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Adverse reactions in mRCC patients documented in routine practice by German office-based oncologists and

Norbert Marschner¹, Lothar Müller², Axel Münch³

¹1 Outpatient-Clinic for Interdisciplinary Oncology and Haematology, Freiburg, Germany.

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners

|February 25, 2016

Abstract:

Background Signal transduction inhibitors (STIs) have considerably improved treatment of advanced/metastasized renal cell carcinoma (mRCC). Most safety data for these drugs are derived from clinical trials. The purpose of this study was to evaluate which adverse drug reactions are documented during first-line treatments in routine clinical practice. Patients and methods The ongoing prospective German mRCC clinical registry is recruiting patients in 110 oncology and urology outpatient centers. Data from the first 250 patients who had completed first-line treatment were analyzed regarding adverse drug reactions (ADRs) documented in patients' medical records. Results Patients were older than in clinical trials and had comorbidities. Patients were treated with the STIs sunitinib (61%), temsirolimus (14%), sorafenib (10%), or bevacizumab combined with interferon (6%). About 520 ADRs were documented, of which 29% resulted in treatment modifications. The most frequently affected organ system was the gastrointestinal system. The most frequently documented ADRs were mucositis/stomatitis (14%), fatigue (14%), diarrhea (12%), and nausea (12%). Conclusions In routine practice, mRCC first-line treatments using STIs frequently lead to ADRs partly necessitating treatment modifications. The pattern of reported ADRs is similar to that reported in clinical trials, but frequencies of events differ, especially for symptoms of multifactorial origin that are not immediately associated with the treatment. These results indicate that perception and documentation of adverse reactions is different between clinical trials and routine practice, and that reviews of patients' medical records might not be the best method to assess safety in routine practice.

Insights

Adverse drug reactions (ADRs) from first-line signal transduction inhibitors (STIs) in metastatic renal cell carcinoma (mRCC) are common in routine practice. Documentation of these ADRs differs from clinical trials, impacting safety assessments.

Area of Science:

Oncology
Pharmacology
Clinical Research

Background:

Signal transduction inhibitors (STIs) have advanced metastatic renal cell carcinoma (mRCC) treatment.
Clinical trial data primarily informs STI safety profiles.
Routine clinical practice safety data for STIs in mRCC is less understood.

Purpose of the Study:

To identify adverse drug reactions (ADRs) documented during first-line STI treatment for mRCC in routine clinical practice.
To compare ADR patterns and frequencies between routine practice and clinical trials.

Main Methods:

Analysis of prospective data from the German mRCC clinical registry.
Inclusion of 250 patients who completed first-line STI treatment.
Review of adverse drug reactions documented in patient medical records.

Main Results:

Patients in routine practice were older and had more comorbidities than in clinical trials.
Gastrointestinal issues (mucositis, stomatitis, diarrhea, nausea) and fatigue were the most frequent ADRs.
Approximately 29% of documented ADRs led to treatment modifications.

Conclusions:

First-line STI treatment for mRCC frequently results in ADRs requiring modifications in routine practice.
ADR patterns resemble clinical trials, but frequencies and documentation differ, especially for multifactorial symptoms.
Medical record review may not fully capture safety in real-world settings, highlighting differences between clinical trials and routine practice.

Read full analysis

Keywords:

Carcinoma drug-related side effects and adverse reactions outpatients registries renal cell

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