Baseline Quality Of Life Assessments Research Articles

Prospective Longitudinal Assessment of Quality of Life After Stereotactic Ablative Radiotherapy for Oligometastases: Analysis of the Population-based SABR-5 Phase II Trial

AimsTo evaluate longitudinal patient-reported quality of life (QoL) in patients treated with stereotactic ablative radiotherapy (SABR) for oligometastases. Materials and methodsThe SABR-5 trial was a population-based single-arm phase II study of SABR to up to five sites of oligometastases, conducted in six regional cancer centres in British Columbia, Canada from 2016 to 2020. Prospective QoL was measured using treatment site-specific QoL questionnaires at pre-treatment baseline and at 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after treatment. Patients with bone metastases were assessed with the Brief Pain Inventory (BPI). Patients with liver, adrenal and abdominopelvic lymph node metastases were assessed with the Functional Assessment of Chronic Illness Therapy-Abdominal Discomfort (FACIT-AD). Patients with lung and intrathoracic lymph node metastases were assessed with the Prospective Outcomes and Support Initiative (POSI) lung questionnaire. The two one-sided test procedure was used to assess equivalence between the worst QoL score and the baseline score of individual patients. The mean QoL at all time points was used to determine the trajectory of QoL response after SABR. The proportion of patients with ‘stable’, ‘improved’ or ‘worsened’ QoL was determined for all time points based on standard minimal clinically important differences (MCID; BPI worst pain = 2, BPI functional interference score [FIS] = 0.5, FACIT-AD Trial Outcome Index [TOI] = 8, POSI = 3). ResultsAll enrolled patients with baseline QoL assessment and at least one follow-up assessment were analysed (n = 133). On equivalence testing, the patients' worst QoL scores were clinically different from baseline scores and met MCID (BPI worst pain mean difference: 1.8, 90% confidence interval 1.19 to 2.42]; BPI FIS mean difference: 1.68, 90% confidence interval 1.15 to 2.21; FACIT-AD TOI mean difference: –8.76, 90% confidence interval –11.29 to –6.24; POSI mean difference: –4.61, 90% confidence interval –6.09 to –3.14). However, the mean FIS transiently worsened at 9, 18 and 21 months but eventually returned to stable levels. The mean FACIT and POSI scores also worsened at 36 months, albeit with a limited number of responses (n = 4 and 8, respectively). Most patients reported stable QoL at all time points (range: BPI worst pain 71–82%, BPI FIS 45–78%, FACIT-AD TOI 50–100%, POSI 25–73%). Clinically significant stability, worsening and improvement were seen in 70%/13%/18% of patients at 3 months, 53%/28%/19% at 18 months and 63%/25%/13% at 36 months. ConclusionsTransient decreases in QoL that met MCID were seen between patients' worst QoL scores and baseline scores. However, most patients experienced stable QoL relative to pre-treatment levels on long-term follow-up. Further studies are needed to characterise patients at greatest risk for decreased QoL.

Prospective Longitudinal Assessment of Quality of Life after Stereotactic Ablative Radiotherapy for Oligometastases: Analysis of the Population-Based SABR-5 Phase II Trial

To evaluate longitudinal patient-reported quality of life (QoL) in patients treated with stereotactic ablative radiotherapy (SABR) for oligometastases. The SABR-5 trial was a population-based single-arm phase II study of SABR to up to 5 sites of oligometastases, conducted in 6 regional cancer centers in British Columbia from 2016 to 2020. Prospective QoL was measured using treatment site-specific QoL questionnaires at pre-treatment baseline and 3, 6, 9, 12, 15, 18, 21, 24, 30, and 36 months after treatment. Patients with bone metastases were assessed with the Brief Pain Inventory (BPI). Patients with liver, adrenal, and abdominopelvic lymph node metastases were assessed with the Functional Assessment of Chronic Illness Therapy-Abdominal Discomfort (FACIT-AD). Patients with lung and intrathoracic lymph node metastases were assessed with the Prospective Outcomes and Support Initiative (POSI) lung questionnaire. The two one-sided test procedure was used to assess equivalence between the worst QoL score and baseline score of individual patients. Mean QoL at all time points was used to determine the trajectory of QoL response after SABR. The proportion of patients with "stable," "improved," or "worsened" QoL was determined for all time points based on standard minimal clinically important differences (MCID; BPI worst pain = 2, BPI Functional Interference Score [FIS] = 0.5, FACIT-AD Trial Outcome Index [TOI] = 8, POSI = 3). All enrolled patients with baseline QoL assessment and at least 1 follow-up assessment were analyzed (n = 135). On equivalence testing, patients' worst QoL scores were clinically different from baseline scores and met MCID (BPI worst pain mean difference: 1.8, 90% CI [1.19 to 2.42]; BPI FIS mean difference: 1.68, 90% CI [1.15 to 2.21]; FACIT-AD TOI mean difference: -8.76, 90% CI [-11.29 to -6.24]; POSI mean difference: -4.61, 90% CI [-6.09 to -3.14]). However, the mean FIS transiently worsened at 9, 18 and 21 months but eventually returned to stable levels. The mean FACIT and POSI scores also worsened at 36 months, albeit with a limited number of responses (n = 4 and 8, respectively). The majority of patients reported stable QoL at all time points (range: BPI worst pain 71-82%, BPI FIS 45-78%, FACIT-AD TOI 50-100%, POSI 25-73%). Clinically significant stability, worsening, and improvement were seen in 70%/13%/18% of patients at 3 months, 53%/28%/19% at 18 months and 63%/25%/13% at 36 months. SABR in the oligometastatic setting can lead to transient decreases in QoL. However, most patients experienced stable QoL relative to pre-treatment levels on long-term follow-up. Further studies are needed to characterize patients at greatest risk for decreased QoL.

