EORTC QLQ-BM22 Research Articles

Hip reconstruction with a combination of prosthesis and recycled autograft treated with liquid nitrogen in metastatic subtrochanteric fracture can improve quality of life: A case report

Introduction and importancePalliative surgery with rigorously selected patients in treating metastatic bone tumour has become more popular recently. This article presents the use of autograft treated by liquid nitrogen in combination with hip prosthesis to reconstruct pathologically subtrochanteric fracture.Case presentationA 54-year-old male suffered left subtrochanteric fracture due to metastatic lesion from his lung cancer. He underwent one-stage surgery for hip tumour resection and reconstruction using the composite of tumour-bearing LNTA and hip prosthesis. He was able to sit in upright position on POD 1 and then to walk without support one month after the operation. His EORTC QLQ-C30 and EORTC QLQ-BM22 scores have significantly improved from 71 and 63 on POD 3 to 53 and 36 at one month after surgery, respectively.Clinical discussionLimb salvage surgery for pathological proximal hip fracture due to metastasis is always challenging. The goal of treatment must include pain-free affected limb with enough function to improve the QoL during the patient's end stage. Several reports on using frozen recycled autograft showed good results regarding anatomical matching, bone healing, function, and cost-effectiveness. We combined prosthesis and LNTA to manage the patient with end stage lung cancer and pathological proximal hip fracture. The patient was satisfied with the 6-month postoperative results before being deceased due to the widespread metastases.ConclusionComposite of LNTA and prosthesis might be a good alternative for treating metastatic fracture due to its anatomical matching, preservation of bone stock and cost-effectiveness where allograft and megaprosthesis are not available.

Improvements in symptoms related to bone metastasis in recipients of Lutetium-177 PSMA-617 for prostate cancer.

96 Background: Prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) targeted to prostate-specific membrane antigen (PSMA) is a new targeted treatment for progressive metastatic castration-resistant prostate cancer (mCRPC). PSMA-RLT conjugates a radionuclide to a small molecule ligand with affinity for PSMA. Recent trials, such as TheraP and VISION, established improvements in progression free survival, overall survival, and patient-reported outcomes (PROs) for PSMA-RLT. Less is known about the impact of PSMA-RLT on symptoms related to bone metastasis (BM), commonly causing significant morbidity in men with mCRPC. The optimal tools for PRO collection with PSMA-RLT are also uncertain. We previously reported improvements in Brief Pain Inventory and now report EORTC QLQ-BM22 data to describe change in symptoms related to bone metastasis among men receiving PSMA-RLT for mCRPC. Methods: From 2015 to 2017, 50 patients received up to 4 cycles of 177Lu-PSMA-617 every 6 weeks (trial registration: ACTRN12615000912583). Patients completed a validated assessment of bone metastasis-related pain (EORTC QLQ-BM22) prior to each cycle and 6 or 12 weeks after the last cycle of 177Lu-PSMA. Change in pain over the course of the study was examined using linear mixed effects models. We also examined whether unadjusted changes in PROs exceeded published cutoffs for minimal clinically important difference scores. Results: Patients reported reduced bone metastasis-related pain at various sites over time ( p =.01). Of 44 patients completing this scale before cycle 2, 22 (50%) reported clinically significant improvement in pain at various sites. At follow-up, of the 37 patients alive, 25 provided evaluable data on bone metastasis-related pain. Of these, 10 (40%) reported clinically significant improvement in pain at various sites. Patients also reported less functional interference from pain over time ( p <.01) and lower consistency, intermittency, and difficulty alleviating pain with medication over time ( p =.01). Before cycle 2 and at follow-up, 26% and 38% of respondents reported clinically significant reduction in functional interference from pain. Before cycle 2 and at follow-up, 33% and 42% of respondents reported clinically significant improvement in consistency, intermittency, and difficulty alleviating pain with medication. Conclusions: 177Lu-PSMA RLT resulted in improvements in bone metastasis-related symptoms, supporting prior findings using other PRO measures. At follow-up, 38-42% of patients completing PRO assessment reported clinically meaningful improvements in bone metastasis-related pain, a significant contributor to quality of life. Clinical trial information: ACTRN12615000912583.

