EORTC Scales Research Articles

Norwegian general population normative data for the European Organization for Research and Treatment of Cancer questionnaires: the Quality of Life Questionnaire-Core 30, the Sexual Health Questionnaire QLQ-SHQ22 and the sexual domains of the QLQ-BR23/BR45

ObjectiveThe aim of this study was to provide sex-, age-, and morbidity-specific Norwegian general population normative values for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires QLQ-C30, the sexual health questionnaire QLQ-SHQ22 and the sexual domains of the breast modules QLQ-BR23 and QLQ-BR45. MethodsA random nationwide sample stratified by sex and age groups (18–29, 30–39, 40–49, 50–59, 60–69 and ≥70 years) was drawn from the Norwegian National Population Register. Participants were notified through national online health services (HelseNorge) and postal mail. The survey included sociodemographic background information, health-related quality of life assessed by the EORTC questionnaires, and morbidity assessed by the Self-Administered Comorbidity Questionnaire. Multivariable linear regression was carried out to estimate the associations of age, sex and morbidity with the EORTC scale and item scores. ResultsOf the 15,627 eligible individuals, 5135 (33%) responded. Women and persons with morbidities reported lower functioning and higher symptom burden than men and persons without morbidities, respectively, on nearly all EORTC scales. Sex differences were most prominent for emotional functioning, pain, fatigue and insomnia (QLQ-C30), body image, sexual functioning (QLQ-BR23/45), importance of sexual activity, libido and fatigue (QLQ-SHQ22). The score differences between persons with and without morbidity were highly significant and largest in the youngest and middle-aged groups. ConclusionThis is the first study to provide normative values for the EORTC sexual health questionnaire QLQ-SHQ22 and the sexual subscales of the QLQ-BR23 and QLQ-BR45 for all, separately in age groups by sex and morbidity.

Abstract PD3-03: Preoperative robotic radiosurgery for early breast cancer: results of the phase II ROCK trial (NCT03520894)

Abstract Introduction. Breast-conserving surgery (BCS) followed by postoperative radiotherapy (RT) still represents the standard of care for early breast cancer (BC) patients. Hypofractionated schedules in maximum 15 fractions are currently accepted as the gold standard for external beam whole and partial breast irradiation (PBI). PBI for selected early BC patients allowed a shorter overall treatment duration and an improved patient compliance as compared to old-fashioned RT schedules. Preoperative PBI, due to the advantage of treating a well-defined volume, has been gaining attention in this multidisciplinary scenario. It avoids local treatment delay and might allow tumour downstaging with increased rates of BCS and improved cosmetic outcomes. Since local recurrence might be driven by biological mechanisms of radioresistance rather than geographical miss, higher dose per fraction may overcome repair mechanisms allowing tumoral cells to escape from conventional RT damage. We report the results of the phase II ROCK trial (NCT03520894), enrolling early BC patients treated with preoperative robotic radiosurgery (prRS), in terms of acute and early late toxicity, disease control, and cosmesis. Material and methods. The study recruited between August 2018 and September 2021 at the Radiation Oncology Unit of the University of Florence (Florence, Italy). Eligible patients were women aged 50+ years, with histologically proven invasive early BC, HR+/HER2- disease, without lymph vascular invasion, tumour size up to 25 mm suitable for BCS. Exclusion criteria were clinical node positive disease, multiple foci tumours, and patients with breast lesion limiting within 5 mm from the skin surface. The study aimed to prospectively assess the safety and feasibility of a single Cyberknife® (Accuray Incorporated, Sunnyvale, CA, USA) 21Gy-fraction prRS in preoperative setting, and to identify predictive factors for outcomes based on biologic and clinical features. The primary endpoint was the acute skin toxicity (from the end of prRS to surgery) according to the RTOG and the EORTC scales. Secondary endpoints were the rate of early late skin and non-skin toxicity as measured 90 days from the end of prRS, the rate of pathological complete response (pCR) according to Chevalier score. Cosmetic outcomes were prospectively scored every 6-month using the BCCT.core software. Results. From August 2018 to September 2021, a total of 70 patients were recruited and enrolled. Of those, 41 were excluded due to tumour biology exclusion criteria and 7 due to multiple foci breast disease evidenced at basal MRI. Therefore, 22 patients were successfully treated with pRS. Median age at diagnosis was 68 years (range 50-86), median tumour size was 14 mm (range 7.5-25). Required target dosimetric parameters were met in all patients, as well as normal tissue constraints. Patients received surgery after a median time of 29 days from biopsy, without any delay or postoperative complication. Overall, three G1 adverse events (13.6%) were recorded within 7 days from prRS (1 erythema, 2 breast pain). Three events (13.6%) were recorded between 7 and 30 days from prRS, one G2 breast oedema and two G1 breast pain. No acute toxicity greater than G2 was recorded. Five patients experienced early late G1 toxicity (1 breast pain, 4 breast induration). One patient reported G2 breast induration. No early late toxicity greater than G2 was observed. At a median follow up of 18 months (range 6-29.8), cosmetic results were scored excellent/good and fair in 14 and 5 patients, respectively, while 3 patients experienced a poor cosmetic outcome. Overall, pCR after surgery was reported in 2 patients (9%). Two patients received postoperative whole breast irradiation, according to histopathological results. Conclusions. ROCK trial showed that a single 21 Gy dose prRS represents a feasible technique for selected patients affected by early BC, showing a good safety profile and a promising effectiveness. Citation Format: Icro Meattini, Giulio Francolini, Vanessa Di Cataldo, Luca Visani, Carlotta Becherini, Erika Scoccimarro, Monica Mangoni, Viola Salvestrini, Laura Masi, Chiara Bellini, Raffaela Doro, Federica Di Naro, Marco Bernini, Jacopo Nori, Lorenzo Orzalesi, Simonetta Bianchi, Lorenzo Livi. Preoperative robotic radiosurgery for early breast cancer: results of the phase II ROCK trial (NCT03520894) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD3-03.

