Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats
Background Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied. Hypothesis/Objectives To determine the maximal tolerated dose (MTD) and dose‐limiting toxicity (DLT) of VRL in tumor‐bearing cats. Animals Cats were included in this prospective phase I trial if the...
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| Veröffentlicht in: | Journal of veterinary internal medicine 2013-07, Vol.27 (4), p.943-948 |
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| creator | Pierro, J.A Mallett, C.L. Saba, C.F. |
| description | Background
Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied.
Hypothesis/Objectives
To determine the maximal tolerated dose (MTD) and dose‐limiting toxicity (DLT) of VRL in tumor‐bearing cats.
Animals
Cats were included in this prospective phase I trial if they had confirmed malignancy, received ≥1 VRL treatment, and had adequate follow‐up. Previous treatment was acceptable, but concurrent chemotherapy or radiotherapy was not permitted.
Methods
Using a modified phase I design, cats were enrolled in cohorts of 3 at a starting dosage of 9 mg/m2. Cats tolerating the first treatment well were eligible to receive additional VRL treatments at escalating dosages; escalations beyond the perceived MTD were permitted based on individual tolerance. Intended treatment interval was 7 days. Patient histories, physical examinations, and complete blood counts were performed weekly.
Results
Nineteen cats were included. Sixty‐one VRL treatments were administered. Median number of treatments was 2 (range, 1–9). Starting dosages were 9–12 mg/m2. Maximal dosage administered was 15.5 mg/m2. The MTD was 11.5 mg/m2. Acute DLTs were neutropenia, vomiting, and nephrotoxicity. Other notable toxicities were weight loss and anemia.
Conclusions and Clinical Importance
Vinorelbine is tolerated in cats at a weekly interval. Recommended starting dosage is 11.5 mg/m2. Neutropenia was transient, lasting |
| doi_str_mv | 10.1111/jvim.12101 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_24P</sourceid><recordid>TN_cdi_proquest_miscellaneous_1400400195</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3067676809</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3951-921a82c7a27c3fd56d742aac14de85eb664d24e2e7eb4e820a95fd579d71b9773</originalsourceid><addsrcrecordid>eNp9kMtOwzAQRS0EouWx4QNQJDYIKWA7sR2LFVRQigp0USg7y0mm4JJHsRugf4-hjwULPNbM5szV6CB0QPAp8e9s8mHKU0IJJhuoTWQkQ8IF30RtnEgSch7jFtpxboIxZYyJbdSiEefUVxudD161g6AXdApTmUwXwdAa3-tx8GSq2kKRmgoCUwXDpqxteAnamuol6OiZ20NbY1042F_OXfR4fTXs3IT9h26vc9EPs0gyEkpKdEIzoanIonHOeC5iqnVG4hwSBqk_MKcxUBCQxpBQrCXzmJC5IKkUItpFx4vcqa3fG3AzVRqXQVHoCurGKRJj7D-RzKNHf9BJ3djKX6ci7KUInmDpqZMFldnaOQtjNbWm1HauCFY_StWPUvWr1MOHy8gmLSFfoyuHHiAL4NMUMP8nSt0-9e5WoeFix7gZfK13tH1TXESCqdF9Vw2GcXcQP49UP_oG15uNmw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3067676809</pqid></control><display><type>article</type><title>Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats</title><source>Wiley Online Library Open Access</source><creator>Pierro, J.A ; Mallett, C.L. ; Saba, C.F.</creator><creatorcontrib>Pierro, J.A ; Mallett, C.L. ; Saba, C.F.</creatorcontrib><description>Background
Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied.
Hypothesis/Objectives
To determine the maximal tolerated dose (MTD) and dose‐limiting toxicity (DLT) of VRL in tumor‐bearing cats.
Animals
Cats were included in this prospective phase I trial if they had confirmed malignancy, received ≥1 VRL treatment, and had adequate follow‐up. Previous treatment was acceptable, but concurrent chemotherapy or radiotherapy was not permitted.
Methods
Using a modified phase I design, cats were enrolled in cohorts of 3 at a starting dosage of 9 mg/m2. Cats tolerating the first treatment well were eligible to receive additional VRL treatments at escalating dosages; escalations beyond the perceived MTD were permitted based on individual tolerance. Intended treatment interval was 7 days. Patient histories, physical examinations, and complete blood counts were performed weekly.
Results
Nineteen cats were included. Sixty‐one VRL treatments were administered. Median number of treatments was 2 (range, 1–9). Starting dosages were 9–12 mg/m2. Maximal dosage administered was 15.5 mg/m2. The MTD was 11.5 mg/m2. Acute DLTs were neutropenia, vomiting, and nephrotoxicity. Other notable toxicities were weight loss and anemia.
