TY - JOUR
T1 - Re-biopsy status among non-small cell lung cancer patients in Japan
T2 - A retrospective study
AU - Nosaki, Kaname
AU - Satouchi, Miyako
AU - Kurata, Takayasu
AU - Yoshida, Tatsuya
AU - Okamoto, Isamu
AU - Katakami, Nobuyuki
AU - Imamura, Fumio
AU - Tanaka, Kaoru
AU - Yamane, Yuki
AU - Yamamoto, Nobuyuki
AU - Kato, Terufumi
AU - Kiura, Katsuyuki
AU - Saka, Hideo
AU - Yoshioka, Hiroshige
AU - Watanabe, Kana
AU - Mizuno, Keiko
AU - Seto, Takashi
N1 - Funding Information:
This study was sponsored by AstraZeneca K.K . We thank all the patients and their families for their support. We would like to thank the following investigators who participated in this study: Hiroshi Tanaka, Department of Internal Medicine, Niigata Cancer Center Hospital; Ichiro Yoshino, Department of Thoracic Surgery, Chiba University Hospital; Masato Shingyoji Division of Thoracic Diseases, Chiba Cancer Center; Ryo Koyama, Department of Respiratory Medicine, Juntendo University Hospital; Norihiko Ikeda, Department of Thoracic and Thyroid Surgery, Tokyo Medical University Hospital; Shuji Murakami, Department of Respiratory Medicine, Kanagawa Cancer Center; Hiroaki Okamoto, Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital; Masahiro Shinoda, Respiratory Disease Center, Internal Medicine, Yokohama City University Medical Center; Kazuo Kasahara, Department of Respiratory Medicine, Kanazawa University Hospital; Shinji Atagi, Department of Thoracic Oncology, Kinki-Chuo Chest Medical Center; Yasuo Iwamoto, Department of Medical Oncology, Hiroshima City Hiroshima Citizens Hospital; Daijiro Harada, Department of Respiratory Medicine, Shikoku Cancer Center. We also thank Dr Michelle Belanger, Marion Barnett, and Helen Roberton, who provided medical writing assistance, and Springer Healthcare Communications. This assistance was funded by AstraZeneca K.K.
Funding Information:
K Nosaki has received investigator's fees from AstraZeneca K.K., and an honorarium from Eli Lilly; M Satouchi has received investigator's fees from AstraZeneca K.K., and lecture fees from Chugai, Taiho, Eli Lilly, Pfizer, AstraZeneca K.K., Boehringer Ingelheim, Bristol-Myers Squibb, Ono and Novartis; T Kurata has received lecture fees and manuscript fees from Eli Lilly, and lecture fees from AstraZeneca K.K., Boehringer Ingelheim, Chugai, Pfizer; T Yoshida has received investigator's fees from AstraZeneca K.K., and honoraria from Boehringer Ingelheim and AstraZeneca K.K.; I Okamoto has received investigator's fees and honoraria from AstraZeneca K.K.; N Katakami has received investigator's fees from AstraZeneca K.K., and lecture fees from Ono, Dainippon Sumitomo Pharma, Chugai, Boehringer Ingelheim, AstraZeneca K.K., Eli Lilly, Taiho, Janssen and Novartis; F Imamura has received investigator's fees and honoraria from AstraZeneca K.K.; K Tanaka has received investigator's fees from AstraZeneca K.K., and lecture fees from Eisai, Merck Serono, and Chugai; Y Yamane has received investigator's fees from AstraZeneca K.K.; N Yamamoto has received consulting fees and honorarium from Boehringer-Ingelheim and Chugai; T Kato has received grants & lecture fees from AstraZeneca K.K., Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eli Lilly, Kirin-Kyowa, Pfizer, Sanofi, Taiho, and lecture fees from Ono, Shionogi, Takeda, Yakult, and grant from Daiichi-Sankyo; K Kiura has received lecture fees and investigator’s fees from Eli Lilly, Chugai, Pfizer, Novartis, Taiho, Astellas, AstraZeneca K.K., Boehringer Ingelheim, and lecture fees from GSK, Meiji Seika Pharma, investigator’s fee from Nippon Kayaku; H Saka has received investigator's fees from AstraZeneca K.K., and research funding from AtraZeneca K.K., Daiichi Sankyo, Ono, Eli Lilly, Bayer Yakuhin, Taiho, Merck, Linical Co. Ltd., Bristol-Myers Squibb, and Sanofi; H Yoshioka has received investigator's fees from AstraZeneca K.K., and honoraria from Eli Lilly, Chugai, Boehringer Ingelheim, and AstraZeneca K.K.; K Watanabe has received investigator's fees from AstraZeneca K.K.; K Mizuno has received investigator's fees from AstraZeneca K.K., and lecture/travel fees from AstraZeneca K.K., Chugai, Boehringer Ingelheim, and Taiho; and T Seto has received investigator's fees and honoraria from AstraZeneca K.K., honoraria from Chugai, Daiichi, Eisai, Eli Lilly, Fuji Pharma Co. Ltd, and Hisamitsu Pharmaceutical Co. Ltd.