Patient Reported Outcomes (PROs) in MC1675, De-Escalated Adjuvant Radiation Therapy (DART) vs. Standard of Care Adjuvant Radiation Therapy (SOC) for HPV Associated Oropharyngeal Squamous Cell Carcinoma

<h3>Purpose/Objective(s)</h3> We previously reported the results of a phase III clinical trial (MC1675) evaluating 30-36 Gy of adjuvant radiation therapy (RT) with weekly docetaxel (DART) vs standard of care (SOC) adjuvant (chemo)RT. Here we report patient reported outcomes (PROs) of this randomized study. <h3>Materials/Methods</h3> The DART regimen consists of transoral robotic-assisted surgery (TORS) & neck dissection for a margin negative resection. Patients (pts) with intermediate risk factors received 30 Gy/1.5 Gy b.i.d. + docetaxel 15 mg/m² days 1 & 8, while pts with extranodal extension (ENE) received a simultaneous boost to 36 Gy/1.8 Gy b.i.d. to ENE+ nodal levels. Pts randomized to SOC received 60 Gy/2.0 Gy qd +/- cisplatin. Pts completed PROs consisting of the FACT-HN, EQ5D, XEQOLS, and EORTC HN-35 post operatively (prior to adjuvant RT), immediately post RT, and at 1-, 3-, 12-, and 24-months post treatment. Mixed models with contrast statements were utilized to test the effect of treatment arm over time and their interaction by analyzing mean difference change from baseline. <h3>Results</h3> Of the 194 patients (DART: 130, SOC: 64) 189 patients completed post-op PROs, 179 immediately post RT, 175 at 1-month, 166 at 3-months, 140 at 12-months, and 74 at 24-months, with no differences in completion rate by study arm (p=.9). Compared to post-op, PROs revealed significant symptom burden post RT and improvement over time, with the DART arm having significantly fewer symptoms in multiple domains of the PROs: FACT-HN Total (p=0.004), FACT-HN Trial Outcome Index (p<0.001, <b>Table 1</b>), and XEQOLS Total Score (p<0.001). Additional significant differences (all favoring DART, all p<0.02) were the EQ5D Index Score, EORTC scales of pain, swallow, speech, social eating, social contact, sex score, dry mouth, open mouth, sticky saliva, felt ill score, and coughing score. Measures of clinically meaningful change and correlation to objective measures of modified barium swallow will be presented. <h3>Conclusion</h3> DART was associated with significantly fewer patient reported symptoms compared to SOC as evidenced by PROs across multiple domains. PROs normalized as expected over time, yet evidence of decreased symptom burden with DART compared to SOC persisted at 12 to 24 months by patient report. If deemed oncologically equivalent for lower risk patients, DART should be considered based on this superiority in PROs and previously reported objective swallowing measures.

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, acquired, hematologic, life-threatening disease characterized by thrombosis, impaired bone marrow function, and complement-mediated hemolysis. The PEGASUS phase III clinical trial demonstrated superiority of pegcetacoplan over eculizumab regarding improvements in hemoglobin levels in patients with suboptimal response to prior eculizumab treatment. The objective of this post hoc analysis was to compare the patient-reported outcome (PRO) response rates observed among PEGASUS participants and the relationships between their PRO scores with clinical and hematological parameters. Data from the 16-week randomized, controlled (1:1 to pegcetacoplan or eculizumab) period of the PEGASUS trial included comparisons of weekly PRO measurements taken using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) scales. A clinically meaningful FACIT-F response was defined as an increase from baseline of ≥5 points. Convergent validity was assessed using conventional threshold correlations between FACIT-F, EORTC QLQ-C30, and laboratory parameters. A clinically meaningful improvement in FACIT-F score was seen in 72.2% of pegcetacoplan-treated patients compared to 22.9% of eculizumab-treated patients. At week 16, the FACIT-F total score correlated with hemoglobin levels (r=0.47, p< 0.0001), absolute reticulocyte count (r=−0.37, p<0.01), and indirect bilirubin levels (r=−0.25, p<0.05). Clinically meaningful improvements in pegcetacoplan-treated patients were also observed for multiple EORTC scales. Fatigue and other self-reported outcomes were correlated with clinically meaningful improvements in clinical and hematological parameters. Clinical trial registration: NCT03500549

An Observational Study on Tolerability and Safety of Cisplatin Chemotherapy in Various Cancer

Abstract: Aim: To find out the safety and tolerability of cisplatin either given as individual therapy or in combination with other anticancer drugs or with radiotherapy. Materials and Methods: A prospective observational study was conducted in the oncology department (inpatient) of tertiary care hospital. The data was collected from the in-patient department after considering inclusion and exclusion criteria for a period of 6 months. Safety was analyzed using EORTC scales and Tolerability was assessed by collecting the laboratory data every week of the therapy. Statistical tools like Chi-square test were applied to the data by using SPSS software. Results: A total of 107 cancer patients, female patients predominated over males. Most common age group were under of 51-60 years. All the patients in our study were treated with cisplatin in combination with radiotherapy than monotherapy or in combination with other anticancer drugs. Higher incidence of tongue cancer cases were reported followed by less number of anal cancer cases. The quality of life and the functioning ability of cancer patients are calculated via EORTC scale. The QOL is highest in esophageal cancer patients and the lowest in cervical cancer patients. The social functioning of the subjects is very good in every cancer whereas the physical functioning is decreased in anal and buccal cancer patients. The cisplatin is given in the combination with radiotherapy for a total of 6 weeks. Every week after the therapy, the blood samples were collected and the toxicities are checked. Nausea and vomiting, fatigue, loss of appetite, insomnia are the side effects seen during the therapy. Few cases of Hematological toxicities like reduction in Hb count, PCV, lymphocyte count and increase in Neutrophil count were seen. By this, we can say that cisplatin is well tolerated and is safe in the chemotherapy with minimal side effects. Conclusion: Cisplatin is well tolerated in adults who are diagnosed with various cancers with minimal side effects which were controlled with supportive therapy. Whereas no serious ADRs reported in the study and no recurrence of the disease was observed. Thus, cisplatin is beneficial in the treatment of various cancers as it is safe and well tolerated. Keywords: Cisplatin, ADR, Re-occurrence, Hb, PCV, Safety and tolerability, Various cancers, EORTC scale.