Associations between health-related fitness and quality of life in newly diagnosed breast cancer patients

Newly diagnosed breast cancer patients face substantial stress and uncertainty that may undermine their quality of life (QoL). The purpose of the present study was to examine the associations between health-related fitness (HRF) and QoL in newly diagnosed breast cancer patients from the Alberta Moving Beyond Breast Cancer Study. Newly diagnosed breast cancer patients with early-stage disease (n = 1458) were recruited between 2012 and 2019 in Edmonton and Calgary, Canada to complete baseline HRF and QoL assessments within 90days of diagnosis. HRF assessments included cardiorespiratory fitness (VO2peak treadmill test), muscular fitness (upper and lower body strength and endurance tests), and body composition (dual x-ray absorptiometry). QoL was assessed by the Medical Outcomes Study Short Form 36 (SF-36) version 2. We used logistic regression analyses to examine the associations between quartiles of HRF and poor/fair QoL (bottom 20%) after adjusting for key covariates. In multivariable analysis, the least fit groups compared to the most fit groups for relative upper body strength (OR = 3.19; 95% CI = 1.98-5.14), lean mass percentage (OR = 2.31; 95% CI = 1.37-3.89), and relative VO2peak (OR = 2.08; 95% CI = 1.21-3.57) were independently at a significantly higher risk of poor/fair physical QoL. No meaningful associations were found for mental QoL. The three main components of HRF (muscular fitness, cardiorespiratory fitness, and body composition) were independently associated with physical QoL in newly diagnosed breast cancer patients. Exercise interventions designed to improve these components of HRF may optimize physical QoL and help newly diagnosed breast cancer patients better prepare for treatments and recovery.

Comparison of Efficacy and Safety of a Combination of Tamsulosin and Mirabegron versus Tamsulosin Alone in the Management of Overactive Bladder in Males with Lower Urinary Tract Symptoms - TAME-Overactive Bladder: An Open-labeled Randomized Controlled Trial.

Overactive bladder (OAB) is a common condition in elderly men with coexisting benign prostatic enlargement (BPE), and it significantly impairs their quality of life (QoL). This study aimed to assess the safety and efficacy of adding beta-3 adrenergic receptor agonist (mirabegron 50 mg) to tamsulosin 0.4 mg for symptomatic men with BPE and OAB symptoms (OABS). It was an open-labeled randomized controlled trial. Ninety men with BPE and International Prostate Symptom Score (IPSS) of more than seven with predominant OABS were enrolled for the study. A detailed history, uroflowmetry, and baseline scores, including IPSS, OABS score (OABSS), and QoL assessment, were done for each patient. After written informed consent, patients were randomized into two groups of 45 each. Group-1 received tamsulosin 0.4 mg and placebo, and Group-2 received a combination of tamsulosin 0.4 mg plus mirabegron 50 mg once daily at bedtime. Follow-up of patients was done at 2nd, 4th, and 8th weeks. Efficacy at 8 weeks was assessed using repeat history for symptoms, uroflowmetry, IPSS, OABSS, and QoL score. After 8 weeks of therapy, collected data were compared to baseline parameters in both groups. Significant improvement with respect to OABSS (P = 0.046), IPSS (P = 0.006), and QoL (P = 0.038) was observed with combination therapy versus tamsulosin alone. There were mild adverse effects, which were self-limiting. A combination of tamsulosin with mirabegron is effective and safe in improving the OABSS, IPSS, and QoL in men with BPE who have predominant OABS.

Quality of life outcomes from the randomized trial of hyperthermic intraperitoneal chemotherapy following cytoreductive surgery for primary ovarian cancer (KOV-HIPEC-01).

