Prophylactic cranial irradiation (PCI) has a detrimental effect on the overall survival (OS) of patients (pts) with extensive disease small cell lung cancer (ED-SCLC): Results of a Japanese randomized phase III trial.

Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Type and Session Title: 
Oral Abstract Session, Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 7503)
Takashi Seto, Toshiaki Takahashi, Takeharu Yamanaka, Hideyuki Harada, Hiroshi Nokihara, Hideo Saka, Makoto Nishio, Kazuhiko Nakagawa, Koichi Takayama, Osamu Ishimoto, Koji Takeda, Hiroshige Yoshioka, Motoko Tachihara, Hiroshi Sakai, Koichi Goto, Nobuyuki Yamamoto; Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan; National Cancer Center, Tokyo, Japan; Shizuoka Cancer Center, Shizuoka, Japan; National Cancer Center Hospital, Tokyo, Japan; National Hospital Organization, Nagoya Medical Center, Nagoya, Japan; Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Kinki University Faculty of Medicine, Osaka, Japan; Kyushu University, Fukuoka, Japan; Sendai Kousei Hospital, Sendai, Japan; Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan; Kurashiki Central Hospital, Kurashiki, Japan; Kobe University Graduate School of Medicine, Kobe, Japan; Saitama Cancer Center, Saitama, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Wakayama Medical University, Wakayama, Japan

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Abstract Disclosures


Background: A previous study has shown that PCI reduced the risk of brain metastases (BM) and prolonged the OS of patients with ED-SCLC (Slotman B et al, NEJM 2007). There were, however, several concerns that arose in association with that study, including the lack of magnetic resonance imaging (MRI) assessment to confirm the absence of BM before enrollment, the use of induction chemotherapy other than platinum, and variations in the radiation doses. Methods: From March 2009, pts with ED-SCLC who had any response to first-line platinum doublet chemotherapy were randomized to either PCI (25Gy/10 fractions) or observation (Obs) alone. The patients were required to prove the absence of BM by MRI prior to enrollment. The primary endpoint was OS and a planned sample size of 330 was determined to detect the hazard ratio (HR) of 0.75 at a significance level of 0.05 and a power of 80%. Secondary endpoints included time to BM (evaluated every 3 months by imaging), progression-free survival (PFS), and adverse effects (AEs). Results: In July 2013, a preplanned interim analysis was conducted for the survival data of 163 pts from 41 centers. The study was terminated because of futility; with a median follow-up of 9.4 months and 111 observed deaths, the median OS was 10.1 and 15.1 months for PCI (n=84) and Obs (n=79), respectively (HR=1.38, 95%CI= 0.95-2.01; stratified log-rank test, P=0.091). Bayesian predictive probability of showing superiority of PCI over Obs was 0.01%. PCI significantly reduced the risk of BM as compared to Obs (32.4% vs 58.0% at 12 months; Gray’s test, P<0.001), whereas PFS was comparable between the two arms (median, 2.2 vs. 2.4 months; HR=1.12, 95%CI=0.82-1.54). No significant difference in AEs greater than Grade 2 was observed between the two arms. Conclusions: PCI after response to chemotherapy had a negative impact on OS in pts with ED-SCLC. Clinical trial information: 000001755.