Real-Time Electronic Patient-Reported Outcomes in Relation to Provider-Documented Adverse Events During Radiation Therapy for Head and Neck Cancer

Poster Viewing E529

Volume 96  Number 2S  Supplement 2016 Abstract 3296; Table 1.

Cancer and/or tx has resulted in changes to my sexual life/health.

On-Treatment (nZ52) Follow-Up (nZ53)

Cancer and/or tx has caused me to be distressed about my sex life/health.

On-Treatment (nZ52) Follow-Up (nZ54)

Author Disclosure: J.Y. Wo: None. L.C. Drapek: None. A. Niemierko: None. B.L. Silvia: None. A.L. Russo: None. P.J. Gray: Independent Contractor; Elekta. Consultant; Elekta. D.T. Miyamoto: None. T.I. Hong: None. J.A. Efstathiou: None. A.L. Zietman: None. J. Temel: None. D.S. Dizon: None.

3297 Real-Time Electronic Patient-Reported Outcomes in Relation to Provider-Documented Adverse Events During Radiation Therapy for Head and Neck Cancer J.R. Niska,1 M.Y. Halyard,1 A.D. Tan,2 P.J. Atherton,2 S.H. Patel,1 and J.A. Sloan2; 1Mayo Clinic, Phoenix, AZ, 2Mayo Clinic, Rochester, MN Purpose/Objective(s): To relate real-time electronic patient-reported outcomes (ePROs) to provider-documented adverse events (AEs) during radiation therapy (RT) for head and neck (H&N) cancer. Materials/Methods: Sixty-five H&N RT patients prospectively completed electronic real-time 12-item linear analogue self-assessments (LASA) at baseline, before biweekly appointments, and at last week of RT. Changes in LASA scores between time-points were calculated. At the same timepoints, AEs were retrospectively recorded and graded using Common Terminology Criteria for Adverse Events v4.0. LASA scores were categorized according to maximum grade AE experienced by each patient at each time-point and analyzed using Kruskal-Wallis methodology. Agreement between LASA scores and maximum grade AE was assessed using Bland-Altman analysis. Results: Most patients reported clinically significant decrease in most ePRO quality of life (QOL) domains. Patients most commonly reported clinically significant decreases in fatigue (77.8% of patients), social activity (75.4%), and overall QOL (74.2%). At treatment completion, patients reported average QOL scores worse than baseline for most domains. During treatment, all patients experienced at least one grade 2 AE with 33.8% experiencing at least one grade 3 AE. At treatment completion, every patient had either grade 2 or grade 3 AE. At baseline, patients experiencing a maximum grade 2 AE reported worse physical well-being than those with only grade 1 AE (48.6 for grade 2, 70.5 for grade 1, PZ0.0190). At week 1, the following QOL domains were statistically worse for patients experiencing maximum grade 2 AE compared to those with maximum grade 1 AE: overall QOL (74.6 for grade 1 vs. 64.5 for grade 2, PZ0.0581), mental well-being (79.2 vs. 66.0, PZ0.0183), physical well-being (71.3 vs. 56.0, PZ0.0162), and fatigue (59.2 vs. 42.5, PZ0.0592). For baseline and week 1, higher AE grade was associated with decreased QOL. This pattern was not evident at later weeks. Using Bland-Altman analysis, QOL scores were relatively worse than AE burden at baseline with QOL scores relatively better than AE burden at treatment completion. Conclusion: Worse QOL was associated with higher grade AEs at earlier time-points but not at later time-points. The impact of provider-documented AEs on patient-reported QOL appears to lessen with time, potentially due to patient acclimation or providers addressing patient needs. Author Disclosure: J.R. Niska: None. M.Y. Halyard: None. A.D. Tan: None. P.J. Atherton: None. S.H. Patel: None. J.A. Sloan: None.

Not at All

A little

Quite a bit

Very much

17 (33%) 10 (19%) 22 (42%) 11 (20%)

14 (27%) 11 (21%) 21 (40%) 22 (41%)

14 (27%) 9 (17%) 4 (8%) 11 (20%)

7 (14%) 23 (43%) 5 (9%) 10 (19%)

P-Value PZ0.008

PZ0.035

3298 Laser Debridement Combined With Low-Level Laser Biostimulation Improves Healing and Pain Control for Oral Mucositis When Compared to Standard Supportive Care in Patients Receiving Concurrent Cetuximab and Radiation for Oropharyngeal Cancer E. Allan,1 C. Barney,1 S. Baum,2 V.M. Diavolitsis,1 D.M. Blakaj,1 J.L. Wobb,1 T. Kessling,3 M. Van Putten,3 and A.D. Bhatt1; 1The James Cancer Hospital and Solove Research Institute, Wexner Medical Center at The Ohio State University, Department of Radiation Oncology, Columbus, OH, 2The Ohio State University Wexner Medical Center, College of Medicine, Columbus, OH, 3The James Cancer Hospital and Solove Research Institute, Wexner Medical Center at The Ohio State University, Department of Maxillofacial Prosthodontics, Columbus, OH Purpose/Objective(s): Oral mucositis (OM) is a near universal side-effect of head and neck radiation therapy (RT) and concurrent chemotherapy or immunotherapy and radiation (CRT) that leads to severe pain, infection, higher rates of hospitalization, and breaks in therapy resulting in reduced treatment efficacy. The 2014 guidelines from The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer included a suggestion that Low Level Laser Therapy (LLLT) was useful for the prevention of OM in patients receiving head and neck RT alone, but no comment could be made regarding its efficacy in the therapeutic setting for severe OM. Efficacy or role of LLLT in setting of chemo or immunotherapy concurrently with RT is not well defined and forms the objective of our study. Materials/Methods: 55 of our patients were referred for laser therapy upon developing RTOG grade 2-3 OM during RT/CRT. These patients received laser debridement and LLLT delivered by 2 maxillofacial prosthodontilets trained in laser operation. Our regimen was accomplished with the use of two lasers; a class IV Er, Cr: YSGG laser (l Z 2.780 mm) for debridement of ulcers, and a class IV diode laser (l Z 940 nm) as bio-stimulation for wound healing and pain control. Treatments were continued on a weekly basis until complete resolution of ulcerations. In order to control for differences in OM and oral pain due to variations in surgery or chemotherapy, we selected the largest uniform contingent within our group of laser-treated patients. Thirteen of the laser-treated patients received definitive RT (no surgery) with concurrent cetuximab. We retrospectively compared this group to 20 control patients receiving the same cancer treatment regimen who also had severe OM (RTOG grade 2 one month after CRT) but did not receive laser therapy. We used the T-test and Fisher’s exact test to compare oral pain scores, RTOG mucositis grade, and narcotic usage at completion of CRT, at 1 month, and 3 months later. Results: Patients in the laser group experienced higher rates of grade 3 OM (92% vs. 60%, PZ0.04) and higher oral pain score (median 8 vs. 4, P<0.001) at completion of CRT. Despite this, they were more likely to report oral pain level of 0 at 1 month (62% vs 10%, PZ0.003) and 3 months (85% vs. 35%, PZ0.006). They were less likely to be using narcotics at 3 months (31% vs. 70%, PZ0.027), and they were less likely to have residual OM (RTOG grade  1) at 3 months (31% vs. 80%, PZ0.006). Conclusion: LLLT combined with laser debridement, in comparison to standard supportive care for OM, significantly improved mucositis grade,