Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer
Summary Background Nanoparticle albumin-bound paclitaxel ( nab -paclitaxel) is a Cremophor EL–free formulation of paclitaxel newly designed to avoid solvent-related toxicities. We have evaluated the safety, tolerability, pharmacokinetics, and tumor response profile of weekly nab -paclitaxel (100 mg/...
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| Veröffentlicht in: | Investigational new drugs 2012-06, Vol.30 (3), p.1132-1137 |
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| creator | Okamoto, Isamu Yamamoto, Nobuyuki Kubota, Kaoru Ohe, Yuichiro Nogami, Naoyuki Murakami, Haruyasu Yamaya, Hidetoshi Ono, Katsuhiro Nakagawa, Kazuhiko |
| description | Summary
Background
Nanoparticle albumin-bound paclitaxel (
nab
-paclitaxel) is a Cremophor EL–free formulation of paclitaxel newly designed to avoid solvent-related toxicities. We have evaluated the safety, tolerability, pharmacokinetics, and tumor response profile of weekly
nab
-paclitaxel (100 mg/m
2
) infusion together with administration of carboplatin at an area under the curve (AUC) of 6 every 3 weeks in Japanese patients with advanced non–small cell lung cancer (NSCLC).
Methods Nab
-paclitaxel (100 mg/m
2
) was administered without steroid or antihistamine premedication as a 30-min intravenous infusion once a week in combination with carboplatin at an AUC of 6 on day 1 of repeated 21-day cycles. The pharmacokinetics of both drugs were analyzed, and both adverse events and treatment response were monitored.
Results
Eighteen patients were enrolled in the study. The most frequent treatment-related toxicities of grade 3 or 4 were neutropenia (67%), leukopenia (50%), and anemia (22%). No severe hypersensitivity reactions were observed despite the lack of premedication, and no unexpected or new toxicities were detected. Pharmacokinetics analysis did not reveal any substantial drug-drug interactions. Seven partial responses were observed among the 18 evaluable patients, yielding a treatment response rate of 38.9%.
Conclusions
The combination of
nab
-paclitaxel (100 mg/m
2
) administered weekly and carboplatin at an AUC of 6 every 3 weeks was well tolerated in Japanese patients with advanced NSCLC. This combination therapy also showed promising antitumor activity and was not associated with relevant pharmacokinetic interactions. |
| doi_str_mv | 10.1007/s10637-011-9674-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1112133691</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2789240291</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-b0e45c659f8ef68ae70d9e2a28a4029ee8879d596db96dc0f50160c077435e0b3</originalsourceid><addsrcrecordid>eNp1UUuO1TAQtBCIeQwcgA2yxNrQjhM7XqIRP2kkFsDa6jideRkSJ9jODG_HCdhwEA7BTTgJHr0BsUHqz6Kqq6Quxh5LeCYBzPMkQSsjQEphtamFvcN2sjFKgK71XbYDqY3Q1poT9iClSwBQ1tT32UklG2XaVu_Yt_c4UD5wDD1f9xhn9MunMVAePU956w98GXjATqzopzHjF5r4Om2Je4zdsk6Yx8BL-T3NS95TxPUgAv78cUV8LSCFnPj1mPcc-ysMnnoelvDr6_c04zRxT2VMW7goegWMD9m9AadEj273Kfv46uWHszfi_N3rt2cvzoVXpsqiA6obrxs7tDToFslAb6nCqsUaKkvUtsb2jdV9V9rD0JRXgAdjatUQdOqUPT3qrnH5vFHK7nLZYiiWTkpZSaW0lYUljywfl5QiDW6N44zx4CS4mwTcMQFXEnA3CThbbp7cKm_dTP3fiz8vL4TqSEgFChcU_7H-r-pvJ2aVhw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1112133691</pqid></control><display><type>article</type><title>Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Okamoto, Isamu ; Yamamoto, Nobuyuki ; Kubota, Kaoru ; Ohe, Yuichiro ; Nogami, Naoyuki ; Murakami, Haruyasu ; Yamaya, Hidetoshi ; Ono, Katsuhiro ; Nakagawa, Kazuhiko</creator><creatorcontrib>Okamoto, Isamu ; Yamamoto, Nobuyuki ; Kubota, Kaoru ; Ohe, Yuichiro ; Nogami, Naoyuki ; Murakami, Haruyasu ; Yamaya, Hidetoshi ; Ono, Katsuhiro ; Nakagawa, Kazuhiko</creatorcontrib><description>Summary
Background
Nanoparticle albumin-bound paclitaxel (
nab
-paclitaxel) is a Cremophor EL–free formulation of paclitaxel newly designed to avoid solvent-related toxicities. We have evaluated the safety, tolerability, pharmacokinetics, and tumor response profile of weekly
nab
-paclitaxel (100 mg/m
2
) infusion together with administration of carboplatin at an area under the curve (AUC) of 6 every 3 weeks in Japanese patients with advanced non–small cell lung cancer (NSCLC).
