Paclitaxel and UFT plus oral calcium folinate in pretreated metastatic breast cancer
This phase I study was designed to determine the maximum tolerated dose (MTD) and dose-limiting side effects of combination treatment with paclitaxel (Taxol) and UFT (uracil and tegafur in a 4:1 molar ratio) plus oral calcium folinate (Orzel) for advanced metastatic breast cancer. After premedicatio...
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| Veröffentlicht in: | Oncology (Williston Park, N.Y.) N.Y.), 1999-07, Vol.13 (7 Suppl 3), p.71 |
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| container_issue | 7 Suppl 3 |
| container_start_page | 71 |
| container_title | Oncology (Williston Park, N.Y.) |
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| creator | Klaassen, U Borquez, D Lang, S Oberhoff, C Harstrick, A Seeber, S Benner, S |
| description | This phase I study was designed to determine the maximum tolerated dose (MTD) and dose-limiting side effects of combination treatment with paclitaxel (Taxol) and UFT (uracil and tegafur in a 4:1 molar ratio) plus oral calcium folinate (Orzel) for advanced metastatic breast cancer. After premedication, patients received paclitaxel as a 3-hour IV infusion (175 mg/m2) on day 1; UFT was administered orally at 300 mg/day (dose level 1), 400 mg/day (dose level 2), 500 mg/day (dose level 3), or 600 mg/day (dose level 4) in combination with 90 mg/day of calcium folinate in three divided doses for 14 days. Twenty patients with pretreated metastatic breast cancer have entered the trial so far. The main toxicity was neutropenia, occurring in 68% of patients. World Health Organization grades 1 and 2 peripheral neuropathy, arthralgia, and myalgia were common but not dose-limiting. All patients had grade 3 alopecia due to paclitaxel. One of six patients treated at dose level 4 experienced a dose-limiting toxicity with neutropenic fever. But within four dose levels MTD was not reached, and the study will continue to accrue patients to dose level 5. Objective responses were observed at all dose levels. In conclusion, the combination of paclitaxel and UFT plus oral calcium folinate seems to be a convenient and effective regimen for patients with pretreated metastatic breast cancer. Phase I is ongoing in order to determine MTD and the recommended dose for phase II testing. |
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After premedication, patients received paclitaxel as a 3-hour IV infusion (175 mg/m2) on day 1; UFT was administered orally at 300 mg/day (dose level 1), 400 mg/day (dose level 2), 500 mg/day (dose level 3), or 600 mg/day (dose level 4) in combination with 90 mg/day of calcium folinate in three divided doses for 14 days. Twenty patients with pretreated metastatic breast cancer have entered the trial so far. The main toxicity was neutropenia, occurring in 68% of patients. World Health Organization grades 1 and 2 peripheral neuropathy, arthralgia, and myalgia were common but not dose-limiting. All patients had grade 3 alopecia due to paclitaxel. One of six patients treated at dose level 4 experienced a dose-limiting toxicity with neutropenic fever. But within four dose levels MTD was not reached, and the study will continue to accrue patients to dose level 5. Objective responses were observed at all dose levels. In conclusion, the combination of paclitaxel and UFT plus oral calcium folinate seems to be a convenient and effective regimen for patients with pretreated metastatic breast cancer. 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After premedication, patients received paclitaxel as a 3-hour IV infusion (175 mg/m2) on day 1; UFT was administered orally at 300 mg/day (dose level 1), 400 mg/day (dose level 2), 500 mg/day (dose level 3), or 600 mg/day (dose level 4) in combination with 90 mg/day of calcium folinate in three divided doses for 14 days. Twenty patients with pretreated metastatic breast cancer have entered the trial so far. The main toxicity was neutropenia, occurring in 68% of patients. World Health Organization grades 1 and 2 peripheral neuropathy, arthralgia, and myalgia were common but not dose-limiting. All patients had grade 3 alopecia due to paclitaxel. One of six patients treated at dose level 4 experienced a dose-limiting toxicity with neutropenic fever. But within four dose levels MTD was not reached, and the study will continue to accrue patients to dose level 5. Objective responses were observed at all dose levels. In conclusion, the combination of paclitaxel and UFT plus oral calcium folinate seems to be a convenient and effective regimen for patients with pretreated metastatic breast cancer. Phase I is ongoing in order to determine MTD and the recommended dose for phase II testing.