Post on 11-Jan-2016
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A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after
a response to chemotherapy (EORTC 08993-22993)
Authors: Slotman et al.LBA #4
Reviewer: Dr Randeep Sangha
Date posted: June 21, 2007
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Background
• High incidence of brain metastases (BM) in SCLC
• Prophylactic cranial irradiation (PCI) in limited disease (LD) SCLC reduces risk of brain metastases and improves survival– PCI used for patients in complete remission– Brain metastases incidence reduced
• 58.6% vs 33.3% with PCI at 3 yrs– Survival increases
• 15.3% vs 20.7% with PCI at 3 yrsAuperin et. al. NEJM 1999;341:476-84
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Study Design• Study Question
– Does PCI have a role in patients with extensive disease (ED) SCLC ?
• Study Population– 286 patients with ED-SCLC accrued between February 2001
to March 2006
• Endpoints– Primary Endpoint
• Cumulative incidence of symptomatic BM
– Secondary Endpoints• Failure free survival (FFS)• Overall Survival (OS)
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R
Treatment A: PCI (20-30 Gy in 5-12 fr)
Treatment B: No PCIED-SCLC with no prior RT to head and neck and no prior malignancy
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PCI No PCI p-value
FFS at 6mos
(%) 23.4 15.5 p= 0.0218
1 yr OS
(%)27.1 13.3 p= 0.0033
RESULTS
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Results• 286 patients with any response to chemotherapy were
randomized equally to each arm (PCI vs no PCI)
• Baseline characteristics similar
• PCI arm– 75.5% with persistent primary thoracic disease– 69.2% with distant metastatic disease
• No PCI arm– 76.9% with persistent primary thoracic disease– 72.7 distant metastatic disease
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Study Commentary
• PCI significantly reduces the risk of symptomatic BM
• PCI significantly prolongs FFS and OS
• PCI is well tolerated and does not adversely influence global quality of life (QoL)/health status
• PCI should be considered in all ED-SCLC patients who have had any response (PR,CR) to initial chemotherapy
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Bottom Line for Canadian Medical Oncologists
A well-designed study demonstrating the benefits of PCI in ED-SCLC patients
ED-SCLC patients who respond to chemotherapy, and have a good performance status, should be referred for PCI