2835 - Patient-Reported Outcomes from a Phase 1-2 Trial of Concurrent Chemoradiation and BMX-001 for Locally Advanced Head and Neck Cancer
Presenter(s)
M. A. Salans1, S. M. Dufault2, J. W. Chan3, W. Zhen4, Y. M. Mowery5, S. Amirpour Harehdasht1, D. A. Macleod6,7, I. Spasojevic8, J. Crapo9, D. M. Brizel10, and S. S. Yom1; 1University of California San Francisco, San Francisco, CA, 2University of California, San Francisco, Department of Epidemiology and Biostatistics, San Francisco, CA, 3Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, 4Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, NE, 5Duke University, Department of Radiation Oncology, Durham, NC, 6BioMimetix JV, LLC, Greenwood Village, CO, 7Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH, 8Department of Medicine, Duke University Medical Center, Durham, NC, 9Biomimetix, Inc., Greenwood Village, CO, 10Department of Head and Neck Surgery and Communication Sciences, Duke University Medical Center, Durham, NC
Purpose/Objective(s): We previously reported the safety and efficacy of radioprotector MnTnBuOE-2-PyP5+ (BMX-001) with chemoradiation (CRT) for head and neck squamous cell carcinoma (HNSCC). This report presents patient-reported outcomes (PROs) from this trial.
Materials/Methods: This multicenter, open-label, phase 1-2 trial included patients with stage III-IVB HNSCC (AJCC 7th ed) undergoing definitive or postoperative CRT. Patients received a subcutaneous BMX-001 loading dose =4 d before CRT and 2x/wk maintenance BMX-001 through 1 wk post-CRT. Three loading/maintenance doses were tested: 7/3.5 mg (level 1), 14/7 mg (level 2) and 28/14 mg (level 3). Level 3 was expanded to assess primary phase 2 endpoints. PROs were assessed at baseline, end of CRT, and 1, 6, and 12 months post-CRT with the Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN, scale for Overall Quality of Life: 0-7), Xerostomia-Related Quality of Life Scale (XeQoLS, 0-4), Dermatology Life Quality Index (DLQI, 0-3) and Functional Assessment of Cancer Therapy-Head & Neck Version 4 (FACT-HN, Total: 0-148, Physical/Functional: 0-28, Emotional: 0-24; Head/Neck: 0-40).
Results: Between 5/2017-12/2019, 29 patients enrolled. Primary sites included oropharynx (n=25, 86%; n=24 HPV+), as well as nasopharynx (n=1), hard palate (n=1), and unknown primary (n=2). Most patients (89.7%) had definitive CRT to 70 Gy, and 79.3% received >200 mg/m2 cisplatin. Most (79.3%) received BMX-001 dose level 3. At baseline, end of CRT, and 1-, 6- and 12-months post-CRT, median OMWQ-HN scores for the Overall Quality of Life question were 6, 4, 5, 6 and 7. Median Mouth/Throat Soreness scores peaked at end of CRT (score: 3) with the greatest impact on Swallowing (score: 2) and Eating (score: 3). These improved 1-month post-CRT (Mouth/Throat Pain: 1, Swallowing: 1, Eating: 1.5) and resolved 6 months post-CRT. Median Total XeQoL scores at baseline, end of CRT, and 1-, 6- and 12-months post-CRT were 0.0, 1.33, 0.37, 0.33 and 0.25, with worst scores in Physical XeQoL across all time points (0.0, 2.0, 0.75, 0.75, 0.70). Median Total DLQI scores were 1 at end of CRT and 0 at all other time points. Median FACT-HN Total scores at baseline, end of CRT and 1-, 6-, and 12-months post-CRT were 129.0, 99.5, 115.5, 130.5, and 136.0. Patients had the greatest drop in FACT-HN Physical, Functional and Head/Neck scores between baseline and end of CRT (median change: -8.0, -7.0, -17.0). Median FACT-HN Functional scores were higher at 12 months post-CRT than baseline (median change: +2.0). FACT-HN Emotional scores were highest 1-month post-CRT (20.0, 21.0, 23.0, 22.5, 21.5).
Conclusion: Patients treated with BMX-001 and CRT for HNSCC experienced the greatest symptom burden in physical, functional, and head and neck cancer-specific domains. On this trial, PRO signals improved as early as 1 month and returned to baseline by 6 months post-CRT, comparing favorably to historical controls and supporting further investigation of BMX-001 in HNSCC.