Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial
Summary Background . Chronic lymphoblastic leukemia (CLL) is the most common adult leukemia and mainly affects the elderly. Chemoimmunotherapy still has a role in the standard frontline therapy for specific population. However, the clinical activity of bendamustine has not been investigated in unfit...
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| Veröffentlicht in: | Investigational new drugs 2022-04, Vol.40 (2), p.349-360 |
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| creator | Zhou, Daobin Xu, Wei Ma, Hongbing Zhao, Chunting Hu, Yu Zhao, Yaozhong Wu, Depei Zhao, Xielan He, Yanjuan Yan, Jinsong Wang, Chunsen Meng, Fanyi Jin, Jie Zhang, Xiaohong Yu, Kang Hu, Jianda Lv, Yue |
| description | Summary
Background
. Chronic lymphoblastic leukemia (CLL) is the most common adult leukemia and mainly affects the elderly. Chemoimmunotherapy still has a role in the standard frontline therapy for specific population. However, the clinical activity of bendamustine has not been investigated in unfit Chinese patients with CLL. This study aimed to compare the efficacy and safety of bendamustine versus chlorambucil for untreated Chinese patients with Binet stage B/C CLL.
Methods.
In this multi-center, randomized, open-label, parallel-controlled, phase III trial, patients with previously untreated CLL were enrolled and randomly assigned (1:1) to receive bendamustine or chlorambucil. The primary endpoint was the objective response rate. Secondary endpoints included progression-free survival, the duration of response, and overall survival. Adverse events were recorded to evaluate safety.
Results
. Of 158 screened patients, 147 were enrolled and randomly allocated to receive bendamustine (n = 72) or chlorambucil (n = 75). After a median follow-up of 25.6 months (IQR 12.5–27.7), 69.0% (95% CI, 56.9–79.5) of bendamustine-treated patients achieved objective response and 37.0% (95% CI, 26.0–49.1) of chlorambucil with a difference of 32.0% (95%CI: 16.6–47.5), demonstrating the superiority of bendamustine to chlorambucil (
p
|
| doi_str_mv | 10.1007/s10637-021-01206-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2620088945</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2620088945</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-1f92eb483bd88bb0d9c73f49c3f830e9f7e0cab7daa04fe6357baa10b748f7723</originalsourceid><addsrcrecordid>eNp9kU1v1DAQhiNERZfCH-CALHHpoS7jOIkTbrDiY6VKXOAcjZ0J6-LYwU6Qll_Tn4qXLSBx4OSR5vE7r_QUxTMB1wJAvUwCGqk4lIKDKKHh5YNiI2olOTRV87DYgGgUb7pOnRePU7oFANmp6lFxLmuQou2aTXH3hvyA05oW64l9p5jWxMzehYiTXo11zHq2RMJlIr-wMOZlDN4a5g7TvA_msBxnWr8iTRaP9HZvPb5iyCL6IUz2Bw1XLMzkuUNN7orNGNE5ctwEv8SQxwzMe0zEdrsdM87mfHT5rEX3pDgb0SV6ev9eFJ_fvf20_cBvPr7fbV_fcCNVvXAxdiXpqpV6aFutYeiMkmPVGTm2EqgbFYFBrQZEqEZqZK00ogCtqnZUqpQXxeUpd47h20pp6SebDDmHnsKa-rIpAdq2q-qMvvgHvQ1r9LldpnKFsq5alanyRJkYUoo09nO0E8ZDL6A_-utP_vrsr__lrz-2eH4fveqJhj9ffgvLgDwBKa_8F4p_b_8n9idiIKie</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2648325487</pqid></control><display><type>article</type><title>Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Zhou, Daobin ; Xu, Wei ; Ma, Hongbing ; Zhao, Chunting ; Hu, Yu ; Zhao, Yaozhong ; Wu, Depei ; Zhao, Xielan ; He, Yanjuan ; Yan, Jinsong ; Wang, Chunsen ; Meng, Fanyi ; Jin, Jie ; Zhang, Xiaohong ; Yu, Kang ; Hu, Jianda ; Lv, Yue</creator><creatorcontrib>Zhou, Daobin ; Xu, Wei ; Ma, Hongbing ; Zhao, Chunting ; Hu, Yu ; Zhao, Yaozhong ; Wu, Depei ; Zhao, Xielan ; He, Yanjuan ; Yan, Jinsong ; Wang, Chunsen ; Meng, Fanyi ; Jin, Jie ; Zhang, Xiaohong ; Yu, Kang ; Hu, Jianda ; Lv, Yue</creatorcontrib><description>Summary
Background
. Chronic lymphoblastic leukemia (CLL) is the most common adult leukemia and mainly affects the elderly. Chemoimmunotherapy still has a role in the standard frontline therapy for specific population. However, the clinical activity of bendamustine has not been investigated in unfit Chinese patients with CLL. This study aimed to compare the efficacy and safety of bendamustine versus chlorambucil for untreated Chinese patients with Binet stage B/C CLL.
