatment should be started without spending time.

Evaluation of tolerability and reactions of immune checkpoint inhibitors.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14605-e14605 ◽  
Author(s):  
Ozlem Nuray Sever ◽  
Ozlem Sonmez ◽  
Osman Gokhan Demir
Keyword(s):  
Monoclonal Antibodies ◽  
Side Effects ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Treatment Interruption ◽  
Ease Of Use ◽  
Treatment Change ◽  
Function Test ◽  
Cessation Of Treatment

e14605 Background: Immunotherapies have revolutionized the treatment of cancer, especially in recent years. Today, there are anti-CTLA-4 antibodies and PD-L1 monoclonal antibodies which are active in use as checkpoint inhibitors. Side effects of these agents have a different spectrum in the form of immuno-related side effects. Methods: In this study, we aimed to evaluate the side effect and tolerability in patients treated with immune checkpoint inhibitors in our clinic. Results: 32 patients who were treated with PD-L1 monoclonal antibodies between August 2015 and January 2017 were screened retrospectively in our clinic. Six of the cases had immuno-related side effects (18.75%). 2 patients had a elevated liver function test. Both patients were diagnosed with NSCLC. In both of them, elevation was detected in the second course of nivolumab treatment, and the USG and hepatitis markers of the patients were normal. Enzymes returned to normal after treatment interruption. In a patient diagnosed with malignant melanoma that receiving pembrolizumab colitis was developed after 3th cycles of the therapy. The treatment of the patient who recovered after steroid administration and treatment interruption continued until the 8th cure. In the third cure of the patient with NSCLC, when nivolumab was used pneumonitis was diagnosed. Steroid treatment was applied for 2 weeks. Our patient continued to use nivolumab for up to 22 cycles. In our patient with malign melanoma that treated with pembrolizumab autoimmune thyroiditis developed. We started prednisolone treatment. After recovery our patient's treatment continued. In one of our patient who was diagnosed with malign melanoma, after the second cure of the treatment, diffuse edema and shortness of breath due to heart failure was detected. Echocardiography revealed a low ejection fraction. Methylprednisolone was started by cessation of treatment. Control ejection fractions normalized. Conclusions: İmmuno-related side effects were regarded as manageable side effects and no treatment change was needed. Immune Checkpoint inhibitors, which have been shown to be useful for survival every day, are proceeding to take a favorable position in the treatment of cancer with ease of use and lack of side effects.

Case series on the safety of mRNA COVID19 vaccines in cancer patients undergoing treatment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14562-e14562
Author(s):  
Faysal Haroun ◽  
Malak Alharbi ◽  
Alison Hong
Keyword(s):  
Side Effects ◽  
Cancer Therapy ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Single Agent ◽  
Case Series ◽  
Vaccine Uptake ◽  
Cancer Center ◽  
High Risk Population ◽  
Patients With Cancer

e14562 Background: Millions of vaccines have been administered since Emergency Use Authorization has been granted for two mRNA COVID-19 vaccines (mCV). The Center for Disease Control (CDC) and Prevention recommends that immunocompromised individuals with no contraindications to vaccines may receive an mCV. The CDC suggests that patients receiving cancer therapies should be consulted about the unknown vaccine safety profile and effectiveness. The American Society of Clinical Oncology recognizes that vaccine may reduce the risk of infection for individuals with cancer. Vaccine trials have not actively enrolled immunocompromised or patients on active cancer therapy; therefore, the potential side effects and efficacy of the mRNA vaccines in these individuals are unexplored. Per state guidelines, many patients with cancer undergoing treatment qualify for vaccination however current vaccine uptake in that population is unknown. Data in this specific high-risk population is needed to increase confidence in the vaccine. We explored adverse events (AE) to the mCV in a small cohort of patients undergoing cancer therapy. Methods: Our case series evaluated patients' tolerance to the voluntary but recommended 2 doses of the mCV while on chemotherapy (CX), checkpoint inhibitors (CPI) or tyrosine kinase inhibitors (TKI) at the George Washington University (GWU) Cancer Center in Washington DC. Patient chart review and phone interviews were conducted. Patients had independently signed up for the mCV at the GWU Hospital or through the DC Health Department. Patients were asked if they had experienced any of the commonly reported side effects listed by the CDC or others new symptoms receiving the vaccine. Results: 12 patients had voluntarily received the mCV, all patients were above the age of 65 with a mean age of 72 (66-85). ECOG performance status was 2 or above in 4 patients. 6 patients were receiving single agent CPI, 1 patient was on combination CX and CPI. 2 patients were on oral TKI for EGFR mutated lung cancer. 3 other patients were on combination CX with rituximab, ramucirumab or radiation. In the 2 patients on daily TKI, treatment was not interrupted for the mCV. In the 10 other patients, all but one patient received the mCV at least one week after the last therapy. Both mCV were tolerated without any life-threatening AE or hospitalization. Pain and swelling at the vaccine site were the most common local AE and reported in 7 patients. 6 patients reported systemic AE most commonly myalgia and headaches. Conclusions: This exploratory analysis in 12 patients with cancer undergoing treatment did not uncover any additional SE signals. Larger studies are needed to evaluate AE and efficacy and to guide recommendations for COVID19 vaccination in this patient population.