Is recent FDA guidance on HRQoL clinical significance a barrier to clinician/patient treatment risk/benefit discussions: An example using EORTC scale endpoints in a randomized, phase 3 trial.

e21066 Background: Recent FDA guidance on clinical significance thresholds (CSTs) may adversely affect the evaluation of EORTC endpoints, thereby altering clinician/patient discussions about treatment (Tx) risk/benefit for emerging Tx. Specifically, FDA now rejects historic CSTs for EORTC measures (e.g., Osoba, 1998 10-point change). FDA’s guidance implies that EORTC function/symptom CSTs should be ±33.331; in addition, Tx arms must separate at the CST. Few, if any, EORTC domains are likely to achieve CSTs 3 times those of Osoba (1998). Holding health-related quality of life (HRQoL) endpoints to this standard may limit detection of clinically meaningful patient-centric Tx benefits &amp; clinician/patients dialogue about HRQoL for emerging cancer Tx. The NCI-conducted Sunitinib trial data (NCT00693992), obtained through Project DataSphere, was used to generate revised deterioration thresholds for EORTC scales under an anchor-based meaningful change approach. This this Phase 3 trial met it’s primary PFS endpoint. Evidence from this research highlights the potential implications of the FDAs position on COA-based CSTs. Methods: The Sunitinib trial was a randomized, phase 3 study comparing the efficacy &amp; safety of Sunitinib versus placebo as a maintenance therapy in non-progressing patients following chemotherapy in advanced non-small cell lung cancer. Symptoms &amp; HRQoL were measured by EORTC LC13. The analysis population consisted of 107 patients in the HRQoL substudy completing the QLQ-C30 Global Health/QoL scale (GHS). The GHS was used to categorize patients into: no change (0 pt. change), deterioration (≤-1 pt. change) &amp; improvement (≥1 pt. change). Deterioration thresholds were estimated as the mean LC13 scale change-scores &amp; visualized with empirical cumulative distribution functions (eCDFs). Results: See Table. Within this population, interpretable mean deterioration CSTs were found Dyspnea, Diarrhea, and Nausea/Vomiting. At these CSTs, Tx arms separated in eCDFs except for Dyspnea. However, while Dyspnea &amp; Diarrhea CSTs exceeded Osoba’s CSTs, none met the FDA criterion of + 33.33 points change. Conclusions: The LC13 scores had interpretable CSTs; evidence suggests FDA’s CST criterion may be unachievable for EORTC scales &amp; may thereby affect HRQoL endpoints. This research was limited by the use of the GHS as an anchor variable rather than a PGIS. The main risk is that FDA’s CST criterion may limit the characterization of truly meaningful Tx benefits for patients &amp; clinician communication with patients about HRQoL for emerging Tx. Clinical trial information: NCT00693992. [Table: see text]

Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma – Interpretation guidance derived from two randomized EORTC trials

ObjectivesA minimally important difference (MID) is the smallest difference in quality of life (QoL) perceived as relevant by patients or clinicians. MIDs aid interpretation of QOL data in research and clinical practice. We aimed to determine MIDs for the EORTC QLQ-C30 for patients with lung cancer or malignant pleural mesothelioma. Materials and MethodsData were drawn from two EORTC-sponsored randomized clinical trials (RCTs): a three-arm RCT of two cisplatin-based treatments and paclitaxel plus gemcitabine in advanced non–small-cell lung cancer, and an RCT comparing cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. MIDs for interpreting within-group change and between-group differences in change over time were computed using anchor-based approaches, for improvements and deteriorations separately. Distribution-based approaches provided corroborative evidence. ResultsThe combined data from the trials comprised 730 patients. Available data allowed us to determine 8/14 anchor-based MIDs for EORTC scales for improvements, and 9/14 MIDs for deterioration. Furthermore, we provided distribution-based estimates for all 14 QLQ-C30 scales. Most MIDs for improvements ranged between 5 and 10, for both within-group and between-group differences. Outliers were appetite loss and constipation, with MIDs up to 15 score points. MIDs were slightly larger for within-group deterioration, ranging from –5 to − 15, with the largest for Nausea/vomiting (−1 to 4) and Appetite loss (−1 to 5). MIDs for between-group differences in deterioration ranged from − 4 (Physical, Role, and Social functioning, and Global quality of life) to −9 (Nausea/vomiting, Appetite loss and Constipation). ConclusionsMIDs vary over scales and for between- versus within-group comparisons; this must be taken into account when interpreting changes. Nevertheless, the majority of MIDs range between 5 and 10 score points, in line with previously used thresholds for QLQ-C30. These findings and those from other tumor-specific MID analyses will inform a planned consensus process identifying commonalities and differences across tumor sites.

