Tepotinib in patients (pts) with NSCLC with MET exon 14 (METex14) skipping: Health-related quality of life (HRQoL).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9575-9575
Author(s):  
Paul K. Paik ◽  
Leora Horn ◽  
Dariusz M. Kowalski ◽  
Jyoti D. Patel ◽  
Frank Griesinger ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Objective Response ◽  
Symptom Burden ◽  
Meaningful Improvement ◽  
Cancer Symptoms ◽  
Related Quality ◽  
Duration Of Response ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

9575 Background: In the phase II VISION study (NCT02864992) tepotinib had promising efficacy (response rate of 40–50% & median duration of response >1 y) and tolerable safety in pts with advanced NSCLC with METex14 skipping (3–4% of NSCLC), who are typically elderly with poor prognosis. Pt reported outcomes (PROs) of HRQoL are described here. Methods: Pts with advanced NSCLC positive for METex14 skipping by tissue or liquid biopsy received oral tepotinib 500 mg once daily; PROs were assessed using QLQ-LC13 (lung cancer symptoms), EORTC QLQ-C30 (Global health status [GHS] & 5 functional scales), and EQ-5D-5L (VAS). Questionnaires were completed at baseline (BL) and every 6 weeks (Wk); results were scored from 0–100 (minimal clinically important difference [MCID] ≥10 points). Mean change from BL was analyzed at Wk 12 (predefined analyses). Results: By 19 Jul 19 cut-off, 130 pts across treatment lines were enrolled (median age 74.2 y), with PROs available for 129. Questionnaire completion rates were 90.1% at Wk 12. Symptom burden at BL was moderate for advanced NSCLC; mean change from BL for PROs are shown in the table (better functioning: lower QLQ-LC13 or higher QLQ-C30 scores). For the QLQ-LC13 symptoms, mean changes from BL indicated a meaningful improvement in coughing, with a median time to improvement (2.8 months) paralleling the onset of objective response (within first 3 months), and a numerical improvement in dyspnea (–2.3 at Wk 12) and chest pain (–4.2 at Wk 12). QLQ-C30 values remained stable over treatment as did EQ-5D-5L scores (higher=better): mean (standard deviation, SD) change from BL score (60 [20.4]) was 6 (18.6) at Wk 6 and 5 (20.9) at Wk 12. Conclusions: In this first analysis of PROs in pts with advanced NSCLC with METex14 skipping with a moderate symptom burden, treatment with tepotinib led to a clinically meaningful improvement in coughing symptoms, while maintaining HRQoL. Coupled with the efficacy and safety profile, the predefined HRQoL analysis from the VISION study supports tepotinib as a promising treatment option for this elderly population with METex14+ NSCLC. Clinical trial information: NCT02864992 . [Table: see text]

Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5570-5570
Author(s):  
Domenica Lorusso ◽  
Nicoletta Colombo ◽  
Antonio Casado Herraez ◽  
Alessandro Santin ◽  
Emeline Colomba ◽  
...  
Keyword(s):  
Compliance Rate ◽  
Primary Analysis ◽  
Meaningful Improvement ◽  
Treatment Groups ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

5570 Background: In Study 309/KEYNOTE-775, lenvatinib + pembrolizumab (L+P) demonstrated significant and clinically meaningful improvement in OS, PFS, and ORR compared with TPC in aEC pts following prior platinum-based systemic therapy. Given the medical complexity/age of EC pts, QoL analyses are critical, but often under-reported. We present results of pt-reported HRQoL for Study 309/KEYNOTE-775. Methods: Pts were randomized 1:1 to receive lenvatinib 20 mg QD PO + pembrolizumab 200 mg IV Q3W (n=411) or TPC (n=416; doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW, 3 wks on/1 wk off). Pt-reported HRQoL was assessed at cycle 1 day 1, day 1 of each subsequent cycle and at time of discontinuation using EORTC QLQ-C30, its EC module QLQ-EN24, and EQ-5D-5L in treated pts who had ≥1 HRQoL assessment available. Higher scores indicate better functioning/QoL (EORTC QLQ-C30, EQ-5D-5L) or worse symptom severity (QLQ-EN24). Changes in EORTC QLQ-C30 global health status (GHS)/QoL was a secondary endpoint. This was analyzed from baseline to the latest timepoint at which overall completion was ≥60% and overall compliance was ≥80%, using constrained longitudinal data analysis; other HRQoL analyses were exploratory. Results: Completion and compliance rates of EORTC QLQ-C30 were >95% in both groups at baseline. Primary analysis was conducted at wk 12 as completion rate was 80% for L+P and 62% for TPC; compliance rate was 93% for L+P and 87% for TPC. Baseline GHS/QoL scores were similar between the L+P group and TPC group: mean (SD) of 65.74 (21.87) vs 65.69 (22.71), respectively. Over 12 wks of follow-up, pts in both groups had slight decreases in GHS/QoL. Similar decreases were observed for pts receiving L+P vs TPC: -5.97 (95% CI: -8.36, -3.58) vs -6.98 (95% CI: -9.63, -4.33). The between-group difference in least-squares (LS) mean score change from baseline to wk 12 for L+P vs TPC was 1.01 points (95% CI: -2.28, 4.31). Over time, QoL scores were generally similar across treatments. Results were similar for other HRQoL endpoints (Table). Conclusions: No significant differences were observed in HRQoL scores between treatment groups. With no standard treatment approach following failure of platinum-based therapy, these data along with previously reported efficacy and safety findings from Study 309/KEYNOTE-775 further support that L+P has an overall favorable benefit/risk profile compared to chemotherapy. Clinical trial information: NCT03517449. [Table: see text]

