Literature DB >> 35242383

Is there a role for sequential afatinib and osimertinib in patients with EGFR mutation?

Natsuhiko Iwamoto1, Young Hak Kim1, Shigeaki Iwatsubo1, Yoshihiro Nishimura2, Yasuhiro Funada1.   

Abstract

Entities:  

Year:  2022        PMID: 35242383      PMCID: PMC8828519          DOI: 10.21037/jtd-21-1700

Source DB:  PubMed          Journal:  J Thorac Dis        ISSN: 2072-1439            Impact factor:   2.895


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Epidermal growth factor receptor (EGFR) mutation is the most common driver mutation in patients with non-small cell lung cancer (NSCLC), and multiple tyrosine kinase inhibitors (TKIs) have been developed targeting EGFR. Accordingly, there are several treatment approaches for this patient population. Recently, Popat et al. presented the results of the UpSwingG study, a global observational study of patients with NSCLC and EGFR mutation who received sequential afatinib and osimertinib treatment (1). The primary objective of the study was to evaluate time to treatment failure (TTF), i.e., the time from the first dose of afatinib to the last dose of osimertinib or death by any cause, and the key secondary objectives were overall survival (OS) and objective response rate (ORR). The median TTF and OS were 27.7 months [95% confidence interval (CI): 24.0–30.2] and 36.5 months (95% CI: 32.9–41.8), respectively, and the ORR was 74% for afatinib and 45% for osimertinib. The authors concluded that sequential afatinib and osimertinib may be a reasonable treatment option for patients with NSCLC and EGFR mutation, and similar results have been reported previously in the GioTag study (2). However, both the UpSwingG and GioTag studies are observational studies that only included T790M mutation-positive patients who most benefit from osimertinib after afatinib failure. As the authors of both studies mentioned, this is the best scenario for EGFR mutation-positive NSCLC patients receiving afatinib as their initial treatment. The current standard first-line treatment for NSCLC patients with EGFR mutation is osimertinib. In the FLAURA study, the median OS for osimertinib was 38.6 months (95% CI: 34.5–41.8), which is numerically similar to that found in the UpSwingG and GioTag studies (1-3). However, a subgroup analysis of the FLAURA study revealed that there was no significant OS difference in patients with L858R mutation, while those with ex 19del derived significant OS benefit from osimertinib (3). Considering its significant OS benefit, mild toxicity, and no need for re-biopsy, osimertinib seems to be the best choice for patients with ex 19del. However, more effective treatment is necessary for patients with L858R mutation. Looking at the efficacy of sequential afatinib and osimertinib treatment based on the mutational subtypes, the median OS was inferior in patients with L858R mutation in both the UpSwingG study (38.0 months for ex 19del vs. 33.1 months for L858R mutation) (1) and GioTag study (41.6 months for ex 19del vs. 33.0 months for L858R mutation) (2). In addition, patients with L858R mutation are less likely to develop T790M after receiving first- or second-generation EGFR-TKI. According to two Japanese studies, the prevalence of T790M after receiving first- or second-generation EGFR-TKI is 55.6% and 63.4% for patients with ex 19del and 43.0% and 37.5% for patients with L858R mutation, respectively (4,5). In fact, the distributions of ex 19del and L858R mutation were 70.7% and 29.3% in the UpSwingG study and 73.5% and 26.0% in the GioTag study, respectively. To summarize, patients with L858R mutation have less chance to develop T790M after afatinib failure, and, more importantly, the treatment efficacy of sequential afatinib and osimertinib for L858R mutation is inferior to that for ex 19del. In this respect, combination therapies with EGFR-TKI and vascular endothelial growth factor (VEGF) or VEGF-receptor (VEGFR) inhibitors are promising. In the RELAY study, although the OS data are still immature, progression-free survival was significantly better for the erlotinib+ramucirumab arm of ex 19del [hazard ratio (HR) 0.65; P=0.0098] and L858R mutation (HR 0.62; P=0.0060) (6). There is growing evidence that compound EGFR mutations and concomitant mutations outside of the EGFR gene, which are significantly associated with the reduced efficacy of EGFR-TKI, are more prevalent in patients with L858R mutation compared to patients with ex 19del (7). Adding a VEGF(R) inhibitor to EGFR-TKI may improve the outcomes of patients with L858R mutation compared with EGFR-TKI alone. The NEJ026 study failed to demonstrate significant OS improvement with erlotinib+bevacizumab in patients with L858R mutation (HR 0.79: 95% CI: 0.460–1.358); however, the study was not designed to detect statistical OS difference in each mutational subtype. Furthermore, effective subsequent treatment might have compromised statistically significant PFS improvement of erlotinib+bevacizumab (8). In conclusion, for patients with ex 19del, osimertinib is currently the best treatment option, though the results of an ongoing comparative study are still awaited (9). On the other hand, more effective treatment is necessary for patients with L858R mutation, and combination with EGFR-TKI and a VEGF(R) inhibitor seems most effective for this patient population. Currently, several phase III studies comparing osimertinib and osimertinib + VEGF(R) inhibitor are ongoing (10,11). The results of these studies might redefine the standard treatment for NSCLC patients with EGFR mutation. Nevertheless, sequential afatinib and osimertinib treatment continues to be an important treatment option in some countries where osimertinib or RELAY regimen are exempt from insurance reimbursement. The article’s supplementary files as
  8 in total