Phase II Multi-Institutional Study of Low-Dose (2 Gy x 2) Palliative Radiotherapy for Symptomatic Bone Metastases From Multiple Myeloma

<h3>Purpose/Objective(s)</h3> Painful osteolytic bone lesions are common in patients with multiple myeloma (MM). Radiotherapy (RT) is effective in providing pain relief from MM bone lesions in over 80% of patients. There is no consensus as to the most effective dose or fractionation for palliation. Shorter courses of RT are not only more convenient for patients and their families, but they also have less impact on timing of systemic therapies. There is precedent for using 2 Gy x 2 for palliation of lymphomas, which have similar radiosensitivity to myeloma. The primary objective is to determine whether treatment with 2 Gy x 2 to painful myeloma bone lesions achieves patient-reported pain reduction comparable to historical controls at 4 weeks. Secondary objectives will assess QOL endpoints, use of analgesia and time to pain relief, and duration of pain relief. <h3>Materials/Methods</h3> Patients who consent to participation will complete quality of life and pain questionnaires (Brief Pain Index, EORTC QLQ-BM22, and EORTC QLQ-C30) prior to treatment and at 2,4,8 weeks and 6 months following treatment. Pain response, as defined by the international consensus on palliative RT for bone metastases, will be measured based on BPI and daily oral morphine equivalent. Reirradiation at standard dose can be considered at ≥4 weeks following initial treatment for indeterminate pain response or pain progression. Cytogenetics and International Myeloma Working Group risk stratification and response criteria are recorded, when available, but are not required for patient participation. <h3>Results</h3> This trial, supported by ILROG, has opened at 7 institutions with one more in process of opening. Prior to COVID, accrual was 1.5 patients per month. Since COVID, enrollment has been at 0.7 patients per month. A total of 18 patients have been accrued. The median age of patients accrued is 65.5 years with 7/18 female patients. Fourteen patients are Caucasian. Twelve patients have an ECOG performance score of 1-2. Thirteen patients had pain response captured at 4 weeks following RT. Of the 5 patients that did not complete questionnaires at 4 weeks post-RT, 2 expired, 1 was lost to follow-up, 1 had a missed evaluation and 1 had pain progression). The most common site of treatment was the shoulder (4/18). <h3>Conclusion</h3> This ongoing prospective trial in palliation of multiple myeloma bone lesions is feasible and able to accrue at multiple institutions and will provide valuable information as to the role of low-dose RT in this population.

The effect of nurse-led pain education of patients with painful bone metastases on pain and quality of life: A multicenter randomized trial.

203 Background: Radiotherapy (RT) is an effective treatment for painful bone metastases, although pain is not always sufficiently controlled. Pain management education may improve patient empowerment and, consequently, reduce pain intensity. The effect of nurse-led education (NLE) in patients undergoing RT for painful bone metastases was investigated as compared to care as usual (CAU). Primary endpoint was pain intensity at 12 weeks, secondary outcome was quality of life (QoL). Methods: In this multicentre, randomised phase 3 study, patients referred for short schedule RT, with uncontrolled pain (a score of ≥5 on a 0-10 numeric rating scale (NRS)), were randomised between NLE or CAU before start of RT. The NLE consisted of a structured interview including assessment of pain knowledge, verbal and written education on all aspects of pain and follow-up phone calls at 1, 4, 8 &amp; 12 weeks to address pain-related questions. Patients in CAU received leaflets on RT, cancer pain and opioid use. Patient characteristics were assessed at baseline. Pain intensity and QoL were evaluated with the Brief Pain Inventory, EORTC QLQ-C15-PAL and EORTC QLQ-BM22 at baseline, and week 1, 4, 8 &amp; 12. Power calculation showed that there were 89 patients per arm needed to detect a 10% difference in number of patients with a NRS &lt; 5 at 12 weeks(1-sided α = 0.05; β 0.8). Results: Between May 2011-April 2016, 354 patients were randomised (176 NLE, 178 CAU), 38 were excluded (30 NRS &lt; 5 at baseline, 7 no short schedule RT, 1 missing informed consent). At twelve weeks, 185 (NLE 95) had completed follow-up (72 stopped filling out questionnaires, 59 died prematurely). Baseline characteristics were similar in both groups; mean age 65 years, 56% men. At week 12, more patients in NLE than in CAU had controlled pain (NRS &lt; 5; respectively 66% and 52%, p = 0.036). Moreover, patients in NLE reached faster a pain score &lt; 5 than patients in CAU (31 versus 54 days respectively, p = 0.026). On all time points, no significant differences in QoL were found between both groups. Conclusions: Controlled pain, i.e. a pain intensity &lt; 5, was reached faster and by more patients with painful bone metastases undergoing RT by the addition of nurse-led pain education. Clinical trial information: NCT01358539.

