EORTC QLQ-C30 Scores Research Articles

Impact of post-chemoradiotherapy superselective/selective neck dissection on patient reported quality of life

To describe patient-reported quality of life (QoL) for patients with HPV/p16-positive oropharyngeal squamous cell carcinoma undergoing post-chemoradiation (CRT) superselective or selective neck dissection (ND) as part of a prospective de-intensification study. Patients received 60Gy IMRT with concurrent weekly cisplatin (30mg/m(2)), followed by preplanned neck dissection of only originally involved nodal levels. QoL measures were assessed using the EORTC QLQ-C30 (general), EORTC H&N-35 (head and neck specific), EAT-10 (swallowing), and NDII (Neck Dissection Impairment Index) questionnaires. Early and late post-ND time points were compared to baseline and post-CRT/pre-ND time points. 37 patients underwent post-CRT superselective or selective ND. Median # of levels and nodes dissected were 2 and 12, respectively. EORTC QLQ-C30, H&N-35, and EAT-10 QoL scores worsened after CRT but continued to improve thereafter despite post-CRT ND. NDII score worsened initially after ND at the early post-ND time point (p=0.023) but had recovered by the late post-ND time point (p=0.672). Initial decrease in NDII was greater with ⩾12 nodes dissected (p=0.007) and was correlated with the total number of nodes dissected (Spearman p=0.027). Use of post-CRT superselective and selective ND did not prevent recovery of most QoL metrics to near baseline. There was early but not late decrement in neck dissection specific QoL (NDII), more pronounced with more nodes dissected.

The role of "closed abdomen" hyperthermic intraperitoneal chemotherapy (HIPEC) in the palliative treatment of neoplastic ascites from peritoneal carcinomatosis: report of a single-center experience.

The purpose of this study was to review the results of a single-center experience in the management of "closed abdomen" hyperthermic intraperitoneal chemotherapy (HIPEC) using a sophisticated technical device (EXIPER®) in the palliative setting of neoplastic ascites from peritoneal carcinomatosis in patients with advanced cancer of different primary sites. The study was an open, prospective, single-center, non-randomized study conducted at the Department of Medical Oncology 1, University of Cagliari, Italy, from May 2006 to October 2012. Fifteen patients with peritoneal carcinomatosis were treated with HIPEC: 5 males and 10 females (age range 51-82, median 62years), for a total of 30 procedures (5 patients were treated more than once). Malignant ascites were from ovarian, uterine cervical, colorectal, gastric, malignant pleural mesothelioma, and unknown primary cancer. Main endpoints were increase of free interval between two consecutive procedures, progressive reduction of ascites volumes and improvement of quality of life assessed with ECOG performance status and EORTC QLQ-C30 questionnaire, and improvement of immunologic function. Twelve patients were completely evaluable while three patients were "lost" to follow-up. The treatment was well tolerated. The mean free interval between two consecutive drainages increased from 11.2 to 39.5days. The mean ascites volume drained decreased from 7.8 to 1.8l. ECOG PS improved in the majority of patients and EORTC QLQ-C30 scores in all patients as well as immunologic function. In September 2015, only one patient was still alive. Our study shows that good results may be achieved in terms of symptom palliation and improvement of quality of life in very advanced cancer patients with MA from PC. The treatment was generally well tolerated considering the limited treatment options available for these patients.

Impact of Major Complications on Patients' Quality of Life After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is an effective treatment for selected patients with peritoneal surface malignancies (PSM). Although it can have significant morbidity, perioperative mortality is low. Little is known about whether major complications after CRS/HIPEC have a lasting impact on patients' quality of life (QOL). We retrospectively reviewed data from a prospectively collected database on patients treated with CRS/HIPEC for PSM (2011-2014). Patients with CRS/HIPEC and 6-month QOL evaluation were included. Major perioperative complications (Clavien-Dindo grade 3/4) were the primary independent variable. QOL was evaluated using the validated EORTC QLQ-C30 score. The primary outcome was 6-month global health score. Secondary outcomes were individual functional and symptom domains. Forty-two patients were analyzed. Median age was 57.5; 64% were female. Origin of PSM was appendix (55%), colorectal (38%), mesothelioma (5%), and small bowel (2%). Fourteen patients (33%) had major (grade 3/4) complications. Median length of stay was 16days; patients experiencing major complications had significantly increased length of stay (35.5 vs. 13days, p<0.01). Major complications included intra-abdominal abscess (9.5%), bleeding (9.5%), symptomatic pleural effusion (7.1%), anastomotic leaks (7.1%), and renal failure (2.4%). The average global health score at 6months was 68.1. The worst-rated symptom scores at 6months were diarrhea (39.8) and fatigue (35.4). There were no significant differences in 6-month QOL scores between patients with and without major complications, globally or in specific domains. Although major complications are common after CRS/HIPEC, QOL at 6months recovers and is similar to those without major complications.

Long-Term Effectiveness of Combined Treatment with Traditional Chinese Medicine and Western Medicine on the Prognosis of Patients with Lung Cancer.

