Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study
Summary Background Previous phase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary-tract cancers (BTCs). In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advance...
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| Veröffentlicht in: | The lancet oncology 2010, Vol.11 (1), p.48-54 |
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| creator | Zhu, Andrew X, Dr Meyerhardt, Jeffrey A, MD Blaszkowsky, Lawrence S, MD Kambadakone, Avinash R, MD Muzikansky, Alona, MS Zheng, Hui, PhD Clark, Jeffrey W, MD Abrams, Thomas A, MD Chan, Jennifer A, MD Enzinger, Peter C, MD Bhargava, Pankaj, MD Kwak, Eunice L, MD Allen, Jill N, MD Jain, Sanjay R, MD Stuart, Keith, MD Horgan, Kerry, BA Sheehan, Susan, RN Fuchs, Charles S, MD Ryan, David P, MD Sahani, Dushyant V, MD |
| description | Summary Background Previous phase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary-tract cancers (BTCs). In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advanced BTCs, and investigated how changes in 18-fluorodeoxyglucose ([18 F]FDG)-PET correlate with clinical outcome. Methods Patients with advanced measurable BTCs were given the following treatment on days 1 and 15 of a 28-day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m2 (10 mg/m2 per min) and oxaliplatin 85 mg/m2 (2-h infusion). [18 F]FDG-PET scans were obtained at baseline and after completion of the second cycle. The primary endpoint was progression-free survival (PFS). Efficacy and safety analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00361231. Findings 35 patients were enrolled and evaluable for efficacy and toxicity. Median PFS was 7·0 months (95% CI 5·3–10·3), and PFS at 6 months was 63% (47–79), which was below the targeted rate of 70%. Grade 3–4 toxic effects included neutropenia (n=7), raised alanine aminotransferase concentrations (n=5), peripheral neuropathy (n=5), and hypertension (n=5). [18 F]FDG-PET scans showed a significant decrease in maximum standardised uptake value (SUVmax ) after two cycles of treatment (5·72 [SD 2·01] at baseline; 3·73 [SD 1·88] after two cycles; p |
| doi_str_mv | 10.1016/S1470-2045(09)70333-X |
| format | Article |
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In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advanced BTCs, and investigated how changes in 18-fluorodeoxyglucose ([18 F]FDG)-PET correlate with clinical outcome. Methods Patients with advanced measurable BTCs were given the following treatment on days 1 and 15 of a 28-day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m2 (10 mg/m2 per min) and oxaliplatin 85 mg/m2 (2-h infusion). [18 F]FDG-PET scans were obtained at baseline and after completion of the second cycle. The primary endpoint was progression-free survival (PFS). Efficacy and safety analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00361231. Findings 35 patients were enrolled and evaluable for efficacy and toxicity. Median PFS was 7·0 months (95% CI 5·3–10·3), and PFS at 6 months was 63% (47–79), which was below the targeted rate of 70%. Grade 3–4 toxic effects included neutropenia (n=7), raised alanine aminotransferase concentrations (n=5), peripheral neuropathy (n=5), and hypertension (n=5). [18 F]FDG-PET scans showed a significant decrease in maximum standardised uptake value (SUVmax ) after two cycles of treatment (5·72 [SD 2·01] at baseline; 3·73 [SD 1·88] after two cycles; p<0·0001). These changes were more pronounced in patients with partial response or stable disease than those with progressive disease (24 patients, −2·80 [SD 1·95] vs five patients, 1·41 [SD 3·13]; p=0·009). Change in SUVmax was a significant predictor of PFS (HR 1·35, 1·14–1·60, p=0·0006) and overall survival (1·25, 1·05–1·50, p=0·01). Interpretation GEMOX-B showed antitumour activity with tolerable safety in patients with advanced BTCs. Decreases in SUVmax on [18 F]FDG-PET scans after treatment were associated with disease control and increases in PFS and overall survival. Funding Genentech Oncology and Sanofi-Aventis.