Phase I dose escalation of stereotactic body radiation therapy and concurrent cisplatin for re-irradiation of unresectable, recurrent squamous cell carcinoma of the head and neck
Mené sur 18 patients traités par radiochirurgie pour un carcinome épidermoïde de la tête et du cou récidivant et inéligibles à la chirurgie (durée médiane de suivi : 9,5 mois), cet essai de phase I évalue la dose maximale tolérée de rayonnements ionisants administrés en concomitance avec du cisplatine
Purpose: Patients with locoregional recurrence of squamous cell carcinoma of the head and neck (SCCHN) have relatively poor outcomes and therefore stereotactic body radiation therapy (SBRT) has been investigated for this patient population. We performed a phase I clinical trial to establish a maximum tolerated dose of SBRT with concurrent cisplatin in previously irradiated locoregionally SCCHN. Methods and materials: Patients with recurrent SCCHN who had previously undergone radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥6 months prior to enrollment, and who were not surgical candidates, or refused surgery were eligible. SBRT was delivered every other day for five fractions. Starting dose level was 6 Gy x 5 fractions, followed by 7 Gy x 5 fractions, and 8 Gy x 5 fractions. Chemotherapy consisted of cisplatin given prior to every SBRT fraction at a dose of 15 mg/m2. Patients were monitored for dose limiting toxicities (DLT) that occurred within 3 months from the start of SBRT. Secondary end points included locoregional failure (LRF), distant metastasis (DM), and overall survival (OS). Results: Twenty patients were enrolled, with 18 patients evaluable for endpoints. One patient at dose level one (30 Gy) died of unknown causes two weeks following completion of treatment. Therefore, an additional three patients were accrued to the 30 Gy dose level, with no further DLTs observed. Three patients were then accrued at dose level 2 (35 Gy), and 9 patients at dose level 3 (40 Gy) without DLTs. At a median follow-up of 9.5 months cumulative incidence of LRF at 2 years was 61% (95% CI 12–66%), cumulative incidence of DM was 11% (95% CI 74–100%) at 2 years, and OS was 22% (95% CI 9–53%) at 2 years. Conclusions: Concurrent cisplatin and re-irradiation with SBRT up to a dose of 40 Gy was safe and feasible in patients locoregionally recurrent or second primary SCCHN.
International Journal of Radiation Oncology, Biology, Physics 2022