Radiation vs. trans-oral surgery for treatment de-escalation in HPV-related oropharyngeal cancers: Primary analysis of the ORATOR2 randomized trial.
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Palma David A, Prisman Eitan, Berthelet Eric, Tran Eric, Hamilton Sarah, Wu Jonn, Eskander Antoine, Higgins Kevin, Karam Irene, Poon Ian, Husain Zain, Enepekides Danny, Hier Michael, Richardson Keith, Mlynarek Alex, Johnson-Obaseki Stephanie, Gaudet Marc, Bayley Andrew, Dowthwaite Samuel, Jackson James E, Dzienis Marcin, O'Neil John, Chandarana Shamir, Banerjee Robyn, Hart Robert, Chung Jeffson, Tenenholtz Todd, Le Hien, Yoo John, Mendez Adrian, Winquist Eric, Kuruvilla Sara, Stewart Paul, Warner Andrew, Mitchell Sylvia, Chen Jeff, Parker Christina, Kwan Keith, Theurer Julie, Bahig Houda, Christopoulos Apostolos, Mendez Lucas C, Sathya Jinka, Hammond J Alex, Read Nancy, Venkatesan Varagur, Fung Kevin, Nichols Anthony C
Аннотация
PATIENTS AND METHODS: Patients with T1-T2 N0-2 HPV-related OPSCC were randomly assigned to primary RT (60 Gy with concurrent weekly cisplatin in node-positive) vs. TOS + neck dissection (ND) (and adjuvant reduced-dose RT depending on pathology). The primary endpoint was 2-year OS (hypothesized to be 94 % in each arm, compared to 84 %). Secondary endpoints included comparisons of survival and quality of life between arms. The trial was stopped early due to two treatment related deaths in the surgical arm.
RESULTS: Sixty-one patients were randomized (n = 30 in RT arm and n = 31 in TOS+ND arm), with a median age of 62 years (IQR: 57-68). The majority were male (n = 51) and never-smokers (n = 31). Median follow-up was 3.7 years (IQR: 3.1-4.5 years). In the RT arm, the primary endpoint for acceptability was met (p = 0.008), and two-year OS was 100 % (95 % confidence interval [CI]: 100-100 %). In the TOS+ND arm, the primary endpoint was not met (p = 0.296) and two-year OS was 90 % (95 % CI: 71-97 %), significantly worse than the RT arm (p = 0.041). Two-year progression-free survival (PFS) were 100 % (95 % CI: 100-100 %) vs. 86 % (95 % CI: 67-95 %) respectively (p = 0.012). Mean (± SD) 2-year MDADI total scores were 89 ± 13 vs. 83 ± 11, respectively (p = 0.11), and grade 2-5 toxicity rates were similar (n = 21 vs. n = 24 respectively, p = 0.51), with no additional grade 5 events.
CONCLUSION: For treatment de-escalation, a primary RT approach achieved excellent oncologic and functional outcomes and should be tested in phase III de-escalation trials.
TRIAL REGISTRATION: Clinicaltrials.gov NCT03210103.