Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer
The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN α-2b, doxorubicin, Adriamycin, and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder carcinoma and 22 cholangiocarcinoma) with...
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| Veröffentlicht in: | Clinical cancer research 2001-11, Vol.7 (11), p.3375-3380 |
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| creator | PATT, Yehuda Z HASSAN, Manal M SCHNIRER, Isac I RAIJMAN, Isaac LOZANO, Richard D WAUGH, Kimberly A HOQUE, Ashraful M FROME, Adam I LAHOTI, Sandeep ELLIS, Lee VAUTHEY, J. Nicolas CURLEY, Steven A |
| description | The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN α-2b, doxorubicin, Adriamycin,
and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder
carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting
chemotherapy doses were as follows: cisplatin, 80 mg/m 2 i.v. over 2 h; doxorubicin, 40 mg/m 2 i.v. over 2 h; and 5-fluorouracil, 500 mg/m 2 by continuous infusion daily for 3 days. IFN α-2b (5 × 10 6 units/m 2 ) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was
21.1% [95% confidence interval (CI), 10–37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates
were 9.5% (95% CI, 1–32%) and 35.3% (95% CI, 14–62%), respectively. Overall median survival time was 14 months (95% CI, 9.5–18.5),
18.1 months (95% CI, 12.1–24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9–17.1) for the gallbladder
carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia
(41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more
active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore,
this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma,
particularly among patients who were refractory to higher priority investigational agents. |
| format | Article |
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and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder
carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting
chemotherapy doses were as follows: cisplatin, 80 mg/m 2 i.v. over 2 h; doxorubicin, 40 mg/m 2 i.v. over 2 h; and 5-fluorouracil, 500 mg/m 2 by continuous infusion daily for 3 days. IFN α-2b (5 × 10 6 units/m 2 ) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was
21.1% [95% confidence interval (CI), 10–37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates
were 9.5% (95% CI, 1–32%) and 35.3% (95% CI, 14–62%), respectively. Overall median survival time was 14 months (95% CI, 9.5–18.5),
18.1 months (95% CI, 12.1–24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9–17.1) for the gallbladder
carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia
(41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more
active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore,
this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma,
particularly among patients who were refractory to higher priority investigational agents.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>PMID: 11705850</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Antineoplastic agents ; Biological and medical sciences ; Chemotherapy ; Medical sciences ; Pharmacology. Drug treatments</subject><ispartof>Clinical cancer research, 2001-11, Vol.7 (11), p.3375-3380</ispartof><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14095345$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>PATT, Yehuda Z</creatorcontrib><creatorcontrib>HASSAN, Manal M</creatorcontrib><creatorcontrib>SCHNIRER, Isac I</creatorcontrib><creatorcontrib>RAIJMAN, Isaac</creatorcontrib><creatorcontrib>LOZANO, Richard D</creatorcontrib><creatorcontrib>WAUGH, Kimberly A</creatorcontrib><creatorcontrib>HOQUE, Ashraful M</creatorcontrib><creatorcontrib>FROME, Adam I</creatorcontrib><creatorcontrib>LAHOTI, Sandeep</creatorcontrib><creatorcontrib>ELLIS, Lee</creatorcontrib><creatorcontrib>VAUTHEY, J. Nicolas</creatorcontrib><creatorcontrib>CURLEY, Steven A</creatorcontrib><title>Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer</title><title>Clinical cancer research</title><description>The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN α-2b, doxorubicin, Adriamycin,
and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder
carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting
chemotherapy doses were as follows: cisplatin, 80 mg/m 2 i.v. over 2 h; doxorubicin, 40 mg/m 2 i.v. over 2 h; and 5-fluorouracil, 500 mg/m 2 by continuous infusion daily for 3 days. IFN α-2b (5 × 10 6 units/m 2 ) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was
21.1% [95% confidence interval (CI), 10–37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates
were 9.5% (95% CI, 1–32%) and 35.3% (95% CI, 14–62%), respectively. Overall median survival time was 14 months (95% CI, 9.5–18.5),
18.1 months (95% CI, 12.1–24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9–17.1) for the gallbladder
carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia
(41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more
active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore,
this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma,
particularly among patients who were refractory to higher priority investigational agents.</description><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><recordid>eNotT0tOwzAUtBCIlsIdvEFi0Uh-sV03SwgUIlWCRVlHL_40RiGu7FTAsbgIZyKlrGakGc3nhExBSpXxfCFPR87UMmOC5xNykdIbYyCAiXMyAVBMLiWbku1Li8nSqqKb6LGjwdHSp12Hg-_ntOoHG52Noac_31nezOl9-Axx33h9kLE3VGarbh9i2EfUvqMuRHrnO4_xa0xEPdASe23jJTlz2CV79Y8z8rp62JRP2fr5sSpv11kLHIbMCs4LI6WxXDAsdKOXpgCQOQowTjtpC4N4OLLQAjhToBqHRrg8V6rIGz4j18fcHSaNnYtju0_1Lvr3cVINghWSCzn6bo6-1m_bDx9trf92RpssRt3WqgaoOVeS_wLRCWPj</recordid><startdate>20011101</startdate><enddate>20011101</enddate><creator>PATT, Yehuda Z</creator><creator>HASSAN, Manal M</creator><creator>SCHNIRER, Isac I</creator><creator>RAIJMAN, Isaac</creator><creator>LOZANO, Richard D</creator><creator>WAUGH, Kimberly A</creator><creator>HOQUE, Ashraful M</creator><creator>FROME, Adam I</creator><creator>LAHOTI, Sandeep</creator><creator>ELLIS, Lee</creator><creator>VAUTHEY, J. Nicolas</creator><creator>CURLEY, Steven A</creator><general>American Association for Cancer Research</general><scope>IQODW</scope></search><sort><creationdate>20011101</creationdate><title>Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer</title><author>PATT, Yehuda Z ; HASSAN, Manal M ; SCHNIRER, Isac I ; RAIJMAN, Isaac ; LOZANO, Richard D ; WAUGH, Kimberly A ; HOQUE, Ashraful M ; FROME, Adam I ; LAHOTI, Sandeep ; ELLIS, Lee ; VAUTHEY, J. Nicolas ; CURLEY, Steven A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h131t-e4339d55de340a9cbc8d91152a41dfcf5e9daa00146c4130717bfad4f227792b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Antineoplastic agents</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>PATT, Yehuda Z</creatorcontrib><creatorcontrib>HASSAN, Manal M</creatorcontrib><creatorcontrib>SCHNIRER, Isac I</creatorcontrib><creatorcontrib>RAIJMAN, Isaac</creatorcontrib><creatorcontrib>LOZANO, Richard D</creatorcontrib><creatorcontrib>WAUGH, Kimberly A</creatorcontrib><creatorcontrib>HOQUE, Ashraful M</creatorcontrib><creatorcontrib>FROME, Adam I</creatorcontrib><creatorcontrib>LAHOTI, Sandeep</creatorcontrib><creatorcontrib>ELLIS, Lee</creatorcontrib><creatorcontrib>VAUTHEY, J. Nicolas</creatorcontrib><creatorcontrib>CURLEY, Steven A</creatorcontrib><collection>Pascal-Francis</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>PATT, Yehuda Z</au><au>HASSAN, Manal M</au><au>SCHNIRER, Isac I</au><au>RAIJMAN, Isaac</au><au>LOZANO, Richard D</au><au>WAUGH, Kimberly A</au><au>HOQUE, Ashraful M</au><au>FROME, Adam I</au><au>LAHOTI, Sandeep</au><au>ELLIS, Lee</au><au>VAUTHEY, J. Nicolas</au><au>CURLEY, Steven A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer</atitle><jtitle>Clinical cancer research</jtitle><date>2001-11-01</date><risdate>2001</risdate><volume>7</volume><issue>11</issue><spage>3375</spage><epage>3380</epage><pages>3375-3380</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN α-2b, doxorubicin, Adriamycin,
and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder
carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting
chemotherapy doses were as follows: cisplatin, 80 mg/m 2 i.v. over 2 h; doxorubicin, 40 mg/m 2 i.v. over 2 h; and 5-fluorouracil, 500 mg/m 2 by continuous infusion daily for 3 days. IFN α-2b (5 × 10 6 units/m 2 ) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was
21.1% [95% confidence interval (CI), 10–37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates
were 9.5% (95% CI, 1–32%) and 35.3% (95% CI, 14–62%), respectively. Overall median survival time was 14 months (95% CI, 9.5–18.5),
18.1 months (95% CI, 12.1–24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9–17.1) for the gallbladder
carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia
(41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more
active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore,
this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma,
particularly among patients who were refractory to higher priority investigational agents.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>11705850</pmid><tpages>6</tpages></addata></record> |
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| source | American Association for Cancer Research; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Antineoplastic agents Biological and medical sciences Chemotherapy Medical sciences Pharmacology. Drug treatments |
| title | Phase II Trial of Cisplatin, Interferon α-2b, Doxorubicin, and 5-Fluorouracil for Biliary Tract Cancer |
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