Mean Global Health Status Score Research Articles

Suicidal Ideation was Associated with Quality of Life Impairment of Patients with Lung Cancer: A Cross-Sectional Study in Vietnam.

This study aimed to measure the quality of life (QOL) of lung cancer patients and evaluate the relationship between QOL and suicidal ideation (SI) in a tertiary hospital in Vietnam. A cross-sectional study was conducted at Bach Mai Hospital in Hanoi, Vietnam. A total of 256 patients with lung cancer were recruited. The QOL of cancer patients was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) version 3. Multivariate Tobit regression was employed to identify associations between SI and QOL. Overall, the mean global health status score was 58.3 ± 15.8, and those with SI had significantly higher scores than those without SI. Regarding functional scales, patients with SI had significantly lower physical functioning (82.22 ± 11.42) compared to those without SI (90.58 ± 11.90) (p<0.05). Meanwhile, regarding symptom scales, scores for fatigue, nausea and vomiting, pain, insomnia, appetite loss, constipation, diarrhea, and financial difficulties among patients with SI were significantly higher than those without SI (p<0.05). In the multivariate analysis, having SI increased the role functioning score (Coef. = 9.41, 95% CI = 0.38-18.45) and diarrhea score (Coef. = 22.33, 95% CI = 2.05-42.60). This study indicated moderate QOL and perceived the lowest social functioning in lung cancer patients. SI was associated with role functioning scores and diarrhea scores. SI should be monitored and controlled regularly in this population during treatment to improve their QOL.

Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response.

Abstract PO1-05-06: Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26)

Abstract Background: Palbociclib (PAL) is a first-in-class cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) for the treatment of HR+/HER2− advanced breast cancer (ABC). In phase 3 clinical trials, PAL+ET prolonged progression-free survival and maintained health-related quality of life (HRQOL) compared with placebo+ET. However, few studies have evaluated the day-to-day effects of PAL+ET treatment on patients’ HRQOL and daily activities in a real-world setting. Here, we report the daily life of the patients treated with PAL+ET or ET alone evaluated with a mobile application and wearable device. Methods: This is a prospective, observational, multicenter study conducted in Japanese women with HR+/HER2- ABC initiating PAL+ET (Group 1) or ET alone (Group 2) in first- or second-line setting. HRQOL was assessed with the EORTC-QLQ-C30 at baseline and Day 15 of each cycle via a smartphone-based application for 6 treatment cycles (24 weeks). Physical activity (PA) data were collected via wearable device (CentrePoint Insight Watch®, ActiGraph LLC, the USA). Patients were instructed to wear the device at all-times, except of while bathing and sleeping, during the baseline period (at least 4 days prior to treatment initiation was recommended) and 6 cycles. PA metrics were averaged on a weekly basis. Patient data, including baseline characteristics, treatment, and adverse events, were collected via electronic case report forms. As primary endpoints, change in Global health status (GHS) of EORTC-QLQ-C30 and “sedentary time” from baseline were evaluated at each time point. No formal hypothesis testing or comparisons between groups was planned. Results: Ninety-nine patients were enrolled (Group 1: 78 patients, Group 2: 21 patients). Patients had a median age of 56/52 years (Group 1/Group 2); 51%/33% had visceral metastases; 86%/86% had ECOG performance status of 0; 76%/91% initiated first-line treatment; 36%/33% were fully employed. Seventy-four of 78 patients (95%) in Group 1 and 20 of 21 patients (95%) in Group 2 completed the 6-cycle observation period. Baseline mean GHS score was 60.9 and 64.3 in Group 1 and 2, respectively. The change from baseline to Cycle 6 in GHS score was 4.6 and 1.2 in Group 1 and 2, respectively, not reaching the deterioration-threshold of 8 points in either treatment group. Results for each functional subscale are summarized in Table 1. Baseline mean “sedentary time” was 580.7 and 565.1 min/day in Group 1 and 2, respectively. The change from baseline to Cycle 6 in “sedentary time” was —67.2 and —139.4 min/day in Group 1 and 2, respectively. Results of other PA metrics are summarized in Table. No new safety signals were identified. Conclusion: In this study, PAL+ET or ET alone did not have any significant adverse impact on HRQOL and PA measured by wearable devices in patients with HR+/HER2- ABC. (NCT04736576) Citation Format: Hiroko Bando, Mari Oba, Aya Ueda, Kaori Terata, Mihoko Doi, Shigenori Nagai, Masaya Hattori, Ken-Ichi Watanabe, Nobuko Tamura, Manabu Futamura, Kei Koizumi, Naoki Niikura, Tempei Miyaji, Yasuaki Muramatsu, Linghua Xu, Norikazu Masuda, Shigehira Saji. Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-05-06.

