Protocolos de tratamiento de disminución de dosis para el carcinoma escamocelular orofaríngeo asociado con el papilomavirus humano
Información
- DOI:
- https://doi.org/10.1002/14651858.CD010271.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 15 febrero 2014see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Enfermedades de oído, nariz y garganta
- Copyright:
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- Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
Liam Masterson (LM) conceived, designed and managed the review.
LM, Daniel Moualed (DM) and Ajmal Masood (AM) screened the titles and abstracts. DM and AM organised retrieval of papers.
LM, DM and AM screened the retrieved papers against the inclusion criteria, appraised the quality of the papers and extracted data.
LM, DM and AM all obtained additional data on published studies.
LM entered data into RevMan 5 (RevMan 2012) and was responsible with DM and AM for data management in the review and analysis of the data.
Raghav C Dwivedi (RCD), Kirsty Rhodes (KR), Richard Benson (RB), Jane Sterling (JS), Holger Sudhoff (HS), Piyush Jani (PJ) and Peter Goon (PG) provided a methodological and clinical perspective.
Sources of support
Internal sources
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Cambridge University Hospitals NHS Trust, UK.
External sources
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LM and PG received a grant from Cancer Research UK (A14962) in support of this work, UK.
Declarations of interest
Liam Masterson: none known.
Daniel Moualed: none known.
Ajmal Masood: none known.
Raghav C Dwivedi: none known.
Richard Benson: none known.
Jane C Sterling: none known.
Kirsty M Rhodes: none known.
Holger Sudhoff: none known.
Piyush Jani: none known.
Peter Goon: none known.
Acknowledgements
We acknowledge the very helpful contributions made by the editorial team of the Cochrane ENT Disorders Group.
Version history
| Published | Title | Stage | Authors | Version |
| 2014 Feb 15 | De‐escalation treatment protocols for human papillomavirus‐associated oropharyngeal squamous cell carcinoma | Review | Liam Masterson, Daniel Moualed, Ajmal Masood, Raghav C Dwivedi, Richard Benson, Jane C Sterling, Kirsty M Rhodes, Holger Sudhoff, Piyush Jani, Peter Goon | |
| 2012 Dec 12 | Non‐surgical interventions for human papilloma virus‐positive local advanced oropharyngeal squamous cell cancer | Protocol | Liam Masterson, Daniel Moualed, Ajmal Masood, Richard Benson, Jane C Sterling, Holger Sudhoff, Piyush Jani, Peter Goon | |
Differences between protocol and review
At the request of the Cochrane ENT Group editorial team we recruited further authors with expertise in systematic research methodology (RCD and KR).
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Humans;
PICO
Study flow diagram.
| Trial | Description |
| A prospective clinical trial without randomisation investigating serum/tissue biomarkers, which may determine the success or failure of cetuximab therapy in 16 patients with locally advanced oropharyngeal SCC. HPV status was noted at baseline | |
| A case‐control study evaluating the responsiveness of HPV‐positive and HPV‐negative oropharyngeal cancer to intensity‐modulated radiotherapy (IMRT), using axial imaging obtained daily during the course of image‐guided radiotherapy (IGRT). HPV status was noted at baseline | |
| A prospective study without randomisation investigating 62 patients with locally advanced oropharyngeal SCC who were treated by induction chemotherapy with intravenous paclitaxel and carboplatin followed by concomitant weekly intravenous paclitaxel and standard fractionation radiation therapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective study without randomisation, which evaluated the tolerability and clinical efficacy of combined oxaliplatin and pemetrexed as an induction chemotherapy regimen in 27 patients with locally advanced oropharyngeal SCC. A minority of patients consented to HPV status determination by a post hoc analysis | |
| A prospective trial without randomisation investigating the efficacy of combining cetuximab with chemotherapy in 41 patients with locally advanced oropharyngeal SCC. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective study without randomisation, which investigated biomarkers in 274 patients with locally advanced oropharyngeal SCC. The patients were recruited from an existing randomised trial comparing radiotherapy/cisplatin with tirapazamine/cisplatin. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples is an ongoing phase II trial that is open‐label and non‐randomised). The study has so far enrolled 7 patients diagnosed as having stage III‐IV primary oropharyngeal SCC with HPV status ascertained at baseline. Patients will undergo an attenuated chemoradiotherapy regimen with the first results due in September 2015 | |
