Expansion part of phase I study of E7090 in patients with cholangiocarcinoma harboring FGFR2 gene fusion and with gastric cancer harboring FGFR2 gene amplification or FGFR2 protein high expression
| العنوان: | Expansion part of phase I study of E7090 in patients with cholangiocarcinoma harboring FGFR2 gene fusion and with gastric cancer harboring FGFR2 gene amplification or FGFR2 protein high expression |
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| المؤلفون: | Yoshito Komatsu, Takako Eguchi Nakajima, Takatoshi Sahara, Tatsuya Ioka, Kensei Yamaguchi, Tsutomu Takashima, Junji Furuse, Manabu Muto, Chigusa Morizane, Masafumi Ikeda, Tomohiro Nishina, Masakazu Yashiro, Makoto Ueno, Hiroshi Yabusaki, Atsushi Miyamoto, Satoru Iwasa, Hiroki Hara, Keiko Minashi, Setsuo Funasaka, Masahiro Tajika |
| المصدر: | Journal of Clinical Oncology. 38:538-538 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Cancer Research, medicine.drug_class, business.industry, Cancer, medicine.disease, FGFR2 Gene Amplification, Tyrosine-kinase inhibitor, Phase i study, Fusion gene, Oncology, medicine, Cancer research, In patient, business |
| الوصف: | 538 Background: E7090 is a selective tyrosine kinase inhibitor against FGFR1-3. This first-in-human phase I study has been conducted in Japan and consists of 2 parts. Based on the toxic, pharmacokinetic, and pharmacodynamic profiles in Part 1, dose escalation study, the recommended dose was determined to be 140 mg QD for Part 2, an expansion study part restricted to patients with tumors harboring FGFR gene alterations. Here we provide the interim analysis results of Part 2. Methods: In Part 2, patients with cholangiocarcinoma harboring FGFR2 gene fusion (CCA cohort) and gastric cancer harboring FGFR2 gene amplification or FGFR2 protein high expression (GC cohort) were enrolled. Patients received oral dosing of E7090 until disease progression or unacceptable toxicity. Safety was assessed using CTCAE version 4.03. Tumor response was evaluated by site investigators using RECIST 1.1. Results: As of 31 March 2019, 16 patients including 6 patients in CCA cohort and 10 patients in GC cohort received E7090 in Part2. Median age was 63 years, 25% were female, ECOG PS of 0 and 1 were 50% respectively. 5 patients (83%) in CCA cohort and 1 patient (10%) in GC cohort achieved partial response as the best overall response. The disease control rates were 100% in CCA cohort and 30% in GC cohort, respectively. Median progression-free survivals were 8.3 months in CCA cohort and 2.8 months in GC cohort at the cut-off date. 2 patients with CCA remain on treatment. The most common treatment-related TEAEs occurring in 30% or more of patients in Part 2 were hyperphosphatemia (100%), palmar–plantar erythrodysesthesia syndrome (56%), paronychia (50%), dysgeusia (38%), stomatitis (31%), diarrhea (31%), increased AST (31%) and blood creatinine increased (31%). Grade≥3 treatment-related TEAEs were reported in 2 out of 16 patients (13%); they were increased AST, lipase increased and retinopathy. Conclusions: This study indicated that E7090 has a manageable safety profile in Part 2 and the promising clinical activity in CCA patients with FGFR2 gene fusion. |
| تدمد: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2020.38.4_suppl.538 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::bba61f0f72203e51eeb713b07a4add38 https://doi.org/10.1200/jco.2020.38.4_suppl.538 |
| رقم الانضمام: | edsair.doi...........bba61f0f72203e51eeb713b07a4add38 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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| DOI: | 10.1200/jco.2020.38.4_suppl.538 |