Displaying One Session

Cordoba Auditorium (Hall 7) Proffered Paper session
Date
30.09.2019
Time
10:15 - 11:45
Location
Cordoba Auditorium (Hall 7)
Chairs
  • Florence Huguet (Paris, France)
  • Lisa F. Licitra (Milan, Italy)
Proffered Paper – Head and neck cancer Proffered Paper session

LBA65 - Double-blind randomized phase II results comparing concurrent high-dose cisplatin chemorradiation (CRT) plus debio 1143 or placebo in high-risk patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN): A GORTEC study (ID 1432)

Presentation Number
LBA65
Lecture Time
10:15 - 10:27
Speakers
  • Jean Bourhis (Lausanne, Switzerland)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45

Abstract

Background

Debio 1143 is an antagonist of Inhibitor of Apoptosis Proteins (IAP) with the potential to enhance the antitumor activity of cisplatin and radiotherapy (RT) through a radiosensitizing effect that is mediated via caspase activation and TNFα-, IFNγ-, CD8+ T-cell dependent pathways.

Methods

This phase II, double-blind, randomized controlled study was conducted by the GORTEC group at 19 sites in France and Switzerland to compare efficacy and safety of Debio 1143 at 200 mg/day (A), oral once daily D1–14 q3w (3 cycles), with matching placebo (B) when added to standard high-dose cisplatin chemoradiation (CRT). Eligible patients had locally advanced, squamous cell carcinoma of the head and neck (SCCHN) and heavy smoking history. Data cut-off was after a minimum 2-year follow-up.

Results

96 patients were randomized and 95 treated (A: 48, B: 47). Median age was 58, with 81% male, 56% ECOG 0, 84% were stage IV, 67% oropharynx primary (88% HPV p16-), 59% consuming alcohol; median smoking history was 40 pack-years, all balanced across arms. Median dose was 70 Gy for RT and 288mg/m2 for cisplatin in both arms. The primary endpoint, locoregional control (LRC) rate at 18 months after CRT end, was improved by 21%; (OR = 2.69, 95% CI: 1.13-6.42, p = 0.026). Overall and complete response rates 6 months after CRT (A vs B) were 67% vs 48% and 52 vs 38% respectively. Median PFS was 16.9 months in arm B and not yet reached in arm A (HR = 0.37, 95% CI: 0.18-0.76, p = 0.007). Median OS was not yet reached (HR = 0.65, 95% CI: 0.32-1.33, p = 0.243). AEs and severe AEs (grades 3/4) were comparable across arms except for grade 3 mucositis, dysphagia and anemia that occurred more often in arm A and two grade 5 AEs reported in arm B.

Conclusions

The primary endpoint was met. LRC rate and PFS significantly improved when Debio 1143 was added to standard CRT in high-risk SCCHN patients. A trend in OS improvement was observed and additional follow-up will provide more mature OS/PFS data. Debio 1143 addition was feasible, safe and did not compromise backbone therapy. These promising results need to be confirmed in a larger phase III study.

Clinical trial identification

EudraCT: 2013-000044-25.

Editorial acknowledgement

Marina Leroy and Berit Sund, from Weber Shandwick.

Legal entity responsible for the study

GORTEC group and Debiopharm International SA GORTEC and Debiopharm International SA.

Funding

Debiopharm International.

