An FDA analysis of the association between adverse events and outcome in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4549-4549
Author(s):  
Chana Weinstock ◽  
Virginia Ellen Maher ◽  
Laura L. Fernandes ◽  
Shenghui Tang ◽  
Sundeep Agrawal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
Study Drug ◽  
Drug Approval ◽  
Systemic Corticosteroids ◽  
Immune Mediated ◽  
Programmed Death ◽  
The Relationship

4549 Background: To assess the relationship between tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated with anti-PD-1/L1 antibodies. Methods: We examined seven trials that led to drug approval and which included 1747 patients with metastatic or locally advanced urothelial cancer treated with an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy and two enrolled patients who were cisplatin-ineligible. The datasets were searched for AESIs, related AESIs, imAEs, and related imAEs. The relationship to study drug was determined by the Investigator. Immune-mediated adverse events were defined as AESIs treated with topical or systemic corticosteroids. Results: In these exploratory analyses, a related AESI was reported in 64% of responding patients and in 34% of patients who did not respond to the anti-PD-1/L1 antibody while a related imAE occurred in 28% and 12% of patients who did and did not respond to study drug, respectively. In a responder analysis, an increase in overall survival was seen in patients with related AESIs compared to those with no related AESI [hazard ratio (HR) 0.42; 95% CI: 0.37, 0.49]. Fifty-seven percent of responding patients with a related AESI reported a related AESI prior to documentation of response. Conclusions: Patients who responded to treatment with an anti-PD-1/L1 antibody were more likely to report a related AESI or related imAE. This relationship did not appear to be due to the increased duration of exposure in responding patients. Systemic corticosteroid use did not appear to affect the duration of response.

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody

2019 ◽  
Vol 37 (30) ◽  
pp. 2730-2737 ◽  
Author(s):  
V. Ellen Maher ◽  
Laura L. Fernandes ◽  
Chana Weinstock ◽  
Shenghui Tang ◽  
Sundeep Agarwal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
Study Drug ◽  
Data Sets ◽  
Systemic Corticosteroids ◽  
Programmed Death ◽  
Programmed Death Protein 1 ◽  
The Relationship

PURPOSE To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated with anti–programmed death protein 1 or ligand 1 (anti–PD-1/L1) antibodies. PATIENTS AND METHODS We examined seven trials in 1,747 patients with metastatic or locally advanced urothelial cancer that led to approval of an anti–PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy, and two enrolled patients who were cisplatin ineligible. The data sets were searched for AESIs, related AESIs, imAEs, and related imAEs. The relationship to study drug was determined by the investigator. ImAEs were defined as AESIs treated with topical or systemic corticosteroids. RESULTS In these exploratory analyses, a related AESI was reported in 64% of responding patients and in 34% of patients who did not respond to the anti–PD-1/L1 antibody, whereas a related imAE occurred in 28% and 12% of patients who did and did not respond to study drug, respectively. In a responder analysis, an increase in overall survival was seen in patients with related AESIs compared with those with no related AESIs (hazard ratio, 0.45; 95% CI, 0.39 to 0.52). Fifty-seven percent of responding patients with a related AESI reported the AESI before documentation of response. CONCLUSION Patients who responded to treatment with an anti–PD-1/L1 antibody were more likely to report a related AESI or related imAE. This relationship did not seem to be due to the increased duration of exposure in responding patients. Systemic corticosteroid use did not appear to affect the duration of response.

Impact of antibiotic use on clinical outcomes in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4557-4557 ◽  
Author(s):  
Chana Weinstock ◽  
Virginia Ellen Maher ◽  
Laura L Fernandes ◽  
Shenghui Tang ◽  
Sundeep Agrawal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Outcomes ◽  
Urothelial Cancer ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Drug Approval ◽  
Antibiotic Use ◽  
Programmed Death ◽  
Programmed Death Protein 1

