A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer

Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer w...

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Veröffentlicht in:The oncologist (Dayton, Ohio) Ohio), 2011-09, Vol.16 (9), p.1197-1202
Hauptverfasser: Yaal‐Hahoshen, Neora, Maimon, Yair, Siegelmann‐Danieli, Nava, Lev‐Ari, Shahar, Ron, Ilan G., Sperber, Fani, Samuels, Noah, Shoham, Jacob, Merimsky, Ofer
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container_issue 9
container_start_page 1197
container_title The oncologist (Dayton, Ohio)
container_volume 16
creator Yaal‐Hahoshen, Neora
Maimon, Yair
Siegelmann‐Danieli, Nava
Lev‐Ari, Shahar
Ron, Ilan G.
Sperber, Fani
Samuels, Noah
Shoham, Jacob
Merimsky, Ofer
description Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty‐five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose‐dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life‐threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline‐ and taxane‐based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy‐induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. 摘要 背景. 本项前瞻性对照研究评估植物源化合物混合物LCS101预防乳腺癌患者化疗所致血液学毒性反应的安全性、耐受性和有效性。 方法. 确诊局部乳腺癌的女性患者随机接受传统化疗添加LCS101或安慰剂胶囊治疗。研究治疗方案为受试者口服LCS101胶囊(2g,每天3次),治疗始于化疗开始前2周,持续至化疗完成。评估受试者的血液学和非血液学毒性反应以及研究治疗方案的耐受性和安全性。 结果. 65例乳腺癌患者入组,分配至LCS101组和安慰剂组分别为34例和31例。0 ~ 1级与2 ~ 4级的血液学毒性反应比较显示,LCS101组严重(2 ~ 4级)贫血(P
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This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty‐five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose‐dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life‐threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline‐ and taxane‐based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy‐induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. 摘要 背景. 本项前瞻性对照研究评估植物源化合物混合物LCS101预防乳腺癌患者化疗所致血液学毒性反应的安全性、耐受性和有效性。 方法. 确诊局部乳腺癌的女性患者随机接受传统化疗添加LCS101或安慰剂胶囊治疗。研究治疗方案为受试者口服LCS101胶囊(2g,每天3次),治疗始于化疗开始前2周,持续至化疗完成。评估受试者的血液学和非血液学毒性反应以及研究治疗方案的耐受性和安全性。 结果. 65例乳腺癌患者入组,分配至LCS101组和安慰剂组分别为34例和31例。0 ~ 1级与2 ~ 4级的血液学毒性反应比较显示,LCS101组严重(2 ~ 4级)贫血(P <0.01)和白细胞减少(P <0.03)的患者显著较少;0 ~ 2级与3 ~ 4级比较显示,治疗组中性粒细胞减少(P<0.04)显著较少。在接受剂量密集方案治疗的患者中,该效应更显著。LCS101治疗在非血液学毒性反应方面无显著效应,不良反应发生率组间无显著差异,两组均未出现严重或威胁生命的事件。 结论. 蒽环类和紫杉烷类为基础的化疗方案中添加LCS101安全、耐受良好,可显著有效地预防早期乳腺癌患者化疗所致部分血液学毒性反应。上述结果支持开展更大样本、更为广泛的相关临床研究。 The safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 were evaluated in the prevention of chemotherapy‐induced hematological toxicity in breast cancer patients in a prospective, controlled study.]]></description><identifier>ISSN: 1083-7159</identifier><identifier>EISSN: 1549-490X</identifier><identifier>DOI: 10.1634/theoncologist.2011-0150</identifier><identifier>PMID: 21712486</identifier><language>eng</language><publisher>Durham, NC, USA: AlphaMed Press</publisher><subject>Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Botanical compounds ; Breast Cancer ; Breast Neoplasms - blood ; Breast Neoplasms - drug therapy ; Chemotherapy ; Double-Blind Method ; Drugs, Chinese Herbal - therapeutic use ; Female ; Hematologic Diseases - chemically induced ; Hematologic Diseases - prevention &amp; control ; Hematological toxicity ; Humans ; Middle Aged ; Phytotherapy ; Plant Preparations - therapeutic use ; Prevention ; Prospective Studies ; Taxoids - administration &amp; dosage ; Taxoids - adverse effects ; Young Adult</subject><ispartof>The oncologist (Dayton, Ohio), 2011-09, Vol.16 (9), p.1197-1202</ispartof><rights>2011 AlphaMed Press</rights><rights>AlphaMed Press 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4707-ba4bc35bf35abfe19df5397585f047b484231a180a8c04555a08f2ba2a44bf053</citedby><cites>FETCH-LOGICAL-c4707-ba4bc35bf35abfe19df5397585f047b484231a180a8c04555a08f2ba2a44bf053</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228177/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228177/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,1411,27901,27902,45550,45551,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21712486$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yaal‐Hahoshen, Neora</creatorcontrib><creatorcontrib>Maimon, Yair</creatorcontrib><creatorcontrib>Siegelmann‐Danieli, Nava</creatorcontrib><creatorcontrib>Lev‐Ari, Shahar</creatorcontrib><creatorcontrib>Ron, Ilan G.