scholarly journals Symptom burden and health-related quality of life impacts of smoldering multiple myeloma: the patient perspective

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Milenka Jean-Baptiste ◽  
Katharine S. Gries ◽  
William R. Lenderking ◽  
John Fastenau
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Symptom Burden ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
Study Participants

Abstract Background Smoldering multiple myeloma (SMM) is an early form of multiple myeloma (MM). SMM is typically considered asymptomatic, and research on how it affects health-related quality of life (HRQoL) is limited. This study assessed the symptoms and HRQoL of patients with SMM and those who progressed from SMM to MM and evaluated the content validity of two patient-reported outcome instruments (EORTC QLQ-C30 and nine items from the EORTC QLQ-MY20) for use in SMM clinical trials. To address these objectives, concept elicitation and cognitive interviews were conducted with SMM patients and recently diagnosed MM patients. Results Fifteen adult SMM and six adult MM participants with a prior SMM diagnosis were interviewed. On average, SMM study participants were 61 years old (46.0–78.0), 11 (73%) were female, and diagnosed 2.6 (±2.0) years ago. Each participant had experienced at least one symptom, most commonly tiredness/fatigue, weakness, and pain. The most common HRQoL impacts were emotional and physical. SMM study participants demonstrated good understanding of both the EORTC QLQ-C30 and EORTC QLQ-MY20 subscales and found them relevant to their SMM health state. The average age of MM participants was 53 years old (39.0–62.0); 5 (83%) were female and diagnosed 1.9 years ago (±2.1). MM participants most commonly reported tiredness, weakness, constipation, shortness of breath, and dry mouth as occurring when they progressed from SMM to MM. Conclusions Although previously described as asymptomatic, these SMM participants reported experiencing symptoms that affected their lives. Additionally, the EORTC subscales measured symptoms SMM patients experienced. The participants with MM reported that the symptom burden and HRQoL impacts increased when diagnosed with MM. These findings suggest the need for increased surveillance of symptoms within the SMM population and further suggest that the EORTC subscales can be used to assess symptoms and impacts in both the SMM and MM populations.

Health-related quality of life (HRQoL) results from ALTA-1L: Phase 3 study of brigatinib vs crizotinib as first-line (1L) ALK therapy in advanced ALK+ non-small cell lung cancer (NSCLC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9084-9084 ◽  
Author(s):  
Rosario Garcia Campelo ◽  
Huamao Mark Lin ◽  
Maurice Perol ◽  
Mohammad Jahanzeb ◽  
Sanjay Popat ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Multicenter Trial ◽  
Meaningful Improvement ◽  
Point Increase ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Secondary Objective ◽  
Eortc Qlq ◽  
Nsclc Patients

