scholarly journals Incidence of Skin and Respiratory Immune-Related Adverse Events Correlates With Specific Tumor Types in Patients Treated With Checkpoint Inhibitors

2021 ◽  
Vol 10 ◽  
Author(s):  
Lynn M. Rose ◽  
Hannah A. DeBerg ◽  
Prakash Vishnu ◽  
Jason K. Frankel ◽  
Adarsh B. Manjunath ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Checkpoint Inhibitors ◽  
Medical Center ◽  
Specific Response ◽  
Specific Tumor ◽  
Wide Range ◽  
Diverse Patient Population ◽  
Pre Treatment ◽  
Grade 3

Checkpoint inhibitors (CPIs) increase antitumor activity by unblocking regulators of the immune response. This action can provoke a wide range of immunologic and inflammatory side effects, some of which can be fatal. Recent studies suggest that CPI-induced immune-related adverse events (irAEs) may predict survival and response. However, little is known about the mechanisms of this association. This study was undertaken to evaluate the influence of tumor diagnosis and preexisting clinical factors on the types of irAEs experienced by cancer patients treated with CPIs. The correlation between irAEs and overall survival (OS) was also assessed. All cancer patients treated with atezolizumab (ATEZO), ipilimumab (IPI), nivolumab (NIVO), or pembrolizumab (PEMBRO) at Virginia Mason Medical Center between 2011 and 2019 were evaluated. irAEs were graded according to the Common Terminology Criteria for Adverse Events (Version 5) and verified independently. Statistical analyses were performed to assess associations between irAEs, pre-treatment factors, and OS. Of the 288 patients evaluated, 59% developed irAEs of any grade, and 19% developed irAEs of grade 3 or 4. A time-dependent survival analysis demonstrated a clear association between the occurrence of irAEs and OS (P < 0.001). A 6-week landmark analysis adjusted for body mass index confirmed an association between irAEs and OS in non-Small Cell Lung Cancer (NSCLC) (P < 0.03). An association between melanoma and skin irAEs (P < 0.01) and between NSCLC and respiratory irAEs (P = 0.03) was observed, independent of CPI administered. Patients with preexisting autoimmune disease experienced a higher incidence of severe irAEs (P = 0.01), but not a higher overall incidence of irAEs (P = 0.6). A significant association between irAEs and OS was observed in this diverse patient population. No correlation was observed between preexisting comorbid conditions and the type of irAE observed. However, a correlation between skin-related irAEs and melanoma and between respiratory irAEs and NSCLC was observed, suggesting that many irAEs are driven by a specific response to the primary tumor. In patients with NSCLC, the respiratory irAEs were associated with a survival benefit.

scholarly journals 522 Transcriptomic changes in cancer patients treated with immune-checkpoint inhibitors

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A552-A552
Author(s):  
Dmitrii Shek ◽  
Bo Gao ◽  
Joey Lai ◽  
Won-Hee Yoon ◽  
Tania Moujaber ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Differentially Expressed Genes ◽  
Immune Checkpoint ◽  
Functional Annotation ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Link Type ◽  
Pre Treatment ◽  
Grade 3 ◽  
Transcriptomic Changes