Immunonutrition hope? Oral nutritional supplement on cancer treatment

To determine the efficacy and safety of antitumoral nutritional supplement (Oncoxin® ), and to describe its mechanism of action. Scoping review according to the recommendations of the Joanna Briggs Institute included patients older than 18 years who have any kind of tumour and receive Oncoxin® as a supplement regarding the efficacy in terms of antitumoral properties, quality of life and survival, safety in terms of adverse events, and the mechanism of action. With no limit for language or setting, MEDLINE (Pubmed), EMBASE (Scopus), LILACS and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from database inception to May 2021. A promising increment of survival and quality of life in terms of Karnofsky and EORTC scales. Regarding the mechanism of action, studies suggest that it modifies inflammatory mediators' expression, as evidenced by the reduction of COX-2, IL-1β, IL-6, TNF-α, IL-1β, IL-12 and IFN-γ. Besides, it promotes an arrest in the progression of cells from G1 into S, along with an increase in p27 and a decrease in cyclin D1 and pRb. It decreases the levels of pro-inflammatory cytokines, it can also decrease cytokines with antitumor activity such as IFN-γ, which should be further explored in larger trials and the long term. Current literature shows promising complementary effects of oral supplements to the standard treatment of cancer patients in diverse scenarios. It might help patients to deal with toxicities and adverse effects related to cancer treatment and improve their nutritional or clinical profiles.

Abstract P6-13-05: Impact of olaparib versus chemotherapy on the use of strong pain medications in gBRCA-mutated HER2-negative metastatic breast cancer and associated patient reported outcomes

Abstract Background: Pain is among the most common and distressing symptoms in patients with cancer, frequently requiring treatment with strong pain medication (SPM). The use of SPM may be associated with an adverse health impact arising from SPM-mediated side effects and/or the underlying deterioration causing SPM use. Regardless of cause, delaying the need for or escalation in SPM use would be desirable. The primary aim of this post-hoc analysis was to assess the impact of olaparib on SPM use compared with chemotherapy treatment of physician’s choice (TPC) in patients with gBRCA-mutated HER2-negative metastatic breast cancer in the OlympiAD study (NCT02000622). Further exploratory analyses were performed to understand the association between SPM use and patient-reported outcomes (PRO). Methods: Data on the first use and dose increase in commonly prescribed SPMs, including opioid analgesics and anesthetics, were obtained from concomitant medication data routinely collected up to 30 days post-discontinuation of study drug in OlympiAD. The impact of study treatment on SPM use was assessed using the time from randomization to on-treatment initiation/dose increase of SPMs. The association between SPM use and PRO were assessed via a mixed-model for repeated measures analysis of EORTC QLQ-C30 data, routinely collected up to RECIST progression, with covariates for treatment, and pre- versus post-initiation or increase in SPMs. Differences in the association between SPMs and PRO, and randomized treatment were assessed via an interaction term. All analyses were performed on the full analysis set of the OlympiAD study. Results: 29.3% of olaparib patients and 30.9% of TPC patients had an on-treatment initiation/dose increase in SPMs during study follow-up. The hazard ratio of the time to on-treatment initiation/dose increase in SPMs comparing olaparib with TPC was 0.55 (95% confidence interval 0.33, 0.90; nominal P=0.0174); 77.2% in the olaparib arm and 66.2% in the TPC arm were event free at 6 months. The mean difference in PRO scores comparing post- versus pre-SPM periods across both study arms are presented in Table 1. For all but one of the EORTC scales, there was no statistical evidence of a difference in mean scores by SPM period according to randomized group. For social functioning, TPC patients experienced a -14.9 (-24.82, -5.07; P=0.0031) point change in the post- versus pre-SPM period, compared with 0.6 (-5.39, 4.22; P=0.8104) for olaparib. Table 1: Mean difference in EORTC QLQ-C30 scales (all randomized patients in OlympiAD)EORTC QLQ-C30 ScaleMean difference post vs pre-SPM (95% CIs; nominal P value)Global health status-3.7 (-8.73; 1.42; P=0.1576)Functioning (decrease equates to worsening)Physical-4.6 (-8.03; -1.08; P=0.0103)Role-7.6 (-13.25; -1.92; P=0.0088)Emotional-4.3 (-8.72; 0.14; P=0.0580)Cognitive-2.4 (-6.72; 2.01; P=0.2894)Social-7.8 (-13.28; -2.25; P=0.0059)Symptoms (increase equates to worsening)Fatigue3.9 (-1.17; 9.05; P=0.1306)Pain6.7 (1.25; 12.23; P=0.0163)Nausea/vomiting4.1 (0.56; 7.69; P=0.0233)Dyspnea4.3 (-1.28; 9.92; P=0.1300)Appetite loss6.3 (0.33; 12.36; P=0.0386)Insomnia2.2 (-3.96; 8.34; P=0.4848)Constipation4.5 (-0.54; 9.57; P=0.0796)Diarrhea-2.9 (-7.37; 1.49; P=0.1935)Financial difficulties5.7 (-0.23; 11.70; P=0.0597) Conclusions: Olaparib appears associated with a delay in the use of, or escalation in, SPM versus TPC. Across study arms, SPM use was associated with a decrement in EORTC QLQ-C30 pain score, as well as worsening in role, physical and social functioning, and symptoms of appetite loss, and nausea and vomiting. These results support the relevance of SPM as an indicator of deterioration in PRO. Further research on the impact of SPM on PRO in breast cancer is required. Citation Format: Chantal Merens, Wendy Bannister, Sven Bergner, Robert Hettle, Charles McCrea, Susan McCutcheon, Arnold Degboe. Impact of olaparib versus chemotherapy on the use of strong pain medications in gBRCA-mutated HER2-negative metastatic breast cancer and associated patient reported outcomes [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-13-05.

A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).