The study aim was to compare the long-term effect of Western medicine and combined treatment with Traditional Chinese Medicine (TCM) and Western medicine on the prognosis (survival rate, symptom distress, physical function, and quality of life) of patients with lung cancer. Longitudinal study. Two medical centers, one each in Northern and Southern Taiwan. Patients newly diagnosed with lung cancer and treated with Western medicine (n = 54) or TCM plus Western medicine (n = 30). Symptom distress, physical function, and quality of life were measured by using the Symptom Distress Scale, Eastern Cooperative Oncology Group-Performance Status Rating, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and EORTC QLQ-LC13), respectively. Data on these measures were collected at baseline (before treatment) and 1, 3, 6, and 12 months after starting treatment. Survival was estimated by Kaplan-Meier curves. Group differences in outcomes were analyzed by generalized estimating equations. Treatment groups did not differ significantly at baseline for demographic information; disease severity; symptom distress; or EORTC QLQ-C30 and QLQ-LC13 scores, except for pain and dyspnea. After adjustment for these baseline effects, the combined-treatment group had better physical function and role function than the Western medicine group at 6 months (p < 0.05). The combined treatment group had better cumulative survival, but this difference did not reach significance. To more precisely estimate the long-term effectiveness of combined treatment on the prognosis of patients with lung cancer, future studies should standardize the number of TCM visits; increase the number of participants by continuous recruitment; and ask patients to complete daily logs with single-item measures of outcomes, such as symptom distress, quality of life, and physical function. Similar studies are suggested in patients with different cancers to develop a collaborative model using Western medicine and TCM.

Quality-of-Life (QoL) in Patients with Advanced Solid Tumors as a Screening Tool During Phase I Clinical Trial Recruitment—Prospective Pilot Study on Implications on Eligibility (S707)

•Recognize QoL as a predictor for serious adverse effect (SAE) occurrence in patients enrolled in phase I oncology clinical trials.•Recognize the importance of interdisciplinary approach when dealing with the oncology patient. Despite physicians attempts to select the “fittest” of subjects for phase I oncology trials using rigorous inclusion/exclusion criteria, many patients still suffer from serious adverse events (SAEs) that lead to increased morbidity and mortality. To assess whether baseline quality-of-life (QoL) scores can predict increased likelihood of SAEs in patients and hence aid investigator judgment in deciding patient fitness for phase I studies. 92 patients with solid tumors were included in this analysis after enrolling in one of 23 phase I solid tumor clinical trials at a comprehensive cancer center in Buffalo, NY. QoL questionnaires (FACT-G, EORTC QLQ-C30 and Medical Outcomes Study Social Support Survey) were administered at baseline. All SAEs that occurred within the first four cycles of treatment were recorded. Fisher’s exact test was used to study the association between categorical variables. A linear transformation was used to standardize QoL scores. P-value ≤ 0.05 was considered statistically significant. Mean age of the patients was 61 years, and 41% were male. Baseline EORTC QLQ-C30 scores were poorer among patients who encountered SAEs (p = 0.01). When EORTC QLQ-C30 scores were further analyzed according to specific domains, worse global health status, functional, and symptom scores were each associated with occurrence of SAEs (p = 0.05, 0.03 and 0.02, respectively). Baseline EORTC QLQ-C30 score is associated with risk of SAEs during phase I trial therapy in patients with advanced solid malignancies. Additional studies are needed to validate this observation and assess efficacy of interventions, such as early palliative care, that might mitigate the risk for SAE in this population.

Comparison of the therapeutic effects of surgery combined with postoperative radiotherapy and standalone radiotherapy in treating spinal metastases of lung cancer

ObjectThere are few studies comparing the therapeutic efficacy between surgery combined with postoperative radiotherapy and standalone radiotherapy in treating spinal metastases of lung cancer. The aim of this clinical study was to compare the clinical and functional efficacy, quality of life, and survival outcomes between surgery combined with postoperative radiotherapy and standalone radiotherapy in treating spinal metastases of lung cancer. MethodsA retrospective analysis of clinical data from June 2008 to December 2013 was performed with 46 patients suffering spinal metastases of lung cancer. Among the studied patients, 25 patients received standalone radiotherapy (radiotherapy group), and the other 21 patients received surgery combined with postoperative radiotherapy (surgery group). Follow-up and survival time were analyzed. Pain levels of the patients were assessed by visual analogue scale (VAS) from pre-treatment to one month and three months after starting treatment. 3 months after surgery, Neurologic deficit of the patients was evaluated using Frankel Grade, and functional impairment were classified by Karnofsky Score. The quality of life (QOL) was assessed by EORTC QLQ-C30 questionnaire. ResultsThe follow-up period of the patients ranged from 2 to 25 months with the average of 8.8 months. In radiotherapy group, the mean survival was 8.5 months with median survival time of 7.8 months. In surgery group, the mean survival was 10.6 months with median survival of 8.4 months. The difference in survival times between the two groups was not statistically significant (P=0.24>0.05). From pre-treatment to one month and three months after treatment initiation, the VAS in both groups showed statistical significant improvement (One month: P<0.01 Three months: P=0.001, p<<0.01). In the surgery group, 85.7% of all patients had functionally useful Frankel Grade D or E after surgery, compared with 71.4% pre-operatively. The percentage was 72.0% in the radiotherapy group post-treatment, compared with 68.0% pre-treatment. The relief of Frankel Grade in surgical group was superior to that of the radiotherapy group (p=0.025, p<0.01). KPS score (80–100) percentages in surgery group and in radiotherapy group were increased by 19% and 13.3%, respectively. The improvement of KPS was more in the surgery group (p=0.013, P<0.01). In radiotherapy group, the EORTC QLQ-C30 score was 86.13±12.11 before treatment and 68.39±14.96 after treatment. In surgery group, the EORTC QLQ-C30 score was 84.09±9.48 before treatment and 54.64±15.17 after treatment. The improvement of patient QOL was more in the surgery group (p=0.004, p<0.01). ConclusionCompared with standalone radiotherapy, surgery combined with postoperative radiotherapy did not significantly prolong the survival time. However, surgery can improve pain, function and QOL of patients with spinal metastases of lung cancer.