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(09)70333-X</identifier><identifier>PMID: 19932054</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors - adverse effects ; Angiogenesis Inhibitors - therapeutic use ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bevacizumab ; Biliary Tract Neoplasms - diagnostic imaging ; Biliary Tract Neoplasms - drug therapy ; Biliary Tract Neoplasms - mortality ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Disease-Free Survival ; Female ; Fluorodeoxyglucose F18 ; Hematology, Oncology and Palliative Medicine ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Organoplatinum Compounds - adverse effects ; Organoplatinum Compounds - therapeutic use ; Positron-Emission Tomography ; Proportional Hazards Models ; Radiopharmaceuticals ; Risk Assessment ; Time Factors ; Treatment Outcome</subject><ispartof>The lancet oncology, 2010, Vol.11 (1), p.48-54</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>Copyright (c) 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-aaa073ecbfee33a2043fb527c0479a6bb5e26422e0fc9381cfa8ee0205d00383</citedby><cites>FETCH-LOGICAL-c446t-aaa073ecbfee33a2043fb527c0479a6bb5e26422e0fc9381cfa8ee0205d00383</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S147020450970333X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27902,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19932054$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhu, Andrew X, Dr</creatorcontrib><creatorcontrib>Meyerhardt, Jeffrey A, MD</creatorcontrib><creatorcontrib>Blaszkowsky, Lawrence S, MD</creatorcontrib><creatorcontrib>Kambadakone, Avinash R, MD</creatorcontrib><creatorcontrib>Muzikansky, Alona, MS</creatorcontrib><creatorcontrib>Zheng, Hui, PhD</creatorcontrib><creatorcontrib>Clark, Jeffrey W, MD</creatorcontrib><creatorcontrib>Abrams, Thomas A, MD</creatorcontrib><creatorcontrib>Chan, Jennifer A, MD</creatorcontrib><creatorcontrib>Enzinger, Peter C, MD</creatorcontrib><creatorcontrib>Bhargava, Pankaj, MD</creatorcontrib><creatorcontrib>Kwak, Eunice L, MD</creatorcontrib><creatorcontrib>Allen, Jill N, MD</creatorcontrib><creatorcontrib>Jain, Sanjay R, MD</creatorcontrib><creatorcontrib>Stuart, Keith, MD</creatorcontrib><creatorcontrib>Horgan, Kerry, BA</creatorcontrib><creatorcontrib>Sheehan, Susan, RN</creatorcontrib><creatorcontrib>Fuchs, Charles S, MD</creatorcontrib><creatorcontrib>Ryan, David P, MD</creatorcontrib><creatorcontrib>Sahani, Dushyant V, MD</creatorcontrib><title>Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Background Previous phase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary-tract cancers (BTCs). In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advanced BTCs, and investigated how changes in 18-fluorodeoxyglucose ([18 F]FDG)-PET correlate with clinical outcome. Methods Patients with advanced measurable BTCs were given the following treatment on days 1 and 15 of a 28-day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m2 (10 mg/m2 per min) and oxaliplatin 85 mg/m2 (2-h infusion). [18 F]FDG-PET scans were obtained at baseline and after completion of the second cycle. The primary endpoint was progression-free survival (PFS). Efficacy and safety analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00361231. Findings 35 patients were enrolled and evaluable for efficacy and toxicity. Median PFS was 7·0 months (95% CI 5·3–10·3), and PFS at 6 months was 63% (47–79), which was below the targeted rate of 70%. Grade 3–4 toxic effects included neutropenia (n=7), raised alanine aminotransferase concentrations (n=5), peripheral neuropathy (n=5), and hypertension (n=5). [18 F]FDG-PET scans showed a significant decrease in maximum standardised uptake value (SUVmax ) after two cycles of treatment (5·72 [SD 2·01] at baseline; 3·73 [SD 1·88] after two cycles; p<0·0001). These changes were more pronounced in patients with partial response or stable disease than those with progressive disease (24 patients, −2·80 [SD 1·95] vs five patients, 1·41 [SD 3·13]; p=0·009). Change in SUVmax was a significant predictor of PFS (HR 1·35, 1·14–1·60, p=0·0006) and overall survival (1·25, 1·05–1·50, p=0·01). Interpretation GEMOX-B showed antitumour activity with tolerable safety in patients with advanced BTCs. Decreases in SUVmax on [18 F]FDG-PET scans after treatment were associated with disease control and increases in PFS and overall survival. Funding Genentech Oncology and Sanofi-Aventis.