Literature DB >> 30481287

OPTIMA: a phase II dose and volume de-escalation trial for human papillomavirus-positive oropharyngeal cancer.

T Y Seiwert1, C C Foster2, E A Blair3, T G Karrison4, N Agrawal3, J M Melotek2, L Portugal3, R J Brisson5, A Dekker1, S Kochanny1, Z Gooi3, M W Lingen6, V M Villaflor7, D T Ginat8, D J Haraf2, E E Vokes9.   

Abstract

BACKGROUND: Patients with HPV+ oropharyngeal squamous cell carcinoma were assigned to dose and volume de-escalated radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy in an effort to limit treatment-related toxicity while preserving efficacy. PATIENTS AND METHODS: Patients were classified as low-risk (≤T3, ≤N2B, ≤10 pack-year history) or high-risk (T4 or ≥N2C or >10 PYH). After three cycles of carboplatin/nab-paclitaxel, response was assessed using Response Evaluation Criteria in Solid Tumors 1.1. Low-risk patients with ≥50% response received 50 Gray (Gy) RT (RT50) while low-risk patients with 30%-50% response or high-risk patients with ≥50% response received 45 Gy CRT (CRT45). Patients with lesser response received standard-of-care 75 Gy CRT (CRT75). RT/CRT was limited to the first echelon of uninvolved nodes. The primary end point was 2-year progression-free survival compared with a historic control of 85%. Secondary end points included overall survival and toxicity.
RESULTS: Sixty-two patients (28 low risk/34 high risk) were enrolled. Of low-risk patients, 71% received RT50 while 21% received CRT45. Of high-risk patients, 71% received CRT45. With a median follow-up of 29 months, 2-year PFS and OS were 95% and 100% for low-risk patients and 94% and 97% for high-risk patients, respectively. The overall 2-year PFS was 94.5% and within the 11% noninferiority margin for the historic control. Grade 3+ mucositis occurred in 30%, 63%, and 91% of the RT50, CRT45, and CRT75 groups, respectively (P = 0.004). Rates of any PEG-tube use were 0%, 31%, and 82% for RT50, CRT45, and CRT75 groups, respectively (P < 0.0001).
CONCLUSIONS: Induction chemotherapy with response and risk-stratified dose and volume de-escalated RT/CRT for HPV+ OPSCC is associated with favorable oncologic outcomes and reduced acute and chronic toxicity. Further evaluation of induction-based de-escalation in large multicenter studies is justified. CLINICAL TRIAL REGISTRATION: Clinical trials.gov identifier: NCT02258659.
© The Author(s) 2018. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Entities:  

Keywords:  chemoradiation; human papillomavirus; induction chemotherapy; oropharyngeal cancer; treatment de-escalation

Year:  2019        PMID: 30481287     DOI: 10.1093/annonc/mdy522

Source DB:  PubMed          Journal:  Ann Oncol        ISSN: 0923-7534            Impact factor:   32.976


  34 in total

1.  Metastatic HPV-Associated Oropharyngeal Versus Primary Pulmonary Squamous Cell Carcinoma: is p16 Immunostain Useful?

Authors:  Jefree J Schulte; Jamie Steinmetz; Larissa V Furtado; Aliya N Husain; Mark W Lingen; Nicole A Cipriani
Journal:  Head Neck Pathol       Date:  2020-04-29

Review 2.  Induction Chemotherapy in Low-Risk HPV+ Oropharyngeal Cancer.

Authors:  James M Dolezal; Ari J Rosenberg
Journal:  Curr Treat Options Oncol       Date:  2022-02-16

Review 3.  Advances in Imaging for HPV-Related Oropharyngeal Cancer: Applications to Radiation Oncology.

Authors:  Travis C Salzillo; Nicolette Taku; Kareem A Wahid; Brigid A McDonald; Jarey Wang; Lisanne V van Dijk; Jillian M Rigert; Abdallah S R Mohamed; Jihong Wang; Stephen Y Lai; Clifton D Fuller
Journal:  Semin Radiat Oncol       Date:  2021-10       Impact factor: 5.421

Review 4.  Nano-Based Approved Pharmaceuticals for Cancer Treatment: Present and Future Challenges.

Authors:  Francisco Rodríguez; Pablo Caruana; Noa De la Fuente; Pía Español; María Gámez; Josep Balart; Elisa Llurba; Ramón Rovira; Raúl Ruiz; Cristina Martín-Lorente; José Luis Corchero; María Virtudes Céspedes
Journal:  Biomolecules       Date:  2022-06-04

Review 5.  HPV-associated oropharyngeal cancer de-escalation strategies and trials: Past failures and future promise.

Authors:  Kaveh Zakeri; Lara Dunn; Nancy Lee
Journal:  J Surg Oncol       Date:  2021-09-30       Impact factor: 2.885

Review 6.  Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.

Authors:  Elaine O Bigelow; Tanguy Y Seiwert; Carole Fakhry
Journal:  Oral Oncol       Date:  2020-04-02       Impact factor: 5.337

Review 7.  Optimizing Treatment De-Escalation in Head and Neck Cancer: Current and Future Perspectives.

Authors:  Ari J Rosenberg; Everett E Vokes
Journal:  Oncologist       Date:  2020-09-21

Review 8.  Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy.

Authors:  Nicolette Taku; Li Wang; Adam S Garden; David I Rosenthal; G Brandon Gunn; William H Morrison; C David Fuller; Jack Phan; Jay P Reddy; Amy C Moreno; Michael T Spiotto; Gregory Chronowski; Shalin J Shah; Lauren L Mayo; Neil D Gross; Renata Ferrarotto; X Ronald Zhu; Xiaodong Zhang; Steven J Frank
Journal:  Curr Treat Options Oncol       Date:  2021-06-04

9.  Low-risk human papilloma virus positive oropharyngeal cancer with one positive lymph node: Equivalent outcomes in patients treated with surgery and radiation therapy versus surgery alone.

Authors:  Reilly A Sample; Carey Burton Wood; Angela L Mazul; Thomas F Barrett; Randal C Paniello; Jason T Rich; Stephen Y Kang; Jose Zevallos; Mackenzie D Daly; Wade L Thorstad; Stephanie Y Chen; Patrik Pipkorn; Ryan S Jackson; Sidharth V Puram
Journal:  Head Neck       Date:  2021-02-15       Impact factor: 3.821

Review 10.  De-Escalation Strategies of (Chemo)Radiation for Head-and-Neck Squamous Cell Cancers-HPV and Beyond.

Authors:  Alexander Rühle; Anca-Ligia Grosu; Nils H Nicolay
Journal:  Cancers (Basel)       Date:  2021-05-04       Impact factor: 6.639

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