TY - JOUR
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
N1 - Funding Information:
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 Sugio Isamu Okamoto okamotoi@kokyu.med.kyushuu.ac.jp Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University Fukuoka Japan Department of Thoracic Oncology, National Cancer Center Hospital Tokyo Japan Division of Thoracic Oncology, Shizuoka Cancer Center Shizuoka Japan Department of Respiratory Medicine, Kumamoto Regional Medical Center Kumamoto Japan Department of Clinical Oncology, Tokyo Medical and Dental University Tokyo Japan Department of Respiratory Medicine, Tokyo Medical and Dental University Tokyo Japan Department of Respiratory Medicine, Iwate Prefectural Central Hospital Morioka Japan Department of Respiratory Medicine, Steel Memorial Yawata Hospital Kita‐Kyushu Japan Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center Asahikawa Japan Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School Tokyo Japan Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital Okayama Japan Department of Respiratory Medicine, Kesen‐numa City Hospital Kesen‐numa Japan Division of Respiratory Medicine, Ishikawa Prefectural Central Hospital Kanazawa Japan Third Department of Internal Medicine, Wakayama Medical University Wakayama Japan Department of Thoracic Medical Oncology, Oita Prefectural Hospital Oita Japan Department of Respiratory Medicine, Fukuoka University Chikushi Hospital Chikushino Japan Clinical Research Support Center Kyushu Fukuoka Japan Medical Information Center, Kyushu University Hospital Fukuoka Japan Department of Thoracic and Breast Surgery, Oita University Oita Japan
Funding Information:
This research was supported by the National Cancer Center Research and Development Fund (26-A-22).
Publisher Copyright:
© AlphaMed Press; the data published online to support this summary are the property of the authors.
PY - 2020/4/1
Y1 - 2020/4/1
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.
AB - 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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U2 - 10.1634/theoncologist.2019-0728
DO - 10.1634/theoncologist.2019-0728
M3 - Article
C2 - 31666370
AN - SCOPUS:85074793617
SN - 1083-7159
VL - 25
SP - 306-e618
JO - Oncologist
JF - Oncologist
IS - 4
ER -
