Open AccessSurvival 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
Author(s) -
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
Publication year - 2020
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2019-0728
Subject(s) - alectinib , medicine , lung cancer , oncology , performance status , crizotinib , confidence interval , alk inhibitor , survival rate , anaplastic lymphoma kinase , cancer , malignant pleural effusion
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.