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Referencias

ADEPT {published data only}

Haughey B. Adjuvant de‐escalation, extracapsular spread, P16+, transoral (ADEPT) trial for oropharynx malignancy. clinicaltrials.gov/ct2/show/NCT01687413 2012 (accessed 22 June 2016). [NCT01687413]CENTRAL

ECOG‐E3311 {published data only}

Ferris R. Phase II randomized trial of transoral surgical resection followed by low‐dose or standard‐dose IMRT in resectable p16+ locally advanced oropharynx cancer. clinicaltrials.gov/ct2/show/NCT01898494 2013 (accessed 22 June 2016). [NCT01898494]CENTRAL

PATHOS {published data only}

Owadally W, Hurt C, Timmins H, Parsons E, Townsend S, Patterson J, et al. PATHOS: a phase II/III trial of risk‐stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for human papillomavirus (HPV) positive oropharyngeal cancer. BMC Cancer 2015;15:602. [NCT02215265]CENTRAL

EORTC 1420 {published data only}

EORTC 1420‐HNCG‐ROG "The best of" trial. http://www.eortc.org/research‐groups/head‐and‐neck‐cancer‐group/ongoing‐projects/. [EORTC 1420‐HNGC‐ROG]CENTRAL

ORATOR {published data only}

Nichols AC, Yoo J, Hammond JA, Fung K, Winquist E, Read N, et al. Early‐stage squamous cell carcinoma of the oropharynx: radiotherapy vs. trans‐oral robotic surgery (ORATOR) ‐ study protocol for a randomized phase II trial. BMC Cancer 2013;13:133. [NCT01590355]CENTRAL

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Holsinger 2015

Holsinger FC, Ferris RL. Transoral endoscopic head and neck surgery and its role within the multidisciplinary treatment paradigm of oropharynx cancer: robotics, lasers and clinical trials. Journal of Clinical Oncology 2015;33(29):3285‐92.

Huang 2015

Huang SH, Hansen A, Rathod S, O'Sullivan B. Primary surgery versus (chemo)radiotherapy in oropharyngeal cancer: the radiation oncologist's and medical oncologist's perspectives. Current Opinion in Otolaryngology & Head and Neck Surgery 2015;23:139‐47.

Jackel 2007

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Lawson 2011

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Luckens 2014

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Masterson 2014a

Masterson L, Moualed D, Liu ZW, Howard JE, Dwivedi RC, Tysome JR, et al. De‐escalation treatment protocols for human papillomavirus‐associated oropharyngeal squamous cell carcinoma: a systematic review and meta‐analysis of current clinical trials. European Journal of Cancer 2014;50(15):2636‐48. [DOI: 10.1016/j.ejca.2014.07.001.]

Masterson 2014b

Masterson L, Moualed D, Masood A, Dwivedi RC, Benson R, Sterling JC, et al. De‐escalation treatment protocols for human papillomavirus‐associated oropharyngeal squamous cell carcinoma. Cochrane Database of Systematic Reviews 2014, Issue 2. [DOI: 10.1002/14651858.CD010271.pub2]

Masterson 2015

Masterson L, Sorgeloos F, Winder D, Lechner M, Marker A, Malhotra S, et al. Deregulation of SYCP2 predicts early stage HPV+ oropharyngeal carcinoma – a prospective whole transcriptome analysis. Cancer Science 2015;106(11):1568‐75.

Masterson 2016

Masterson L, Winder D, Ball SLR, Vaughan K, Lehmann M, Scholtz LU, et al. Molecular analyses of unselected head and neck cancer cases demonstrates that human papillomavirus transcriptional activity is positively associated with survival and prognosis. BMC Cancer 2016;16:367. [DOI: 10.1186/s12885‐016‐2398‐7]

Mehanna 2012

Mehanna H, Beech T, Nicholson T, El‐Hariry I, McConkey C, Paleri V, et al. The prevalence of human papillomavirus in oropharyngeal and nonoropharyngeal head and neck cancer: a systematic review and meta‐analysis of trends by time and region. Head and Neck 2013;35(5):747‐55. [DOI: 10.1002/hed.22015]

