Longitudinal analysis of quality of life following treatment with asunercept plus reirradiation versus reirradiation in progressive glioblastoma patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2022-2022
Author(s):  
Wolfgang Wick ◽  
Andriy Krendyukov ◽  
Klaus Junge ◽  
Thomas Höger ◽  
Claudia Kunz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Progression Free Survival ◽  
Neurological Status ◽  
Recurrent Glioblastoma ◽  
Logrank Test ◽  
Kaplan Meier ◽  
Health Related Qol ◽  
Using Data ◽  
Eortc Qlq

2022 Background: Palliation of symptoms and the maintenance of quality of life (QoL) are important goals in cancer treatment.1,2 Beyond progression free survival (PFS) and overall survival (OS), health related QoL was one of the secondary endpoints in the asunercept plus irradiation Phase II trial (NCT01071837) in recurrent glioblastoma.3 Current analysis presents time to deterioration (TtD) of QoL using data from this study. Methods: Data from patients (pts) with a baseline and ≥1 post-baseline QoL assessment were included in this analysis. TtD was defined as the time from randomization to the first deterioration in the EORTC QLQ-C15, PAL EORTC QLQ-BN20 and Medical Research Council (MRC)-Neurological status. Deterioration was defined as a decrease of ≥10 points from baseline in the QLQ-C15 PAL overall QoL and functioning scales, an increase of ≥10 points from baseline in the QLQ-C15 PAL fatigue scale and the QLQ-BN20 total sum of score, and a rating of “Worse” in the MRC-Neurological status. Pts without a deterioration were censored at the last QoL assessment. Kaplan-Meier estimates were used to describe TtD and both treatment groups compared using the logrank test. The relationship between progression of disease (PD) and QoL deterioration has been investigated. Results: Compared to reirradiation alone, treatment with asunercept + reirradiation was associated with significant improvement of TtD (P≤0.01; Table). PD was a key driver for QoL deterioration and the median TtD was comparable with PFS in favour of the asunercept treatment arm. Conclusions: Treatment with asunercept plus irradiation significantly prolongs TtD and maintains QoL, versus reirradiation alone in progressive glioblastoma patients. Clinical trial information: NCT01071837. References: 1. NCCN. Central Nervous System Cancers. Version 2018.2; 2. Stupp R et al. Ann Oncol 2014;25(S3):iii93-iii101; 3. Wick et al. Clin Cancer Res 2014;20:6304–13.[Table: see text]

scholarly journals Longitudinal analysis of quality of life following treatment with Asunercept plus reirradiation versus reirradiation in progressive glioblastoma patients

2019 ◽  
Vol 145 (3) ◽  
pp. 531-540
Author(s):  
Wolfgang Wick ◽  
Andriy Krendyukov ◽  
Klaus Junge ◽  
Thomas Höger ◽  
Harald Fricke
Keyword(s):  
Quality Of Life ◽  
Neurological Status ◽  
Recurrent Glioblastoma ◽  
Rank Test ◽  
Treatment Groups ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
The Central Nervous System ◽  
Eortc Qlq

Abstract Purpose Glioblastoma is an aggressive malignant cancer of the central nervous system, with disease progression associated with deterioration of neurocognitive function and quality of life (QoL). As such, maintenance of QoL is an important treatment goal. This analysis presents time to deterioration (TtD) of QoL in patients with recurrent glioblastoma receiving Asunercept plus reirradiation (rRT) or rRT alone. Methods Data from patients with a baseline and ≥ 1 post-baseline QoL assessment were included in this analysis. TtD was defined as the time from randomisation to the first deterioration in the EORTC QLQ-C15, PAL EORTC QLQ-BN20 and Medical Research Council (MRC)-Neurological status. Deterioration was defined as a decrease of ≥ 10 points from baseline in the QLQ-C15 PAL overall QoL and functioning scales, an increase of ≥ 10 points from baseline in the QLQ-C15 PAL fatigue scale and the QLQ-BN20 total sum of score, and a rating of “Worse” in the MRC-Neurological status. Patients without a deterioration were censored at the last QoL assessment. Kaplan–Meier estimates were used to describe TtD and treatment groups (Asunercept + rRT or rRT alone) were compared using the log-rank test. Results Treatment with Asunercept + rRT was associated with significant improvement of TtD compared with rRT alone for QLQ-CL15 PAL overall QoL and physical functioning, and MRC Neurological Status (p ≤ 0.05). In the Asunercept + rRT group, QoL was maintained beyond progresison of disease (PoD). Conclusion Treatment with Asunercept plus rRT significantly prolongs TtD and maintains QoL versus rRT alone in recurrent glioblastoma patients.