4557 Background: Previous data has suggested that patients treated with anti-PD-1/L1 antibodies who receive antibiotics during their therapy might have dramatically decreased progression-free and overall survival 1,2. This has clinical implications for management of patients with suspected bacterial infection while on treatment with these agents. We assessed the relationship between antibiotic use and tumor response rate, progression-free survival, and overall survival in a large dataset of patients with urothelial cancer treated with anti-PD-1/L1 antibodies. Methods: We examined seven trials that led to drug approval and which included 1747 patients with metastatic or locally advanced urothelial cancer treated with an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy and two enrolled patients who were cisplatin-ineligible. Six were single arm trials and one was a randomized controlled trial whose control arm is not included in these analyses. Concomitant medication datasets were searched for systemic antibiotic used by each patient while on treatment. Results: Overall, 51% of patients (n=892) were exposed to antibiotics (ABX+) and 49% (n=855) were not exposed (ABX-). In these exploratory analyses, small numeric differences in OS, PFS, and ORR were seen in ABX+ vs. ABX- patients. Median OS was 9.23 vs. 9.86 months, median PFS was 105 vs 101 days, and ORR was 20% vs. 21% in ABX+ vs. ABX- patients, respectively. Conclusions: Patients who were treated with antibiotics while on therapy with an anti-PD-1/L1 antibody for urothelial cancer had similar outcomes to those who were not treated with antibiotics. Numeric differences in outcomes were not significant and did not duplicate previous analysis demonstrating a median OS that was doubled in ABX- patients1. Our exploratory analyses do not appear to demonstrate a clear need for practitioners to avoid antibiotic use in patients treated with PD-1/L1 agents for fear of significantly impacting clinical outcomes. References: 1) Tinsley et. al., ASCO annual meeting 2018, abstract 3010 2) Routy et. al., Science 05 Jan 2018: Vol. 359, Issue 6371. [Table: see text]

Vaccination and Associated Adverse Events in Dogs Previously Treated for Primary Immune-Mediated Hemolytic Anemia

2019 ◽  
Vol 55 (1) ◽  
pp. 29-34 ◽  
Author(s):  
Alaina Moon ◽  
Julia Veir
Keyword(s):  
Adverse Events ◽  
Hemolytic Anemia ◽  
Rabies Vaccine ◽  
Initial Diagnosis ◽  
Canine Distemper ◽  
Time Period ◽  
Immune Mediated ◽  
Secondary Objective ◽  
Previously Treated ◽  
The Relationship

ABSTRACT This study described the rate of vaccine reactions in a population of dogs receiving vaccines after diagnosis of primary immune-mediated hemolytic anemia (IMHA). A secondary objective was to describe the time elapsed between vaccination and initial diagnosis of IMHA. A medical record search identified cases meeting criteria for primary IMHA. Owners and referring veterinarians were surveyed regarding vaccination of the dog following diagnosis. Referring veterinarians were surveyed regarding vaccination prior to diagnosis of IMHA. A completed survey was returned in 44 cases. Twenty-two dogs received vaccinations after diagnosis, and 22 dogs did not. The median time elapsed between vaccination and initial diagnosis was 280 days. No dog was vaccinated within 30 days of diagnosis. Two of the following possible reactions were noted out of 22 dogs vaccinated: vomiting and urticarial eruption in a dog administered a rabies and canine distemper vaccine, and recurrent anemia in a dog administered a rabies vaccine. The rate of vaccine reactions was higher than previously reported, although the time period evaluated was longer than in previous studies. The relationship between initial vaccination and development of IMHA, and between vaccination and vaccine reaction, in this population is uncertain and may reflect coincidence or differences in susceptibility.

scholarly journals A case report of psoriasis flare following immunotherapy: Report of an important entity and literature review

2020 ◽  
Vol 8 ◽  
pp. 2050313X1989770 ◽  
Author(s):  
Anastasia Politi ◽  
Dimas Angelos ◽  
Davide Mauri ◽  
George Zarkavelis ◽  
George Pentheroudakis
Keyword(s):  
Adverse Events ◽  
Cytotoxic T Lymphocyte ◽  
Checkpoint Inhibitors ◽  
Skin Lesions ◽  
Inflammatory Disorder ◽  
Immune Mediated ◽  
Programmed Death ◽  
History Of ◽  
Programmed Death 1 ◽  
Cessation Of Treatment

Immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte–associated antigen-4 and anti-programmed death-1, are a type of cancer immunotherapy approved for late-stage malignancy treatment. However, such therapies often induce immune-related adverse events. During anti-programmed death-1 blockade therapy, the most commonly reported adverse effects are skin toxicities, such as psoriasis—a chronic immune-mediated inflammatory disorder affecting the skin. We present the clinical characteristics of flared psoriasis in one patient under anti-programmed death-1 therapy who was diagnosed with T2N2M0/IIIB squamous lung carcinoma with a history of psoriasis for the past 5 years, exacerbated after the first cycle of nivolumab. After the third cycle, the extensive skin plaques necessitated treatment cessation. Following the discontinuation of anti-programmed death-1 treatment, skin lesions were treated locally. Possibly, anti-programmed death-1 immunotherapy can trigger immune-mediated diseases, such as psoriasis. Physicians should be alert to immune-related adverse events. Continuation or permanent cessation of treatment depends on the severity and reversibility of immune-related adverse events.