1.  Re-biopsy status among non-small cell lung cancer patients in Japan: A retrospective study.

Authors:  Kaname Nosaki; Miyako Satouchi; Takayasu Kurata; Tatsuya Yoshida; Isamu Okamoto; Nobuyuki Katakami; Fumio Imamura; Kaoru Tanaka; Yuki Yamane; Nobuyuki Yamamoto; Terufumi Kato; Katsuyuki Kiura; Hideo Saka; Hiroshige Yoshioka; Kana Watanabe; Keiko Mizuno; Takashi Seto
Journal:  Lung Cancer       Date:  2016-07-06       Impact factor: 5.705

2.  Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial.

Authors:  Kazuhiko Nakagawa; Edward B Garon; Takashi Seto; Makoto Nishio; Santiago Ponce Aix; Luis Paz-Ares; Chao-Hua Chiu; Keunchil Park; Silvia Novello; Ernest Nadal; Fumio Imamura; Kiyotaka Yoh; Jin-Yuan Shih; Kwok Hung Au; Denis Moro-Sibilot; Sotaro Enatsu; Annamaria Zimmermann; Bente Frimodt-Moller; Carla Visseren-Grul; Martin Reck
Journal:  Lancet Oncol       Date:  2019-10-04       Impact factor: 41.316

3.  Bevacizumab plus erlotinib versus erlotinib alone in Japanese patients with advanced, metastatic, EGFR-mutant non-small-cell lung cancer (NEJ026): overall survival analysis of an open-label, randomised, multicentre, phase 3 trial.

Authors:  Yosuke Kawashima; Tatsuro Fukuhara; Haruhiro Saito; Naoki Furuya; Kana Watanabe; Shunichi Sugawara; Shunichiro Iwasawa; Yoshio Tsunezuka; Ou Yamaguchi; Morihito Okada; Kozo Yoshimori; Ichiro Nakachi; Masahiro Seike; Koichi Azuma; Futoshi Kurimoto; Yukari Tsubata; Yuka Fujita; Hiromi Nagashima; Gyo Asai; Satoshi Watanabe; Masaki Miyazaki; Koichi Hagiwara; Toshihiro Nukiwa; Satoshi Morita; Kunihiko Kobayashi; Makoto Maemondo
Journal:  Lancet Respir Med       Date:  2021-08-26       Impact factor: 30.700

4.  Sequential afatinib and osimertinib in patients with EGFR mutation-positive NSCLC and acquired T790M: A global non-interventional study (UpSwinG).

Authors:  Sanjay Popat; Hyun Ae Jung; Shin Yup Lee; Maximilian J Hochmair; Seung Hyeun Lee; Carles Escriu; Min Ki Lee; Maria R Migliorino; Yong Chul Lee; Nicolas Girard; Hasan Daoud; Angela Märten; Satoru Miura
Journal:  Lung Cancer       Date:  2021-09-21       Impact factor: 5.705

5.  Association of EGFR Exon 19 Deletion and EGFR-TKI Treatment Duration with Frequency of T790M Mutation in EGFR-Mutant Lung Cancer Patients.

Authors:  Norikazu Matsuo; Koichi Azuma; Kazuko Sakai; Satoshi Hattori; Akihiko Kawahara; Hidenobu Ishii; Takaaki Tokito; Takashi Kinoshita; Kazuhiko Yamada; Kazuto Nishio; Tomoaki Hoshino
Journal:  Sci Rep       Date:  2016-11-04       Impact factor: 4.379

6.  Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC.

Authors:  Suresh S Ramalingam; Johan Vansteenkiste; David Planchard; Byoung Chul Cho; Jhanelle E Gray; Yuichiro Ohe; Caicun Zhou; Thanyanan Reungwetwattana; Ying Cheng; Busyamas Chewaskulyong; Riyaz Shah; Manuel Cobo; Ki Hyeong Lee; Parneet Cheema; Marcello Tiseo; Thomas John; Meng-Chih Lin; Fumio Imamura; Takayasu Kurata; Alexander Todd; Rachel Hodge; Matilde Saggese; Yuri Rukazenkov; Jean-Charles Soria
Journal:  N Engl J Med       Date:  2019-11-21       Impact factor: 91.245

7.  Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study.

Authors:  Maximilian J Hochmair; Alessandro Morabito; Desiree Hao; Cheng-Ta Yang; Ross A Soo; James C-H Yang; Rasim Gucalp; Balazs Halmos; Angela Märten; Tanja Cufer
Journal:  Future Oncol       Date:  2020-08-28       Impact factor: 3.404

  8 in total

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