ObjectiveTo investigate the health-related quality of life (HRQOL) related to hyperthermic intraperitoneal chemotherapy (HIPEC) following primary or interval cytoreductive surgery for primary ovarian cancer.MethodsBetween 2010 and 2016, a total of 184 patients were randomly assigned to receive cytoreductive surgery with HIPEC (n=92) or without HIPEC (n=92). Quality of life (QOL) assessment was evaluated at baseline (before surgery); on postoperative day 7; after the 3rd and 6th cycle of adjuvant chemotherapy; and at 3, 6, 9, and 12 months after randomization. Patient-reported QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC-QLQ-C30), ovarian cancer questionnaire modules (QLQ-OV28), and the MD Anderson Symptoms Inventory (MDASI).ResultsOf the 184 patients enrolled, 165 (83/92 in the HIPEC group and 82/92 in the control group) participated in the baseline QOL assessment. There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization.ConclusionHIPEC with cytoreductive surgery showed no statistically significant difference in HRQOL outcomes. Thus, implementation of HIPEC during either primary or interval cytoreductive surgery does not impair HRQOL.Trial RegistrationClinicalTrials.gov Identifier: NCT01091636

Feasibility and Acceptability of Digital Legacy-Making: An Innovative Story-Telling Intervention for Adults With Cancer.

This study examined the feasibility, burden and acceptability of a legacy-making intervention in adults with cancer and preliminary effects on patient quality-of-life (QOL) measures. We conducted a Stage IB pilot, intervention study. The intervention was a digital video legacy-making interview of adults with advanced cancer to create a digital video of their memories and experiences. Baseline and post-video QOL assessments included: Functional Assessment of Cancer Therapy-General (FACT-G), Patient Dignity Inventory (PDI), Hospital Anxiety and Depression Scale (HADS), and Emotional Thermometers for distress, anxiety, anger, help and depression. Participants received a final copy of the digital video for distribution to their families. Adults (n = 16) ages 38-83 years old with an advanced or life-limiting cancer diagnosis completed an intervention. Feasibility and acceptability was strong with 0% attrition. While the pilot study was not powered for quantitative significance, there were changes from baseline to post-intervention in the participants' total or subscale FACT-G scores, PDI, HADS anxiety or depression scores, and Emotional Thermometer scores. A digital video legacy-making intervention is feasible for adults with cancer without significant negative outcomes for individuals completing the study. It remains unclear whether this intervention contributes to positive quality of life outcomes.

Comparison of child report and parent-proxy report using PROMIS-25 in the chiropractic care for children

• Parents and their children perceived improvements in the child’s quality of life with chiropractic care. • The majority of parents assess the change/improvements in their child’s quality of life similarly to their children. • The number of days from baseline to comparative assessment of quality of life was identified as an important factor in the differences in perceived change in anxiety, peer-relationships, mobility, and pain interference. Baseline quality of life assessments were also identified as having a strong predictive effect on the difference in perceived change in quality of life.

Results of a phase Ib trial of encapsulated rapamycin in prostate cancer patients under active surveillance to prevent progression.

34 Background: At low doses, rapamycin inhibits cell proliferation and angiogenesis while augmenting CD8 T-cell responses, cumulatively producing an antitumor effect. Oral rapamycin is limited by variable bioavailability. Encapsulated rapamycin (eRapa) incorporates submicron rapamycin particles into a pH-sensitive polymer, improving bioavailability and allowing for consistent and lower dosing. Here, we present results of a phase Ib trial evaluating safety and treatment effects of eRapa in patients with low-grade prostate cancer (PCa). Methods: PCa patients with Gleason ≤7 (3+4) under active surveillance were enrolled in a 3+3 study with 3 dosing cohorts (0.5mg weekly, 1mg weekly, and 0.5mg daily) to determine the optimal dosing. Patients were treated for 3 months (m) and followed for 6m. Safety, labs (including PSA), pharmacokinetics, immune response, and quality of life (QOL) were assessed for each cohort. Results: 14 patients were enrolled; 3 in cohort 1, 3 in cohort 2, and 8 in cohort 3. 2 patients withdrew for non-dose limiting toxicity (DLT) (grade 1-2) adverse events (AEs) in cohort 3, leaving 6 evaluable. A single grade 3 DLT (neutropenia) occurred in cohort 3. No AEs > Grade 1 occurred in cohorts 1/2. Peak serum rapamycin concentration ([Rapa]) was 7 ng/mL after a 1 mg dose (2h after administration). Stable trough levels (2 ng/mL) were established after 48 hrs and persisted to 13wks. Central memory CD8 T cells and CD3+/CD56+ NK cells were more prevalent in cohort 3 than other cohorts at 1m (p = 0.027 and p = 0.041) and 3m (p = 0.023 and p = 0.049). There was no significant change in PSA level; no patients clinically progressed on therapy. In cohort 3, there were no differences between baseline and 3m QOL assessments but there was a suggestion of withdrawal effects at 6m. Conclusions: Treatment with low dose eRapa is safe and well-tolerated. The dose of 0.5mg daily produced stable serum [Rapa] through the duration of treatment and resulted in a positive immune impact. Further investigation with low dose and/or intermittent dosing of eRapa as a preventive agent in PCa and other indications will be required to establish clinical benefit. Clinical trial information: NCT03618355.

Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years.

Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

P2.03a-039 ABOUND.70+: Interim Quality of Life (QoL) Results of nab-Paclitaxel/Carboplatin Treatment of Elderly Patients With NSCLC: Topic: Clinical Trials

QoL data in elderly patients with NSCLC receiving chemotherapy are limited, although these assessments can help inform treatment decisions. Interim QoL outcomes from the ongoing ABOUND.70+ study are reported here. Patients aged ≥ 70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 + carboplatin AUC 6 on day 1 every 21 days or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles. The primary endpoint is the percentage of patients with grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression adverse events. QoL (an exploratory endpoint) was assessed on day 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L). This analysis included 119 patients; 88 patients (74%) completed baseline + ≥ 1 post baseline QoL assessments. The median age was 76 years (range, 70-93 years); 30% of patients were ≥ 80 years of age, 56% were male, and 99% had an ECOG PS 0-1. In general, LCSS symptom burden index and average total scores improved during cycles 1-4. The LCSS item of cough improved each cycle, with a mean change of 18.98 mm from baseline to end of cycle 4 on the visual analog scale (VAS; 95% CI, 8.42-29.54 mm). Fifty percent of patients had a clinically meaningful improvement (≥ 10 mm [VAS]) from baseline in the composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis. More than 80% of patients maintained/improved in each EQ-5D-5L dimension from baseline; complete resolution of baseline pain/discomfort, anxiety/depression, and self-care items was reported by ≥ 55% of patients (Table). Clinically meaningful improvements in several QoL dimensions were observed in elderly patients with NSCLC treated with nab-paclitaxel/carboplatin. These data support the role of nab-paclitaxel/carboplatin in this patient population. NCT02151149.

Significance of baseline and change in quality of life scores in predicting clinical outcomes in an international phase III trial of advanced pancreatic cancer: NCIC CTG PA.3

BackgroundThere is insufficient information regarding the prognostic significance of baseline and change in quality of life (QoL) scores on overall survival (OS) in advanced pancreatic cancer. MethodsQoL was assessed prospectively using the EORTC QLQ-C30 as part of the PA.3 trial of gemcitabine + erlotinib (G + E) vs. gemcitabine + placebo (G + P). Relevant variables and QoL scores at baseline and change at 8 weeks were analyzed by Cox stepwise regression to determine predictors of OS. Results222 of 285 patients (pts) treated with G + E and 220 of 284 pts treated with G + P completed baseline QoL assessments. In a multivariable Cox analysis combining all pts, better QoL physical functioning (PF) score independently predicted longer OS (HR 0.86; CI: 0.80–0.93), as did non-white race (HR 0.64; CI: 0.44–0.95), PS 0–1 (HR 0.65; CI: 0.50–0.85), locally advanced disease (HR 0.55; CI: 0.43–0.71) and G + E (HR 0.78; CI: 0.64–0.96). Improvement in physical function at week 8 also predicted for improved survival (HR 0.89; CI: 0.81–0.97 for 10 point increase in score, p = 0.02). ConclusionIn addition to clinical variables, patient reported QoL scores at baseline and change from baseline to week 8 added incremental predictive information regarding survival for advanced pancreatic cancer patients.

Patient-reported outcomes from MA.17R: A randomized trial of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.

LBA506 Background: MA.17R is a Canadian Cancer Trials Group (CCTG) led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor (AI) as adjuvant therapy for hormone-receptor positive breast cancer. The primary endpoint was disease-free survival. Quality of life (QOL) was a secondary endpoint. Methods: QOL was measured with the SF-36 (2 summary scores and 8 domains) and menopause-specific QOL (MENQOL) (4 symptom domains) at baseline and every 12 months (mo) up to 60 mo. QOL assessment was mandatory for CCTG centres but optional to centres in other groups. Mean change scores from baseline were calculated at 12 and 36 mo. Between-arm differences were assessed with the Wilcoxon test. Results: 1918 patients were randomized and 1428 patients completed the baseline QOL assessment. Compliance with QOL measures was over 85%. Baseline summary scores for SF-36 physical (PCS, 47.5 for letrozole and 47.9 for placebo) and mental (MCS, 55.5 for letrozole and 54.8 for placebo) were close to population norms (50). No differences were seen between groups in mean change scores for the SF-36 PCS and MCS and the other 8 QOL domains. Patients randomized to letrozole reported worse vasomotor symptoms (12 mo p = 0.02, 36 mo p = 0.03) and worse sexual functioning (12 mo p = 0.01, 36 mo p = 0.01). Further analyses with follow up to 60 months will be presented. Conclusions: No differences were seen in overall QOL measured by the SF 36 summary measures between letrozole and placebo groups. Differences existed for vasomotor symptoms and sexual functioning which were worse in the letrozole group and attributed to improvements in mean scores seen for women randomized to placebo. The data indicate that continuation of AI therapy after 5 years prior treatment is not associated with a deterioration of overall QOL. Treatment related vasomotor and sexual functioning alterations occur with ongoing treatment. Clinical trial information: NCT00754845.

