Excellent Outcomes and Orbital Preservation for Advanced T4 Sino-Nasal Cancers Using Combined Chemotherapy, Intensity Modulated Radiation Therapy, and Surgery

Abstract

inhibitor that may potentiate the efficacy of concurrent radiation therapy (RT) and docetaxel (D). A Phase 2 trial was conducted to determine the efficacy and toxicities of the combination in patients with LA-SCCHN. Materials/Methods: Patients (pts) with previously untreated Stage III-IVb SCCHN received daily RTwith IMRT using dose painting: 70 Gy at 2 Gy/ fx to the primary tumor and gross nodes, 63 Gy at 1.8 Gy/fx to the highrisk nodal levels, and 56 Gy at 1.6 Gy/fx to the elective neck. Daily E (150 mg) was started 2 weeks prior to beginning RT. Elrotinib and D (20 mg/ m/week) were given concurrently with RT and pts were maintained on daily E for up to two years following the completion of RT. Data was collected on site of failures and HPV status, RT schedules, and toxicities. Toxicity was scored using CTCAE v3. Probabilities of survivals were estimated by the Kaplan-Meier method. Differences in outcomes according to HPV status, were evaluated using the log-rank test. Results: 43 pts (33 male), median age 57 years (range 35-75), with Stage III or IV (81%) were enrolled. Median follow-up is now 29.1 months (range 1.4 60.5). The primary site of disease was as follows: oropharynx (28), larynx (11) and oral cavity (4). Mean RT dose was 69.9 Gy to the primary site (range 61.2-72.4 Gy) and the mean duration of RT was 53 days. One pt died during chemoRT from a narcotic overdose. HPV status was available for 36 pts (23 HPV+). For all pts, 3-year locoregional failure-free survival (LFFS), distant metastasis-free survival (DMFS), progression-free survival (PFS), and overall survival (OS) were 81.1%, 76.8%, 64.6%, 73.7% respectively. HPV positive status showed a trend toward improved LFFS at 3 yrs (95.7% vs 71.6%, pZ0.06), PFS (82.6% vs 43.6%, pZ0.06), and OS (77.0% vs 66.1%, pZ0.36). Grade 3 leukopenia was noted in a majority of pts. Grade 4 hematologic toxicity was observed in 13 pts and Grade 4 GI toxicity was noted in 2 pts. Conclusions: Erlotinib in combination with RT and docetaxel is an active and tolerable treatment regimen for pts with LA-SCCHN with acceptable toxicities. HPV positive status was associated with a trend toward improved LFFS, PFS, and OS. Acknowledgment: This reseach was supported in part by Genentech, NIH grants P30 CA43703 and M01 RR-000080. Author Disclosure: M. Yao: None. C. Woods: None. P. Savvides: None. P. Lavertu: None. R. Rezaee: None. C. Zender: None. P. Fu: None. M. Gibson: None. J. Wasman: None. M. Machtay: Q. Leadership; RTOG.