Effects of a Home-Based Exercise Intervention Program on Physical Capacity and Fatigue in Patients with Myelodysplastic Syndrome (MDS) - a Feasibility Study

Introduction:Cancer-related fatigue (CrF) is a frequent and disabling symptom in hematological malignancies and associated with significant impairment in quality of life (QoL). Patients suffer from tiredness, weakness and limited capability. CrF involves physical, psychological, mental and social aspects, and often leads to inactivity or depressive mood. There is evidence for the benefit of exercise and physical activity on CrF, but clinical trials targeting patients with MDS are missing.Methods:We conducted a prospective, non-randomized trial to assess the feasibility, safety and efficacy of a home-based exercise intervention in patients with IPSS low to intermediate risk MDS. Subjects underwent an introduction and first exercise session at baseline (T0) under supervision of a physiotherapist. Workout sessions were then performed unsupervised in an outpatient setting. Patients were asked to record results in a sports diary. Exercise schedule contained six sessions per week - endurance or strength training in daily turns - over 12 weeks (T1). Follow-up assessment was performed at week 24 (T2).Endurance training included walking, running, cycling or swimming at patient´s preference. Strength training consisted of six exercises with an elastic strap for both upper and lower limb and the spine. Subjects were examined three times (T0, T1, T2). All examinations included 6-minutes walking distance (6-MWD), an ergometer check, isometric strength measurement of lower limb and isokinetic strength measurement of the abdomen and back. Quality of life and fatigue were assessed by the EORTC QLQ-C30 and Multidimensional Fatigue Inventory (MFI).Results:Twenty-one patients (13 male, 8 female) with low to intermediate risk MDS were included. Median age was 66 years (range 29-87). Fifteen patients completed the program at week 12 (T1). Twelve patients voluntarily continued the exercise program until week 24 (T2). The primary endpoint was met, since 11 patients (52%) performed more than 75% of all planned session. Median number of individual workout session was 54 (range 1-72). There were no adverse events reported due to the intervention. Main reasons for missed training sessions were doctor´s appointments or hospitalization, other private appointments, followed by acute infection and general weakness.Six-minute walking distance (6-MWD) improved from 570 meters (m) (T0) to 645 m (T1, +13%) and 660 m (T2, +16%). Among other parameters of physical capacity, strength of lower limbs increased from 2230 Newton (N) (T0) to 2570 (T1, +15%) and 2730 (T2, +22%). Between T0, T1 and T2 most functional measures like global health status (53 vs. 50 vs. 52), role functioning (62 vs. 49 vs. 61) and social functioning (63 vs. 58 vs. 53) were equal or slightly decreased. General fatigue did not significantly change over time (49 vs. 52 vs. 47 using the EORTC QLQ-C30 score [scale 0-100] and 12.2 vs. 12.4 vs. 11.9 on MFI [scale 0-21]. Results of all endurance and resistance parameters and QoL measures including fatigue subscales are displayed in Table 1.Conclusion:These data provide evidence that an unsupervised outpatient exercise program is feasible in MDS patients. The results of this pilot study also demonstrate that patients' acceptance of the program is high and physical capacity can be improved. Fatigue as a predominant symptom did not worsen during observational period. Further studies are therefore warranted. [Display omitted] DisclosuresSchuler:PharmaMar: Research Funding. Ehninger:Cellex GmbH: Equity Ownership. Platzbecker:Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Boehringer: Research Funding.

Quality of Life in Elderly Patients with Acute Myeloid Leukemia Undergoing Induction Chemotherapy

