Clinical Investigation
Quality of Life After Palliative Radiation Therapy for Patients With Painful Bone Metastases: Results of an International Study Validating the EORTC QLQ-BM22

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Purpose

Radiation therapy (RT) is an effective method of palliating painful bone metastases and can improve function and reduce analgesic requirements. In advanced cancer patients, quality of life (QOL) is the primary outcome of interest over traditional endpoints such as survival. The purpose of our study was to compare bone metastasis-specific QOL scores among patients who responded differently to palliative RT.

Methods and Materials

Patients receiving RT for bone metastases across 6 countries were prospectively enrolled from March 2010-January 2011 in a trial validating the QLQ-BM22 and completed the QLQ-BM22 and the core measure (QLQ-C30) at baseline and after 1 month. Pain scores and analgesic intake were recorded, and response to RT was determined according to the latest published guidelines. The Kruskal-Wallis nonparametric and Wilcoxon rank sum tests compared changes in QOL among response groups. A Bonferroni-adjusted P<.003 indicated statistical significance.

Results

Of 79 patients who received palliative RT, 59 were assessable. Partial response, pain progression, and indeterminate response were observed in 22, 8, and 29 patients, respectively; there were no patients with a complete response. Patients across all groups had similar baseline QOL scores apart from physical functioning (patients who progressed had better initial functioning). One month after RT, patients who responded had significant improvements in 3 of 4 QLQ-BM22 domains (painful site, P<.0001; painful characteristic, P<.0001; and functional interference, P<.0001) and 3 QLQ-C30 domains (physical functioning, P=.0006; role functioning, P=.0026; and pain, P<.0001). Patients with progression in pain had significantly worse functional interference (P=.0007) and pain (P=.0019).

Conclusions

Patients who report pain relief after palliative RT also have better QOL with respect to bone metastasis-specific issues. The QLQ-BM22 and QLQ-C30 are able to discriminate among patients with varying responses and are recommended for use in future bone metastasis clinical trials.

Introduction

Radiation therapy (RT) is an efficacious, clinically efficient, and cost-effective method of palliating painful bone metastases. The rates of overall response and complete response to RT when all randomized controlled trial data are pooled are approximately 70% and 28%, respectively, and in cases of “uncomplicated” bone metastases, where there is no fracture or neurologic compromise, single-dose treatment provides a response equivalent to multiple treatments (1). As such, significant savings are made in both cost and resource use 2, 3, 4.

In patients with advanced disease, treatment strategies aim to improve or maintain quality of life (QOL) over traditional endpoints such as survival. RT not only manages pain resulting from bone metastases but can also help reduce analgesic intake and the side effects of analgesics, which may negatively impact QOL (5).

Assessment of QOL is most frequently conducted with validated tools either by the patients themselves or by proxy, although the reliability of the latter is controversial (6). Both the European Organisation for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) groups offer questionnaires for assessment of QOL in cancer patients. Issues common among all patients are typically assessed by use of a “core measure,” such as the EORTC QLQ-C30 (7) or FACT-G (8). Because these may not address specific issues that are important to certain subpopulations, disease-specific instruments are also available.

The EORTC QLQ-BM22 was designed to be used in conjunction with the core QLQ-C30 and addresses issues expected in patients with bone metastases. Domains covered include painful sites, painful characteristics, functional interference, and psychosocial aspects relating to bone metastases. In a 400-patient sample, the validity, reliability, cross-cultural applicability, and sensitivity of the QLQ-BM22 were successfully established (9).

Previous studies of QOL in patients with bone metastases have shed useful light on the patients' QOL and pain 10, 11. However, some of these studies' results may have been limited, because only more general assessments of QOL were available and many may not have been rigorously validated tools for this population. Hence the aim of this study was to determine the changes in bone metastasis-specific QOL scores in patients undergoing palliative RT, using robust and specific QOL measures for patients with bone metastases.

Section snippets

Patient population

Patients with bone metastases undergoing various treatments were enrolled in an international trial validating the QLQ-BM22 from March 2010-January 2011 (9); this study includes a subset of patients who received RT. The QLQ-BM22 and QLQ-C30 were administered at baseline and at 1 month after treatment for all patients; in addition, the worst pain score in the past 24 hours at the site to be treated was determined. All patients were 18 years or older and had histologically confirmed primary

Results

A total of 79 patients received RT and had recorded pain medication use and scores at baseline (Table 1). The mean age was 63 years, and the median Karnofsky Performance Status was 70. The majority of patients were enrolled from Canada (44%), followed by Cyprus, Egypt, Brazil, India, and France. Primary cancers of the breast (21 [26.6%]), prostate (17 [21.5%]), and lung (16 [20.2%]) were most common. Of these patients, 59 had complete follow-up QOL data and were used for further analysis.

There

Discussion

Patients who achieve pain relief from palliative RT also report better QOL in symptom and functional domains related to painful bone metastases. This is the first international study that analyzed QOL changes after palliative RT using a bone metastasis-specific instrument. We also showed that the QLQ-BM22 is able to differentiate patients who respond to treatment from those who do not.

Prior studies assessing QOL in this population have used generalized tools such as the core EORTC QLQ-C30 or

Acknowledgment

The authors are thankful for the generous support of the Bratty Family Fund, Michael and Karyn Goldstein Cancer Research Fund, Joseph and Silvana Melara Cancer Research Fund, and Ofelia Cancer Research Fund.

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Conflict of interest: Andrew Bottomley is a coauthor of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group measurement system. The tools are provided free to academic researchers, but the EORTC charges a user fee for the use of the EORTC QLQ-C30 in industry-sponsored research to cover the cost of future psychometric validation, testing, and translation of quality-of-life tools. There are no other conflicts of interest.

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