TY - JOUR
T1 - First and repeat rebiopsy for detecting EGFR T790M mutation in non-small-cell lung cancer
T2 - CS-Lung-003 prospective observational registry study
AU - Kudo, Kenichiro
AU - Nishii, Kazuya
AU - Makimoto, Go
AU - Ishikawa, Nobuhisa
AU - Tsubata, Yukari
AU - Kodani, Masahiro
AU - Fujimoto, Nobukazu
AU - Yamasaki, Masahiro
AU - Kubota, Tetsuya
AU - Takigawa, Nagio
AU - Fujitaka, Kazunori
AU - Kanaji, Nobuhiro
AU - Shibayama, Takuo
AU - Itano, Junko
AU - Ando, Chihiro
AU - Hotta, Katsuyuki
AU - Kiura, Katsuyuki
N1 - Funding Information:
This work was supported the 2016 Chugoku Occupational Health Association Grant.
Funding Information:
EI received honoraria from AstraZeneca, Eli Lilly Japan, Boehringer Ingelheim, and Chugai Pharmaceutical. EI received additional research funding from Eli Lilly Japan and the MSD. Dr. Hotta reports personal fees from Pfizer, grants and personal fees from AstraZeneca, grants and personal fees from Chugai, grants and personal fees from Lilly, personal fees from Takeda, grants and personal fees from MSD, grants and personal fees from BMS, personal fees from Ono, personal fees from Nippon Kayaku, personal fees from Taiho, personal fees from Boehringer, outside the submitted work. Dr. Takigawa reports personal fees from AstraZeneca, grants and personal fees from Daiichi Sankyo Pharmaceutical, grants and personal fees from Chugai Pharmaceutical, grants and personal fees from Taiho Pharmaceutical, grants and personal fees from Pfizer, grants and personal fees from Boehringer Ingelheim, personal fees from Ono Pharmaceutical, personal fees from MSD, grants and personal fees from Eli Lilly, grants from Kyowa Hakko Kirin, grants from Nippon Kayaku, personal fees from Eisai, personal fees from Bristol-Myers Squibb, outside the submitted work. TM received honoraria from Takeda Pharmaceutical, Kyowa Hakko Kirin, Chugai Pharmaceutical, Novartis Pharmaceutical, Otsuka Pharmaceutical, Astellas Pharmaceutical, AsahiKASEI, Sumitomo Dainippon Pharmaceutical, Mochida Pharmaceutical, Bristol–Myers Squibb, Pfizer, Nippon Shinyaku, Janssen Pharmaceutical, Celgene, Eisai, Mundipharma, and Meiji Seika Pharma. TM also received research funding from Akeda Pharmaceutical and Kyowa Hakko Kirin. KO received research grants from Boehringer Ingelheim and Novartis Pharmaceuticals, Japan. KK received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi Sankyo Pharmaceuticals, Chugai Pharmaceuticals, Taiho Pharmaceuticals, Boehringer Ingelheim, and Sanofi Aventis. All remaining authors declare no conflict of interest regarding this study.
Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2022
Y1 - 2022
N2 - Purpose: Osimertinib is still essential for the treatment of epidermal growth factor receptor (EGFR)-T790M-positive non-small-cell lung cancer (NSCLC) even in a relapsed setting, which suggests the importance of rebiopsy. The clinical value of repeat rebiopsy in patients with NSCLC who are T790M-negative on a first rebiopsy remains unclear. In this study, we examined the status of the first rebiopsy and evaluated the frequency of repeat rebiopsy of T790M-negative tumors detected by the first rebiopsy. Methods: We reviewed 144 patients with NSCLC with major EGFR mutations, but not T790M, who received first- or second-generation EGFR tyrosine kinase inhibitors (TKIs), registered in the prospective, umbrella-type lung cancer patient registry (CS-Lung-003). Results: Overall, 63 patients (44%) underwent the first rebiopsy. In the first rebiopsy, 51 (81%) and 12 (19%) of 63 underwent histological/cytological rebiopsy and liquid biopsy with the blood sampling, respectively. In the repeat rebiopsy, 23 (85%) and 4 (15%) of 27 underwent histological/cytological rebiopsy and liquid biopsy, respectively. The most frequently rebiopsied site was a pulmonary lesion (n = 24, 38.7%). Overall, 29 (46.0%) of 63 patients harbored the T790M mutation. Interestingly, a high detection rate of cancer cells did not necessarily indicate a high detection rate of the T790M mutation (p < 0.01). Among 34 patients with T790M-negative tumors confirmed on the first rebiopsy, 20 (58.8%) underwent repeat rebiopsies following interval therapy, revealing that seven (36.8%) had T790M-positive tumors. Osimertinib yielded median progression-free survival of 11.8 and 16.2 months in patients with the 790M mutation detected by the first rebiopsy and repeat rebiopsy, respectively. Conclusion: In our prospective cohort, the T790M mutation was detected in 46% of patients who underwent the first rebiopsy. Repeat rebiopsy may increase the ability to detect the T790M mutation positivity rate.
AB - Purpose: Osimertinib is still essential for the treatment of epidermal growth factor receptor (EGFR)-T790M-positive non-small-cell lung cancer (NSCLC) even in a relapsed setting, which suggests the importance of rebiopsy. The clinical value of repeat rebiopsy in patients with NSCLC who are T790M-negative on a first rebiopsy remains unclear. In this study, we examined the status of the first rebiopsy and evaluated the frequency of repeat rebiopsy of T790M-negative tumors detected by the first rebiopsy. Methods: We reviewed 144 patients with NSCLC with major EGFR mutations, but not T790M, who received first- or second-generation EGFR tyrosine kinase inhibitors (TKIs), registered in the prospective, umbrella-type lung cancer patient registry (CS-Lung-003). Results: Overall, 63 patients (44%) underwent the first rebiopsy. In the first rebiopsy, 51 (81%) and 12 (19%) of 63 underwent histological/cytological rebiopsy and liquid biopsy with the blood sampling, respectively. In the repeat rebiopsy, 23 (85%) and 4 (15%) of 27 underwent histological/cytological rebiopsy and liquid biopsy, respectively. The most frequently rebiopsied site was a pulmonary lesion (n = 24, 38.7%). Overall, 29 (46.0%) of 63 patients harbored the T790M mutation. Interestingly, a high detection rate of cancer cells did not necessarily indicate a high detection rate of the T790M mutation (p < 0.01). Among 34 patients with T790M-negative tumors confirmed on the first rebiopsy, 20 (58.8%) underwent repeat rebiopsies following interval therapy, revealing that seven (36.8%) had T790M-positive tumors. Osimertinib yielded median progression-free survival of 11.8 and 16.2 months in patients with the 790M mutation detected by the first rebiopsy and repeat rebiopsy, respectively. Conclusion: In our prospective cohort, the T790M mutation was detected in 46% of patients who underwent the first rebiopsy. Repeat rebiopsy may increase the ability to detect the T790M mutation positivity rate.
KW - EGFR
KW - First rebiopsy
KW - Lung cancer
KW - Osimertinib
KW - Repeat rebiopsy
KW - T790M
UR - http://www.scopus.com/inward/record.url?scp=85127625869&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127625869&partnerID=8YFLogxK
U2 - 10.1007/s00432-021-03893-z
DO - 10.1007/s00432-021-03893-z
M3 - Article
C2 - 35386002
AN - SCOPUS:85127625869
SN - 0171-5216
JO - Journal of Cancer Research and Clinical Oncology
JF - Journal of Cancer Research and Clinical Oncology
ER -
