Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial
Background There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC. Methods A multicenter, cooperative group, single-arm, phase II trial was conducted between...
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| Veröffentlicht in: | Annals of surgical oncology 2019-12, Vol.26 (13), p.4489-4497 |
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| creator | Wei, Alice C. Ou, Fang-Shu Shi, Qian Carrero, Xiomara O’Reilly, Eileen M. Meyerhardt, Jeffrey Wolff, Robert A. Kindler, Hedy L. Evans, Douglas B. Deshpande, Vikram Misdraji, Joseph Tamm, Eric Sahani, Dushyant Moore, Malcolm Newman, Elliot Merchant, Nipun Berlin, Jordan Goff, Laura W. Pisters, Peter Posner, Mitchell C. |
| description | Background
There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC.
Methods
A multicenter, cooperative group, single-arm, phase II trial was conducted between April 2009 and November 2013 (ACOSOG Z5041). Patients with biopsy-confirmed PDAC in the pancreatic head without evidence of involvement of major mesenteric vessels (resectable) were eligible. Patients (
n
=
123) received an 8-week cycle of G+E before and after surgery. The primary endpoint was 2-year overall survival (OS), and secondary endpoints included toxicity, response, resection rate, and time to progression. Resectability was assessed retrospectively by central review. The study closed early due to slow accrual, and no formal hypothesis testing was performed.
Results
Overall, 114 patients were eligible, consented, and initiated protocol treatment. By central radiologic review, 97 (85%) of the 114 patients met the protocol-defined resectability criteria. Grade 3+ toxicity was reported in 60% and 79% of patients during the neoadjuvant phase and overall, respectively. Twenty-two of 114 (19%) patients did not proceed to surgery; 83 patients (73%) were successfully resected. R0 and R1 margins were obtained in 67 (81%) and 16 (19%) resected patients, respectively, and 54 patients completed postoperative G+E (65%). The 2-year OS rate for the entire cohort (
n
=
114) was 40% (95% confidence interval [CI] 31–50), with a median OS of 21.3 months (95% CI 17.2–25.9). The 2-year OS rate for resected patients (
n
=
83) was 52% (95% CI 41–63), with a median OS of 25.4 months (95% CI 21.8–29.6).
Conclusions
For resectable PDAC, perioperative G+E is feasible. Further evaluation of neoadjuvant strategies in resectable PDAC is warranted with more active systemic regimens. |
| doi_str_mv | 