Early tumor response assessment may avoid serious immune‐related adverse events in nivolumab and ipilimumab combination therapy for stage IV melanoma

Author(s):  
T. Maeda ◽  
A. Hiura ◽  
J. Uehara ◽  
R. Toyoshima ◽  
T. Nakagawa ◽  
...  
2010 ◽  
Vol 49 (2) ◽  
pp. 252-255 ◽  
Author(s):  
Sara M. Willems ◽  
Paula S. Koekkoek ◽  
Thomas C. Kwee ◽  
Maurice A.A.J. van den Bosch

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 58-58
Author(s):  
Daan Rauwerdink ◽  
Dennie T. Frederick ◽  
Tatyana Sharova ◽  
Genevieve Marie Boland

58 Background: Systemic immune checkpoint blockade therapy anti-PD1 nivolumab combined with anti-CTLA-4 ipilimumab is an effective therapy for metastatic melanoma. The treatment, however, has a high frequency of immune related adverse events. Interestingly, immune-related adverse events in anti-PD1 and anti-CTLA4 monotherapy have been associated with an improved overall survival in melanoma. Whether immune-related events correlate with enhanced outcomes in ipilimumab/nivolumab combination therapy is unknown. Methods: Clinical data from patients diagnosed with untreated cutaneous stage IV melanoma receiving ipilimumab/nivolumab combination therapy between 2015-2018 at the Massachusetts General Hospital (MGH) and have been analyzed retrospectively. Tumor response was measured using RECIST criteria. Primary endpoints were frequencies and characteristics of immune-related adverse events, overall survival, and response to therapy. Results: A total of 57 patients received ipilimumab/nivolumab combination therapy. During a mean follow-up period of 26 months, 28 (49%) patients completed the therapy. Immune-related adverse events were observed in 45 (79%) patients, with rash (28%), colitis (23), hepatitis (21%) and fever (21%) being the most frequent. Overall survival was 29 months in patients with immune-adverse related events and 14 months in the group without any adverse events (p-value < 0.01). The onset of hypophysitis correlated with tumor response (p = 0.02) and hepatitis showed a trend in a correlation to response of therapy (p = 0.06). Conclusions: Our study demonstrates the association between improved overall survival and the onset of immune-related adverse events in ipilimumab/nivolumab combination therapy. A trend correlated with improved outcomes and onset of immune-related adverse events was seen in hepatitis and was significantly associated with hypophysitis, however these results must be interpretated carefully as larger studies must confirm our findings. Despite small study size, we are the first to describe an association between immune-related adverse events in ipilimumab/nivolumab combination therapy.


2007 ◽  
Vol 34 (6Part24) ◽  
pp. 2649-2649 ◽  
Author(s):  
Y Cao ◽  
S Mukherji ◽  
C Tsien ◽  
T L Chenevert ◽  
A Eisbruch

2021 ◽  
Author(s):  
Shuai Liang ◽  
Chengming Li ◽  
Lu Wang ◽  
Dongshui Xu ◽  
Zhao Liu ◽  
...  

Abstract Background: To investigate the tumor volume, pre-treatment inflammatory biomarkers (pre-IBs), and their dynamic changes on early tumor response (ETR) in elderly patients (≥70 years) with esophageal squamous cell carcinoma (ESCC) underwent radiotherapy.Methods: The ETR was assessed according to RECIST 1.1 at 1 month after radiotherapy. The tumor volume ((gross tumor volume (GTV) at the initial treatment planning (GTVi), and GTV at shrinking irradiation field planning (GTVs)), IBs (neutrophil/lymphocyte (NLR), platelet/lymphocyte (PLR), and lymphocyte/monocyte (LMR)) which also included during treatment IBs (dur-IBs), and clinical variables were collected and analyzed from 197 patients received radiotherapy at our institution between 2015 and 2020. The tumor volume change rate (TVCR) and dynamic changes of IBs (delta-IBs) were defined as follows: TVCR=(1-GTVs/GTVi)×100%, delta-IBs=1-dur-IBs/pre-IBs. A nomogram based on logistic regression analysis were then established for predicting ETR.Results: GTVi and pre-LMR significantly decreased, pre-NLR, and pre-PLR significantly increased during radiotherapy or chemoradiotherapy (all P<0.001). Multivariate analysis indicated that TVCR [OR, 0.197; 95%CI, 0.093-0.414; P<0.001], pre-NLR [OR, 2.568; 95%CI, 1.031-6.394; P=0.043], and delta-NLR [OR, 2.831; 95%CI, 1.126-7.119; P=0.027] were statistically significant with ETR. And c-index of the nomogram established by combining all independent predictors for ETR was 0.769 [95%CI, 0.161–0.302].Conclusion: TVCR, Pre-NLR, and delta-NLR were significant with ETR in elderly patients with ESCC who underwent radiotherapy. And the developed nomogram with superior prediction ability for ETR could assist in patients counseling and guide to make individual treatments and follow-up strategies.


Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3808
Author(s):  
Giovanna Orsatti ◽  
Carlo Morosi ◽  
Chiara Giraudo ◽  
Alessia Varotto ◽  
Filippo Crimì ◽  
...  

Radiological response to neoadjuvant chemotherapy is currently used to assess the efficacy of treatment in pediatric patients with rhabdomyosarcoma (RMS), but the association between early tumor response on imaging and survival is still controversial. The aim of this study was to investigate the prognostic value of assessing radiological response after induction therapy in pediatric RMS, comparing four different methods. This retrospective, two-center study was conducted on 66 non-metastatic RMS patients. Two radiologists measured tumor size on pre- and post-treatment magnetic resonance (MR) or computed tomography (CT) images using four methods: considering maximal diameter with the 1D-RECIST (Response Evaluation Criteria in Solid Tumors); multiplying the two maximal diameters with the 2D-WHO (World Health Organization); multiplying the three maximal diameters with the 3D-EpSSG (European pediatric Soft tissue sarcoma Study Group); obtaining a software-assisted volume assessment with the 3D-Osirix. Each patient was classified as a responder or non-responder based on the proposed thresholds for each method. Tumor response was compared with survival using Kaplan–Meier plots, the log-rank test, and Cox’s regression. Agreement between methods and observers (weighted-κ) was also calculated. The 5-year event-free survival (5yr-EFS) calculated with the Kaplan–Meier plots was significantly longer for responders than for non-responders with all the methods, but the 3D assessments differentiated between the two groups better than the 1D-RECIST or 2D-WHO (p1D-RECIST = 0.018, p2D-WHO = 0.007, p3D-EpSSG and p3D-Osirix < 0.0001). Comparing the 5yr-EFS of responders and non-responders also produced adjusted hazard ratios of 3.57 (p = 0.0158) for the 1D-RECIST, 5.05 for the 2D-WHO (p = 0.0042), 14.40 for the 3D-EpSSG (p < 0.0001) and 11.60 for the 3D-Osirix (p < 0.0001), indicating that the volumetric measurements were significantly more strongly associated with EFS. Inter-method agreement was excellent between the 3D-EpSSG and the 3D-Osirix (κ = 0.98), and moderate for the other comparisons (0.5 < κ < 0.8). The 1D-RECIST and the 2D-WHO tended to underestimate response to treatment. Inter-observer agreement was excellent with all methods (κ > 0.8) except for the 2D-WHO (κ = 0.7). In conclusion, early tumor response was confirmed as a significant prognostic factor in RMS, and the 3D-EpSSG and 3D-Osirix methods predicted response to treatment better than the 1D-RECIST or 2D-WHO measurements.


Sign in / Sign up

Export Citation Format

Share Document