Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

Abstract

A B S T R A C T PurposeProphylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here. Patients and MethodsPatients (age, 18 to 75 years; WHO Յ 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter. ResultsCompliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P ϭ .018) and 3 months (P ϭ .055). ConclusionPCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care.

Local control rate and prognosis after sequential chemoradiation for small cell carcinoma of the bladder

“…Therefore, patients with complete response to chemotherapy are offered prophylactic cranial irradiation. 24,25 Similarly, patients with SCCB show a risk for the development of brain metastases. Siefker-Radtke et al reported up to 26.7% brain metastases in patients with SCCB.…”

The Role of Prophylactic Cranial Irradiation for Non-small Cell Lung Cancer

“…Interestingly, the main reason for patient refusal to participate in the GawkowskaSuwińska et al study was fear of alopecia. A study of PCI for small cell lung cancer commented that decline in QOL was specifically linked to hair-loss and fatigue (32); therefore if PCI is implemented consideration of hair-loss and fatigue management should be areas of focus. Other late toxicities recorded include mild headache or slight lethargy (22.2%), moderate headache or great lethargy (11.1%) and severe headaches (2.5%) (18).…”

Content validation of the EORTC QLQ-BN20+2 with patients and health care professionals to assess quality of life in brain metastases

“…The QLQ-BN20 has been used to assess QOL in lung cancer patients undergoing prophylactic cranial irradiation [23]. Conducting content validation aims to demonstrate the subjective validity of the questionnaire, as primary brain tumour patients may present with slightly different issues than brain metastases patients.…”