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https://www.readbyqxmd.com/read/29226313/model-based-assessments-of-cyp-mediated-drug-drug-interaction-risk-of-alectinib-physiologically-based-pharmacokinetic-modeling-supported-clinical-development
#1
Yumi Cleary, Michael Gertz, Peter N Morcos, Li Yu, Kuresh Youdim, Alex Phipps, Stephen Fowler, Neil Parrott
Alectinib is a selective anaplastic lymphoma kinase (ALK) inhibitor approved for the treatment of ALK-positive non-small cell lung cancer. Alectinib and its major active metabolite M4 exhibited drug-drug interaction (DDI) potential through cytochrome P450 (CYP) enzymes CYP3A4 and CYP2C8 in vitro. Clinical relevance of the DDI risk was investigated as part of a rapid development program to fulfil the breakthrough therapy designation. Therefore, a strategy with a combination of physiologically based pharmacokinetic (PBPK) modeling and limited clinical trials focused on generating informative data for modeling was taken to ensure extrapolation ability of DDI risk...
December 11, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29207989/case-report-continued-treatment-with-alectinib-is-possible-for-patients-with-lung-adenocarcinoma-with-drug-induced-interstitial-lung-disease
#2
Tatsuya Nitawaki, Yoshihiko Sakata, Kodai Kawamura, Kazuya Ichikado
BACKGROUND: Alectinib, a second-generation anaplastic lymphoma kinase (ALK) inhibitor, is a key drug for ALK rearranged lung adenocarcinoma. Interstitial lung disease (ILD) is an important adverse effect of alectinib, which generally requires termination of treatment. However, we treated two patients with drug-induced ILD who continued to receive alectinib. CASE PRESENTATION: Patient 1 was a 57-year-old male with an ALK-rearranged Stage IV lung adenocarcinoma who was administered alectinib as first-line therapy...
December 6, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/29201885/alectinib-can-replace-crizotinib-as-standard-first-line-therapy-for-alk-positive-lung-cancer
#3
EDITORIAL
Takehiro Uemura, Toyoaki Hida
No abstract text is available yet for this article.
November 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/29187012/targeted-therapies-in-non-small-cell-lung-cancer-a-focus-on-alk-ros1-tyrosine-kinase-inhibitors
#4
Assunta Sgambato, Francesca Casaluce, Paolo Maione, Cesare Gridelli
Anaplastic lymphoma kinase (ALK) and ROS1 rearrangements define important molecular subgroups of advanced non-small cell lung cancer (NSCLC). The identification of these genetic driver alterations created new potential for highly active therapeutic interventions. After discovery of ALK rearrangements in NSCLC, it was recognized that these confer sensitivity to ALK inhibition. Areas covered: Crizotinib, the first-in-class ALK/ROS1/MET inhibitor, was initially approved as second-line treatment of ALK-positive advanced NSCLC but after this, it was firmly established as the standard first-line therapy for advanced ALK-positive NSCLC...
November 29, 2017: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29174221/lung-toxicity-in-non-small-cell-lung-cancer-patients-exposed-to-alk-inhibitors-report-of-a-peculiar-case-and-systematic-review-of-the-literature
#5
REVIEW
Benedetta Pellegrino, Francesco Facchinetti, Paola Bordi, Mario Silva, Letizia Gnetti, Marcello Tiseo
Lung toxicity is a potential fatal effect involving non-small-cell lung cancer (NSCLC) patients exposed to tyrosine kinase inhibitors (TKIs). Moving from our experience regarding a patient who developed lung toxicity while receiving 2 different anaplastic lymphoma kinase (ALK)-TKIs, we performed a systematic review to assess the epidemiologic magnitude and the clinical significance of such toxicity in NSCLC patients treated with ALK-TKIs. Studies were identified using MEDLINE and additional sources (European Society for Medical Oncology, American Society of Clinical Oncology, and World Conference on Lung Cancer abstracts) in agreement with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane guidelines...
October 28, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29151522/a-case-of-large-cell-neuroendocrine-carcinoma-harboring-an-alk-rearrangement-with-response-to-alectinib
#6
Nobuyoshi Hayashi, Akihisa Fujita, Toyohiro Saikai, Hirotugu Takabatake, Mie Sotoshiro, Kyuutarou Sekine, Akihiko Kawana
Anaplastic lymphoma kinase (ALK) rearrangement is most commonly observed in lung adenocarcinoma in a subset of lung cancer. Large-cell neuroendocrine carcinoma (LCNEC) harboring an ALK rearrangement is very rare. Based on the findings from a transbronchial lung biopsy, a 75-year-old non-smoking woman was diagnosed with LCNEC with multiple liver and bone metastases. After seven cycles of cytotoxic chemotherapy, her genotype testing demonstrated ALK rearrangement. Subsequently, she was administered alectinib and exhibited a partial response...