Effects of regorafenib therapy on health-related quality of life (HRQoL) in patients with metastatic colorectal cancer (mCRC) in the phase III CONCUR trial.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 697-697 ◽  
Author(s):  
Shukui Qin ◽  
Tae Won Kim ◽  
Thomas Cheung Yau ◽  
Brigette Ma ◽  
Hongming Pan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Multikinase Inhibitor ◽  
Entire Treatment Period ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Mean Time

697 Background: The CONCUR trial (NCT01584830) showed that the multikinase inhibitor regorafenib (REG) significantly improved overall survival and progression-free survival vsplacebo (PBO) in Asian patients with mCRC who had progressed on approved standard therapies. HRQoL was an exploratory endpoint. Methods: In this international multicenter trial conducted in Asia, patients were randomized 2:1 to receive REG 160 mg (n=136) or PBO (n=68) once daily for the first 3 weeks of each 4-week cycle. Prespecified QoL analyses were conducted on all 204 patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol-five dimension questionnaire (EQ-5D). HRQoL outcomes were expressed as time-adjusted area under the curve (AUC) to allow descriptive evaluations of QoL in the REG and PBO groups across the entire treatment period. Individual domains were also compared using descriptive statistics. Results: Overall, changes in HRQoL were similar in the REG and PBO groups. Difference in least-squares (LS) mean time-adjusted AUC of the EORTC QLQ-C30 global health status/QoL (GH) score: −0.40 (95% CI: −3.53 to 2.72); differences in LS mean time-adjusted AUC for EQ-5D index and visual analog scale (VAS) scores: −0.03 (95% CI: −0.08 to 0.01) and −1.18 (95% CI: −4.01 to 1.66), respectively. The PBO group had <5 patients after cycle 3, so results should be interpreted with caution. Changes from baseline scores in cycles 2 and 3 did not appear to differ between REG and PBO on the 15 domains of the EORTC QLQ-C30, the EQ-5D index, and the VAS. Conclusions: No substantial differences in overall changes in HRQoL were seen between patients treated with REG and PBO in the CONCUR trial. Clinical trial information: NCT01584830. [Table: see text]

Quality of life at baseline in the international open-label early-access program of trifluridine/tipiracil in previously treated metastatic colorectal cancer (phase IIIb).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 803-803 ◽  
Author(s):  
Alfredo Falcone ◽  
Julien Taieb ◽  
Timothy Jay Price ◽  
Jean Francois Seitz ◽  
Lucjan Wyrwicz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Open Label ◽  
Early Access ◽  
Phase Iiib ◽  
Health Related Qol ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
Ecog Ps

