Evidence map›Paper›PMID 28296581›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Three-Year Follow-Up of an Alectinib Phase I/II Study in ALK-Positive Non-Small-Cell Lung Cancer: AF-001JP.

Tomohide Tamura, Katsuyuki Kiura, Takashi Seto, Kazuhiko Nakagawa, Makoto Maemondo, Akira Inoue, Toyoaki Hida, Hiroshige Yoshioka, Masao Harada, Yuichiro Ohe and 7 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
9.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
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  4. Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Tomohide TamuraTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Katsuyuki KiuraTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Takashi SetoTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Kazuhiko NakagawaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Makoto MaemondoTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Akira InoueTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Toyoaki HidaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Hiroshige YoshiokaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Masao HaradaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Yuichiro OheTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Naoyuki NogamiTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Haruyasu MurakamiTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Hiroshi KurikiTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Tadashi ShimadaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Tomohiro TanakaTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Kengo TakeuchiTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Makoto NishioTomohide Tamura, St Luke's International Hospital; Yuichiro Ohe, National Cancer Center Hospital; Hiroshi Kuriki, Tadashi Shimada, and Tomohiro Tanaka, Chugai Pharmaceutical; Kengo Takeuchi, Japanese Foundation for Cancer Research; Makoto Nishio, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo; Katsuyuki Kiura, Okayama University Hospital, Okayama; Takashi Seto, National Kyusyu Cancer Center, Fukuoka; Kazuhiko Nakagawa, Kindai University, Osaka-Sayama; Makoto Maemondo, Miyagi Cancer Center, Natori; Akira Inoue, Tohoku University, Sendai; Toyoaki Hida, Aichi Cancer Center, Nagoya; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Masao Harada, Hokkaido Cancer Center, Sapporo; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center, Matsuyama; and Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka, Japan.
Japanese Foundation For Cancer Research · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose Alectinib is an anaplastic lymphoma kinase (ALK) -specific kinase inhibitor that seems to be effective against non-small-cell lung cancer (NSCLC) with a variety of ALK mutations. The primary analysis of AF-001JP reported a promising overall response rate. To assess progression-free survival (PFS) and overall survival (OS), patients from the phase II part of AF-001JP were followed up for approximately 3 years. Patients and Methods Oral alectinib 300 mg was administered twice per day to patients with ALK inhibitor-naïve, ALK-positive NSCLC who had progressed after one or more regimens of previous chemotherapy. In this long-term follow-up, efficacy (PFS, OS), correlation between tumor shrinkage and PFS, safety of alectinib, and relief of cancer symptoms were evaluated. Results At the updated data cutoff (September 10, 2015; first patient in August 30, 2011, last patient in April 18, 2012), 25 of 46 phase II patients were still receiving alectinib. Disease progression was confirmed in 18 patients (39%); median PFS was not reached (3-year PFS rate, 62%; 95% CI, 45 to 75). Fourteen patients had brain metastases at baseline; of these, 6 remained in the study without CNS and systemic progression. Tumor shrinkage and PFS showed no correlation. The 3-year OS rate was 78% (13 events). The most common treatment-related adverse event (all grades) was increased blood bilirubin (36.2%). Most cancer symptoms were relieved early, and medication for symptoms was dramatically decreased during alectinib therapy. Conclusion Alectinib was effective in this 3-year follow-up with a favorable safety profile over a long administration period in ALK-positive NSCLC without previous ALK inhibitor treatment.

Indexed as

AdultAgedAnaplastic Lymphoma KinaseAntineoplastic AgentsCarbazolesCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDisease ProgressionFemaleFollow-Up StudiesHumansHyperbilirubinemiaLung NeoplasmsMaleMiddle AgedPiperidinesalectinibALK protein, humanAnaplastic Lymphoma KinaseAntineoplastic AgentsCarbazolesPiperidinesReceptor Protein-Tyrosine Kinases

Identifiers

PMID28296581
PMCPMC5455704
OpenAlexW2599827235

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.