1470P - The effect of prophylactic cranial irradiation (PCI) in the patients with extensive-disease small-cell lung cancer (ED-SCLC): Results of a Japanese...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Small-Cell Lung Cancer
Surgery and/or Radiotherapy of Cancer
Presenter Tateaki Naito
Citation Annals of Oncology (2014) 25 (suppl_4): iv511-iv516. 10.1093/annonc/mdu355
Authors T. Naito1, T. Takahashi1, T. Yamanaka2, H. Harada3, T. Seto4, M. Satouchi5, S. Oizumi6, N. Katakami7, K. Shibata8, M. Maemondo9, K. Kiura10, H. Okamoto11, K. Minato12, N. Yamamoto13
  • 1Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 2Department Of Biostatistics, National Cancer Center, Kashiwa/JP
  • 3Division Of Radiation Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 4Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 5Thoracic Oncology, Hyogo Cancer Center, 673-8558 - Akashi/JP
  • 6First Department Of Medicine, Hokkaido University School of Medicine, 060-8638 - Sapporo/JP
  • 7Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe/JP
  • 8Departmento Of Medical Oncology, Kouseiren Takaoka Hospital, JP-933-8555 - Takaoka/JP
  • 9Department Of Respiratory Medicine, Miyagi Cancer Center, Natori/JP
  • 10Department Of Respiratory Medicine, Okayama University Hospital, Okayama/JP
  • 11Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, JP-240-8555 - Yokohama/JP
  • 12Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta/JP
  • 13Third Department Of Internal Medicine, Wakayama Medical University, Wakayama/JP

Abstract

Aim

A previous study has shown that PCI reduced the risk of brain metastases (BM) and prolonged the overall survival (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. The aim of this study is to assess the efficacy and safety of the PCI in the patients with ED-SCLC.

Methods

From March 2009, patients with ED-SCLC who had any response to first-line chemotherapy (platinum agent plus irinotecan or etoposide) 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, 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 might have a negative impact on OS in pts with ED-SCLC. Updated safety data will be presented at the conference.

Disclosure

All authors have declared no conflicts of interest.