scholarly journals HOUT-04. ASSOCIATION OF COMMON PATIENT-REPORTED IMMUNOTHERAPY SYMPTOMATIC SIDE EFFECTS AND PSEUDOPROGRESSION IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM (CNS) TUMORS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi112-vi112
Author(s):  
Yamini Vyas ◽  
Elizabeth Vera ◽  
Christine Bryla ◽  
Sonja Crandon ◽  
Jing Wu ◽  
...  
Keyword(s):  
Side Effects ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Symptom Burden ◽  
Disease Status ◽  
Shortness Of Breath ◽  
Tumor Patients ◽  
Common Diagnosis ◽  
Patient Reported ◽  
Symptomatic Side

Abstract BACKGROUND Immunotherapy agents have unique symptomatic side effects; patient-reported outcomes (PROs) can help to characterize the benefits and burdens associated with therapy. Common immunotherapy-associated symptoms include pain, fatigue, shortness of breath, and irregular bowel patterns. The purpose of this study was to assess the severity of symptoms and their association with imaging changes in CNS tumor patients undergoing single agent or combination treatment with immune checkpoint inhibitors (ICIs). METHODS Patients completed the MDASI-BT or MDASI-SP at baseline and longitudinally (every 8 weeks), and results through cycle 4 are reported. Neuro-imaging was categorized as stable, possible ICI-related pseudoprogression, or progression by clinical team review. RESULTS 29 Brain Tumor (BT) and 6 Spinal Tumor patients participated; the majority of which were male (62%) and white (91%), ranging 24-74yo (mean = 46). Glioblastoma was the most common diagnosis (31%) followed by medulloblastoma (16%), with 56% of patients having greater than 2 recurrences prior to the study. At baseline, both brain and spine tumor patients reported moderate to severe fatigue (Brain=4, Spine=6) and pain (Spine=5) with shortness of breath and pain worsening over time. BT patients with pseudoprogression were more likely to report increased fatigue (87%) and pain (63%) compared to those with stable (29%) or true progressive (17%) disease on imaging. BT patients with pseudoprogression also reported worsening of cognitive (43%) and neurologic (57%) symptom burden. CONCLUSIONS In contrast to the common pseudoprogression after chemoradiation, treatment-specific symptoms were worse with ICI-related pseudoprogression by MRI where an immunologic reaction was the likely cause of the imaging worsening. These results suggest that commonly used symptom and functional assessments to distinguish true progression from pseudoprogression may not be helpful with immunotherapy. Additional studies including those with pathologic confirmation of progression or pseudoprogression combined with outcomes measures are needed to develop more accurate determinations of disease status.

Evaluation of the correlation between antibiotic use and survival in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6509-6509
Author(s):  
Paz J. Vellanki ◽  
Shanthi Marur ◽  
Pradeep Bandaru ◽  
Pallavi Shruti Mishra-Kalyani ◽  
Kunthel By ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Single Agent ◽  
Cox Proportional Hazards ◽  
Intestinal Microbiome ◽  
Control Group ◽  
Apparent Difference ◽  
Control Groups ◽  
Hpv Status ◽  
And Control

6509 Background: Recent evidence suggests that treatment with systemic antibiotics (Abx) disrupts the intestinal microbiome and may be associated with decreased survival for patients receiving treatment with ICIs for advanced cancers, including R/M HNSCC. However, a potential confounder is that Abx use identifies a subgroup of patients with a worse prognosis. The FDA examined the association between Abx use and survival for ICIs and other drugs used for the treatment of patients with R/M HNSCC. Methods: Data submitted to the FDA from three randomized controlled trials with ICI as a single agent or with chemotherapy (ICI group) compared to chemotherapy and/or cetuximab (Control group) were pooled. The association between systemic Abx use within 30 days of initiating anticancer therapy and survival for the ICI and Control groups was evaluated using Kaplan-Meier (KM) estimates and compared using Cox proportional hazards regression models, controlling for ECOG performance status, line of therapy, HPV status, PD-L1 expression, and other important prognostic factors. Results: In the ICI and Control groups, 36% and 46% of patients received Abx, respectively. For the ICI group, the difference in KM-estimated median overall survival (OS) was 5.6 months based on receipt of Abx (hazard ratio [HR] 1.70). Abx had no impact on OS for the Control group. Similar trends were observed for progression-free survival (PFS). Conclusions: In this exploratory analysis, systemic Abx within 30 days of initiating treatment for R/M HNSCC was associated with decreased survival for patients treated with ICIs compared with patients who did not receive Abx. Use of Abx had no apparent difference in survival in the control group. Further examination of the association between Abx use and clinical outcomes for patients with R/M HNSCC treated with ICIs is needed. [Table: see text]