Baseline Patient-Reported Quality-of-Life Is Not Related to Overall Survival in Patients Receiving Stereotactic Body Radiation Therapy for Thoracic Malignancies: A Preliminary Report

(NSQ) histology and have expanded to include oral targeted therapies. This study examines oral and infused SATx by line of therapy (LOT) and histology in a more recent population-based cohort. Materials/Methods: Patients aged 66 who had Medicare Parts A/B/D fee-for-service insurance coverage and were diagnosed with stage IIIB/IV NSCLC in 2007-9 were identified in the United States SEER-Medicare data and classified as squamous (SQ), NSQ, or unclassified histology (not otherwise specified [NOS]). We examined patients’ demographic and clinical characteristics, patterns of SATx (chemotherapy, tyrosine kinase inhibitors, and monoclonal antibodies), and the relationship of SATx to histology. Results: Of 7080 eligible patients, 26% had SQ, 51% had NSQ, and 24% had NOS histology; 28% were stage IIIB and 72% stage IV. Overall, 44% of all patients received at least first-line (1L) SATx (NSQ 46%, SQ 41%, NOS 43%; PZ.0013 across all categories and PZ.0006 for NSQ vs SQ). Only 19% of all patients received secondline (2L) SATx (NSQ 21%, SQ 16%, NOS 18%; P<.0001 across all categories and for NSQ vs SQ); expressed as a proportion of patients who received 1L, 43% received 2L (NSQ 45%, SQ 37%, NOS 42%; PZ.0014 across all categories and PZ.0003 for NSQ vs SQ). Eight percent of all patients received a third-line (3L) of SATx (NSQ 9%, SQ 6%, NOS 7%; PZ.0019 across all categories and PZ.0016 for NSQ vs SQ); expressed as a proportion of patients who received 2L, 40% received 3L (NSQ 41%, SQ 40%, NOS 38%; PZ.51 across all categories and PZ.73 for NSQ vs SQ). SATx was variable, with 48, 67, and 64 distinct regimens observed in 1L, 2L, and 3L, respectively. Carboplatin-paclitaxel (33%) and erlotinib (14%) were the most common 1L regimens; pemetrexed (2LZ20%; 3LZ21%) and erlotinib (2LZ17%; 3LZ20%) were the most common SATxs in 2L and 3L. Conclusions: Despite recent innovations in SATx for adv NSCLC, more than half of patients do not receive 1L SATx, with progressively fewer receiving 2L and 3L. SQ patients are less likely than NSQ patients to receive SATx across all lines, possibly related to fewer options for SQ patients. Author Disclosure: L.S. Orsini: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. B. Korytowsky: A. Employee; BristolMyers Squibb. M. Stock; Bristol-Myers Squibb. A. Petrilla: A. Employee; IMS Health. J.P. Wisnivesky: E. Research Grant; GlaxoSmithKline, Aventis. F. Honoraria; IMS Health, Merck. G. Consultant; EHE International. C. Craver: E. Research Grant; University of North Carolina at Charlotte. M. Salvati: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb. D. Hines: None. P.Z. Donga: A. Employee; IMS Health. C. Blanchette: None. R.L. Wade: E. Research Grant; BristolMyers Squibb. J.R. Penrod: A. Employee; Bristol-Myers Squibb. M. Stock; Bristol-Myers Squibb.

Significance of baseline quality of life scores in predicting clinical outcomes in an international phase III trial of advanced pancreatic cancer: NCIC CTG PA.3.