BackgroundImmune-checkpoint inhibitors (ICIs) are monoclonal antibodies that block inhibitory CTLA-4/PD-1 signalling pathways and thus boost cytotoxic T cell antitumor activity. ICIs have been proven effective in various malignancies, but there is a lack of knowledge regarding factors associated with ICI efficacy and safety. This study aims to examine transcriptomic changes in cancer patients treated with ICIs and their potential association with related clinical outcomes.MethodsThis is a prospective multicentre cohort study (NCT04631731) recruiting cancer patients treated with (1) ICI monotherapy; (2) ICI dual therapy; (3) ICI + kinase inhibitor; (4) ICI + platinum-doublet chemotherapy. Peripheral blood is collected at baseline and 6–8 weeks after first ICI treatment as well as after the development of immune-related adverse events (irAEs, grade 2 and higher). Whole transcriptome sequencing (Novaseq S4 300 cycle lane, Illumina) was performed and followed by functional annotation using the ConsensusPath-DB platform.Results22 patients were recruited to the study and had paired blood taken. Two patients had developed grade 3–4 irAEs. RNA sequencing analysis identified 3,000 genes that were significantly dysregulated at week 6–8 after ICI commencement as compared to pre-treatment in n=20 recruited patients without irAEs (figure 1). Functional annotation established that 132 pathways were associated with the identified set of dysregulated genes. Among them: (1) pre-NOTCH processing in Golgi, (2) Interleukin-15 signalling; (3) STAT5 activation, and (4) RORA activation of gene expression possessed a gene set enrichment of at least 80% and p<0.01. In 2 patients with grade 3 immune-mediated hepatitis, both treated with combination of CTLA-4/PD-1 inhibitors, analysis revealed that 360 and 325 were 2-fold up- and downregulated respectively upon onset of toxicity as compared to both pre-treatment and 1-week post-steroid treatment. Interestingly, this gene set possessed minimal overlap when compared to genes dysregulated in patients without irAEs. Moreover, functional annotation established different pathways that were associated with toxicity. The highest enrichment scores belonged to pathways regulating cell cycle and apoptotic pathways driven by CDC25A, p53 and BCL-2, among others.Abstract 522 Figure 1Volcano plot representing the differentially expressed genesThe figure representing differentially expressed genes elucidated in this pilot study. N=3000 genes were significantly dysregulated between pre- and week 6–8 post-IO commencement.ConclusionsThe preliminary analysis of the first 22 patients recruited to NCT04631731 confirms that ICI treatment interferes with expression of coding and non-coding RNAs. Importantly, patients with and without irAEs show different patterns of transcriptomic changes as well as variability among activated cellular pathways. This data emphasises the need for further exploration and validation of transcriptomic changes in a larger cohort. In the near future, RNA signatures may be utilised as biomarkers to rapidly and accurately diagnose irAEs.AcknowledgementsN/ATrial RegistrationClinicalTrials.Gov identification number: NCT04631731ReferencesN/AEthics ApprovalThis study has been approved by the Western Sydney Local Health District (WSLHD) Human Research Ethics Committee on the November 9th, 2020 to be conducted at Blacktown and Westmead Public Hospitals of the WSLHD, Sydney, NSW, Australia.ConsentEach participant recruited to this translational study has provided written consent approved on the November 6th, 2020 (MASTER version) by the WSLHD HREC.

SAINT: Results of a phase 1/2 study of safety/efficacy using safe amounts of ipilimumab, nivolumab, and trabectedin as first-line treatment of advanced soft tissue sarcoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11016-11016 ◽  
Author(s):  
Erlinda Maria Gordon ◽  
Victoria S. Chua-Alcala ◽  
Katherine Kim ◽  
Seiya Liu ◽  
Nicole Angel ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Phase 1 ◽  
Safety Analysis ◽  
Phase 2 ◽  
First Line ◽  
Efficacy Analysis ◽  
First Line Therapy ◽  
Pre Treatment ◽  
Grade 3

11016 Background: Sarcoma cells are most immunogenic earlier in the disease course and prior to treatment when the immune system can recognize and destroy them. Hypothesis: Immune checkpoint inhibitors would be most effective when given as first line therapy. Methods: This is an IRB-approved dose-seeking Phase 1/2 protocol using defined doses of I (1 mg/kg i.v. q 12 weeks), N (3 mg/kg i.v. q 2 weeks) and escalating doses of T (1.0, 1.2, 1.5 mg/m2 i.v. q 3 weeks), employing the “Cohort of Three” design, followed by a Phase 2 using the MTD of trabectedin. Results: Nine subjects were treated in Phase 1 of the study, and 31 subjects in Phase 2. Safety analysis: at Dose 1: Grade 3 treatment-related adverse events (TRAEs) included fatigue (n = 1), increased TSH (n = 1). At Dose 2, Grade 4 TRAEs included thrombocytopenia with bleeding, DLT (n = 1), increased CK (n = 1); Grade 3 TRAEs included anemia (n = 1), myalgia (n = 1), increased TSH (n = 1), decreased TSH (n = 1), increased AST (n = 1). Efficacy analysis (evaluable patients): At Dose 1: Disease Control Rate (DCR = CR, PR, SD) was 67%, median PFS, 18 weeks; median OS, 50 weeks; At Dose 2: PR (n-1), DCR 60%, median PFS, 24 weeks; median OS, > 46 weeks. At Phase 2, MTD Dose 2 (PUPs): Safety analysis (n = 31): Grade 3 TRAEs included fatigue (n = 2), increased ALT (n = 6), increased AST (n = 4), hypernatremia (n = 1), hyponatremia (n = 1), dehydration (n = 1), rash (n = 1), port cellulitis (n = 1), psoriasis exacerbation (n = 1), increased TSH (n = 1), decreased hemoglobin (n = 2), neutropenia (n = 1). Efficacy analysis (N = 23 evaluable): PR (n-5; 2 UPS, 1 synovial sarcoma, 1 liposarcoma, 1 leiomyosarcoma,), BORR 22%, DCR 96%. Median PFS and OS not yet reached. After 4 treatment cycles, one resected tumor showed 80% necrosis and a greater number (30%) of CD8+ killer T cells, in the TME compared to archived pre-treatment tumor. Conclusions: These data suggest that the SAINT protocol (1) is safe with manageable adverse events, with no additive toxicity, and (2) may control tumor growth. Phase 2 of the study is on-going. Clinical trial information: NCT03138161.

