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.


Journal

The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837

Informations de publication

Date de publication:
04 2020
Historique:
received: 24 08 2019
accepted: 15 09 2019
entrez: 17 4 2020
pubmed: 17 4 2020
medline: 22 6 2021
Statut: ppublish

Résumé

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. 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. 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. 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). 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.

Sections du résumé

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.

Identifiants

pubmed: 32297438
doi: 10.1634/theoncologist.2019-0728
pmc: PMC7160311
doi:

Substances chimiques

Carbazoles 0
Piperidines 0
Protein Kinase Inhibitors 0
Crizotinib 53AH36668S
Anaplastic Lymphoma Kinase EC 2.7.10.1
alectinib LIJ4CT1Z3Y

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

306-e618

Informations de copyright

© AlphaMed Press; the data published online to support this summary are the property of the authors.

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Auteurs

Eiji Iwama (E)

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Yasushi Goto (Y)

Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Haruyasu Murakami (H)

Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Shinsuke Tsumura (S)

Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan.

Hiroyuki Sakashita (H)

Department of Clinical Oncology, Tokyo Medical and Dental University, Tokyo, Japan.
Department of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.

Yoshiaki Mori (Y)

Department of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka, Japan.

Noriaki Nakagaki (N)

Department of Respiratory Medicine, Steel Memorial Yawata Hospital, Kita-Kyushu, Japan.

Yuka Fujita (Y)

Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.

Masahiro Seike (M)

Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Akihiro Bessho (A)

Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.

Manabu Ono (M)

Department of Respiratory Medicine, Kesen-numa City Hospital, Kesen-numa, Japan.

Masaru Nishitsuji (M)

Division of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.

Hiroaki Akamatsu (H)

Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Ryotaro Morinaga (R)

Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan.

Takanori Akagi (T)

Department of Respiratory Medicine, Fukuoka University Chikushi Hospital, Chikushino, Japan.

Takayuki Shimose (T)

Clinical Research Support Center Kyushu, Fukuoka, Japan.

Shoji Tokunaga (S)

Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.

Nobuyuki Yamamoto (N)

Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Yoichi Nakanishi (Y)

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Kenji Sugio (K)

Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.

Isamu Okamoto (I)

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

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Classifications MeSH