803 Background: Pivotal phase 3 RECOURSE trial evaluated efficacy and safety of trifluridine/tipiracil (FTD/TPI, also known TAS-102) in metastatic colorectal cancer (mCRC) without collecting quality of life (QoL) data (Mayer et al. N Engl J Med 2015;372:1909-19). We set up a phase IIIb open-label, early access program to confirm safety and to assess QoL in mCRC in real-world practice (EudraCT Number: 2016‐002311‐18). First patient (pt) was enrolled in Oct 2016; enrolment is ongoing. Methods: Eligible pts had histologically confirmed mCRC previously treated with, or not considered candidates for, available therapies. Other inclusion criteria include Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Pts planned to receive FTD/TPI (35 mg/m2 bid) orally on days 1–5 and days 8–12 of each 28-day cycle. Pts health-related QoL were measured with the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the EuroQol 5-dimension, 3-level (EQ-5D) questionnaires and visual analogue scale (VAS). For the EORTC QLQ-C30 global health status, EQ-5D utility values and VAS, scores could range to a maximum of 100 representing a better health-related QoL. EORTC QLQ-C30 and EQ-5D were considered non evaluable when responses were missing for one third or at least one of the dimensions, respectively. QoL was measured at baseline, every 4 weeks on treatment, and at treatment discontinuation. Results: A total of 298 pts from 7 countries had received at least 1 dose of treatment as of 7 March 2017. Among 271 patients, 39.5% and 60.1% had respectively ECOG PS 0 and 1 at baseline except 1 pt was enrolled with ECOG PS 2. Out of these 298 pts, 263, 261 and 258 were evaluable at baseline for EORTC QLQ-C30 global health status, EQ-5D utility values and VAS, respectively. These means were 62.4 (standard deviation [SD] 21.3), 73.6 (SD 20.3) and 66.1 (SD 19.1), respectively. Conclusions: Analysis of pt QoL in the real-world practice shows it may be substantially deteriorated in heavily pretreated pts with advanced mCRC in spite of having an ECOG PS of 0/1. Preliminary safety /efficacy and QoL results are expected in summer 2018. Clinical trial information: 2016-002311-18.

scholarly journals Current state of antiangiogenic therapy in neuro-oncology and own experience of its use in the radiosurgical treatment of recurrent glioblastoma

2021 ◽  
Vol 27 (1) ◽  
pp. 34-43
Author(s):  
Oleksandr Y. Glavatskyi ◽  
Oksana V. Zemskova ◽  
Hennadii V. Khmelnytskyi ◽  
Konstantin A. Kardash ◽  
Iryna M. Shuba ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Antiangiogenic Therapy ◽  
Intensity Modulated Radiotherapy ◽  
Main Group ◽  
Recurrent Glioblastoma ◽  
Full Blood Count ◽  
Control Group ◽  
Significant Difference ◽  
Eortc Qlq

Objective: to study the effect of antiangiogenic therapy on the quality of life and the level of headache in patients with recurrent glioblastoma who underwent radiosurgical treatment. Materials and methods. A prospective randomized single-center study carried out at the Romodanov Neurosurgery Institute of National Academy of Medical Sciences of Ukraine in 2019-2020 involving 45 patients with GB with clinical and radiological signs of disease progression and local tumor recurrence. In this regard, patients underwent radiosurgical treatment. In the main group (BEV+) 21 patients after stereotactic radiosurgery (SRS) underwent antiangiogenic therapy with Bevacizumab (BEV). In the control group (BEV–), 24 patients did not receive antiangiogenic therapy after SRS. SRS with the use of a linear accelerator «Trilogy» (6 MeV) using intensity-modulated radiotherapy (IMRT). BEV was administered intravenously, once every 3 weeks at a dose of 10 mg / kg body weight. Antiangiogenic therapy was performed under the condition of preserved liver and kidney function, values of full blood count and blood biochemistry within normal range. Global health status and headache levels were calculated according to EORTC QLQ-C30 v. 3.0 and QLQ-BN20 before and six weeks after radiosurgery in the main and control groups. Results. There was no a statistically significant difference between the studied groups of patients’ in quality of life (p = 0.707372) and in headache level (p = 0.846660) before the SRS. Six weeks after SRS, patients in the main group had a statistically significantly higher quality of life (p = 0.000015) and a lower level of headache than patients in the control group (p = 0.000035). During the observation period in patients of both groups there were no adverse events of III-IV degree of toxicity, in particular specific complications of antiangiogenic therapy (hypertension, bleeding, thromboembolism, leukopenia, proteinuria, gastrointestinal disorders, etc.). Conclusions. Antiangiogenic therapy statistically significantly improves the quality of life and reduces the level of headache in patients who underwent radiosurgical treatment for glioblastoma recurrence.