scholarly journals 257 Combination of adenosine antagonists A2AR (TT-10) and A2BR (TT-4) with checkpoint inhibitors demonstrate anti-tumor activity in CT-26 murine colon tumor allograft model

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A279-A279
Author(s):  
Desa Rae Pastore ◽  
Sushant Kumar ◽  
Brian Schwartz ◽  
Kasim Mookhtiar ◽  
Vijay Reddy
Keyword(s):  
Flow Cytometry ◽  
Tumor Growth ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Vehicle Control ◽  
Receptor Expression ◽  
Adenosine Antagonists ◽  
Adenosine Antagonist ◽  
Tumor Measurements ◽  
And Control

BackgroundTT-10 and TT-4 are potent and selective antagonists of adenosine A2A receptor (A2AR) and A2B receptor (A2BR) respectively. Both agents are being developed for the treatment of advanced cancers initially as monotherapy, using high levels of adenosine receptor expression in tumor tissue as biomarker.MethodsBalb/c mice were implanted with CT-26 cells and randomly assigned to 8 groups per study; (1) vehicle control, (2) adenosine antagonist - 1 mg/kg A2AR (TT-10) 1 mg/kg or 3 mg/kg A2BR (TT-4), (3) 10 mg/kg Anti-mPD-1, (4) 5 mg/kg Anti-mCTLA-4, (5) 100 mg/kg Irinotecan, (6) adenosine antagonist + Anti-mPD-1, (7) adenosine antagonist + Anti-mCTLA-4, (8) adenosine antagonist+ Irinotecan. Adenosine antagonists and control were given daily by oral gavage, Anti-mPD-1, Anti-mCTLA-4 and Irinotecan were administered Intraperitoneal. Treatment was started on day 1 post implant and mice were followed until individual tumor volume reached 2,000 or 3000 mm3 (as defined by protocol) or moribund. Tumor measurements and weights were taken every 2 to 3 days. In addition, a subset of mice were investigated for changes in peripheral whole blood and intra-tumor analysis on days 3 and 10 via flow cytometry. The populations of interest included CD223+, CD3+, CD4+, CD8+, CD25+FoxP3+, CD25-CD69+ and CD44+CD62L.ResultsAll implanted mice developed measurable tumors. Mean suppression of tumor growth was observed to be greater in single agent adenosine antagonists TT-10 and TT-4 when compared to the vehicle control and was observed to show overall greater suppression of tumor growth when combined with anti-mPD-1 or anti-m-CTLA-4. Tumor infiltrating lymphocyte analysis by flow cytometry, showed higher amounts of CD25+FoxP3+ present in control mice at day 3, than was observed in mice that were treated with A2AR alone, A2AR + anti-mPD-1 and A2AR + anti-m-CTLA-4.ConclusionsTT-10 and TT-4 alone was superior to vehicle control in slowing tumor growth. However, the combination of TT-10 + Anti-mPD-1 and TT-4 + Anti-mCTLA-4 showed the greatest tumor response and growth suppression. Furthermore, a striking reduction of CD25+FoxP3+ within the tumor was observed at day 3 in mice treated with A2AR alone, A2AR + anti-mPD-1 and A2AR + anti-m-CTLA-4 when compared to the vehicle control.

Effects of Virgin Coconut Oil as Adjunct Therapy in the Treatment of Allergic Rhinitis

2016 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Nazli Zainuddin ◽  
Nurul Azira Mohd Shah ◽  
Rosdan Salim
Keyword(s):  
Allergic Rhinitis ◽  
Side Effects ◽  
Coconut Oil ◽  
Test Group ◽  
Nasal Symptom ◽  
Control Group ◽  
Virgin Coconut Oil ◽  
Control Groups ◽  
Significant Difference ◽  
And Control

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.

