Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib: Updated Results of Lung Oncology Group in Kyushu 1401

Eiji Iwama, Yasushi Goto, Haruyasu Murakami, Shinsuke Tsumura, Hiroyuki Sakashita, Yoshiaki Mori, Noriaki Nakagaki, Yuka Fujita, Masahiro Seike, Akihiro Bessho, Manabu Ono, Masaru Nishitsuji, Hiroaki Akamatsu, Ryotaro Morinaga, Takanori Akagi, Takayuki Shimose, Shoji Tokunaga, Nobuyuki Yamamoto, Yoichi Nakanishi, Kenji SugioIsamu Okamoto

Research output: Contribution to journalArticle

Abstract

Lessons Learned: Alectinib confers a pronounced survival benefit in patients with ALK rearrangement-positive non-small cell lung cancer and a poor performance status. Survival benefit of alectinib for patients with a poor performance status was consistent regardless of the presence of central nervous system metastases. Background: We previously reported a marked objective response rate (ORR) and safety for alectinib treatment in patients with ALK rearrangement-positive non-small cell lung cancer (NSCLC) and a poor performance status (PS) in the Lung Oncology Group in Kyushu (LOGiK) 1401 study. It remained unclear, however, whether alectinib might also confer a long-term survival benefit in such patients. Methods: Eighteen patients with ALK rearrangement-positive advanced NSCLC and a PS of 2, 3, or 4 (n = 12, 5, and 1, respectively) were enrolled in LOGiK1401 between September 2014 and December 2015 and received alectinib. We have now updated the survival data for the study. Results: The median follow-up time for all patients was 27.3 months. The median progression-free survival (PFS) was 16.2 months (95% confidence interval [CI], 7.1–30.8 months), and the median survival time (MST) and the 3-year overall survival rate were 30.3 months (95% CI, 11.5 months to not reached) and 43.8% (95% CI, 20.8–64.7%), respectively. This survival benefit was similarly manifest in patients with a PS of 2 (MST, 20.5 months) and those with a PS of ≥3 (MST, not reached). PFS did not differ between patients with or without central nervous system (CNS) metastases at baseline (median of 17.5 and 16.2 months, respectively, p =.886). Conclusion: Alectinib showed a pronounced survival benefit for patients with ALK rearrangement-positive NSCLC and a poor PS regardless of the presence of CNS metastases, a patient population for which chemotherapy is not indicated.

Original languageEnglish
JournalOncologist
DOIs
Publication statusAccepted/In press - Jan 1 2019

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Survival Analysis
Non-Small Cell Lung Carcinoma
Lung
Survival
Central Nervous System
Confidence Intervals
Neoplasm Metastasis
Disease-Free Survival
CH5424802
Survival Rate
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib : Updated Results of Lung Oncology Group in Kyushu 1401. / Iwama, Eiji; Goto, Yasushi; Murakami, Haruyasu; Tsumura, Shinsuke; Sakashita, Hiroyuki; Mori, Yoshiaki; Nakagaki, Noriaki; Fujita, Yuka; Seike, Masahiro; Bessho, Akihiro; Ono, Manabu; Nishitsuji, Masaru; Akamatsu, Hiroaki; Morinaga, Ryotaro; Akagi, Takanori; Shimose, Takayuki; Tokunaga, Shoji; Yamamoto, Nobuyuki; Nakanishi, Yoichi; Sugio, Kenji; Okamoto, Isamu.

In: Oncologist, 01.01.2019.

