Literature Review: A roundup of the important recent studies

From: ENT Today, August 2010

• Clarity Needed on Which Patients with PTC Can Be Safely Observed
• HPV Status an Independent Prognostic Factor for Oropharyngeal Cancer Survival
• Laryngeal Framework Surgery Has High Level of Efficacy
• Demographic Disparities Exist Among Children with Otitis Media
• Bioabsorbable Miniplates for Subglottic Stenosis Are Safe and Effective
• Surgery for Chronic Rhinosinusitis May Help Sleep, Sex

 

Clarity Needed on Which Patients with PTC Can Be Safely Observed

CLINICAL QUESTION

Can localized papillary thyroid cancer (PTC) forgo surgery and be observed?

Background: Recent epidemiologic trends have documented a dramatic increase in the incidence of PTC, much of it due to the overdiagnosis of subclinical PTC. In 2006, the authors published a landmark study demonstrating this increase and raised the question of whether the definition or treatment approach deserves revision.

Study design: Retrospective cohort of incident localized papillary thyroid cancer with comparison of a selected subgroup without treatment (<1.5 percent of the overall cohort) to the cohort overall

Setting: National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) cancer registry program with data on cause of death from the National Vital Statistics System

Synopsis: Over 35,000 patients with localized PTC undergoing surgery were compared in outcome to a selected subgroup of 440 patients who were observed. While there was a significant difference (2 percent at 20 years) in cancer-specific survival in favor of the treatment group (P<0.001), the authors concluded that this was not clinically significant.

The central limitation is that the conclusion, “Papillary thyroid cancers of any size that are limited to the thyroid gland (no extraglandular extension or lymph node metastases at presentation) have favorable outcomes whether or not they are treated in the first year after diagnosis and whether they are treated by hemithyroidectomy or total thyroidectomy,” is not substantiated by the data and ignores significant existing literature. Namely, the study did not specifically analyze by size, age, sex, family history, radiation exposure or the specific timing or type of treatment. The conclusion seems to suggest that patients may be observed regardless of the presence of numerous well-documented adverse prognostic factors. The registry lacked sufficient medical history, stage, histology and treatment details to allow multivariate adjustment. Additionally, the conclusion, justifying a relatively unselected approach to PTC observation, is based upon a highly selected subset out of a huge national registry. Furthermore, while the differences were statistically significant, the authors interpreted the findings to lack clinical significance.

Bottom line: While it is likely that highly selected patients with PTC can be safely observed, the conclusions of this paper cannot be taken literally because the authors are unable to specify in which patients with localized PTC observation is safe. Surgeons, endocrinologists and ultrasonographers should adhere to national guidelines specifying that most nodules less than 1 centimeter should not be biopsied unless otherwise indicated.

Reference: Davies L, Welch HG. Thyroid cancer survival in the United States: observational data from 1973 to 2005. Arch Otolaryngol Head Neck Surg. 2010;136(5):440-444.

—Reviewed by Erich M. Sturgis, MD, MPH

 

HPV Status an Independent Prognostic Factor for Oropharyngeal Cancer Survival

CLINICAL QUESTION

What is the independent effect of human papillomavirus (HPV) on oropharyngeal cancer survival?

Background: HPV has been associated with oropharyngeal cancer risk and appears to underlie the rising incidence of this disease in the U.S. and Europe. HPV-positive oropharyngeal cancers may be associated with a better prognosis than HPV-negative oropharyngeal cancers.

Study design: Retrospective analysis of HPV tumor status and survival of oropharyngeal cancer patients within a phase III randomized trial for stage III/IV squamous cell carcinoma of the head and neck, including 360 patients receiving accelerated fractionation (concomitant boost) radiotherapy with concurrent cisplatin (experimental arm) and 361 patients receiving standard fractionation radiotherapy with concurrent cisplatin (control arm)

Setting: Within the multi-institutional cooperative Radiation Therapy Oncology Group (RTOG) randomized phase III clinical trial (RTOG 0129)

Synopsis: This study presents the retrospective analysis of HPV tumor status and survival of 323 oropharyngeal cancer patients within RTOG 0129. There was no difference in survival associated with treatment arm. However, there was a significantly lower risk (after multivariate adjustment) for death (58 percent lower) or relapse (51 percent lower) for patients with HPV-positive oropharyngeal cancer as compared with patients with HPV-negative oropharyngeal cancer, and a similar protective effect was seen for tumors overexpressing p16 (another marker of HPV). Smoking status (smoker vs. nonsmoker with cutoff set at <10 pack-years) was the second most important prognostic factor after HPV. N-stage was the third critical prognosticator for patients with HPV-positive cancers, while T-stage was the third critical prognosticator for HPV-negative cancers.

