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Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial

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Abstract

Background

Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients.

Materials and methods

Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial.

Results

In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8–34.4), 26.2 (95% CI, 18.2–36.6) and 25.4 months (95% CI, 17.4–36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx–hypopharynx primary tumors treated with IC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.

Conclusion

After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx–hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team.

ClinicalTrials.gov identifier NCT00261703

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Acknowledgements

The authors thank the patients and the medical and nursing staff from all the participating institutions. Dr. Carral (Hospital Lucus Augusti, Lugo, Spain) and Dr. Pérez-Segura (Hospital Clínico San Carlos, Madrid, Spain). Statistics and Data Management: Pivotal. Support for third-party writing assistance for this manuscript was provided by Pivotal.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

  1. Medical Oncology Department, Hospital Universitario Severo Ochoa, Avda. de Orellana, s/n, 28911, Leganés (Madrid), Spain

    R. Hitt

  2. Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain

    L. Iglesias

  3. Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Calalunya, Spain

    A. López-Pousa

  4. Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain

    A. Berrocal-Jaime & A. J. Cunquero-Tomas

  5. Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain

    J. J. Grau & N. Baste

  6. Medical Oncology Department, Hospital Universitario de Burgos, Castilla y León, Spain

    C. García-Girón

  7. Medical Oncology Department, Hospital Universitario Miguel Servet, Aragón, Spain

    J. Martínez-Trufero

  8. Medical Oncology Department, Hospital del Mar, Barcelona, Spain

    M. Guix

  9. Cancer Research Program (CIBERONC), Institut Mar d Investigacions Mèdiques (IMM), Barcelona, Spain

    M. Guix

  10. Medical Oncology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain

    J. Lambea-Sorrosal

  11. Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain

    E. del Barco-Morillo, A. Ocaña & J. J. Cruz-Hernández

  12. Institute for Biomedical Research of Salamanca (IBSAL), Castilla y León, Spain

    E. del Barco-Morillo, A. Ocaña & J. J. Cruz-Hernández

  13. ENT Department, Hospital de la Santa Creu i Sant Pau, Catalunya, Spain

    X. León-Vintró

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  1. R. Hitt
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  2. L. Iglesias
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Consortia

the Spanish Head and Neck Cancer Cooperative Group (TTCC)

Corresponding author

Correspondence to R. Hitt.

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Conflict of interest

R. Hitt has received honoraria for advisory role from Merck. L. Iglesias has received honoraria for advisory role from Merck, Serono, MSD, BMS, Bayer, Sanofi, AstraZeneca, Novartis and Kura Oncology. A. Berrocal-Jaime has received honoraria for advisory role from BMS, MSD, Roche, Novartis, Pierre Fabre, Merck, Pfizer, Sanofi and Incyte. J. Martínez-Trufero has received honoraria for advisory role from Pharmamar, Merck, Lilly, Eisai, BMS and Bayer. J. Lambrea-Sorrosal has received honoraria for advisory role from Merck, Sanofi, MSD and BMS. E. del Barco-Morillo has received honoraria for advisory role from Roche and AstraZeneca. A. J. Cunquero-Tomas has received honoraria for advisory role from Novartis, Roche, Merck, BMS and Pierre-Fabré. N. Baste has received honoraria for advisory role from Merck, Nanobiotics, AstraZeneca, MSD and BMS. J. J. Cruz has received honoraria for advisory role from Merck, BMS, MSD, Roche, Astra Zeneca and Novartis. All remaining authors have declared no conflicts of interest.

Ethical approval

The study was conducted following the local and national regulations (Spanish agency: Agencia Nacional del Medicamento), including the ethical approval of the ethics committee in each hospital and in compliance with the Helsinki declaration.

Informed consent

All patients received and signed an informed consent following the local and national regulations.

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Hitt, R., Iglesias, L., López-Pousa, A. et al. Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial. Clin Transl Oncol 23, 764–772 (2021). https://doi.org/10.1007/s12094-020-02467-8

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