Conclusions and Clinical Importance
Vinorelbine is tolerated in cats at a weekly interval. Recommended starting dosage is 11.5 mg/m2. Neutropenia was transient, lasting <7 days; vomiting was self‐limiting in most cases. Although VRL‐associated nephrotoxicity has not been reported, potential attribution of this toxicity to VRL must not be discounted. Further investigation of the efficacy of VRL in feline malignancies is warranted.</description><identifier>ISSN: 0891-6640</identifier><identifier>EISSN: 1939-1676</identifier><identifier>DOI: 10.1111/jvim.12101</identifier><identifier>PMID: 23662626</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Animals ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - therapeutic use ; Breast cancer ; Cancer ; Cancer therapies ; Carcinoma - drug therapy ; Carcinoma - veterinary ; Cat Diseases - drug therapy ; Cats ; Chemotherapy ; Clinical trials ; Dose-Response Relationship, Drug ; Feline ; Female ; Hematology ; Male ; Mastocytoma - drug therapy ; Mastocytoma - veterinary ; Metastasis ; Navelbine ; Oncology ; Sarcoma ; Sarcoma - drug therapy ; Sarcoma - veterinary ; Toxicity ; Vaccines ; Vinblastine - administration & dosage ; Vinblastine - analogs & derivatives ; Vinblastine - therapeutic use</subject><ispartof>Journal of veterinary internal medicine, 2013-07, Vol.27 (4), p.943-948</ispartof><rights>Copyright © 2013 by the American College of Veterinary Internal Medicine</rights><rights>Copyright © 2013 by the American College of Veterinary Internal Medicine.</rights><rights>2013. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3951-921a82c7a27c3fd56d742aac14de85eb664d24e2e7eb4e820a95fd579d71b9773</citedby><cites>FETCH-LOGICAL-c3951-921a82c7a27c3fd56d742aac14de85eb664d24e2e7eb4e820a95fd579d71b9773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjvim.12101$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjvim.12101$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,11562,27924,27925,45574,45575,46052,46476</link.rule.ids><linktorsrc>$$Uhttps://onlinelibrary.wiley.com/doi/abs/10.1111%2Fjvim.12101$$EView_record_in_Wiley-Blackwell$$FView_record_in_$$GWiley-Blackwell</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23662626$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pierro, J.A</creatorcontrib><creatorcontrib>Mallett, C.L.</creatorcontrib><creatorcontrib>Saba, C.F.</creatorcontrib><title>Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats</title><title>Journal of veterinary internal medicine</title><addtitle>J Vet Intern Med</addtitle><description>Background
Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied.
Hypothesis/Objectives
To determine the maximal tolerated dose (MTD) and dose‐limiting toxicity (DLT) of VRL in tumor‐bearing cats.
Animals
Cats were included in this prospective phase I trial if they had confirmed malignancy, received ≥1 VRL treatment, and had adequate follow‐up. Previous treatment was acceptable, but concurrent chemotherapy or radiotherapy was not permitted.
Methods
Using a modified phase I design, cats were enrolled in cohorts of 3 at a starting dosage of 9 mg/m2. Cats tolerating the first treatment well were eligible to receive additional VRL treatments at escalating dosages; escalations beyond the perceived MTD were permitted based on individual tolerance. Intended treatment interval was 7 days. Patient histories, physical examinations, and complete blood counts were performed weekly.
Results
Nineteen cats were included. Sixty‐one VRL treatments were administered. Median number of treatments was 2 (range, 1–9). Starting dosages were 9–12 mg/m2. Maximal dosage administered was 15.5 mg/m2. The MTD was 11.5 mg/m2. Acute DLTs were neutropenia, vomiting, and nephrotoxicity. Other notable toxicities were weight loss and anemia.
Conclusions and Clinical Importance
Vinorelbine is tolerated in cats at a weekly interval. Recommended starting dosage is 11.5 mg/m2. Neutropenia was transient, lasting <7 days; vomiting was self‐limiting in most cases. Although VRL‐associated nephrotoxicity has not been reported, potential attribution of this toxicity to VRL must not be discounted. Further investigation of the efficacy of VRL in feline malignancies is warranted.</description><subject>Animals</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Breast cancer</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Carcinoma - drug therapy</subject><subject>Carcinoma - veterinary</subject><subject>Cat Diseases - drug therapy</subject><subject>Cats</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Dose-Response Relationship, Drug</subject><subject>Feline</subject><subject>Female</subject><subject>Hematology</subject><subject>Male</subject><subject>Mastocytoma - drug therapy</subject><subject>Mastocytoma - veterinary</subject><subject>Metastasis</subject><subject>Navelbine</subject><subject>Oncology</subject><subject>Sarcoma</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - veterinary</subject><subject>Toxicity</subject><subject>Vaccines</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - analogs & derivatives</subject><subject>Vinblastine - therapeutic use</subject><issn>0891-6640</issn><issn>1939-1676</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtOwzAQRS0EouWx4QNQJDYIKWA7sR2LFVRQigp0USg7y0mm4JJHsRugf4-hjwULPNbM5szV6CB0QPAp8e9s8mHKU0IJJhuoTWQkQ8IF30RtnEgSch7jFtpxboIxZYyJbdSiEefUVxudD161g6AXdApTmUwXwdAa3-tx8GSq2kKRmgoCUwXDpqxteAnamuol6OiZ20NbY1042F_OXfR4fTXs3IT9h26vc9EPs0gyEkpKdEIzoanIonHOeC5iqnVG4hwSBqk_MKcxUBCQxpBQrCXzmJC5IKkUItpFx4vcqa3fG3AzVRqXQVHoCurGKRJj7D-RzKNHf9BJ3djKX6ci7KUInmDpqZMFldnaOQtjNbWm1HauCFY_StWPUvWr1MOHy8gmLSFfoyuHHiAL4NMUMP8nSt0-9e5WoeFix7gZfK13tH1TXESCqdF9Vw2GcXcQP49UP_oG15uNmw</recordid><startdate>201307</startdate><enddate>201307</enddate><creator>Pierro, J.A</creator><creator>Mallett, C.L.