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angiogenesis Inhibitors - adverse effects</subject><subject>Angiogenesis Inhibitors - therapeutic use</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bevacizumab</subject><subject>Biliary Tract Neoplasms - diagnostic imaging</subject><subject>Biliary Tract Neoplasms - drug therapy</subject><subject>Biliary Tract Neoplasms - mortality</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Fluorodeoxyglucose F18</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Organoplatinum Compounds - therapeutic use</subject><subject>Positron-Emission Tomography</subject><subject>Proportional Hazards Models</subject><subject>Radiopharmaceuticals</subject><subject>Risk Assessment</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1470-2045</issn><issn>1474-5488</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkc-O0zAQxiMEYpeFRwBZnEDawDhOmoQDCK3KH2klkOihN2vijFsvaVxsp2x4O94MJy0gceFiW6NvfuP5viR5zOEFB754-YXnJaQZ5MUzqJ-XIIRI13eS81jO0yKvqrvz-yg5Sx54fwPASw7F_eSM17XIoMjPk59LrY1CNTLsW-ZRUxiZ1WxDO2UCNqanS2ZvsTP7DoPpL2ddQwdU5seww4aZnmF7wF5RrJvOoBvT4FAFpqai83OHss7RRLD9hFdb7Dfkp2ZepbobrLMt2dtx0w3KemKflyv23YQtU53p4wc7Zoeg7I5eMWT7LUZJxnwY2vFhck9j5-nR6b5IVu-Wq6sP6fWn9x-v3l6nKs8XIUVEKAWpRhMJgdEVoZsiKxXkZY2LpikoW-RZRqBVLSquNFZEEF1qAUQlLpKnR-ze2W8D-SBv7OD6OFFmADXP4hlFxVGknPXekZZ7Z3bREclBTrHJOTY5ZSKhlnNsch37npzgQ7Oj9m_XKacoeHMUUNzwYMhJrwxNnhtHKsjWmv-OeP0P4bezX2kk_2cZLn0m4QiZGFDPhLX4Bci_v9A</recordid><startdate>2010</startdate><enddate>2010</enddate><creator>Zhu, Andrew X, Dr</creator><creator>Meyerhardt, Jeffrey A, MD</creator><creator>Blaszkowsky, Lawrence S, MD</creator><creator>Kambadakone, Avinash R, MD</creator><creator>Muzikansky, Alona, MS</creator><creator>Zheng, Hui, PhD</creator><creator>Clark, Jeffrey W, MD</creator><creator>Abrams, Thomas A, MD</creator><creator>Chan, Jennifer A, MD</creator><creator>Enzinger, Peter C, MD</creator><creator>Bhargava, Pankaj, MD</creator><creator>Kwak, Eunice L, MD</creator><creator>Allen, Jill N, MD</creator><creator>Jain, Sanjay R, MD</creator><creator>Stuart, Keith, MD</creator><creator>Horgan, Kerry, BA</creator><creator>Sheehan, Susan, RN</creator><creator>Fuchs, Charles S, MD</creator><creator>Ryan, David P, MD</creator><creator>Sahani, Dushyant V, MD</creator><general>Elsevier Ltd</general><general>Elsevier Limited</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>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>2010</creationdate><title>Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study</title><author>Zhu, Andrew X, Dr ; Meyerhardt, Jeffrey A, MD ; Blaszkowsky, Lawrence S, MD ; Kambadakone, Avinash R, MD ; Muzikansky, Alona, MS ; Zheng, Hui, PhD ; Clark, Jeffrey W, MD ; Abrams, Thomas A, MD ; Chan, Jennifer A, MD ; Enzinger, Peter C, MD ; Bhargava, Pankaj, MD ; Kwak, Eunice L, MD ; Allen, Jill N, MD ; Jain, Sanjay R, MD ; Stuart, Keith, MD ; Horgan, Kerry, BA ; Sheehan, Susan, RN ; Fuchs, Charles S, MD ; Ryan, David P, MD ; Sahani, Dushyant V, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-aaa073ecbfee33a2043fb527c0479a6bb5e26422e0fc9381cfa8ee0205d00383</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angiogenesis Inhibitors - 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adverse effects</topic><topic>Organoplatinum Compounds - therapeutic use</topic><topic>Positron-Emission Tomography</topic><topic>Proportional Hazards Models</topic><topic>Radiopharmaceuticals</topic><topic>Risk Assessment</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhu, Andrew X, Dr</creatorcontrib><creatorcontrib>Meyerhardt, Jeffrey A, MD</creatorcontrib><creatorcontrib>Blaszkowsky, Lawrence S, MD</creatorcontrib><creatorcontrib>Kambadakone, Avinash R, MD</creatorcontrib><creatorcontrib>Muzikansky, Alona, MS</creatorcontrib><creatorcontrib>Zheng, Hui, PhD</creatorcontrib><creatorcontrib>Clark, Jeffrey W, MD</creatorcontrib><creatorcontrib>Abrams, Thomas A, MD</creatorcontrib><creatorcontrib>Chan, Jennifer A, MD</creatorcontrib><creatorcontrib>Enzinger, Peter C, MD</creatorcontrib><creatorcontrib>Bhargava, Pankaj, MD</creatorcontrib><creatorcontrib>Kwak, Eunice L, MD</creatorcontrib><creatorcontrib>Allen, Jill N, MD</creatorcontrib><creatorcontrib>Jain, Sanjay