Alectinib for Patients with ALK Rearrangement–Positive Non–Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401)

Eiji Iwama, Yasushi Goto, Haruyasu Murakami, Taishi Harada, Shinsuke Tsumura, Hiroyuki Sakashita, Yoshiaki Mori, Noriaki Nakagaki, Yuka Fujita, Masahiro Seike, Akihiro Bessho, Manabu Ono, Akihito Okazaki, Hiroaki Akamatsu, Ryotaro Morinaga, Shinichiro Ushijima, Takayuki Shimose, Shoji Tokunaga, Akinobu Hamada, Nobuyuki Yamamoto & 3 others Yoichi Nakanishi, Kenji Sugio, Isamu Okamoto

Research output: Contribution to journalArticle

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Abstract

Introduction Alectinib has shown marked efficacy and safety in patients with anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangement–positive NSCLC and a good performance status (PS). It has remained unclear whether alectinib might also be beneficial for such patients with a poor PS. Methods Eligible patients with advanced ALK rearrangement–positive NSCLC and a PS of 2 to 4 received alectinib orally at 300 mg twice daily. The primary end point of the study was objective response rate (ORR), and the most informative secondary end point was rate of PS improvement. Results Between September 2014 and December 2015, 18 patients were enrolled in this phase II study. Of those patients, 12, five, and one had a PS of 2, 3, or 4, respectively, whereas four patients had received prior crizotinib treatment. The ORR was 72.2% (90% confidence interval: 52.9–85.8%). The ORR did not differ significantly between patients with a PS of 2 and those with a PS of 3 or higher (58.3% and 100%, respectively [p = 0.114]). The PS improvement rate was 83.3% (90% confidence interval: 64.8–93.1%, p < 0.0001), with the frequency of improvement to a PS of 0 or 1 being 72.2%. The median progression-free survival was 10.1 months. Toxicity was mild, with the frequency of adverse events of grade 3 or higher being low. Neither dose reduction nor withdrawal of alectinib because of toxicity was necessary. Conclusions Alectinib is a treatment option for patients with ALK rearrangement–positive NSCLC and a poor PS.

Original languageEnglish
Pages (from-to)1161-1166
Number of pages6
JournalJournal of Thoracic Oncology
Volume12
Issue number7
DOIs
Publication statusPublished - Jul 1 2017

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Non-Small Cell Lung Carcinoma
Lung
Confidence Intervals
Patient Safety
CH5424802
Disease-Free Survival
Therapeutics
Genes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Alectinib for Patients with ALK Rearrangement–Positive Non–Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401). / Iwama, Eiji; Goto, Yasushi; Murakami, Haruyasu; Harada, Taishi; Tsumura, Shinsuke; Sakashita, Hiroyuki; Mori, Yoshiaki; Nakagaki, Noriaki; Fujita, Yuka; Seike, Masahiro; Bessho, Akihiro; Ono, Manabu; Okazaki, Akihito; Akamatsu, Hiroaki; Morinaga, Ryotaro; Ushijima, Shinichiro; Shimose, Takayuki; Tokunaga, Shoji; Hamada, Akinobu; Yamamoto, Nobuyuki; Nakanishi, Yoichi; Sugio, Kenji; Okamoto, Isamu.

In: Journal of Thoracic Oncology, Vol. 12, No. 7, 01.07.2017, p. 1161-1166.

Research output: Contribution to journalArticle

Iwama, E, Goto, Y, Murakami, H, Harada, T, Tsumura, S, Sakashita, H, Mori, Y, Nakagaki, N, Fujita, Y, Seike, M, Bessho, A, Ono, M, Okazaki, A, Akamatsu, H, Morinaga, R, Ushijima, S, Shimose, T, Tokunaga, S, Hamada, A, Yamamoto, N, Nakanishi, Y, Sugio, K & Okamoto, I 2017, 'Alectinib for Patients with ALK Rearrangement–Positive Non–Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401)', Journal of Thoracic Oncology, vol. 12, no. 7, pp. 1161-1166. https://doi.org/10.1016/j.jtho.2017.02.012
Iwama, Eiji ; Goto, Yasushi ; Murakami, Haruyasu ; Harada, Taishi ; Tsumura, Shinsuke ; Sakashita, Hiroyuki ; Mori, Yoshiaki ; Nakagaki, Noriaki ; Fujita, Yuka ; Seike, Masahiro ; Bessho, Akihiro ; Ono, Manabu ; Okazaki, Akihito ; Akamatsu, Hiroaki ; Morinaga, Ryotaro ; Ushijima, Shinichiro ; Shimose, Takayuki ; Tokunaga, Shoji ; Hamada, Akinobu ; Yamamoto, Nobuyuki ; Nakanishi, Yoichi ; Sugio, Kenji ; Okamoto, Isamu. / Alectinib for Patients with ALK Rearrangement–Positive Non–Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401). In: Journal of Thoracic Oncology. 2017 ; Vol. 12, No. 7. pp. 1161-1166.
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abstract = "Introduction Alectinib has shown marked efficacy and safety in patients with anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangement–positive NSCLC and a good performance status (PS). It has remained unclear whether alectinib might also be beneficial for such patients with a poor PS. Methods Eligible patients with advanced ALK rearrangement–positive NSCLC and a PS of 2 to 4 received alectinib orally at 300 mg twice daily. The primary end point of the study was objective response rate (ORR), and the most informative secondary end point was rate of PS improvement. Results Between September 2014 and December 2015, 18 patients were enrolled in this phase II study. Of those patients, 12, five, and one had a PS of 2, 3, or 4, respectively, whereas four patients had received prior crizotinib treatment. The ORR was 72.2{\%} (90{\%} confidence interval: 52.9–85.8{\%}). The ORR did not differ significantly between patients with a PS of 2 and those with a PS of 3 or higher (58.3{\%} and 100{\%}, respectively [p = 0.114]). The PS improvement rate was 83.3{\%} (90{\%} confidence interval: 64.8–93.1{\%}, p < 0.0001), with the frequency of improvement to a PS of 0 or 1 being 72.2{\%}. The median progression-free survival was 10.1 months. Toxicity was mild, with the frequency of adverse events of grade 3 or higher being low. Neither dose reduction nor withdrawal of alectinib because of toxicity was necessary. Conclusions Alectinib is a treatment option for patients with ALK rearrangement–positive NSCLC and a poor PS.",
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T1 - Alectinib for Patients with ALK Rearrangement–Positive Non–Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401)