10.1245/s10434-019-07685-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6868305</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2275260647</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4161-f10bc5a32cc8b546d652ad9f3513bc5f0c1e86a43800f7f6f9e7a27faf0b26393</originalsourceid><addsrcrecordid>eNp9ks1u1DAUhSMEoqXwAiyQBZsiFPB_EhZIo1EZRqo0IygbNpbjue64SuypnVTqji1PwPvxJHhIKYUFC8s_97vH9tEpiqcEvyaUizeJYM54iUlT4krWoiT3ikMi8hGXNbmf11jWZUOlOCgepXSBMakYFg-LA0Y4qQnDh8X3NUQXdhD14K4ALaA3btCt8_Dj67dXeZzELgzOuxatuzGhtfYmQoZN2IxhAx7MEPprZENEHyHlnW47uIOhWYaC0dE4H3r9Fs3mq0-rBfoiMCfoeNZ1LrPwEq23OgFaLtFZdLp7XDywukvw5GY-Kj6_PzmbfyhPV4vlfHZaGk4kKS3BrRGaUWPqVnC5kYLqTWOZICwXLDYEaqk5qzG2lZW2gUrTymqLWypZw46Kd5Pubmx72BjwQ9Sd2kXX63itgnbq74p3W3UerpSsZZ3NzAIvJoGQBqdSdg_M1gS_N0ZR2tCKV1Wmjm-uieFyhDSo3iUDXac9hDFlsBJUYsn36PN_0IswRp9N2FNMMNLIDNEJMjGkFMHevphgtQ-HmsKhcjjUr3Aokpue3f3rbcvvNGSATUDKJX8O8c_V_5H9Cbj1x4U</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>227353196</pqid></control><display><type>article</type><title>Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Wei, Alice C. ; Ou, Fang-Shu ; Shi, Qian ; Carrero, Xiomara ; O’Reilly, Eileen M. ; Meyerhardt, Jeffrey ; Wolff, Robert A. ; Kindler, Hedy L. ; Evans, Douglas B. ; Deshpande, Vikram ; Misdraji, Joseph ; Tamm, Eric ; Sahani, Dushyant ; Moore, Malcolm ; Newman, Elliot ; Merchant, Nipun ; Berlin, Jordan ; Goff, Laura W. ; Pisters, Peter ; Posner, Mitchell C.</creator><creatorcontrib>Wei, Alice C. ; Ou, Fang-Shu ; Shi, Qian ; Carrero, Xiomara ; O’Reilly, Eileen M. ; Meyerhardt, Jeffrey ; Wolff, Robert A. ; Kindler, Hedy L. ; Evans, Douglas B. ; Deshpande, Vikram ; Misdraji, Joseph ; Tamm, Eric ; Sahani, Dushyant ; Moore, Malcolm ; Newman, Elliot ; Merchant, Nipun ; Berlin, Jordan ; Goff, Laura W. ; Pisters, Peter ; Posner, Mitchell C.</creatorcontrib><description>Background
There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC.
Methods
A multicenter, cooperative group, single-arm, phase II trial was conducted between April 2009 and November 2013 (ACOSOG Z5041). Patients with biopsy-confirmed PDAC in the pancreatic head without evidence of involvement of major mesenteric vessels (resectable) were eligible. Patients (
n
=
123) received an 8-week cycle of G+E before and after surgery. The primary endpoint was 2-year overall survival (OS), and secondary endpoints included toxicity, response, resection rate, and time to progression. Resectability was assessed retrospectively by central review. The study closed early due to slow accrual, and no formal hypothesis testing was performed.
Results
Overall, 114 patients were eligible, consented, and initiated protocol treatment. By central radiologic review, 97 (85%) of the 114 patients met the protocol-defined resectability criteria. Grade 3+ toxicity was reported in 60% and 79% of patients during the neoadjuvant phase and overall, respectively. Twenty-two of 114 (19%) patients did not proceed to surgery; 83 patients (73%) were successfully resected. R0 and R1 margins were obtained in 67 (81%) and 16 (19%) resected patients, respectively, and 54 patients completed postoperative G+E (65%). The 2-year OS rate for the entire cohort (
n
=
114) was 40% (95% confidence interval [CI] 31–50), with a median OS of 21.3 months (95% CI 17.2–25.9). The 2-year OS rate for resected patients (
n
=
83) was 52% (95% CI 41–63), with a median OS of 25.4 months (95% CI 21.8–29.6).