Quality of life in responders after palliative radiation therapy for painful bone metastases using EORTC QLQ-C30 and EORTC QLQ-BM22: results of a Brazilian cohort.

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment. A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site. From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33). Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

Micro-invasive surgery combined with intraoperative radiotherapy for the treatment of spinal metastasis.

This is a retrospective analysis of the strategy and clinical results of surgery combined with intraoperative radiotherapy (IORT) to treat spinal metastases. We delivered tumour-conformal IORT in 40 patients with 52 metastatic vertebrae based on our surgical classification system. The strategies were evaluated with respect to neurologic function and spinal stability. The EORTC QLQ-BM22, visual analogue scale (VAS) and the Frankel Scale were used to assess quality of life, pain and neurologic function. Local control was evaluated every 3months using X-rays and MRI. Micro-invasive IORT was performed in 42 vertebrae (80.8%), and open surgery with IORT was performed in 10 vertebrae (19.2%). Single-level, 2-level and 3-level IORT was performed in 30, 8 and 2 cases, respectively. The delivered dose was 9.2±3.6Gy (8-15Gy) with a depth of 10.1±2.1mm. The actual IORT treatment time was 5min and 16s. The follow-up period was 6-23months (mean: 12.5months). The local control rate was 92.3%. The EORTC QLQ-BM22 scores showed that patients had significant improvements in pain location, degree and function after treatment (P<0.01). Thirty-five patients (89.7%) achieved pain relief throughout the follow-up period. VAS scores were significantly reduced by 3.4 points 3months after treatment. Neurological function was improved in 7 patients (87.5%). No radiation-related complications were observed. Surgery combined with tumour-conformal IORT can effectively relieve pain, achieve good local control and improve QOL.

Minimal Clinically Important Differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL Modules in Patients With Bone Metastases

Minimal Clinically Important Differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL Modules in Patients With Bone Metastases

250: Minimal Clinically Important Differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-Pal Modules in Patients with Bone Metastases

250: Minimal Clinically Important Differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-Pal Modules in Patients with Bone Metastases

Classification of painful bone metastases as mild, moderate, or severe using both EORTC QLQ-C15-PAL and EORTC QLQ-BM22.

Previous studies have determined optimal cut points (CPs) for the classification of pain severity as mild, moderate, or severe using only the Brief Pain Inventory (BPI) or the BPI in conjunction with a quality of life (QOL) tool. The purpose of our study was to determine the optimal CPs based on correlation with only QOL outcomes. We conducted an analysis of 298 patients treated with radiation therapy for painful bone metastases on a phase III randomized trial. Prior to treatment, patients provided their worst pain score on a scale of 0 (no pain) to 10 (worst possible pain), as well as completed the European Organization of Cancer Research and Treatment (EORTC) QOL Questionnaire Bone Metastases module (QLQ-BM22) and the EORTC QOL Questionnaire Core-15 Palliative (QLQ-C15-PAL). Optimal CPs were determined to be those that yielded the largest F ratio for the between category effect on each subscale of the QLQ-BM22 and QLQ-C15-PAL using the multivariate analysis of variance (MANOVA). The two largest F ratios for Wilk's λ, Pillai's Trace, and Hotelling's Trace were for CPs 5,6 and 5,7. Combining both, the optimal CPs to differentiate between mild, moderate, and severe pain were 5 and 7. Pain scores of 1-5, 6, and 7-10 were classified as mild, moderate, and severe, respectively. Patients with severe pain experienced greater functional interference and poorer QOL when compared to those with mild pain. Our results suggest that, based on the impact of pain on QOL measures, pain scores should be classified as follows: 1-5 as mild pain, 6 as moderate pain, and 7-10 as severe pain. Optimal CPs vary depending on the type of outcome measurement used.

