Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial

Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel–platinum–cetuximab) showed promising results, with a median overall survival of 14·0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and saf...

Full description

Saved in:
Bibliographic Details
Published in:The lancet oncology 2021-04, Vol.22 (4), p.463-475
Main Authors: Guigay, Joël, Fayette, Jérôme, Saada-Bouzid, Esma, Martin, Laurent, Capitain, Olivier, Castanie, Hélène, Vansteene, Damien, Schafhausen, Philippe, Johnson, Alison, Even, Caroline, Duplomb, Sophie, Evrard, Camille, Laguerre, Brigitte, Chevassus-Clément, Cécile, Sinigaglia, Laura, Keilholz, Ulrich, Bourhis, Jean, Mesia, Ricard, BABA-HAMED, Nabil, BABIN, Emmanuel, BERA, Guillaume, BETRIAN-LAGARDE, Sarah, BLOT, Emmanuel, BOREL, Christian, BRUYAS, Amandine, CALAIS, Gilles, CARPIUC, Ioana, CHAPET, Sophie, CHATELLIER, Thierry, CHELI, Sandrine, CLATOT, Florian, COJOCARASU, Oana, COUTTE, Alexandre, DALLOZ, Pierre, DELHOMMEAU, Melissa, DE RAUCOURT, Dominique, DEBOURDEAU, Philippe, DUBOS-ARVIS, Catherine, DUCOULOMBIER, Agnès, EL KOURI, Claude, FALKOWSKI, Sabrina, FERRAND, François-Regis, GATINEAU, Michel, GERVAIS, Radj, GRAS, Louis, HASBINI, Ali, HENAULT, Stéphane, HERRERA GOMEZ, Ruth Gabriela, HUGUET, Florence, LAGRANGE, Aurélie, LE FOLL, Christine, LINOT, Benjamin, LOPEZ, Qian, MAYACHE-BADIS, Lamia, MINNE, Floriane, NEIDHARDT, Eve Marie, PAVILLET, Julien, PEYRADE, Frédéric, POINTREAU, Yohann, RAMEE, Jean-François, RAUCHE, Camille, RICHARD, Sandrine, RIZZO, Claudia, ROLLAND, Frédéric, STEFANI, Laetitia, THERY, Jean-Christophe, TOULLEC, Clémence, TOURANI, Jean-Marc, TOUSSAINT, Philippe, VAULEON, Elodie, VIRET, Frédéric, WALER, Sabine, ATZPODIEN, Jens, FIETKAU, Rainer, GRANIZKA, Thordis, GUNTINAS-LICHINUS, Orlando, HADLER-MIKESCH, Kristina, HAHN, Dennis, INHESTERN, Johanna, KELLNER, Karolin, KLINGHAMMER, Konrad, KRONENBERGER, Roland, LUEDTKE-HECKENKAMP, Kerstin, PIRLICH, Markus, ROTHMANN, Frank, TOMETTEN, Mareike, WOHLFARTH, Sabine, ZEBRALLA, Veit, ZIPFEL, Matthias, ADANSA KLEIN, Juan Carlos, ARRAZUBI, Virginia, CABALLERO DAROQUI, Javier, CASTELO, Beatriz, GALLEGO, Oscar, IGLESIAS DOCAMPO, Lara Carmen, MARTINEZ DEL PRADO, Maria, MARTINEZ-TRUFERO, Javier, PASTOR BORGONON, Miguel, PEREZ RUIZ, Elisabeth, RUBIO CASADEVALL, Jordi
Format: Article
Language:English
Subjects:
5-Fluorouracil
Adult
Adverse events
Aged
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Cancer therapies
Cetuximab - administration & dosage
Chemotherapy
Cisplatin
Cisplatin - administration & dosage
Colony-stimulating factor
Contraindications
Disease control
Docetaxel - administration & dosage
Dosage
Female
Fluorouracil - administration & dosage
France - epidemiology
Germany - epidemiology
Granulocyte colony-stimulating factor
Head & neck cancer
Humans
Immunotherapy
Infections
Intravenous administration
Leukocytes (granulocytic)
Male
Metastases
Metastasis
Middle Aged
Monoclonal antibodies
Neoplasm Metastasis
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - epidemiology
Neoplasm Recurrence, Local - pathology
Neutropenia
Patients
Pembrolizumab
Platinum
Platinum - administration & dosage
Quality of life
Safety
Sepsis
Septic shock
Solid tumors
Spain - epidemiology
Squamous cell carcinoma
Squamous Cell Carcinoma of Head and Neck - drug therapy
Squamous Cell Carcinoma of Head and Neck - epidemiology
Squamous Cell Carcinoma of Head and Neck - pathology
Targeted cancer therapy
Toxicity
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel–platinum–cetuximab) showed promising results, with a median overall survival of 14·0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum–fluorouracil–cetuximab) in this setting. This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18–70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m2 on day 1 of cycle 1 and 250 mg/m2 weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m2 was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m2 on day 1–4, cisplatin 100 mg/m2 on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m2 on day 1 of cycle 1 and 250 mg/m2 weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m2 cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695. Between Oct 10, 2014, and Nov 29, 2017, 541 pa
ISSN:1470-2045
1474-5488
DOI:10.1016/S1470-2045(20)30755-5