Originally published as JCO Early Release 10.1200/JCO.2008.17.0746 on December 1 2008

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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

Berend J. Slotman, Murielle E. Mauer, Andrew Bottomley, Corinne Faivre-Finn, Gijs W.P.M. Kramer, Elaine M. Rankin, Michael Snee, Matthew Hatton, Pieter E. Postmus, Laurence Collette, Suresh Senan

From the Radiation Oncology, VU University Medical Center; Pulmonary Diseases, VU University Medical Center, Amsterdam; Arnhem's Radiotherapeutisch Instituut, Arnhem, the Netherlands; European Organisation for the Research and Treatment of Cancer (EORTC) Headquarters, Statistics Department; EORTC Headquarters, Quality of Life Department, Brussels, Belgium; Clinical Oncology, Christie Hospital, Manchester; Cancer Medicine, University of Dundee Ninewells Hospital, Dundee; Clinical Oncology, Cookridge Hospital, Leeds; Cancer Research Center, Weston Park Hospital, Sheffield, United Kingdom

Corresponding author: Berend J. Slotman, MD, PhD, Department of Radiation Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands; e-mail: bj.slotman{at}vumc.nl

Purpose Prophylactic 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 Methods Patients (age, 18 to 75 years; WHO 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.

Results Compliance 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 = .018) and 3 months (P = .055).

Conclusion PCI 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.

published online ahead of print at www.jco.org on December 1, 2008.

Supported by Grants No. 5U10-CA11488-29 through 5U10 CA11488-37 from the National Cancer Institute (Bethesda, MD), as well as by the EORTC Charitable Trust. Content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute. Data management was supported by the Dutch Cancer Society (CKTO).

Presented in part in abstract format at the 43rd Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-5, 2007 and the IASLC World Conference, Seoul, Korea, September 2-6, 2007.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00016211 [ClinicalTrials.gov] .

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