scholarly journals Immune-related adverse events of COVID-19 vaccination in skin cancer patients receiving immune-checkpoint inhibitor treatment

2021 ◽  
Author(s):  
Sophia B. Strobel ◽  
Devayani Machiraju ◽  
Katharina A. Kälber ◽  
Jessica C. Hassel
Keyword(s):  
Side Effects ◽  
Skin Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Vaccine Type ◽  
Small Cohort ◽  
Grade 3 ◽  
Few Data

AbstractTo date, few data are available regarding Adverse events (AEs) in cancer patients who are vaccinated for coronavirus disease 2019 (COVID-19) while being actively treated with Immune-checkpoint inhibitors (ICIs). We aimed to assess the safety of COVID-19 vaccines approved in Germany. Specifically, we investigated the frequency of general side effects and immune-related AEs of COVID-19 vaccination. A triage survey was used to collect the following information for patients with metastatic skin cancer: vaccine type, date of receipt of each dose of vaccine, and self-reported side effects. Clinical data were retrieved from the patients’ medical records. Of 130 patients with metastatic skin cancer, 89 patients were on immunotherapy and received COVID-19 vaccination. Of these 89 patients (median age: 64 years; 57 [64%] men), 89% had melanoma, and 71% received ICI therapy with a PD-1 antibody. Eighty-eight percent received an mRNA-based COVID-19 vaccination. The median follow-up time was 125 days after the first vaccination, and 84 days after the second. The most common observed side effects were mild to moderate pain at the injection site (40%), followed by fatigue (24%). Grade 3 irAEs were reported in eight patients, seven of whom were on nivolumab plus ipilimumab combination treatment. Of the 19 patients vaccinated within 72 h before/after ICI, five developed irAEs within 17 days (1–17 days). This small cohort study suggests that approved COVID-19 vaccinations are safe for use in cancer patients receiving ICIs. However, some precautions should be taken, especially regarding the timing of vaccination and ICI treatment.

Comparison of efficacy and safety of checkpoint inhibitors in patients with genitourinary cancers aged below and above 75 years.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16101-e16101
Author(s):  
Gerald Bastian Schulz ◽  
Bernadett Szabados ◽  
Annabel Spek ◽  
Michael D. Staehler ◽  
Christian Stief ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Cancer Patients ◽  
Renal Cell ◽  
Urothelial Cancer ◽  
Checkpoint Inhibitors ◽  
The Elderly ◽  
Genitourinary Cancers ◽  
Grade 3