9084 Background: Results from ALTA-1L (NCT 02737501 ), an international, multicenter trial, showed that brigatinib vs crizotinib as 1L ALK therapy significantly prolongs progression-free survival (PFS; HR: 0.49, 95% CI, 0.33, 0.74) in advanced ALK+ NSCLC. HRQoL was evaluated as a secondary objective. Methods: ALK+ NSCLC patients were randomized 1:1 to brigatinib 90 mg daily for 7 days, then 180 mg daily or crizotinib 250 mg twice daily as 1L ALK therapy; treatment cycles were 28 days. HRQoL was assessed with the EORTC QLQ-C30 and LC13. Change from baseline, duration of improvement and time to worsening were analyzed in the ITT-PRO population (n = 131 for both groups). Results: HRQoL compliance was > 90% for brigatinib and crizotinib. Global health status (GHS)/QoL improved starting at cycle 2, with clinically meaningful improvement (≥10-point increase) noted with brigatinib at cycles 5−8, 10−13, 17 and 19 and crizotinib at cycle 6. Brigatinib substantially improved overall HRQoL vs crizotinib, as demonstrated by the estimated mean difference on change from baseline (4.1, P< 0.05) and duration of improvement for GHS/QoL (HR = 0.16, P< 0.001). Improved GHS/QoL with brigatinib vs crizotinib was also supported by improvement in several functional domains (Table) and for these symptoms ( P< 0.05): fatigue, nausea/vomiting and appetite loss. No domains significantly favored crizotinib. Brigatinib showed a trend to prolong time to worsening of dyspnea vs crizotinib (HR 0.65, 95% CI 0.38, 1.12). Table: HRQoL results brigatinib vs crizotinib Clinical trial information: NCT02737501. Conclusions: Consistent with the prolongation of PFS seen in 1L treatment of advanced ALK+ NSCLC, brigatinib improved HRQoL and prolonged the duration of improvement in GHS/QoL, and the majority of functional and symptom domains vs crizotinib.[Table: see text]

scholarly journals Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3826
Author(s):  
Oumar Billa ◽  
Franck Bonnetain ◽  
Jérôme Chamois ◽  
Angeline Ligey ◽  
Valérie Ganansia ◽  
...  
Keyword(s):  
Head And Neck ◽  
Satisfaction With Care ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact ◽  
Routine Assessment ◽  
Eq Vas

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

scholarly journals Reliability and validity of Amharic version of EORTC QLQ-C30 and QLQ-BR23 modules for assessing health-related quality of life among breast cancer patients in Ethiopia

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Diriba Alemayehu Gadisa ◽  
Esayas Tadesse Gebremariam ◽  
Getnet Yimer Ali
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Health Related Quality ◽  
Breast Cancer Patients ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Abstract Background Breast cancer is the most common cancer among women and it affects quality of life of those women. So far, the two most frequently used tools for assessing health related quality of life in breast cancer patients, EORTC QLQ-C30 and EORTC QLQ-BR23 modules, were not validated in Ethiopia. Hence, the present study aimed to assess the psychometric properties of the tools among Ethiopian breast cancer patients. Methods Institutional based longitudinal study was conducted from January 1 to May 1, 2017 GC at only nationwide oncology center, Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. A total of 146 patients who visited the facility during that period, with no missing quality of life data, were selected for analysis. The psychometric properties of the EORTC QLQ-C30 and EORTC QLQ-BR23 were evaluated in terms of reliability, convergent, divergent, construct and clinical validity using SPSS version 22. Results Satisfactory internal consistency reliability (Cronbach’s α coefficients > 0.7) was confirmed, except for cognitive function (α = 0.516) of EORTC QLQ-C30 and body image (α = 0.510) of EORTC QLQ-BR23. Multiple-trait scaling analysis demonstrated a good convergent and divergent validity. No scaling errors were observed. Most items in EORTC QLQ-BR23 possessed a weak or no correlation with its own dimension in EORTC QLQ-C30 (r < 0.4) except with some of symptom scales. A statistically significant chemotherapy induced quality of life scores changes (P ≤ 0.05) were observed in all dimensions of both instruments between baseline and the end of first cycle chemotherapy, except for body image (P = 0.985) and sexual enjoyment (P = 0.817) of EORTC QLQ-BR23, indicating clinical validity. Conclusion Amharic version of the EORTC QLQ-C30 and EORTC QLQ-BR23 modules are valid and adequately reliable tool and can be used for clinical and epidemiological cancer researches to study the health related quality of life (HRQoL) of women with breast cancer in Ethiopia.

Health-Related Quality of Life As a Survival Predictor for Patients With Localized Head and Neck Cancer Treated With Radiation Therapy