6006 Background: The incidence of OPSCC has risen rapidly, due to an epidemic of human papillomavirus (HPV) infection. Radiation therapy (RT) has historically been the standard treatment, but transoral robotic surgery (TORS) has surpassed RT in the US as the most common approach, based on assumptions of reduced toxicity or improved quality of life (QOL). No randomized trials have previously compared these treatments. Methods: The ORATOR trial (NCT01590355) enrolled patients with T1-T2 N0-2(≤4 cm) OPSCC amenable to TORS. We randomly assigned patients, stratified by p16 status, to RT (70 Gy/35 fractions, with chemotherapy if N1-2) vs. TORS (± adjuvant [chemo]RT based on pathology). The primary endpoint was a definitive comparison of swallowing QOL at 1-year using the MD Anderson Dysphagia Inventory (MDADI), powered to detect a 10-point improvement (a clinically-meaningful change [CMC]) in the TORS arm. Secondary endpoints included adverse events (AEs), other QOL outcomes [including EORTC scales, the Voice Handicap Index-10, Neck Dissection Impairment Index, and Patient Neurotoxicity Questionnaire], overall- and progression-free survival (OS, PFS). All analyses were pre-specified and intention-to-treat. Results: Between 2012 and 2017, 68 patients were randomized (n = 34 in each arm), in Canada and Australia. Median age was 59 years; 87% were male. Primary tumor sites were palatine tonsil (74%) or base of tongue (26%). Arms were well-balanced for baseline factors, including p16 status (88% in each arm). Median follow-up was 27 months. MDADI scores at 1-year were statistically superior in the RT arm (mean ± SD: 86.9 ± 11.4 vs. 80.1 ± 13.0 in the TORS arm; p = 0.042), but not meeting the definition of a CMC. For the other QOL metrics, outcomes were similar at 1-year. Feeding tube rates at 1-year were 3% (n = 1) vs. 0% respectively. Rates of treatment-related grade ≥2 AEs were similar (91% vs. 100%, p = 0.24), with more neutropenia, constipation and tinnitus in the RT arm and more trismus in the TORS arm (all p &lt; 0.05). There was one TORS bleeding-related death. OS and PFS were similar. Conclusions: RT had superior swallowing QOL scores at 1 year compared to TORS, but the difference was not a CMC. Toxicities differed between the arms. This study provides the first level 1 evidence to inform patients of the QOL impact of both approaches. Clinical trial information: NCT01590355.

Hypofractionated volumetric modulated arc therapy with SIB adjuvant to breast preservation surgery: retrospective experience from a Regional Cancer Centre in Eastern India

AbstractBackground:The incidence of breast cancer has surpassed cervical cancer in India and it has now become the most common cancer in women. Multiple randomised studies have reported lowα/βvalue in the range of 3–4 for breast cancer, which predict a potential radiobiological advantage for hypofractionated radiotherapy resulting in such schedules becoming standard in many centers with reduction in overall treatment time. Volumetric modulated arc therapy (VMAT) is a novel technique of delivering radiotherapy that reduces treatment delivery time, requires less monitor units (MU) and offers good conformity. The mean dose to normal tissue may be minimised using this technique although there will be inferior sparing if we consider the low-dose volume such asV5, the effect of which is not quantifiable yet.Aim:Reporting acute toxicity, cosmetic effects, and quality of life in patients of early breast cancer treated with adjuvant hypofractionated VMAT with SIB.Material and Methods:The records of 44 patients registered at the hospital between August 2014 and December 2015 were included in this analysis. Acute toxicities were analysed using CTCAE v4.03. Cosmetic outcomes were assessed using Harvard scale, while quality of life outcomes were assessed using EORTC scales and Health Related quality of life (HRQOL) questionnaires (QLQ-C30 and QLQ-BR23).Results:No grade ≥2 skin toxicities were recorded. Breast pain was recorded as Grade 1 in 13·8% patients and Grade 1 fatigue in 18·2%. The maximum haematological abnormality grade recorded was Grade 1. Cosmesis was assessed at the baseline, 6 months, 1 year and 2 years. A total of 88·6% of the patients had an Excellent or good cosmesis at the baseline, which was similar even at 6 months, at 88·7%, improved further at 1 year to 90·9%. At 6 months post radiotherapy, high functional scale QOL scores were noted.Conclusion:The technique is associated with minimum acute toxicity, good to excellent cosmesis and acceptable quality of life.

Health related quality of life for multiple myeloma patients according to treatment strategy after autologous stem cell transplant: a cross-sectional study using EORTC, EQ-5D and MY-20 scales

Maintenance (MT) may be prescribed after autologous stem cell transplant (ASCT) but there are often concerns about the impact on quality of life (QoL). QoL was compared between baseline patients (30–100 days post-ASCT and had not commenced MT); MT patients (>100 days post-ASCT and receiving MT), and no MT (>100 days post-ASCT and not receiving MT). Patients completed the EuroQoL five dimension (EQ-5D), the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30), and the QoL Questionnaire Myeloma 20 module (QLQ-MY20). Differences between groups were explored with ordinary least squares regressions. Across US and Canada, 303 patients participated. Regression analyses found few differences between MT and no MT. Only diarrhea (EORTC-QLQ C30) and future perspectives (MY-20) domains differentiated; patients on MT scored worse for diarrhea (+9.43; p = .0358) and future perspectives (−11.39; p = .0196). Collectively, the results suggest that MT is not associated with a notable QoL detriment.