Disclosure

J. Bourhis: Advisory / Consultancy: Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS. X. Sun: Honoraria (self): Novartis; Honoraria (self): Merck. Y. Pointreau: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD; Advisory / Consultancy: EMD Serono. C. Le Tourneau: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen. A. Coutte: Honoraria (self): Merck; Honoraria (self): Takeda; Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): Sanofi. M. Kaminsky-Forrett: Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck; Advisory / Consultancy: EMD Serono; Honoraria (self): AstraZeneca. M. Alfonsi: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: EMD Serono. P. Boisselier: Honoraria (self): Merck-Serono; Honoraria (self): BMS; Honoraria (self): Roche; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: MSD. L. Martin: Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck; Advisory / Consultancy: BMS; Advisory / Consultancy: EMD Serono. J. Delord: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Honoraria (self), Research grant / Funding (institution): MSD; Advisory / Consultancy: EMD Serono; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Genentech. F. Clatot: Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Elly Lilly. J. Miroir: Honoraria (self): Novartis; Honoraria (self): Merck. F. Rolland: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Travel / Accommodation / Expenses: Ipsen; Honoraria (self): Merck; Advisory / Consultancy: BMS; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: AstraZeneca. P. Crompton: Full / Part-time employment, employee: Debiopharm; Shareholder / Stockholder / Stock options: GSK. S. Brienza: Advisory / Consultancy, Full / Part-time employment, consultant: Debiopharm; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: EMD Serono. S.A. Szyldergemajn: Full / Part-time employment, employee: Debiopharm. C. Even: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck-Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Innate Pharma. Y. Tao: Research grant / Funding (institution): Debiopharm; Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Merck Serono. All other authors have declared no conflicts of interest.

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Proffered Paper – Head and neck cancer Proffered Paper session

1108O - Chemotherapy plus local-regional radiotherapy versus chemotherapy alone in primary metastatic nasopharyngeal carcinoma: A randomized, open-label, phase III trial (ID 5308)

Presentation Number
1108O
Lecture Time
10:27 - 10:39
Speakers
  • Mingyuan Chen (Guangzhou, Guangdong, China)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45

Abstract

Background

The role of locoregional radiotherapy in patients with primary metastatic nasopharyngeal carcinoma (mNPC) is unclear.

Methods

In our open-label, phase 3, multi-centre randomized controlled trial, patients with primary mNPC, staged at IVc at the diagnosis of NPC were enrolled. Key inclusion criteria were CR or PR evaluated by imaging study after three cycles of chemotherapy according to the RECST v1.1; a KPS of at least 70. Eligible patients were randomly assigned in a 1:1 ratio to receive either chemotherapy plus radiotherapy or chemotherapy alone. Chemotherapy regimens were fluorouracil at 5 g/m2 over 120 h and cisplatin at 100 mg/m2 on day 1 once every 3 weeks for a maximum of six cycles. The primary endpoint was OS. We did efficacy analyses in ITT population. Safety analyses were done in patients receiving allocated treatment. This study is registered with ClinicalTrials.gov, number NCT02111460, and is ongoing.

Results

Between April 2014 and August 2018, 126 eligible patients were randomly assigned to receive chemotherapy plus radiotherapy (n = 63), or chemotherapy alone (n = 63). In August 2018, the randomization was temporarily suspended due to an imbalance in deaths between the two groups and the ad hoc IDMC and the ethics committee of SYSUCC both recommended that the trial be permanently closed to new patient enrollment after IDMC confirmed the previously identified imbalance with this additional follow-up data in February 2019. The median follow-up time for OS was 25.2 months. The median OS was 40.2 months (95%CI 25.7-54.7) in the chemotherapy plus radiotherapy group and 24.5 months (95%CI 15.3-33.7) in the chemotherapy alone (HR 0.45 95% CI 0.25-0.80; P = 0.007). No significant differences between the two treatment groups were observed in terms of hematological toxicity and gastrointestinal reaction. The frequency of grade 2-3 skin reaction and grade 3-4 mucositis in chemotherapy plus radiotherapy was significantly higher than those in chemotherapy alone groups (P < 0.05).

Conclusions

Chemotherapy plus radiotherapy significantly improved overall survival in primary metastatic nasopharyngeal carcinoma with acceptable toxicity and tolerability.

Clinical trial identification

NCT02111460; Release date: April 11, 2014.

Legal entity responsible for the study

The author.

Funding

The Program of Sun Yat-sen University for Clinical Research 5010 Program (No.201310).

Disclosure

All authors have declared no conflicts of interest.