Translation into Portuguese, cross-cultural adaptation and validation of "The European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Bone Metastases-22".

The aim of the present study was to conduct a cross-cultural adaptation (with translation into Brazilian Portuguese) and validation of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Bone Metastases-22 (EORTC QLQ-BM22). Ninety-five bone metastasis patients (31 men and 64 women, mean age 58.36±8.90 years) took part in the investigation. The translation guide of the EORTC was used to translate from English into Brazilian Portuguese and adapt the instrument culturally. The reliability and the face, content and construct validities were tested. Internal consistency was estimated using Cronbach's alpha for the total score, pain and functional subscales of the EORTC QLQ-BM22 (0.93, 0.86, 0.90). Reliability was analyzed by Pearson's correlation and intraclass correlation coefficients (ICCs). The correlations were higher than the recommended value of 0.75, which indicated good test-retest reliability. Construct validity was demonstrated by correlation with the questionnaire medical outcome study questionnaire 36-Item Short Form Survey (SF-36). It showed significant correlation between the fields of QLQ-BM22 and the SF-36 (P≤0.001). The EORTC QLQ-BM22 was translated into Brazilian Portuguese, was culturally adapted and was proven to be reliable, with face, content and construct validity.

A prospective study validating the EORTC QLQ-BM22 bone metastases module in patients with painful bone metastases undergoing palliative radiotherapy

PurposeQuality of life (QOL) can be compromised in patients with bone metastases, and validated QOL instruments are required to accurately measure QOL outcomes in this population. This study investigated the validity, reliability and responsiveness of the EORTC QLQ-BM22 module with the EORTC QLQ-C15-PAL instrument in bone metastases. MethodsThe studied patients underwent palliative radiotherapy to bone metastases in the randomized NCIC CTG SC 23 trial. Multi-trait scaling analysis was performed to determine convergent and divergent validity among scales. Pearson coefficients were calculated to determine the correlation between items of the two instruments. The clinical validity and responsiveness of the QLQ-BM22 was tested by known group comparisons of different performance status and response to radiotherapy. Results204 patients completed both questionnaires at baseline and 42day follow-up. On multi-trait scaling analysis, there was mixed evidence of construct validity (explained by the questionnaire format and population characteristics). There was little correlation between most QLQ-BM22 and QLQ-C15-PAL items (except for conceptually related scales) validating their complementary nature. There were statistically significant differences in all QLQ-BM22 scale scores in groups with KPS<80 vs. KPS⩾80 and three out of four QLQ-BM22 scale scores in “responders” vs. “non-responders” to radiotherapy. In patients who responded to radiotherapy, there were statistically significant differences in all QLQ-BM22 scale scores between baseline and follow-up. ConclusionThis study further validates the use of the QLQ-BM22 as a robust and sensitive instrument to assess QOL in patients with bone metastases treated with palliative radiotherapy.

Magnetic resonance guided focused ultrasound surgery for pain palliation of bone metastases: early experience of clinical application in China

