Effect of hypofractionated, palliative radiotherapy on quality of life in late-stage oral cavity cancer: A prospective clinical trial

Abstract

Context:The study was designed to evaluate the effect of a hypofractionated, palliative conformal radiotherapy regimen of 5250 cGy in 15 fractions in inoperable/incurable oral cavity carcinoma.Aims:The primary objective was to assess the change in the quality of life (QOL) with respect to pain and mouth opening pre- and post-radiotherapy using standardized questionnaires. The secondary objective was to assess overall QOL using the same questionnaires and also to assess response rates, survival, compliance, early and late toxicity.Settings and Design:This was a single-arm, prospective trial. Patients with incurable oral cavity cancer referred for palliative intent radiotherapy to the Department of Radiotherapy, RCC, JIPMER were recruited into the study.Subjects and Methods:Forty-eight patients were recruited and twenty-five patients were given conformal radiotherapy to a dose of 52.5 Gy in 15 fractions. QOL was assessed using the European Organization of Research and Treatment of Cancer (EORTC) questionnaires before and 2 months after the completion of radiotherapy. The response assessment was made using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 2 months after radiotherapy. The early and late toxicities were assessed at 2 months and 6 months after radiotherapy completion, respectively.Statistical Analysis Used:Sample size was calculated to be 53. The Wilcoxon signed-rank test was used to compare QOL scores pre- and post-radiotherapy. Median survival was assessed using the Kaplan–Meier method.Results:There was a significant improvement in the pain, mouth opening, speech, social contact, social eating, felt ill items of the EORTC QLQ-H and N35 questionnaire and role functioning, emotional functioning, social functioning, fatigue, pain, insomnia, appetite loss, financial difficulties, and Global QOL subscales of the QLQ-C30 questionnaire. 72% of the patients had grade 3 acute radiation oral mucositis and 36% had grade 3 acute radiation dermatitis. There were no significant treatment breaks due to toxicity. There were no grade 3 late toxicities observed. Overall median survival was 5.1 months. The overall response rate was 47%. The median time to treatment completion was 24 days.Conclusions:The improvement in QOL parameters suggests that the regimen of 52.5 Gy in 15 fractions is suitable for palliative intent radiotherapy in late-stage oral cavity cancer for effective palliation for short periods.

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

“…Among the published trials, 116 trials 24-139 (52%) used PROs. PROs were primary end points in 45 trials 20,26,28,30,[34][35][36][37]42,48,53,[56][57][58][61][62][63]66,70,74,75,77,79,83,85,93,94,97,103,[108][109][110]113,115,117,118,124,125,127,128,130,133,134,137 (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials 24,25,27,29,[31][32][33]38,40,41,[43]…”

“…Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials [24][25][26]33,34,36,41,48,49,51,53,64,73,76,78,[83][84][85][88][89][90]93,98,107,111,112,120,126,127,129,130,134 ), and trial-specific unvalidated measures (25 trials 27,31,36,39,47,[50][51][52]70,79,99,101,102,108,109,114,116,117,119,132,133,[135][136]…”

“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement). Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO).…”

“…Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO). In published trials, a more recent year of trial publication was associated with a more frequent use of a PRO as a secondary (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03), but not as a primary (OR, 1.01 [95% CI, 0.97-1.05]; P = .7) end point, per logistic regression (Figure 1).…”

“…Metastases and thoracic primaries were the most common treated sites (eFigure 3 in the Supplement), including in 37 published trials (82%) with a PRO as a primary end point and in 50 published trials (70%) with a PRO as a secondary end point. The most prevalent PROMs were the Numeric Rating Scale or Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials) (Figure 2). A more recent year of publication was significantly associated with a less frequent use of trial-specific unvalidated PROMs (OR, 0.89 [95% CI, 0.84-0.95]; P < .001) per logistic regression.…”