alexa Adverse Events in Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL): A Literature Review of Recent Clinical Trials
ISSN: 2329-6917

Journal of Leukemia
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Review Article

Adverse Events in Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL): A Literature Review of Recent Clinical Trials

Horst-Dieter Hummel1,2*, Max S Topp1, Ellen T Chang3,4, Victoria M Chia5, Michael A Kelsh5, Martha L Doemland3, Shilpa Alekar6 and Anthony S Stein7

1Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany

2Comprehensive Cancer Center Mainfranken, University of Würzburg, Würzburg, Germany

3Health Sciences Practice, Exponent, Inc., Menlo Park, CA, and Washington, DC, USA

4Division of Epidemiology, Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA

5Center for Observational Research, Amgen Inc, Thousand Oaks, CA, USA

6Global Safety, Amgen Inc, Thousand Oaks, CA, USA

7Department of Hematology/Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA

*Corresponding Author:
Horst-Dieter Hummel
Department of Internal Medicine II
University Hospital Würzburg, Würzburg, Germany
Tel: +49-931/201-40916
Fax: +49-931/201-640017
E-mail: [email protected]

Received date: February 24, 2016; Accepted date: March 25, 2016; Published date: March 28, 2016

Citation: Hummel HD, Topp MS, Chang ET, Chia VM, Kelsh MA, et al. (2016) Adverse Events in Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL): A Literature Review of Recent Clinical Trials. J Leuk 4:208. doi:10.4172/2329-6917.1000208

Copyright: © 2016 Hummel HD, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Background: With the introduction of new therapy options for adult patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL), a better understanding of existing toxicity profiles is needed. Methods: A systematic literature review was conducted to summarize the toxicity profiles in clinical trials using chemotherapeutic regimens, tyrosine kinase inhibitor (TKI)-based approaches in Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-negative (Ph-) R/R ALL, or other targeted therapies. Seventeen eligible articles were identified that reported toxicity profiles. We grouped adverse events into the following categories: hematological, infectious, gastrointestinal, cardiovascular/renal/hepatic, and neurological, stratified by treatment type. Treatment-related or early/induction mortality was also summarized. Results: With cytotoxic chemotherapy and its combinations, hematological adverse events were the most common, affecting virtually all patients, followed by infections, which were reported in most patients. Neurologic toxicity was the most common adverse event associated with liposomal vincristine. TKI-based treatments showed a distinct safety profile compared with the chemotherapies. Although hematological adverse events still represented the most common toxicity, infections were less common with TKI-based therapies (9-18%) than with chemotherapies (56-100%). Nausea, vomiting, and diarrhea were the predominant gastrointestinal adverse events after receipt of TKIs, whereas mucositis appeared to be more characteristic of cytotoxic chemotherapy. Conclusions: This paper provides a systematic review of the safety profile of current standard chemotherapy for adults with R/R Ph- or Ph+ ALL. Overall, documentation of adverse events was highly variable across the studies, precluding direct comparisons or pooling of results. However, this systematic literature review is the first to summarize and quantify the toxicity profiles of mainly chemotherapeutic and TKI-based regimens for adult patients with R/R ALL, providing a baseline for comparison with emerging therapies.

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