To evaluate the safety and efficacy of magnetic resonance guided focused ultrasound surgery (MRgFUS) in treatment for pain palliation of bone metastases. Eighty-one patients of painful bone metastases were volunteered to screen for this study in Shanghai General Hospital from June 2014 to February 2015. Twenty-three patients among them were treated by MRgFUS, who was more than 18-years old, having the ability to fully understand the informed consent of the research, suffering with pain of numeric rating scale (NRS) ≥ 4, non-received radiotherapy or chemotherapy for pain palliation of bone metastases in the past two weeks. The NRS, the standard question of Brief Pain Inventory (BPI-QoL), and the standard question of Europe Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Bone Metastases 22 (EORTC QLQ-BM22) were respectively recorded before and 1-week, 1-month, 3-month after the treatment. The related adverse events of MRgFUS were observed and recorded in 3 months after the treatment as well. (1)Twenty-three metastatic bone tumor lesions of 23 patients were treated by MRgFUS, the treatment data was as follows: the mean treatment time was (88 ± 33) minutes, the mean sonication number was 13 ± 8. (2) Adverse events included: pain in therapy area 3/23, which spontaneous relieving within one week; numbness in lower limb (1/23), which relieved after physiotherapy. (3) The NRS of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 6.0 ± 1.5, 3.7 ± 1.7,3.1 ± 2.0, and 2.2 ± 1.0,which significantly decreased after the treatment (P<0.01). (4) The BPI-QoL score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 39 ± 16, 27 ± 18, 26 ± 18, and 21 ± 18, which significantly decreased after the treatment (P<0.01). (5) The EORTC QLQ-BM22 score of before treatment and at 1-week, 1-month, and 3-month after treatment respectively was 52 ± 13, 44 ± 12, 42 ± 12, and 39 ± 12, which also significantly decreased after the treatment (P<0.01). MRgFUS can be used as a non-invasive, safe, and effective method for treating painful bone metastases. Its clinical benefits of pain palliation and patient's quality of life improving are sustained after the treatment at least to 3 months.

Validation of the Chinese version of EORTC QLQ-BM22 in patients with bone metastases.

Our aim is to test the validity, reliability, and acceptability of the Chinese version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Bone Metastases 22 (EORTC QLQ-BM22) module to assess health-related quality of life (HRQOL) in patients with bone metastases in China. Patients with histological confirmation of malignancy and bone metastases from Tianjin Cancer Institution and Hospital from June 2013 to April 2014 were enrolled in this study. All patients self-administered the EORTC QLQ-BM22 and the EORTC QLQ-C30. The Karnofsky Performance Scale (KPS) was performed to evaluate scores. The reliability and validity tests of the questionnaires were based on Cronbach's α coefficients, Pearson correlation test, and Wilcoxon rank sum nonparametric test. Internal consistency reliabilities of all the four scales were acceptable. Scales measuring similar HRQOL aspects were found to correlate with one another between EORTC QLQ-BM22 and EORTC QLQ-C30, but differences still existed. Significant differences were demonstrated in the scores of all four subscales of the QLQ-BM22 between the two KPS subgroups (KPS ≤ 80; KPS > 80). Meanwhile, the compliance for item completion of the QLQ-BM22 was satisfactory. The Chinese version of EORTC QLQ-BM22 is a reliable and valid instrument, which is appropriate for measuring the HRQOL of patients with bone metastases in China.

Comparison of minimally invasive surgery with standard open surgery for vertebral thoracic metastases causing acute myelopathy in patients with short- or mid-term life expectancy: surgical technique and early clinical results

OBJECT Spinal metastasis is common in patients with cancer. About 70% of symptomatic lesions are found in the thoracic region of the spine, and cord compression presents as the initial symptom in 5%-10% of patients. Minimally invasive spine surgery (MISS) has recently been advocated as a useful approach for spinal metastases, with the aim of decreasing the morbidity associated with more traditional open spine surgery; furthermore, the recovery time is reduced after MISS, such that postoperative chemotherapy and radiotherapy can begin sooner. METHODS Two series of oncological patients, who presented with acute myelopathy due to vertebral thoracic metastases, were compared in this study. Patients with complete paraplegia for more than 24 hours and with a modified Bauer score greater than 2 were excluded from the study. The first group (n = 23) comprised patients who were prospectively enrolled from May 2010 to September 2013, and who were treated with minimally invasive laminotomy/laminectomy and percutaneous stabilization. The second group (n = 19) comprised patients from whom data were retrospectively collected before May 2010, and who had been treated with laminectomy and stabilization with traditional open surgery. Patient groups were similar regarding general characteristics and neurological impairment. Results were analyzed in terms of neurological recovery (American Spinal Injury Association grade), complications, pain relief (visual analog scale), and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 and EORTC QLQ-BM22 scales) at the 30-day follow-up. Operation time, postoperative duration of bed rest, duration of hospitalization, intraoperative blood loss, and the need and length of postoperative opioid administration were also evaluated. RESULTS There were no significant differences between the 2 groups in terms of neurological recovery and complications. Nevertheless, the MISS group showed a clear and significant improvement in terms of blood loss, operation time, and bed rest length, which is associated with a more rapid functional recovery and discharge from the hospital. Postoperative pain and the need for opioid administration were also significantly less pronounced in the MISS group. Results from the EORTC QLQ-C30 and QLQ-BM22 scales showed a more pronounced improvement in quality of life at follow-up in the MISS group. CONCLUSIONS In the authors' opinion, MISS techniques should be considered the first choice for the treatment for patients with spinal metastasis and myelopathy. MISS is as safe and effective for spinal cord decompression and spine fixation as traditional surgery, and it also reduces the impact of surgery in critical patients. However, further studies are needed to confirm these findings.