November 20, 2017: Internal Medicine
https://www.readbyqxmd.com/read/29149104/cumulative-incidence-rates-for-cns-and-non-cns-progression-in-two-phase-ii-studies-of-alectinib-in-alk-positive-nsclc
#7
Shirish Gadgeel, Alice T Shaw, Fabrice Barlesi, Lucio Crinò, James Chih-Hsin Yang, Anne-Marie C Dingemans, Dong-Wan Kim, Filippo de Marinis, Mathias Schulz, Shiyao Liu, Ravindra Gupta, Ahmed Kotb, Sai-Hong Ignatius Ou
BACKGROUND: We evaluated the cumulative incidence rate (CIR) of central nervous system (CNS) and non-CNS progression in alectinib-treated patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) to determine the extent to which alectinib may treat or control CNS disease. METHODS: Patients with crizotinib-pretreated locally advanced or metastatic disease received alectinib 600 mg orally twice daily in two phase II trials. All patients underwent baseline imaging and regular centrally reviewed scans...
November 16, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/29079636/alk-fusions-in-a-wide-variety-of-tumor-types-respond-to-anti-alk-targeted-therapy
#8
Jeffrey S Ross, Siraj M Ali, Omotayo Fasan, Jared Block, Sumanta Pal, Julia A Elvin, Alexa B Schrock, James Suh, Sahar Nozad, Sungeun Kim, Hwa Jeong Lee, Christine E Sheehan, David M Jones, Jo-Anne Vergilio, Shakti Ramkissoon, Eric Severson, Sugganth Daniel, David Fabrizio, Garrett Frampton, Vince A Miller, Philip J Stephens, Laurie M Gay
BACKGROUND: Genomic fusions of the anaplastic lymphoma kinase gene (ALK) are a well-established therapy target in non-small cell lung cancer (NSCLC). From a survey of 114,200 clinical cases, we determined the prevalence of ALK rearrangements (rALK) in non-NSCLC tumors and report their responsiveness to therapies targeting ALK. MATERIALS AND METHODS: Comprehensive genomic profiling of 114,200 relapsed and metastatic malignancies, including both solid tumors and hematolymphoid cancers, was performed using a hybrid-capture, adaptor ligation-based next-generation sequencing assay...
October 27, 2017: Oncologist
https://www.readbyqxmd.com/read/29061835/clinical-efficacy-of-alectinib-in-patients-with-alk-rearranged-non-small-cell-lung-cancer-after-ceritinib-failure
#9
Yuko Oya, Tatsuya Yoshida, Hiroaki Kuroda, Junichi Shimizu, Yoshitsugu Horio, Yukinori Sakao, Toyoaki Hida, Yasushi Yatabe
Several second-generation inhibitors of anaplastic lymphoma kinase (ALK) have demonstrated potent activity in ALK rearrangement-positive non-small cell lung cancer (NSCLC). Two of these agents, ceritinib, and alectinib, recently received approval for the treatment of ALK-rearranged NSCLC in Japan. The efficacy of treatment with a second-generation ALK inhibitor after failure with a different second-generation ALK inhibitor remains unclear. We present a series of eight patients with ALK-rearranged NSCLC treated with alectinib who experienced disease progression after ceritinib...
November 2017: Anticancer Research
https://www.readbyqxmd.com/read/29048652/activation-of-src-signaling-mediates-acquired-resistance-to-alk-inhibition-in-lung-cancer
#10
Ryohei Yoshida, Takaaki Sasaki, Yoshinori Minami, Yukiko Hibino, Shunsuke Okumura, Masatoshi Sado, Naoyuki Miyokawa, Satoshi Hayashi, Masahiro Kitada, Yoshinobu Ohsaki
Anaplastic lymphoma kinase (ALK) fusion oncogenes occur in approximately 3-5% of non-small cell lung cancer (NSCLC) cases. Various ALK inhibitors are in clinical use for the treatment of ALK-NSCLC, including the first generation ALK inhibitor, crizotinib, and recently the more highly potent alectinib and ceritinib. However, most tumors eventually become resistant to ALK specific inhibitors. To address the mechanisms underlying the development of ALK inhibitor resistance, we used iTRAQ quantitative mass spectrometry and phosphor-receptor tyrosine kinase arrays to investigate intracellular signaling alterations in ALK inhibitor resistant NSCLC cell lines...
