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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