Original article
A cross-sectional investigation of fatigue in advanced renal cell carcinoma treatment: Results from the FAMOUS study

https://doi.org/10.1016/j.urolonc.2013.09.009Get rights and content

Abstract

Objective

With an increasing choice of new treatment options, the management of side effects to maintain a chosen treatment if likely to be effective on the tumor remains important. The perception of side effects however varies between the physician and the patient, leading to possible wrong assumptions on tolerability that result in dose modifications, which may ultimately affect effectiveness. The aim was to assess fatigue in patients with advanced or metastatic renal cell carcinoma (RCC) by comparing the evaluation of the physician to the one provided by their respective patient. In addition, we aimed to assess possible influences of fatigue on parameters of quality of life.

Methods

Patients receiving systemic treatment for advanced RCC and their physicians were questioned independently regarding incidence and severity of fatigue and its effect on quality of life.

Results

Both physicians and patients completed 98 matching questionnaires. Patients were treated with sunitinib, sorafenib, bevacizumab combined with interferon alpha, temsirolimus, everolimus, or interferon alpha alone. Incidence and severity of fatigue was differently assessed by patients and physicians, with fatigue being more severe when reported by the patient. The severity of fatigue increased with progressing treatment lines. Quality of life was significantly lower in patients experiencing fatigue compared with patients without fatigue. Emotional, functional, and physical well-being were all affected by fatigue, the latter being the most affected subscale. Social well-being was least affected.

Conclusion

Fatigue is a complex and cumulative condition of patients treated for advanced RCC, and it considerably affects patient's quality of life. As many of its underlying causes may be treated, the divergent perception of occurrence and severity of fatigue should be integrated in treatment concepts. The active role of the patient in helping to manage ailments through assessment should be implemented when optimizing treatment of RCC.

Introduction

Renal cell carcinoma (RCC) represents approximately 4% of adult malignancies [1] but displays the highest mortality rate of all urologic tumors with 40% of patients dying from the disease [1]. As RCC does not immediately lead to clinical symptoms, many of the patients present with advanced or metastatic disease (mRCC) at diagnosis [2]. An increasing number of treatment options for patients have become available. Beside effectiveness and safety, quality of life has gained importance when deciding on the type of treatment. However, perception and assessment of various aspects concerning this area can differ among health care workers, treating physicians, and patients [3], [4]. Physicians appear to underestimate pain, but rate emotional problems higher compared with patients [4].

Fatigue is a complex and cumulative condition of patients treated for advanced RCC, and it considerably affects patient's quality of life. It is anticipated that fatigue is highly prevalent in these patients, and that the frequency of reporting as well as assessment of severity may differ between physicians and patients. However, a direct comparison in a blinded manner was not executed till date. Thus, objective data like the presented attempt—despite all methodological implications—are rare. Therefore, this work was initiated to compare assessment of fatigue as evaluated by physicians and patients with mRCC. Furthermore, possible influences of fatigue on quality of life were analyzed. We focused on the assessment of fatigue, as it is one of the most common ailments affecting patients with cancer. It is also a common side effect of mRCC treatments [5], [6], [7].

The term fatigue can be defined as a sense of exhaustion above normal [8]. Causes of fatigue are difficult to determine and multiple factors may be influential. First, functional factors exist such as tumor burden, anticancer treatment, and low hemoglobin levels leading to anemia with fatigue as a symptom. Secondly, sociopsychological effects are noted as being responsible for fatigue. Fatigue is associated with a decrease in patients' activities, which in turn can result in loneliness, isolation, and depression [8].

Section snippets

Patients and methods

One hundred German oncology and urology outpatient centers are currently participating in the collection of data for the multicentre, prospective, noninterventional clinical mRCC Registry (study number in ClinicalTrials.gov registry: NCT00610012). Since starting in December 2007, 1,000 patients are intended to be recruited by the end of 2012. Among other information, the registry documents data on the medical history and all systemic therapies for a maximum of 3 years for each patient.

For this

Patient characteristics

Overall, 271 questionnaires were sent to 72 physicians. Of them, 167 questionnaires were returned by the physicians (response rate, 62%). Subsequently, 98 questionnaires were returned by corresponding patients (response rate, 59%) and analyzed. Table 1 presents the patient characteristics; 72% of patients were male. This ratio reflects patient characteristics of the mRCC Registry [12] and coincides with published data [13]. At the time of questionnaire completion, 64.3% of patients (n = 63)

Discussion

With limited available data on quality of life of patients with mRCC receiving systemic treatment, the aim of this study was to evaluate the perception of fatigue by physicians and patients. In addition, possible effects of fatigue on quality of life were examined.

Fatigue was reported for and by almost all patients in this study. The incidence of fatigue was independent of treatment line. In general, patients judged fatigue to be more severe than their physicians. Several studies comparing

Acknowledgments

The authors thank all outpatient centers and patients participating in the mRCC registry. They also thank the Arbeitskreis Klinische Studien in onkologischen und hämatologischen Praxen e.V. as well as the Bund der Urologen e.G. for supporting the registry. The authors would like to thank Victoria Smith-Machnow and Martina Jänicke for the support in preparing the article.

The mRCC registry is funded by iOMEDICO AG. The FAMOUS project was supported by GlaxoSmithKline GmbH & Co. KG.

References (31)

  • K.C.A. Sneeuw et al.

    Evaluating the quality of life of cancer patients: assessments by patients, significant others, physicians and nurses

    Br J Cancer

    (1999)
  • T.K. Choueiri et al.

    u. a. Angiogenesis inhibitor therapies for metastatic renal cell carcinoma: effectiveness, safety and treatment patterns in clinical practice-based on medical chart review

    BJU Int

    (2010)
  • P. Ivanyi et al.

    Novel therapies in advanced renal cell carcinoma: management of adverse events from sorafenib and sunitinib

    Dtsch Arztebl Int

    (2008)
  • H. Flechtner et al.

    Fatigue and quality of life: lessons from the real world

    Oncologist

    (2003)
  • D.F. Cella et al.

    u. a. The functional assessment of cancer therapy scale: development and validation of the general measure

    J Clin Oncol

    (1993)
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