R, MD</creatorcontrib><creatorcontrib>Stuart, Keith, MD</creatorcontrib><creatorcontrib>Horgan, Kerry, BA</creatorcontrib><creatorcontrib>Sheehan, Susan, RN</creatorcontrib><creatorcontrib>Fuchs, Charles S, MD</creatorcontrib><creatorcontrib>Ryan, David P, MD</creatorcontrib><creatorcontrib>Sahani, Dushyant V, MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhu, Andrew X, Dr</au><au>Meyerhardt, Jeffrey A, MD</au><au>Blaszkowsky, Lawrence S, MD</au><au>Kambadakone, Avinash R, MD</au><au>Muzikansky, Alona, MS</au><au>Zheng, Hui, PhD</au><au>Clark, Jeffrey W, MD</au><au>Abrams, Thomas A, MD</au><au>Chan, Jennifer A, MD</au><au>Enzinger, Peter C, MD</au><au>Bhargava, Pankaj, MD</au><au>Kwak, Eunice L, MD</au><au>Allen, Jill N, MD</au><au>Jain, Sanjay R, MD</au><au>Stuart, Keith, MD</au><au>Horgan, Kerry, BA</au><au>Sheehan, Susan, RN</au><au>Fuchs, Charles S, MD</au><au>Ryan, David P, MD</au><au>Sahani, Dushyant V, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2010</date><risdate>2010</risdate><volume>11</volume><issue>1</issue><spage>48</spage><epage>54</epage><pages>48-54</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><coden>LANCAO</coden><abstract>Summary Background Previous phase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary-tract cancers (BTCs). In this phase 2 study, we assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOX-B) in patients with advanced BTCs, and investigated how changes in 18-fluorodeoxyglucose ([18 F]FDG)-PET correlate with clinical outcome. Methods Patients with advanced measurable BTCs were given the following treatment on days 1 and 15 of a 28-day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m2 (10 mg/m2 per min) and oxaliplatin 85 mg/m2 (2-h infusion). [18 F]FDG-PET scans were obtained at baseline and after completion of the second cycle. The primary endpoint was progression-free survival (PFS). Efficacy and safety analyses were by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00361231. Findings 35 patients were enrolled and evaluable for efficacy and toxicity. Median PFS was 7·0 months (95% CI 5·3–10·3), and PFS at 6 months was 63% (47–79), which was below the targeted rate of 70%. Grade 3–4 toxic effects included neutropenia (n=7), raised alanine aminotransferase concentrations (n=5), peripheral neuropathy (n=5), and hypertension (n=5). [18 F]FDG-PET scans showed a significant decrease in maximum standardised uptake value (SUVmax ) after two cycles of treatment (5·72 [SD 2·01] at baseline; 3·73 [SD 1·88] after two cycles; p<0·0001). These changes were more pronounced in patients with partial response or stable disease than those with progressive disease (24 patients, −2·80 [SD 1·95] vs five patients, 1·41 [SD 3·13]; p=0·009). Change in SUVmax was a significant predictor of PFS (HR 1·35, 1·14–1·60, p=0·0006) and overall survival (1·25, 1·05–1·50, p=0·01). Interpretation GEMOX-B showed antitumour activity with tolerable safety in patients with advanced BTCs. Decreases in SUVmax on [18 F]FDG-PET scans after treatment were associated with disease control and increases in PFS and overall survival. Funding Genentech Oncology and Sanofi-Aventis.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>19932054</pmid><doi>10.1016/S1470-2045(09)70333-X</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2010, Vol.11 (1), p.48-54 |
| issn | 1470-2045 1474-5488 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aged Aged, 80 and over Angiogenesis Inhibitors - adverse effects Angiogenesis Inhibitors - therapeutic use Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bevacizumab Biliary Tract Neoplasms - diagnostic imaging Biliary Tract Neoplasms - drug therapy Biliary Tract Neoplasms - mortality Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease-Free Survival Female Fluorodeoxyglucose F18 Hematology, Oncology and Palliative Medicine Humans Kaplan-Meier Estimate Male Middle Aged Organoplatinum Compounds - adverse effects Organoplatinum Compounds - therapeutic use Positron-Emission Tomography Proportional Hazards Models Radiopharmaceuticals Risk Assessment Time Factors Treatment Outcome |
| title | Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study |
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