Journal Article

Importance of including patients with comorbidities in clinical trials

Spencer, Kristen R, Mehnert, Janice M

2016

Overview

Furthermore, to assess endpoints such as safety and early efficacy is difficult if one cannot judge whether toxicities are related to the burden of cancer disease, pre-existing comorbid disease, or the experimental agent. [...]strict eligibility requirements, including performance status, are needed to test novel therapies in early stages. Patients with metastatic melanoma and HIV on highly active antiretroviral therapy have reportedly tolerated immunotherapy well, with no apparent effects on HIV disease activity serologically and no adverse pharmacokinetic interactions with highly active antiretroviral therapy.7,8 Ravi and colleagues described the use of immunotherapy in nine patients with hepatitis B and C with advanced melanoma; although viral loads fluctuated in some patients during therapy, this had no apparent clinical significance.9 It must be emphasised that these anecdotal reports cannot be applied broadly in clinical practice. Jim West/Science Photo Library We declare no competing interests. 1 HH Chao, T Mayer, J Concato, Prostate cancer, comorbidity, and participation in randomized controlled trials of therapy, J Investig Med, Vol. 58, 2010, 566-568 2 D St Germain, AM Denicoff, EP Dimond, Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual, J Oncol Pract, Vol. 10, 2014,...

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Autoimmune diseases / Cancer therapies / Clinical trials / Clinical Trials as Topic / Comorbidity / Drug therapy / Hematology, Oncology and Palliative Medicine / Hepatitis / Hepatitis B / Highly active antiretroviral therapy / Humans / Immunotherapy / Melanoma / Metastases / Metastasis / Patient safety / Patient Selection / Prostate cancer