</creatorcontrib><creatorcontrib>Sperber, Fani</creatorcontrib><creatorcontrib>Samuels, Noah</creatorcontrib><creatorcontrib>Shoham, Jacob</creatorcontrib><creatorcontrib>Merimsky, Ofer</creatorcontrib><title>A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer</title><title>The oncologist (Dayton, Ohio)</title><addtitle>Oncologist</addtitle><description><![CDATA[Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty‐five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose‐dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life‐threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline‐ and taxane‐based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy‐induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. 摘要 背景. 本项前瞻性对照研究评估植物源化合物混合物LCS101预防乳腺癌患者化疗所致血液学毒性反应的安全性、耐受性和有效性。 方法. 确诊局部乳腺癌的女性患者随机接受传统化疗添加LCS101或安慰剂胶囊治疗。研究治疗方案为受试者口服LCS101胶囊(2g,每天3次),治疗始于化疗开始前2周,持续至化疗完成。评估受试者的血液学和非血液学毒性反应以及研究治疗方案的耐受性和安全性。 结果. 65例乳腺癌患者入组,分配至LCS101组和安慰剂组分别为34例和31例。0 ~ 1级与2 ~ 4级的血液学毒性反应比较显示,LCS101组严重(2 ~ 4级)贫血(P <0.01)和白细胞减少(P <0.03)的患者显著较少;0 ~ 2级与3 ~ 4级比较显示,治疗组中性粒细胞减少(P<0.04)显著较少。在接受剂量密集方案治疗的患者中,该效应更显著。LCS101治疗在非血液学毒性反应方面无显著效应,不良反应发生率组间无显著差异,两组均未出现严重或威胁生命的事件。 结论. 蒽环类和紫杉烷类为基础的化疗方案中添加LCS101安全、耐受良好,可显著有效地预防早期乳腺癌患者化疗所致部分血液学毒性反应。上述结果支持开展更大样本、更为广泛的相关临床研究。 The safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 were evaluated in the prevention of chemotherapy‐induced hematological toxicity in breast cancer patients in a prospective, controlled study.]]></description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Botanical compounds</subject><subject>Breast Cancer</subject><subject>Breast Neoplasms - blood</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Chemotherapy</subject><subject>Double-Blind Method</subject><subject>Drugs, Chinese Herbal - therapeutic use</subject><subject>Female</subject><subject>Hematologic Diseases - chemically induced</subject><subject>Hematologic Diseases - prevention &amp; control</subject><subject>Hematological toxicity</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Phytotherapy</subject><subject>Plant Preparations - therapeutic use</subject><subject>Prevention</subject><subject>Prospective Studies</subject><subject>Taxoids - administration &amp; dosage</subject><subject>Taxoids - adverse effects</subject><subject>Young Adult</subject><issn>1083-7159</issn><issn>1549-490X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd1u1DAQhS0EoqXwCuAHIMXjnzq5AKmNgFZaWKSCxJ3lOHbXKLEjxynsHY_QZ-RJ8LK0ondczUhzzjdjH4ReADmGE8Zf5Y2NwcQhXvk5H1MCUBEQ5AE6BMGbijfk68PSk5pVEkRzgJ7M8zdSJA2jj9EBBQmU1yeH6OYUf0pxnqzJ_tq-xG0MOcVhsD2-zEu_xdHhsgyfxayDN3ooinGKS-jxB_8jL8niVXsJBLCLCbcbO8YiT3ra_vp5cxH6xRTSuR11_nPsLWAoXfYxzNgHfJasnjNudTA2PUWPnB5m--xvPUJf3r393J5Xq_X7i_Z0VRkuiaw6zTvDROeY0J2z0PROsEaKWjjCZcdrThloqImuDeFCCE1qRztNNeedI4IdoTd77rR0o-2NLe_Wg5qSH3Xaqqi9uj8JfqOu4rVilNYgZQHIPcCU_5uTdXdeIGoXkroXktqFpHYhFefzf1ff-W5TKYLXe8F3P9jt_3LV-mO7Bmgk-w36Jqri</recordid><startdate>201109</startdate><enddate>201109</enddate><creator>Yaal‐Hahoshen, Neora</creator><creator>Maimon, Yair</creator><creator>Siegelmann‐Danieli, Nava</creator><creator>Lev‐Ari, Shahar</creator><creator>Ron, Ilan G.</creator><creator>Sperber, Fani</creator><creator>Samuels, Noah</creator><creator>Shoham, Jacob</creator><creator>Merimsky, Ofer</creator><general>AlphaMed Press</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>5PM</scope></search><sort><creationdate>201109</creationdate><title>A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer</title><author>Yaal‐Hahoshen, Neora ; Maimon, Yair ; Siegelmann‐Danieli, Nava ; Lev‐Ari, Shahar ; Ron, Ilan G. ; Sperber, Fani ; Samuels, Noah ; Shoham, Jacob ; Merimsky, Ofer</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4707-ba4bc35bf35abfe19df5397585f047b484231a180a8c04555a08f2ba2a44bf053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Botanical compounds</topic><topic>Breast