Preoperative immune checkpoint inhibitor therapy may be of benefit in early-stage NSCLC. This multicenter trial assesses the feasibility of neoadjuvant durvalumab.
Pts IB>4cm–IIIA, non N2 resectable NSCLC (TNM 8th edition) receive 3 courses of durvalumab 750 mg (days 1, 15, 29) then underwent resection, between day 2 and 14 after last infusion. Primary endpoint was % of complete surgical resection (R0); secondary endpoints safety, overall survival (OS), disease-free survival (DFS), time between first infusion and surgery, response rate (RECIST 1.1), major pathological response (MPR).
50 pts included between April 2017 and August 2019. 46 eligible. 67.4% males, median age, 61 y; all ECOG PS 0-1; 98% smokers; 23 adenocarcinoma, 19 squamous; clinical stages IB/IIA/IIB/IIIA n = 5/13/27/1. Among the 46 operated pts, 9 had pneumonectomy, 31 lobectomy, 3 bilobectomy, and 3 an exploratory thoracotomy (2 pleural carcinosis; 1 esophageal invasion). Study was stopped because of an excess in 90-day postoperative mortality (4 deaths, 9%, 1 unknown (died at home); 2 acute respiratory failures; 1 tracheal fistula). 3 out of 4 deceased pts had cardiovascular comorbidities (3 arterial hypertensions; 1 peripheral arterial disease; 1 ischemic heart disease), or other (1 severe COPD; 1 diabetes). 41 pts were R0 (90%). There was no Grade 3-5 durvalumab related AEs. 4/46 pts had PR, 36 SD and 6 PD. Median time between first infusion and surgery was 37 (range: 29-46). Median OS and DFS was not reached; 18-m OS: 88.7% [95% CI: 74.9-95.1] 18-m RFS: 69.7% [95% CI: 53.2-81.3].
Enrollment was stopped because of excessive 90-day postoperative mortality. Deaths were due to postoperative complications possibly related to comorbidities and not to direct durvalumab toxicity. MPR rates and ongoing correlative analyses will be presented.
NCT03030131.
French Cooperative Thoracic Intergroup (IFCT).
AstraZeneca.
M. Wislez: Advisory/Consultancy: Boeringher Ingelheim; Speaker Bureau/Expert testimony: Boeringher Ingelheim; Advisory/Consultancy: Roche; Speaker Bureau/Expert testimony: Roche; Travel/Accommodation/Expenses: Roche; Non-remunerated activity/ies: Roche; Advisory/Consultancy: MSD; Speaker Bureau/Expert testimony: MSD; Travel/Accommodation/Expenses: MSD; Non-remunerated activity/ies: MSD; Advisory/Consultancy: BMS; Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy: AstraZeneca; Speaker Bureau/Expert testimony: AstraZeneca; Travel/Accommodation/Expenses: AstraZeneca; Speaker Bureau/Expert testimony: Amgen; Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (self): BMS. J. Mazieres: Advisory/Consultancy: Roche; Research grant/Funding (institution): Roche; Advisory/Consultancy: AstraZeneca; Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: BMS; Research grant/Funding (institution): BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Hengruii; Advisory/Consultancy: Daiichi; Advisory/Consultancy: Boehringer; Advisory/Consultancy: Takeda. A. Lavole: Travel/Accommodation/Expenses: BMS. G. Zalcman: Honoraria (self): Pfizer; Research grant/Funding (institution): Roche; Advisory/Consultancy: BMS; Honoraria (self): BMS; Travel/Accommodation/Expenses: BMS; Honoraria (self): AstraZeneca; Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD. O. Molinier: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Tesaro; Travel/Accommodation/Expenses: Boehringer Ingelheim. M.A. Massiani: Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Elivie; Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Boehringer Ingelheim; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: MSD. D. Damotte: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (self): MedImmune; Honoraria (self): AbbVie; Travel/Accommodation/Expenses: AbbVie. M. Antoine: Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): AstraZeneca. V. Westeel: Honoraria (self): Roche; Advisory/Consultancy: BMS; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Roche; Advisory/Consultancy: Takeda; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: BMS; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Boehringer Ingelheim; Travel/Accommodation/Expenses: BMS; Research grant/Funding (institution): BMS; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Roche; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Fresenius; Research grant/Funding (institution): Merck-Serono. All other authors have declared no conflicts of interest.