September 28, 2017: International Journal of Oncology
https://www.readbyqxmd.com/read/29027209/heterogeneous-distribution-of-alectinib-in-neuroblastoma-xenografts-revealed-by-matrix-assisted-laser-desorption-ionisation-mass-spectrometry-imaging-a-pilot-study
#11
Shoraku Ryu, Mitsuhiro Hayashi, Hiroaki Aikawa, Isamu Okamoto, Yasuhiro Fujiwara, Akinobu Hamada
BACKGROUND AND PURPOSE: The penetration of the anaplastic lymphoma kinase (ALK) inhibitor alectinib in neuroblastomas and the relationship between alectinib and ALK expression are unknown. The aim of this study was to perform a quantitative investigation of the inter- and intra-tumoural distribution of alectinib in different neuroblastoma xenograft models using matrix-assisted laser desorption ionisation mass spectrometry imaging (MALDI-MSI). EXPERIMENTAL APPROACH: The distribution of alectinib in NB1 (ALK amplification) and SK-N-FI (ALK wild-type) xenograft tissues was analysed using MALDI-MSI...
October 13, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/29021430/crizotinib-induced-rectal-perforation-with-abscess
#12
Asako Yanagisawa, Noriko Hayama, Hiroyuki Amano, Makoto Nakamura, Satoshi Hirano, Sukeyuki Nakamura, Hiroshi Tabeta
An 86-year-old Japanese man was diagnosed with stage IV lung adenocarcinoma. The patient was treated with crizotinib after EML4-ALK rearrangement was detected from his pleural effusion. He subsequently developed abdominal pain and rebound tenderness in the right lower abdomen. Contrast-enhanced abdominal CT showed a low-density area in the abdominal cavity. The size of the abscess was decreased by drainage and the administration of antibiotics. Fistulography revealed a fistula from the rectum to the abscess, and a diagnosis of lower intestinal tract perforation with abscess formation was made...
October 11, 2017: Internal Medicine
https://www.readbyqxmd.com/read/28979145/anaplastic-lymphoma-kinase-inhibition-in-metastatic-non-small-cell-lung-cancer-clinical-impact-of-alectinib
#13
REVIEW
Ittai B Muller, Adrianus J de Langen, Elisa Giovannetti, Godefridus J Peters
A subset of non-small cell lung cancer (NSCLC) tumors (5%) harbors an anaplastic lymphoma kinase (ALK) translocation that drives tumorigenesis. The clinically approved first-line treatment crizotinib specifically inhibits ALK and improves progression-free survival (PFS) in treated and untreated patients by 4 months compared to standard chemotherapy. While some patients relapse after crizotinib treatment due to resistance mutations in ALK, second-generation ALK inhibitors effectively induce tumor response and prolong PFS...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28977547/dramatic-response-to-alectinib-in-inflammatory-myofibroblastic-tumor-with-anaplastic-lymphoma-kinase-fusion-gene
#14
Masafumi Saiki, Fumiyoshi Ohyanagi, Ryo Ariyasu, Junji Koyama, Tomoaki Sonoda, Shingo Nishikawa, Satoru Kitazono, Noriko Yanagitani, Atsushi Horiike, Hironori Ninomiya, Yuichi Ishikawa, Makoto Nishio
Inflammatory myofibroblastic tumor (IMT) is a neoplasm characterized by the proliferaton of myofibroblasts with the infiltration of inflammatory cells. There is no standard treatment for patients with recurrent or metastatic IMT. We describe here a patient with hyper-progressive IMT with an anaplastic lymphoma kinase (ALK) fusion gene that dramatically responded to alectinib without adverse events. His dramatic and enduring response supports the observation that alectinib may be considered a good treatment option for rare aggressive ALK-positive tumors...
September 18, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28955006/phase-i-ii-study-of-alectinib-in-lung-cancer-with-ret-fusion-gene-study-protocol
#15
Shinji Takeuchi, Toshinori Murayama, Kenichi Yoshimura, Takahiro Kawakami, Shizuko Takahara, Yasuhito Imai, Yoshikazu Kuribayashi, Katsuhiko Nagase, Koichi Goto, Makoto Nishio, Yoshinori Hasegawa, Miyako Satouchi, Katsuyuki Kiura, Takashi Seto, Seiji Yano
BACKGROUND: The rearranged during transfection (RET) fusion gene was discovered as a driver oncogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. METHODS/DESIGN: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design...