Cancer</topic><topic>Breast Neoplasms - blood</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Chemotherapy</topic><topic>Double-Blind Method</topic><topic>Drugs, Chinese Herbal - therapeutic use</topic><topic>Female</topic><topic>Hematologic Diseases - chemically induced</topic><topic>Hematologic Diseases - prevention &amp; control</topic><topic>Hematological toxicity</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Phytotherapy</topic><topic>Plant Preparations - therapeutic use</topic><topic>Prevention</topic><topic>Prospective Studies</topic><topic>Taxoids - administration &amp; dosage</topic><topic>Taxoids - adverse effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yaal‐Hahoshen, Neora</creatorcontrib><creatorcontrib>Maimon, Yair</creatorcontrib><creatorcontrib>Siegelmann‐Danieli, Nava</creatorcontrib><creatorcontrib>Lev‐Ari, Shahar</creatorcontrib><creatorcontrib>Ron, Ilan G.</creatorcontrib><creatorcontrib>Sperber, Fani</creatorcontrib><creatorcontrib>Samuels, Noah</creatorcontrib><creatorcontrib>Shoham, Jacob</creatorcontrib><creatorcontrib>Merimsky, Ofer</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The oncologist (Dayton, Ohio)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yaal‐Hahoshen, Neora</au><au>Maimon, Yair</au><au>Siegelmann‐Danieli, Nava</au><au>Lev‐Ari, Shahar</au><au>Ron, Ilan G.</au><au>Sperber, Fani</au><au>Samuels, Noah</au><au>Shoham, Jacob</au><au>Merimsky, Ofer</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer</atitle><jtitle>The oncologist (Dayton, Ohio)</jtitle><addtitle>Oncologist</addtitle><date>2011-09</date><risdate>2011</risdate><volume>16</volume><issue>9</issue><spage>1197</spage><epage>1202</epage><pages>1197-1202</pages><issn>1083-7159</issn><eissn>1549-490X</eissn><abstract><![CDATA[Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy‐induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty‐five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose‐dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life‐threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline‐ and taxane‐based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy‐induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. 摘要 背景. 本项前瞻性对照研究评估植物源化合物混合物LCS101预防乳腺癌患者化疗所致血液学毒性反应的安全性、耐受性和有效性。 方法. 确诊局部乳腺癌的女性患者随机接受传统化疗添加LCS101或安慰剂胶囊治疗。研究治疗方案为受试者口服LCS101胶囊(2g,每天3次),治疗始于化疗开始前2周,持续至化疗完成。评估受试者的血液学和非血液学毒性反应以及研究治疗方案的耐受性和安全性。 结果. 65例乳腺癌患者入组,分配至LCS101组和安慰剂组分别为34例和31例。0 ~ 1级与2 ~ 4级的血液学毒性反应比较显示,LCS101组严重(2 ~ 4级)贫血(P <0.01)和白细胞减少(P <0.03)的患者显著较少;0 ~ 2级与3 ~ 4级比较显示,治疗组中性粒细胞减少(P<0.04)显著较少。在接受剂量密集方案治疗的患者中,该效应更显著。LCS101治疗在非血液学毒性反应方面无显著效应,不良反应发生率组间无显著差异,两组均未出现严重或威胁生命的事件。 结论. 蒽环类和紫杉烷类为基础的化疗方案中添加LCS101安全、耐受良好,可显著有效地预防早期乳腺癌患者化疗所致部分血液学毒性反应。上述结果支持开展更大样本、更为广泛的相关临床研究。 The safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 were evaluated in the prevention of chemotherapy‐induced hematological toxicity in breast cancer patients in a prospective, controlled study.]]></abstract><cop>Durham, NC, USA</cop><pub>AlphaMed Press</pub><pmid>21712486</pmid><doi>10.1634/theoncologist.2011-0150</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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1549-490X
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3228177
source Oxford Journals Open Access Collection; MEDLINE; Wiley Online Library Journals Frontfile Complete; EZB-FREE-00999 freely available EZB journals; PubMed Central
subjects Adolescent
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Botanical compounds
Breast Cancer
Breast Neoplasms - blood
Breast Neoplasms - drug therapy
Chemotherapy
Double-Blind Method
Drugs, Chinese Herbal - therapeutic use
Female
Hematologic Diseases - chemically induced
Hematologic Diseases - prevention & control
Hematological toxicity
Humans
Middle Aged
Phytotherapy
Plant Preparations - therapeutic use
Prevention
Prospective Studies
Taxoids - administration & dosage
Taxoids - adverse effects
Young Adult
title A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy‐Induced Hematological Complications in Breast Cancer
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