Comparative effectiveness of proton therapy versus photon therapy as part of concurrent chemoradiotherapy for locally advanced cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6521-6521 ◽  
Author(s):  
Brian Christopher Baumann ◽  
Nandita Mitra ◽  
Joanna Harton ◽  
Ying Xiao ◽  
Andrzej Wojcieszynski ◽  
...  
Keyword(s):  
Overall Survival ◽  
Propensity Score ◽  
Adverse Events ◽  
Comparative Effectiveness ◽  
Performance Status ◽  
Locally Advanced ◽  
Grade 3 ◽  
Unplanned Hospitalizations ◽  
Locally Advanced Cancer ◽  
Disease Free

6521 Background: Concurrent chemo-radiotherapy is standard-of-care curative treatment for many cancers, but is associated with substantial morbidity. Proton therapy may increase the tolerability or effectiveness of concurrent chemo-radiotherapy by reducing radiation to normal tissues. Methods: We conducted a comparative effectiveness study of adult non-metastatic cancer patients treated with curative intent with proton chemo-radiotherapy vs. photon chemo-radiotherapy from 2011-2016 at the University of Pennsylvania. Re-irradiation and disease sites treated with photon-only therapy were excluded. Data on adverse events and survival was gathered prospectively. Primary endpoint was 90-day adverse events associated with unplanned hospitalizations (CTCAEv4 grade ≥3 adverse events). Secondary endpoints included decline in ECOG performance status during treatment, 90-day grade ≥2 adverse events, disease-free survival (DFS) and overall survival (OS). Modified Poisson regression models with inverse propensity score weighting were fit for both outcomes. Propensity scores were estimated using an ensemble machine-learning approach. Results: 1,483 patients were included (391 proton/1,092 photon). Proton patients were significantly older (median 66 vs. 61), had less favorable Charlson-Deyo comorbidity scores (median 3.0 vs. 2.0), and had lower integral radiation dose to tissues outside the target (p < 0.05 for all). Baseline toxicity and performance status were similar (p > 0.05). In propensity score weighted-analyses, proton chemo-radiotherapy was associated with significantly lower relative risk (RR) of 90-day grade ≥3 adverse events [11.5%(95%CI 8.3-14.7%) for protons; 27.6%(95%CI 24.9-30.2%) for photons; RR 0.31, 95%CI 0.15-0.66, p < 0.01]; 90-day grade ≥2 adverse events (RR 0.78, 95%CI 0.65-0.93, p < 0.01); and decline in performance status during treatment (RR 0.51, 95%CI 0.37-0.71, p < 0.01). There was no difference in DFS or OS. Conclusions: In adults with locally advanced cancer, proton chemo-radiotherapy was associated with significantly reduced acute adverse events causing unplanned hospitalizations with similar disease-free and overall survival.

scholarly journals PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer

2020 ◽  
Author(s):  
Robert A Huddart ◽  
Arlene O Siefker-Radtke ◽  
Arjun V Balar ◽  
Mehmet A Bilen ◽  
Thomas Powles ◽  
...  
Keyword(s):  
Phase Ii ◽  
Urothelial Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Response Rates ◽  
Complete Response ◽  
First Line ◽  
First Line Therapy ◽  
Programmed Death ◽  
Metastatic Urothelial Cancer

The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and -negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).

Neoadjuvant vascular targeted photodynamic therapy in urothelial cancer: Preclinical data.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 321-321
Author(s):  
Barak Rosenzweig ◽  
Renato B Corradi ◽  
Sadna Budhu ◽  
Ricardo Alvim ◽  
Pedro Guiraldes Recabal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Photodynamic Therapy ◽  
Local Recurrence ◽  
Therapeutic Efficacy ◽  
Urothelial Cancer ◽  
Statistical Tests ◽  
Locally Advanced ◽  
Long Term Memory ◽  
Recurrence Rates ◽  
Targeted Photodynamic Therapy

