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Head and neck cancer, excluding thyroid

2417 - First line Cetuximab and Cisplatin with or without Paclitaxel in recurrent/metastatic head and neck cancer: a randomized phase IIb trial

Date

09 Sep 2017

Session

Head and neck cancer, excluding thyroid

Topics

Cytotoxic Therapy;  Head and Neck Cancers

Presenters

Paolo Bossi

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

P. Bossi1, L.H. Hollander2, R. Miceli3, D. Ferrari4, S. Vecchio5, G. Moretti6, M. Merlano7, F. Caponigro8, C. Moro9, E. Vaccher10, O. Alabisio11, A. Caldara12, A. Russo13, F. Ferrau14, F. Nolè15, L. Licitra16

Author affiliations

  • 1 Head And Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Oncology, IRCCS Istituto di ricerche farmacologiche Mario Negri, 20156 - Milan/IT
  • 3 Department Of Medical Statistics, Biometry And Bioinformatics, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 4 Medical Oncology, Ospedale San Paolo, 20154 - Milan/IT
  • 5 Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova/IT
  • 6 Medical Oncology, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
  • 7 Clinical Oncology, Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 8 Medical Oncology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 9 Medical Oncology, Azienda Ospedaliera Papa Giovanni XXIII, 24127 - Bergamo/IT
  • 10 Medical Oncology, Centro di Riferimento Oncologico, 33081 - Aviano/IT
  • 11 Medical Oncology, A.O. Universitaria Maggiore della Carità, 28100 - Novara/IT
  • 12 Medical Oncology, Ospedale Santa Chiara, 38122 - Trento/IT
  • 13 Medical Oncology, AOU Policlinico "Paolo Giaccone", 90127 - Palermo/IT
  • 14 Medical Oncology, Ospedale San Vincenzo, 98039 - Taormina/IT
  • 15 Medical Oncology, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 16 Head And Neck Medical Oncology Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
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Resources

Abstract 2417

Background

Cisplatin (Cis), continuous infusion 5FU and Cetuximab (Cet) (EXTREME) first-line treatment extends overall survival (OS) over Cis and 5FU of recurrent/metastatic squamous cell head and neck cancer (RM SCCHN) patients. In EXTREME, Cet has been added to a 2-drug combination, which has never shown superiority over any single drug. In this scenario, we are left with an open question about the significance of adding 1 or 2 drugs to biotherapy. In addition, a significant number of pts are excluded from EXTREME for the high incidence of ≥ G3 adverse events (AEs) (>80%), most of them attributable to 5FU. Paclitaxel (P) is active and safe, both alone and with Cis. We conducted a phase IIb trial comparing a 2-drug Cet-Cis regimen with a 3-drug combination (substituting 5FU with P) in terms of progression-free survival (PFS) and tolerability.

Methods

Eligible pts had confirmed untreated R/M SCCHN. Pts were randomized to a 3 vs. a 2-drug combination (Cet + Cis w/o P) with maintenance Cet after 6 cycles. Primary endpoint was PFS; secondary end-points were overall survival (OS), response rate (RR) and toxicity. We assumed a non-inferiority margin of 1.40 as compatible with efficacy.

Results

200 pts were randomized and 191 evaluable. Pt characteristics were balanced in the 2 arms. Inferiority hypothesis was rejected (upper limit of one-sided 90% CI of PFS hazard ratio

Conclusions

A 2-drug Cet and Cis regimen proved to be non-inferior in PFS to a 3-drug combination with Cet, Cis and P. The median OS of both regimens is comparable with the 10.1 mos in EXTREME, while life-threatening toxicity rate appeared reduced. These regimens warrant further investigation as a backbone to immunotherapeutic agents.

Clinical trial identification

EudraCT: 2011-002564-24

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale Tumori Milano

Funding

Merck Serono

Disclosure

All authors have declared no conflicts of interest.

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