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Dexamethasone - therapeutic use</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Leucovorin - administration & dosage</subject><subject>Leucovorin - therapeutic use</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - therapeutic use</subject><subject>Premedication</subject><subject>Tegafur - administration & dosage</subject><subject>Tegafur - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Uracil - administration & dosage</subject><subject>Uracil - therapeutic use</subject><issn>0890-9091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1j9FKxDAURPOguOvqL0h-oHDbJk3zKIurwsL60H1ebm4SiKTdkqSgf29BhYFhDszA3LAt9BoqDbresPucPwGaroP-jm1qEKJpO7VlwwdSDAW_XOQ4WX4-DHyOS-bXhJETRgrLyP01hgmL42Hic3IluTVYPrqCuWAJxM2KclkLE7n0wG49xuwe_3zHzoeXYf9WHU-v7_vnYzU3oEolVS-1EbZG79HqVSDJG5RGEQioe9JWkdeaRCOM7LVHr4HAaum0VNTu2NPv7ryY0dnLnMKI6fvyf6_9ATTMTGI</recordid><startdate>19990701</startdate><enddate>19990701</enddate><creator>Klaassen, U</creator><creator>Borquez, D</creator><creator>Lang, S</creator><creator>Oberhoff, C</creator><creator>Harstrick, A</creator><creator>Seeber, S</creator><creator>Benner, S</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>19990701</creationdate><title>Paclitaxel and UFT plus oral calcium folinate in pretreated metastatic breast cancer</title><author>Klaassen, U ; Borquez, D ; Lang, S ; Oberhoff, C ; Harstrick, A ; Seeber, S ; Benner, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p207t-57859b4d1affad9ad905cfba5b7c04018c9d7cf99c424b589faf90c0d95e957c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Agents, Hormonal - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Dexamethasone - therapeutic use</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Leucovorin - administration & dosage</topic><topic>Leucovorin - therapeutic use</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - therapeutic use</topic><topic>Premedication</topic><topic>Tegafur - administration & dosage</topic><topic>Tegafur - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Uracil - administration & dosage</topic><topic>Uracil - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Klaassen, U</creatorcontrib><creatorcontrib>Borquez, D</creatorcontrib><creatorcontrib>Lang, S</creatorcontrib><creatorcontrib>Oberhoff, C</creatorcontrib><creatorcontrib>Harstrick, A</creatorcontrib><creatorcontrib>Seeber, S</creatorcontrib><creatorcontrib>Benner, S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Oncology (Williston Park, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Klaassen, U</au><au>Borquez, D</au><au>Lang, S</au><au>Oberhoff, C</au><au>Harstrick, A</au><au>Seeber, S</au><au>Benner, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Paclitaxel and UFT plus oral calcium folinate in pretreated metastatic breast cancer</atitle><jtitle>Oncology (Williston Park, N.Y.)</jtitle><addtitle>Oncology (Williston Park)</addtitle><date>1999-07-01</date><risdate>1999</risdate><volume>13</volume><issue>7 Suppl 3</issue><spage>71</spage><pages>71-</pages><issn>0890-9091</issn><abstract>This phase I study was designed to determine the maximum tolerated dose (MTD) and dose-limiting side effects of combination treatment with paclitaxel (Taxol) and UFT (uracil and tegafur in a 4:1 molar ratio) plus oral calcium folinate (Orzel) for advanced metastatic breast cancer. After premedication, patients received paclitaxel as a 3-hour IV infusion (175 mg/m2) on day 1; UFT was administered orally at 300 mg/day (dose level 1), 400 mg/day (dose level 2), 500 mg/day (dose level 3), or 600 mg/day (dose level 4) in combination with 90 mg/day of calcium folinate in three divided doses for 14 days. Twenty patients with pretreated metastatic breast cancer have entered the trial so far. The main toxicity was neutropenia, occurring in 68% of patients. World Health Organization grades 1 and 2 peripheral neuropathy, arthralgia, and myalgia were common but not dose-limiting. All patients had grade 3 alopecia due to paclitaxel. One of six patients treated at dose level 4 experienced a dose-limiting toxicity with neutropenic fever. But within four dose levels MTD was not reached, and the study will continue to accrue patients to dose level 5. Objective responses were observed at all dose levels. In conclusion, the combination of paclitaxel and UFT plus oral calcium folinate seems to be a convenient and effective regimen for patients with pretreated metastatic breast cancer. Phase I is ongoing in order to determine MTD and the recommended dose for phase II testing.</abstract><cop>United States</cop><pmid>10442367</pmid></addata></record> |
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| identifier | ISSN: 0890-9091 |
| ispartof | Oncology (Williston Park, N.Y.), 1999-07, Vol.13 (7 Suppl 3), p.71 |
| issn | 0890-9091 |
| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals |
| subjects | Administration, Oral Adult Aged Antineoplastic Agents, Hormonal - therapeutic use Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast Neoplasms - drug therapy Dexamethasone - therapeutic use Female Follow-Up Studies Humans Leucovorin - administration & dosage Leucovorin - therapeutic use Middle Aged Neoplasm Metastasis Paclitaxel - administration & dosage Paclitaxel - therapeutic use Premedication Tegafur - administration & dosage Tegafur - therapeutic use Treatment Outcome Uracil - administration & dosage Uracil - therapeutic use |
| title | Paclitaxel and UFT plus oral calcium folinate in pretreated metastatic breast cancer |
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