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Proffered Paper – Head and neck cancer Proffered Paper session

1109O - A phase II study of monalizumab in patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN): Results of the I1 cohort of the EORTC-HNCG-1559 trial (UPSTREAM) (ID 3257)

Presentation Number
1109O
Lecture Time
10:39 - 10:51
Speakers
  • Rachel Galot (Brussels, Belgium)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45

Abstract

Background

Patients (pts) with RM SCCHN progressing after platinum have a median overall survival (OS) of 7-8 months with nivolumab or pembrolizumab. No other drug has shown meaningful activity in this setting. HLA-E is a non-classical MHC molecule that is highly expressed in 70% of SCCHN. By binding to the NKG2A receptor expressed on NK cells and T-lymphocytes, HLA-E inhibits their cytotoxic function. Monalizumab (mona) is a human IgG4 antibody targeting the NKG2A receptor.

Methods

The UPSTREAM trial is a biomarker-driven umbrella trial of several targeted therapies and immunotherapy for RM SCCHN (post platinum, ECOG 0-1, measurable disease). The immunotherapy 1 (I1) cohort was a phase II, single arm, proof-of-concept substudy evaluating the efficacy of single agent mona. Non-eligible pts for the biomarker-driven cohorts were included in the I1 cohort. Mona was given as an infusion (10 mg/kg) on day 1 of each cycle (14 days). The primary endpoint was objective response rate (RECISTv1.1) during the first 16 weeks. A two-stage Simon design was used (H1 15%, H0 3%, α 8%, power 90%) with planned interruption of accrual if no response was seen after 25 pts. Secondary endpoints included toxicity (CTCAEv4.03), progression-free survival (PFS), response duration and OS.

Results

27 RM SCCHN pts were included in the 1st stage (median age: 62 yrs, oral cavity (26%), oropharynx (41%), hypopharynx (26%), larynx (7%)). 16 (59%) were pretreated with anti-PD(-L)1 compounds. No objective response was recorded. Stable disease was observed in 6 pts (22%). Disease progression was recorded in all but one patient and the median PFS was 7.4 wks (95% CI: 6.6-7.9 wks). Based on 16/27 deaths currently recorded, median OS was 27.7 wks (95% CI: 13-53.9 wks). Mona showed a favorable safety profile: 59% pts reported grade >/= 3 adverse events, none of them treatment-related. The final results of these preliminary data will be presented at ESMO.

Conclusions

The substudy of mona in monotherapy did not meet its primary objective and was closed at interim for futility. Median PFS was 7.4 wks. Mona has a favorable safety profile and is under investigation in combination with durvalumab within the UPSTREAM trial.

Clinical trial identification

NCT03088059.

Legal entity responsible for the study

EORTC.

Funding

EORTC, Innate Pharma.

Disclosure

R. Galot: Advisory / Consultancy: Innate Pharma; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Astellas. C. Le Tourneau: Advisory / Consultancy: MSD; Advisory / Consultancy: Merck-Serono; Advisory / Consultancy: BMS; Advisory / Consultancy: Amgen; Advisory / Consultancy: Roche; Advisory / Consultancy: GSK; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Nanobiotix. C. Even: Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Innate Pharma. L.F. Licitra: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Research grant / Funding (institution): EISAI; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck-Serono; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Debiopharm; Advisory / Consultancy, Research grant / Funding (institution): Sobi; Honoraria (self), Advisory / Consultancy, For teaching in medical meetings: Incyte Biosciences Italy srl; Advisory / Consultancy: Doxa Pharma; Honoraria (self), For public speaking in medical meetings: Amgen; Advisory / Consultancy: Nanobiotics; Advisory / Consultancy: GSK; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Exelixis; Research grant / Funding (institution): IRX Therapeutics; Research grant / Funding (institution): Pfizer. M. Kaminsky-Forrett: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): AstraZeneca; Advisory / Consultancy: EMD Serono. J. Machiels: Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: Innate Pharma; Honoraria (institution), Research grant / Funding (institution): Merck Serono; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (institution), Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (institution), Research grant / Funding (institution): Novartis; Honoraria (institution), Research grant / Funding (institution): Janssen; Honoraria (institution), Research grant / Funding (institution): Incyte; Research grant / Funding (institution), Travel / Accommodation / Expenses: Amgen; Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Data safety monitoring board with honoraria: Debio; Advisory / Consultancy, Data safety monitoring board with honoraria: Nanobiotix; Non-remunerated activity/ies, investigator and study coordinator: EORTC. All other authors have declared no conflicts of interest.

