Long‐term effects of crizotinib in ALK‐positive tumors (excluding NSCLC): A phase 1b open‐label study
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced non‐small‐cell lung cancer (NSCLC). However, ALK rearrangements are also implicated in other malignancies, including anaplastic large‐cell ly...
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Published in | American journal of hematology Vol. 93; no. 5; pp. 607 - 614 |
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Main Authors | , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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01.05.2018
John Wiley and Sons Inc |
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Abstract | Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced non‐small‐cell lung cancer (NSCLC). However, ALK rearrangements are also implicated in other malignancies, including anaplastic large‐cell lymphoma and inflammatory myofibroblastic tumors (IMTs). In this ongoing, multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013; NCT01121588), patients with ALK‐positive advanced malignancies other than NSCLC were to receive a starting dose of crizotinib 250 mg twice daily. Primary endpoints were safety and objective responses based on Response Evaluation Criteria in Solid Tumors version 1.1 or National Cancer Institute International Response Criteria. Forty‐four patients were enrolled (lymphoma, n = 18; IMT, n = 9; other tumors, n = 17). The objective response rate was 53% (95% confidence interval [CI], 28–77) for lymphoma, with 8 complete responses (CRs) and 1 partial response (PR); 67% (95% CI, 30–93) for IMTs, with 1 CR and 5 PRs; and 12% (95% CI, 2–36) for other tumors, with 2 PRs in patients affected by colon carcinoma and medullary thyroid cancer, respectively. The median duration of treatment was almost 3 years for patients with lymphoma and IMTs, with 2‐year progression‐free survival of 63% and 67%, respectively. The most common treatment‐related adverse events were diarrhea (45.5%) and vision disorders (45.5%), mostly grade 1. These findings indicate strong and durable activity of crizotinib in ALK‐positive lymphomas and IMTs. The safety profile was consistent with the known safety profile of crizotinib even with long‐term treatment. |
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AbstractList | Abstract
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced non‐small‐cell lung cancer (NSCLC). However,
ALK
rearrangements are also implicated in other malignancies, including anaplastic large‐cell lymphoma and inflammatory myofibroblastic tumors (IMTs). In this ongoing, multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013; NCT01121588), patients with ALK‐positive advanced malignancies other than NSCLC were to receive a starting dose of crizotinib 250 mg twice daily. Primary endpoints were safety and objective responses based on Response Evaluation Criteria in Solid Tumors version 1.1 or National Cancer Institute International Response Criteria. Forty‐four patients were enrolled (lymphoma,
n
= 18; IMT,
n
= 9; other tumors,
n
= 17). The objective response rate was 53% (95% confidence interval [CI], 28–77) for lymphoma, with 8 complete responses (CRs) and 1 partial response (PR); 67% (95% CI, 30–93) for IMTs, with 1 CR and 5 PRs; and 12% (95% CI, 2–36) for other tumors, with 2 PRs in patients affected by colon carcinoma and medullary thyroid cancer, respectively. The median duration of treatment was almost 3 years for patients with lymphoma and IMTs, with 2‐year progression‐free survival of 63% and 67%, respectively. The most common treatment‐related adverse events were diarrhea (45.5%) and vision disorders (45.5%), mostly grade 1. These findings indicate strong and durable activity of crizotinib in ALK‐positive lymphomas and IMTs. The safety profile was consistent with the known safety profile of crizotinib even with long‐term treatment. Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced non‐small‐cell lung cancer (NSCLC). However, ALK rearrangements are also implicated in other malignancies, including anaplastic large‐cell lymphoma and inflammatory myofibroblastic tumors (IMTs). In this ongoing, multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013; NCT01121588), patients with ALK‐positive advanced malignancies other than NSCLC were to receive a starting dose of crizotinib 250 mg twice daily. Primary endpoints were safety and objective responses based on Response Evaluation Criteria in Solid Tumors version 1.1 or National Cancer Institute International Response Criteria. Forty‐four patients were enrolled (lymphoma, n = 18; IMT, n = 9; other tumors, n = 17). The objective response rate was 53% (95% confidence interval [CI], 28–77) for lymphoma, with 8 complete responses (CRs) and 1 partial response (PR); 67% (95% CI, 30–93) for IMTs, with 1 CR and 5 PRs; and 12% (95% CI, 2–36) for other tumors, with 2 PRs in patients affected by colon carcinoma and medullary thyroid cancer, respectively. The median duration of treatment was almost 3 years for patients with lymphoma and IMTs, with 2‐year progression‐free survival of 63% and 67%, respectively. The most common treatment‐related adverse events were diarrhea (45.5%) and vision disorders (45.5%), mostly grade 1. These findings indicate strong and durable activity of crizotinib in ALK‐positive lymphomas and IMTs. The safety profile was consistent with the known safety profile of crizotinib even with long‐term treatment. Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced non‐small‐cell lung cancer (NSCLC). However, ALK rearrangements are also implicated in other malignancies, including anaplastic large‐cell lymphoma and inflammatory myofibroblastic tumors (IMTs). In this ongoing, multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013; NCT01121588), patients with ALK‐positive advanced malignancies other than NSCLC were to receive a starting dose of crizotinib 250 mg twice daily. Primary endpoints were safety and objective responses based on Response Evaluation Criteria in Solid Tumors version 1.1 or National Cancer Institute International Response Criteria. Forty‐four patients were enrolled (lymphoma, n = 18; IMT, n = 9; other tumors, n = 17). The objective response rate was 53% (95% confidence interval [CI], 28–77) for lymphoma, with 8 complete responses (CRs) and 1 partial response (PR); 67% (95% CI, 30–93) for IMTs, with 1 CR and 5 PRs; and 12% (95% CI, 2–36) for other tumors, with 2 PRs in patients affected by colon carcinoma and medullary thyroid cancer, respectively. The median duration of treatment was almost 3 years for patients with lymphoma and IMTs, with 2‐year progression‐free survival of 63% and 67%, respectively. The most common treatment‐related adverse events were diarrhea (45.5%) and vision disorders (45.5%), mostly grade 1. These findings indicate strong and durable activity of crizotinib in ALK‐positive lymphomas and IMTs. The safety profile was consistent with the known safety profile of crizotinib even with long‐term treatment. |
Author | Edenfield, William Jeffrey Van Tine, Brian A. Taylor, Matthew Huang, Huiqiang Zhang, Li Shi, Yuankai Beck, Joseph T. Paolini, Jolanda Esaki, Taito Kim, Tae Min Horibe, Keizo Selaru, Paulina Orlov, Sergey Braiteh, Fadi Gambacorti‐Passerini, Carlo Tamura, Kenji Ahn, Jin‐Seok Wu, Shang‐Ju |
AuthorAffiliation | 2 St Petersburg Medical University St Petersburg Russia 10 Cancer Institute of Greenville Health System Greenville South Carolina 14 Washington University School of Medicine St. Louis Missouri 3 State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Sun Yat‐Sen University Cancer Center Guangdong China 15 National Taiwan University Hospital Taipei Taiwan 1 University of Milano Bicocca, San Gerardo Hospital Monza Italy 13 National Cancer Center Hospital Tokyo Japan 8 Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul South Korea 18 Seoul National University Hospital Seoul South Korea 5 Department of Medical Oncology Sun‐Yat Sen University Cancer Center Guangdong China 16 Pfizer Oncology Milan Italy 12 Oregon Health & Science University Portland Oregon 11 Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sc |
AuthorAffiliation_xml | – name: 3 State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Sun Yat‐Sen University Cancer Center Guangdong China – name: 4 Comprehensive Cancer Centers of Nevada Las Vegas Nevada – name: 1 University of Milano Bicocca, San Gerardo Hospital Monza Italy – name: 8 Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul South Korea – name: 10 Cancer Institute of Greenville Health System Greenville South Carolina – name: 16 Pfizer Oncology Milan Italy – name: 18 Seoul National University Hospital Seoul South Korea – name: 9 Highlands Oncology Group Fayetteville Arkansas – name: 6 National Kyushu Cancer Center Fukuoka Japan – name: 13 National Cancer Center Hospital Tokyo Japan – name: 12 Oregon Health & Science University Portland Oregon – name: 7 National Hospital Organization Nagoya Medical Center Nagoya Japan – name: 11 Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing China – name: 14 Washington University School of Medicine St. Louis Missouri – name: 15 National Taiwan University Hospital Taipei Taiwan – name: 5 Department of Medical Oncology Sun‐Yat Sen University Cancer Center Guangdong China – name: 17 Pfizer Oncology La Jolla California – name: 2 St Petersburg Medical University St Petersburg Russia |