Evaluation and application of the simplified Chinese version of the EORTC QLQ-BM22 questionnaire for quality of life in patients with bone metastases

Objective To translate the EORTC QLQ-BM22 into simplified Chinese and evaluate its utility. Methods Translate, reverse translate and cultural adjustment: Authors translated the English version of EORTC QLQ-BM22 into simplified Chinese. Two individual native English-speakers translated the Chinese version back into English. The reverse translated version was sent to EORTC for reviewing. From Sept 2012 to March 2013, we enrolled 10 patients with bone metastases (mean age 59.4, 37-78). There were 6 male and 4 female. Patients were asked to complete the questionnaire and questions about understanding of the questionnaire were recorded. How well patients could understand the questionnaire was evaluated and modification was made accordingly. From April 2013 to March 2014, 50 patients with bone metastases were admitted in our hospital. They were asked to take the questionnaire before and three days, one month, three months and 6 months after operation. The scores were analyzed and quality of life was evaluated. Results EORTC approved the translation of the simplified Chinese version of EORTC QLQ-BM22 questionnaire due to its accuracy to reflect the original version, and the Chinese version was online. Patients found no difficulty in understanding the questionnaire, and could complete the form without too much effort. We had 27 male and 23 female who participated in our survey (mean age 57.2, 46 to 84). According to the scores, scale of pain, sites of pain, and function were all significantly improved postoperatively. Patients received elevated quality of life with surgical treatment. Conclusion Simplified Chinese version of EORTC QLQ-BM22 could be used as an effective questionnaire in evaluating the quality of life for patients with bone metastases. Key words: Skeleton; Neoplasm metastasis; Questionnaires

Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.

153 Background: Progression-free survival and objective response rate were significantly improved with T-DM1 vs TPC in TH3RESA. The impact of treatment on quality of life is a key aspect in determining treatment value. Here we present the PRO results from the TH3RESA study. Methods: Patients were randomized 2:1 to T-DM1 (3.6 mg/kg every 21 days) or TPC. Patients were asked to complete the EORTC QLQ-C30 (a 30-item questionnaire assessing symptom bother, functioning and health status) and the EORTC QLQ-BM22 (a 22-item survey evaluating pain from bone metastases) at the start of each cycle. Data from patients with a baseline and ≥1 post-baseline assessment were included; a clinically meaningful difference was defined as ≥10 points. Time to pain progression (TPP) was assessed using the Kaplan-Meier method and Cox proportional-hazards models. Results: A greater proportion of patients in the T-DM1 arm (n=297) vs. the TPC arm (n=117) experienced a clinically meaningful improvement in global health status (57.8% [95% CI; 52.0–63.3] vs. 47.1% [95% CI; 38.4–56.4]). The most bothersome symptoms in the T-DM1 arm as measured by the EORTC QLQ-C30 were fatigue and pain. Over the first 10 T-DM1 treatment cycles, 19–30% of patients reported being impacted “quite a bit” or “very much” by fatigue, and 16–25% by pain. Nausea/vomiting and diarrhea were perceived as more tolerable, with 1–5% and 1–4% of patients reporting “quite a bit” or “very much” impact, respectively. TTP was 2.9 months in the T-DM1 arm vs 3.6 months in the TPC arm, but was not significantly different (HR 1.12 [95% CI; 0.82–1.52], p = 0.495). Mean baseline EORTC QLQ-BM22 pain scores were similar in the T-DM1 (n = 306) and TPC arms (n = 130); (25.4 ± 23.8 [SD]) and (27.3 ± 24.4), respectively. There were no clinically meaningful changes in pain levels from baseline over time in either arm. Conclusions: For patients on T-DM1, the most impactful symptoms were fatigue and pain, while the least bothersome were diarrhea and nausea/vomiting; distribution of severity of impact was relatively stable over the first 10 cycles of treatment. TPP was similar between the T-DM1 and TPC arms. Clinical trial information: NCT01419197.

Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy - a prospective trial

BackgroundTo evaluate the local response according to stability after radiotherapy (RT) with a special focus on quality-of-life (QoL), fatigue, pain and emotional distress in patients with unstable spinal bone metastases.MethodsIn this prospective trial, 30 patients were treated from September 2011 until March 2013. The stability of osteolytic metastases in the thoracic and lumbar spine was evaluated on the basis of the Taneichi-score after three and six months. EORTC QLQ-BM22, EORTC QLQ-FA13, and QSC-R10 were assessed at baseline, and three months after RT.ResultsAfter 3 months, 25% (n = 6) and after 6 months 33.3% (n = 8) were classified as stable. QoL, fatigue, and emotional distress showed no difference over the course. The pain response 3 months after RT showed a significant difference (p < 0.001). Pathological fractures occurred in 8.3% of the patients (n = 2) within six months following RT.ConclusionsOur trial demonstrated that RT can improve stability in one third of patients over a 6-months period with unstable spinal metastases. Importantly, for these patients pain relief was detected but RT had no impact on QoL, fatigue, and emotional distress.Trial registrationClinical trial identifier NCT01409720.

The reliability and validity of the Iranian version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with Bone Metastases: the EORTC QLQ-BM22

The aim of the present study was to evaluate the psychometric properties of the measure among a sample of Iranian patients with bone metastases. One hundred and seventy-seven patients with bone metastases undergoing various treatments were recruited from Imam Khomeini Hospital in Tehran to participate in the study. The coefficient alpha affirmed internal consistency reliability of the Quality of Life Questionnaire for patients with Bone Metastases (QLQ-BM22). This measure discriminated well between subgroups of the patients based on performance status and responding to treatment. Confirmatory factor analysis confirmed the factorial validity of the four hypothesized QLQ-BM22 scales. Patients in this study had a similar interpretation of the items on the QLQ-BM22 regardless of gender. All scales of the QLQ-BM22 were sensitive to change after treatment over a month’s follow-up, with the exception of psychosocial aspects. The Persian version of the EORTC QLQ-BM22 was highly reliable and is valid for use among patients with bone metastases who are undergoing various treatment regimes.

Comparison of the EORTC QLQ‐BM22 and the BOMET‐QOL quality of life questionnaires in patients with bone metastases

Bone metastases are a common complication of advanced cancer and often result in a decrease in patients' quality of life. Very few specific modules have been created to accurately assess quality of life in this patient group. The purpose of this study was to compare two questionnaires, the European Organization for Research and Treatment of Cancer quality of life questionnaire for patients with bone metastases (EORTC QLQ-BM22) and the bone metastases quality of life questionnaire (BOMET-QOL. A literature search was conducted in Medline, Health and Psychosocial Instruments, Embase and Embase Classic to identify studies that discussed the development, validation and reliability of the (EORTC) QLQ-BM22 and the BOMET-QOL. Studies that discussed the development and validity of the questionnaire along with studies using these tools were included. Both questionnaires were developed in collaboration with patients and health-care professionals. The QLQ-BM22 is over twice the length of the BOMET-QOL, with 22 questions as compared to 10. The QLQ-BM22 has four subscales while the BOMET-QOL has no subscales. The QLQ-BM22 gives a more in-depth analysis of symptoms and well-being and includes issues such as mobility, side effects, complications of treatment and dependency. The BOMET-QOL is shorter and gives an overall assessment of pain and mobility. Scoring, item format, organization and response options vary between the questionnaires but the recall period for both is the previous week. Both questionnaires have been determined valid and reliable. The QLQ-BM22 and the BOMET-QOL are designed specifically for patients with bone metastases and each has strengths and weaknesses. Use of one over the other is ultimately dependent on trial design and investigators' goals.

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

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. 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. 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). 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.