Quality of Life in Patients Undergoing Emergency Surgery for Complex Colorectal Cancer: Protocol and Piloting of the Surgical Utilization and Recovery Patterns for Advanced Stage Colorectal Cancer Study.

Introduction: Globally, cancer is the leading cause of mortality, with colorectal neoplasia ranking third in terms of incidence and mortality worldwide. Patients face disease- and treatment-specific impacts, which can significantly influence their quality of life (QoL). Aim: This study aimed to propose a protocol to measure in-hospital and long-term QoL in patients with complicated colorectal cancer (CRC). Material and Methods: multicenter prospective observational cohort study. Results: QoL is a multidimensional concept that includes criteria for physical, mental, emotional, and social functionality as perceived by the patient. Periodically evaluating QoL offers measurable and objective tools to intervene at the appropriate time to decrease the Years of Life Lost and Years Lived with Disabilities for CRC patients. However, a structured and functional system requires dedicated and common institutional effort. A pilot study using this protocol included 69 patients, 65.12+-10.92 years, M:F ratio = 56.5:43.5%. Surgical procedure was right hemicolectomy, left colectomy, transverse colectomy, sigmoidectomy, total colectomy, rectal resection, and colorectal resection with stoma (ileostomy or colostomy) in 21.7%, 11.6%, 2.9%, 11.6%, 1.4%, 23.2%, and 27.5% of the cases, respectively. The mean Global Health Status Score, Symptom Score, and Functional Score was 82.36+-18.60, 11.89+-10.27, and 86.27, 74.50-94.11, respectively. Conclusions: CRC diagnosis has major effects on patients physical and psychological status, and concentrated efforts should be made by the involved medical team and healthcare systems to improve QoL throughout the treatment pathway.

CTNI-60. TREATMENT OF RECURRENT GLIOBLASTOMA WITH APG-157 VIA EXPANDED ACCESS: PRELIMINARY RESULTS FROM SIX PATIENTS FROM A SINGLE-CENTER STUDY

Abstract INTRODUCTION Glioblastoma (GBM) is the most common primary central nervous system malignancy. There is poor long-term survival with a median survival of two years and little consensus on second line therapies after progression. APG-157 is a new class of botanical drugs developed under FDA’s Botanical Drugs Guidance. The purpose of this study is to assess the safety and effect of APG-157 on the six-month survival and quality of life (QoL) of patients with recurrent GBM. METHODS Approval was obtained from the Baylor Scott and White IRB (# 022-230, Approval number 58100462000) and under group expanded access protocol (IND 162339). Major inclusion criteria include histologically proven GBM and unequivocal tumor progression 12 weeks after completion of standard first-line therapy. APG-157 was administered either as monotherapy or in combination with temozolomide or tumor-treating fields. Adverse events were assessed at each study visit. Patient data were collected from study conception through April 25, 2023. RESULTS A total of 6 patients (3 male, 3 females) were treated (median age was 54). A median of 2 treatment cycles were administered. 2 Patients withdrew from the study voluntarily, 2 patients expired while on treatment, and 2 patients continued treatment at the time of data analysis. 47.4% (9/19) of the questionnaire time points were completed, however, we saw low QoL (EORTC-QLQ-C30 and EORTC-QLQ-BN20) with a mean global health status score of 4.5. No patient saw a significant increase in their symptoms and one patient reported a 6-point decrease in their neurological symptoms. One patient who was on monotherapy of APG-157 for two months showed stable disease by MRI evaluation. There were no reported adverse events from the study medication. CONCLUSION Future follow-up and a larger sample size are necessary to confirm the impact of APG-157 on six-month survival and QoL.

Quality of Life in Male Breast Cancer: Prospective Study of the International Male Breast Cancer Program (EORTC10085/TBCRC029/BIG2-07/NABCG).