Moore 2009

Moore EJ, Olsen KD, Kasperbauer JL. Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes. Laryngoscope 2009;119(11):2156–64. [DOI: 10.1002/lary.20647]

Moore 2013

Moore EJ, Hinni ML. Critical review: transoral laser microsurgery and robotic‐assisted surgery for oropharynx cancer including human papillomavirus‐related cancer. International Journal of Radiation Oncology, Biology, Physics 2013;85(5):1163‐7. [PUBMED: 23182390]

More 2013

More YI, Tsue TT, Girod DA, Harbison J, Sykes KJ, Williams C, et al. Functional swallowing outcomes following transoral robotic surgery vs primary chemoradiotherapy in patients with advanced‐stage oropharynx and supraglottis cancers. JAMA Otolaryngology Head & Neck Surgery 2013;139(1):43‐8.

Morisod 2016

Morisod B, Simon C. Meta‐analysis on survival of patients treated with transoral surgery versus radiotherapy for early‐stage squamous cell carcinoma of the oropharynx. Head & Neck 2016;38 Suppl 1:E2143‐50.

NCCN 2015

Pfister DG, Spencer S, Brizel DM, Burtness BA, Busse PM, Caudell JJ, et al. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Head and Neck Cancers. http://www.nccn.org2015:1‐187.

Parmar 1998

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Parsons 2002

Parsons JT, Mendenhall WM, Stringer SP, Amdur RJ, Hinerman RW, Villaret DB, et al. Squamous cell carcinoma of the oropharynx: surgery, radiation therapy, or both. Cancer 2002;94(11):2967‐80. [PUBMED: 12115386]

Pyeon 2007

Pyeon D, Newton MA, Lambert PF, den Boon JA, Sengupta S, Marsit CJ, et al. Fundamental differences in cell cycle deregulation in human papillomavirus‐positive and human papillomavirus‐negative head/neck and cervical cancers. Cancer Research 2007;67:4605‐19.

Rathod 2015

Rathod S, Livergant J, Klein J, Witterick I, Ringash J. A systematic review of quality of life in head and neck cancer treated with surgery with or without adjuvant treatment. Oral Oncology 2015;51:888‐900.

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Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

ADEPT

1) PARTICIPANTS: T1‐4a tumours; all have positive neck disease with extracapsular spread

2) INTERVENTION: all patients have endoscopic head and neck surgery

ECOG‐E3311

1) PARTICIPANTS: advanced (T3‐4) tumours only

2) INTERVENTION: all patients receive endoscopic head and neck surgery/surgical intervention

PATHOS

1) ALLOCATION: randomisation only after stratification by stage/high‐risk features of excised tumour/neck nodes

2) PARTICIPANTS: T1‐3, N0‐2b

3) INTERVENTION: all patients receive endoscopic head and neck surgery/surgical intervention

Characteristics of ongoing studies [ordered by study ID]

EORTC 1420

Trial name or title

EORTC 1420‐HNCG‐ROG "The best of" trial

Methods

Parallel‐group randomised controlled trial

Participants

Exact details awaited

Interventions

Experimental:

Endoscopic head and neck surgery

Comparator:

Radiotherapy

Exact details awaited

Outcomes

Primary:

  • Swallowing function (using the MDADI score) (time frame: within the first year after the 2 treatment strategies)

Secondary:

  • Locoregional tumour control rate (time frame: at the end of 1 and 2 years)

  • Overall survival (time frame: at the end of 1, 2 and 5 years)

  • Functional assessment (time frame: at the end of 2 years)

  • Complication rate (time frame: at the end of 2 years)

  • QOL (time frame: up to 2 years)

  • Cost‐effectiveness

Starting date

Mid 2016

Contact information

Co‐ordinator: Prof Christian Simon

Notes

http://www.eortc.org/research‐groups/head‐and‐neck‐cancer‐group/ongoing‐projects/

ORATOR

Trial name or title

A phase II randomised trial for early‐stage squamous cell carcinoma of the oropharynx: radiotherapy vs trans‐oral robotic surgery (ORATOR)

