Abstract 671P
Background
Post-surgery chemoradiation (pCRT) is standard in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), although there is still a need to improve the outcome. We performed an open-label, single-arm, multicenter trial (EudraCT No. 2007-002659-17) and investigated safety and efficacy of escalating the multimodal therapy by adding concomitant and maintenance cetuximab (CTX).
Methods
Patients with surgically resected LA-SCCHN with margins <5mm and/or extracapsular nodal extension (ECE) received adjuvant therapy in nine German sites from Aug 2008 to Jan 2012. Intensity modulated radiation therapy (RT) in three dose levels (61.6/56/50.4 Gy in 28 fractions) was administered. Cisplatin (20 mg/m2) and 5-flurorouracil (600 mg/m2) were given on days 1-5 and 29-33 of RT. CTX was started seven days prior to RT at 400 mg/m2 followed by weekly doses of 250 mg/m2. Maintenance CTX was administered biweekly at 500 mg/m2 for six months. Primary endpoints were serious acute toxicity rate and 2-years disease free survival (DFS). Secondary objectives included incidence of loco-regional relapse (LRR), progression-free survival (PFS), overall survival (OS), and late toxicity. Data was investigated with descriptive statistics and survival analyses using the Kaplan-Meier method.
Results
Five of 83 enrolled patients did not meet inclusion criteria leaving 78 for analysis. 66% had oropharyngeal, 8% laryngeal and 26% oral cavity tumor. ECE was present in 63% of the cases, close margin or R1 resection represented with 22% and 54%, respectively. Median age was 56 years (range: 29-70). 81% were male. Mean Charlson Comorbidity Index was 3.7 (range: 2-7). 34% had a smoking history of <10 packyears. Median follow-up was 26.1 months. 2-years DFS was 72.2% (95% CI: 62.2%-83.6%). Probability of LRR was 15% (95% CI: 5-24%) in two years. 1-year OS was 90.3% (95% CI: 79.4-95.4%), 2-years OS was 87.0% (95% CI: 83.7-97.4%). The cumulative rate of severe late toxicity was 53.8%.
Conclusions
According to our results, pCRT+CTX followed by a six-months maintenance CTX resulted in a favorable outcome by a relative high toxicity burden.
Clinical trial identification
EudraCT 2007-002659-17.
Editorial acknowledgement
Legal entity responsible for the study
Heinrich-Heine-University, Düsseldorf.
Funding
Merck KGaA, Darmstadt, Germany.
Disclosure
B.F. Tamaskovics: Financial Interests, Personal, Invited Speaker: Merck Darmstadt; Financial Interests, Personal, Advisory Board: BMS, Merck Darmstadt, Sanofi; Financial Interests, Institutional, Invited Speaker: MSD, BMS, AstraZeneca; Non-Financial Interests, Institutional, Product Samples: KLS Martin Group, Tuttlingen, Germany. C. Matuschek: Financial Interests, Personal, Other, travel expenses: Merck KGaA. J. Debus: Financial Interests, Institutional, Research Grant: Viewray Inc, CRI - The Clinical Research Institute GmbH, Accuray International Sarl, RaySearch Laboratories AB, Vision RT Limited, Merck KGaA, Astellas Pharma GmbH, AstraZeneca GmbH, Siemens Healthcare GmbH, Solution Akademie GmbH, Ergomed PLC Surrey Research Park, Boehringer Ingelheim Pharma GmbH & CoKG, PTW-Freiburg Dr. Pychlau GmbH, Nanobiotix S.A., Accuray Incorporated; Financial Interests, Personal, Research Grant: Quintiles GmbH, Pharmaceutical Research Associates GmbH. U. Ganswindt: Financial Interests, Institutional, Funding: Brainlab AG; Financial Interests, Personal, Invited Speaker: Brainlab AG, BMS, MSD, Janssen-Cilag/Janssen Oncology, Roche; Financial Interests, Personal, Advisory Board: PharmaMar, Novocure, Bayer Vital. M. Mäurer: Financial Interests, Personal, Funding: DFG German Research Foundation. M. Stuschke: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Sanofi-Aventis, Janssen-Cilag; Financial Interests, Institutional, Research Grant: AstraZeneca. E. Boelke: Financial Interests, Personal, Invited Speaker: Merck KGaA. W. Budach: Financial Interests, Personal and Institutional, Research Grant: Merck KGaA; Financial Interests, Personal, Advisory Board: Merck KGaA, BMS, MSD, Pfizer, AstraZeneca. All other authors have declared no conflicts of interest.