Author_xml | – sequence: 1 givenname: Carlo surname: Gambacorti‐Passerini fullname: Gambacorti‐Passerini, Carlo email: carlo.gambacorti@unimib.it organization: University of Milano Bicocca, San Gerardo Hospital – sequence: 2 givenname: Sergey surname: Orlov fullname: Orlov, Sergey organization: St Petersburg Medical University – sequence: 3 givenname: Li surname: Zhang fullname: Zhang, Li organization: Collaborative Innovation Center for Cancer Medicine, Sun Yat‐Sen University Cancer Center – sequence: 4 givenname: Fadi surname: Braiteh fullname: Braiteh, Fadi organization: Comprehensive Cancer Centers of Nevada – sequence: 5 givenname: Huiqiang surname: Huang fullname: Huang, Huiqiang organization: Sun‐Yat Sen University Cancer Center – sequence: 6 givenname: Taito surname: Esaki fullname: Esaki, Taito organization: National Kyushu Cancer Center – sequence: 7 givenname: Keizo surname: Horibe fullname: Horibe, Keizo organization: National Hospital Organization Nagoya Medical Center – sequence: 8 givenname: Jin‐Seok surname: Ahn fullname: Ahn, Jin‐Seok organization: Samsung Medical Center, Sungkyunkwan University School of Medicine – sequence: 9 givenname: Joseph T. surname: Beck fullname: Beck, Joseph T. organization: Highlands Oncology Group – sequence: 10 givenname: William Jeffrey surname: Edenfield fullname: Edenfield, William Jeffrey organization: Cancer Institute of Greenville Health System – sequence: 11 givenname: Yuankai orcidid: 0000-0002-3342-4964 surname: Shi fullname: Shi, Yuankai organization: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College – sequence: 12 givenname: Matthew surname: Taylor fullname: Taylor, Matthew organization: Oregon Health & Science University – sequence: 13 givenname: Kenji orcidid: 0000-0002-3514-9927 surname: Tamura fullname: Tamura, Kenji organization: National Cancer Center Hospital – sequence: 14 givenname: Brian A. surname: Van Tine fullname: Van Tine, Brian A. organization: Washington University School of Medicine – sequence: 15 givenname: Shang‐Ju surname: Wu fullname: Wu, Shang‐Ju organization: National Taiwan University Hospital – sequence: 16 givenname: Jolanda surname: Paolini fullname: Paolini, Jolanda organization: Pfizer Oncology – sequence: 17 givenname: Paulina surname: Selaru fullname: Selaru, Paulina organization: Pfizer Oncology – sequence: 18 givenname: Tae Min surname: Kim fullname: Kim, Tae Min organization: Seoul National University Hospital |
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Notes | Funding information Pfizer Inc Carlo Gambacorti‐Passerini and Tae Min Kim contributed equally to the lead authorship of this article. Funding information Pfizer Inc |
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Snippet | Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive advanced... Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK-positive or ROS1-positive advanced... Abstract Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), MET, and ROS1, is approved for treatment of patients with ALK‐positive or ROS1‐positive... |
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SubjectTerms | Adolescent Adult Aged Anaplastic large-cell lymphoma Anaplastic Lymphoma Kinase - antagonists & inhibitors Anaplastic Lymphoma Kinase - genetics Cancer Carcinoma, Non-Small-Cell Lung - complications Carcinoma, Non-Small-Cell Lung - drug therapy Colon Crizotinib - adverse effects Crizotinib - pharmacology Diarrhea Enzyme inhibitors Female Hematology Humans Inflammation Long-term effects Lung cancer Lung Neoplasms Lymphoma Male Middle Aged Mutation Neoplasms - complications Neoplasms - drug therapy Non-small cell lung carcinoma Patients Protein-tyrosine kinase Safety Solid tumors Targeted cancer therapy Thyroid cancer Treatment Outcome Tumors Young Adult |
Title | Long‐term effects of crizotinib in ALK‐positive tumors (excluding NSCLC): A phase 1b open‐label study |
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