e16101 Background: Checkpoint-inhibitors have recently been introduced in the treatment of patients with genitourinary cancers. However, the use in elderly patients is controversial due to putative age-associated changes including the dysregulation of the immune system. We sought to investigate the safety and efficacy of immunotherapy in patients younger and older than 75 years of age. Methods: We conducted a retrospective review of patients with renal cell carcinoma and urothelial cancer treated with different immunotherapeutic agents between August 2015 and September 2018 at a high-volume single institution. Eligible patients received at least one cycle of single agent or a combination of checkpoint inhibitors as first or following treatment line. Immune-related adverse events (irAE) were graded using the NCI CTCAE v 4.0. Clinicopathological parameters including gender, cancer entity, ECOG, adverse events, comorbidities and response to treatment were stratified by age ≥ 75 vs. < 75 years and tested with a Pearson's chi-squared test. Additionally, we evaluated the impact of irAE on oncological outcome using the log-rank test. Results: 79 patients were identified, of those 27 (34.2%) were 75 years and older (15 renal cell carcinoma and 12 urothelial cancer patients) and 52 (65.8%) were younger than 75 years (39 renal cell carcinoma and 13 urothelial cancer patients). 2 complete responses were achieved in the elderly group and 6 in the younger group (p = 0.56). Disease control rate (stable disease, partial and complete response) was 48,1% in the elderly group and 53.8% in the younger group (p = 0.631). We observed a total of 30 irAEs (18 grade 1-2 and 12 grade 3-4), with an even distribution among the groups (≥75 years: 1 grade 4 AE; < 75 years: 12 grade 3-4 AEs). Except for ECOG ≥2 (p = 0.009) and ≥2 comorbidities (p < 0.001), there was no difference when groups were stratified by age. Both disease control rate and irAE did not differ between age subgroups. Occurrence of irAE showed no impact on oncological survival. Conclusions: The study demonstrates that patients over 75 years of age with renal cell and urothelial cancer treated with checkpoint-inhibitors respond with a good toxicity profile and an efficacy comparable with the younger population. irAE seem to have no impact on prognosis.

scholarly journals 807 Immunotherapy related adverse events: a single center experience

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A844-A844
Author(s):  
Wei Yang ◽  
Julie Rowe ◽  
Sophia Lee ◽  
Jing Zhang ◽  
Mohammad Rahbar
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Study Data ◽  
List Type ◽  
Prior Chemotherapy ◽  
Grade 3

BackgroundAs the role of immune checkpoint inhibitors (ICIs) expands in many malignancies, including hepatocellular carcinoma (HCC), a better understanding of the predictors of immunotherapy-related adverse events (irAEs) is needed due to the complexity that ICIs add to patient care.1–5MethodsWe conducted a single-institution retrospective chart review for cancer patients of any type who received at least one ICI between January 2015 and December 2020. Demographic, social, cancer-related, laboratory, and treatment variables were collected, along with irAE data. Exploratory statistical analysis was performed to find predictors of increased irAEs.ResultsA total of 342 patients were included in the study: 133 women and 209 men. Median age was 65 years. The most common cancers were lung (110, 32.07%), kidney (51, 14.87%), and HCC (43, 12.54%). All patients received at least one dose of ICI (table 1); 11 received combination ICIs. One hundred and two (26.53%) patients developed irAEs of any grade (table 2). Nineteen patients (5.56%) had a grade 3 or 4 irAE; 20 patients required systemic steroids. No biologics were used for the management of severe irAEs. Patients who received prior chemotherapy were less likely to develop irAEs (odds ratio [OR] = 0.42, p = 0.0006). A history of hyperthyroidism or hypothyroidism was associated with more irAEs (p = 0.011). Combination ICI led to more irAEs overall (OR = 2.91, p = 0.043), as well as grade 3 or 4 events (OR = 5.32, p = 0.008). A trend toward more grade 3 or 4 events occurred in HCC patient (OR = 2.78, p = 0.06). Older patients showed a trend toward more irAEs (p = 0.08).Worse peri-treatment renal function was associated with an increased risk of irAE (OR = 1.86, p = 0.047). A higher peri-treatment hemoglobin nadir was associated with a lower risk of irAE (OR = 0.45, p = 0.07). Several other variables had ORs or confidence intervals close to 1, including number of sessions of ICI and higher baseline AST.ConclusionsPrior chemotherapy, worse renal function, and thyroid dysfunction were associated with irAEs, whereas higher hemoglobin nadir was protective against irAE. Unlike the current literature, our study included a large number of HCC patients. The higher irAE incidence in our study could be associated with this higher number of HCC patients; however, further studies are needed.ReferencesBrahmer JR, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline. JCO 2018;36:1714–1768.National Comprehensive Cancer Network. Management of Immunotherapy-Related Toxicities, 2021. https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf.Kartolo A, Sattar J, Sahai V, Baetz T, Lakoff JM. Predictors of immunotherapy-induced immune-related adverse events. Curr Oncol 2018;25:e403–e410.Suresh K, et al. Pneumonitis in non–small cell lung cancer patients receiving immune checkpoint immunotherapy: incidence and risk factors. Journal of Thoracic Oncology 2018;13:1930–1939.Colen RR, et al. Radiomics to predict immunotherapy-induced pneumonitis: proof of concept. Invest New Drugs 2018;36:601–607.Ethics ApprovalThe study involving retrospective review of patient records was approved under the Institutional Review Board. All records identifying the patient was be kept confidential and, to the extent permitted by the applicable laws and/or regulations, were not be made publicly available. Patient names will not be supplied to third parties. A unique study number will be assigned to each patient. Study data stored electronically will be stored in a password-protected, encrypted computers. Paper study data will be maintained by the primary investigators in the locked research offices.ConsentN/AAbstract 807 Table 1Immune checkpoint inhibitors receivedAbstract 807 Table 2irAE incidence