P1.06-032 The Humanistic Burden of Advanced Non-Small Cell Lung Cancer Patients in Europe - A Real World Survey

Previous publications have demonstrated that advanced Non-Small Cell Lung Cancer (aNSCLC) patients have worse HRQoL compared to the general population. Few publications have focused on the impact of aNSCLC on activities of daily living and the humanistic burden incurred by different groups of aNSCLC patients in the real world setting. Data were taken from a multi-center, cross-sectional study of aNSCLC patients conducted in France, Germany and Italy. The study consisted of three components: medical chart review, patient questionnaire and caregiver questionnaire. Overall, 683 consulting patients were recruited via treating physicians. Patients’ health state was quantified using the EuroQoL-5D (EQ-5D-3L - comprising of five domains: mobility, self-care, ability to perform usual activities, pain, anxiety and depression) and the burden on HRQoL quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30 item questionnaire yielding five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Analysis was stratified by patients’ line of therapy. Statistical significance was assessed using Mann-Whitney U tests. Patients’ mean (SD) age was 65.2 (9.7), 68.8% were male and 89.0% had stage IV NSCLC. Over two-thirds (71%) of patients were receiving 1st line advanced therapy, whilst 29% were receiving later lines of therapy. Regarding histology, 74% of patients were non-squamous compared to 26% squamous. The mean EQ-5D-3L index for 2nd line or later patients was significantly lower compared to patients on 1st line treatment (0.57 vs 0.65; p=0.002). Three domains showed significant decreases: mobility, self-care and ability to perform usual activities. In terms of EORTC scores, patients on later lines of treatment experienced a lower overall global health status (QL2) compared to 1st line patients (43.8 vs 50.7; p<0.001). Significant differences were also observed in all other EORTC scales except for diarrhea. 1st line aNSCLC patients have a diminished health state in comparison to the general population (EQ-5D scores 0.65 v 0.78). In addition compared to other cancer sufferers, aNSCLC patients have a worse QoL (QLQ-C-30 QL2 score 48.8 v 61.5 for stage IIIB/IV cancer patients). The real world study shows that both health status and QoL significantly worsen with advancement to later lines of treatment. The results show a high unmet need for more effective 1st–line treatments to prevent disease progression while maintaining patient quality of life.

Percepción de la calidad de vida y satisfacción con la asistencia sanitaria recibida en un grupo de pacientes oncológicos terminales que reciben cuidados paliativos en un hospital de Zaragoza, España

Background and objectiveThe aim of this study is to determine the perceived quality of life of terminal cancer patients receiving palliative care, and the influence of health care satisfaction in the quality of life of these patients. EORTC scales were used to collect this information. Patients and methodsDescriptive cross-sectional study was conducted on 47 terminal cancer patients on palliative care in the Oncology Unit of the «Hospital Clínico Universitario Lozano Blesa», Zaragoza (Spain), during February, March and April 2014. The quality of life and the satisfaction with the health care were evaluated using the EORTC QLQ C15-PAL and EORTC INPATSAT32 questionnaires. ResultsThe participants had a mean age of 64 years, and included 57.4% males. All participants had a main support person, being their partner in 74.5% of cases. The most frequent diagnoses were lung, breast and colon cancer. Patients considered they had a good quality of life with a mean of 51.77 points, calculated with EORTC QLQ C15-PAL questionnaire. The satisfaction with health care, calculated with EORTC INPATSAT32, showed a good satisfaction with the medication and nursing care, as well as with the services and organisation, with 57.88, 57.54, and 52.2 points, respectively. In general, patients were very satisfied with the health care provided, with a mean score of 83 points. ConclusionsThe patients obtained a good quality of life, and they were very satisfied with the health care in general, although there was no relationship between the two.

Postoperative Health-Related Quality of Life of Cervical Cancer Patients - A Comparison between the Wertheim-Meigs Operation and Total Mesometrial Resection (TMMR).

Introduction: The present study compares for the first time the standard therapy for cervical cancer in FIGO-stages IB-IIB, radical hysterectomy according to the Wertheim-Meigs operation, with the newly developed, nerve-sparing surgical technique, total mesometrial resection (TMMR) with regard to postoperative, health-related quality of life. Method: In the framework of a multicentre, retrospective cohort study a total of 110 cervical cancer patients were interviewed once by means of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the cervical cancer module (EORTC QLQ-CX24). The influence of the surgical method was investigated by analysis of covariance under control of age and the time elapsed between treatment and interview. Results: An influence of the therapeutic method was demonstrated in the EORTC scales physical function (p = 0.047), role function (p = 0.016), fatigue (p = 0.028), pain (p = 0.018), shortness of breath (p = 0.034), lack of appetite (p = 0.006) and diarrhoea (p = 0.012) in favour of the 74 women treated by TMMR. With regard to cognitive, emotional and social functioning as well as cervical cancer-specific symptoms, no significant differences between the therapy groups were found. Conclusion: The findings presented in this study suggest a superiority of TMMR in comparison to the previously employed radical hysterectomy according to Wertheim-Meigs with regard to the postoperative quality of life, especially in the fields of physical activity and fatigue. This needs to be validated in the course of prospective, multicentre studies. In addition, it must be clarified as to what extent the found effects are, in particular, due to the omission of an additional radiotherapy.

