High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study
A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of c...
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| Veröffentlicht in: | Tumori 1999-07, Vol.85 (4), p.234-238 |
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| creator | Roth, A Kolaric, K Zupanc, D Oresic, V Roth, A Ebling, Z |
| description | A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination.
A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228).
In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P |
| doi_str_mv | 10.1177/030089169908500404 |
| format | Article |
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A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228).
In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P<0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered.
The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.</description><identifier>ISSN: 0300-8916</identifier><identifier>EISSN: 2038-2529</identifier><identifier>DOI: 10.1177/030089169908500404</identifier><identifier>PMID: 10587023</identifier><language>eng</language><publisher>United States</publisher><subject>Antibiotics, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cisplatin - administration & dosage ; Drug Administration Schedule ; Epirubicin - administration & dosage ; Female ; Fluorouracil - administration & dosage ; Humans ; Male ; Middle Aged ; Proportional Hazards Models ; Prospective Studies ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - pathology ; Survival Analysis ; Treatment Outcome</subject><ispartof>Tumori, 1999-07, Vol.85 (4), p.234-238</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c299t-e8b809daed4d128e98802744e32f47ec64ce04ac4416375fac8c0347c6484e623</citedby><cites>FETCH-LOGICAL-c299t-e8b809daed4d128e98802744e32f47ec64ce04ac4416375fac8c0347c6484e623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10587023$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roth, A</creatorcontrib><creatorcontrib>Kolaric, K</creatorcontrib><creatorcontrib>Zupanc, D</creatorcontrib><creatorcontrib>Oresic, V</creatorcontrib><creatorcontrib>Roth, A</creatorcontrib><creatorcontrib>Ebling, Z</creatorcontrib><title>High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study</title><title>Tumori</title><addtitle>Tumori</addtitle><description>A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination.
A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228).
In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P<0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered.
The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.</description><subject>Antibiotics, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cisplatin - administration & dosage</subject><subject>Drug Administration Schedule</subject><subject>Epirubicin - administration & dosage</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - pathology</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0300-8916</issn><issn>2038-2529</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkM1KAzEUhYMotlZfwIXkBUZvfmaSuJNirVBwo-shTTJtZNoMSUapT--MdSEIFw6X75yzOAhdE7glRIg7YABSkUopkCUAB36CphSYLGhJ1SmajoZidEzQRUrvo4VW1TmaECilAMqmKC_9ZottSC7h0OCyaNo-xNBHbXyL9d5i1_nYr73xe_zp8xaH-KOhz9j41LU6D2Q4bT_03jiLNzrl6A024xvvscZx6Ak7_zXAlHt7uERnjW6Tu_rVGXpbPL7Ol8Xq5el5_rAqDFUqF06uJSirneWWUOmUlEAF547RhgtnKm4ccG04JxUTZaONNMC4GIDkrqJshuix18SQUnRN3UW_0_FQE6jHCev_Ew6hm2Oo69c7Z_9Ejpuxb5X-bP0</recordid><startdate>19990701</startdate><enddate>19990701</enddate><creator>Roth, A</creator><creator>Kolaric, K</creator><creator>Zupanc, D</creator><creator>Oresic, V</creator><creator>Roth, A</creator><creator>Ebling, Z</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>19990701</creationdate><title>High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study</title><author>Roth, A ; Kolaric, K ; Zupanc, D ; Oresic, V ; Roth, A ; Ebling, Z</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c299t-e8b809daed4d128e98802744e32f47ec64ce04ac4416375fac8c0347c6484e623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Antibiotics, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cisplatin - administration & dosage</topic><topic>Drug Administration Schedule</topic><topic>Epirubicin - administration & dosage</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - pathology</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roth, A</creatorcontrib><creatorcontrib>Kolaric, K</creatorcontrib><creatorcontrib>Zupanc, D</creatorcontrib><creatorcontrib>Oresic, V</creatorcontrib><creatorcontrib>Roth, A</creatorcontrib><creatorcontrib>Ebling, Z</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Tumori</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roth, A</au><au>Kolaric, K</au><au>Zupanc, D</au><au>Oresic, V</au><au>Roth, A</au><au>Ebling, Z</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study</atitle><jtitle>Tumori</jtitle><addtitle>Tumori</addtitle><date>1999-07-01</date><risdate>1999</risdate><volume>85</volume><issue>4</issue><spage>234</spage><epage>238</epage><pages>234-238</pages><issn>0300-8916</issn><eissn>2038-2529</eissn><abstract>A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination.
A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228).
In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P<0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered.
The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.</abstract><cop>United States</cop><pmid>10587023</pmid><doi>10.1177/030089169908500404</doi><tpages>5</tpages></addata></record> |
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| subjects | Antibiotics, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cisplatin - administration & dosage Drug Administration Schedule Epirubicin - administration & dosage Female Fluorouracil - administration & dosage Humans Male Middle Aged Proportional Hazards Models Prospective Studies Stomach Neoplasms - drug therapy Stomach Neoplasms - pathology Survival Analysis Treatment Outcome |
| title | High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study |
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