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; Shoji, Tetsuo; Hamada, Akinobu; Yamamoto, Nobuyuki; Nakanishi, Yoichi; Sugio, Kenji; Okamoto, Isamu

doi:10.1016/j.jtho.2017.02.012

Cited by 46 publications

(38 citation statements)

References 15 publications

(30 reference statements)

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“…However, these results must be interpreted with caution due to the different study populations enrolled; that is, the pre–approval studies did not include patients with ECOG PS ≥2, or with crizotinib pretreatment, and included fewer patients aged ≥75 years. Furthermore, we did not see any increased incidence of ADR in patients with ECOG PS ≥2 vs ≤1, suggesting that alectinib may be tolerable in patients with poor PS, as previously reported, or in those who had been pretreated with crizotinib vs crizotinib‐naïve patients. Visual disturbances and gastrointestinal effects, which are frequently reported with crizotinib, occurred at a low rate with alectinib, as observed in AF‐001JP …”

Section: Discussionsupporting

confidence: 80%

Safety and effectiveness of alectinib in a real‐world surveillance study in patients with ALK‐positive non–small‐cell lung cancer in Japan

Masuda

Ohe²,

Gemma

et al. 2019

Cancer Science

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We conducted a large‐scale surveillance study as a post–marketing commitment to investigate the safety and effectiveness of alectinib in patients with ALK ‐positive non–small‐cell lung cancer ( NSCLC ) in Japan. Patients receiving 300 mg twice‐daily alectinib (September 2014 to June 2015) were monitored until termination of alectinib or completion of 18 months of treatment at 519 Japanese study sites. The primary endpoint was the incidence of adverse drug reactions ( ADR ), which are important identified risks for alectinib in Japanese patients. Overall survival ( OS ), a key secondary endpoint, was assessed according to information on outcome. Overall, 1251 patients were enrolled. The median patient age was 62.0 years; 12.9% of patients were aged ≥75 years. At baseline, 63.0% of patients had received crizotinib and 40.6% had brain metastases. Altogether, 1512 ADR occurred in 654 patients (53.6%), with 164 grade ≥3 ADR in 123 patients (10.1%). Commonly occurring ADR were hepatic disorders (all grades, 19.8%; grade ≥3, 2.0%), decreased neutrophil and/or white blood cell count (all grades, 7.6%; grade ≥3, 1.1%), and interstitial lung disease (all grades, 3.8%; grade ≥3, .7%). Median OS was not estimable. The 18‐month cumulative OS rate was longer in patients with ECOG performance status ≤1 (vs 2 or ≥3; 83.7% vs 44.5% or 27.2%), without prior crizotinib (vs with; 81.1% vs 73.4%), receiving first‐line alectinib (vs second and third or later line; 83.0% vs 79.2% or 71.9%), without brain metastases (vs with; 79.5% vs 71.5%). These data confirm the favorable safety and effectiveness of alectinib in patients with ALK ‐positive NSCLC in Japan.

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Section: Discussionsupporting

confidence: 80%

Safety and effectiveness of alectinib in a real‐world surveillance study in patients with ALK‐positive non–small‐cell lung cancer in Japan

Masuda

Ohe²,

Gemma

et al. 2019

Cancer Science

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“…Molecular-targeted drugs usually showed milder toxicity than cytotoxic chemotherapy [ 13 – 16 ]. It is also important that they showed beneficial results in patients with poor PS in relatively small, but prospective studies [ 17 , 18 ].…”

Section: Outlinementioning

confidence: 99%

The Japanese Lung Cancer Society Guideline for non-small cell lung cancer, stage IV

et al. 2019

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According to rapid development of chemotherapy in advanced non-small cell lung cancer (NSCLC), the Japan Lung Cancer Society has been updated its own guideline annually since 2010. In this latest version, all of the procedure was carried out in accordance with grading of recommendations assessment, development and evaluation (GRADE) system. It includes comprehensive literature search, systematic review, and determination of the recommendation by multidisciplinary expert panel which consisted of medical doctors, pharmacists, nurses, statisticians, and patients from patient advocacy group. Recently, we have had various types of chemotherapeutic drugs like kinase inhibitors or immune-checkpoint inhibitors. Thus, the guideline proposes to categorize patients into three entities: (1) driver oncogene-positive, (2) PD-L1 ≥ 50%, and (3) others. Based on this subgroup, 31 clinical questions were described. We believe that this attempt enables clinicians to choose appropriate treatment easier. Here, we report an English version of the Japan Lung Cancer Society Guidelines 2018 for NSCLC, stages IV.