2009 ◽  
Vol 27 (18) ◽  
pp. 2970-2976 ◽  
Author(s):  
François Meyer ◽  
André Fortin ◽  
Michel Gélinas ◽  
Abdenour Nabid ◽  
François Brochet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Head And Neck ◽  
Prognostic Value ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Purpose To assess the added prognostic value for overall survival (OS) of baseline health-related quality of life (HRQOL) and of early changes in HRQOL among patients with localized head and neck cancer (HNC) treated with radiation therapy. Patients and Methods All 540 patients with HNC who participated in a randomized trial completed two HRQOL instruments before radiation therapy: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the Head and Neck Radiotherapy Questionnaire. Six months after the end of radiation therapy, 497 trial participants again completed the two HRQOL instruments. During the follow-up, 179 deaths were observed. Multivariate Cox proportional hazards models were used to test whether HRQOL variables, baseline and change, provided additional prognostic value beyond recognized prognostic factors. Results The baseline EORTC QLQ-C30 physical functioning (PF) score was an independent predictor of OS. The hazard ratio (HR) associated with a 10-point increment in baseline PF was 0.87 (95% CI, 0.81 to 0.94). In multivariate models, the change in HRQOL was significantly associated with OS for most HRQOL dimensions. Among these, PF change was the strongest predictor. The magnitude of the association between PF change and survival decreased over time. At 1 year, the HR associated with a positive PF change of 10 points was 0.75 (95% CI, 0.68 to 0.83). After PF is taken into account, no other HRQOL variable was associated with survival. Conclusion Our findings indicate that both baseline PF and PF change provide added prognostic value for OS beyond established predictors in patients with HNC. Assessing HRQOL could help better predict survival of cancer patients.

Measuring the functional decline of people with advanced-stage non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19605-e19605
Author(s):  
Linda Denehy ◽  
Andrew Murnane ◽  
Meinir Krishnasamy ◽  
Karla Gough ◽  
Catherine Granger ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Physical Function ◽  
Advanced Nsclc ◽  
Functional Decline ◽  
Timed Up And Go ◽  
Curative Intent ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

e19605 Background: People affected by lung cancer maybe highly symptomatic. This study aimed to quantify changes in physical function and health-related quality of life (HRQoL) in patients with advanced NSCLC. Methods: A prospective cohort study was performed. Patients with stage III and IV NSCLC were recruited within one month of starting treatment and assessed at baseline, 2, 4 and 6 months or until they became too unwell. HRQoL and functional status were measured using the EORTC QLQ-C30, the 6-minute walk test (6MWT) and timed up and go test (TUG). Comparisons between baseline and follow-up assessments were carried out by fitting linear mixed models to each outcome separately. Results: 39 patients (21 male) were included in the analysis; median age of 63 (range 40-80). 59% were receiving treatment with curative intent. 28% had stage 4 disease with 26% deceased by 4 months. Response rates at 2 and 4 months were 71.8% and 53.8% for 6MWT and TUG and 87.2% and 64.1% for EORTC. The mean 6MWT at baseline was significantly lower than predicted for the age, sex and height of the cohort (417.9 versus 550.4 metres, p<0.0005). Significant decline in mean 6MWT distance was seen at 2 (decrease of 42.4m, 95%CI -59.0, -25.7, p<0.0005) and 4 month follow-ups (decrease of 63.6m, 95%CI -85.6, -41.5, p<0.0005) compared to baseline. Significant increases in time taken to complete the TUG were also seen at 2 (increase of 0.76 sec, 95%CI 0.54 – 0.98, p<0.0005) and 4 month follow-ups (increase of 1.01 sec, 95%CI 0.76 – 1.27, p<0.0005) compared with baseline. In contrast, global health status and physical functioning as assessed by the QLQ-C30 showed small but significant decreases at the 2 month follow-up compared to baseline (decrease of 8.04, p=0.01 and decrease of 7.67, p=0.024 respectively), but no significant differences between baseline and the 4 month follow-up. Conclusions: Patients with advanced NSCLC show clinically and statistically significant decrements in physical function at commencement of treatment. This continues to decline rapidly and significantly over time, despite small changes in self-reported HRQoL. The 6MWT demonstrated clinically relevant changes in physical function. Interventions to address this problem are urgently needed.

Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 153-153 ◽  
Author(s):  
Karen Bartley ◽  
Hans Wildiers ◽  
Sung-Bae Kim ◽  
Ian E. Krop ◽  
Jennifer Kang ◽  
...  
Keyword(s):  
Health Status ◽  
Objective Response ◽  
Cox Proportional Hazards ◽  
Her2 Positive ◽  
Meaningful Improvement ◽  
Symptom Bother ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
The Impact