Methods.
In this multi-center, randomized, open-label, parallel-controlled, phase III trial, patients with previously untreated CLL were enrolled and randomly assigned (1:1) to receive bendamustine or chlorambucil. The primary endpoint was the objective response rate. Secondary endpoints included progression-free survival, the duration of response, and overall survival. Adverse events were recorded to evaluate safety.
Results
. Of 158 screened patients, 147 were enrolled and randomly allocated to receive bendamustine (n = 72) or chlorambucil (n = 75). After a median follow-up of 25.6 months (IQR 12.5–27.7), 69.0% (95% CI, 56.9–79.5) of bendamustine-treated patients achieved objective response and 37.0% (95% CI, 26.0–49.1) of chlorambucil with a difference of 32.0% (95%CI: 16.6–47.5), demonstrating the superiority of bendamustine to chlorambucil (
p
< 0.001). The median progression-free survival was longer for bendamustine (16.5 months; 95% CI, 11.3–24.7) versus chlorambucil (9.6 months; 95% CI, 8.7–11.8;
p
< 0.001). A longer median duration of response was seen in those receiving bendamustine (19.2 months; 95% CI, 11.8–29.1) than chlorambucil (10.7 months; 95% CI, 5.6–13.6;
p
= 0.0018). Median overall survival was not reached in either group. Overall survival at 18 months was 88% for bendamustine versus 85% for chlorambucil. Most common adverse events in both groups were neutropenia and thrombocytopenia.
Conclusion.
In untreated Chinese patients with Binet stage B/C CLL, bendamustine induced the better objective response and resulted in longer progression-free survival than chlorambucil. Overall, these results validate the role of bendamustine as an effective and safe first-line therapy in this population.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-021-01206-2</identifier><identifier>PMID: 35031896</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Adverse events ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Bendamustine Hydrochloride - adverse effects ; Chlorambucil ; Chlorambucil - adverse effects ; Chronic lymphocytic leukemia ; Humans ; Leukemia ; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy ; Lymphatic leukemia ; Medicine ; Medicine & Public Health ; Neutropenia ; Oncology ; Patients ; Pharmacology/Toxicology ; Phase III Studies ; Progression-Free Survival ; Safety ; Survival ; Thrombocytopenia</subject><ispartof>Investigational new drugs, 2022-04, Vol.40 (2), p.349-360</ispartof><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021</rights><rights>2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.</rights><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-1f92eb483bd88bb0d9c73f49c3f830e9f7e0cab7daa04fe6357baa10b748f7723</citedby><cites>FETCH-LOGICAL-c375t-1f92eb483bd88bb0d9c73f49c3f830e9f7e0cab7daa04fe6357baa10b748f7723</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10637-021-01206-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-021-01206-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27915,27916,41479,42548,51310</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35031896$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhou, Daobin</creatorcontrib><creatorcontrib>Xu, Wei</creatorcontrib><creatorcontrib>Ma, Hongbing</creatorcontrib><creatorcontrib>Zhao, Chunting</creatorcontrib><creatorcontrib>Hu, Yu</creatorcontrib><creatorcontrib>Zhao, Yaozhong</creatorcontrib><creatorcontrib>Wu, Depei</creatorcontrib><creatorcontrib>Zhao, Xielan</creatorcontrib><creatorcontrib>He, Yanjuan</creatorcontrib><creatorcontrib>Yan, Jinsong</creatorcontrib><creatorcontrib>Wang, Chunsen</creatorcontrib><creatorcontrib>Meng, Fanyi</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Zhang, Xiaohong</creatorcontrib><creatorcontrib>Yu, Kang</creatorcontrib><creatorcontrib>Hu, Jianda</creatorcontrib><creatorcontrib>Lv, Yue</creatorcontrib><title>Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Background
. Chronic lymphoblastic leukemia (CLL) is the most common adult leukemia and mainly affects the elderly. Chemoimmunotherapy still has a role in the standard frontline therapy for specific population. However, the clinical activity of bendamustine has not been investigated in unfit Chinese patients with CLL. This study aimed to compare the efficacy and safety of bendamustine versus chlorambucil for untreated Chinese patients with Binet stage B/C CLL.