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Proffered Paper – Head and neck cancer Proffered Paper session

Invited Discussant LBA65, 1108O and 1109O (ID 6779)

Lecture Time
10:51 - 11:06
Speakers
  • Marco C. Merlano (Cuneo, Italy)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45
Proffered Paper – Head and neck cancer Proffered Paper session

1110O - Personalized treatment according to geriatric assessment in first-line recurrent and/or metastatic (R/M) head and neck squamous cell cancer (HNSCC) patients aged 70 or over: ELAN (ELderly heAd and Neck cancer) FIT and UNFIT trials (ID 3250)

Presentation Number
1110O
Lecture Time
11:06 - 11:18
Speakers
  • Joel Guigay (Nice, CEDEX 2, France)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45

Abstract

Background

The main challenges in patients (pts) > = 70y are to cope with the treatment benefit/risk ratio and tumor related symptoms; no standard systemic treatment has been validated. With GERICO-GORTEC groups, we developed a large prospective clinical program named ELAN to improve the management of elderly HNSCC using an adapted geriatric evaluation feasible in daily practice and to set new standards of care for these pts. We report the results of ELAN FIT and UNFIT trials dedicated to elderly R/M HNSCC pts.

Methods

To be included in one of the 2 trials, 1st line R/M SCCHN pts > = 70y must first be enrolled in ELAN-ONCOVAL study where they were classified as fit or unfit, using the ELAN geriatric evaluation (EGE). Comprehensive Geriatric Assessment was optional. Fit pts were proposed to be enrolled in the 2-stage phase II ELAN-FIT trial, which evaluated the cetuximab-carboplatin-5FU (EXTREME) combination in terms of efficacy (objective response at 12 weeks) and safety assessed by lack of grade > =4 toxicity and lack of loss of independence. Unfit pts were proposed to be enrolled in the randomized phase III ELAN-UNFIT trial, that compared 2 monotherapies, cetuximab (Cx) 500 mg/m² every 2 weeks versus weekly methotrexate (MTX) 40 mg/m² in terms of failure free survival (failures are progression, treatment stop, loss > = 2 points in Activities in Daily Living scale or death).

Results

160 pts were enrolled in the trials. The UNFIT trial was stopped after futility analysis. Main results are shown in the table.

ELAN-FIT trialELAN-UNFIT trial N = 82
Carbo-5FU-cetux (n = 78)CX arm (n = 41)MTX arm (n = 41)Pts PS ECOG 0-1 (n = 47) (2 arms together)Pts PS ECOG 2 (n = 35) (2 arms together)
Adverse events > =grade 424%27%22%13%40%
Objective response rateAt W12: 38% (central review)12%15%13%14%
OS median (months)14.7 (95%CI=11.0-18.2)4.6 (95%CI=2.4-7.3)4.6 (95%CI=2.3-7.7)7.3 (95%CI=4.6-9.6)2.1 (95%CI=1.5-3.2)
1-year OS rate58% (95%CI=46%-68%)22.5% (95% CI=12.3%-37.5%)14.6% (95% CI=6.9%-28.4%)27.7% (95% CI=16.9%-41.8%)5.9% (95% CI=1.6%-19.1%)
PFS median (months)7.1 (95%CI=5.5-8.2)2.4 (95%CI=1.5-3.8)2.8 (95%CI=1.6-4.2)3.8 (95%CI=2.6-5.5)1.5 (95%CI=1.2-2.3)
1-year PFS rate24.5% (95%CI=15.5%-34.6%)7.5% (95% CI=2.6%-19.9%)7.3% (95% CI=2.5%-19.4%)12.8% (95% CI=6.0%-25.2%)0%

Conclusions

Fit elderly pts as selected using EGE, benefited from carboplatin based EXTREME regimen, with promising overall survival (OS), which compares favourably with that of younger pts. For unfit elderly pts, there was no efficacy difference of Cx and MTX. PS ECOG 2 pts did not benefit from systemic treatment. New therapeutic options should be explored for ECOG 0-1 unfit elderly pts.