Aims: In elderly patients with acute myeloid leukemia (AML), complete remission (CR) rate following intensive chemotherapy is approximately 45%, considerably lower than in younger patients, with a shorter duration of remission and high treatment-related mortality (30-50%). Median survival is about 12 months. Intensive chemotherapy is indicated in a small proportion of "fit" elderly patients. In a phase III, prospective, randomized, open-label, multicenter trial designed to assess the efficacy of post-remission treatment with 5-Azacitidine versus best supportive care (BSC) in patients > 60 years of age with AML in CR after conventional induction ("3+7") and consolidation chemotherapy, quality of life (QoL) was assessed from diagnosis. We present interim results of changes of QoL.Methods: Patients with newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from myelodysplastic syndrome without contraindications for intensive chemotherapy and with an ECOG performance status < 3 are included. Induction chemotherapy consists of two courses of "3+7": Daunorubicin 40 mg/m2 daily days 1-3 and cytarabine 100 mg/m2 daily continuous IV infusion days 1-7. Patients in CR receive consolidation (cytarabine 800 mg/m2 3 hour infusion bid days 1-3) and are randomized 1:1 to receive BSC or 5-Azacitidine maintenance therapy up to 4 years and six months until AML recurrence. QoL assessment was performed using the EORTC QLQ-C30 and the QOL-E v.3 questionaires.Results: QoL results assessed at 3 time points are reported: 1) baseline; 2) at hematological recovery immediately after the first "3+7" course; and 3) after consolidation at randomization. Ninety-nine patients (male/female 50/49) of median age 70 (IQR 65-74) years have been enrolled. At diagnosis, mean hemoglobin was 9.2 (SD ± 2.4) g/dL, leukocytes were 7.9 (2.3-29.6)/µL, platelet count was 54 (IQR 29-85) Gi/L and bone marrow blasts were 70 (IQR 50-85)%. Seventy-five patients had "de novo" AML. Twenty-three patients had comorbidities. Forty-three patients had an ECOG PS 1 and 28 had ECOG PS 2. Baseline median QOL-E scores were poor (≤60) in all dimensions, except for fatigue (76, IQR 52-85). EORTC QLQ-C30 confirmed that fatigue was not prevalent at diagnosis (median 33, IQR 22-56). Median baseline EORTC QLQ-C30 scores were good in all domains except for global health status (GHS, median 50, IQR 33-67). Gender, comorbidities, bone marrow blasts and secondary AML were not related to QoL. Baseline Hb levels correlated with QOL-E functional (r=0.0216, p=0.14), fatigue (r=0.256, p=0.002) and disease-specific (r=0.247, p=0.010) scores and with EORTC QLQ-C30 GHS (r=0.270, p=0.001), physical (r=0.304, p<0.0001), role (r=0.281, p=0.001), cognitive (r=0.262, p=0.003), social (r=0.229, p=0.010) functions and fatigue (r=-0.280, p=0.001), dyspnea (r=-0.287, p=0.001) and appetite loss (r=0.244, p=0.007). Age correlated with QOL-E disease specific scores (r=0.242, p=0.012). There were no changes in QOL-E scores following 1st "3+7". However, the EORTC QLQ-C30 detected deterioration in physical function from median 80, IQR 60-93, to 67, IQR 52-87 (p=0.008), in role function from median 83, IQR 67-100, to 67, IQR 33-83 (p=0.023) and in GHS from median 50, IQR 33-69, to 67, IQR 50-75 (p=0.002) and improvement in dyspnea (p=0.023). Forty patients obtained a CR. Interestingly, baseline role function was better (median 83, IQR 67-100) in cases obtaining a CR than in resistant patients (median 67, IQR 33-83, p=0.007). Patients obtaining CR experienced improvements after consolidation in median QOL-E physical scores from 56, IQR 41-72 to 63, IQR 50-84 (p=0.033), disease-specific domain scores from 59, IQR 48-67 to 74, IQR 67-85 (p=0.003) and treatment-outcome index scores from 55, IQR 32-77, to 79, IQR 41-86 (p=0.026). Median EORTC QLQ-C30 emotional function improved after consolidation therapy from 83, IQR 67-92, to 92, IQR 77-100 (p=0.015) as well as GHS from median 50, IQR 33-65 to 67, IQR 58-83 (p=0.002). Dyspnea and insomnia regressed while financial problems increased.Conclusions: Elderly patients with AML at diagnosis identified as fit for chemotherapy generally do not present fatigue, though health status is poor and is mainly correlated with Hb levels. Role function may predict response to induction chemotherapy. Patients obtaining CR perceive improvements in global health, including physical and emotional QoL and symptoms. DisclosuresOliva:Celgene: Other: Advisory Board, Speakers Bureau; Amgen: Consultancy; Novartis: Speakers Bureau.

Patients' and health professionals' understanding of and preferences for graphical presentation styles for individual-level EORTC QLQ-C30 scores.

Purpose To investigate patients’ and health professionals’ understanding of and preferences for different graphical presentation styles for individual-level EORTC QLQ-C30 scores.MethodsWe recruited cancer patients (any treatment and diagnosis) in four European countries and health professionals in the Netherlands. Using a questionnaire, we assessed objective and self-rated understanding of QLQ-C30 scores and preferences for five presentation styles (bar and line charts, with or without color coding, and a heat map).ResultsIn total, 548 patients and 227 health professionals participated. Eighty-three percent of patients and 85 % of professionals self-rated the graphs as very or quite easy to understand; this did not differ between graphical presentation styles. The mean percentage of correct answers to questions objectively assessing understanding was 59 % in patients, 78 % in medical specialists, and 74 % in other health professionals. Objective understanding did not differ between graphical formats in patients. For non-colored charts, 49.8 % of patients did not have a preference. Colored bar charts (39 %) were preferred over heat maps (20 %) and colored line charts (12 %). Medical specialists preferred heat maps (46 %) followed by non-colored bar charts (19 %), whereas these charts were equally valued by other health professionals (both 32 %).ConclusionThe substantial discrepancy between participants’ high self-rated and relatively low objective understanding of graphical presentation of PRO results highlights the need to provide sufficient guidance when presenting such results. It may be appropriate to adapt the presentation of PRO results to individual preferences. This could be facilitated when PROs are administered and presented to patients and health professionals electronically.

The Brazilian Version of the Edmonton Symptom Assessment System (ESAS) Is a Feasible, Valid and Reliable Instrument for the Measurement of Symptoms in Advanced Cancer Patients.

PurposesTo develop and validate a Portuguese version of the Edmonton Symptom Assessment System (ESAS) in Brazilian patients with advanced cancer.MethodsThe ESAS was translated and then back translated into Portuguese in accordance with international guidelines. The final version was approved by an Expert Committee after pilot testing on 24 advanced cancer patients. Subsequently, we evaluated the time to complete the assessment, the number of unanswered items, internal consistency, convergent validity, and known-group validity in a sample of 249 advanced cancer patients who completed the ESAS along with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), Hospital Anxiety and Depression Scale (HADS), and Epworth Sleepiness Scale (ESS). A total of 90 clinically stable patients were retested after 4 to 96 hours (test-retest reliability), and 80 patients answered the ESAS after 21 (±7) days to measure scale responsiveness using an anchor-based method.ResultsThe ESAS was completed in a mean time of only 2.2 minutes. The internal consistency was good (Cronbach's alpha = 0.861), and the removal of single items did not change the overall alpha value. For convergent validity, Spearman’s correlation coefficients between the ESAS symptom scores and the corresponding EORTC QLQ-C30 and ESS symptom scores ranged between 0.520 (95% CI = 0.424–0.605) and 0.814 (95% CI = 0.760–0.856), indicating moderate to strong correlations. Test-retest reliability values were considered adequate, with intraclass correlation coefficients ranging from 0.758 (95% CI = 0.627–0.843) to 0.939 (95% CI = 0.905–0.960).ConclusionsESAS is a feasible, valid and reliable multi-symptom assessment instrument for use in Brazil.

Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).

Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients. This randomized trial investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan. Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events. Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Median patient age was 50 years. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed. IP may control moderate-severe CRF in breast cancer patients. The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.

Posterior laminectomy and vertebroplasty combined with radiofrequency ablation in spinal metastases from malignant tumors

Objective: To investigate the safety and efficacy of laminectomy combined with vertebroplasty in spinal metastases from rapid-growth tumors. Methods: Clinical data of 23 patients with spinal metastases of lung cancer, who were admitted to the Cancer Hospital from July 2008 to May 2012, were retrospectively analyzed. Thirteen male and ten female patients, with an age range from 40 years to 65 years and a mean age of 51.5, were examined. All patients received posterior laminectomy to relieve spinal cord compression. Afterward, vertebroplasty combined with radiofrequency ablation was conducted, followed by the internal fixation of vertebrae (instrumental fixation). Operation time, blood loss, and bone cement leakage rate were analyzed. One month before and after the operation, pain measurement was conducted using visual analog scale (VAS) and neurologic deficit (spinal cord injury) by Frankel Grade. Functional impairment was classified by Karnofsky performance status (KPS) score. Quality of life was assessed by the European Organization for Research and Treatment questionnaire (EORTC QLQ-C30). Results: The mean operation time was 163±87.36 min. Blood boss was 430±130.35 mL. Bone cement leakage rate was 21.7%. One month before and after surgery, the VAS showed statistical significance (t=25.6, P<0.01). After surgery, 78.3% of all patients exhibited functionally satisfactory Frankel Grade D or E, compared with 43.5% of patients before the operation. KPS score (80 to 100) percentage was 69.6% after surgery compared with 34.8% before surgery. One month after the operation, remission of various degrees was seen in 10 of 18 patients who had sphincteric dysfunction before surgery (55.6%). The EORTC QLQ-C30 score was 85.39±8.99 before and 52.78±15.17 after operation. The quality of life improved significantly (t=11.6, P<0.01). Conclusion: Posterior laminectomy and vertebroplasty combined with radiofrequency ablation for spinal metastases from lung cancer is safe and effective. The treatment can improve pain, function, and life quality of patients with lung cancer spinal metastases.

OC-097 An externally validated nomogram to predict the risk of bowel dysfunction following an anterior resection

Introduction Almost half of the patients undergoing an anterior resection for rectal cancer report quality of life impairment due to bowel dysfunction. The Low Anterior Resection Syndrome (LARS) score is an internationally validated patient reported outcome measure (PROM) designed to assess the severity of these symptoms. 1 The aims of this study were to (i) produce a LARS score prediction model based on the risk factors for bowel dysfunction (ii) to validate the model externally and (iii) to incorporate findings into a nomogram for use in clinical practice. Method Patients who were recurrence free and more than one-year post restorative anterior resection (UK, 2001–2011; Denmark, 2001–2007 (median 54 and 56 months since surgery respectively), were invited to complete EORTC QLQ-C30, LARS and Wexner incontinence scores. Demographics, tumour characteristics, pre/post-operative treatment, and surgical procedures were recorded. Advanced linear regression shrinkage techniques (i.e. LASSO) were used independently for both datasets (UK, DK) for an unbiased selection of the most influential factors. Finally a nomogram based on linear regression was generated. Results The model was developed from 463 British patients and validated in 938 Danes. The respective cohorts were similar in gender (females 40% [184/463] versus 43% [402/938] NS) but differed by age (65 [13] versus 64 [13], p = 0.013), pre-operative radiotherapy (31.6% [145/463] versus 20.4% [191/938], p = 0.001), tumour height (median [IQR] 9 cm [4] versus 11 [4], p = 0.001), global quality of life (mean (SD) QLQ C30 Scale, 77 (19) versus 78 (21), p = 0.001) and LARS score (mean (SD) 26.1 (11) versus 24.5 (12), p = 0.012). Tumour height (from the anal verge) and pre-operative radiotherapy were the key variables in the nomogram with several additional factors including age, gender and temporary stoma influencing the predicted LARS score. Conclusion This is the first nomogram to predict patient reported bowel dysfunction following an anterior resection. Despite differences between cohorts, with the UK tending to restore lower tumours and use more pre-operative radiotherapy, we were able to externally validate the model in a Danish population. Colorectal Surgeons and Nurse Specialists may use this predictive tool to help patients understand their risk of bowel dysfunction, it is intended to aid the consent process and highlight patients that may need additional post-operative support. Disclosure of interest None Declared. Reference Juul T, Ahlberg M, Biondo S, et al . International validation of the low anterior resection syndrome (LARS) score. Ann Surg. 2014;259(4):728–34

Abstract P5-17-03: Quality of life results from a phase 2, multicenter, single-arm study of eribulin mesylate plus trastuzumab as first-line therapy for locally recurrent or metastatic HER2+ breast cancer

