M J Awan1, L Nedzi2, D Wang3, V Tumati2, B Sumer4, X-J Xie5, I Smith2, J Truelson4, R Hughes6, L L Myers4, P Lavertu7, S Wong8, M Yao9. 1. Department of Radiation Oncology, Case Western Reserve University, Cleveland, USA; University Hospitals of Cleveland, Cleveland, USA. 2. Department of Radiation Oncology, University of Texas Southwestern, Dallas, USA. 3. Department of Radiation Oncology, Rush University Medical Center, Chicago, USA. 4. Department of Otolaryngology Head and Neck Surgery, USA. 5. Department of Clinical Sciences, University of Texas Southwestern, Dallas, USA. 6. Internal Medicine - Medical Oncology, University of Texas Southwestern, Dallas, USA. 7. University Hospitals of Cleveland, Cleveland, USA; Department of Otolaryngology Head and Neck Surgery, Case Western Reserve University; Cleveland, USA. 8. Department of Internal Medicine - Medical Oncology, Medical College of Wisconsin, Milwaukee, USA. 9. Department of Radiation Oncology, Case Western Reserve University, Cleveland, USA; University Hospitals of Cleveland, Cleveland, USA. Electronic address: min.yao@uhhospitals.org.
Abstract
Background: The optimal regimen of chemotherapy and reirradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multicenter phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Materials and methods: Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS ≥ 70 were eligible for this trial. Cetuximab 400 mg/m2 was delivered as a loading dose in week 1 followed by weekly cetuximab 250 mg/m2 and cisplatin 30 mg/m2 concurrent with 6 weeks of intensity-modulated radiotherapy to a dose of 60-66 Gy in 30 daily fractions. Patients who previously received both concurrent cetuximab and cisplatin with radiation or who received radiotherapy less than 6 months prior were ineligible. Results: From 2009 to 2013, 48 patients enrolled on this trial, 2 did not receive any protocol treatment. Of the remaining 46 patients, 34 were male and 12 female, with a median age of 62 years (range 36-85). Treatment was feasible and only 1 patient did not complete the treatment course. Common grade 3 or higher acute toxicities were lymphopenia (46%), pain (22%), dysphagia (13%), radiation dermatitis (13%), mucositis (11%) and anorexia (11%). There were no grade 5 acute toxicities. Eight grade 3 late toxicities were observed, four of which were swallowing related. With a median follow-up of 1.38 years, the 1-year overall survival (OS) was 60.4% and 1-year recurrence-free survival was 34.1%. On univariate analysis, OS was significantly improved with young age (P = 0.01). OS was not associated with radiation dose, surgery before re-XRT or interval from prior XRT. Conclusions: Concurrent cisplatin and cetuximab with re-XRT is feasible and offers good treatment outcomes for patients with high-risk features. Younger patients had significantly improved OS. ClinicalTrials.Gov Identifier: NCT00833261.
Background: The optimal regimen of chemotherapy and reirradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multicenter phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Materials and methods: Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS ≥ 70 were eligible for this trial. Cetuximab 400 mg/m2 was delivered as a loading dose in week 1 followed by weekly cetuximab 250 mg/m2 and cisplatin 30 mg/m2 concurrent with 6 weeks of intensity-modulated radiotherapy to a dose of 60-66 Gy in 30 daily fractions. Patients who previously received both concurrent cetuximab and cisplatin with radiation or who received radiotherapy less than 6 months prior were ineligible. Results: From 2009 to 2013, 48 patients enrolled on this trial, 2 did not receive any protocol treatment. Of the remaining 46 patients, 34 were male and 12 female, with a median age of 62 years (range 36-85). Treatment was feasible and only 1 patient did not complete the treatment course. Common grade 3 or higher acute toxicities were lymphopenia (46%), pain (22%), dysphagia (13%), radiation dermatitis (13%), mucositis (11%) and anorexia (11%). There were no grade 5 acute toxicities. Eight grade 3 late toxicities were observed, four of which were swallowing related. With a median follow-up of 1.38 years, the 1-year overall survival (OS) was 60.4% and 1-year recurrence-free survival was 34.1%. On univariate analysis, OS was significantly improved with young age (P = 0.01). OS was not associated with radiation dose, surgery before re-XRT or interval from prior XRT. Conclusions: Concurrent cisplatin and cetuximab with re-XRT is feasible and offers good treatment outcomes for patients with high-risk features. Younger patients had significantly improved OS. ClinicalTrials.Gov Identifier: NCT00833261.
Authors: Alexander W MacFarlane; Ho-Man Yeung; R Katherine Alpaugh; Essel Dulaimi; Paul F Engstrom; Arvind Dasari; Kerry S Campbell; Namrata Vijayvergia Journal: Cancer Immunol Immunother Date: 2021-01-04 Impact factor: 6.630
Authors: Michael Kharouta; Chad Zender; Tarun Podder; Rod Rezaee; Pierre Lavertu; Nicole Fowler; Jason Thuener; Shawn Li; Kate Clancy; Zhengzheng Xu; Min Yao Journal: Front Oncol Date: 2021-03-18 Impact factor: 6.244