4053 Background: There is insufficient information regarding the prognostic significance of baseline Quality of life (QoL) scores on overall survival (OS) and adverse events (AEs) in advanced pancreatic cancer. Methods: QoL was assessed prospectively using the EORTC QLQ-C30 and AEs were graded using the NCI Common Toxicity Criteria version 2.0 as part of the PA.3 trial of gemcitabine + erlotinib (G+E) vs. gemcitabine + placebo (G+P). Relevant clinical variables, ECOG performance status (PS), and QoL scores at baseline were analyzed by Cox stepwise regression to determine predictors of OS and AEs. QoL scores were transformed by square root. Results: 222 of 285 patients (pts) (78%) treated with G+E and 220 of 284 pts (77%) treated with G+P completed baseline QoL assessments. In a multivariate Cox analysis (MVA) combining all pts, better QoL physical function (PF) score independently and incrementally predicted longer OS (HR 0.91; CI: 0.83-1.00), as did non-white race (HR 0.62; CI: 0.42-0.91), PS 0-1 (vs. PS 2 - HR 0.64; CI: 0.49-0.84), locally advanced pancreatic cancer (LAPC) (vs. metastatic - HR 0.54; CI: 0.42-0.69) and G+E (vs. G+P - HR 0.79; CI: 0.64-0.98). More financial difficulty (HR 0.92; CI: 0.87-0.98) and PS 0-1 (HR: 0.36; CI: 0.17-0.77) predicted a lower risk of grade 3 or higher AEs. In a MVA of pts treated with G+E, pain intensity &lt;20 (vs. ≥ 20 - HR 0.68; CI:0.52-0.88) and LAPC (HR 0.67; CI: 0.48-0.91) were associated with longer OS, while better QoL cognitive (HR 0.71; CI: 0.50-1.00), worse constipation (HR 0.89; CI: 0.81-0.98) and worse financial scores (HR 0.86; CI: 0.78-0.94), better dyspnea score (HR 0.82; CI: 0.71-0.93) and PS 0-1 (HR 0.21; CI: 0.05-0.78) predicted for lower risk of AEs. In a MVA of pts treated with G+P, better global QoL score (HR 0.91; CI:0.85-0.98) and LAPC (HR 0.57; CI: 0.40-0.82) were predictors of longer OS while no variables predicted grade 3 or higher AEs. Conclusions: In addition to clinical variables (including physician assessed PS), patient reported QoL scores added incremental predictive information regarding survival and adverse events for advanced pancreatic cancer patients treated with systemic chemotherapy.

Survival and health‐related quality of life in patients with spinal metastases originated from primary hepatocellular carcinoma

In recent years, there have been more and more clinical trails focused on patient-reported outcomes (PRO), especially in the assessment of quality of life (QOL). Previous report on QOL assessment on patients with spinal metastases from primary hepatocellular carcinoma (HCC) is rare. And there is no standard treatment for those patients. The purpose of the current study is to determine whether spinal surgery could improve QOL in HCC patients with spinal metastases and prolong their survival. We conducted a single-center, non-randomized, prospective, longitudinal study in two groups: surgery group and non-surgery group. When diagnosed, all eligible patients completed a baseline QOL assessment using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. All patients' quality of life was subsequently assessed again at another 4 time points: 1, 3, 6 and 9 months after diagnosis. From July 1, 2007 to March 31, 2009, we identified 62 patients (surgery group n = 29, non-surgery group n = 33) who were eligible for the observational study. Only 21 patients in the surgery group and 22 patients in the non-surgery group survived more than 9 months and completed all 5 follow-up QOL assessments. The median survival time was 12.6 months in the surgery group and 13.7 months in the non-surgery group (P = 0.530). The results suggested that whether in the surgery or non-surgery group, QOL scores in 9-month period after diagnosis decreased in the same mode, and surgical treatment for spinal metastases could improve neither patients' QOL nor survival. Spinal surgery could not provide benefits for patients with spinal metastases from HCC in QOL or survival. We do not recommend surgical treatment for patients with metastases from HCC to the spine.

Three, two, or one drug chemotherapy for frail or elderly patients with advanced gastroesophageal cancer (321GO): A feasibility study.

97 Background: The median age of death from gastroesophageal (GO) cancer is 77 years. Palliative chemotherapy can improve survival and quality of life. Current standard combination regimens have been developed in trials involving patients of median age under 65 years with predominantly good performance status (PS). In light of audit and survey evidence of widespread use of arbitrarily modified chemotherapy schedules in frail and elderly patients, better evidence is needed to guide treatment. Based on our experience with the MRC FOCUS trial in colorectal cancer, 321GO aimed to test the feasibility of a randomised trial comparing chemotherapy in frail and elderly patients with advanced GO cancer. Methods: Patients with advanced GO cancer considered unfit for full-dose 3-drug chemotherapy, were randomly allocated (1:1:1) to 3, 2 or 1 drug chemotherapy at 80% dose of standard regimens with EOX: epirubicin 40mg/m2 d1, oxaliplatin 104mg/m2 d1, capecitabine 500mg/m2 bd x21d, OX: oxaliplatin 104mg/m2 d1, capecitabine 500mg/m2 bd x21d or X: capecitabine 1000mg/m2 bd d1-14, then 7 day rest. The primary endpoint for feasibility required 45 patients to be recruited over 18 months. Secondary endpoints included tolerability, treatment benefit and compliance with detailed health and quality of life (QoL) assessment. Results: 55 patients were recruited over an average of 18 months for each of the six recruiting centres; 17 to EOX, 19 to OX and 18 to X. The median age was 75. 37 (66%) patients were of WHO PS 0 or 1 and 18 (33%) were of PS 2. After 6-weeks, 12 (71%), 9 (47%) and 9 (50%) patients in the EOX, OX and X arms had experienced a treatment delay, dose reduction, grade 3 toxicity or stopped treatment. Treatment benefit (no radiological progression or clinical deterioration) at 12 weeks was seen in 8 (47%), 11 (58%) and 3 (16%) patients for EOX, OX and X respectively. Compliance with baseline health and QoL assessment was 98% at baseline and 69% at 12 weeks. Conclusions: A phase III trial randomising frail or elderly patients with advanced GO cancer to alternative chemotherapy regimens is feasible. EOX was associated with greater toxicity compared with OX; X offered no improvement in tolerability over OX.