Impact on quality of life of adding cetuximab to irinotecan in patients who have failed prior oxaliplatin-based therapy: The EPIC trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4003-4003 ◽  
Author(s):  
C. Eng ◽  
J. Maurel ◽  
W. Scheithauer ◽  
L. Wong ◽  
M. Lutz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Global Health Status ◽  
Significant Difference ◽  
Eortc Qlq ◽  
The Impact

4003 Background: EPIC, a multinational phase III clinical trial examined the impact of cetuximab on survival in pretreated EGFR- expressing metastatic colorectal (MCRC) patients (pts). Pts were randomized to either cetuximab 400 mg/m2 followed by 250 mg/m2 weekly and irinotecan 350 mg/m2 q 3 weeks or irinotecan alone. The primary endpoint was overall survival (OS) with quality of life being one of the secondary endpoints. Methods: Health Related Quality of life (HRQoL) of pts in this trial was assessed through the EORTC QLQ-C30 questionnaire, version 3.0. Pts completed the questionnaire pretreatment, every second cycle, and at first follow-up visit. HRQoL was compared between treatment arms using a Wei-Lachin test. Results: Baseline demographics were balanced between the arms. Cetuximab plus irinotecan (n=648) was superior to irinotecan alone (n=650) in progression-free survival (HR 0.69, p<.0001) and response rate (16.4 vs 4.2%, p<.0001). OS was comparable between the arms, but may have been influenced by subsequent therapy: 46% of subjects in the irinotecan alone arm received cetuximab, 89% of them in combination with irinotecan. Baseline HRQoL scores did not significantly differ between treatment arms for 11 of the 15 scales. For 4 scales (Social Functioning, Fatigue, Dyspnea, and Appetite Loss), there were statistically significant differences in baseline scores, in favor of the cetuximab plus irinotecan arm. Non- compliance rates (missing questionnaires) were similar between the arms. A statistically significant difference was noted for pts in the cetuximab plus irinotecan arm in HRQoL on 10 of the 15 scales as compared to patients in the irinotecan arm, with the scores of the cetuximab plus irinotecan arm consistently higher, as noted by the scales of Global Health Status (p=.047), pain (p< .0001), and nausea (p<.0001). Conclusions: In addition to statistically significant improvements in PFS and RR in patients receiving cetuximab plus irinotecan compared with irinotecan alone, HRQoL was better preserved on the combination arm with less deterioration in symptom scores (pain, nausea, insomnia), as well as global health status scores. No significant financial relationships to disclose.

scholarly journals Measuring quality of life in people living with and beyond cancer in the UK

2021 ◽  
Author(s):  
Elisavet Moschopoulou ◽  
◽  
Jennifer Deane ◽  
Morvwen Duncan ◽  
Sharif A. Ismail ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ease Of Use ◽  
Positive Correlation ◽  
Health Related Qol ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Correlation Tests ◽  
Eortc Qlq ◽  
The Uk

Abstract Purpose The aim of this study was to identify the most appropriate measure of quality of life (QoL) for patients living with and beyond cancer. Methods One hundred eighty-two people attending cancer clinics in Central London at various stages post-treatment, completed a series of QoL measures: FACT-G, EORTC QLQ-C30 , IOCv2 (positive and negative subscales) and WEMWBS, a wellbeing measure. These measures were chosen as the commonest measures used in previous research. Correlation tests were used to assess the association between scales. Participants were also asked about pertinence and ease of completion. Results There was a significant positive correlation between the four domain scores of the two health-related QoL measures (.32 ≤ r ≤ .72, P < .001), and a significant large negative correlation between these and the negative IOCv2 subscale scores (− .39 ≤ r ≤ − .63, P < .001). There was a significant moderate positive correlation between positive IOCv2 subscale and WEMWBS scores (r = .35, P < .001). However, neither the FACT-G nor the EORTC showed any significant correlation with the positive IOCv2 subscale. Participants rated all measures similarly with regards to pertinence and ease of use. Conclusion There was little to choose between FACT-G, EORTC, and the negative IOC scales, any of which may be used to measure QoL. However, the two IOCv2 subscales capture unique aspects of QoL compared to the other measures. The IOCv2 can be used to identify those cancer survivors who would benefit from interventions to improve their QoL and to target specific needs thereby providing more holistic and personalised care beyond cancer treatment.

