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Palliative radiotherapy in advanced cancer patients treated with immune-checkpoint inhibitors: The PRACTICE study.

ABSTRACT: In the present study, the influence of purely palliative radiotherapy (pRT) on the outcomes of patients with advanced cancer undergoing immune checkpoint blockade was evaluated. Patients were stratified into three groups: Patients who had received pRT within 6 months prior to the initiation of immunotherapy (previous pRT); patients who received pRT during immunotherapy (concurrent pRT); and patients who did not receive RT prior to or during immunotherapy (no RT group), and these groups were compared. The median overall survival (mOS), median progression free survival (mPFS) and median time-to-treatment failure (mTTF) for the previous pRT group were significantly shorter compared with the no RT group (mOS, 3.6 vs. 12.1 months, respectively, P=0.0095; mPFS 1.8 vs. 5.4 months, respectively, P=0.0016; mTTF 1.8 vs. 5.7 months, respectively, P=0.0035). The concurrent pRT group had a longer mTTF compared with the previous pRT group and similar outcomes to the no RT group. In the previous pRT group, 26.9% of the patients experienced immune-related adverse events compared with 40.1% of patients in the no RT group. Despite the use of pRT during immunotherapy being considered safe, the results of the present study suggest that pRT has a negative effect on immune balance.

SUBMITTER: Bersanelli M

PROVIDER: S-EPMC6951237 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Palliative radiotherapy in advanced cancer patients treated with immune-checkpoint inhibitors: The PRACTICE study.

Bersanelli Melissa M Lattanzi Elisabetta E D'Abbiero Nunziata N Buti Sebastiano S Leonetti Alessandro A Canè Maria Giulia MG Trapani Salvatore S Gravina Gianluca G Porzio Giampiero G Cannita Katia K Marino Pietro Di PD Grassadonia Antonino A Tinari Nicola N Tursi Michele De M Giaiacopi Elisa E Michiara Maria M Bordi Paola P Perrone Fabiana F Caravatta Luciana L Trignani Marianna M Genovesi Domenico D Natoli Clara C Ficorella Corrado C Tiseo Marcello M Cortellini Alessio A

Biomedical reports 20191213 2

In the present study, the influence of purely palliative radiotherapy (pRT) on the outcomes of patients with advanced cancer undergoing immune checkpoint blockade was evaluated. Patients were stratified into three groups: Patients who had received pRT within 6 months prior to the initiation of immunotherapy (previous pRT); patients who received pRT during immunotherapy (concurrent pRT); and patients who did not receive RT prior to or during immunotherapy (no RT group), and these groups were comp ...[more]

PMID: 31929875

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Project description:BackgroundReal-world data enables evaluation of immune checkpoint inhibitor (ICI) use in advanced melanoma management. We examined characteristics and outcomes of ICI-treated patients with advanced melanoma and organ dysfunction (baseline and emergent).Materials and methodsThis retrospective observational study used electronic health records derived from a nationwide data set to examine advanced melanoma patients treated with first-line ICIs (2011-2018). Clinical characteristics, real-world time to treatment discontinuation (rwTTD), and overall survival (OS) were analyzed for patients with normal organ function and those with organ dysfunction prior to ICI initiation. Patients with emergent dysfunction in the 90 days following ICI initiation were identified, and potentially associated characteristics were explored.ResultsOf 2,407 patients included, 1,884 and 1,717 had evaluable renal and hepatic laboratory values, respectively. Patients with baseline renal dysfunction (2.4%) were older and more frequently male, and less frequently treated with ICI combinations, than patients with normal renal function. Patients with baseline hepatic dysfunction (2.8%) were similar to patients with normal hepatic function regarding demographics and treatments received. Patients with baseline organ dysfunction displayed shorter rwTTD and OS. Among patients with normal baseline organ function, 4.6% and 7.4% developed renal and hepatic dysfunction within 90 days of ICI initiation, respectively; this was associated with combination ICI treatment.ConclusionPatients with advanced melanoma and baseline organ dysfunction frequently receive ICI treatment but have poorer clinical outcomes than patients with normal organ function. Among patients with normal renal and hepatic function at ICI initiation, emergent organ dysfunction rates in this real-world cohort are similar to those reported in clinical trials.Implications for practiceReal-world data provide an opportunity to understand treatment patterns, toxicity, and clinical outcomes among patients treated outside of clinical trials. This study confirms that patients with advanced melanoma and baseline renal or hepatic dysfunction are being treated with ICI therapy more frequently as monotherapy than in combination therapy. For those real-world patients with normal baseline organ function, emergent renal and hepatic dysfunction are both more common in patients treated with combination versus ICI monotherapy.