Cutaneous Adverse Events of Immune Checkpoint Inhibitors: A Summarized Overview

2019 ◽  
Vol 14 (1) ◽  
pp. 14-20 ◽  
Author(s):  
Kerasia-Maria Plachouri ◽  
Eleftheria Vryzaki ◽  
Sophia Georgiou
Keyword(s):  
Side Effects ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Skin Toxicity ◽  
Maculopapular Rash ◽  
Symptomatic Treatment ◽  
Stevens Johnson Syndrome ◽  
Life Threatening ◽  
Skin Side Effects

Background:The introduction of Immune Checkpoint Inhibitors in the recent years has resulted in high response rates and extended survival in patients with metastatic/advanced malignancies. Their mechanism of action is the indirect activation of cytotoxic T-cells through the blockade of inhibitory receptors of immunomodulatory pathways, such as cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein-1 (PD-1) and its ligand (PD-L1). Despite their impressive therapeutic results, they can also induce immune-related toxicity, affecting various organs, including the skin.Objective:To provide an updated summarized overview of the most common immune-mediated cutaneous side effects and their management.Method:English articles derived from the databases PubMed and SCOPUS and published between 2009 and 2018, were analyzed for this narrative review.Results:The most common adverse cutaneous reactions include maculopapular rash, lichenoid reactions, vitiligo and pruritus, with severity Grade 1 or 2. Less frequent but eventually life-threatening skin side effects, including Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms and Toxic Epidermal necrolysis, have also been reported.Conclusion:Basic knowledge of the Immune-Checkpoint-Inhibitors-induced skin toxicity is necessary in order to recognize these treatment-related complications. The most frequent skin side effects, such as maculopapular rash, vitiligo and pruritus, tend to subside under symptomatic treatment so that permanent discontinuation of therapy is not commonly necessary. In the case of life-threatening side effects, apart from the necessary symptomatic treatment, the immunotherapy should be permanently stopped. Information concerning the management of ICIs-mediated skin toxicity can be obtained from the literature as well as from the Summary of Product Characteristics of each agent.

scholarly journals TNF-Alpha Inhibitors for Chronic Urticaria: Experience in 20 Patients

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Freja Lærke Sand ◽  
Simon Francis Thomsen
Keyword(s):  
Side Effects ◽  
Chronic Urticaria ◽  
Treatment Options ◽  
Significant Proportion ◽  
Response Duration ◽  
Immunosuppressive Drugs ◽  
Tnf Alpha ◽  
High Dose ◽  
Duration Of Treatment ◽  
Durable Response

Patients with severe chronic urticaria may not respond to antihistamines, and other systemic treatment options may either be ineffective or associated with unacceptable side effects. We present data on efficacy and safety of adalimumab and etanercept in 20 adult patients with chronic urticaria. Twelve (60%) patients obtained complete or almost complete resolution of urticaria after onset of therapy with either adalimumab or etanercept. Further three patients (15%) experienced partial response. Duration of treatment ranged between 2 and 39 months. Those responding completely or almost completely had a durable response with a mean of 11 months. Six patients (30%) experienced side effects and five patients had mild recurrent upper respiratory infections, whereas one patient experienced severe CNS toxicity that could be related to treatment with TNF-alpha inhibitor. Adalimumab and etanercept may be effective and relatively safe treatment options in a significant proportion of patients with chronic urticaria who do not respond sufficiently to high-dose antihistamines or in whom standard immunosuppressive drugs are ineffective or associated with unacceptable side effects.

scholarly journals 353 Safety and efficacy of tumor infiltrating lymphocytes (TIL, LN-145) in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A378-A378
Author(s):  
Antonio Jimeno ◽  
Sophie Papa ◽  
Missak Haigentz ◽  
Juan Rodríguez-Moreno ◽  
Julian Schardt ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Checkpoint Inhibitors ◽  
Adoptive Cell Therapy ◽  
Single Agent ◽  
Objective Response ◽  
Tumor Resection ◽  
Tumor Infiltrating Lymphocytes ◽  
Open Label ◽  
Safety And Efficacy ◽  
Infiltrating Lymphocytes