Intensity-modulated radiotherapy in head and neck cancer: Results of the prospective study GORTEC 2004–03

Background and purposeIn 2003, the French Authority for Health (HAS) recommended the use of intensity modulated radiotherapy (IMRT) in prospective trial before its routine use. The Oncology and Radiotherapy Group for Head and Neck Cancer (GORTEC) proposed to evaluate prospectively acute and late toxicities, locoregional control and overall survival for patients treated for head and neck cancer (HNC) with IMRT and bilateral neck irradiation. Materials and methodsBetween 2002 and 2008, 208 patients with HNC were treated with IMRT in 8 centres. There were 38 nasopharynx, 117 oropharynx, 25 pharyngo-larynx, 24 oral cavity and 4 unknown primary (28.5% stage I–II and 71% Stage III–IV). Ninety-three patients (46%) had postoperative IMRT and 78 patients (37.5%) received concurrent chemotherapy. The doses were 70Gy to the gross tumour, 66Gy to the high-risk postoperative sites and 50Gy to the subclinical disease. Toxicities were graded according to the RTOG–EORTC scales. ResultsThe median follow-up was 25.3months (range: 0.4–72months). There were 29 local–regional failures: 24 were in-field, three were marginal and one was out-field. The two-year loco-regional control and overall survival were 86% and 86.7%, respectively. At 18months, grade ⩾2 xerostomia was 16.1%. A mean dose to the spared parotid below 28Gy led to significantly less grade ⩾2 xerostomia (8.5% vs 24%) with a relative risk of 1.2 [95% CI: 1.02–1.41, p=0.03]. Grade ⩾2 xerostomia increased by approximately 3% per Gy of mean parotid dose up to 28, Gy then 7% per Gy above 33Gy. ConclusionsIMRT for HN cancer seems to reduce late toxicities without jeopardising local control and overall survival.

Symptomatic burden in myelofibrosis (MF): Prospective international assessment in 128 MF patients.

6610 Background: The symptomatic burden in patients (pts) with myeloproliferative neoplasm myelofibrosis (MF) is significant and being evaluated as a major target of experimental therapies. We conducted an international prospective assessment of symptomatic burden in MF. Methods: Pts with MF (either primary myelofibrosis [PMF] or from antecedent polycythemia vera [PVMF] or essential thrombocythemia [ETMF]) were enrolled in Argentina, France, Italy, Puerto Rico, Spain, Sweden, Uruguay, and USA. Pts completed translated versions of Myeloproliferative Symptom Assessment Form (MPN-SAF) and EORTC-QLQ-C30. Results: Data from 128 MF pts was combined for analysis (PMF [59%], ETMF [22%], and PVMF [19%]). Age (mean 65, range 34-89) and gender (46% F) were common for this disease. Pts were an average of 5.5yrs from MF diagnosis. Many pts had anemia (58% Hob<11 g/dL), leukopenia (10% WBC<3.5 x 109/L), thrombocytopenia (28% platelets <150 x 109/L). The majority of pts were symptomatic for most symptoms surveyed (Table). 43% of pts endorsed clinically deficient QOL (MPN-SAF score >4/10). 67% of pts with deficient QOL had at least one lab abnormality. Worse QOL correlated with higher BFI score (r=0.68, p<0.001), inactivity (r=0.54, p<0.001), and concentration problems (r=0.54, p<0.001). In EORTC scales, worse QOL was associated with fatigue (r=0.57, p<0.001) and reduced physical (r=0.61, p<0.001), role (r=0.62, p<0.001), and social functioning (r=0.57, p<0.001). EORTC scores indicated symptom severity in MF was similar to metastatic cancer, particularly for decreased QOL (62 vs 56), physical functioning (75 vs 76), and fatigue (42 vs 42). Conclusions: Overall, our data indicate that MF adversely effects physical and emotional functioning and QOL. This severe profile justifies the search for MF therapies that seek to improve symptoms. Prevalence of common MF symptoms (n=128). Patient symptom Prevalence Fatigue 99% QOL 92% Inactivity 79% Abdominal discomfort 73% Early satiety 73% Insomnia 72% Concentration 70% Sad mood 69% Sexual problems 69% Night Sweats 64% Abdominal pain 62% Dizziness 60% Numbness 59% Cough 55% Bone pain 54% Itching 51% Weight loss 48% Headache 44% Fevers 25%

Health Related Quality of Life (HRQOL) in Patients Receiving Chemoimmunotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) or Fludarabine and Cyclophosphamide (FC) for First Line Therapy with Advanced Chronic Lymphocytic Leukemia (CLL).