| A prospective study without randomisation, which investigated 358 patients with locally advanced oropharyngeal SCC. The patients were recruited from an existing randomised trial comparing altered fractionation radiotherapy with chemoradiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective study without randomisation, which investigated the clinical outcomes of 38 patients with stage III‐IV HNSCC. Patients were recruited from an existing phase II trial (Eastern Cooperative Oncology Group 2303) of induction chemotherapy with weekly cetuximab, paclitaxel and carboplatin x 6 followed by chemoradiotherapy with weekly cetuximab. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective study without randomisation, which investigated 52 patients with locally advanced oropharyngeal SCC. The patients received either concomitant boost (69.2 Gy) or conventionally fractionated (70 Gy) radiotherapy, with concurrent paclitaxel/carboplatin. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective study without randomisation, which investigated 66 patients with oropharyngeal SCC. The purpose of the study was to analyse the influence of HPV infection on the outcome of a randomised clinical trial (p‐CAIR) of conventional versus 7 days per week postoperative radiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A prospective cohort study of 169 patients with locally advanced oropharyngeal SCC treated with chemoradiation therapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| HNSCC: head and neck squamous cell carcinoma | |
| Trial | Description |
| This double‐blind, placebo‐controlled study investigated the clinical outcomes of 331 patients with early and late‐stage HNSCC. Participants were recruited from an existing nationwide cohort (Danish Head and Neck Cancer Group). All participants were treated by conventional radiotherapy +/‐ nimorazole. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) | |
| This trial investigated the clinical outcomes of 794 patients with early and late‐stage HNSCC. Participants were recruited from an existing nationwide cohort (Danish Head and Neck Cancer Group) who were all treated by either conventional or accelerated radiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) | |
| 323 patients with locally advanced oropharyngeal SCC were included in this study. The patients were recruited from an existing randomised trial comparing standard fractionation radiotherapy with accelerated fractionation radiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) | |
| This study investigated the concurrent use of cetuximab with cisplatin and radiation in 895 patients with locally advanced HNSCC. The study was terminated early at the third interim analysis because there was a less than 10% chance the study would be positive for the primary endpoint (only data from the experimental arm were available for analysis). Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 status (a post hoc analysis from pre‐treatment biopsy samples) | |
| 190 patients with locally advanced oropharyngeal SCC were included in this study. The patients were recruited from an existing randomised trial comparing 4 different radiotherapy protocols. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) | |
| 111 patients with locally advanced stage oropharyngeal SCC. The patients were recruited from an existing randomised trial (TAX 324) comparing induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| 185 patients with stage III‐IV oropharyngeal SCC. The patients were recruited from an existing phase III randomised trial (Trans‐Tasman Radiation Oncology Group 02.02) comparing concurrent radiotherapy and cisplatin with or without tirapazamine. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) | |
| HNSCC: head and neck squamous cell carcinoma | |
| Trial | Description |
| A phase I prospective trial investigating de‐intensification chemoradiation protocols in 40 patients with either early or late‐stage oropharyngeal SCC. HPV‐positive status formed part of the inclusion criteria. The study design is not appropriate for inclusion as it was not randomised and incorporated a planned surgical intervention (neck dissection) 1 to 3 months after completion of medical therapy | |