Prospective data about quality of life (QoL) in men with breast cancer (BC) are lacking. A prospective registry (EORTC10085) of men with all BC stages, including a QoL correlative study, was performed as part of the International Male Breast Cancer Program. Questionnaires at BC diagnosis included the EORTC QLQ-C30 and BR23 (BC specific module), adapted for men. High functioning and global health/QoL scores indicate high functioning levels/high QoL; high symptom-focused measures scores indicate high symptoms/problems levels. EORTC reference data for healthy men and women with BC were used for comparisons. Of 422 men consenting to participate, 363 were evaluable. Median age was 67 years, and median time between diagnosis and survey was 1.1 months. A total of 114 men (45%) had node-positive early disease, and 28 (8%) had advanced disease. Baseline mean global health status score was 73 (SD: 21), better than in female BC reference data (62, SD: 25). Common symptoms in male BC were fatigue (22, SD: 24), insomnia (21, SD: 28), and pain (16, SD: 23), for which women's mean scores indicated more burdensome symptoms at 33 (SD: 26), 30 (SD: 32), and 29 (SD: 29). Men's mean sexual activity score was 31 (SD: 26), with less sexual activity in older patients or advanced disease. QoL and symptom burden in male BC patients appears no worse (and possibly better) than that in female patients. Future analyses on impact of treatment on symptoms and QoL over time, may support tailoring of male BC management.

Oncological and quality of life outcomes following extralevator versus standard abdominoperineal excision for rectal cancer.

INTRODUCTION There is increasing and conflicting research debating the oncological benefits of extralevator abdominoperineal excision (ELAPE) compared with standard abdominoperineal excision (SAPE). However, there is very little in the literature on the long-term effects on patients' wellbeing following the two procedures. The aim of this study was to determine the oncological outcomes and long-term quality of life (QoL) of patients at two hospitals having undergone ELAPE or SAPE. METHODS Consecutive patients with rectal cancer who underwent either ELAPE or SAPE between January 2009 and June 2015 at a single centre were analysed. Oncological outcomes were determined by histology and follow-up imaging. QoL data were obtained prospectively using the QLQ-C30 and QLQ-CR29 questionnaires. RESULTS A total of 48 patients (36 male, 12 female; 27 ELAPE, 21 SAPE) were reviewed. The mean age was 67.4 years and the median follow-up duration was 44 months (range: 6-79 months). Four patients (2 ELAPE, 2 SAPE) developed local recurrence. Rates of distant metastasis were similar (ELAPE: 11%, SAPE: 14%). There was no significant difference in mean global health status score (ELAPE: 77.3, SAPE: 65.3). Impotence was the most frequently reported problem (mean symptom scores of 89.7 and 78.8 for ELAPE and SAPE respectively). CONCLUSIONS This is the largest study with the longest follow-up period that compares QoL after ELAPE with that after SAPE. Although more radical in nature, ELAPE did not demonstrate any significant impact on QoL compared with SAPE. There was no significant difference in long-term oncological outcome between the groups. Impotence remains a significant problem for all patients and they should be well informed of this risk prior to surgery.

First Australian experience of treating localised prostate cancer patients with CyberKnife stereotactic radiotherapy: early PSA response, acute toxicity and quality of life.