Project description:BackgroundImmune checkpoint inhibition (ICI) improves survival outcomes for patients with several types of cancer including metastatic melanoma (MM), but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations.MethodsTo examine the potential confounding impact of such variables, we analyzed advanced cancer patients enrolled prospectively in a clinicopathological database with protocol-driven follow up and treated with ICI. We tested the associations between developing ST, stratified as no (n = 617), mild (n = 191), and severe (n = 63), and progression-free survival (PFS) and overall survival (OS) in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival associating with adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model.ResultsBoth mild and severe ST were significantly associated with improved PFS and OS (all P < 0.001). However, when adjusting for the time from treatment initiation to time of skin event, severe ST was not associated with PFS benefit both in univariable and multivariable analyses (P = 0.729 and P = 0.711, respectively). Receiving systemic steroids for ST did not lead to significant differences in PFS or OS compared to patients who did not receive systemic steroids.ConclusionsOur data reveal the influence of time to event and its severity as covariates in analyzing the relationship between ST and ICI outcomes. These differences in outcomes cannot be solely explained by the use of immunosuppressive medications, and thus highlight the importance of host- and disease-intrinsic factors in determining ICI response and toxicity.Trial registrationThe patient data used in this manuscript come from patients who were prospectively enrolled in two institutional review board-approved databases at NYU Langone Health (institutional review board #10362 and #S16-00122).

Project description:AimsSurvival benefit of liver cancer patients who undergo palliative radiotherapy varies from person to person. The present study aims to identify indicators of survival of advanced liver cancer patients receiving palliative radiotherapy.Patients and methodsOne hundred and fifty-nine patients treated with palliative radiotherapy for advanced liver cancer were retrospectively assessed. Of the 159 patients, 103 patients were included for prediction model construction in training phase, while other 56 patients were analyzed for external validation in validation phase. In model training phase, clinical characteristics of included patients were evaluated by Kaplan-Meier curves and log-rank test. Thereafter, multivariable Cox analysis was taken to further identify characteristics with potential for prediction. In validation phase, a separate dataset including 56 patients was used for external validation. Harrell's C-index and calibration curve were used for model evaluation. Nomograms were plotted based on the model of multivariable Cox analysis.ResultsThirty-one characteristics of patients were investigated in model training phase. Based on the results of Kaplan-Meier plots and log-rank tests, 6 factors were considered statistically significant. On multivariable Cox regression analysis, bone metastasis (HR = 1.781, P = 0.026), portal vein tumor thrombus (HR = 2.078, P = 0.015), alpha-fetoprotein (HR = 2.098, P = 0.007), and radiation dose (HR = 0.535, P = 0.023) show significant potential to predict the survival of advanced liver cancer patients treated with palliative radiotherapy. Moreover, nomograms predicting median overall survival, 1- and 2-year survival probability were plotted. The Harrell's C-index of the predictive model is 0.709(95%CI, 0.649-0.769) and 0.735 (95%CI, 0.666-0.804) for training model and validation model respectively. Calibration curves of the 1- and 2-year overall survival of the predictive model indicate that the predicted probabilities of OS are very close to the actual observed outcomes both in training and validation phase.ConclusionBone metastasis, portal vein tumor thrombus, alpha-fetoprotein and radiation dose are independent prognostic factors for the survival of advanced liver cancer patients treated with palliative radiotherapy.

Dataset Information

Palliative radiotherapy in advanced cancer patients treated with immune-checkpoint inhibitors: The PRACTICE study.

Publications

Palliative radiotherapy in advanced cancer patients treated with immune-checkpoint inhibitors: The PRACTICE study.

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