Hypoxia-Directed Treatment of Human Papillomavirus-Related Oropharyngeal Carcinoma.
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Lee Nancy Y, Sherman Eric J, Schöder HeiKo, Wray Rick, Boyle Jay O, Singh Bhuvanesh, Grkovski Milan, Paudyal Ramesh, Cunningham Louise, Zhang Zhigang, Hatzoglou Vaios, Katabi Nora, Diplas Bill H, Han James, Imber Brandon S, Pham Khoi, Yu Yao, Zakeri Kaveh, McBride Sean M, Kang Jung J, Tsai C Jillian, Chen Linda C, Gelblum Daphna Y, Shah Jatin P, Ganly Ian, Cohen Marc A, Cracchiolo Jennifer R, Morris Luc G T, Dunn Lara A, Michel Loren S, Fetten James V, Kripani Anuja, Pfister David G, Ho Alan L, Shukla-Dave Amita, Humm John L, Powell Simon N, Li Bob T, Reis-Filho Jorge S, Diaz Luis A, Wong Richard J, Riaz Nadeem
Аннотация
METHODS: We enrolled patients with HPV-related oropharyngeal carcinoma to receive de-escalated definitive chemoradiotherapy in a phase II study (ClinicalTrials.gov identifier: NCT03323463). Patients first underwent surgical removal of disease at their primary site, but not of gross disease in the neck. A baseline 18F-fluoromisonidazole positron emission tomography scan was used to measure tumor hypoxia and was repeated 1-2 weeks intratreatment. Patients with nonhypoxic tumors received 30 Gy (3 weeks) with chemotherapy, whereas those with hypoxic tumors received standard chemoradiotherapy to 70 Gy (7 weeks). The primary objective was achieving a 2-year locoregional control (LRC) of 95% with a 7% noninferiority margin.
RESULTS: One hundred fifty-eight patients with T0-2/N1-N2c were enrolled, of which 152 patients were eligible for analyses. Of these, 128 patients met criteria for 30 Gy and 24 patients received 70 Gy. The 2-year LRC was 94.7% (95% CI, 89.8 to 97.7), meeting our primary objective. With a median follow-up time of 38.3 (range, 22.1-58.4) months, the 2-year progression-free survival (PFS) and overall survival (OS) rates were 94% and 100%, respectively, for the 30-Gy cohort. The 70-Gy cohort had similar 2-year PFS and OS rates at 96% and 96%, respectively. Acute grade 3-4 adverse events were more common in 70 Gy versus 30 Gy (58.3% v 32%; P = .02). Late grade 3-4 adverse events only occurred in the 70-Gy cohort, in which 4.5% complained of late dysphagia.
CONCLUSION: Tumor hypoxia is a promising approach to direct dosing of curative-intent chemoradiotherapy for HPV-related carcinomas with preserved efficacy and substantially reduced toxicity that requires further investigation.