AU - Iwama, Eiji

AU - Goto, Yasushi

AU - Murakami, Haruyasu

AU - Harada, Taishi

AU - Tsumura, Shinsuke

AU - Sakashita, Hiroyuki

AU - Mori, Yoshiaki

AU - Nakagaki, Noriaki

AU - Fujita, Yuka

AU - Seike, Masahiro

AU - Bessho, Akihiro

AU - Ono, Manabu

AU - Okazaki, Akihito

AU - Akamatsu, Hiroaki

AU - Morinaga, Ryotaro

AU - Ushijima, Shinichiro

AU - Shimose, Takayuki

AU - Tokunaga, Shoji

AU - Hamada, Akinobu

AU - Yamamoto, Nobuyuki

AU - Nakanishi, Yoichi

AU - Sugio, Kenji

AU - Okamoto, Isamu

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Introduction Alectinib has shown marked efficacy and safety in patients with anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangement–positive NSCLC and a good performance status (PS). It has remained unclear whether alectinib might also be beneficial for such patients with a poor PS. Methods Eligible patients with advanced ALK rearrangement–positive NSCLC and a PS of 2 to 4 received alectinib orally at 300 mg twice daily. The primary end point of the study was objective response rate (ORR), and the most informative secondary end point was rate of PS improvement. Results Between September 2014 and December 2015, 18 patients were enrolled in this phase II study. Of those patients, 12, five, and one had a PS of 2, 3, or 4, respectively, whereas four patients had received prior crizotinib treatment. The ORR was 72.2% (90% confidence interval: 52.9–85.8%). The ORR did not differ significantly between patients with a PS of 2 and those with a PS of 3 or higher (58.3% and 100%, respectively [p = 0.114]). The PS improvement rate was 83.3% (90% confidence interval: 64.8–93.1%, p < 0.0001), with the frequency of improvement to a PS of 0 or 1 being 72.2%. The median progression-free survival was 10.1 months. Toxicity was mild, with the frequency of adverse events of grade 3 or higher being low. Neither dose reduction nor withdrawal of alectinib because of toxicity was necessary. Conclusions Alectinib is a treatment option for patients with ALK rearrangement–positive NSCLC and a poor PS.

AB - Introduction Alectinib has shown marked efficacy and safety in patients with anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangement–positive NSCLC and a good performance status (PS). It has remained unclear whether alectinib might also be beneficial for such patients with a poor PS. Methods Eligible patients with advanced ALK rearrangement–positive NSCLC and a PS of 2 to 4 received alectinib orally at 300 mg twice daily. The primary end point of the study was objective response rate (ORR), and the most informative secondary end point was rate of PS improvement. Results Between September 2014 and December 2015, 18 patients were enrolled in this phase II study. Of those patients, 12, five, and one had a PS of 2, 3, or 4, respectively, whereas four patients had received prior crizotinib treatment. The ORR was 72.2% (90% confidence interval: 52.9–85.8%). The ORR did not differ significantly between patients with a PS of 2 and those with a PS of 3 or higher (58.3% and 100%, respectively [p = 0.114]). The PS improvement rate was 83.3% (90% confidence interval: 64.8–93.1%, p < 0.0001), with the frequency of improvement to a PS of 0 or 1 being 72.2%. The median progression-free survival was 10.1 months. Toxicity was mild, with the frequency of adverse events of grade 3 or higher being low. Neither dose reduction nor withdrawal of alectinib because of toxicity was necessary. Conclusions Alectinib is a treatment option for patients with ALK rearrangement–positive NSCLC and a poor PS.

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