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“…The reasons for exclusion were not relevant (n = 50), retrospective chart reviews (n = 7), no specific data for outcome measures (n = 7), no sufficient ALK-positive NSCLC (n = 3), data overlapping (n = 16), and no available data on results (n = 5). A total of 20 clinical trials were included in the final analysis with 18 studies [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]26,28,29] in English and two studies [25,27] in Chinese.…”

Section: Selection Of Relevant Studiesmentioning

confidence: 99%

“…Except for 13 global multicenter trials [10,11,14,[16][17][18][19][20][21][22][23][24]29], the seven remaining studies were conducted in China [12,[25][26][27] and Japan [13,15,28]. Four studies [10,12,21,26] (1344 patients), three studies [11,16,28] (406 patients), and three studies [14,15,23] (243 patients) used a single arm design for the efficacy of crizotinib, ceritinib, and alectinib, respectively. Five studies [18][19][20]25,27] (967 patients), two studies [22,24] (607 patients), one study [29] (72 patients), and two studies [13,17] (510 patients) investigated the efficacy of crizotinib versus chemotherapy, ceritinib versus chemotherapy, alectinib versus chemotherapy, and alectinib versus crizotinib, respectively.…”

Section: General Characteristics Of Studiesmentioning

confidence: 99%

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Efficacy of Crizotinib, Ceritinib, and Alectinib in ALK-Positive Non-Small Cell Lung Cancer Treatment: A Meta-Analysis of Clinical Trials

Hoang

Myung

Pham

et al. 2020

Cancers

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This study aimed to evaluate the efficacy of anaplastic lymphoma kinase (ALK)-inhibitors in the treatment of ALK-positive non-small cell lung cancer (NSCLC) by using a meta-analysis of clinical trials. We searched PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov by using keywords related to the topic in August 2018. The pooled effect sizes were calculated based on a random-effects model. We also performed subgroup meta-analysis by types of ALK inhibitors (crizotinib, ceritinib, and alectinib). A total of 20 clinical trials with 10 single-arm trials and 10 double-arm trials were included in the final meta-analysis. The median overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), 1 year survival rate, and 2 year survival rate were 19.14 months, 8.47 months, 62%, 78%, 74%, and 62%, respectively. ALK inhibitors showed a significantly superior efficacy compared with chemotherapy (hazard ratio (HR) for OS, 0.83; HR for PFS, 0.43; rate difference (RD) for ORR, 0.23; and RD for DCR, 0.10). The current meta-analysis of clinical trials showed the significant efficacy of ALK inhibitors in the treatment of ALK-positive NSCLC. Further head-to-head trials are needed to compare their efficacy with other types of NSCLC treatment regimens. PROSPERO registration: CRD42018085987.

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

Abstract: Alectinib is a treatment option for patients with ALK rearrangement-positive NSCLC and a poor PS.

Cited by 46 publications

References 15 publications

Safety and effectiveness of alectinib in a real‐world surveillance study in patients with ALK‐positive non–small‐cell lung cancer in Japan

Safety and effectiveness of alectinib in a real‐world surveillance study in patients with ALK‐positive non–small‐cell lung cancer in Japan

The Japanese Lung Cancer Society Guideline for non-small cell lung cancer, stage IV

Efficacy of Crizotinib, Ceritinib, and Alectinib in ALK-Positive Non-Small Cell Lung Cancer Treatment: A Meta-Analysis of Clinical Trials

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