Methods Nab
-paclitaxel (100 mg/m
2
) was administered without steroid or antihistamine premedication as a 30-min intravenous infusion once a week in combination with carboplatin at an AUC of 6 on day 1 of repeated 21-day cycles. The pharmacokinetics of both drugs were analyzed, and both adverse events and treatment response were monitored.
Results
Eighteen patients were enrolled in the study. The most frequent treatment-related toxicities of grade 3 or 4 were neutropenia (67%), leukopenia (50%), and anemia (22%). No severe hypersensitivity reactions were observed despite the lack of premedication, and no unexpected or new toxicities were detected. Pharmacokinetics analysis did not reveal any substantial drug-drug interactions. Seven partial responses were observed among the 18 evaluable patients, yielding a treatment response rate of 38.9%.
Conclusions
The combination of
nab
-paclitaxel (100 mg/m
2
) administered weekly and carboplatin at an AUC of 6 every 3 weeks was well tolerated in Japanese patients with advanced NSCLC. This combination therapy also showed promising antitumor activity and was not associated with relevant pharmacokinetic interactions.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-011-9674-9</identifier><identifier>PMID: 21537886</identifier><identifier>CODEN: INNDDK</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Adult ; Aged ; Albumins - administration & dosage ; Albumins - adverse effects ; Albumins - pharmacokinetics ; Alopecia ; Anemia ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics ; Area Under Curve ; Asian Continental Ancestry Group ; Baldness ; Cancer therapies ; Carboplatin - administration & dosage ; Carboplatin - adverse effects ; Carboplatin - pharmacokinetics ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - metabolism ; Chemotherapy ; Drug dosages ; Female ; Histamine ; Hospitals ; Humans ; Leukopenia ; Lung cancer ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Nanoparticles ; Neutropenia ; Oncology ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Paclitaxel - pharmacokinetics ; Patient safety ; Peripheral neuropathy ; Pharmacokinetics ; Pharmacology ; Pharmacology/Toxicology ; Phase I Studies ; Response rates ; Solvents ; Steroids ; Studies ; Tumors</subject><ispartof>Investigational new drugs, 2012-06, Vol.30 (3), p.1132-1137</ispartof><rights>Springer Science+Business Media, LLC 2011</rights><rights>Springer Science+Business Media, LLC 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-b0e45c659f8ef68ae70d9e2a28a4029ee8879d596db96dc0f50160c077435e0b3</citedby><cites>FETCH-LOGICAL-c372t-b0e45c659f8ef68ae70d9e2a28a4029ee8879d596db96dc0f50160c077435e0b3</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/s10637-011-9674-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-011-9674-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21537886$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Okamoto, Isamu</creatorcontrib><creatorcontrib>Yamamoto, Nobuyuki</creatorcontrib><creatorcontrib>Kubota, Kaoru</creatorcontrib><creatorcontrib>Ohe, Yuichiro</creatorcontrib><creatorcontrib>Nogami, Naoyuki</creatorcontrib><creatorcontrib>Murakami, Haruyasu</creatorcontrib><creatorcontrib>Yamaya, Hidetoshi</creatorcontrib><creatorcontrib>Ono, Katsuhiro</creatorcontrib><creatorcontrib>Nakagawa, Kazuhiko</creatorcontrib><title>Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Background
Nanoparticle albumin-bound paclitaxel (
nab
-paclitaxel) is a Cremophor EL–free formulation of paclitaxel newly designed to avoid solvent-related toxicities. We have evaluated the safety, tolerability, pharmacokinetics, and tumor response profile of weekly
nab
-paclitaxel (100 mg/m
2
) infusion together with administration of carboplatin at an area under the curve (AUC) of 6 every 3 weeks in Japanese patients with advanced non–small cell lung cancer (NSCLC).
Methods Nab
-paclitaxel (100 mg/m
2
) was administered without steroid or antihistamine premedication as a 30-min intravenous infusion once a week in combination with carboplatin at an AUC of 6 on day 1 of repeated 21-day cycles. The pharmacokinetics of both drugs were analyzed, and both adverse events and treatment response were monitored.
