Browsing by Author "Hart, Robert"

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    Chronic opioid use following surgery for head and neck cancer patients undergoing free flap reconstruction
    (2021-04-23) Hinther, Ashley; Rasool, Alysha; Nakoneshny, Steven C; Chandarana, Shamir P; Hart, Robert; Matthews, T. W; Dort, Joseph C
    Abstract Background Physician opioid-prescribing patterns have significant impacts on the current opioid crisis. Patients who use opioids in the postoperative period are at risk of developing chronic postoperative opioid use. This study determined the rate of chronic postoperative opioid use among head and neck cancer patients undergoing primary surgery with free-flap reconstruction. Additionally, this study identified major risk factors associated with the development of chronic postoperative opioid use. Methods A retrospective chart review was performed for all adults (age ≥ 18 years) undergoing primary head and neck surgical resection with free-flap reconstruction between January 2008 and December 2015. Patients were identified from a prospectively collected database, Otobase™. Data from the provincial drug insurance program were used to capture drug dispensing information to determine chronic opioid use at 3- and 12-months postoperatively. Data extracted from Otobase™ included patient demographics, social habits, clinical stage, pathological stage, type of surgery, and adjuvant treatment. Results The total cohort was comprised of 212 patients. Chronic opioid use at 3- and 12- months postoperatively was observed in 136 (64%) and 116 (55%) patients, respectively. Of the 212 patients, 85 patients (40%) were identified as preoperative opioid users and 127 were opioid naïve (60%). Of the 85 patients who were preoperative opioid users, 70 (82%) and 63 (77%) patients continued to use opioids 3- and 12-months postoperatively, respectively. The proportion of opioid-naïve patients who were using opioids at 3- and 12-months postoperatively was 52% (66 patients) and 42% (53 patients), respectively. Identified risk factors included preoperative opioid use, prior tobacco use, advanced pathologic T-stage, and adjuvant treatment. Conclusions Among head and neck cancer patients that have undergone major resection with free-flap reconstruction, the prevalence of chronic postoperative opioid users was considerable. Identified risk factors included preoperative opioid use, prior tobacco use, tumor stage, and adjuvant treatment. Graphical abstract
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    Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial
    (2020-02-14) Nichols, Anthony C; Lang, Pencilla; Prisman, Eitan; Berthelet, Eric; Tran, Eric; Hamilton, Sarah; Wu, Jonn; Fung, Kevin; de Almeida, John R; Bayley, Andrew; Goldstein, David P; Eskander, Antoine; Husain, Zain; Bahig, Houda; Christopoulous, Apostolos; Hier, Michael; Sultanem, Khalil; Richardson, Keith; Mlynarek, Alex; Krishnan, Suren; Le, Hien; Yoo, John; MacNeil, S. D; Mendez, Adrian; Winquist, Eric; Read, Nancy; Venkatesan, Varagur; Kuruvilla, Sara; Warner, Andrew; Mitchell, Sylvia; Corsten, Martin; Rajaraman, Murali; Johnson-Obaseki, Stephanie; Eapen, Libni; Odell, Michael; Chandarana, Shamir; Banerjee, Robyn; Dort, Joseph; Matthews, T. W; Hart, Robert; Kerr, Paul; Dowthwaite, Samuel; Gupta, Michael; Zhang, Han; Wright, Jim; Parker, Christina; Wehrli, Bret; Kwan, Keith; Theurer, Julie; Palma, David A
    Abstract Background Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. Methods This is a multicenter phase II study randomizing one hundred and forty patients with T1–2 N0–2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50–60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. Discussion This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.