scholarly journals Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Luisa Maria Griewing ◽  
Claudia Schweizer ◽  
Philipp Schubert ◽  
Sandra Rutzner ◽  
Markus Eckstein ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Weight Change ◽  
Immune Checkpoint ◽  
Detection Rate ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Patient Questionnaire ◽  
Organ Specific ◽  
Tumor Entities

Abstract Background Immune checkpoint inhibitors (ICI) have become standard treatment in different tumor entities. However, safe treatment with ICI targeting the PD-1/PD-L1 axis requires early detection of immune-related adverse events (irAE). There exist different questionnaires of drug manufacturers for the detection of irAE that have not been validated so far. Methods The prospective non-interventional ST-ICI trial studied treatment with PD-1/PD-L1 ICI alone or combined with radiotherapy. In the current analysis, the detection rate of self-reported irAE with a patient questionnaire containing 41 different questions was compared to clinician-reported irAE. Results Between April 2017 and August 2019, a total of 104 patients were prospectively enrolled. NSCLC (44%) and HNSCC (42%) were the most frequent tumor entities. A total of 784 questionnaires were collected. A total of 29 irAE were reported by clinicians. The most frequent irAE was hypothyroidism (9%), followed by skin reactions (5%), hepatitis (4%), diarrhea (3%), and pneumonitis (3%). Questions that became significantly more often positive at time points of clinician-reported irAE were “weight change”, “difficulty to grip things”, “bloody or mucous stool” and “insomnia”. Self-reported organ-specific questions detected at least 50% of clinician-reported irAE of gastrointestinal, lung, endocrine, and skin irAE. It was not possible to detect hepatic irAE with the questionnaire. Conclusion Questionnaires can help to detect gastrointestinal, lung, endocrine, or skin irAE, but not hepatic irAE. Questions on “weight change” and “insomnia” may help to increase the detection rate of irAE, besides organ-specific questions. These results are a valuable contribution to the future development of a specific and practicable questionnaire for early self-reported detection of irAE during ICI therapy in cancer patients. Trial registration ClinicalTrials.gov, NCT03453892. Registered on 05 March 2018.

scholarly journals 526 Removal of soluble tumor necrosis factors receptors 1/2 in patients with metastatic solid tumors using immune apheresis

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A556-A556
Author(s):  
Ayala Tamir ◽  
Hagit Harati ◽  
Nethanel Asher ◽  
Ronen Stoff ◽  
Shirly Grynberg ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Checkpoint Inhibitors ◽  
Medical Center ◽  
Central Line ◽  
Affinity Column ◽  
Mass Cytometry ◽  
Cytokine Detection ◽  
Full Study ◽  
Immuno Assay ◽  
Differential Increase

