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Poster Display session 3

4036 - Final results of a phase II study of induction chemotherapy (CT) with paclitaxel (PTX) and panitumumab (P) followed by radiotherapy (RT) and P in patients (pts) with locally advanced head and neck cancer (LAHNC) no candidates to platinum: study PANTERA

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Head and Neck Cancers

Presenters

Javier Martinez Trufero

Citation

Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252

Authors

J. Martinez Trufero1, R. Mesia Nin2, M.E. Ortega Izquierdo3, A. Lozano4, B. Cirauqui Cirauqui5, J. Rubió Casadevall6, M. Taberna Sanz7, M. Pastor Borgoñon8, J. Lambea Sorrosal9, L. Iglesias10, S. Vázquez7, E. del Barco Morillo11, P. Perez Segura12, A. Lopez Pousa13, J.M. Ponce14, J.J. Cruz-Hernández15

Author affiliations

  • 1 Dept. Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 2 Medical Oncology Department, Institut Català d'Oncologia, Badalona/ES
  • 3 Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza/ES
  • 4 Servicio De Oncología Radioteràpica, Hospital Duran i Reynals, Hospitalet de Llobregat/ES
  • 5 Medical Oncology Department, Catalan Institute of Oncology (ICO)., Badalona/ES
  • 6 Medical Oncology, University Hospital Josep Trueta, Girona/ES
  • 7 Department Of Medical Oncology, Catalan Institute of Oncology (ICO), Hospital Duran i Reynals, ONCOBELL, IDIBELL, 08907 - L'Hospitalet Barcelona/ES
  • 8 Servicio De Oncología Médica, Hospital Universitario y Politecnico La Fe, Valencia/ES
  • 9 Servicio De Oncología Médica, Hospital Clínico Universitario de Zaragoza, Zaragoza/ES
  • 10 Oncology, University Hospital 12 de Octubre, Madrid/ES
  • 11 Instituto De Investigación Biomédica De Salamanca, Instituto de Investigación Biomédica de Salamanca, Salamanca/ES
  • 12 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 13 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 08041 - Barcelona/ES
  • 14 Medical, UCMORA Zaragoza, Zaragoza/ES
  • 15 Oncología Médica, Hospital Universitario de Salamanca, Salamanca/ES

Resources

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Abstract 4036

Background

Patients (pts) not candidates to platinum-based therapies have limited therapeutic options. The addition of P to PTX followed by RT + P may be an alternative to platinum-based therapy. This study aimed to evaluate the activity of P + PTX as induction treatment (Tx) in pts with LAHNC.

Methods

Phase II, single arm, multicenter study, in pts≥18 years with CT/RT-naive stage III-IVb LAHNC not candidates to aggressive Tx. All pts received PTX (80 mg/m2/week [w]) + P (6 mg/kg every 2w) during 9w as induction Tx followed by P and RT (70 Gy/35 fractions/7w).The primary endpoint was RR after induction Tx. With a Simon’s two stage design, p1 at the end of the study was defined as > 36 of 61 patients achieving complete (CR) or partial response (PR) to induction Tx.

Results

The study included 51 pts: median 70 years (range 45-84), 98% men. Reasons for cisplatin ineligibility: > 70 years old in 3 pts, mild or moderate adult comorbidity [ACE-27 comorbidity index] in 46 pts, severe adult comorbidity in 1 pt and ECOG: 2 in 1 pt. RR after induction was 66.7% (95% confidence interval [CI]: 53.7-79.6): 8 (15.7%) CR and 26 (51.0%) PR. Median progression-free survival was 12.2 months (m) (95% CI: 7.6 - 35.0] and median overall survival was 31.5 m (95%: 14.3 - not reached) with a median duration of follow-up of 31.9 m (range, 1-61). Incidence of grade 3/4 P and/or PTX-related Adverse Events (AEs) was 72.5%. Most frequent grade 3/4 P and/or PTX- related AEs (>5% of pts) were: 5.9% dermatitis, 5.9% neutropenia, 5.9% dry mouth, 5.9% stomatitis, 7.8% asthenia, 15.7% eruption, 15.7% skin toxicity and 27.5% mucosal inflammation. Five (9.8%) pts had fatal AEs, 2 (3.9%) of them related to P and/or PTX.

Conclusions

Despite the study ended prematurely, the RR observed is higher than the pre-specified boundary to consider the treatment active to justify further studies. PTX combined with P as induction Tx provide a clinically significant benefit with an acceptable safety profile.

Clinical trial identification

2012-003038-17.

Editorial acknowledgement

Marta Muñoz-Tudurí (TFS, S.L.).

Legal entity responsible for the study

Study carried out by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC).

Funding

Amgen S.A.

Disclosure

J. Martinez Trufero: Advisory / Consultancy: PharmaMar, Merck, Lilly, Eisai, Bristol-Myers; Honoraria (self), Medical meetings sponsor: PharmaMar, Merck, Lilly, Eisai. R. Mesia Nin: Advisory / Consultancy: Merck, BMS, MSD, AZ, Roche, Nanobiotix; Speaker Bureau / Expert testimony: Merck, BMS, MSD. M. Taberna Sanz: Non-remunerated activity/ies: Merck; Non-remunerated activity/ies: AstraZeneca; Honoraria (self): Merck; Honoraria (self): Nanobiotics; Honoraria (self): MSD; Honoraria (self): Bristol Myers. J. Lambea Sorrosal: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck-Serono, MSD, Bristol. All other authors have declared no conflicts of interest. L. Iglesias: Honoraria (self), Advisory / Consultancy: Merck Serono, MSD, BMS, Bayer, Sanofi; Honoraria (self), medical education with honoraria: Merck Serono, MSD, AstraZeneca y BMS; Research grant / Funding (institution): Merck Serono, MSD, AstraZeneca, BMS, Novartis, Kura Oncology, Sanofi y Kura Oncology. P. Perez Segura: Speaker Bureau / Expert testimony: BMS, Merck. J.J. Cruz-Hernández: Honoraria (self): Amgen, AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Roche; Advisory / Consultancy, Advisory Board: Bristol-Myers Squibb, Merck, MSD, Roche, Pfizer, Janssen Cilag; Advisory / Consultancy, Consulting: Roche.

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