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Previous Volume 357:664-672 August 16, 2007 Number 7 Next

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ABSTRACT

Background We conducted a randomized trial of prophylactic cranial irradiation in patients with extensive small-cell lung cancer who had had a response to chemotherapy.

Methods Patients between the ages of 18 and 75 years with extensive small-cell lung cancer were randomly assigned to undergo prophylactic cranial irradiation (irradiation group) or receive no further therapy (control group). The primary end point was the time to symptomatic brain metastases. Computed tomography or magnetic resonance imaging of the brain was performed when any predefined key symptom suggestive of brain metastases was present.

Results The two groups (each with 143 patients) were well balanced regarding baseline characteristics. Patients in the irradiation group had a lower risk of symptomatic brain metastases (hazard ratio, 0.27; 95% confidence interval [CI], 0.16 to 0.44; P<0.001). The cumulative risk of brain metastases within 1 year was 14.6% in the irradiation group (95% CI, 8.3 to 20.9) and 40.4% in the control group (95% CI, 32.1 to 48.6). Irradiation was associated with an increase in median disease-free survival from 12.0 weeks to 14.7 weeks and in median overall survival from 5.4 months to 6.7 months after randomization. The 1-year survival rate was 27.1% (95% CI, 19.4 to 35.5) in the irradiation group and 13.3% (95% CI, 8.1 to 19.9) in the control group. Irradiation had side effects but did not have a clinically significant effect on global health status.

Conclusions Prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs disease-free and overall survival. (ClinicalTrials.gov number, NCT00016211 [ClinicalTrials.gov] .)

Source Information

From the Departments of Radiation Oncology (B.S., S.S.) and Pulmonary Diseases (P.P.), VU University Medical Center, Amsterdam; and Arnhem's Radiotherapeutisch Instituut, Arnhem (G.K.) — both in the Netherlands; Christie Hospital, Manchester (C.F.-F.); University of Dundee Ninewells Hospital, Dundee (E.R.); Cookridge Hospital, Leeds (M.S.); and Weston Park Hospital, Sheffield (M.H.) — all in the United Kingdom; and the Departments of Statistics (L.C.) and Medical Research (E.M.), European Organisation for Research and Treatment of Cancer Data Center, Brussels.

Dr. Kramer is deceased.

Address reprint requests to Dr. Slotman at the Department of Radiation Oncology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands, or at bj.slotman{at}vumc.nl.

Full Text of this Article

Related Letters:

Prophylactic Cranial Irradiation in Small-Cell Lung Cancer
Shivnani A. T., Fujiwara Y., Hotta K., Kiura K., Khandelwal S. R., Ghaemmaghami M., Slotman B., Postmus P., Senan S.
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N Engl J Med 2007; 357:1977-1978, Nov 8, 2007. Correspondence

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