Concurrent cetuximab versus platinum-based chemoradiation for the definitive treatment of locoregionally advanced head and neck cancer.

The purpose of this study was to present our experience utilizing cetuximab and platinum-based concurrent chemoradiotherapy for the definitive treatment of head and neck squamous cell carcinoma (HNSCC). Patients (n = 177) who received definitive concurrent chemoradiotherapy for HNSCC were stratified into 3 groups: receiving cetuximab monotherapy (n = 24), cetuximab and chemotherapy combination (n = 33), or platinum-based chemotherapy without cetuximab (n = 120). Primary endpoints were freedom from relapse, event-free survival, and overall survival (OS). Patients receiving cetuximab monotherapy were older with lower Karnofsky performance status (KPS) and higher Charlson comorbidity scores compared with those treated with combination cetuximab and chemotherapy or platinum-based concurrent chemoradiotherapy. Patients treated with platinum-based concurrent chemoradiotherapy exhibited significantly better freedom from relapse, event-free survival, and OS compared with those receiving cetuximab monotherapy or cetuximab and chemotherapy combination therapies (all p < .05). Differences between patients receiving cetuximab monotherapy and platinum-based concurrent chemoradiotherapy held on multivariate Cox regression. This study suggests that platinum-based concurrent chemoradiotherapy is superior to cetuximab-based monotherapy for the definitive treatment of HNSCC.

Tang C ，Chan C ，Jiang W ，Murphy JD ，von Eyben R ，Colevas AD ，Pinto H ，Lee-Enriquez N ，Kong C ，Le QT ... -  《-》

Final Results of a Randomized Phase 2 Trial Investigating the Addition of Cetuximab to Induction Chemotherapy and Accelerated or Hyperfractionated Chemoradiation for Locoregionally Advanced Head and Neck Cancer.

The role of cetuximab in the treatment of locoregionally advanced head and neck squamous cell cancer (LA-HNSCC) remains poorly defined. In this phase 2 randomized study, we investigated the addition of cetuximab to both induction chemotherapy (IC) and hyperfractionated or accelerated chemoradiation. Patients with LA-HNSCC were randomized to receive 2 cycles of weekly IC (cetuximab, paclitaxel, carboplatin) and either Cetux-FHX (concurrent cetuximab, 5-fluorouracil, hydroxyurea, and 1.5 Gy twice-daily radiation therapy every other week to 75 Gy) or Cetux-PX (cetuximab, cisplatin, and accelerated radiation therapy with delayed concomitant boost to 72 Gy in 42 fractions). The primary endpoint was progression-free survival (PFS), with superiority compared with historical control achieved if either arm had 2-year PFS ≥70%. 110 patients were randomly assigned to either Cetux-FHX (n=57) or Cetux-PX (n=53). The overall response rate to IC was 91%. Severe toxicity on IC was limited to rash (23% grade ≥3) and myelosuppression (38% grade ≥3 neutropenia). The 2-year rates of PFS for both Cetux-FHX (82.5%) and Cetux-PX (84.9%) were significantly higher than for historical control (P<.001). The 2-year overall survival (OS) was 91.2% for Cetux-FHX and 94.3% for Cetux-PX. With a median follow-up time of 72 months, there were no significant differences in PFS (P=.35) or OS (P=.15) between the treatment arms. The late outcomes for the entire cohort included 5-year PFS, OS, locoregional failure, and distant metastasis rates of 74.1%, 80.3%, 15.7%, and 7.4%, respectively. The 5-year PFS and OS were 84.4% and 91.3%, respectively, among human papillomavirus (HPV)-positive patients and 65.9% and 72.5%, respectively, among HPV-negative patients. The addition of cetuximab to IC and chemoradiation was tolerable and produced long-term control of LA-HNSCC, particularly among poor-prognosis HPV-negative patients. Further investigation of cetuximab may be warranted in the neoadjuvant setting and with non-platinum-based chemoradiation.

Seiwert TY ，Melotek JM ，Blair EA ，Stenson KM ，Salama JK ，Witt ME ，Brisson RJ ，Chawla A ，Dekker A ，Lingen MW ，Kocherginsky M ，Villaflor VM ，Cohen EE ，Haraf DJ ，Vokes EE ... -  《-》

Concurrent Radiotherapy With Cetuximab or Platinum-based Chemotherapy for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck.

Lu SM ，Lien WW 《-》

Concurrent cetuximab and postoperative radiation in resected high-risk squamous cell carcinomas of the head and neck: A single-institution experience.

Postoperative cisplatin and radiation is the standard of care for high-risk squamous cell carcinoma of the head and neck (SCCHN). We have used cetuximab and radiation in the postoperative setting for patients deemed poor candidates for cisplatin. We retrospectively identified 40 patients who received cetuximab and radiation for resected locoregionally advanced SCCHN between 2006 and 2013 at our institution. The 2-year Kaplan-Meier estimates were: overall survival (OS) 41%, recurrence-free survival (RFS) 34%, locoregional control 63%, and distant metastatic control 59%. Eastern Cooperative Oncology Group (ECOG) performance status ≥1 predicted for inferior OS (hazard ratio [HR] = 5.43; p = .003), RFS (HR = 4.07; p = .007), and locoregional control (HR = 4.92; p = .04) in multivariate analysis. Patients with resected high-risk SCCHN treated with postoperative cetuximab and radiation have suboptimal therapeutic outcomes. Further study of the efficacy and cost-effectiveness compared to radiation alone is warranted. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1318-1323, 2016.

Araki D ，Redman MW ，Martins R ，Eaton K ，Baik C ，Chow L ，Goulart B ，Lee S ，Santana-Davila R ，Liao J ，Parvathaneni U ，Laramore G ，Futran N ，Mendez E ，Bhrany A ，Rodriguez CP ... -  《-》

Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized control

Burtness B ，Bourhis JP ，Vermorken JB ，Harrington KJ ，Cohen EE ... -  《Trials》