321 Background: Recurrence and progression following surgical treatment of locally advanced urothelial cancer is high spurring a need to develop effective, well-tolerated neoadjuvant strategies. We examined the efficacy and immunotherapeutic mechanism of neoadjuvant sub-ablative vascular targeted photodynamic therapy (sbVTP) in urothelial cancer. Methods: Following urothelial tumor implantation, mice were randomized to receive neoadjuvant sbVTP (WST-11; TOOKAD Soluble, Steba Biotech, France) or sham treatment 17 days prior to surgical resection. Therapeutic efficacy was evaluated by local and systemic response and survival studies. Immunohistochemistry and flow cytometry were used to elucidate mechanism. Kaplan-Meier, Mann-Whitney and Fischer exact test were used to analyze the data. All statistical tests were two-sided. Results: On the day of surgery, tumor volume was 1222 mm3 (95% CI 976-1468 mm3) vs. 135 mm3 (95% CI 66-204 mm3, p < 0.0001) and systemic progression was 30% vs. 7% (p<0.05), for control vs. sbVTP treated animals, respectively. Median progression free survival and overall survival were 45 and 55 days respectively for surgery only group and significantly longer (50% not reached, p<0.05) for the sbVTP + surgery group. Local recurrence rates were significantly lower in neoadjuvant treated animals. Neoadjuvant sbVTP was associated with increase in early antigen presenting cells followed by long term memory, effectory and active T-cell increase in spleen, lungs and blood. Conclusions: Neoadjuvant sbVTP treatment demonstrates evidence of therapeutic efficacy through an immune mediated response in this murine urothelial cancer model by delaying local and systemic progression, prolonging progression free and overall survival, and reducing local recurrence. Evaluation of this form of therapy in clinical trials is warranted.

scholarly journals Immune-Related Adverse Events, Need for Systemic Immunosuppression, and Effects on Survival and Time to Treatment Failure in Patients With Melanoma Treated With Ipilimumab at Memorial Sloan Kettering Cancer Center

2015 ◽  
Vol 33 (28) ◽  
pp. 3193-3198 ◽  
Author(s):  
Troy Z. Horvat ◽  
Nelly G. Adel ◽  
Thu-Oanh Dang ◽  
Parisa Momtaz ◽  
Michael A. Postow ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Treatment Failure ◽  
Systemic Corticosteroid ◽  
Standard Dose ◽  
Corticosteroid Treatment ◽  
Cancer Center ◽  
Time To Treatment ◽  
Systemic Corticosteroids ◽  
Time To Treatment Failure

Purpose Ipilimumab is a standard treatment for metastatic melanoma, but immune-related adverse events (irAEs) are common and can be severe. We reviewed our large, contemporary experience with ipilimumab treatment outside of clinical trials to determine the frequency of use of systemic corticosteroid or anti-tumor necrosis factor α (anti-TNFα) therapy and the effect of these therapies on overall survival (OS) and time to treatment failure (TTF). Patients and Methods We reviewed retrospectively the medical records of patients with melanoma who had received treatment between April 2011 and July 2013 with ipilimumab at the standard dose of 3 mg/kg. We collected data on patient demographics, previous and subsequent treatments, number of ipilimumab doses, irAEs and how they were treated, and overall survival. Results Of the 298 patients, 254 (85%) experienced an irAE of any grade. Fifty-six patients (19%) discontinued therapy because of an irAE, most commonly diarrhea. Overall, 103 patients (35%) required systemic corticosteroid treatment for an irAE; 29 (10%) also required anti-TNFα therapy. Defining TTF as either starting a new treatment or death, estimated median TTF was 5.7 months. Twelve percent of patients experienced long-term disease control without receiving additional antimelanoma therapy. OS and TTF were not affected by the occurrence of irAEs or the need for systemic corticosteroids. Conclusion IrAEs are common in patients treated with ipilimumab. In our experience, approximately one-third of ipilimumab-treated patients required systemic corticosteroids, and almost one-third of those required further immune suppression with anti-TNFα therapy. Practitioners and patients should be prepared to treat irAEs and should understand that such treatment does not affect OS or TTF.

scholarly journals Urothelial cancer: population-based analysis of the problem in Ukraine

2021 ◽  
Vol 4 (2) ◽  
pp. 4-10
Author(s):  
M.V. Pikul ◽  
E.O. Stakhovsky ◽  
O.A. Voylenko ◽  
O.E. Stakhovsky ◽  
Yu.V. Vitruk ◽  
...  
Keyword(s):  
Overall Survival ◽  
Urinary Tract ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
Upper Urinary Tract ◽  
Radical Nephroureterectomy ◽  
Chi Square ◽  
Urothelial Tumors ◽  
Organ Sparing ◽  
Locally Advanced Tumors

