BACKGROUND: Tyrosine kinase inhibitors (TKIs) are remarkably effective in patients with non-small cell lung carcinoma (NSCLC) harboring driver gene mutations and rearrangements. Crizotinib, a small-molecule TKI, has been demonstrated to be an efficacious drug against c-ros oncogene 1-rearranged NSCLC (ROS1-NSCLC) in clinical trials. However, information regarding the use of crizotinib in clinical practice in Japan is limited. METHODS: Subjects with a definite diagnosis of advanced/relapsed ROS1-NSCLC were selected from consecutive NSCLC patients treated at the National Cancer Center Hospital between December 2014 and May 2018. We retrospectively assessed the efficacy and safety of crizotinib in clinical practice. RESULTS: Among 24 patients with ROS1-NSCLC, the ROS1 rearrangement status was assessed using reverse transcription polymerase chain reaction (RT-PCR) (n=17), fluorescence in situ hybridization (FISH) (n=8), or next-generation sequencing (n=5) (some overlap occurred). Thirteen patients were treated with crizotinib in clinical practice. Among the 10 patients in whom clinical efficacy could be evaluated, the objective response rate (ORR) was 80.0% [95% confidence interval (CI), 49.0 to 94.3]. The median follow-up time was 35.5 months (95% CI, 8.9 to 44.6), the median progression-free survival (PFS) time was 10.0 months (95% CI, 5.1 to 27.0), and the median overall survival (OS) time was 28.7 months (95% CI, 6.7 to not reached). The most common adverse events were an aspartate/alanine aminotransferase (AST/ALT) increased and vision disorder. No severe adverse events related to crizotinib occurred. CONCLUSIONS: The use of crizotinib in patients with ROS1-NSCLC was effective and well tolerated in clinical practice in Japan without severe adverse events.
BACKGROUND: Tyrosine kinase inhibitors (TKIs) are remarkably effective in patients with non-small cell lung carcinoma (NSCLC) harboring driver gene mutations and rearrangements. Crizotinib, a small-molecule TKI, has been demonstrated to be an efficacious drug against c-ros oncogene 1-rearranged NSCLC (ROS1-NSCLC) in clinical trials. However, information regarding the use of crizotinib in clinical practice in Japan is limited. METHODS: Subjects with a definite diagnosis of advanced/relapsed ROS1-NSCLC were selected from consecutive NSCLC patients treated at the National Cancer Center Hospital between December 2014 and May 2018. We retrospectively assessed the efficacy and safety of crizotinib in clinical practice. RESULTS: Among 24 patients with ROS1-NSCLC, the ROS1 rearrangement status was assessed using reverse transcription polymerase chain reaction (RT-PCR) (n=17), fluorescence in situ hybridization (FISH) (n=8), or next-generation sequencing (n=5) (some overlap occurred). Thirteen patients were treated with crizotinib in clinical practice. Among the 10 patients in whom clinical efficacy could be evaluated, the objective response rate (ORR) was 80.0% [95% confidence interval (CI), 49.0 to 94.3]. The median follow-up time was 35.5 months (95% CI, 8.9 to 44.6), the median progression-free survival (PFS) time was 10.0 months (95% CI, 5.1 to 27.0), and the median overall survival (OS) time was 28.7 months (95% CI, 6.7 to not reached). The most common adverse events were an aspartate/alanine aminotransferase (AST/ALT) increased and vision disorder. No severe adverse events related to crizotinib occurred. CONCLUSIONS: The use of crizotinib in patients with ROS1-NSCLC was effective and well tolerated in clinical practice in Japan without severe adverse events.
Authors: Julien Mazières; Gérard Zalcman; Lucio Crinò; Pamela Biondani; Fabrice Barlesi; Thomas Filleron; Anne-Marie C Dingemans; Hervé Léna; Isabelle Monnet; Sacha I Rothschild; Federico Cappuzzo; Benjamin Besse; Luc Thiberville; Damien Rouvière; Rafal Dziadziuszko; Egbert F Smit; Jurgen Wolf; Christian Spirig; Nicolas Pecuchet; Frauke Leenders; Johannes M Heuckmann; Joachim Diebold; Julie D Milia; Roman K Thomas; Oliver Gautschi Journal: J Clin Oncol Date: 2015-02-09 Impact factor: 44.544
Authors: Alice T Shaw; Sai-Hong I Ou; Yung-Jue Bang; D Ross Camidge; Benjamin J Solomon; Ravi Salgia; Gregory J Riely; Marileila Varella-Garcia; Geoffrey I Shapiro; Daniel B Costa; Robert C Doebele; Long Phi Le; Zongli Zheng; Weiwei Tan; Patricia Stephenson; S Martin Shreeve; Lesley M Tye; James G Christensen; Keith D Wilner; Jeffrey W Clark; A John Iafrate Journal: N Engl J Med Date: 2014-09-27 Impact factor: 91.245
Authors: Kristin Bergethon; Alice T Shaw; Sai-Hong Ignatius Ou; Ryohei Katayama; Christine M Lovly; Nerina T McDonald; Pierre P Massion; Christina Siwak-Tapp; Adriana Gonzalez; Rong Fang; Eugene J Mark; Julie M Batten; Haiquan Chen; Keith D Wilner; Eunice L Kwak; Jeffrey W Clark; David P Carbone; Hongbin Ji; Jeffrey A Engelman; Mari Mino-Kenudson; William Pao; A John Iafrate Journal: J Clin Oncol Date: 2012-01-03 Impact factor: 44.544
Authors: Klarisa Rikova; Ailan Guo; Qingfu Zeng; Anthony Possemato; Jian Yu; Herbert Haack; Julie Nardone; Kimberly Lee; Cynthia Reeves; Yu Li; Yerong Hu; Zhiping Tan; Matthew Stokes; Laura Sullivan; Jeffrey Mitchell; Randy Wetzel; Joan Macneill; Jian Min Ren; Jin Yuan; Corey E Bakalarski; Judit Villen; Jon M Kornhauser; Bradley Smith; Daiqiang Li; Xinmin Zhou; Steven P Gygi; Ting-Lei Gu; Roberto D Polakiewicz; John Rush; Michael J Comb Journal: Cell Date: 2007-12-14 Impact factor: 41.582
Authors: Kurtis D Davies; Sakshi Mahale; David P Astling; Dara L Aisner; Anh T Le; Trista K Hinz; Aria Vaishnavi; Paul A Bunn; Lynn E Heasley; Aik-Choon Tan; D Ross Camidge; Marileila Varella-Garcia; Robert C Doebele Journal: PLoS One Date: 2013-12-13 Impact factor: 3.240