IntroductionThis study is to evaluate biochemical response, acute toxicity and health‐related quality‐of‐life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT) in the first Australian CyberKnife facility.MethodsForty‐five consecutive patients with clinically localised prostate cancer were treated with SBRT using CyberKnife technology and enrolled in this study. Protocol treatment consisted of 36.25 Gy in five fractions. PSA and acute toxicity was assessed at each follow‐up visit and QOL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Global Health Status (GHS) C30 and PR25 questionnaires and the Karnofsky Performance Status (KPS). Distance of travel for treatment was recorded.ResultsThe median prostate‐specific antigen (PSA) level declined from the initial value of 6.9 ng/mL to 1.5 ng/mL at 6 months and 0.6 ng/mL at 18 months post‐treatment. Results were similar in patients who did not receive hormone therapy. Acute grade 1 gastrointestinal (GI) and genitourinary (GU) toxicities were found in 11.1% and 24.4% of patients respectively. Acute grade 2 GI and GU toxicities were found in 2.2% and 11.1% of patients respectively. There were no grade 3 and grade 4 toxicities. Mean urinary symptom score was 14.8 at baseline, 17.2 at 6 weeks and 18.3 at 6 months (P > 0.05). Mean bowel symptom score was 2.7 at baseline, 4.2 at 6 weeks and 6.3 at 6 months (P > 0.05). The mean GHS score improved from 81.3 at baseline to 82.4 at 6 weeks, and was 75.6 at 6 months (P > 0.05, not significant). Compared to baseline KPS, there was a significant mean decrease from baseline of 96.7 to 93.3 at the 6‐week follow‐up (P = 0.0043), which then recovered to 94.3 at the 6‐month follow‐up (P = 0.1387).ConclusionsEarly results show promising PSA response. Acute toxicity seemed comparable to results from conventionally fractionated radiotherapy and to international prostate SBRT studies. EORTC PR25 and C30 scores did not reveal any significant change from baseline, and although there was a decrease in KPS, the absolute decrease was small.

MA13.11 Investigating the Feasibility of Establishing a Prospective Cohort of Lung Cancer Patients Following Radiotherapy with Curative Intent

Worldwide lung cancer is the biggest cause of cancer mortality (Cancer Research UK, 2012) and is the UK’s second most commonly diagnosed malignancy (Macmillan Cancer Support, 2013). Early detection and treatment significantly improves five year survival rates but curative treatments can impact on patients’ health and wellbeing. To date little research has been conducted to establish the support needs and recovery patterns of health and wellbeing among lung cancer patients treated with curative intent radiotherapy. This limits our ability to identify those most at risk of poorer health and wellbeing outcomes and target services effectively to support patients better. This study assesses the feasibility of collecting patient reported outcomes measures (PROMs) and clinical details to understand recovery after curative intent radiotherapy treatment for lung cancer. This mixed methods study used a prospective, longitudinal cohort design. Eligible patients awaiting curative intent radiotherapy were recruited from six UK sites between October 2015 and June 2016. Questionnaires were completed before undergoing radiotherapy and 3 months later. The questionnaires included validated patient reported outcome measures, including quality of life, symptoms, social support, wellbeing and socio-demographic details. Participants’ medical details were collected by healthcare professionals (HCPs) including cancer type, stage, treatment, and comorbid conditions. Study procedures were evaluated in a qualitative process evaluation. Of 229 eligible patients, 136 consented to the study with 73% uptake of those approached. A further 13 patients provided reduced consent to collect demographic and medical information only. Preliminary results: response rates 76% at baseline and 65% at 3 months. Of baseline responders: 59% were male; the median age was 70 years; 29% lived alone; 61% were home owner-occupiers and 20% were current smokers. Baseline EORTC-QLQ-C30 results showed a mean global health status score of 56.6 and patients were most affected by dyspnea and fatigue with mean scores of 48.8 and 45.0. These are in line with expected scores based on reference data. To date 9 HCPs, 7 patients and 2 stakeholders have been interviewed as part of the process evaluation, study processes and procedures are deemed acceptable to participants. This study demonstrates it is feasible to recruit a cohort of lung cancer patients prospectively to assess wellbeing and patterns of recovery following radiotherapy. This novel approach to understanding lung cancer patients’ experiences of survival will enhance our ability to target appropriate and timely support to those most at risk of poorer health and wellbeing.

Salvage endoscopic nasopharyngectomy is superior to intensity-modulated radiation therapy for local recurrence of selected T1–T3 nasopharyngeal carcinoma – A case-matched comparison