Neoadjuvant immune checkpoint inhibitors induce major pathologic response (MPR) rates in 17- 45% of NSCLCs. We report the results of a phase 2 trial of neoadjuvant A for NSCLC.
Patient (pts) with clinical stage IA (≥ 2 cm)-IIIA non N2 NSCLC eligible for surgery, PS 0-1, received 1 injection of A (1200 mg IV D1) followed by surgery between D21-D28. The primary endpoint was the rate of pts without major toxicities or morbidities from D1 until 1 month after the surgery. Fresh tumour tissue was analysed within 4 hours after surgery. Response by RECIST1.1 and major pathological response (MPR; ≤10% viable tumour) were assessed.
From December 2016 to February 2020, 30 pts were enrolled in two centres. The mean age of pts was 64, 50% were female, 7% never smokers, 83% had adenocarcinomas. Pathological stages were I (n=15, 50%), II (n=6, 20%) III (n=9, 30%). All pts had their planned surgery, none were delayed by >15 days. 29 had R0 resection, 1 had R1. Three pts experienced surgical complications: 1 respiratory distress grade 3 with sepsis grade 4, 1 heart block atrioventricular and 1 paresthesia grade 1. There was no grade 5 toxicity. Treatment-related adverse effects (TRAEs) included only one grade 1 parietal pain related to surgery. No RECIST radiological response and no MPR were observed. After A, 15/29 tumours were PD-L1 TC3 or IC3 based on the SP142 assay. 17/30 (56%) tumours had necrosis (med. 5% of tumour surface, 0-80). 20/29 cases had histopathological features of response according to the immune-related pathologic response criteria (irPRC), with isolated or combined features of immune activation (19/20), tissue repair (15/20) and/or tumour cell death (9/20).NGS (11 genes) was performed in 23 tumours resulting in 14
Surgery after one infusion of A was safe. The short delay between A and surgery might explain the absence of MPR.
NCT02994576.
Gustave Roussy.
Roche-Genentech.
B. Besse: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Blueprint Medicines; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Cristal Therapeutics; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Inivata; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck KGaA; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Nektar; Research grant/Funding (institution): Onxeo; Research grant/Funding (institution): OSE immunotherapeutics; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pharma Mar; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Spectrum Pharmaceuticals; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Tiziana Pharma; Research grant/Funding (institution): Tolero Pharmace. J. Adam: Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): msd; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self): BMS. N. Chaput-Gras: Research grant/Funding (institution): Roche. D. Planchard: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Merck KGaA; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche-Genentech; Advisory/Consultancy: Samsung; Honoraria (self), Advisory/Consultancy: Per CME; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Prime oncology; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novaris. L. Mezquita: Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Tecnofarma; Honoraria (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Research grant/Funding (self): Boehringer Ingelheim. J. Remon Masip: Travel/Accommodation/Expenses: Ose Pharma; Advisory/Consultancy: AstraZeneca; Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Pfizer; Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: BMS. P. Lavaud: Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Janssen; Travel/Accommodation/Expenses: Mundi Pharma; Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: AstraZeneca. C. Naltet: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: pfizer. A. Gazzah: Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): bms; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Johnson & Johnson; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): NH TherAGuiX. B. Duchemann: Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): MSD; Travel/Accommodation/Expenses: Oxyvie; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: AstraZeneca. F. Barlesi: Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ACEA; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Ipsen; Research grant/Funding (self): Ignyta; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Innate Pharma; Research grant/Funding (institution): Loxo; Research grant/Funding (institution): MedImmune; Honoraria (self), Research grant/Funding (institution): Merck KGaA; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self), Research grant/Funding (self): Takeda; Honoraria (self), Research grant/Funding (institution): Pierre Fabre. J-C. Soria: Honoraria (self): Clovis; Honoraria (self), Full/Part-time employment: AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Grammamabs; Honoraria (self): Mission Therapeutics; Honoraria (self): Merus; Honoraria (self): Eli Lilly; Shareholder/Stockholder/Stock options: Gritstone; Honoraria (self): Symphogen; Honoraria (self): Tarveda; Honoraria (self): Pfizer; Honoraria (self): Pharma Mar; Honoraria (self): Roche-Genentech; Honoraria (self): Sanofi; Honoraria (self): Servier; Honoraria (self): Bayer; Honoraria (self): Blend therapeutics; Honoraria (self): Astex; Honoraria (self): Pierre Fabre. C. Caramella: Honoraria (self): pfizer; Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): AstraZeneca; Honoraria (self): Roche. All other authors have declared no conflicts of interest.