Abstract 3438Poster Board III-326 INTRODUCTIONChemoimmunotherapies like the FCR combination have been shown to increase complete remission rates and progression-free survival in patients with CLL in comparison to chemotherapies without biologicals (Hallek et al., ASH 2008). Until now little is known on HRQOL outcome of CLL patients receiving chemoimmunotherapy. Therefore we assessed the HRQOL in patients with advanced CLL, who were randomized between FC and FCR treatment within an international randomized trial of the German CLL Study Group (GCLLSG). METHODS817 pts with good physical fitness as defined by a cumulative illness rating scale (CIRS) score of up to 6 and a creatinine clearance (cr cl) ≥ 70 ml/min were enrolled between July 2003 and March 2006. Pts were randomly assigned to receive 6 courses of either FC (N=409; F 25mg/m2 i.v. d1–3 and C 250 mg/m2 i.v. d1–3; q 28 days) or FC plus R (N=408; 375 mg/m2 i.v. d 0 at first cycle and 500 mg/m2 d1 all subsequent cycles; q 28 days). The EORTC C30 questionnaires were sent to all patients included in Germany or Austria at baseline, after 3, 6, 12 months (mo) and then in yearly follow-up (FU). In all other countries questionnaires were handed out to the patients personally on the same time points during their visits in the study center. The analysis of the questionnaires was performed according to the EORTC recommendations (Aaronson et al., 1993). The questionnaire contained a global health scale, five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain, nausea and vomiting) as well as six single items (dyspnea, appetite loss, sleep disturbances, financial impact, constipation and diarrhea). Mean score values of the EORTC scales ranged between 0 and 100. High scores in the functional scales represent good HRQOL, low scores in the symptom scales a low symptom burden. RESULTSHRQOL was evaluated in 763 (93%) of the included patients who completed at least one questionnaire (376 (49%) FC and 387 (51%) FCR treated patients). The compliance rate was significantly higher in those countries, where the questionnaire was handed out personally (96% in other countries versus 92% in Germany and Austria; P=0.013). Pts answering the baseline questionnaire and at least one further questionnaire (444; 58%) were compared to those how did not (319, 42%): pts with only one or a missing baseline questionnaire had a significantly higher CIRS score (1,7 vs 1,4; P=0.007) and more frequently leukocytopenias (24% CTC grade 3 and 4 leukocytopenias vs 13%; P< 0.001). Age, distribution of Binet stages, gender, poor prognostic factors (del(11q) or del(17p), unmutated IgVH) and treatment arms were similar distributed between both groups. There were also no differences in the rate of other toxicities or response rates. A total of 482 questionnaires were available initially, 406 at interim staging, 454 at final staging, 496 after 12 mo FU, 414 after 24 mo FU and 198 after 36 mo FU.A comparison of the two treatment arms at interim or final staging after 3 and 6 months respectively showed no significant difference between both arms with regards to the global health status, functional scales and symptom scales. Dyspnoe was scored significantly higher during FC treatment in comparison to FCR (23 versus 18; P = 0.023). At 12, 24 and 36 months of FU no significant difference between FC and FCR in all functional scales, symptom scales, single item and global health status was found. Both treatment arms showed slight improvement (defined as difference of 5-10 points) of global health status at 12 months FU in comparison to baseline (FC: 62 at baseline vs 68 at FU 12; FCR: 62 vs 70). CONCLUSIONSAlthough the FCR regimen is associated with a higher rate of cytopenias in patients' perception this increased hematological toxicity does not result in a difference in HRQOL between both treatment arms. After a median observation time of 38 mo the better efficacy of the FCR regimen with regards on response rates and progression-free survival does not yet result in an improved HRQOL. For the final evaluation of HRQOL outcome after chemoimmunotherapy a longer is FU is needed. DisclosuresEichhorst:Roche: Honoraria, Research Funding; Mundipharma: Research Funding; Hospira: Honoraria. Fischer:Roche: Travel Grand; Munipharma: Travel Grand. Fink:Roche: Travel Grand. Fingerle-Rowson:OrthoBiotech: Employment; Roche: Honoraria. Westermann:Roche: Travel Grand. Wendtner:Roche: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; BayerSchering: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Hallek:Roche: Research Funding, Speakers Bureau; Mundipharma: Research Funding, Speakers Bureau.

P02-269 A new proposed protocol to evaluate anxiety, depression and the needs of cancer patients

Aims:To examine the perceived needs by patients and radiotherapists using a modified by us version of the Camberwell Assessment of Need (CAN).Methods:We eliminated 4/22 areas of the CAN scale -ideated for psychotic patients- in order to adapt it to oncological subjects (naming it CANo). Each of the scale areas values: the existence of a specific need; the help received from care-givers; the help coming from social services; the completeness of the help received. CANo was administrated to 30 solid cancer subjects consecutively admitted in 2007 to the Radiotherapy Department of Novara Hospital (Italy), and to their respective treating radiotherapists. Patients with cognitive impairment were excluded. Patients were also administrated the following protocol: HADS (Hospital anxiety and depression scale); Paykel's list of stressful events; MBTI (Mayer-Briggs Type Indicator); EORTC QLQ-C30.Results:Anxiety and depression occurred at any level in 15/30 of cases. There was a significant correlation (Spearman coefficient: SC) between the numbers of needs on CANo scale and anxiety (SC:0.4; p=0.002) or depression (SC:0.48; p=0.006) levels. Higher scores in all functional EORTC scales corresponded to lower needs detected by CANo. Patient needs were perceived less important by patients themselves than their physicians (mean satisfied need scores: 1.87 vs. 3; unsatisfied need scores: 0.63 vs. 1.03). The staff overestimated patient physical health needs (7/30 vs 3/30), psychological distress (20/30 vs 5/30), relationship difficulties (9/30 vs 2/30), received information correctness (7/30 vs 2/30).Conclusions:The CANo scale may be useful to detect oncological patient needs and to improve the quality of care.

Self -Reported Quality of Life in users and non-users of dietary supplements in cancer

8232 Background: Hospital-based surveys suggest that cancer patients routinely use dietary supplements, which include vitamins, minerals, and herbs. We described the QoL characteristics of users of dietary supplements versus non-users. Methods: A survey of 225 adult cancer patients presenting for treatment at Cancer Treatment Centers of America at Midwestern Regional Medical Center was completed between 11/01 and 10/03. A validated instrument (McCune Questionnaire) assessed the use of 56 dietary supplements in the past month. QoL was evaluated using the EORTC QLQ-C30 questionnaire. The mean QoL scores were compared between the dietary supplement users and non-users using linear regression models controlling for tumor site. Results: Of 225 patients, 91 (40%) were males and 134 (60%) females. 136 (57%) patients had failed prior treatment while 65 (29%) were newly diagnosed. 67 (30%) had breast cancer, 40 (18%) colorectal cancer, and 32 (14%) lung cancer. 164 (73%) had used dietary supplements in the past month while 61 (27%) had not. Patients with colorectal and breast cancer had statistically significantly better QoL as compared to those with lung cancer for most EORTC scales. Mean EORTC QoL scores were significantly better among the dietary supplement users for physical and emotional function scales and fatigue, nausea, appetite loss, and constipation symptom scales after adjusting for tumor site (Table 1). Conclusions: Contrary to some of the previously published research this study found better QoL among the users of dietary supplements, as compared to non-users. The next step in this research is to prospectively evaluate the patterns of changing QoL in relation to dietary supplement use across the entire duration of cancer diagnosis and treatment. Table 1. Relationship between dietary supplement use and QoL after adjusting for tumor site No significant financial relationships to disclose.