2017: Journal of Medical Investigation: JMI
https://www.readbyqxmd.com/read/28955002/the-case-of-double-primary-lung-adenocarcinomas-with-an-egfr-mutation-and-alk-translocation-successfully-treated-with-alectinib-at-the-post-surgical-recurrence
#16
Yoshio Tsunezuka, Nobuyoshi Tanaka, Hideki Fujimori, Yuki Togashi, Satoko Baba, Kengo Takeuchi, Kazuyoshi Katayanagi, Hiroshi Kurumaya, Hironori Kitade, Shinji Atagi, Seiji Yano
A 36-year-old male was found two nodules in the right lower lobe of the lung. After the surgical resection, both lesions were diagnosed as invasive adenocarcinomas. One lesion was primarily lepidic growth component with EGFR-L858R mutation, and the other was micropapillary component with ALK translocation accompanying mediastinal lymphnode metastases. While he experienced disease recurrence, the disease was controlled by an ALK inhibitor, given based on the findings of surgical specimens. This is the first case who had two simultaneous lung cancers with EGFR mutation and ALK translocation in each respective lesion, and was successfully treated with ALK inhibitor at the post-surgical recurrence...
2017: Journal of Medical Investigation: JMI
https://www.readbyqxmd.com/read/28932515/the-j-alex-trial-is-frontline-alectinib-a-new-standard-of-care
#17
EDITORIAL
Jeffrey Zweig, Heather A Wakelee
No abstract text is available yet for this article.
August 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28878445/phase-ii-trial-of-ch5424802-alectinib-hydrochloride-for-recurrent-or-refractory-alk-positive-anaplastic-large-cell-lymphoma-study-protocol-for-a-non-randomized-non-controlled-trial
#18
Hirokazu Nagai, Reiji Fukano, Masahiro Sekimizu, Akiko Kada, Akiko M Saito, Ryuta Asada, Tetsuya Mori
Currently, a standard therapy has not been established for recurrent or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma. While there are many treatment options, such as hematopoietic stem cell transplantation, patients with resistant disease to conventional chemotherapies have particularly poor prognosis. There is urgent need to develop new drugs because of the lack of a standard therapy and poor prognoses. This phase II trial is designed for evaluating the efficacy and safety of alectinib hydrochloride for patients with recurrent or refractory anaplastic lymphoma kinase -positive anaplastic large cell lymphoma...
August 2017: Nagoya Journal of Medical Science
https://www.readbyqxmd.com/read/28856564/the-current-landscape-of-anaplastic-lymphoma-kinase-alk-in-non-small-cell-lung-cancer-emerging-treatment-paradigms-and-future-directions
#19
Angel Qin, Shirish Gadgeel
Tumorigenic rearrangements in anaplastic lymphoma kinase (ALK) account for 3-7% of all non-small cell lung cancers (NSCLC). Treatment with targeted tyrosine kinase inhibitors (TKIs) has shown impressive clinical responses. Crizotinib was the first agent approved for front-line therapy of ALK-rearranged NSCLC after it demonstrated superiority to chemotherapy in response rate, duration of response, and progression-free survival. However, eventually all patients progress on crizotinib therapy, with the central nervous system (CNS) being the most common site, which served as the impetus for the development of more potent next-generation ALK inhibitors...
August 31, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28794371/successful-treatment-with-alectinib-for-choroidal-metastasis-in-anaplastic-lymphoma-kinase-rearranged-non-small-cell-lung-cancer
#20
Tomoko Funazo, Kyohei Morita, Naoya Ikegami, Chisato Konishi, Satoshi Nakao, Ryo Ariyasu, Masato Taki, Kazuhiko Nakagawa, Moon Hee Hwang, Chie Yoshimura, Toshiaki Wakayama, Yasuo Nishizaka
Choroidal metastasis is rare in cancer patients and it may cause visual disturbances that reduce their quality of life. In non-small cell lung cancer (NSCLC), targeted therapy against actionable driver mutations has gradually replaced radiotherapy as the treatment of choice for choroidal metastasis. Recently, there have been several case reports of choroidal metastasis in patients with anaplastic lymphoma kinase (ALK)-rearranged NSCLC. We herein report the case of a 40-year-old Japanese woman diagnosed with choroidal metastasis of an ALK-rearranged NSCLC who received alectinib as the first-line chemotherapy...
September 1, 2017: Internal Medicine
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