BackgroundTNFα is a cytokine produced by immune cells and by tumor cells. The soluble forms of membrane TNF receptors 1/2 (sTNF-R1/2) act as decoy to neutralize TNFα, and are highly abundant in cancer patients. Elimination of sTNF-R1/2 may therefore unmask endogenous TNFα, to presumably exert anti-neoplastic effects and reverse resistance to immune checkpoint inhibitors. Immune Apheresis (IA) is a procedure designed to specifically capture sTNF-R1/2 from plasma by passing it over an affinity column. Here we employed Immunicom’s LW-02 Immunopheresis® device for removal of sTNF-R1/2 from plasma of cancer patients.MethodsIn cohort A, patients with melanoma, RCC, NSCLC or TNBC refractory to standard therapy were treated with IA only. IA treatment of 2 plasma volumes was done x3/week, for three treatment cycles (4 weeks each) up to a total of 36 treatments. Cohort B patients currently receive concurrent IA and Nivolumab therapy (240mg q2 weeks starting on week 5). sTNF-Rs removal and circulating inflammatory biomarkers were measured by immuno-assays, such as multiplex cytokine detection and mass cytometry. Pre- and post-treatment tumor biopsies were analyzed for tumor markers and TILs by immunohistochemistry.ResultsCohort A included six patients (3 Melanoma and 3 TNBC): three patients completed full study regimen, and three others were withdrawn due to clinical progression. AEs included chills (4/6), fever (2/6), anemia (6/6), central line thrombosis (1/6) and pulmonary embolism (1/6) All were Grade 2 except G3 anemia (1/6). There were no treatment related SAE’s. sTNF-Rs levels were significantly reduced, followed by enhanced detection of TNFα, and IFNγ in some cases. In two patients, CD8 counts and PD-1 and PD-L1 expression were increased. Congruently, blood mass cytometry showed reduction in Treg subsets and differential increase of CD8 subsets following treatment.ConclusionsThe use of Immunicom’s LW-02 Immunopheresis® device in combination with Terumo BCT Spectra Optia Apheresis System is safe and efficient in the removal of sTNF-Rs from blood plasma. Subsequent immuno-assay analyses indicated formation of inflammatory response which may facilitate effects of immunotherapy, yet to be investigated in cohort B.Trial RegistrationNCT04142931Ethics ApprovalSheba Medical Center Ethics Committee, 6136-19ConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal

The role of nutritional assessment for predicting Radiotherapy-induced adverse events in patients with gastric cancer

2021 ◽  
Author(s):  
Wenjie Sun ◽  
Guichao Li ◽  
Jing Zhang ◽  
Ji Zhu ◽  
Zhen Zhang
Keyword(s):  
Gastric Cancer ◽  
Body Weight ◽  
Adverse Events ◽  
Cancer Patients ◽  
Body Weight Loss ◽  
Nutritional Factors ◽  
Nrs 2002 ◽  
Grade 3 ◽  
Gastric Cancer Patients

Objectives: The aim of this study was to investigate the role of nutritional factors in predicting radiotherapy-associated toxicities for gastric cancer patients. Methods: A total of 285 gastric cancer patients who underwent radiotherapy in our hospital between 2010 and 2017 were included in this retrospective study. Nutritional status assessment included body weight loss (BWL), body mass index (BMI), serum albumin, nutrition risk screening 2002(NRS-2002), patient-generated subjective global assessment(PG-SGA) and nutritional risk index (NRI). Results: Of all patients, 19.6% were underweight (BMI <18.5 kg/m2), 25.6% were hypoalbuminemia (<35 g l−1) and 48.8% lost ≥10% of body weight in the 6 month interval before radiotherapy(BWL). Meanwhile, 73.3%, 78.6 and 47.2% of the patients were diagnosed as malnutrition based on NRS-2002, PG-SGA and NRI, respectively. Hematological adverse events were present in 91.2% (≥Grade 1) and 20.4% (≥Grade 3) of the patients. Non-hematological adverse events occurred in 89.8% (≥Grade1) and 14.4% (≥Grade 3) of the patients. Multivariate analyses indicated that only hypoalbuminemia(<35 g l−1) was independent predictor for Grade 3/4 hematological and non-hematological adverse events. Meanwhile, higher BWL(≥10%) was also independent predictor for Grade 3/4 non-hematological adverse events. NRS-2002, PG-SGA and NRI score were not associated with treatment-induced adverse events. Conclusions: Body weight loss and serum albumin are useful factors for predicting severe adverse events in gastric cancer patients who undergo radiotherapy. Advances in knowledge: The use of nutritional factors in predicting severe adverse events enables implementation of individualized treatment strategies for early and intensive nutritional interventions in high-risk patients.

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