Abstract Introduction: Eribulin mesylate is a nontaxane microtubule dynamics inhibitor that has showed an overall survival benefit relative to other commonly used agents in patients with ≥2 prior MBC therapies. Primary data from a phase 2 trial for first-line eribulin + trastuzumab [TRAS] in HER2+ patients with MBC showed an objective response rate of 71%, clinical benefit rate of 84.6%, disease control rate of 96.2%, PFS of 11.6 months, and tolerability similar to known profiles for these agents. Here, we present prespecified QoL, efficacy, and safety/tolerability results. Methods: Patients received eribulin mesylate 1.4 mg/m2 IV on days 1 and 8 of each 21-day cycle and initial TRAS (8 mg/kg IV/day 1), followed by 6 mg/kg on day 1 of each subsequent cycle. Response, PFS, QoL as measured by EORTC QoL assessment tool (QLQ-C30) and QLQ-BR23, and tolerability were assessed. Percentage of patients with at least ±10-point change from baseline was calculated at each visit. Time to deterioration was defined as time from first dose to worsening in QoL score that reached minimally clinically important difference (MID) (ie, 10 points in global health status [GHS] in QLQ-C30) without further improvement of at least MID; this was estimated overall and by response status. Results: At cycle 6 (n=44; completion rate=84.6% of 52 patients enrolled), more patients fell in the stable category (within +/-10 points change from baseline), except for pain (47.7% with improvement), cognitive functioning (45.5% worsening), fatigue and systemic therapy side effects (50% worsening for each), and arm symptoms (47.7% improvement) (Table). Median times to deterioration for GHS/QoL were 7.6 months overall (n=51), and 7.6 and 7.0 months for responders (n=36) and nonresponders (n=15), respectively (HR 0.73; 95% CI 0.32, 1.68; P=0.446). Mean symptom scores in EORTC QLQ-C30 were significantly correlated with corresponding AE rates for fatigue (r=0.31), nausea/vomiting (r=0.50), pain (r=0.41), dyspnea (r=0.49), insomnia (r=0.35), constipation (r=0.30), and diarrhea (0.40; P≤0.03 for all comparisons). The most common treatment-related AEs (all grade incidence ≥25%) were alopecia (88.5%), fatigue (69.2%), peripheral neuropathy (69.2%), neutropenia (59.6%), nausea (46.2%), diarrhea (32.7%), anemia (25%), constipation (25%), and decreased appetite (25%). Table. Qol EORTC QLQ-C30 Scores: Change from Baseline to Cycle 6 (n=44)Functional orCategory, n (%)Symptom ScaleImprovedStableWorsenedGHS/Qol13 (29.5)23 (52.3)8 (18.2)Physical10 (22.7)26 (59.1)8 (18.2)Role13 (29.5)20 (45.5)11 (25.0)Emotional17 (38.6)18 (40.9)9 (20.5)Cognitive6 (13.6)18 (40.9020 (45.5)Social12 (27.3)18 (40.9)14 (31.8)Fatigue14 (31.8)8 (18.2)22 (50.0)Nausea/vomiting9 (20.5)24 (54.5)11 (25.0)Pain21 (47.7)14 (31.8)9 (20.5)Dyspnea12 (27.3)19 (43.2)13 (29.5) Conclusions: Given the improvements in pain and in arm and breast symptoms, long median time to deterioration in functioning/symptom scales in this analysis, and the tumor response rates and safety profile in the primary analysis, combination eribulin/TRAS may be an acceptable treatment option for locally recurrent or HER2+ MBC and merits further study in larger clinical trials. Citation Format: Lee Schwartzberg, Sharon Wilks, Shannon Puhalla, Joyce O'Shaughnessy, Erhan Berrak, James Song, David Cox, Linda Vahdat. Quality of life results from a phase 2, multicenter, single-arm study of eribulin mesylate plus trastuzumab as first-line therapy for locally recurrent or metastatic HER2+ breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-17-03.

Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer

To assess the efficacy of inhaled ginger aromatherapy on nausea, vomiting and health-related quality of life (HRQoL) in chemotherapy breast cancer patients. Single-blind, controlled, randomized cross-over study. Patients received 5-day aromatherapy treatment using either ginger essential oil or fragrance-matched artificial placebo (ginger fragrance oil) which was instilled in a necklace in an order dictated by the treatment group sequence. Two oncology clinics in the East Coast of Peninsular Malaysia. VAS nausea score, frequency of vomiting and HRQoL profile (EORTC QLQ-C30 scores). Sixty female patients completed the study (age=47.3±9.26 years; Malay=98.3%; on highly emetogenic chemotherapy=86.7%). The VAS nausea score was significantly lower after ginger essential oil inhalation compared to placebo during acute phase (P=0.040) but not sustained for overall treatment effect (treatment effect: F=1.82, P=0.183; time effect: F=43.98, P<0.001; treatment×time effect: F=2.04; P=0.102). Similarly, there was no significant effect of aromatherapy on vomiting [F(1, 58)=0.29, P=0.594]. However, a statistically significant change from baseline for global health status (P<0.001) was detected after ginger essential oil inhalation. A clinically relevant 10 points improvement on role functioning (P=0.002) and appetite loss (P<0.001) were also documented while patients were on ginger essential oil. At present time, the evidence derived from this study is not sufficiently convincing that inhaled ginger aromatherapy is an effective complementary therapy for CINV. The findings for HRQoL were however encouraging with significant improvement in several domains.

Janus kinase-1 and Janus kinase-2 inhibitors for treating myelofibrosis.

