Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01).
BACKGROUND
We recently published the results of the PCI99 randomised trial comparing the effect of a prophylactic cranial irradiation (PCI) at 25 or 36 Gy on the incidence of brain metastases (BM) in 720 patients with limited small-cell lung cancer (SCLC). As concerns about neurotoxicity were a major issue surrounding PCI, we report here midterm and long-term repeated evaluation of neurocognitive functions and quality of life (QoL).


METHODS
At predetermined intervals, the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and brain module were used for self-reported patient data, whereas the EORTC-Radiation Therapy Oncology Group Late Effects Normal Tissue-Subjective, Objective, Management, Analytic scale was used for clinicians' assessment. For each scale, the unfavourable status was analysed with a logistic model including age, grade at baseline, time and PCI dose.


RESULTS
Over the 3 years studied, there was no significant difference between the two groups in any of the 17 selected items assessing QoL and neurological and cognitive functions. We observed in both groups a mild deterioration across time of communication deficit, weakness of legs, intellectual deficit and memory (all P < 0.005).


CONCLUSIONS
Patients should be informed of these potential adverse effects, as well as the benefit of PCI on survival and BM. PCI with a total dose of 25 Gy remains the standard of care in limited-stage SCLC.
Radiation Oncology Department. Electronic address: lepechoux@igr.fr.
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Le Péchoux
Biostatistics and Epidemiology Unit, Institut Gustave-Roussy, Villejuif, France.
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Laplanche
Department of Clinical Oncology, The Christie, Manchester, UK.
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Faivre-Finn
Medical Oncology Department, Institutul Oncologic I. Chiricuta, Cluj-Napoca, Romania.
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Ciuleanu
Radiation Oncology Department, MAASTRO Clinic, Maastricht, The Netherlands.
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Wanders
Radiation Oncology Department, Centre François Baclesse, Caen, France.
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Lerouge
Radiation Oncology Department, Arnhem's Radiotherapeutisch Instituut, Arnhem, The Netherlands.
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Keus
Department of Clinical Oncology, Weston Park Hospital, Sheffield, UK.
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Hatton
Radiation Oncology Department, Cleveland Clinic Foundation, Cleveland, USA.
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Videtic
Radiation Oncology Department, VU University Medical Centre, Amsterdam, The Netherlands.
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Senan
Radiation Oncology Department, University of Miami School of Medicine, Miami, USA.
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Wolfson
Department of Clinical Oncology, Beatson Oncology Centre, Glasgow, UK.
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Jones
Radiation Oncology Department, Karolinska Institutet, Stockholm, Sweden.
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Arriagada
Department of Pneumology, Hôpital Lyautey, Strasbourg, France.
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Quoix
Biostatistics and Epidemiology Unit, Institut Gustave-Roussy, Villejuif, France.
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Dunant
D001921:Brain / Q000473:pathology / Q000528:radiation effects; D001932:Brain Neoplasms / Q000517:prevention & control* / Q000532:radiotherapy / Q000556:secondary; D003072:Cognition Disorders / Q000209:etiology; D016371:Cranial Irradiation / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008175:Lung Neoplasms / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy*; D008569:Memory Disorders / Q000209:etiology; D019964:Mood Disorders / Q000209:etiology; D009483:Neuropsychological Tests; D011788:Quality of Life; D055752:Small Cell Lung Carcinoma / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome