Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset

Katsuyuki Kiura, Fumio Imamura, Hiroshi Kagamu, Shingo Matsumoto, Toyoaki Hida, Kazuhiko Nakagawa, Miyako Satouchi, Isamu Okamoto, Mitsuhiro Takenoyama, Yasuhito Fujisaka, Takayasu Kurata, Masayuki Ito, Kota Tokushige, Ben Hatano, Makoto Nishio

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Abstract

Background: In the global, Phase 3, ASCEND-5 study, ceritinib improved progression-free survival (PFS) vs chemotherapy in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib and platinum-based chemotherapy. Here, we report efficacy and safety in a subset of Japanese patients from the ASCEND-5 study. Methods: Patients with advanced ALK-rearranged NSCLC received oral ceritinib 750 mg/day or chemotherapy (intravenous pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 [investigator's choice], every 21 days). Results: Among the 231 patients, 29 were Japanese, of which, 11 were treated with ceritinib and 18 were treated with chemotherapy (5 with pemetrexed and 13 with docetaxel). All the patients received prior crizotinib and one or two lines of prior chemotherapy for advanced disease. Median follow-up time was 16.6 months for ceritinib arm and 16.4 months for chemotherapy arm in the overall population. The median PFS by blinded independent review committee was 9.8 months (95% CI, 4.3-14.0) in ceritinib arm vs 1.6 months (95% CI, 1.4-3.0) in chemotherapy arm. Grade 3 or 4 adverse events, suspected to be study drug related, were reported in 36.4% of ceritinib arm and 72.2% of chemotherapy arm, respectively. No Grade 3 or 4 events of diarrhea, nausea and vomiting were reported in both the treatment arms. Adverse events leading to study drug discontinuation were reported in one patient in each arm: Grade 3 central-nervous system metastases in ceritinib-treated patient and Grade 3 febrile neutropenia in chemotherapy-treated patient. Conclusions: Consistent with overall population, ceritinib demonstrated better efficacy compared with the standard second-line chemotherapy in Japanese patients with crizotinib-resistant ALK+ NSCLC.

Original languageEnglish
Pages (from-to)367-375
Number of pages9
JournalJapanese journal of clinical oncology
Volume48
Issue number4
DOIs
Publication statusPublished - Apr 1 2018

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Non-Small Cell Lung Carcinoma
Drug Therapy
docetaxel
Pemetrexed
Disease-Free Survival
crizotinib
ceritinib
anaplastic lymphoma kinase
Febrile Neutropenia
Mouth Neoplasms
Advisory Committees
Platinum
Pharmaceutical Preparations
Nausea
Population
Vomiting
Diarrhea
Central Nervous System
Research Personnel
Neoplasm Metastasis

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5) : Japanese subset. / Kiura, Katsuyuki; Imamura, Fumio; Kagamu, Hiroshi; Matsumoto, Shingo; Hida, Toyoaki; Nakagawa, Kazuhiko; Satouchi, Miyako; Okamoto, Isamu; Takenoyama, Mitsuhiro; Fujisaka, Yasuhito; Kurata, Takayasu; Ito, Masayuki; Tokushige, Kota; Hatano, Ben; Nishio, Makoto.

In: Japanese journal of clinical oncology, Vol. 48, No. 4, 01.04.2018, p. 367-375.

Research output: Contribution to journalArticle

Kiura, K, Imamura, F, Kagamu, H, Matsumoto, S, Hida, T, Nakagawa, K, Satouchi, M, Okamoto, I, Takenoyama, M, Fujisaka, Y, Kurata, T, Ito, M, Tokushige, K, Hatano, B & Nishio, M 2018, 'Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset', Japanese journal of clinical oncology, vol. 48, no. 4, pp. 367-375. https://doi.org/10.1093/jjco/hyy016
Kiura, Katsuyuki ; Imamura, Fumio ; Kagamu, Hiroshi ; Matsumoto, Shingo ; Hida, Toyoaki ; Nakagawa, Kazuhiko ; Satouchi, Miyako ; Okamoto, Isamu ; Takenoyama, Mitsuhiro ; Fujisaka, Yasuhito ; Kurata, Takayasu ; Ito, Masayuki ; Tokushige, Kota ; Hatano, Ben ; Nishio, Makoto. / Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5) : Japanese subset. In: Japanese journal of clinical oncology. 2018 ; Vol. 48, No. 4. pp. 367-375.
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abstract = "Background: In the global, Phase 3, ASCEND-5 study, ceritinib improved progression-free survival (PFS) vs chemotherapy in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib and platinum-based chemotherapy. Here, we report efficacy and safety in a subset of Japanese patients from the ASCEND-5 study. Methods: Patients with advanced ALK-rearranged NSCLC received oral ceritinib 750 mg/day or chemotherapy (intravenous pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 [investigator's choice], every 21 days). Results: Among the 231 patients, 29 were Japanese, of which, 11 were treated with ceritinib and 18 were treated with chemotherapy (5 with pemetrexed and 13 with docetaxel). All the patients received prior crizotinib and one or two lines of prior chemotherapy for advanced disease. Median follow-up time was 16.6 months for ceritinib arm and 16.4 months for chemotherapy arm in the overall population. The median PFS by blinded independent review committee was 9.8 months (95{\%} CI, 4.3-14.0) in ceritinib arm vs 1.6 months (95{\%} CI, 1.4-3.0) in chemotherapy arm. Grade 3 or 4 adverse events, suspected to be study drug related, were reported in 36.4{\%} of ceritinib arm and 72.2{\%} of chemotherapy arm, respectively. No Grade 3 or 4 events of diarrhea, nausea and vomiting were reported in both the treatment arms. Adverse events leading to study drug discontinuation were reported in one patient in each arm: Grade 3 central-nervous system metastases in ceritinib-treated patient and Grade 3 febrile neutropenia in chemotherapy-treated patient. Conclusions: Consistent with overall population, ceritinib demonstrated better efficacy compared with the standard second-line chemotherapy in Japanese patients with crizotinib-resistant ALK+ NSCLC.",
author = "Katsuyuki Kiura and Fumio Imamura and Hiroshi Kagamu and Shingo Matsumoto and Toyoaki Hida and Kazuhiko Nakagawa and Miyako Satouchi and Isamu Okamoto and Mitsuhiro Takenoyama and Yasuhito Fujisaka and Takayasu Kurata and Masayuki Ito and Kota Tokushige and Ben Hatano and Makoto Nishio",
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T1 - Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5)

T2 - Japanese subset

AU - Kiura, Katsuyuki

AU - Imamura, Fumio

AU - Kagamu, Hiroshi

AU - Matsumoto, Shingo

AU - Hida, Toyoaki

AU - Nakagawa, Kazuhiko

AU - Satouchi, Miyako

AU - Okamoto, Isamu

AU - Takenoyama, Mitsuhiro

AU - Fujisaka, Yasuhito

AU - Kurata, Takayasu

AU - Ito, Masayuki

AU - Tokushige, Kota

AU - Hatano, Ben

AU - Nishio, Makoto

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: In the global, Phase 3, ASCEND-5 study, ceritinib improved progression-free survival (PFS) vs chemotherapy in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib and platinum-based chemotherapy. Here, we report efficacy and safety in a subset of Japanese patients from the ASCEND-5 study. Methods: Patients with advanced ALK-rearranged NSCLC received oral ceritinib 750 mg/day or chemotherapy (intravenous pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 [investigator's choice], every 21 days). Results: Among the 231 patients, 29 were Japanese, of which, 11 were treated with ceritinib and 18 were treated with chemotherapy (5 with pemetrexed and 13 with docetaxel). All the patients received prior crizotinib and one or two lines of prior chemotherapy for advanced disease. Median follow-up time was 16.6 months for ceritinib arm and 16.4 months for chemotherapy arm in the overall population. The median PFS by blinded independent review committee was 9.8 months (95% CI, 4.3-14.0) in ceritinib arm vs 1.6 months (95% CI, 1.4-3.0) in chemotherapy arm. Grade 3 or 4 adverse events, suspected to be study drug related, were reported in 36.4% of ceritinib arm and 72.2% of chemotherapy arm, respectively. No Grade 3 or 4 events of diarrhea, nausea and vomiting were reported in both the treatment arms. Adverse events leading to study drug discontinuation were reported in one patient in each arm: Grade 3 central-nervous system metastases in ceritinib-treated patient and Grade 3 febrile neutropenia in chemotherapy-treated patient. Conclusions: Consistent with overall population, ceritinib demonstrated better efficacy compared with the standard second-line chemotherapy in Japanese patients with crizotinib-resistant ALK+ NSCLC.

AB - Background: In the global, Phase 3, ASCEND-5 study, ceritinib improved progression-free survival (PFS) vs chemotherapy in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib and platinum-based chemotherapy. Here, we report efficacy and safety in a subset of Japanese patients from the ASCEND-5 study. Methods: Patients with advanced ALK-rearranged NSCLC received oral ceritinib 750 mg/day or chemotherapy (intravenous pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 [investigator's choice], every 21 days). Results: Among the 231 patients, 29 were Japanese, of which, 11 were treated with ceritinib and 18 were treated with chemotherapy (5 with pemetrexed and 13 with docetaxel). All the patients received prior crizotinib and one or two lines of prior chemotherapy for advanced disease. Median follow-up time was 16.6 months for ceritinib arm and 16.4 months for chemotherapy arm in the overall population. The median PFS by blinded independent review committee was 9.8 months (95% CI, 4.3-14.0) in ceritinib arm vs 1.6 months (95% CI, 1.4-3.0) in chemotherapy arm. Grade 3 or 4 adverse events, suspected to be study drug related, were reported in 36.4% of ceritinib arm and 72.2% of chemotherapy arm, respectively. No Grade 3 or 4 events of diarrhea, nausea and vomiting were reported in both the treatment arms. Adverse events leading to study drug discontinuation were reported in one patient in each arm: Grade 3 central-nervous system metastases in ceritinib-treated patient and Grade 3 febrile neutropenia in chemotherapy-treated patient. Conclusions: Consistent with overall population, ceritinib demonstrated better efficacy compared with the standard second-line chemotherapy in Japanese patients with crizotinib-resistant ALK+ NSCLC.

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