BackgroundSalvage ENPG and IMRT are more effective treatments for rNPC than traditional 2-dimensional radiotherapy. However, compared with IMRT, the benefits of ENPG have not yet been clearly described. MethodsWe defined a resectable area in which the disease could be radically removed using ENPG and our imaging specialists selected eligible patients with tumors confined to this resectable area from a database of rNPC patients. Using propensity scores to adjust for some potential prognostic factors, a well-balanced cohort of 144 limited rNPC patients was created by matching each patient who underwent ENPG (study group) with one who underwent IMRT (control group). Morbidity, long-term oncological results, treatment-related complications, medical costs, and quality of life were compared. ResultsCompared with IMRT, ENPG was associated with a relatively good overall survival (5-year OS, 77.1% vs 55.5%, P=.003), QOL conservation (mean global health status score, 57.6 vs 29.8, P<.001), and significant decreases in post-treatment complications (12.5% vs 65.3%, P<.001), medical costs (23 645.90 vs 118 122.53 Yuan, P<.001)≈(€2371.71 vs 11,847.80, P<.001). ConclusionsSalvage ENPG may be more effective for maximizing survival and QOL benefits and minimizing treatment-related complications and medical costs for limited rNPC patients, as compared with IMRT.

Efficacy and Safety Of Three Bortezomib-Based Induction and Maintenance Regimens In Previously Untreated, Transplant-Ineligible Multiple Myeloma (MM) Patients (Pts): Final Results From The Randomized, Phase 3b, US Community-Based UPFRONT Study (NCT00507416)

Efficacy and Safety Of Three Bortezomib-Based Induction and Maintenance Regimens In Previously Untreated, Transplant-Ineligible Multiple Myeloma (MM) Patients (Pts): Final Results From The Randomized, Phase 3b, US Community-Based UPFRONT Study (NCT00507416)

Cross Sectional Assessment of Health Related Quality of Life (HRQoL) among Patients with Cancer in Malaysia

Health Related Quality of Life (HRQoL) is an important aspect in identifying cancer patients' perceptions of being diagnosed with cancer and the assessment of treatment outcomes. The present study aimedto assess the profile and predicators of HRQoL of Malaysian oncology patients. A cross sectional study adopting the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was conducted. All cancer patients attending Penang General Hospital between August-November 2011 were approached. Descriptive statistics were used to assess demographic and disease related characteristics of the patients. All analyses were performed using SPSS v 16.0. Three hundred and ninety three cancer patients met the inclusion criteria and were enrolled in the study. The mean age was 53.9 (SD±13) years. The cohort was dominated by females (n=260, 66.2%). Nearly half (n=190, 48.3%) of the participants were of Malay ethnicity, practicing Islam as their religion (n=194, 49.4%). Two hundred and ninety six (n=296, 75.3%) had beene diagnosed with cancer within six months to 3 years previously. The most common primary cancer site was breast (n=143, 36.4%). The mean Global Health Status (GHS) score was 60.7 (SD=21.3). Females (mean GHS score of 62.3, p=0.035) with Malay ethnicity (mean GHS score of 63.8, p=0.047), practicing Islam as their religion (mean GHS score of 63.0, p=0.011) had better GHS scores. Patients having medical insurance had good scores (mean 65.6, p=0.021). Marital status was significantly associated with GHS scores (p=0.022). Bone cancer patientshad the lowest mean GHS score of 49.2 (p=0.044). Patients at very advanced stages of cancer featured a low GHS mean score of 52.2 (p<0.001). The present study identified many demographic and disease related factors which may contribute to the HRQoL of cancer patients, pointing to the necessity for improved management of disease symptoms and provision of psychological and financial support.

Combination of Pseudocontinent Perineal Colostomy and Appendicostomy

Abdominal perineal resection (APR) with applied colostomy remains the standard treatment for low rectal cancer; however, to date, a very high morbidity rate has been reported. The aims of this study were to assess fecal continence, persistence of disease-related symptoms, and quality of life in patients with low rectal cancer after APR and pseudocontinent perineal colostomy and concomitant appendicostomy. We included 17 patients with low rectal cancer who underwent APR at our hospital in this cross-sectional study. Following APR, pseudocontinent perineal colostomy and concomitant appendicostomy were performed. Patients then underwent antegrade colonic enema with tap water. Patients' symptoms, fecal continence, and quality of life were evaluated at regular time intervals. After a median follow-up of 12 months, 15 of 17 patients completed the study period. All patients were able to perform an antegrade enema by themselves. Mean continence score was 7 (out of 20) based on the Wexner Scale scoring system. Mean global health status score was 78, physical function was 93, and emotional function was 88. Minor morbidity was observed in 6 patients (40%). Pseudocontinent perineal colostomy with appendicostomy provides an acceptable level of continence and functional and emotional improvement in patients with low rectal cancer undergoing APR. Hence, this combinative method could be considered as an alternative for abdominal colostomy in selected patients.

