In The News

Call for Public Comments on AHRQ Comparative Effectiveness Draft

Report of Radiation Therapy for Head and Neck Cancer

The Agency for Healthcare Research and Quality (AHRQ) has recently conducted an assessment to update its initial findings from a comparative effectiveness review (CER No. 20) published in 2010 on radiotherapy for head and neck cancers.  In addition to the technologies assessed in 2010 (2DCRT, 3DCRT, and IMRT), the updated report also evaluates information pertaining to SBRT and Proton Beam Therapy.  Information on the draft report, its summary and conclusions, key questions and findings, and where to access the report and submit comments is below:

Public comment deadline is noon EST, Monday, May 27, 2014.

For those interested in commenting, the draft update of the CER and instructions for submitting comments, can be found on AHRQ’s website at:  http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayProduct&productID=1905

Summary and Conclusions

  • “The main finding of CER No. 20 was that late xerostomia was reduced and QOL domains related to xerostomia were improved in patients treated with IMRT compared with those who received either 3DRT or 2DRT.”
  • “Evidence was insufficient to draw relative conclusions on survival or tumor control; adverse events other than late xerostomia (e.g., mucositis, dysphagia, skin toxicities, osteoradionecrosis of the jaw); whether patient and tumor characteristics affected relative outcomes; or whether physician experience and treatment characteristics affected relative clinical outcomes such as survival or treatment-associated adverse events.”   
  • “Moderate strength evidence from the update shows a reduction of the incidence of late grade 2 or higher xerostomia with IMRT compared with 3DRT, which strengthens the conclusion on this toxicity and comparison from CER No. 20.”
  • “Evidence in the update is insufficient to show a difference between IMRT and 3DRT in overall survival or locoregional tumor control rates.”
  • “We found no new evidence to alter any conclusions of CER No. 20 for any other toxicity or oncologic outcomes or comparisons”

Other important statements/findings:

  • “In general, applicability assessment would depend on a body of evidence sufficient to form new conclusions about the comparative outcomes of 3DRT, IMRT, SBRT, and PBRT in treatment of head and neck cancer. However, comparative evidence that meets study selection criteria for this CER update is sparse for 3DRT, IMRT, and SBRT, and nonexistent for PBRT.”
  • “Our updated systematic literature search and review revealed no relevant evidence-based guidelines we could compare with our findings for any of the key questions.” 
  • “The primary research gap we identified is a continuing lack of evidence from well-executed comparative studies (randomized or otherwise) to draw conclusions on the relative clinical benefits and harms of the RT interventions used in patients with head and neck cancer. We also identified some potential impediments to the type of rigorous comparative studies we suggest are necessary to determine their comparative effectiveness.  We urge that rigorous methods be used for the conduct of RCTs, particularly intention-to-treat analysis and adjustment of survival data to account for all patients based on their treatment plans.  Primary outcomes would include overall survival, cancer-specific survival, and local control. Pre-specified systematic collection of adverse events using validated criteria (e.g., CTCAE) is necessary to permit accurate assessment of relative benefits and risks of the interventions. As we allude to in the Introduction of this report, the potential impact of tumor tissue human papillomavirus positivity on oncologic outcomes and management of such patients has been increasing in importance.  Studies are needed to identify reduced intensity therapies that still yield satisfactory oncologic outcomes.”
  • “One study of 3DRT versus SBRT reported overall survival and local control in the setting of RT with or without concurrent CRT among patients with nasopharyngeal cancer. However, 22 percent of unidentified patients in the 3DRT arm received concurrent high-dose rate brachytherapy so the oncologic outcomes are not included in this synthesis.” 

The 4 key questions the evaluators considered and their findings are as follows:

Key Question 1: Comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT regarding adverse events and QOL

  • New comparative evidence assessed in this update strengthens the conclusion from CER No. 20 that the risk of grade 2 or higher late xerostomia is significantly lower in patients treated with IMRT than 3DRT.  
  • Evidence remains insufficient to draw relative conclusions on adverse events other than late xerostomia (e.g., mucositis, dysphagia, skin toxicities, osteoradionecrosis of the jaw) that alter conclusions of CER No. 20. 
  • Post-treatment toxicities were reported inconsistently across studies, precluding comparisons within the body of evidence. We are uncertain whether the limited evidence on RT-associated toxicities overall reflects their absence or that the investigators did not systematically collect or report them.

Key Question 2: Comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT regarding tumor control and patient survival

  • As we found in CER No. 20, comparative evidence assessed in this update was insufficient to draw relative conclusions on any oncologic outcomes.
  • The key oncologic outcomes were not reported universally across studies, so we could not make comparisons across a larger body of evidence.

Key Question 3: Comparative effectiveness of 3DRT, IMRT, SBRT, or PBRT for specific patient and tumor characteristics

  • In CER No. 20, no comparative studies addressed these issues. In this update, we did not identify any new evidence that specifically addressed Key Question 4.

Key Question 4: Comparative effectiveness of 3DRT, IMRT, SBRT, or PBRT because of differences in user experience, treatment planning, treatment delivery, and target volume delineation

  • In CER No. 20, no comparative studies addressed these issues. In this update, we did not identify any new evidence that specifically addressed Key Question 4.