Concurrent chemotherapy and thoracic radiotherapy (CRT) followed by prophylactic cranial irradiation (PCI) is the standard strategy in limited stage small cell lung cancer (LS-SCLC).
STIMULI is a 1:1 randomized phase II international trial aiming to demonstrate superiority of consolidation immunotherapy treatment (C) vs observation (O) after standard CRT and PCI, in patients (pts) with LS-SCLC. C consisted of four cycles of nivolumab (1 mg/kg, Q3W) plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months (m). The trial was designed to test two co-primary endpoints, progression-free survival (PFS) by RECIST 1.1 criteria, and overall survival (OS), at 1-sided alpha of 1% and 4%, respectively. Trial enrollment closed prematurely due to slow accrual, after half the initial sample size. The statistical analyses plan was updated to address PFS as primary endpoint to be tested at the full 5% 1-sided significance level. 81 PFS events were needed to achieve a power of 80% for testing an HR of 0.57. Secondary endpoints include OS, time to treatment failure (TTF), and safety.
222 pts were enrolled with 153 randomized after completion of CRT and PCI, 78 to C and 75 to O. Median age 62 years, 60% males, 34%/65% current/former smokers, 31%/66% ECOG PS 0/1. In C, 40 PFS events were observed, with median PFS 10.7 m (95% CI 7.0-Not Estimable (NE)) vs 42 events and median 14.5 m (8.2-NE) in O, HR=1.02 (0.66-1.58), 2-sided p=0.93. Two-year PFS rate was 43% (31-55) and 40% (28-52) in C and O respectively. Median OS was not reached in C, while it was 31.6 m (26.1-NE) in O, HR=1.06 (0.61-1.86), p=0.83. One-year OS rate was 79% (68-87) in C and 89% (78-94) in O. Exploratory subgroups will be presented. In C, median time to treatment discontinuation was only 1.7 m. Grade≥3 AEs were experienced by 62% pts in C and 25% in O, with 4 and 1 fatal AE, respectively.
PFS for LS-SCLC pts is not found different between C and O, possibly due to the short period on active treatment observed in the study.
NCT02046733.
European Thoracic Oncology Platform (ETOP).
Bristol-Myers Squibb.