Myelofibrosis is a bone marrow disorder characterized by excessive production of reticulin and collagen fiber deposition caused by hematological and non-hematological disorders. The prognosis of myelofibrosis is poor and treatment is mainly palliative. Janus kinase inhibitors are a novel strategy to treat people with myelofibrosis. To determine the clinical benefits and harms of Janus kinase-1 and Janus kinase-2 inhibitors for treating myelofibrosis secondary to hematological or non-hematological conditions. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library 2014, Issue 11), Ovid MEDLINE (from 1946 to 13 November 2014), EMBASE (from 1980 to 12 January 2013), and LILACS (from 1982 to 20 November 2014). We searched WHO International Clinical Trials Registry Platform and The metaRegister of Controlled Trials. We also searched for conference proceedings of the American Society of Hematology (from 2009 to October 2013), European Hematology Association (from 2009 to October 2013), American Society of Clinical Oncology (from 2009 to October 2013), and European Society of Medical Oncology (from 2009 to October 2013). We included searches in FDA, European Medicines Agency, and Epistemonikos. We handsearched the references of all identified included trials, and relevant review articles. We did not apply any language restrictions. Two review authors independently screened search results. We included randomized clinical trials comparing Janus kinase-1 and Janus kinase-2 inhibitors with placebo or other treatments. Both previously treated and treatment naive patients were included. We used the hazard ratio (HR) and 95% confidence interval (95% CI) for overall survival, progression-free survival and leukemia-free survival, risk ratio (RR) and 95% CI for reduction in spleen size and adverse events binary data, and standardized mean differences (SMD) and 95% CI for continuous data (health-related quality of life). Two review authors independently extracted data and assessed the risk of bias of included trials. Primary outcomes were overall survival, progression-free survival and adverse events. We included two trials involving 528 participants, comparing ruxolitinib with placebo or best available therapy (BAT). As the two included trials had different comparators we did not pool the data. The confidence in the results estimates of these trials was low due to the bias in their design, and their limited sample sizes that resulted in imprecise results.There is low quality evidence for the effect of ruxolitinib on survival when compared with placebo at 51 weeks of follow-up (HR 0.51, 95% CI 0.27 to 0.98) and compared with BAT at 48 weeks of follow-up (HR 0.70, 95% CI 0.20 to 2.47). Similarly there was very low quality evidence for the effect of ruxolitinib on progression free survival compared with BAT (HR 0.81, 95% CI 0.47 to 1.39).There is low quality evidence for the effect of ruxolitinib in terms of quality of life. Compared with placebo, the drug achieved a greater proportion of patients with a significant reduction of symptom scores (RR 8.82, 95% CI 4.40 to 17.69), and treated patients with ruxolitinib obtained greater MFSAF scores at the end of follow-up (MD -87.90, 95% CI -139.58 to -36.22). An additional trial showed significant differences in EORTC QLQ-C30 scores when compared ruxolitinib with best available therapy (MD 7.60, 95% CI 0.35 to 14.85).The effect of ruxolitinib on reduction in the spleen size of participants compared with placebo or BAT was uncertain (versus placebo: RR 64.58, 95% CI 9.08 to 459.56, low quality evidence; versus BAT: RR 41.78, 95% CI 2.61 to 669.75, low quality evidence).There is low quality evidence for the effect of the drug compared with placebo on anemia (RR 2.35, 95% CI 1.62 to 3.41), neutropenia (RR 3.57, 95% CI 1.02 to 12.55) and thrombocytopenia (RR 9.74, 95% CI 2.32 to 40.96). Ruxolitinib did not result in differences versus BAT in the risk of anemia (RR 1.35, 95% CI 0.91 to 1.99, low quality evidence) or thrombocytopenia (RR 1.20; 95% CI 0.44 to 3.28, low quality evidence). The risk of non-hematologic grade 3 or 4 adverse events (including fatigue, arthralgia, nausea, diarrhea, extremity pain and pyrexia) was similar when ruxolitinib was compared with placebo or BAT. The rate of neutropenia comparing ruxolitinib with standard medical treatment was not reported by the trial. Currently, there is insufficient evidence to allow any conclusions regarding the efficacy and safety of ruxolitinib for treating myelofibrosis. The findings of this Cochrane review should be interpreted with caution as they are based on trials sponsored by industry, and include a small number of patients. Unless powered randomized clinical trials provide strong evidence of a treatment effect, and the trade-off between potential benefits and harms is established, clinicians should be cautious when administering ruxolitinib for treating patients with myelofibrosis.

Impact of diabetes mellitus on quality of life in patients with breast cancer

Objective To investigate the impact of diabetes on quality of life in breast cancer patients. Methods A cross-sectional study was conducted among 3 344 community patients suffering from breast cancer during April to July 2013, in Shanghai. Data were collected using a questionnaire, which included socio-demographic situation, diagnosis, and treatment of cancer, as well as diabetes mellitus. European Organization for Research and Treatment of Cancer QOL Questionnaire-C30(EORTC QLQ-C30)Simplified Chinese Version and Functional Assessment of Cancer Therapy(FACT-G)Simplified Chinese Version were used to investigate the quality of life in the patients. The quality of life scores in breast cancer patients with and without diabetes were compared. Results The prevalence of diabetes was 14.38% in the patients with breast cancer. Breast cancer patients without diabetes reported significantly higher EORTC QLQ-C30 scores in physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning, global health, lower EORTC QLQ-C30 scores in fatigue, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and higher FACT-G scores in physical well-being, social/family well-being, emotional well-being, functional well-being, compared with the patients with diabetes(P<0.05). Conclusions Diabetes mellitus affects the quality of life in patients with breast cancer. Integrated measures for chronic disease management should be taken to improve the quality of life in patients with breast cancer as well as diabetes mellitus. (Chin J Endocrinol Metab, 2015, 31: 43-46) Key words: Diabetes; Breast cancer; Quality of life