Clinical trial identification

ELAN-UNFIT: NCT01884623 ELAN-FIT: NCT01864772.

Legal entity responsible for the study

Gustave Roussy and GORTEC.

Funding

INCA PAIR, Merck, Sandoz, GEMLUC-GEFLUC.

Disclosure

J. Guigay: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Innate Pharma; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck. C. Even: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Innate Pharma. L. Geoffrois: Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self): Ipsen; Honoraria (self): Novartis; Travel / Accommodation / Expenses: Merck Serono. C. Sire: Travel / Accommodation / Expenses: Merck. J. Fayette: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Innate; Honoraria (self), Advisory / Consultancy: Biogen. F. Peyrade: Advisory / Consultancy: MSD; Advisory / Consultancy: Merck. P. Debourdeau: Non-remunerated activity/ies: Pfizer; Honoraria (self): Leo Pharma; Honoraria (self): Bayer. Y. Pointreau: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD. All other authors have declared no conflicts of interest.

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Proffered Paper – Head and neck cancer Proffered Paper session

1111O - Cisplatin reduces costs and provides more quality adjusted life years (QALYs) than cetuximab in chemoradiotherapy for patients with HPV-positive oropharyngeal cancer (HPV+OPC) (ID 2064)

Presentation Number
1111O
Lecture Time
11:18 - 11:30
Speakers
  • David A. Jones (Oxford, United Kingdom)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45

Abstract

Background

Results from De-ESCALaTE HPV confirmed the dominance of cisplatin over cetuximab chemoradiotherapy for tumour control in patients with HPV+OPC. We report a comparison of QoL, resource use and healthcare costs in both arms, as well as updated 24 month survival and recurrence.

Methods

At various intervals from baseline to 24 months post treatment (PT), patient reported QoL and resource use were assessed through the EQ-5D-5L and a trial-specific resource use questionnaire supplemented by case report forms. Healthcare costs were estimated by applying UK-based unit cost to resource use items. Missing data were imputed. Differences in mean EQ-5D-5L utility index and adjusted cumulative QALYs were compared using the Wilcoxon signed-rank test and linear regression respectively. Mean resource usage and costs were compared though two-sample t-tests.

Results

334 patients were randomised to cisplatin (n = 166) or cetuximab (n = 168). EQ-5D-5L utility index scores showed substantially lower mean QoL at the end of treatment for both study arms compared to baseline, before both recovering by 12 months PT. No significant differences between arms were detected at any time point. The difference in cumulative quality-adjusted survival, adjusted for baseline QoL, gender and comorbidities, widened over time and became significant at 6 months PT. By 24 months PT, mean difference was 0.107 QALYs in favour of cisplatin (95% CI: 0.029 to 0.186, p = 0.007), driven by the higher rate of mortality in the cetuximab arm. We found no statistically significant differences in the mean number or cost of hospital inpatient days, day case/outpatient visits, A&E visits, or primary/community care contacts. The cost of cetuximab-based chemoradiotherapy was, however, £7780 (P < 0.001) more expensive. Total costs at 24 months PT averaged £13517 (SE: £345) per patient for cisplatin and £21064 (SE: £400) for cetuximab. Treatment with cetuximab therefore significantly increased total cost per patient by £7547 (95% CI: £6512 to £8582).

Conclusions

When added to radiotherapy, cisplatin chemotherapy provided more QALYs and was less costly than cetuximab.

Clinical trial identification

NCT01874171.

Legal entity responsible for the study

Hisham Mohamed Mehanna.

Funding

Cancer Research UK.

Disclosure

H. Mehanna: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Spouse / Financial dependant: Warwickshire Head and Neck Clinic; Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi Pasteur; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck; Honoraria (self), Research grant / Funding (self): AstraZeneca; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Silence Therapeutics. All other authors have declared no conflicts of interest.

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Proffered Paper – Head and neck cancer Proffered Paper session

Invited Discussant 110O and 1111O (ID 6780)

Lecture Time
11:30 - 11:45
Speakers
  • Florence Huguet (Paris, France)
Location
Cordoba Auditorium (Hall 7), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
10:15 - 11:45