This study is limited by the retrospective analysis of HPV status (unavailable for 25 percent of patients) within a prospective trial with two different treatment arms, potential misclassifications of HPV or smoking status, and possible inability to generalize the findings to patients not treated with radiotherapy. The HPV-tested and unavailable groups, however, were similar with respect to baseline characteristics and survival, major misclassifications are unlikely given the expected demographic and stage characteristics of the HPV-positive group, and virtually all stage III/IV surgically treated oropharyngeal patients will also receive radiation. The sophisticated three-way categorization of risk for death from oropharyngeal cancer may lead to the incorporation of HPV status and possibly smoking status into the staging system and will likely result in treatment modifications.

Bottom line: HPV status is a strong independent prognostic factor for survival among patients with oropharyngeal cancer, and the effect of HPV status on survival appears further modified by smoking history.

Reference: Ang KK, Harris J, Wheeler R, et al. Human papillomavirus and survival of patients with oropharyngeal cancer. New Engl J Med. 2010;363(1):24-35.

—Reviewed by Erich M. Sturgis, MD, MPH

 

Laryngeal Framework Surgery Has High Level of Efficacy

CLINICAL QUESTION

What are the success and complication rates of laryngeal framework surgery (LFS), including medialization laryngoplasty (ML) and arytenoid adduction (AA)?

Background: Since its introduction in the 1970s, LFS, comprised of ML and AA, has been increasingly utilized for vocal fold paralysis and glottal incompetence. Little is known, however, about the incidence of ML/AA surgery nationwide or its success and complications.

Study design: A 25-item questionnaire was mailed to 6,644 board-certified otolaryngologists. Their responses were compared to the findings of a 1998 study to assess trends over time. The 1998 study had concentrated primarily on ML as an indicator of experience with LFS.

Setting: Department of Otolaryngology and the School of Dental Medicine, University of Pittsburgh, Pittsburgh, Penn.

Synopsis: Of the response rate of 25.7 percent (n=1,707), 63 percent perform ML and/or AA, representing 29,748 procedures. Experience with Silastic medialization implants was shown to have decreased over time, while utilization of other materials has increased. The overall complication rate was 15 percent, including 0.8 percent implant extrusion and 6 percent in revision rates. Compared to 1998, there was an overall relative decrease in complication rates with increased experience with ML. The most common revision was placement of a larger implant. Airway compromise requiring intervention was observed in 2.2 percent and suboptimal voice outcome in 4 percent. While the study encompassed more than double the procedures reported in 1998, the number of surgeons performing these surgeries has not significantly increased. Study limitations were possible physician selection bias and the reliance on physician memory for survey input.

Bottom line: LFS plays an increased role as a treatment modality for vocal fold paralysis, with complication rates only slightly increased and the need for revision surgery unchanged as compared to 1998.

Reference: Young VN, Zullo TG, Rosen CA. Analysis of laryngeal framework surgery: 10-year follow-up to a national survey. Laryngoscope. 2010;120(8):1602-1608.

—Reviewed by Sue Pondrom

 

Demographic Disparities Exist Among Children with Otitis Media

CLINICAL QUESTION

What are the current racial/ethnic and socioeconomic disparities in the prevalence of frequent ear infections (FEI) among children in the U.S.?

Background: There has been an increase in the prevalence of otitis media reported in the U.S. in the 1980s and 1990s. An understanding of the size and distribution of the population of children with FEI is important because these patients often require more invasive and costly treatments.

Study design: Cross-sectional study

Setting: Massachusetts Eye and Ear Infirmary and Harvard Medical School, Boston; University of California, Los Angeles; and Brigham and Women’s Hospital, Boston

Synopsis: Researchers used the National Health Interview Survey from 1997 to 2006 to evaluate children reported by parents or guardians to have had three or more ear infections during a 12-month period. Researchers evaluated age, sex, race/ethnicity, income level and insurance status using multivariate analysis to determine the influence of demographic variables on the prevalence of FEI.