| A phase II trial that is open‐label and non‐randomised. The study will enrol 36 patients diagnosed as having stage III‐IV oropharyngeal SCC with HPV status ascertained at baseline. Patients will undergo an attenuated chemoradiotherapy regimen with the first results due in January 2021 | |
| A prospective study without randomisation, which analysed the temporal regression of cervical lymph nodes following primary radiotherapy or chemoradiation therapy (CRT) in 317 patients with N2‐N3 oropharyngeal SCC. Statistical models will be used to compare the risk of death or recurrence among patients stratified by p16 status (a post hoc analysis from pre‐treatment biopsy samples) | |
| A phase II trial that is open‐label and non‐randomised. The study has so far enrolled 2 patients diagnosed with stage III‐IV primary oropharyngeal SCC with HPV status ascertained at baseline. Patients who respond to induction chemotherapy will undergo an attenuated radiotherapy dose schedule | |
| A phase III study comparing chemoradiation against induction chemotherapy followed by bioradiation (radiotherapy + cetuximab). The main outcome of the trial is overall survival and secondary endpoints are response rate, progression‐free survival, role of biomolecular prognostic factors (EGFR, HPV) and toxicity. Initial results will be available in 2014. DNA PCR and p16 IHC will determine HPV status but there is no stratification on this basis (as reported by the lead author) | |
| A prospective trial without randomisation evaluating de‐escalation treatment in early and late‐stage SCC of the oropharynx. HPV status will be established at baseline for 60 patients. Treatment is dictated by the staging of disease at presentation and will consist of de‐escalated daily fractionated radiation therapy alone (63 Gy) or concurrent weekly cisplatin de‐escalated chemoradiation therapy. Nodal metastases will receive 70 Gy in 35 fractions | |
| A phase I dose escalation trial of a Listeria monocytogenes based vaccine in patients with oropharyngeal SCC. The study is non‐randomised and aims to recruit 161 patients who have recently completed standard‐protocol chemoradiotherapy or surgery and have confirmed HPV16 status | |
| Patients with locoregionally advanced head and neck cancer were treated with cetuximab, carboplatin, paclitaxel induction chemotherapy for 2 cycles. Patients were then randomised to A: cetuximab, 5‐FU, hydroxyurea and hyperfractionated week‐on, week‐off radiotherapy (72 to 74 Gy) (CetuxFHX), or B: cetuximab, cisplatin, accelerated radiation with concomitant boost (72 Gy) (CetuxPX). Primary endpoints were 1‐ and 2‐year progression‐free and overall survival. The lead author has reported that HPV status will be determined by post hoc analysis | |
| A phase III trial (NCIC‐CTG) that is multicentre, randomised and open‐label in design. The study will enrol 320 patients with locally advanced HNSCC who will be randomised to standard fractionation radiotherapy (70 Gy in 7 weeks) with concurrent cisplatin chemotherapy or accelerated fractionation radiotherapy (70 Gy in 6 weeks) with the molecular targeting agent panitumumab (similar in activity spectrum to cetuximab but with a reduced dermatological/allergy profile). The primary outcome will be progression‐free survival. Primary data collection is due to be completed in March 2015. The lead author has reported that HPV status will be determined by post hoc analysis (p16 IHC/HPV DNA PCR) | |
| A phase II trial that is open‐label and non‐randomised. The study will enrol 39 patients diagnosed to have stage III‐IV oropharyngeal SCC with HPV status ascertained at baseline by PCR +/‐ p16 immunohistochemistry. All enrolled patients will undergo an attenuated radiotherapy treatment dose | |
| A phase I, prospective, non‐randomised trial involving 38 participants with locally advanced oropharyngeal SCC. The study will investigate the side effects and optimal dose range for vorinostat when given together with cisplatin and radiation therapy. HPV status established at baseline | |
| A phase II prospective trial without randomisation involving 37 participants with stage III‐IV HNSCC. The study will investigate the effect of erlotinib combined with docetaxel and radiotherapy. HPV status established at baseline | |
| EGFR: epidermal growth factor receptor | |