Results
Eighteen patients were enrolled in the study. The most frequent treatment-related toxicities of grade 3 or 4 were neutropenia (67%), leukopenia (50%), and anemia (22%). No severe hypersensitivity reactions were observed despite the lack of premedication, and no unexpected or new toxicities were detected. Pharmacokinetics analysis did not reveal any substantial drug-drug interactions. Seven partial responses were observed among the 18 evaluable patients, yielding a treatment response rate of 38.9%.
Conclusions
The combination of
nab
-paclitaxel (100 mg/m
2
) administered weekly and carboplatin at an AUC of 6 every 3 weeks was well tolerated in Japanese patients with advanced NSCLC. This combination therapy also showed promising antitumor activity and was not associated with relevant pharmacokinetic interactions.</description><subject>Adult</subject><subject>Aged</subject><subject>Albumins - administration & dosage</subject><subject>Albumins - adverse effects</subject><subject>Albumins - pharmacokinetics</subject><subject>Alopecia</subject><subject>Anemia</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</subject><subject>Area Under Curve</subject><subject>Asian Continental Ancestry Group</subject><subject>Baldness</subject><subject>Cancer therapies</subject><subject>Carboplatin - administration & dosage</subject><subject>Carboplatin - adverse effects</subject><subject>Carboplatin - pharmacokinetics</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - metabolism</subject><subject>Chemotherapy</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Histamine</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Leukopenia</subject><subject>Lung cancer</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nanoparticles</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Paclitaxel - pharmacokinetics</subject><subject>Patient safety</subject><subject>Peripheral neuropathy</subject><subject>Pharmacokinetics</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Phase I Studies</subject><subject>Response rates</subject><subject>Solvents</subject><subject>Steroids</subject><subject>Studies</subject><subject>Tumors</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</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>eNp1UUuO1TAQtBCIeQwcgA2yxNrQjhM7XqIRP2kkFsDa6jideRkSJ9jODG_HCdhwEA7BTTgJHr0BsUHqz6Kqq6Quxh5LeCYBzPMkQSsjQEphtamFvcN2sjFKgK71XbYDqY3Q1poT9iClSwBQ1tT32UklG2XaVu_Yt_c4UD5wDD1f9xhn9MunMVAePU956w98GXjATqzopzHjF5r4Om2Je4zdsk6Yx8BL-T3NS95TxPUgAv78cUV8LSCFnPj1mPcc-ysMnnoelvDr6_c04zRxT2VMW7goegWMD9m9AadEj273Kfv46uWHszfi_N3rt2cvzoVXpsqiA6obrxs7tDToFslAb6nCqsUaKkvUtsb2jdV9V9rD0JRXgAdjatUQdOqUPT3qrnH5vFHK7nLZYiiWTkpZSaW0lYUljywfl5QiDW6N44zx4CS4mwTcMQFXEnA3CThbbp7cKm_dTP3fiz8vL4TqSEgFChcU_7H-r-pvJ2aVhw</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>Okamoto, Isamu</creator><creator>Yamamoto, Nobuyuki</creator><creator>Kubota, Kaoru</creator><creator>Ohe, Yuichiro</creator><creator>Nogami, Naoyuki</creator><creator>Murakami, Haruyasu</creator><creator>Yamaya, Hidetoshi</creator><creator>Ono, Katsuhiro</creator><creator>Nakagawa, Kazuhiko</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></search><sort><creationdate>20120601</creationdate><title>Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer</title><author>Okamoto, Isamu ; Yamamoto, Nobuyuki ; Kubota, Kaoru ; Ohe, Yuichiro ; Nogami, Naoyuki ; Murakami, Haruyasu ; Yamaya, Hidetoshi ; Ono, Katsuhiro ; Nakagawa, Kazuhiko</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-b0e45c659f8ef68ae70d9e2a28a4029ee8879d596db96dc0f50160c077435e0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Albumins - administration & dosage</topic><topic>Albumins - adverse effects</topic><topic>Albumins - pharmacokinetics</topic><topic>Alopecia</topic><topic>Anemia</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</topic><topic>Area Under Curve</topic><topic>Asian Continental Ancestry Group</topic><topic>Baldness</topic><topic>Cancer therapies</topic><topic>Carboplatin - administration & dosage</topic><topic>Carboplatin - adverse effects</topic><topic>Carboplatin - pharmacokinetics</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - metabolism</topic><topic>Chemotherapy</topic><topic>Drug dosages</topic><topic>Female</topic><topic>Histamine</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Leukopenia</topic><topic>Lung cancer</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nanoparticles</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Paclitaxel - pharmacokinetics</topic><topic>Patient safety</topic><topic>Peripheral neuropathy</topic><topic>Pharmacokinetics</topic><topic>Pharmacology</topic><topic>Pharmacology/Toxicology</topic><topic>Phase