Survival analysis of 121 patients with spinal metastases accepted spinal surgery

Objective To investigate the safety and efficacy of surgery in 121 patients with spinal metastases.Methotds A retrospective analysis of clinical data from April 2009 to March 2013 was performed in 121 patients with spinal metastases.From 37 to 65 years,69 males and 42 females with mean age of 55.6 years.Primary tumor origin:Lung 35(28.9％),Breast 26(21.4％),Renal 17 (14.0％),Prostate 20 (16.5％),Thyroid 14 (11.6％),Liver 2 (1.7％),Colon 1 (0.8％),other 6 (5.0％).All patients received surgery.Follow-up and survival time were analyzed.In preoperation and postoperative 3 month,pain levels were assessed by visual analogue scale (VAS),neurologic deficit was evaluated by Frankel Grade and functional impairment was classified by Karnofsky Score.The quality of the life was assessed by EORTC QLQ-C30 questionnaire.Survival analysis was evaluated by Kaplan-meier.Results The period of follow-up ranged from 5 to 35 months with the average of 15.9 months.The mean survival was 14.5 months.1-year survival was 53.5％.2-year survival was 36.5％.In patients with lung cancer,the mean survival was 8.5months.1-year survival was 14.3％.2-year survival was 11.4％.In patients with breast cancer,the mean survival was 31 months.1-year survival was 57.7％.2-year survival was 46.2％.In preoperation and postoperative 3 month,the VAS showed statistical significance (t=21.6,P＜0.01) ;Post-operatively,80.3％ of all patients had functionally useful Frankel Grade D or E compared with 43.5％ pre-operatively.KPS score (80-100) percentage was 75.6％ postoperatively compared with 33.4％ preoperatively.In 1month postoperatively,35 of 75 patients who were sphincteric dysfunction preoperatively were improved.The EORTC QLQ-C30score was 83.39±7.23 in preoperation and 51.34±14.27 in postoperaion.The quality of life was impoved significantly (t=12.6,P＜0.01).Conclusion Surgical treatment was effective in improving quality of life by providing better pain control,enabling patients to regain or maintain mobility,and offering improved sphincter control.In all patients,the number of patents with spinal metastases from breast and lung cancer is higher.Compared with spinal metastases from breast cancer,the proportion of lung cancer origin received surgery is higher. Key words: Spine; Neoplasm metastasis; Metastasectomy; Treatment outcome

The correlation between post-traumatic stress disorder and life quality of children and adolescents with cancer

Objective To investigate post-traumatic stress disorder (PTSD) and life quality (QOL) of children and adolescents with cancer,and analyze the correlation between PTSD and QOL and study whether PTSD would influence QOL.Methods We investigated PTSD by using the PTSD-SS,and investigated QOL by using the EORTC QLQ-C30 V3,and the data was performed by SPSS 17.0.Results The PTSD-SS total score and the scores of EORTC QLQ-C30 of function field and of whole life quality field were negatively correlated,and the PTSD-SS total score and the scores in symptom field and six single measurement of EORTC QLQ-C30 were positively correlated.Conclusions PTSD of children and adolescents with cancer was closely related with the poor functional status and the high level of symptoms problem.PTSD has affected QOL.The higher level the PTSD is,the lower level of QOL will be. Key words: Cancer; Children; Adolescent; Post-traumatic stress disorder; Life quality

Multicenter phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with first-line tyrosine kinase inhibitor (TKI) therapy.

455 Background: Everolimus has shown the efficacy and the safety in the phase III trial (RECORD-1) in patients with mRCC after failure of Vascular Endothelial Growth Factor Receptor-TKI. However, 26% of patients received two TKIs (sunitinib and sorafenib) as previous therapy in RECORD-1. In addition, as pre-treatment before TKI, 65% of patients received cytokine therapy and 13% of patients received chemotherapy. Therefore, there is still no clear evidence of everolimus as second line setting after failure of 1st-line TKI therapy. Methods: This study is an open-label, multi-center, single-arm, phase II trial. Primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, objective response rate, time-to-treatment-failure, safety and quality of life (EORTC QLQ-C30, FKSI-DRS, EQ-5D). Key eligibility criteria are RCC with clear cell component, patients who received one TKI as first line therapy, patients who did not receive cytokine and chemotherapy and ECOG performance status 0-1. Results: 57 patients were enrolled from 02/11 to 12/12. Median age was 63 years, common sites of metastasis were lung (32.7%) and bone (12.2%), 79.6% had previous nephrectomy, previous TKI therapy were sunitinib (69.4%), sorafenib (22.4%) and axitinib (8.2%). Median PFS was 4.4 months (95% confidence interval: 3.7-6.0). 8.2% had partial response and 57.1% had stable disease according to RECIST v.1.0. The incidence of adverse events (AEs) of all grades was 95.9%. Major AEs were stomatitis (49.0%), hypertriglyceridemia (26.5%) and hypercholesterolemia (24.5%). Serious AEs were stomatitis (10.2%), interstitial lung disease (6.1%) and rash (6.1%). There were no treatment related deaths. All QOL scores were not changed at 2 months, while dyspnea and global health scores of EORTC QLQ-C30 and FKSI-DRS score were worsened at 4 months. Conclusions: This study is a first report of everolimus as second line setting after failure of 1st-line TKI. Further study and long-term follow-up would be warranted. Clinical trial information: UMIN000004742.