BackgroundSingle agent checkpoint inhibitors (CPI) are an approved first or second-line therapy in head and neck squamous cell carcinoma (HNSCC), but their efficacy is limited. Adoptive cell therapy with tumor infiltrating lymphocytes (TIL, LN-145) has demonstrated efficacy in multiple malignancies alone or in combination with CPI. To improve HNSCC therapy, a combination of pembrolizumab and LN-145 was explored.MethodsIOV-COM-202 is an ongoing Phase 2 multicenter, multi-cohort, open-label study evaluating LN-145 in multiple settings and indications, and here we report cohort 2A which enrolled CPI naïve HNSCC patients who received the combination of LN-145 and pembrolizumab. Key eligibility criteria include up to 3 lines of prior therapy, ECOG <1, at least one resectable metastasis for LN-145 production, and at least another measurable lesion after tumor resection. Primary endpoints are ORR per RECIST v1.1 by investigator and safety as measured by the incidence of grade ≥ 3 treatment-emergent adverse events (TEAEs). LN-145 production method uses central GMP manufacturing in a 22-day process yielding a cryopreserved TIL product (figure 1). Preconditioning chemotherapy consists of cyclophosphamide/fludarabine, followed by LN-145, and then < 6 doses of IL-2 over <3 days. Pembrolizumab is initiated post-tumor harvest but prior to LN-145 and continues after LN-145 infusion Q3W until toxicity or progression (figure 2).ResultsNine (N=9) HNSCC patients have received LN-145 plus pembrolizumab, with a median duration of follow up of 6.9 months. Nine and 8 patients were evaluable for safety and efficacy, respectively. Mean number of prior therapies was 1.1 with 89% of the patients having received prior chemotherapy. Four were HPV+, 2 HPV-, 3 unknown. The Treatment Emergent Adverse Event (TEAE) profile was consistent with the underlying advanced disease and the known AE profiles of pembrolizumab, the lymphodepletion and IL-2 regimens. The most common TEAE were chills, hypotension, anemia, thrombocytopenia, pyrexia, fatigue and tachycardia. Four patients had a confirmed, objective response with an ORR of 44% (1 CR, 3 PR, 4 SD, 1 NE) per RECIST 1.1. The disease control rate at data cutoff was 89% in 9 patients, and 7 of the 8 evaluable patients (87.5%) had a reduction in target lesions. Median DOR was not reached.Abstract 353 Figure 1Iovance LN-145 (autologous TIL cell therapy product) ManufacturingAbstract 353 Figure 2IOV-COM-202 Study SchemaConclusionsLN-145 can be safely combined with pembrolizumab in patients with metastatic HNSCC. LN-145 plus pembrolizumab shows early signs of improved efficacy particularly when compared with literature reports of pembrolizumab alone in a comparable patient population. Enrollment is ongoing and updated data will be presented.Trial RegistrationNCT03645928Ethics ApprovalThe study was approved by Advarra Institutional Review Board, under protocol number: Pro00035064.

scholarly journals PD-1/PD-L1 checkpoint inhibitors during late stages of life: an ad-hoc analysis from a large multicenter cohort

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daniele Santini ◽  
Tea Zeppola ◽  
Marco Russano ◽  
Fabrizio Citarella ◽  
Cecilia Anesi ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Burden Of Disease ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Advanced Cancer Patients ◽  
Primary Tumors ◽  
Multicenter Cohort ◽  
Frail Patients ◽  
Ecog Ps ◽  
Late Stages

Abstract Background The favourable safety profile and the increasing confidence with immune checkpoint inhibitors (ICIs) might have boosted their prescription in frail patients with short life expectancies, who usually are not treated with standard chemotherapy. Methods The present analysis aims to describe clinicians’ attitudes towards ICIs administration during late stages of life within a multicenter cohort of advanced cancer patients treated with single agent PD-1/PD-L1 checkpoint inhibitors in Italy. Results Overall, 1149 patients with advanced cancer who received single agent PD-1/PD-L1 checkpoint inhibitors were screened. The final study population consisted of 567 deceased patients. 166 patients (29.3%) had received ICIs within 30 days of death; among them there was a significantly higher proportion of patients with ECOG-PS ≥ 2 (28.3% vs 11.5%, p < 0.0001) and with a higher burden of disease (69.3% vs 59.4%, p = 0.0266). In total, 35 patients (6.2%) started ICIs within 30 days of death; among them there was a higher proportion of patients with ECOG-PS ≥ 2 (45.7% vs 14.5%, p < 0.0001) and with a higher burden of disease (82.9% vs 60.9%, p = 0.0266). Primary tumors were significantly different across subgroups (p = 0.0172), with a higher prevalence of NSCLC patients (80% vs 60.9%) among those who started ICIs within 30 days of death. Lastly, 123 patients (21.7%) started ICIs within 3 months of death. Similarly, within this subgroup there was a higher proportion of patients with ECOG-PS ≥ 2 (29.3% vs 12.8%, p < 0.0001), with a higher burden of disease (74.0% vs 59.0%, p = 0.0025) and with NSCLC (74.0% vs 58.8%, p = 0.0236). Conclusion Our results confirmed a trend toward an increasing ICIs prescription in frail patients, during the late stages of life. Caution should be exercised when evaluating an ICI treatment for patients with a poor PS and a high burden of disease.

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