scholarly journals Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Consuelo Nóhpal de la Rosa ◽  
Jonathan Krell ◽  
Emily Day ◽  
Aaron Clarke ◽  
Meena Reddi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Standard Treatment ◽  
Progression Free Survival ◽  
Statistical Analysis Plan ◽  
Weekly Paclitaxel ◽  
Free Survival ◽  
Secondary Outcomes ◽  
Eortc Qlq

Abstract Background Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer. Objective To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase. Results This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis. Discussion The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant’s progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment in September 2018. An interim analysis was performed in early 2021, the results of which advised continuation of the trial. The study recruitment is ongoing and is due to complete by the end of 2021. Trial registration ClinicalTrials.govNCT03648489. Registered on 27 August 2018

scholarly journals Observational Study to Assess Quality of Life in Patients with Pancreatic Neuroendocrine Tumors Receiving Treatment with Everolimus: The OBLIQUE Study (UK Phase IV Trial)

2019 ◽  
Vol 108 (4) ◽  
pp. 317-327 ◽  
Author(s):  
John K. Ramage ◽  
Pankaj Punia ◽  
Olusola Faluyi ◽  
Andrea Frilling ◽  
Tim Meyer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Global Health ◽  
Clinical Outcomes ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Mean Difference ◽  
Neuroendocrine Neoplasms ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Background/Aims: To assess health-related quality of life (HRQoL), treatment patterns, and clinical outcomes of adult (≥18 years) patients with advanced (unresectable or metastatic) pancreatic neuroendocrine neoplasms (PanNENs) treated with everolimus in routine clinical practice. Methods: In a prospective, non-interventional, multi-center study patients administered at least one 10 mg dose of everolimus were evaluated for change in HRQoL (EORTC QLQ-C30 Global Health Status scale) from baseline after 6 months treatment (primary endpoint). Secondary endpoints included disease-specific HRQoL measures (EORTC QLQ-G.I.NET21), clinical outcomes, everolimus treatment patterns, and safety. Results: Forty-eight patients were recruited (between August 2013 and March 2015); the median treatment duration was 27.8 months. EORTC QLQ-C30 Global Health score was not significantly different from baseline after 6 months of treatment (mean difference –1.9 points, p = 0.660, n = 30). In pairwise analyses, the only significant changes in HRQoL from baseline were for EORTC QLQ-C30 physical functioning score at month 3 (adjusted mean difference –8.8 points, p = 0.002, n = 36) and the EORTC QLQ-G.I.NET21 disease-related worries scores at months 1 and 2 (adjusted mean differences: –11.5 points [p = 0.001, n = 44] and –8.8 points [p = 0.017, n = 43], respectively). Disease progression or death was recorded in 44.4% (n = 20/45) patients during follow-up; median progression-free survival was 25.1 months and the cumulative survival rate at 3 years was 71%. No new safety signals were detected. Conclusions: The OBLIQUE study demonstrates that HRQoL is maintained in patients with PanNENs during treatment with everolimus in a UK real-world setting. This study adds to the limited HRQoL data available in this patient group.

Impact on quality of life (QoL) of the addition of docetaxel (T) to neoadjuvant cisplatin plus 5-fluorouracil treatment in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN): EORTC study 24971

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5522-5522 ◽  
Author(s):  
J. Bernier ◽  
C. Coens ◽  
E. Remenar ◽  
C. Van Herpen ◽  
J. Germa Lluch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Treatment Time ◽  
Performance Status ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Progression Free Survival ◽  
Eortc Qlq ◽  
The Impact