Methods

Parallel‐group randomised controlled trial

Participants

Inclusion criteria:

  • Age 18 or older

  • Willing to provide informed consent

  • ECOG performance status 0‐2

  • Histologically confirmed squamous cell carcinoma primary tumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)

  • Tumour stage: T1 or T2, with likely negative resections at surgery

  • Nodal stage: N0, N1 (<= 3 cm) or N2 (up to 2 nodes between 1 cm and 3 cm, on either side of the neck), without extranodal extension on pre‐randomisation imaging

  • Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomisation

Exclusion criteria:

  • Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery

  • Prior history of head and neck cancer within 5 years

  • Prior head and neck radiation at any time

  • Metastatic disease

  • Inability to attend full course of radiotherapy or follow‐up visits

  • Neck disease with unknown primary site

  • Prior invasive malignant disease unless disease‐free for at least 5 years or more, with the exception of non‐melanoma skin cancer

  • Unable or unwilling to complete QOL questionnaires

Interventions

Experimental:

TORS + neck dissection using Da Vinci Robot. Cautery spatula. 1 cm margins. Frozen sections + proceed until negative margins if feasible.

Comparator:

Radiotherapy ± chemotherapy

Gross tumour and nodes: 70 Gy in 35 fractions over 7 weeks. High‐risk nodal areas: 63 Gy in 35 fractions over 7 weeks. Low‐risk nodal areas: 56 Gy in 35 fractions over 7 weeks

Outcomes

Primary:

  • QOL (time frame: 1 year post‐treatment)

Secondary:

  • Overall survival (time frame: at the end of 3 years and at the end of 5 years)

  • Progression‐free survival (time frame: at the end of 3 years and at the end of 5 years)

  • Quality of life at other time points (time frame: every 6 months for 5 years from 1st date of treatment)

  • Toxicity (time frame: 5 years from date of first treatment)

  • Swallowing function (time frame: 5 years from date of first treatment)

Starting date

June 2012

Contact information

Primary Investigator: David Palma, MD, PhD; [email protected]

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada, N6A 4L6

Primary Investigator: Anthony Nichols, MD

Same address

Notes

https://clinicaltrials.gov/ct2/show/NCT01590355

ECOG: Eastern Cooperative Oncology Group
MDADI: MD Anderson Dysphagia Inventory
QOL: quality of life
TORS: transoral robotic surgery

Process for sifting search results and selecting studies for inclusion.
Figuras y tablas -
Figure 1

Process for sifting search results and selecting studies for inclusion.

Summary of findings for the main comparison. Minimally invasive surgery versus radiotherapy/chemoradiotherapy for small‐volume primary oropharyngeal carcinoma

Minimally invasive surgery versus radiotherapy/chemoradiotherapy for small‐volume primary oropharyngeal carcinoma

Patient or population: patients with small‐volume primary oropharyngeal carcinoma

Settings: inpatient

Intervention: transoral, minimally invasive surgery (transoral robotic surgery/transoral laser microsurgery) with or without adjuvant radiotherapy or adjuvant chemoradiotherapy

Comparison: primary radiotherapy with or without induction or concurrent chemotherapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Primary radiotherapy ± induction or concurrent chemotherapy

Transoral, minimally invasive surgery ± adjuvant radiotherapy or adjuvant chemoradiotherapy

Overall survival

No data

No data

No data

No data

Locoregional control

No data

No data

No data

No data

Progression‐free survival

No data

No data

No data

No data

Gastrostomy rate (at 1 year)

No data

No data

No data

No data

Tracheostomy rate

No data

No data

No data

No data

Swallowing function (MDADI)

No data

No data

No data

No data

Quality of life (EORTC QLQ‐C30 and H&N35)

No data

No data

No data

No data

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; EORTC: European Organisation for Research and Treatment of Cancer; MDADI: MD Anderson Dysphagia Inventory

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Figuras y tablas -
Summary of findings for the main comparison. Minimally invasive surgery versus radiotherapy/chemoradiotherapy for small‐volume primary oropharyngeal carcinoma