S. Peters: Honoraria (self): AbbVie; Honoraria (self): Amgen; Honoraria (self): AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Biocartis; Honoraria (self): Boehringer-Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Clovis; Honoraria (self): Daiichi Sankyo; Honoraria (self): Debiopharm; Honoraria (self): Eli Lilly; Honoraria (self): Roche; Honoraria (self): Foundation Medicine; Honoraria (self): Illumina; Honoraria (self): Janssen; Honoraria (self): Merck Sharp and Dohme; Honoraria (self): Merck Serono; Honoraria (self): Merrimack; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Honoraria (self): Pfizer; Honoraria (self): Regeneron; Honoraria (self): Sanofi; Honoraria (self): Seattle Genetics; Honoraria (self): Takeda. U. Dafni: Advisory/Consultancy: Roche. M. Dómine: Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Eli Lilly. A. Curioni-Fontecedro: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Merck Sharp and Dohme; Honoraria (self), Advisory/Consultancy: Takeda. O. Molinier: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Takeda. D. Moro-Sibilot: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Eli Lilly. K. Nackaerts: Honoraria (institution): AbbVie; Honoraria (institution): Eli Lilly; Honoraria (institution): MSD; Honoraria (institution): Roche; Honoraria (institution): Takeda Millennium. A. Insa Mollá: Honoraria (self): BMS; Honoraria (self): Roche. G. López Vivanco: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche. J. Madelaine: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Boehringer-Ingelheim. S. Popat: Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): Takeda; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): MSD; Honoraria (self): EMD Serono; Honoraria (self): Guardant Health; Honoraria (self): AbbVie; Honoraria (self): Boehringer-Ingelheim; Honoraria (self): OncLive; Honoraria (self): Medscape; Honoraria (self): Incyte; Honoraria (self): Paradox Pharmaceuticals; Honoraria (self): Eli Lilly. M. Reck: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Samsung. D. De Ruysscher: Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy: Celgene; Advisory/Consultancy: Merck/Pfizer; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: MSD; Advisory/Consultancy: Seattle Genetics; Research grant/Funding (institution): Boehringer-Ingelheim; Research grant/Funding (institution): Philips; Research grant/Funding (institution): Olink. C. Le Pechoux: Honoraria (institution), Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Nanobiotix; Advisory/Consultancy: Roche; Honoraria (institution): Amgen; Honoraria (institution): Medscape; Honoraria (institution): Lilly; Honoraria (self): PriME Oncology. R. Stahel: Honoraria (self): AbbVie; Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self), Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (self): MSD; Honoraria (self), Research grant/Funding (self): Pfizer; Honoraria (self), Research grant/Funding (self): Roche; Honoraria (self): Takeda; Research grant/Funding (self): BMS; Research grant/Funding (self): Genentech. All other authors have declared no conflicts of interest.
Concurrent chemoradiotherapy is the standard treatment of LS SCLC. BID TRT of 45 Gy is the most recommended schedule. Only 30% are cured, and there is a need for better treatment. A higher TRT dose might improve local control and survival, and we conducted a phase II trial comparing BID TRT of 45 Gy with 60 Gy. There have been major concerns about toxicity from BID TRT. Here we present the patient reported health-related quality of life (HRQoL) from our trial.
Patients received 4 courses of platinum/etoposide (PE) and were randomized to receive TRT of 45 or 60 Gy after the second PE-course. Responders received prophylactic cranial irradiation (PCI) of 25-30 Gy. Patients reported HRQoL on the EORTC QLQ C30/LC13 at weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation), 16 (end of PCI), 22, 32, 42 and 52. Primary HRQoL-endpoints were dysphagia, dyspnea, global QoL and physical function. A difference in mean score of ≥10 was considered clinically relevant.
Between 2014-2018, 160 patients eligible for the present analyses were enrolled. Median age was 65, 58% women, 10% had PS 2 and 81% stage III. There were no significant differences in objectively assessed toxicity, and there was less radiotoxicity than in many previous studies. The high-dose arm achieved a significantly improved 2-year survival (primary endpoint) (46% vs. 70%; p=.002) and median overall survival (23 vs. 42 months; p=.027). The completion rate of questionnaires at each timepoint ranged from 61%-76%. Patients reported an increase in dysphagia from TRT with a max. level at w8 (45 Gy: mean score 45.1 points, 60 Gy: 51.9). 60 Gy patients had more dysphagia at w12 (45 Gy: 18.3, 60 Gy: 32.8) and w16 (45 Gy: 7.3, 60 Gy: 18.4), but after w22, the level of dysphagia returned to pre-treatment values in both arms. There were no significant differences in dyspnea, global quality of life or physical functioning, or on any other HRQoL scales, at any timepoint.
High-dose BID TRT significantly improved survival and was well tolerated both in terms of toxicity and patient reported HRQoL, though some patients on the high-dose arm needed a longer time to recover from radiation-induced dysphagia.
NCT02041845.
NTNU-Norwegian University of Science and Technology.
The Norwegian Cancer Society and The Liaison Committee for Education, Research and Innovation in Central Norway.
All authors have declared no conflicts of interest.