153 Background: Progression-free survival and objective response rate were significantly improved with T-DM1 vs TPC in TH3RESA. The impact of treatment on quality of life is a key aspect in determining treatment value. Here we present the PRO results from the TH3RESA study. Methods: Patients were randomized 2:1 to T-DM1 (3.6 mg/kg every 21 days) or TPC. Patients were asked to complete the EORTC QLQ-C30 (a 30-item questionnaire assessing symptom bother, functioning and health status) and the EORTC QLQ-BM22 (a 22-item survey evaluating pain from bone metastases) at the start of each cycle. Data from patients with a baseline and ≥1 post-baseline assessment were included; a clinically meaningful difference was defined as ≥10 points. Time to pain progression (TPP) was assessed using the Kaplan-Meier method and Cox proportional-hazards models. Results: A greater proportion of patients in the T-DM1 arm (n=297) vs. the TPC arm (n=117) experienced a clinically meaningful improvement in global health status (57.8% [95% CI; 52.0–63.3] vs. 47.1% [95% CI; 38.4–56.4]). The most bothersome symptoms in the T-DM1 arm as measured by the EORTC QLQ-C30 were fatigue and pain. Over the first 10 T-DM1 treatment cycles, 19–30% of patients reported being impacted “quite a bit” or “very much” by fatigue, and 16–25% by pain. Nausea/vomiting and diarrhea were perceived as more tolerable, with 1–5% and 1–4% of patients reporting “quite a bit” or “very much” impact, respectively. TTP was 2.9 months in the T-DM1 arm vs 3.6 months in the TPC arm, but was not significantly different (HR 1.12 [95% CI; 0.82–1.52], p = 0.495). Mean baseline EORTC QLQ-BM22 pain scores were similar in the T-DM1 (n = 306) and TPC arms (n = 130); (25.4 ± 23.8 [SD]) and (27.3 ± 24.4), respectively. There were no clinically meaningful changes in pain levels from baseline over time in either arm. Conclusions: For patients on T-DM1, the most impactful symptoms were fatigue and pain, while the least bothersome were diarrhea and nausea/vomiting; distribution of severity of impact was relatively stable over the first 10 cycles of treatment. TPP was similar between the T-DM1 and TPC arms. Clinical trial information: NCT01419197.

Health-related quality of life (HRQoL) of pembrolizumab (pembro) versus physician choice single-agent paclitaxel, docetaxel, or irinotecan in subjects with advanced/metastatic adenocarcinoma (ACC) or squamous cell carcinoma (SCC) of the esophagus that has progressed after first-line standard therapy (KEYNOTE-181).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4048-4048 ◽  
Author(s):  
Antoine Adenis ◽  
Amit Kulkarni ◽  
Gustavo Colagiovanni Girotto ◽  
Christelle De La Fouchardiere ◽  
Helene Senellart ◽  
...  
Keyword(s):  
Cox Regression ◽  
Single Agent ◽  
Open Label ◽  
P Values ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

4048 Background: KEYNOTE-181 (NCT02564263) is an open-label, randomized, phase 3 trial in ACC and SCC of the esophagus that evaluated IV pembro 200 mg Q3W for up to 2 years vs investigator choice of single-agent paclitaxel/docetaxel/irinotecan (control). Pembro was superior to control for OS in patients with PD-L1 CPS ≥10 (N = 222; median 9.3 vs 6.7 months; P= 0.0074). Here we present results of prespecified HRQoL analyses in this population. Methods: The EORTC QLQ-C30 and EORTC QLQ-OES18 were administered at baseline; weeks 2, 3, 4, 6, 9, 12, 18; every 9 weeks up to 1 year/end of treatment; and 30-day safety follow-up visit. Data from patients receiving ≥1 dose of study treatment and completing ≥1 HRQoL assessment were analyzed. Least squares mean (LSM) score change from baseline to week 9, 95% CI, and nominal P values were calculated. Time to deterioration (TTD) (≥10-point decline from baseline) was assessed by Kaplan-Meier method and Cox regression model. HRs, 95% CIs, and nominal P values are provided. Results: The HRQoL population included 218 PD-L1 CPS ≥10 patients (107 pembro, 111 control). QLQ-C30 compliance at week 9 was 88.9% for pembro and 83.9% for control. There was no significant difference in LSM between arms (3.68; 95% CI –2.28, 9.64; P= 0.2248) in global health status (GHS)/QoL score. Week 9 QLQ-OES18 compliance was 88.4% for pembro and 83.3% for control. QLQ-OES18 scores were not significantly different between arms. TTD for pain (HR 1.02; 95% CI 0.58, 1.81; P= 0.5282), reflux (HR 1.69; 95% CI 0.83, 3.47; P= 0.9254), and dysphagia (HR 1.81; 95% CI 0.97, 3.37; P= 0.9693) subscales were not significantly different between arms. Conclusions: Over 9 weeks, patients treated with pembro had stable GHS/QoL scores similar to those of patients treated with single-agent docetaxel/paclitaxel/irinotecan. Combined with the superior OS and lower rate of treatment-related AEs seen with pembro, these data support clinically meaningful benefit of pembro in esophageal cancer patients with PD-L1 CPS ≥10. Clinical trial information: NCT02564263.

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