5522 Background: The EORTC 24971 trial compared the efficacy and safety of two neoadjuvant regimens in the treatment of stage III or IV, M0 SCCHN. Eligible patients (pts) with primary tumor sites in the oral cavity, oropharynx, hypopharynx, and larynx and WHO performance status (PS) ≤1) were randomized to 2–4 cycles of cisplatin (P) 100 mg/m2 day 1, followed by a continuous infusion of 5-fluorouracil (F) 1000 mg/m2/day from days 1- 5 (PF), or T 75 mg/m2 + P 75 mg/m2 day 1 then F 750 mg/m2/day from days 1 - 5 (TPF), followed by locoregional radiation therapy (RT). The impact of the two regimens on QoL was a secondary endpoint. Methods: QoL was assessed at baseline, at cycles 2 and 4, and 6 and 9 months after RT using the EORTC QLQ-C30 questionnaire to obtain the Global Health Status/Quality of Life (GHS/QoL) score, and the Head and Neck Performance Status Scale (PSS-HN) to assesses the normality of diet, eating in public, and understandability of speech on a scale of 0 to 100. The EORTC QLQ-HN35 questionnaire was also administered at those time-points. Results: 358 pts were randomized to PF (181 pts) or TPF (177 pts). Baseline (BL) characteristics of the pts were well balanced between groups. TPF was superior to PF in terms of response rate, progression-free survival (primary endpoint), overall survival, and tolerability. Compliance with the QLQ-C30 questionnaire was good ranging from 96% at BL to 41% at 9 months post RT, and was similar between the treatment arms. GHS/QoL scores were comparable at BL between the two arms (p = 0.54) and improved in both arms on starting treatment. Over time this score remained stable with TPF, but decreased after RT with PF (treatment-time interaction: p = 0.009). Evolution of the PSS-H&N score was better on TPF (normality of diet p= 0.0064; eating in public p = 0.0004; understandability of speech p = 0.0003). Moreover, TPF was associated with a 30% reduction in the risk of WHO PS deterioration (p = 0.0158) Conclusions: The use of docetaxel in neoadjuvant treatment of SCCHN improves efficacy without deleterious effects on QoL and functional outcomes. [Table: see text]

Quality-of-life findings in patients with midgut neuroendocrine tumors: Results of the NETTER-1 phase III trial.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 348-348 ◽  
Author(s):  
Jonathan R. Strosberg ◽  
Edward M. Wolin ◽  
Beth Chasen ◽  
Matthew H. Kulke ◽  
David L Bushnell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Global Health Status ◽  
High Dose ◽  
Eortc Qlq ◽  
The Impact

348 Background: Neuroendocrine tumor progression is associated with decline in quality of life, both due to tumor and hormone-related symptoms. The Phase III NETTER-1 trial randomized patients with advanced, progressive midgut NETs to receive treatment with 177Lu-DOTATATE (177Lu; Lutathera) versus high-dose (60 mg) Octreotide LAR (Oct). EORTC questionnaires C30 and GINET21 were assessed during the trial in order to determine the impact of treatment on health-related quality of life (HRQoL). Methods: Patients completed EORTC QLQ-30 and QLQ-G.I.NET21 questionnaires at baseline and every 12 weeks thereafter until disease progression. Raw scores were converted to a 100-point scale and individual changes from baseline scores were assessed. Clinically relevant ( ≥ 10 point) deterioration/improvement was considered clinically significant. Results: Clinically and statistically significant improvements in QoL were observed in the 177Lu arm versus the Oct arm at certain time points in key domains of HRQoL including global health status and diarrhea. In mean, global health status improved in 28% of patients on 177Lu arm vs. 15% on Oct, and worsened in 18% of patients on 177Lu vs. 26% on Oct. Diarrhea improved in 39% of patients on 177Lu vs. 23% on Oct, and worsened in 19% of patients on 177Lu vs. 23% on Oct. There was a trend towards improvement in pain that was not statistically significant. Flushing appeared to improve compared to baseline in both arms of the study with no clear advantage to treatment with 177Lu vs. Oct. Conclusions: QoL analysis suggests benefit in important domains associated with 177Lu treatment compared to high-dose octreotide in patients with advanced midgut NETs, and confirms the treatment value of 177Lu on patient QoL, in addition to the meaningful increase in progression-free survival already reported. Clinical trial information: NCT01578239.

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