Quality of Life in Patients after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Is It Worth the Risk?

To investigate the course of health-related quality of life (HQL) over time in patients with peritoneal carcinomatosis (PC) after complete cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Prospective, single-center, nonrandomized cohort study using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Ninety patients who underwent CRS and HIPEC for PC in our institution were enrolled in the study. Mean age was 56 years (range 27-77 years) (61% female). Primary tumor was colorectal in 21%, ovarian in 19%, pseudomyxoma peritonei in 16%, an appendix tumor in 16%, gastric cancer in 10%, and peritoneal mesothelioma in 13% of cases. Mean peritoneal carcinomatosis index was 22 (range 2-39). Mean global health status score was 69±25 preoperatively and 55±20, 66±22, 66±23, 71±23, and 78±21 at months 1, 6, 12, 24, and 36, respectively. Physical and role function recovered significantly at 6 months and were close to baseline at the 24-month measurement. Emotional function starting from a low baseline recovered to baseline by month 12. Cognitive and social function had slow recovery on follow-up. Fatigue, diarrhea, dyspnea, and sleep disturbance were symptoms persistent at 6-month follow-up, improving later on in survivors. Survivors after CRS and HIPEC have postoperative quality of life similar to preoperatively, with most of the reduced elements recovering after 6-12 months. We conclude that reduced quality of life of patients after CRS and HIPEC should not be used as an argument to deny surgical therapy to these patients.

Patient-Reported Quality of Life (QoL) in Elderly, Newly Diagnosed Multiple Myeloma (MM) Patients Receiving Bortezomib-Based Combinations: Results From All Randomized Patients in the Community-Based, Phase 3b UPFRONT Study

Abstract 1864 Background: In addition to determining the efficacy and safety of different treatment options for MM, the impact of treatment and associated toxicities on patient-reported QoL should be evaluated. The US community-based phase 3b UPFRONT study compares the efficacy and safety of three bortezomib (VELCADE®, Vc)-based regimens, Vc-dexamethasone (VcD), Vc-thalidomide-dexamethasone (VcTD), and Vc-melphalan-prednisone (VcMP), followed by weekly Vc maintenance, in elderly, newly diagnosed, transplant-ineligible MM patients. Updated efficacy and safety data are reported elsewhere at this meeting; here we present patient-reported QoL results – a secondary endpoint of the trial – from all 502 randomized patients, who received up to a maximum of 13 treatment cycles. Methods: Patients with symptomatic MM were randomized (1:1:1) to receive eight 21-day cycles of VcD (Vc 1.3 mg/m2, days 1, 4, 8, 11; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [cycles 1–4]), days 1, 2, 4, 5 [cycles 5–8]), VcTD (Vc as before; T 100 mg/day, days 1–21; D as before), or VcMP (Vc as before; M 9 mg/m2, and P 60 mg/m2, days 1–4, every other cycle) induction, followed by five 35-day cycles of maintenance with Vc 1.6 mg/m2, days 1, 8, 15, 22. QoL was assessed using the EORTC QLQ-C30 questionnaire, which includes global health status, physical, role, cognitive, emotional, and social functioning, and symptom scales of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Global health status scores combine overall health and QoL scores, with higher scores reflecting better health status. Questionnaires were completed prior to dosing on day 1 of cycle 1 (baseline), prior to dosing on day 1 of every odd-numbered cycle, at the end-of-treatment visit, and every 12 weeks until progressive disease. Patient-reported QoL scores presented herein represent data collected within 1 year of randomization regardless of discontinuation status; for patients who died, missing assessments were assigned the worst possible score of 0. A linear mixed effect model was used to assess QoL changes over time, both within and between treatment arms. Sensitivity analyses were conducted to test the robustness of the primary analysis. Results: Patient baseline characteristics were well balanced across the VcD (n=168), VcTD (n=167), and VcMP (n=167) arms as reported previously (Niesvizky et al, EHA 2011). Median age was 74.5 (VcD), 73.0 (VcTD), and 72.0 (VcMP) years, and 71%, 62%, and 72% of patients had ISS stage II/III disease. QoL assessments were available at baseline and ≥1 post-baseline time point for 78% (VcD), 69% (VcTD), and 78% (VcMP) of patients. Observed data showed a downward trend in mean global health status score until cycle 7 (VcD, VcMP) or 9 (VcTD), followed by a trend to stabilizing/improving score thereafter (Figure). Symptom scores changed very little during induction in all arms, except for nausea/vomiting and diarrhea, with moderate improvements seen during maintenance. After fitting observed data with a linear mixed effect model, a significant decrease in mean global health status score from baseline to cycle 7 (induction period) was evident in all arms (VcD, p=0.0127; VcTD, p Conclusions: The observed data, linear mixed model estimates, and sensitivity analyses all show a common trend to a transient decrease in QoL during VcD, VcTD, and VcMP induction followed by a subsequent trend to improvement/stabilization in QoL during single-agent Vc maintenance. The trend to decreasing QoL seen during Vc-based induction may reflect the onset of treatment-related toxicities (particularly for VcTD, which was associated with somewhat higher toxicity rates). Post-induction improvements/stabilization in QoL may reflect the beneficial impact of achieving a response and the limited toxicity profile associated with weekly Vc maintenance. Disclosures: Niesvizky:Celgene: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Millennium Pharmaceuticals, Inc.: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Onyx: Research Funding. Flinn:Millennium Pharmaceuticals, Inc.: Research Funding. Rifkin:Onyx: Membership on an entity9s Board of Directors or advisory committees; Amgen: Speakers Bureau; Celgene: Speakers Bureau; Millennium Pharmaceuticals, Inc.: Membership on an entity9s Board of Directors or advisory committees, Speakers Bureau. Charu:Pfizer: Equity Ownership; Bristol-Myers Squibb: Equity Ownership; Roche: Research Funding; GSK: Research Funding; Celgene: Research Funding; Novartis: Honoraria, Membership on an entity9s Board of Directors or advisory committees; Amgen: Equity Ownership, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding. Neuwirth:Millennium Pharmaceuticals, Inc.: Employment. Huang:Millennium Pharmaceuticals, Inc: Employment. Choi:Millennium Pharmaceuticals, Inc.: Employment. Corzo:Millennium Pharmaceuticals, Inc.: Employment.

