81987
document
Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission . BACKGROUND Prophylactic cranial irradiation in patients with small-cell lung cancer decreases the overall rate of brain metastases without an effect on overall survival . It has been suggested that this treatment may increase neuropsychological syndromes and brain abnormalities indicated by computed tomography scans . However , other retrospective data suggested a beneficial effect on overall survival for patients in complete remission . PURPOSE Our purpose was to evaluate the effects of prophylactic cranial irradiation on brain metastasis , overall survival , and late-occurring toxic effects in patients with small-cell lung cancer in complete remission . METHODS We conducted a prospective study of 300 patients who had small-cell lung cancer that was in complete remission . The patients were randomly assigned to receive either prophylactic cranial irradiation delivering 24 Gy in eight fractions during 12 days ( treatment group ) or no prophylactic cranial irradiation ( control group ) . A neuropsychological examination and a computed tomography scan of the brain were performed at the time of random assignment and repeatedly assessed at 6 , 18 , 30 , and 48 months . Patterns of failure were analyzed according to total event rates and also according to an isolated first site of relapse , using a competing-risk approach . RESULTS Two hundred ninety-four patients who did not have brain metastases at the time of random assignment were analyzed . The 2-year cumulative rate of brain metastasis as an isolated first site of relapse was 45 % in the control group and 19 % in the treatment group ( P < 10 ( -6 ) ) . The total 2-year rate of brain metastasis was 67 % and 40 % , respectively ( relative risk = 0.35 ; P < 10 ( -13 ) ) . The 2-year overall survival rate was 21.5 % in the control group and 29 % in the treatment group ( relative risk = 0.83 ; P = .14 ) . There were no significant differences between the two groups in terms of neuropsychological function or abnormalities indicated by computed tomography brain scans . CONCLUSIONS Prophylactic cranial irradiation given to patients with small-cell lung cancer in complete remission decreases the risk of brain metastasis threefold without a significant increase in complications . A possible beneficial effect on overall survival should be tested with a higher statistical power . IMPLICATIONS The results of the trial favor , at present , the indication of prophylactic cranial irradiation for patients who are in complete remission . A longer follow-up and confirmatory trials are needed to fully assess late-occurring toxic effects . The possible effect on overall survival needs to be evaluated with a larger number of patients in complete remission , and a meta-analysis of similar trials is recommended .
81988
Intervention_Physical
Prophylactic cranial irradiation
81989
Intervention_Physical
prophylactic cranial irradiation
81990
Intervention_Physical
prophylactic cranial irradiation
81991
Intervention_Physical
no prophylactic cranial irradiation ( control group )
81992
Intervention_Physical
Prophylactic cranial irradiation
81993
Outcome_Mortality
overall survival .
81994
Outcome_Mortality
brain metastasis , overall survival
81995
Outcome_Adverse-effects
late-occurring toxic effects
81996
Outcome_Mental
2-year cumulative rate of brain metastasis
81997
Outcome_Mental
relapse
81998
Outcome_Physical
total 2-year rate of brain metastasis
81999
Outcome_Mortality
2-year overall survival rate
82000
Outcome_Physical
neuropsychological function or abnormalities
82001
Outcome_Mortality
overall survival
82002
Participant_Condition
small-cell lung cancer in complete remission .
82003
Participant_Condition
patients with small-cell lung cancer
82004
Participant_Condition
patients in complete remission
82005
Participant_Condition
patients with small-cell lung cancer in complete remission
82006
Participant_Sample-size
300
82007
Participant_Condition
patients who had small-cell lung cancer that was in complete remission
82008
Participant_Sample-size
Two hundred ninety-four patients
82009
Participant_Condition
patients with small-cell lung cancer in complete remission
82010
Participant_Condition
patients who are in complete remission
82011
Participant_Condition
patients in complete remission