Baseline Quality of Life Assessed with the EORTC QLQ-C30 Predicts the Treatment Outcome of Patients with Diffuse Large B-Cell Lymphoma: Results of a Prospective Cohort Study

Abstract 1595 Background:The self-reported Quality of life (QoL) assessment has been widely used as an endpoint for clinical trials along with traditional endpoints of response and survival because the QoL can provide the health-related information, and it should be considered another parameter to estimate the efficacy of treatment. However, there is growing evidence that the QoL assessment can be used as a prognostic factor in cancer patients. Thus, the prognostic value of baseline QoL was reported in several different types of cancers independent of other clinical prognostic factors. Considering the performance status of patients is an important prognostic factor in lymphoma, the assessment of QoL at diagnosis might be an informative tool for predicting treatment outcome of lymphoma. However, few data exists regarding the prognostic relevance of baseline QoL in patients with lymphoma. Thus, we evaluated the prognostic impact of baseline QoL on the outcome of patients with diffuse large B-cell lymphoma (DLBCL), the most common subtype of non-Hodgkin lymphoma. Methods:The Samsung Medical Center Lymphoma Cohort Study (SMCLCS) is a prospective cohort study registering patients diagnosed with Hodgkin and non-Hodgkin lymphoma at the Samsung Medical Center (NCT00822731). All patients completed the version 3.0 of the European Organization for Research and Treatment of Cancer (EORTC) Core Questionnaire (QLQ-C30) after they provided written inform consents. Among patients registered in the SMCLCS, we analyzed the baseline QoL and clinical data of 263 patients consecutively diagnosed with DLBCL between September 2008 and February 2011. Primary CNS lymphoma was excluded, thus, all patients were treated with rituximab-CHOP. We made a prognostic model according to the scores of three items: (1) Global health status representing general health condition, (2) Functional scale representing physical function, (3) Symptom scales representing symptoms and signs. Each item was counted as one point if the score of each item was higher than 50. Thus, patients were classified as good (3 points), moderate (2 points) and poor QoL (score =0 or 1) groups. The QoL scores of patients with marginal zone B-cell lymphoma (MZL, n = 110) were used as a control. Results:The median score of Global health status was 50 (range 0–100) while the median scores of Functional and Symptom scales were 78.4 (24.1–100.0) and 79 (25.9–100.0), respectively in patients with DLBCL. These scores were significantly lower than a control group, MZL (P < 0.05). When patients were categorized into three groups, the good and moderate QoL groups accounted for 43.0% (n = 113) and 41.1% (n = 108) of patients, respectively. The proportion of poor QoL group of DLBCL was 16.0% (n = 42), and it was higher than that of MZL (2.7%). When the QoL at diagnosis was compared with other clinical factors, the poor QoL was significantly associated with poor ECOG performance status (≤ grade 2) whereas age older than 60 years was not significantly related with the poor QoL. The clinical factors representing high tumor burden such as elevated serum LDH, the number of extranodal involvement and Ann Arbor stage were significantly associated with the QoL model, thus, patients with high tumor burden showed poor QoL (P < 0.05). In consistent with this, patients with high or high-intermediate International Prognostic Index showed worse QoL scores than low or low-intermediate risk group. The frequency of treatment-related mortality was significantly higher in patients belonging to moderate and poor QoL groups than good QoL group (P < 0.05). As a result, more than 20% of the moderate or poor QoL group failed to complete the planned treatment schedule of rituximab-CHOP while only 10% of patients of the good QoL group could not finish the treatment. As a result, the overall survival of the good QoL group was significantly better than moderate and poor QoL groups (p < 0.05). This risk stratification based on the baseline QoL assessment was independently prognostic for overall survival in the multivariate analysis after controlling for International Prognostic Index. Conclusion:The baseline quality of life assessed with the EORTC QLQ-C30 is significantly associated with high tumor burden and worse overall survival of DLBCL. Thus, this prospective result suggests that the it may become a feasible prognostic factor in patients with DLBCL. Disclosures:No relevant conflicts of interest to declare.