I Studies</topic><topic>Response rates</topic><topic>Solvents</topic><topic>Steroids</topic><topic>Studies</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Okamoto, Isamu</creatorcontrib><creatorcontrib>Yamamoto, Nobuyuki</creatorcontrib><creatorcontrib>Kubota, Kaoru</creatorcontrib><creatorcontrib>Ohe, Yuichiro</creatorcontrib><creatorcontrib>Nogami, Naoyuki</creatorcontrib><creatorcontrib>Murakami, Haruyasu</creatorcontrib><creatorcontrib>Yamaya, Hidetoshi</creatorcontrib><creatorcontrib>Ono, Katsuhiro</creatorcontrib><creatorcontrib>Nakagawa, Kazuhiko</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>Nursing & Allied Health Database</collection><collection>Access via ABI/INFORM (ProQuest)</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</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 Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</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 (Alumni Edition)</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>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>ProQuest One Business</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><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Okamoto, Isamu</au><au>Yamamoto, Nobuyuki</au><au>Kubota, Kaoru</au><au>Ohe, Yuichiro</au><au>Nogami, Naoyuki</au><au>Murakami, Haruyasu</au><au>Yamaya, Hidetoshi</au><au>Ono, Katsuhiro</au><au>Nakagawa, Kazuhiko</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2012-06-01</date><risdate>2012</risdate><volume>30</volume><issue>3</issue><spage>1132</spage><epage>1137</epage><pages>1132-1137</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><coden>INNDDK</coden><abstract>Summary
Background
Nanoparticle albumin-bound paclitaxel (
nab
-paclitaxel) is a Cremophor EL–free formulation of paclitaxel newly designed to avoid solvent-related toxicities. We have evaluated the safety, tolerability, pharmacokinetics, and tumor response profile of weekly
nab
-paclitaxel (100 mg/m
2
) infusion together with administration of carboplatin at an area under the curve (AUC) of 6 every 3 weeks in Japanese patients with advanced non–small cell lung cancer (NSCLC).
Methods Nab
-paclitaxel (100 mg/m
2
) was administered without steroid or antihistamine premedication as a 30-min intravenous infusion once a week in combination with carboplatin at an AUC of 6 on day 1 of repeated 21-day cycles. The pharmacokinetics of both drugs were analyzed, and both adverse events and treatment response were monitored.
Results
Eighteen patients were enrolled in the study. The most frequent treatment-related toxicities of grade 3 or 4 were neutropenia (67%), leukopenia (50%), and anemia (22%). No severe hypersensitivity reactions were observed despite the lack of premedication, and no unexpected or new toxicities were detected. Pharmacokinetics analysis did not reveal any substantial drug-drug interactions. Seven partial responses were observed among the 18 evaluable patients, yielding a treatment response rate of 38.9%.
Conclusions
The combination of
nab
-paclitaxel (100 mg/m
2
) administered weekly and carboplatin at an AUC of 6 every 3 weeks was well tolerated in Japanese patients with advanced NSCLC. This combination therapy also showed promising antitumor activity and was not associated with relevant pharmacokinetic interactions.</abstract><cop>Boston</cop><pub>Springer US</pub><pmid>21537886</pmid><doi>10.1007/s10637-011-9674-9</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6997 |
| ispartof | Investigational new drugs, 2012-06, Vol.30 (3), p.1132-1137 |
| issn | 0167-6997 1573-0646 |
| language | eng |
| recordid | cdi_proquest_journals_1112133691 |
| source | MEDLINE; SpringerNature Journals |
| subjects | Adult Aged Albumins - administration & dosage Albumins - adverse effects Albumins - pharmacokinetics Alopecia Anemia Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics Area Under Curve Asian Continental Ancestry Group Baldness Cancer therapies Carboplatin - administration & dosage Carboplatin - adverse effects Carboplatin - pharmacokinetics Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - metabolism Chemotherapy Drug dosages Female Histamine Hospitals Humans Leukopenia Lung cancer Male Medicine Medicine & Public Health Middle Aged Nanoparticles Neutropenia Oncology Paclitaxel - administration & dosage Paclitaxel - adverse effects Paclitaxel - pharmacokinetics Patient safety Peripheral neuropathy Pharmacokinetics Pharmacology Pharmacology/Toxicology Phase I Studies Response rates Solvents Steroids Studies Tumors |
| title | Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non–small cell lung cancer |
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