Publisher Copyright:
© 2016 AstraZeneca K.K.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Objective Disease progression because of acquired resistance is common in advanced or metastatic epidermal growth factor receptor (EGFR)-mutation positive non-small cell lung cancer (NSCLC), despite initial response to EGFR-tyrosine kinase inhibitors (TKIs). In Japan, transbronchial tissue biopsy is the most common sampling method used for re-biopsy to identify patients eligible for treatment. We aimed to investigate the success rate of re-biopsy and re-biopsy status of patients with advanced or metastatic NSCLC completing first-line EGFR-TKI therapy. Patients and methods This was a retrospective, multi-center, Japanese study. The target patients in the study were EGFR mutation-positive NSCLC patients. The primary endpoint was the success rate (number of cases in which tumor cells were detected/total number of re-biopsies performed × 100). Secondary endpoints included differences between the status of the first biopsy and that of the re-biopsy in the same patient population, and the details of cases in which re-biopsy could not be carried out. Re-biopsy-associated complications were also assessed. Results Overall, 395 patients were evaluated (median age 63 years), with adenocarcinoma being the most common tumor type. Re-biopsy was successful in 314 patients (79.5%). Compared with the sampling method at first biopsy, at re-biopsy, the surgical resection rate increased from 1.8% to 7.8%, and percutaneous tissue biopsy increased from 7.6% to 29.1%, suggesting the difficulty of performing re-biopsy. Approximately half of the patients had T790M mutations, which involved a Del19 mutation in 55.6% of patients and an L858R mutation in 43.0%. Twenty-three patients (5.8%) had re-biopsy- associated complications, most commonly pneumothorax. Conclusions Success rate for re-biopsy in this study was approximately 80%. Our study sheds light on the re-biopsy status after disease progression in patients with advanced or metastatic NSCLC. This information is important to improve the selection of patients who may benefit from third-generation TKIs.
AB - Objective Disease progression because of acquired resistance is common in advanced or metastatic epidermal growth factor receptor (EGFR)-mutation positive non-small cell lung cancer (NSCLC), despite initial response to EGFR-tyrosine kinase inhibitors (TKIs). In Japan, transbronchial tissue biopsy is the most common sampling method used for re-biopsy to identify patients eligible for treatment. We aimed to investigate the success rate of re-biopsy and re-biopsy status of patients with advanced or metastatic NSCLC completing first-line EGFR-TKI therapy. Patients and methods This was a retrospective, multi-center, Japanese study. The target patients in the study were EGFR mutation-positive NSCLC patients. The primary endpoint was the success rate (number of cases in which tumor cells were detected/total number of re-biopsies performed × 100). Secondary endpoints included differences between the status of the first biopsy and that of the re-biopsy in the same patient population, and the details of cases in which re-biopsy could not be carried out. Re-biopsy-associated complications were also assessed. Results Overall, 395 patients were evaluated (median age 63 years), with adenocarcinoma being the most common tumor type. Re-biopsy was successful in 314 patients (79.5%). Compared with the sampling method at first biopsy, at re-biopsy, the surgical resection rate increased from 1.8% to 7.8%, and percutaneous tissue biopsy increased from 7.6% to 29.1%, suggesting the difficulty of performing re-biopsy. Approximately half of the patients had T790M mutations, which involved a Del19 mutation in 55.6% of patients and an L858R mutation in 43.0%. Twenty-three patients (5.8%) had re-biopsy- associated complications, most commonly pneumothorax. Conclusions Success rate for re-biopsy in this study was approximately 80%. Our study sheds light on the re-biopsy status after disease progression in patients with advanced or metastatic NSCLC. This information is important to improve the selection of patients who may benefit from third-generation TKIs.
KW - Epidermal growth factor receptor mutation
KW - Non-small cell lung cancer
KW - Re-biopsy
KW - Resistance
KW - T790 M
KW - Tyrosine kinase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=84984782786&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84984782786&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2016.07.007
DO - 10.1016/j.lungcan.2016.07.007
M3 - Article
C2 - 27794396
AN - SCOPUS:84984782786
SN - 0169-5002
VL - 101
SP - 1
EP - 8
JO - Lung Cancer
JF - Lung Cancer
ER -