Health-related quality of life outcomes in Scandinavian patients after radical prostatectomy or watchful waiting: a critical appraisal

Health-related quality of life outcomes in Scandinavian patients after radical prostatectomy or watchful waiting: a critical appraisal

Quality-of-life assessment in a randomized, double-blind study of sipuleucel-T in men with androgen-dependent prostate cancer.

4648 Background: Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response to prostate cancer. P-11 is a phase III study in men with prostate specific antigen (PSA) progression after radical prostatectomy. Following 3 to 4 months of androgen deprivation therapy (ADT), men were randomized 2:1 to treatment with sipuleucel-T or control. Methods: Quality of life (QoL) was assessed at baseline (following ADT and prior to randomization) and at Wks 13 and 26 after treatment. The global rating of change evaluated overall QoL (about the same, worse, or better) compared to baseline. The brief fatigue inventory (BFI) scored fatigue level (now, usual, and worst in last 24 hours) and fatigue interference with general activity for 6 activities. Fatigue scores ranged from 0 (none) to 10 (worst). The linear analogue scale (LAS) was based on self-assessment of state of health (0 to 100, with 100= “perfect health”). Missing data were not imputed. Results: 176 patients were randomized to sipuleucel-T (n=117) or control (n=59). 98% of subjects had a baseline QoL assessment, and 92% of subjects had at least 1 post-treatment assessment. As expected with ADT, in the 3 months prior to sipuleucel-T, QoL measures declined and were comparable in both arms. Following initiation of study treatment, no significant differences in QoL were observed between treatment groups (Table). Conclusions: Sipuleucel-T can be administered without negative effects on QoL in this patient population. Baseline Week 13 Week 26 Sipuleucel-T Control Sipuleucel-T Control Sipuleucel-T Control N 116 57 103-105 58-59 91-92 52-53 Global QOL Change Better NA NA 18.4% 13.8% 15.2% 11.3% Same NA NA 73.8% 82.8% 77.2% 81.1% Worse NA NA 7.8% 3.4% 7.6% 7.5% Fatigue (0-10) Worst severity Mean (SE) 2.0 (0.24) 2.2 (0.37) 1.8 (0.23) 2.2 (0.38) 1.6 (0.26) 1.6 (0.35) Average interference Mean (SE) 1.1 (0.17) 1.1 (0.24) 1.0 (0.16) 0.9 (0.20) 0.9 (0.19) 0.9 (0.21) LAS (0-100%) Mean (SE) 83.5% (1.22) 82.1% (1.62) 83.4% (1.25) 81.7% (1.71) 83.2% (1.18) 80.8% (1.91)

Quality of life after intensive care: A systematic review of the literature

To evaluate quality of life at least 12 months after discharge from the intensive care unit of adult critically ill patients, to evaluate the methodology used to assess long-term quality of life, and to give an overview of factors influencing quality of life. EMBASE-PubMed, MEDLINE (OVID), SCI/Web of Science, the Cochrane Library, Google Scholar, and personal files. Data extraction was performed independently and cross-checked by two reviewers using a predefined data extraction form. Eligible studies were published between 1999 and 2009 and assessed quality of life ≥12 months after intensive care unit discharge by means of the Medical Outcomes Study 36-Item Short Form Health Survey, the RAND 36-Item Health Survey, EuroQol-5D, and/or the Nottingham Health Profile in adult intensive care unit patients. Fifty-three articles (10 multicenters) were included, with the majority of studies performed in Europe (68%). The Medical Outcomes Study 36-Item Short Form Health Survey was used in 55%, and the EuroQol-5D, the Nottingham Health Profile, the RAND 36-Item Health Survey, or a combination was used in 21%, 9%, 8%, or 8%, respectively. A response rate of ≥80% was attained in 26 studies (49%). Critically ill patients had a lower quality of life than an age- and gender-matched population, but quality of life tended to improve over years. The worst reductions in quality of life were seen in cases of severe acute respiratory distress syndrome, prolonged mechanical ventilation, severe trauma, and severe sepsis. Study quality criteria, defined as a baseline quality of life assessment, the absence of major exclusion criteria, a description of nonresponders, and a comparison with a reference population were met in only four studies (8%). Results concerning the influence of severity of illness, comorbidity, preadmission quality of life, age, gender, or acquired complications were conflicting. Quality of life differed on diagnostic category but, overall, critically ill patients had a lower quality of life than an age- and gender-matched population. A minority of studies met the predefined methodologic quality criteria. Results concerning the influence of the patients' characteristics and illnesses on long-term quality of life were conflicting.