Evidence map›Paper›PMID 41962312›Full record

Trial reportESMO open2026

Durvalumab combined with weekly carboplatin/paclitaxel as first-line treatment of patients with recurrent and/or metastatic HNSCC not eligible for cisplatin-based chemotherapies: results of the multicenter prospective study FRAIL-IMMUNE.

J Fayette, C Cropet, C Toullec, M Burgy, A Bruyas, C Sire, A Lagrange, F Clatot, M Vinches, M Iacob and 9 more

Abstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

J FayetteMedical Oncology, Centre Léon Bérard, Lyon, France. Electronic address: jerome.fayette@lyon.unicancer.fr.
C CropetDepartment of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
C ToullecMedical Oncology, Institut Sainte-Catherine, Avignon, France.
M BurgyMedical Oncology, Centre Paul Strauss, Strasbourg, France.
A BruyasMedical Oncology, Hôpital de la Croix-Rousse, Lyon, France.
C SireMedical Oncology, Groupe Hospitalier Bretagne Sud, Lorient, France.
A LagrangeMedical Oncology, Centre Georges François Leclerc, Dijon, France.
F ClatotMedical Oncology, Centre Henri Becquerel, Rouen, France.
M VinchesMedical Oncology, Institut de Cancérologie de Montpellier, Montpellier, France.
M IacobMedical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.
L MartinMedical Oncology, Clinique des Ormeaux, Le Havre, France.
M-C KaminskyMedical Oncology, Institut de Cancérologie de Lorraine Alexis Vautrin, Nancy, France.
D VansteeneMedical Oncology, Institut de Cancérologie de l'Ouest René Gauducheau, St Herblain, France.
S SalasMedical Oncology, Hôpital de la Timone, Marseille, France.
A ChampagnacBiopathology Department, Centre Léon Bérard, Lyon, France.
P SaintignyDepartment of Translational Medicine, Centre Léon Bérard, Lyon, France.
J GautierDepartment of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
D PérolDepartment of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
J BourhisGroupe d'Oncologie et de Radiothérapie de la Tête et du Cou (GORTEC), Tours, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPembrolizumab, combined with platinum-5-FU or as a monotherapy, is the standard treatment of patients with recurrent and/or metastatic (R/M) head and neck squamous-cell carcinoma (HNSCC). This treatment is used exclusively in programmed death-ligand 1 (PD-L1)-positive patients in Europe, whereas it is used in the USA regardless of PD-L1 status. However, substantial toxicities, notably those related to cisplatin-based chemotherapy, preclude the use of combination therapy in fragile patients. We investigated the efficacy and tolerance of first-line durvalumab combined with weekly carboplatin/paclitaxel in R/M HNSCC patients who were ineligible for cisplatin. PATIENTS AND

methodsThis prospective multicenter single-arm phase II study assessed tolerance in R/M HNSCC patients with an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-1 (run-in phase study feasibility, then cohort A) and ECOG-PS 2 (cohort B), frail, not eligible for standard cisplatin-based chemotherapy. In the first-line, patients received four 28-day chemotherapy cycles (carboplatin AUC2; paclitaxel 80 mg/m

resultsFrom 16 May 2019 to 4 March 2021, 64 patients with an ECOG-PS of 1 (cohort A) from 13 French authorized centers (hospital, cancer centers) were included and received study treatments. Cohort B enrolled 40 patients with an ECOG-PS of 2 from 25 Aug 2021 and 9 March 2023 and 39 were assessable. With 40 patients with an ECOG-PS of 0-1 [62.5%, unilateral 95% confidence interval (CI) 51.5%-∞], and 20 patients with an ECOG-PS of 2 (51.3%, unilateral 95% CI 37.1%-∞) alive at 12 months, the study met its primary endpoints.

conclusionsThe promising results in frail patients with an ECOG-PS of 0-1 and 2 encourages further investigation of durvalumab with weekly carboplatin/paclitaxel in first-line R/M HNSCC patients in a comparative phase III clinical trial.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarboplatinHead and Neck NeoplasmsNeoplasm Recurrence, LocalPaclitaxelSquamous Cell Carcinoma of Head and NeckAgedCisplatinFemaleHumansMaleMiddle AgedProspective StudiesAntibodies, MonoclonalCarboplatinCisplatindurvalumabPaclitaxelcarboplatincisplatin ineligibilityimmunotherapypaclitaxelrecurrent and/or metastatic head and neck squamous-cell carcinoma (R/M HNSCC)weekly chemotherapy

Identifiers

PMID41962312
PMCPMC13091201

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.