Quality of life assessment in patients above 60, below 50 years of age during and after curative radiotherapy in head and neck cancers

5552 Background: To evaluate the Quality of life in patients above 60 and below 50 years during and after curative radiotherapy in head and neck cancers. Methods: Head and Neck cancer patients who are to undergo curative radiotherapy (RT) were divided into two groups, 49 patients (Group A,above 60 years) and 40 patients (Group B,below 50). Quality of life assessment was done using EORTC QLQ C-30 version-2 at 4 phases;Pretreatment-Phase I,during RT-Phase II,1-month post RT-Phase III and 6 months post RT-Phase IV.Statistical analysis was done with mean scores using ’t’ test. Results: Physical functioning (PF)scores in both groups were highest in phase I (69.4;77.5, p &lt; 0.035) and lowest in phase II (40; 50, p &lt; 0.008) and the difference was statistically significant. Although PF scores declined in both groups in phase II, overall PF score remained higher in group B than in group A in all phases.Role functioning score remained low in both groups and the difference were not statistically significant at all phases. Emotional functioning score was highest in phase I (68.37; 69.15), but declined as treatment progressed, consequent to depression.The values improved over time, restored to near pretreatment values at phase IV. Cognitive functioning scores in both groups was also highest in phase I (70.07; 79.17). Social functioning of both groups declined during RT (42.52; 45)compared to pre RT values (73.47; 77.09). The mean Global Health Status score was higher in group B compared to group A at all phases, yet there was no statistical significance.The scores declined during RT (66.87 vs 35.62 &amp; 64.79 vs 34.01), improved overtime but did not reach pre RT scores.The symptom scores were all higher for elderly patients compared with younger patients at all phases, implying elderly patients experienced more symptoms, with greater experience of symptoms during RT. Conclusions: Quality of Life of elderly patients was lower compared to younger patients at phase II in terms of physical functioning, social and emotional functioning. Global Health Status score was higher for younger patients than elderly at all phases, and declined in phase II. No significant financial relationships to disclose.