Methods.
In this multi-center, randomized, open-label, parallel-controlled, phase III trial, patients with previously untreated CLL were enrolled and randomly assigned (1:1) to receive bendamustine or chlorambucil. The primary endpoint was the objective response rate. Secondary endpoints included progression-free survival, the duration of response, and overall survival. Adverse events were recorded to evaluate safety.
Results
. Of 158 screened patients, 147 were enrolled and randomly allocated to receive bendamustine (n = 72) or chlorambucil (n = 75). After a median follow-up of 25.6 months (IQR 12.5–27.7), 69.0% (95% CI, 56.9–79.5) of bendamustine-treated patients achieved objective response and 37.0% (95% CI, 26.0–49.1) of chlorambucil with a difference of 32.0% (95%CI: 16.6–47.5), demonstrating the superiority of bendamustine to chlorambucil (
p
< 0.001). The median progression-free survival was longer for bendamustine (16.5 months; 95% CI, 11.3–24.7) versus chlorambucil (9.6 months; 95% CI, 8.7–11.8;
p
< 0.001). A longer median duration of response was seen in those receiving bendamustine (19.2 months; 95% CI, 11.8–29.1) than chlorambucil (10.7 months; 95% CI, 5.6–13.6;
p
= 0.0018). Median overall survival was not reached in either group. Overall survival at 18 months was 88% for bendamustine versus 85% for chlorambucil. Most common adverse events in both groups were neutropenia and thrombocytopenia.
Conclusion.
In untreated Chinese patients with Binet stage B/C CLL, bendamustine induced the better objective response and resulted in longer progression-free survival than chlorambucil. Overall, these results validate the role of bendamustine as an effective and safe first-line therapy in this population.</description><subject>Adult</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Bendamustine Hydrochloride - adverse effects</subject><subject>Chlorambucil</subject><subject>Chlorambucil - adverse effects</subject><subject>Chronic lymphocytic leukemia</subject><subject>Humans</subject><subject>Leukemia</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy</subject><subject>Lymphatic leukemia</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Phase III Studies</subject><subject>Progression-Free Survival</subject><subject>Safety</subject><subject>Survival</subject><subject>Thrombocytopenia</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp9kU1v1DAQhiNERZfCH-CALHHpoS7jOIkTbrDiY6VKXOAcjZ0J6-LYwU6Qll_Tn4qXLSBx4OSR5vE7r_QUxTMB1wJAvUwCGqk4lIKDKKHh5YNiI2olOTRV87DYgGgUb7pOnRePU7oFANmp6lFxLmuQou2aTXH3hvyA05oW64l9p5jWxMzehYiTXo11zHq2RMJlIr-wMOZlDN4a5g7TvA_msBxnWr8iTRaP9HZvPb5iyCL6IUz2Bw1XLMzkuUNN7orNGNE5ctwEv8SQxwzMe0zEdrsdM87mfHT5rEX3pDgb0SV6ev9eFJ_fvf20_cBvPr7fbV_fcCNVvXAxdiXpqpV6aFutYeiMkmPVGTm2EqgbFYFBrQZEqEZqZK00ogCtqnZUqpQXxeUpd47h20pp6SebDDmHnsKa-rIpAdq2q-qMvvgHvQ1r9LldpnKFsq5alanyRJkYUoo09nO0E8ZDL6A_-utP_vrsr__lrz-2eH4fveqJhj9ffgvLgDwBKa_8F4p_b_8n9idiIKie</recordid><startdate>20220401</startdate><enddate>20220401</enddate><creator>Zhou, Daobin</creator><creator>Xu, Wei</creator><creator>Ma, Hongbing</creator><creator>Zhao, Chunting</creator><creator>Hu, Yu</creator><creator>Zhao, Yaozhong</creator><creator>Wu, Depei</creator><creator>Zhao, Xielan</creator><creator>He, Yanjuan</creator><creator>Yan, Jinsong</creator><creator>Wang, Chunsen</creator><creator>Meng, Fanyi</creator><creator>Jin, Jie</creator><creator>Zhang, Xiaohong</creator><creator>Yu, Kang</creator><creator>Hu, Jianda</creator><creator>Lv, Yue</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20220401</creationdate><title>Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial</title><author>Zhou, Daobin ; Xu, Wei ; Ma, Hongbing ; Zhao, Chunting ; Hu, Yu ; Zhao, Yaozhong ; Wu, Depei ; Zhao, Xielan ; He, Yanjuan ; Yan, Jinsong ; Wang, Chunsen ; Meng, Fanyi ; Jin, Jie ; Zhang, Xiaohong ; Yu, Kang ; Hu, Jianda ; Lv, Yue</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-1f92eb483bd88bb0d9c73f49c3f830e9f7e0cab7daa04fe6357baa10b748f7723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Bendamustine Hydrochloride - adverse effects</topic><topic>Chlorambucil</topic><topic>Chlorambucil - adverse effects</topic><topic>Chronic lymphocytic leukemia</topic><topic>Humans</topic><topic>Leukemia</topic><topic>Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy</topic><topic>Lymphatic leukemia</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Phase III Studies</topic><topic>Progression-Free Survival</topic><topic>Safety</topic><topic>Survival</topic><topic>Thrombocytopenia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhou, Daobin</creatorcontrib><creatorcontrib>Xu, Wei</creatorcontrib><creatorcontrib>Ma, Hongbing</creatorcontrib><creatorcontrib>Zhao, Chunting</creatorcontrib><creatorcontrib>Hu, Yu</creatorcontrib><creatorcontrib>Zhao, Yaozhong</creatorcontrib><creatorcontrib>Wu, Depei</creatorcontrib><creatorcontrib>Zhao, Xielan</creatorcontrib><creatorcontrib>He, Yanjuan</creatorcontrib><creatorcontrib>Yan, Jinsong</creatorcontrib><creatorcontrib>Wang, Chunsen</creatorcontrib><creatorcontrib>Meng, Fanyi</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Zhang, Xiaohong</creatorcontrib><creatorcontrib>Yu, Kang</creatorcontrib><creatorcontrib>Hu, Jianda</creatorcontrib><creatorcontrib>Lv, Yue</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>ABI/INFORM Collection (ProQuest)</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection (Proquest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>Consumer Health Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Global</collection><collection>ProQuest Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>One Business (ProQuest)</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhou, Daobin</au><au>Xu, Wei</au><au>Ma, Hongbing</au><au>Zhao, Chunting</au><au>Hu, Yu</au><au>Zhao, Yaozhong</au><au>Wu, Depei</au><au>Zhao, Xielan</au><au>He, Yanjuan</au><au>Yan, Jinsong</au><au>Wang, Chunsen</au><au>Meng, Fanyi</au><au>Jin, Jie</au><au>Zhang, Xiaohong</au><au>Yu, Kang</au><au>Hu, Jianda</au><au>Lv, Yue</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2022-04-01</date><risdate>2022</risdate><volume>40</volume><issue>2</issue><spage>349</spage><epage>360</epage><pages>349-360</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><abstract>Summary
Background
. Chronic lymphoblastic leukemia (CLL) is the most common adult leukemia and mainly affects the elderly. Chemoimmunotherapy still has a role in the standard frontline therapy for specific population. However, the clinical activity of bendamustine has not been investigated in unfit Chinese patients with CLL. This study aimed to compare the efficacy and safety of bendamustine versus chlorambucil for untreated Chinese patients with Binet stage B/C CLL.
