The impact of concurrent granulocyte–macrophage colony-stimulating factor on quality of life in head and neck cancer patients: results of the randomized, placebo-controlled Radiation Therapy Oncology Group 9901 trial

Abstract

Purpose The Radiation Therapy Oncology Group (RTOG) conducted a randomized, placebo-controlled, trial evaluating the efficacy of GM-CSF in reducing mucosal injury and symptom burden from curative radiotherapy for head-and-neck (H&N) cancer. Methods Eligible patients with H&N cancer receiving radiation encompassing ≥ 50% of the oral cavity or oropharynx received subcutaneous GM-CSF or placebo. Quality of life (QoL) was assessed using the RTOG modified University of Washington H&N symptom questionnaire at baseline, 4, 13, 26 and 48 weeks from radiation initiation. Results Of 125 eligible patients, 114 were evaluable for QoL (58 GM-CSF, 56 placebo). Patient demographics, clinical characteristics, and baseline symptom scores were well balanced between the treatment arms. At the end of the acute period (13 weeks) patients in both arms reported negative change in total symptom score indicating increase in symptom burden relative to baseline (mean −18.4 GM-CSF, −20.8 placebo). There was no difference in change in total symptom score (p>0.05) or change in mucous, pain, eating, or activity domain scores (p>0.01) between patients in the GM-CSF and placebo arms. Analysis limited to patients treated per protocol or with an acceptable protocol deviation also found no difference in change in total symptom score (p>0.05) or change in domain scores (p>0.01) between treatment arms. Provider assessment of acute mucositis during treatment did not correlate with patient-reported mucous domain and total symptom scores (p>0.05) Conclusion GM-CSF administered concurrently during head-and-neck radiation does not appear to significantly improve patient-reported QoL symptom burden.

Trends in the 15D health-related quality of life over the first year following diagnosis of head and neck cancer

“…Various attempts to reduce radiation toxicity regarding mucosal appears to provide little improvement in patient-reported symptoms, which sometimes differs from the clinician's judgment on symptom relief [35]. In a group of patients undergoing septoplasty, the mean 15D score worsened 6 months after surgery [18].…”

Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis

“…In all studies, the oncologic treatment method is described: chemotherapy [2], combined chemotherapy and radiotherapy [3,10,11], radiotherapy [11], chemotherapy [12,13,14], combined chemotherapy and radiotherapy [15,16], radiotherapy [17,18], combined chemotherapy and radiotherapy [18], chemotherapy [19], combined chemotherapy and radiotherapy [20], radiotherapy [20], chemotherapy [21], combined chemotherapy and radiotherapy [22,23], radiotherapy [24], combined chemotherapy and radiotherapy [25], radiotherapy [26], combined chemotherapy and radiotherapy [27], chemotherapy [28]. …”

Clinical role of filgrastim in the management of patients at risk of prolonged severe neutropenia: An evidence‐based review

“…A recent meta‐analysis of nine randomised clinical trials including 2197 patients (filgrastim, n= 1130; placebo or no treatment, n = 1067) showed that the use of filgrastim led to a decrease in FN incidence (relative risk [RR] 0.63, 95% CI 0.53‐0.75), a result further confirmed in two observational studies . A meta‐analysis of five randomised clinical trials and one non‐randomised clinical trial with a total of 1409 patients (filgrastim, n = 714; placebo or no treatment, n = 695) reported a decreased incidence in grade 3/4 neutropenia with filgrastim (RR 0.50, 95% CI 0.37‐0.68) …”