The aim of this work was to conduct a population analysis on the basis of the National Cancer Registry with the primary goal: to determine the effectiveness of urothelial cancer treatment in Ukraine; and the secondary goal: to identify the main trends and approaches to therapy with an assessment of their impact on overall survival. Materials and methods. The design of the study was retrospective observational. The analysis was conducted based on the data of the National Cancer Registry from 2008 to 2020. A total of 12,698 patients with urothelial tumors of the upper urinary tract and bladder who underwent surgical treatment were analyzed. Statistical sampling was performed based on the creation of the most homogeneous groups of patients with bladder cancer (BC) and the upper urinary tract carcinoma (UUTc) who had the required number of notified parameters for further analysis. The primary objectives of the analysis were to determine: the average age of primary detection of the studied nosologies, level of detection depending on gender, frequency of diagnosis verification before surgery, extent of surgery, frequency of postoperative complications based on data on 30-day rehospitalization, the level of deviation of the principles for prophylactic medical patients’ examination from generally accepted recommendations. The secondary objective was to assess the cumulative survival of patients with urothelial tumors depending on the localization of the primary tumor and the type of surgery (organ-sparing or radical). Results. Organ-sparing treatment was more typical for BC, while radical treatment was performed in 15 % of patients with carcinomas. Organ-sparing treatment was more typical for UUTc (40 %). It should be noted that in this nosology it is accep­table for invasive forms of urothelial cancer. The level of 30-day hospita­lization was low in both pathologies, with a slightly greater advantage of UUTc. The level of complications is grade III according to the Clavien-Dindo classification, averaging 0.2 % for the entire pool of patients. For BC, the overall survival rates by stages were: I — 73 %, II — 49 %, III — 18 % and IV — 11 % (chi-square = 1,807.207; p = 0.000001). For UUTc, the levels of 5-year overall survival correspond to the literature data, but there is a significant negative tendency to decrease the latter after a ­10-year period for all stages (chi-square = 146.298; p = 0.000003). In Ukraine, organ-sparing treatment for UUTc was not inferior to radical nephroureterectomy in the context of 5-year survival (51.3 vs. 51 %; log-rank test). The obtained data testify in favor of the 15% advantage of the total survival of patients who underwent radical nephroureterectomy at the premises of the National Cancer Institute (high volume center), compared to other regions of Ukraine. Levels of 5- and ­10-year survival in both nosologies were characterized by a statistically non-significant advantage of UUTc over BC of 7 %. Conclusions. Superficial and locally advanced tumors are the most complex ones in the treatment of urothelial cancer of the bladder and upper urinary tract in Ukraine. Superficial tumors require the most radical surgeries and subsequent effective local treatment. Locally advanced tumors require a comprehensive approach to treatment, adequate systemic therapy influences the final indicators of overall survival. In cases of surgical resectability and preservation of renal function, UUTc requires organ-sparing treatment; this approach aims to increase creatinine clearance in patients before systemic chemotherapy and to reduce the likelihood of progression of comorbidities and associated mortality.

Outcomes of ipilimumab treatment-related adverse events in patients with metastatic melanoma (MM) who received systemic corticosteroids in a phase III trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8539-8539 ◽  
Author(s):  
Jean-Francois Baurain ◽  
Michael Smylie ◽  
Paolo Antonio Ascierto ◽  
Laslo Roman ◽  
Stephen Houston ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Reactions ◽  
Treatment Guidelines ◽  
Cytotoxic T Lymphocyte ◽  
Human Monoclonal Antibody ◽  
Immunosuppressive Agents ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Systemic Corticosteroids ◽  
Immune Mediated

8539 Background: Ipilimumab (ipi) is a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to augment antitumor immune responses. In a phase III trial, ipi at 10 mg/kg plus dacarbazine (DTIC) improved overall survival in previously untreated patients (pts) with MM. In ipi studies, the most common drug-related adverse events (AEs) were immune-related, which were generally reversible using treatment guidelines involving prompt recognition, intervention (corticosteroids, and rarely, alternative immunosuppressive agents), and possible discontinuation of therapy. The purpose of this analysis is to evaluate outcomes of ipi treatment-related AEs with use of systemic corticosteroids. Methods: AEs were reported from the first ipi dose up to 70 days after the last dose. Immune-mediated adverse reactions (imARs) were used to characterize inflammatory AEs in previously untreated pts with MM who received ipi plus DTIC in a phase III trial. This analysis includes the imAR categories of hepatitis, dermatitis, enterocolitis, and endocrinopathies. Results: More than 70% of pts who received corticosteroids had complete resolution of the imAR, ie, last reported Grade (Gr) of 0 (Table). In pts for whom a high-grade imAR had not completely resolved at the last report, ≥50% had improved to Gr 1. Conclusions: In the majority of pts treated with ipi at 10 mg/kg plus DTIC who received corticosteroids for the management of imARs, as recommended per treatment guidelines, the most common imARs had completely resolved or improved to Gr 1. [Table: see text]

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