Methods.
In this multi-center, randomized, open-label, parallel-controlled, phase III trial, patients with previously untreated CLL were enrolled and randomly assigned (1:1) to receive bendamustine or chlorambucil. The primary endpoint was the objective response rate. Secondary endpoints included progression-free survival, the duration of response, and overall survival. Adverse events were recorded to evaluate safety.
Results
. Of 158 screened patients, 147 were enrolled and randomly allocated to receive bendamustine (n = 72) or chlorambucil (n = 75). After a median follow-up of 25.6 months (IQR 12.5–27.7), 69.0% (95% CI, 56.9–79.5) of bendamustine-treated patients achieved objective response and 37.0% (95% CI, 26.0–49.1) of chlorambucil with a difference of 32.0% (95%CI: 16.6–47.5), demonstrating the superiority of bendamustine to chlorambucil (
p
< 0.001). The median progression-free survival was longer for bendamustine (16.5 months; 95% CI, 11.3–24.7) versus chlorambucil (9.6 months; 95% CI, 8.7–11.8;
p
< 0.001). A longer median duration of response was seen in those receiving bendamustine (19.2 months; 95% CI, 11.8–29.1) than chlorambucil (10.7 months; 95% CI, 5.6–13.6;
p
= 0.0018). Median overall survival was not reached in either group. Overall survival at 18 months was 88% for bendamustine versus 85% for chlorambucil. Most common adverse events in both groups were neutropenia and thrombocytopenia.
Conclusion.
In untreated Chinese patients with Binet stage B/C CLL, bendamustine induced the better objective response and resulted in longer progression-free survival than chlorambucil. Overall, these results validate the role of bendamustine as an effective and safe first-line therapy in this population.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>35031896</pmid><doi>10.1007/s10637-021-01206-2</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6997 |
| ispartof | Investigational new drugs, 2022-04, Vol.40 (2), p.349-360 |
| issn | 0167-6997 1573-0646 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2620088945 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Adverse events Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Bendamustine Hydrochloride - adverse effects Chlorambucil Chlorambucil - adverse effects Chronic lymphocytic leukemia Humans Leukemia Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Lymphatic leukemia Medicine Medicine & Public Health Neutropenia Oncology Patients Pharmacology/Toxicology Phase III Studies Progression-Free Survival Safety Survival Thrombocytopenia |
| title | Bendamustine versus chlorambucil in treatment of chronic lymphocytic leukaemia in China: a randomized, open-label, parallel-controlled, phase III clinical trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-14T19%3A20%3A58IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Bendamustine%20versus%20chlorambucil%20in%20treatment%20of%20chronic%20lymphocytic%20leukaemia%20in%20China:%20a%20randomized,%20open-label,%20parallel-controlled,%20phase%20III%20clinical%20trial&rft.jtitle=Investigational%20new%20drugs&rft.au=Zhou,%20Daobin&rft.date=2022-04-01&rft.volume=40&rft.issue=2&rft.spage=349&rft.epage=360&rft.pages=349-360&rft.issn=0167-6997&rft.eissn=1573-0646&rft_id=info:doi/10.1007/s10637-021-01206-2&rft_dat=%3Cproquest_cross%3E2620088945%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2648325487&rft_id=info:pmid/35031896&rfr_iscdi=true |