1260P - A phase II study of erlotinib as first-line treatment in Japanese advanced NSCLC patients harboring EGFR mutations

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Non-small-cell lung cancer
Biological therapy
Presenter Atsushi Horiike
Authors A. Horiike1, M. Nishio1, K. Goto2, N. Yamamoto3, K. Chikamori4, M. Maemondo5, T. Hida6, N. Katakami7, T. Tamura8
  • 1Thoracic Oncology Center, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Koto-ku, Tokyo/JP
  • 2Thoracic Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 3Division Of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo/JP
  • 4Oncology Medicine, National Hospital Organization,Yamaguchi - Ube Medical Center, Ube/JP
  • 5Department Of Respiratory Medicine, Miyagi Cancer Center, Natori/JP
  • 6Department Of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya/JP
  • 7Division Of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe/JP
  • 8Division Of Internal Medicine And Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo/JP



Several studies of EGFR TKIs have shown a benefit in response and progression-free survival (PFS) for NSCLC patients harboring EGFR mutations in the first-line setting. This is the first prospective study to investigate erlotinib for the first-line treatment of NSCLC patients harboring EGFR mutations in Japanese patients.


We undertook the single-arm phase II study at 25 centers. Eligible patients were adults (over 20 years) with advanced or recurrent NSCLC harboring EGFR mutations (Exon 19 deletions (19del) or Exon 21 L858R mutation) with no prior chemotherapy for NSCLC. The primary endpoint was progression-free survival (PFS) and safety. Secondary endpoints were overall response rate (ORR), disease control rate (DCR), overall survival (OS), and response duration.


Between April 8 and October 6 2010, 103 patients were enrolled. All patients were administered erlotinib and included in the safety analysis. One patient was excluded from efficacy analysis, because of the deviation of GCP. Thus 102 patients were analyzed in the efficacy analysis.

At Data cut-off (Sep 1, 2011), median PFS assessed by Independent Review Committee was 11.8 months [95 %CI 9.7- not reached]. The updated median PFS incorporated with follow up assessments will be obtained in August 2012. The most common adverse events were rash and diarrhea in 82.5 % and 80.6 % respectively, with Grade 3 was 13.6 % and 1.0 % respectively, and there were no Grade 4/5 rash and diarrhea. Six treatment-related ILD like events were reported by investigators, and of which two were fatal. ORR was 78.4 %, DCR was 95.1 %, and response duration was 11.1 months [95 %CI 9.4- not reached], OS data is immature at this time (only ten deaths events). Median PFS in 50 patients with 19del was 12.5 months, in 50 patients with L858R was 11.0 months, and two patients with L858R/T790M was 3.8months.


This study showed a promising efficacy and safety profile of erlotinib in Japanese advanced NSCLC patients harboring EGFR mutations.


A. Horiike: Corprate-sponsored research: Chugai, Pfizer, Merck, KyowaKirin, Taiho, Eisai, Novartis, AMGEN.

M. Nishio: Corporate-sponsored research: Chugai, Eli Lillly, Pfizer, DiichiSankyo, KyowaKirin, Taiho, Eisai, Novartis. Lecture fees: Chugai.

K. Goto: Corporate-sponsored research: Chugai, Pfizer, KyowaKirin, Taiho, Eisai, Merckserono, Boehringer Ingelheim Lecture fees: Chugai, Taiho, Ono.

N. Yamamoto: Corporate-sponsored research: Chugai, Pfizer, KyowaKirin.

K. Chikamori: Corporate-sponsored research: Chugai, Taiho, Nippon Kayaku Lecture fees: Eli Lilly.

M. Maemondo: Corporate-sponsored research: Chugai, Taiho, Janssen Lecture fees: Chugai, Eli Lilly.

T. Hida: Corporate-sponsored research: Chugai, Eli Lilly, Bayer, Pfizer, DaiichiSankyo, KyowaKirin, Taiho, Boehringer Ingelheim, Merck, Aventis.

N. Katakami: Corporate-sponsored research: Chugai, Pfizer, Kyowakirin, Ono, Janssen, Merckserono, Boehringer Ingelheim,Dainipponsumitomo, Eisai, Shionogi.

T. Tamura: Corporate-sponsored research: Chugai, DaiichiSankyo, Boehringer Ingelheim, Abbott, Eisai, Bristol-Myers Squib, KyowaKirin Lecture fees: Taiho, Eli Lilly, Chugai