Research output: Contribution to journalArticle

Iwama, E, Goto, Y, Murakami, H, Tsumura, S, Sakashita, H, Mori, Y, Nakagaki, N, Fujita, Y, Seike, M, Bessho, A, Ono, M, Nishitsuji, M, Akamatsu, H, Morinaga, R, Akagi, T, Shimose, T, Tokunaga, S, Yamamoto, N, Nakanishi, Y, Sugio, K & Okamoto, I 2019, 'Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib: Updated Results of Lung Oncology Group in Kyushu 1401', Oncologist. https://doi.org/10.1634/theoncologist.2019-0728
Iwama, Eiji ; Goto, Yasushi ; Murakami, Haruyasu ; Tsumura, Shinsuke ; Sakashita, Hiroyuki ; Mori, Yoshiaki ; Nakagaki, Noriaki ; Fujita, Yuka ; Seike, Masahiro ; Bessho, Akihiro ; Ono, Manabu ; Nishitsuji, Masaru ; Akamatsu, Hiroaki ; Morinaga, Ryotaro ; Akagi, Takanori ; Shimose, Takayuki ; Tokunaga, Shoji ; Yamamoto, Nobuyuki ; Nakanishi, Yoichi ; Sugio, Kenji ; Okamoto, Isamu. / Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib : Updated Results of Lung Oncology Group in Kyushu 1401. In: Oncologist. 2019.
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abstract = "Lessons Learned: Alectinib confers a pronounced survival benefit in patients with ALK rearrangement-positive non-small cell lung cancer and a poor performance status. Survival benefit of alectinib for patients with a poor performance status was consistent regardless of the presence of central nervous system metastases. Background: We previously reported a marked objective response rate (ORR) and safety for alectinib treatment in patients with ALK rearrangement-positive non-small cell lung cancer (NSCLC) and a poor performance status (PS) in the Lung Oncology Group in Kyushu (LOGiK) 1401 study. It remained unclear, however, whether alectinib might also confer a long-term survival benefit in such patients. Methods: Eighteen patients with ALK rearrangement-positive advanced NSCLC and a PS of 2, 3, or 4 (n = 12, 5, and 1, respectively) were enrolled in LOGiK1401 between September 2014 and December 2015 and received alectinib. We have now updated the survival data for the study. Results: The median follow-up time for all patients was 27.3 months. The median progression-free survival (PFS) was 16.2 months (95{\%} confidence interval [CI], 7.1–30.8 months), and the median survival time (MST) and the 3-year overall survival rate were 30.3 months (95{\%} CI, 11.5 months to not reached) and 43.8{\%} (95{\%} CI, 20.8–64.7{\%}), respectively. This survival benefit was similarly manifest in patients with a PS of 2 (MST, 20.5 months) and those with a PS of ≥3 (MST, not reached). PFS did not differ between patients with or without central nervous system (CNS) metastases at baseline (median of 17.5 and 16.2 months, respectively, p =.886). Conclusion: Alectinib showed a pronounced survival benefit for patients with ALK rearrangement-positive NSCLC and a poor PS regardless of the presence of CNS metastases, a patient population for which chemotherapy is not indicated.",
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T1 - Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib

T2 - Updated Results of Lung Oncology Group in Kyushu 1401

AU - Iwama, Eiji

AU - Goto, Yasushi

AU - Murakami, Haruyasu

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 - Nishitsuji, Masaru

AU - Akamatsu, Hiroaki

AU - Morinaga, Ryotaro

AU - Akagi, Takanori

AU - Shimose, Takayuki

AU - Tokunaga, Shoji

AU - Yamamoto, Nobuyuki

AU - Nakanishi, Yoichi

AU - Sugio, Kenji

AU - Okamoto, Isamu

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Lessons Learned: Alectinib confers a pronounced survival benefit in patients with ALK rearrangement-positive non-small cell lung cancer and a poor performance status. Survival benefit of alectinib for patients with a poor performance status was consistent regardless of the presence of central nervous system metastases. Background: We previously reported a marked objective response rate (ORR) and safety for alectinib treatment in patients with ALK rearrangement-positive non-small cell lung cancer (NSCLC) and a poor performance status (PS) in the Lung Oncology Group in Kyushu (LOGiK) 1401 study. It remained unclear, however, whether alectinib might also confer a long-term survival benefit in such patients. Methods: Eighteen patients with ALK rearrangement-positive advanced NSCLC and a PS of 2, 3, or 4 (n = 12, 5, and 1, respectively) were enrolled in LOGiK1401 between September 2014 and December 2015 and received alectinib. We have now updated the survival data for the study. Results: The median follow-up time for all patients was 27.3 months. The median progression-free survival (PFS) was 16.2 months (95% confidence interval [CI], 7.1–30.8 months), and the median survival time (MST) and the 3-year overall survival rate were 30.3 months (95% CI, 11.5 months to not reached) and 43.8% (95% CI, 20.8–64.7%), respectively. This survival benefit was similarly manifest in patients with a PS of 2 (MST, 20.5 months) and those with a PS of ≥3 (MST, not reached). PFS did not differ between patients with or without central nervous system (CNS) metastases at baseline (median of 17.5 and 16.2 months, respectively, p =.886). Conclusion: Alectinib showed a pronounced survival benefit for patients with ALK rearrangement-positive NSCLC and a poor PS regardless of the presence of CNS metastases, a patient population for which chemotherapy is not indicated.

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