Prophylactic Cranial Irradiation in Extensive Disease SCLC

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, GijsW.P.M. Kramer, Elaine M. Rankin, Michael Snee, Matthew Hatton, Pieter E. Postmus, Laurence Collette, and Suresh Senan Journal of clinical oncology, vol.27 January1st, 2009 P.78-84 Presented by Kanograt 16/6/53To evaluate of prophylactic cranial irradiation on health-related quality of life (HRQOL) and patient-reported symptoms SCLC; extensive disease Brain metastases are common and poor response PCI significantly decreases the risk of symptomatic brain metastases and increases significantly overall survival But it can also have adverse effects Patients age18-75 yrs, WHO or =10 points : moderate improvement or worsening < 10 points: not to be clinically significant > 20 points : large effectsStatistical analysis software version 9286 patients (143 in each arm ) 280 patients had at least one valid HRQOL and 268 had a baseline assessment HRQOL were to be performed until 3 yrs after random assignment or death Median survival times around 6 months Data obtained up to 9 months were included in the Analysis because to small number of patients ‘ data at 1 year Baseline HRQOL scores: similar in both arms No significant difference in compliance between two arms Noncomplete HRQOL : administrative failure 40.1 % : too ill to complete the questionnaire 23.8 %12 mo 9 mo only 6 pts in non-PCI arm 6 mo 3 mo Sharp decrease cognitive func. Rapid deterioration -> informative drop out at 6 weeks : 8 points up to 3 months : 20 points ( 12.5 %) large effectsC: N/V F: headaches G: motor dysfunction H: weakness of legsHair loss and fatigue: Significantly Hair loss mean score 36.5 VS 11.7 Fatigue mean score 43.2 VS 29.3Maximum mean difference Role functioning: 9.4 (week 6th ) Cognitive functioning: 8.8 (month 3th) Emotional functioning: 7.4 (week 6th ) not to be clinically significant similar to global health status No assessment due to small number of patients with data at later time points Statistically significant for appetite loss, constipation, N/V, social functioning, future uncertainty, headache, motor dysfunction and weakness of the legs at 6 weeks and/or at 3months Worsening of HRQOL on some scalesRCT in 1990: PCI reduced incidence of brain metastasis without increasing toxicity if not given concurrently with chemotherapy Meta-analysis: 3-yr survival rate 21% VS 15%This study: Reduction in hazard rate for symptomatic brain metastases 75% due to poor survival of any response to CMT, short and relatively low-dose fractionation Return rate of HRQOL forms: Brain metas. VS no brain metas. 31.8% VS 56.8% Brain metastases: lack of reporting > reporting of deteriorationCognitive functioning: 8.8 points higher at 3mo. due to lower rate of patients with brain met. or self-report of cognitive functioning group More fatigue in PCI group can also affect cognitive functioning Survival was shorter than expected->limiting power estimates considerably PCI improves survival and reduces the incidences of brain metastases in patients who response to CMT for ED-SCLC PCI should be offered and told of benefits/possible negative impact on function scale