Lead Investigator: Rentao Yu, Chongqing Medical University
Title of Proposal Research: Cutaneous adverse effects of immunotherapy medications in the treatment of cancers and their associations with overall survival
Vivli Data Request: 7857
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
The project background: Immune checkpoint inhibitors (ICIs) are typical immunotherapy drugs, a type of cancer treatment that helps your immune system fight cancer. As an immune checkpoint blockade, ICIs block immune checkpoints from taking the brakes off of cancer-fighting T cells. ICIs are the most important innovations in oncology therapeutics and have improved the treatment landscape of advanced malignancies. It has been estimated that in 2019 over 200 thousand patients were eligible for treatment with ICI therapy annually in the US alone. However, despite the efficacy of ICIs, immune-related adverse events (irAEs) occur in more than a third of all treated patients and are associated with lasting morbidity, mortality, and impaired quality of life, of which cutaneous irAEs (cirAEs, irAEs relating to or affecting the skin) are the most frequently reported toxic effects, occurring in 20% to 40% of all treated patients. Actually, it has been reported that cirAEs are the most common side effect secondary to immunotherapy, presented as both local reaction in skin and/or systemic poisoning.
Necessity of the research: The indications of ICIs in cancer treatment have expanded, so a growing number of patients will be exposed to immunotherapy. In turn, an increasing number and severity of cirAEs will occur if not intervened upon. However, prior studies examining these toxicities in detail have considered only the presentation of events evaluated by dermatologists. The associations between cirAEs and survival outcomes remain underexplored across care settings.
How the research will add to medical science or patient care: Fully categorizing the spectrum of cirAEs encountered in the context of immune checkpoint blockade and understanding the association between cirAEs and overall survival will help to tailor therapy and manage these side effects most effectively.
How the research will be conducted: This research will enroll all clinical trials in Vivli database that involves ICIs therapy of cancer. The types of cirAEs and management, overall survival will be recorded and analyzed.
What design and methods you have you chosen and why: Cohort study design will be applied in this study. Cox proportional hazards model (a statistical method to analyze the effect of several risk factors on survival, or the time it takes for a specific event to happen) will be performed to determine the prognostic association of cirAEs with overall survival.
Requested Studies:
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Data Contributor: Roche
Study ID: NCT03434379
Sponsor ID: YO40245
A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Data Contributor: Roche
Study ID: NCT02951767
Data Request ID: 00007857
Sponsor ID: GO29293 (Cohort 1)
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy
Data Contributor: Roche
Study ID: NCT02924883
Sponsor ID: WO30085
A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Data Contributor: Roche
Study ID: NCT02908672
Sponsor ID: CO39262
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02763579
Sponsor ID: GO30081
Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors
Data Contributor: Daiichi Sankyo
Study ID: NCT02452424
Sponsor ID: PLX108-14
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367794
Sponsor ID: GO29437
A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367781
Sponsor ID: GO29537
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436
A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
Data Contributor: Roche
Study ID: NCT02322814
Sponsor ID: WO29479
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02302807
Sponsor ID: GO29294
A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02108652
Sponsor ID: GO29293 (Cohort 2)
A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02031458
Sponsor ID: GO28754
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915
A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Data Contributor: Roche
Study ID: NCT01903993
Sponsor ID: GO28753
A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT01846416
Sponsor ID: GO28625
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT02420821
Sponsor ID: WO29637
A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT01984242
Sponsor ID: WO29074