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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. Background.
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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 SanghaDate posted: June 21, 2007
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 yrs Auperin et. al. NEJM 1999;341:476-84
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)
Treatment A: PCI (20-30 Gy in 5-12 fr) R Treatment B: No PCI ED-SCLC with no prior RT to head and neck and no prior malignancy
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
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
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