Intensity Modulated Radiation Therapy Alone Vs Intensity Modulated Radiation Therapy and Brachytherapy for T1-T2N0M0 Oropharyngeal Cancers: Results from A Randomized Controlled Trial
Abstract
PURPOSE
To compare clinical outcomes of intensity modulated radiation therapy (IMRT) alone vs IMRT+ brachytherapy (BT) in patients with T1-T2N0M0 oropharyngeal squamous cell cancers (OPSCC).
METHODS AND MATERIALS
This open-label randomized controlled trial was conducted at Tata Memorial Hospital, Mumbai, India. Patients with stage I and II OPSCC were considered for IMRT to a dose of 50Gy/25#/5 weeks in phase I followed by randomization (1:1) to further treatment with IMRT (20Gy/10#/2 weeks) or BT (192Ir high dose rate - 21Gy/7fractions/2 fractions per day). The primary endpoint of the trial was the reduction in xerostomia at 6 months evaluated using 99mTc salivary scintigraphy. Severe salivary toxicity (xerostomia) was defined as post-treatment salivary excretion fraction ratio <45%. Secondary endpoints were local control (LC), disease free survival (DFS) and overall survival (OS).
RESULTS
Between November 2010 to February 2020, 90 patients were randomized to IMRT(N=46) alone or IMRT+BT(N=44). Eleven patients (8 residual/recurrent disease, 2 lost to follow up, 1 second primary) in the IMRT arm and 9 patients (8 residual/recurrence, 1 lost to follow up) in the BT arm were not evaluable at 6 months for the primary endpoint. At 6 months, xerostomia rates using salivary scintigraphy were 14% (5/35: 95% CI 5%-30%) in the BT arm while it was seen in 44% (14/32: 95%CI 26%-62%) in the IMRT arm (p=0.008). Physician rated RTOG grade ≥2 xerostomia at any time point was observed in 30%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.
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