BackgroundThe incidence of oropharyngeal squamous cell carcinoma (OPSCC) has markedly increased over the last three decades due to newly found associations with human papillomavirus (HPV) infection. Primary radiotherapy (RT) is the treatment of choice for OPSCC at most centers, and over the last decade, the addition of concurrent chemotherapy has led to a significant improvement in survival, but at the cost of increased acute and late toxicity. Transoral robotic surgery (TORS) has emerged as a promising alternative treatment, with preliminary case series demonstrating encouraging oncologic, functional, and quality of life (QOL) outcomes. However, comparisons of TORS and RT in a non-randomized fashion are susceptible to bias. The goal of this randomized phase II study is to compare QOL, functional outcomes, toxicity profiles, and survival following primary RT (± chemotherapy) vs. TORS (± adjuvant [chemo] RT) in patients with OPSCC.Methods/DesignThe target patient population comprises OPSCC patients who would be unlikely to require chemotherapy post-resection: Tumor stage T1-T2 with likely negative margins at surgery; Nodal stage N0-2, ≤3 cm in size, with no evidence of extranodal extension on imaging. Participants will be randomized in a 1:1 ratio between Arm 1 (RT ± chemotherapy) and Arm 2 (TORS ± adjuvant [chemo] RT). In Arm 1, patients with N0 disease will receive RT alone, whereas N1-2 patients will receive concurrent chemoradiation. In Arm 2, patients will undergo TORS along with selective neck dissections, which may be staged. Pathologic high-risk features will be used to determine the requirement for adjuvant radiotherapy +/- chemotherapy. The primary endpoint is QOL score using the M.D. Anderson Dysphagia Inventory (MDADI), with secondary endpoints including survival, toxicity, other QOL outcomes, and swallowing function. A sample of 68 patients is required.DiscussionThis study, if successful, will provide a much-needed randomized comparison of the conventional strategy of primary RT vs. the novel strategy of primary TORS. The trial is designed to provide a definitive QOL comparison between the two arms, and to inform the design of an eventual phase III trial for survival outcomes.Trial registrationNCT01590355

Women who use tracheoesophageal speech may be differentially penalized for dimensions related to voice quality. Limitations in voice did not necessarily translate into worse overall quality of life, indicating that auditory-perceptual evaluation and quality of life questionnaires are evaluating different aspects of function after laryngectomy.

Patients using TES had similar V-RQOL outcomes compared to ES and both performed significantly better than ELS. For ELS, the total V-RQOL score was better with longer time after surgery and older age.

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BACKGROUND This study examined relationships between communicative participation and post-laryngectomy speech outcomes including: a) listener-rated speech intelligibility and acceptability; and b) patient-rated speech acceptability and voice handicap. METHODS Thirty-six laryngectomized individuals completed the Communicative Participation Item Bank short form and the Voice Handicap Index-10. They provided recordings from the Sentence Intelligibility Test (SIT) and a reading passage, and rated their own speech acceptability. Forty-eight inexperienced listeners transcribed the SIT sentences to derive intelligibility scores. Eighteen additional listeners judged speech acceptability using rating scales. RESULTS Listeners judged tracheoesophageal speakers significantly more intelligible and acceptable than electrolaryngeal speakers (p < .05). Speech acceptability was significantly more acceptable to speakers than listeners (p < .05). Weak, non-significant relationships were found between communicative participation and listener-rated outcomes. Stronger, significant relationships were found between communicative participation and self-rated speech acceptability and voice handicap (p < .05). CONCLUSIONS Patient-reported communication outcomes are complementary to listener-rated outcomes.