</creator><creator>Saba, C.F.</creator><general>Blackwell Publishing Ltd</general><general>John Wiley & Sons, Inc</general><scope>BSCLL</scope><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>K9.</scope><scope>7X8</scope></search><sort><creationdate>201307</creationdate><title>Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats</title><author>Pierro, J.A ; Mallett, C.L. ; Saba, C.F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3951-921a82c7a27c3fd56d742aac14de85eb664d24e2e7eb4e820a95fd579d71b9773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Animals</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Breast cancer</topic><topic>Cancer</topic><topic>Cancer therapies</topic><topic>Carcinoma - drug therapy</topic><topic>Carcinoma - veterinary</topic><topic>Cat Diseases - drug therapy</topic><topic>Cats</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Dose-Response Relationship, Drug</topic><topic>Feline</topic><topic>Female</topic><topic>Hematology</topic><topic>Male</topic><topic>Mastocytoma - drug therapy</topic><topic>Mastocytoma - veterinary</topic><topic>Metastasis</topic><topic>Navelbine</topic><topic>Oncology</topic><topic>Sarcoma</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - veterinary</topic><topic>Toxicity</topic><topic>Vaccines</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - analogs & derivatives</topic><topic>Vinblastine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pierro, J.A</creatorcontrib><creatorcontrib>Mallett, C.L.</creatorcontrib><creatorcontrib>Saba, C.F.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of veterinary internal medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Pierro, J.A</au><au>Mallett, C.L.</au><au>Saba, C.F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats</atitle><jtitle>Journal of veterinary internal medicine</jtitle><addtitle>J Vet Intern Med</addtitle><date>2013-07</date><risdate>2013</risdate><volume>27</volume><issue>4</issue><spage>943</spage><epage>948</epage><pages>943-948</pages><issn>0891-6640</issn><eissn>1939-1676</eissn><abstract>Background
Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied.
Hypothesis/Objectives
To determine the maximal tolerated dose (MTD) and dose‐limiting toxicity (DLT) of VRL in tumor‐bearing cats.
Animals
Cats were included in this prospective phase I trial if they had confirmed malignancy, received ≥1 VRL treatment, and had adequate follow‐up. Previous treatment was acceptable, but concurrent chemotherapy or radiotherapy was not permitted.
Methods
Using a modified phase I design, cats were enrolled in cohorts of 3 at a starting dosage of 9 mg/m2. Cats tolerating the first treatment well were eligible to receive additional VRL treatments at escalating dosages; escalations beyond the perceived MTD were permitted based on individual tolerance. Intended treatment interval was 7 days. Patient histories, physical examinations, and complete blood counts were performed weekly.
Results
Nineteen cats were included. Sixty‐one VRL treatments were administered. Median number of treatments was 2 (range, 1–9). Starting dosages were 9–12 mg/m2. Maximal dosage administered was 15.5 mg/m2. The MTD was 11.5 mg/m2. Acute DLTs were neutropenia, vomiting, and nephrotoxicity. Other notable toxicities were weight loss and anemia.
Conclusions and Clinical Importance
Vinorelbine is tolerated in cats at a weekly interval. Recommended starting dosage is 11.5 mg/m2. Neutropenia was transient, lasting <7 days; vomiting was self‐limiting in most cases. Although VRL‐associated nephrotoxicity has not been reported, potential attribution of this toxicity to VRL must not be discounted. Further investigation of the efficacy of VRL in feline malignancies is warranted.</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>23662626</pmid><doi>10.1111/jvim.12101</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of veterinary internal medicine, 2013-07, Vol.27 (4), p.943-948 |
| issn | 0891-6640 1939-1676 |
| language | eng |
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| subjects | Animals Antineoplastic Agents - administration & dosage Antineoplastic Agents - therapeutic use Breast cancer Cancer Cancer therapies Carcinoma - drug therapy Carcinoma - veterinary Cat Diseases - drug therapy Cats Chemotherapy Clinical trials Dose-Response Relationship, Drug Feline Female Hematology Male Mastocytoma - drug therapy Mastocytoma - veterinary Metastasis Navelbine Oncology Sarcoma Sarcoma - drug therapy Sarcoma - veterinary Toxicity Vaccines Vinblastine - administration & dosage Vinblastine - analogs & derivatives Vinblastine - therapeutic use |
| title | Phase I Clinical Trial of Vinorelbine in Tumor-Bearing Cats |
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