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Original Investigation |

Modern Image-Guided Intensity-Modulated Radiotherapy for Oropharynx Cancer and Severe Late Toxic Effects Implications for Clinical Trial Design ONLINE FIRST

Matthew C. Ward, MD1; Richard Blake Ross, BS2; Shlomo A. Koyfman, MD1; Robert Lorenz, MD3; Eric D. Lamarre, MD3; Joseph Scharpf, MD3; Brian B. Burkey, MD3; Nikhil P. Joshi, MD1; Neil M. Woody, MD, MS1; Brandon Prendes, MD3; Narcissa Houston, MHA1; Chandana A. Reddy, MS1; John F. Greskovich, MD, MBA1; David J. Adelstein, MD4
[+] Author Affiliations
1Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio
2School of Medicine, Case Western Reserve University, Cleveland, Ohio
3Department of Otolaryngology, Head & Neck Surgery, Head & Neck Institute, Cleveland Clinic, Cleveland, Ohio
4Department of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio
JAMA Otolaryngol Head Neck Surg. Published online July 20, 2016. doi:10.1001/jamaoto.2016.1876
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Importance  Late toxic effects are common after definitive radiotherapy and chemoradiotherapy for oropharynx cancer and are considered a significant contributor to decreased quality of life for survivors. The incidence of severe late toxic effects may be reduced by modern narrow-margin image-guided intensity-modulated radiotherapy (IG-IMRT), current supportive care improvements, and the changing epidemiology of oropharynx cancer.

Objective  Assess the incidence of severe late toxic effects after modern definitive non-operative treatment for oropharynx cancer.

Design, Setting, and Participants  For this single-institution retrospective review, 156 patients with stage I-IVB squamous cell carcinoma of the oropharynx treated between April 2009 and February 2015 at a tertiary-referral academic multidisciplinary head and neck practice were recruited.

Interventions  Definitive narrow-margin IG-IMRT to a dose of 66 Gy (to convert milligray to rad, multiply by 0.1) or higher with or without concurrent cisplatin.

Main Outcomes and Measures  The primary outcome was the prospectively collected 2-year cumulative incidence of severe late toxic effects (Common Terminology Criteria for Adverse Events grade 3 or higher) occurring 3 months or more after radiotherapy. Toxic effect end points investigated included esophageal stricture requiring dilation, aspiration pneumonia hospitalization, vocal dysfunction, delayed feeding tube insertions, and osteoradionecrosis. Feeding tube dependence at 1 year was also considered a severe late toxic effect. Secondary outcomes collected include physician-reported grade 2 or higher neck fibrosis and xerostomia. The competing risks of recurrence and death were accounted for using the Gray method.

Results  One-hundred fifty-six patients (median [range] age, 58 [37-96] years) were identified; 130 patients (83%) were HPV positive. Concurrent cisplatin was delivered in 131 patients (84%) and 5 patients (3%) underwent an adjuvant neck dissection. The median (range) follow-up for survivors was 22 (4-73) months from diagnosis. The projected 2-year locoregional control was 93% (95% CI, 88.4%-97.6%) and overall survival was 88% (95% CI, 82.2%-94.0%). Thirty-eight patients (23%) required a feeding tube during treatment. The cumulative incidence of severe late toxic effects adjusted for competing risks at 2-year posttreatment was 2.3% (95% CI, 0%-5.6%). One patient required free-flap reconstruction for grade 3 osteoradionecrosis at 47 months. At 1 year, 2 patients (1%) experienced grade 2 neck fibrosis and 38 patients (23%) experienced grade 2 xerostomia.

Conclusions and Relevance  These results suggest that severe late toxic effects after modern definitive IG-IMRT, with or without cisplatin, for oropharynx cancer is likely uncommon. The importance of late toxic effect reduction in current and future investigational strategies, including clinical trials, should be considered.

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Figure 1.
T and N Classification (156 Patients)

This matrix presents the clinical T (size of primary tumor and whether it has invaded nearby tissue) and N (regional lymph nodes involved) American Joint Committee on Cancer classifications of the disease.

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Figure 2.
Cumulative Incidence of Severe Late Toxic Effects

This figure presents the cumulative incidence of severe late toxic effects.

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Figure 3.
On-Treatment Feeding Tubes Remaining in Place Over Time

This figure demonstrates the duration of acute feeding tube use for those feeding tubes placed during treatment. The median duration of acute feeding tube use was 1.7 months after the end of radiotherapy and at 6 months after radiotherapy; all but 2 feeding tubes placed during therapy were removed.

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