A limitation of the study was that the data set is based on parent-reported presence of ear infection rather than on medical records and physician diagnosis. Additionally, the survey was not designed to differentiate among the different types of ear infections, nor can it verify the self-reported race/ethnicity status. Nonetheless, the authors found that FEI was more commonly reported in white and Hispanic children than in black children and children of other races or ethnic groups. Furthermore, a larger portion of children in households below the poverty level reported FEI. Black, Hispanic and other races and ethnic groups had a decreased odds ratio for FEI relative to white children; income below poverty level predicted FEI, but lack of insurance coverage did not.

Bottom line: Despite increasing awareness, notable racial/ethnic and socioeconomic disparities exist among children with FEI, indicating a need for efforts to eliminate these disparities and improve care.

Reference: Vakharia KT, Shapiro NL, Bhattacharyya N. Demographic disparities among children with frequent ear infections in the United States. Laryngoscope. 2010;120(8):1667-1670.

—Reviewed by Sue Pondrom

 

Bioabsorbable Miniplates for Subglottic Stenosis Are Safe and Effective

CLINICAL QUESTION

What is the efficacy and safety of bioabsorbable miniplates as an alternative to autologous grafts in single-stage laryngotracheal reconstruction for subglottic stenosis?

Background: Since the 1960s, the incidence of acquired subglottic stenosis has dramatically increased due to the improved survival of low birth weight infants and the increased use of long-term endotracheal intubation in neonates. The majority of laryngotracheal airway expansion procedures for mild to moderate subglottic stenosis have relied on the use of autologous cartilage grafts. This study presents an alternative to this method, bioabsorbable miniplating.

Study design: Case series

Setting: Department of Otolaryngology, Case Western Reserve University, Cleveland, Ohio

Synopsis: Ten patients received a standard approach to the laryngotracheal complex with a poly-L-lactic-acid-polyglycolic-acid bioabsorbable miniplate placed over the cricoid defect. If there was concern for suprastomal collapse, additional plates were placed inferiorly. All patients had a well-healed and fully mucosalized anterior tracheal wall with no evidence of plate or suture exposure at the time of extubation. In addition, there were no postoperative complications directly attributable to the use of the absorbable plate, and all patients were successfully decannulated at the time of discharge. With follow-up ranging from 14 to 63 months, no patients required revision reconstruction or repeat tracheostomy

Bottom line: The use of bioabsorbable plates in select patients is a safe and effective alternative to the use of autologous cartilage grafts for single-stage laryngotracheal reconstruction for anterior subglottic stenosis.

Reference: Sprecher RC. Single-stage laryngotracheal reconstruction using bioabsorbable miniplates. Laryngoscope. 2010;120(8):1655-1661.

—Reviewed by Sue Pondrom

 

Surgery for Chronic Rhinosinusitis May Help Sleep, Sex

CLINICAL QUESTION

What is the impact of surgery on the sleep and sexual function of patients with chronic rhinosinusitis (CRS)?

Background: Recent evaluations of the effects of CRS on the quality of life (QoL) have shown that CRS has a significant QoL impact even in comparison with chronic debilitating diseases such as diabetes and congestive heart failure. Recent interest has focused on the QoL aspects of sleep and sexual function.

Study design: Retrospective review of CRS patients who have undergone endoscopic sinus surgery

Setting: Cleveland Clinic, Ohio; Oregon Health and Science University, Portland; and Miami University, Oxford, Ohio

Synopsis: For 113 patients with CRS who completed the Rhinosinusitis Disability Index (RSDI) prior to surgery and at least nine months following endoscopic sinus surgery, the researchers found that mean response scores regarding both sexual activity and sleep between preoperative and postoperative scores showed improvement post-surgery. The same surgeon performed all the endoscopic sinus surgery, with 66 percent of the patients undergoing revision surgery. The only subgroup analysis that did not show a significant improvement was in subjects with aspirin intolerance.

The authors suggested that longer-term follow-up would be valuable in determining whether the results of this study are sustainable. Another limitation noted was the lack of assessment of medical therapy as a confounding factor in the postoperative improvement. The authors added that this is a common limitation in outcomes studies in patients with CRS, because medical therapy is tailored to the individual case and to curbing inflammation in the postoperative period.

Bottom line: Patients who choose surgical treatment may experience improvement in sleep and sexual function based on their responses to the RSDI.

Reference: Benninger MS, Khalid AN, Benninger RM, et al. Surgery for chronic rhinosinusitis may improve sleep and sexual function. Laryngoscope. 2010; 120(8):1696-1700.

—Reviewed by Sue Pondrom

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