Conclusions
For resectable PDAC, perioperative G+E is feasible. Further evaluation of neoadjuvant strategies in resectable PDAC is warranted with more active systemic regimens.</description><identifier>ISSN: 1068-9265</identifier><identifier>ISSN: 1534-4681</identifier><identifier>EISSN: 1534-4681</identifier><identifier>DOI: 10.1245/s10434-019-07685-1</identifier><identifier>PMID: 31418130</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adenocarcinoma ; Adenocarcinoma - drug therapy ; Adenocarcinoma - surgery ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; BIOPSY ; Cancer therapies ; CARCINOMAS ; Chemotherapy ; Combined Modality Therapy ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Erlotinib Hydrochloride - therapeutic use ; Female ; Gemcitabine ; Humans ; Hypotheses ; HYPOTHESIS ; Inhibitor drugs ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; PANCREAS ; Pancreatic cancer ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - surgery ; Pancreatic Tumors ; Pancreaticoduodenectomy ; PATIENTS ; RADIOLOGY AND NUCLEAR MEDICINE ; Response rates ; SURGERY ; Surgical Oncology ; Targeted cancer therapy ; TOXICITY ; Tumors ; Veins & arteries</subject><ispartof>Annals of surgical oncology, 2019-12, Vol.26 (13), p.4489-4497</ispartof><rights>Society of Surgical Oncology 2019</rights><rights>Annals of Surgical Oncology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4161-f10bc5a32cc8b546d652ad9f3513bc5f0c1e86a43800f7f6f9e7a27faf0b26393</citedby><cites>FETCH-LOGICAL-c4161-f10bc5a32cc8b546d652ad9f3513bc5f0c1e86a43800f7f6f9e7a27faf0b26393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1245/s10434-019-07685-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1245/s10434-019-07685-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31418130$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://www.osti.gov/biblio/22927477$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Wei, Alice C.</creatorcontrib><creatorcontrib>Ou, Fang-Shu</creatorcontrib><creatorcontrib>Shi, Qian</creatorcontrib><creatorcontrib>Carrero, Xiomara</creatorcontrib><creatorcontrib>O’Reilly, Eileen M.</creatorcontrib><creatorcontrib>Meyerhardt, Jeffrey</creatorcontrib><creatorcontrib>Wolff, Robert A.</creatorcontrib><creatorcontrib>Kindler, Hedy L.</creatorcontrib><creatorcontrib>Evans, Douglas B.</creatorcontrib><creatorcontrib>Deshpande, Vikram</creatorcontrib><creatorcontrib>Misdraji, Joseph</creatorcontrib><creatorcontrib>Tamm, Eric</creatorcontrib><creatorcontrib>Sahani, Dushyant</creatorcontrib><creatorcontrib>Moore, Malcolm</creatorcontrib><creatorcontrib>Newman, Elliot</creatorcontrib><creatorcontrib>Merchant, Nipun</creatorcontrib><creatorcontrib>Berlin, Jordan</creatorcontrib><creatorcontrib>Goff, Laura W.</creatorcontrib><creatorcontrib>Pisters, Peter</creatorcontrib><creatorcontrib>Posner, Mitchell C.</creatorcontrib><title>Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial</title><title>Annals of surgical oncology</title><addtitle>Ann Surg Oncol</addtitle><addtitle>Ann Surg Oncol</addtitle><description>Background
There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC.
Methods
A multicenter, cooperative group, single-arm, phase II trial was conducted between April 2009 and November 2013 (ACOSOG Z5041). Patients with biopsy-confirmed PDAC in the pancreatic head without evidence of involvement of major mesenteric vessels (resectable) were eligible. Patients (
n
=
123) received an 8-week cycle of G+E before and after surgery. The primary endpoint was 2-year overall survival (OS), and secondary endpoints included toxicity, response, resection rate, and time to progression. Resectability was assessed retrospectively by central review. The study closed early due to slow accrual, and no formal hypothesis testing was performed.
Results
Overall, 114 patients were eligible, consented, and initiated protocol treatment. By central radiologic review, 97 (85%) of the 114 patients met the protocol-defined resectability criteria. Grade 3+ toxicity was reported in 60% and 79% of patients during the neoadjuvant phase and overall, respectively. Twenty-two of 114 (19%) patients did not proceed to surgery; 83 patients (73%) were successfully resected. R0 and R1 margins were obtained in 67 (81%) and 16 (19%) resected patients, respectively, and 54 patients completed postoperative G+E (65%). The 2-year OS rate for the entire cohort (
n
=
114) was 40% (95% confidence interval [CI] 31–50), with a median OS of 21.3 months (95% CI 17.2–25.9). The 2-year OS rate for resected patients (
n
=
83) was 52% (95% CI 41–63), with a median OS of 25.4 months (95% CI 21.8–29.6).
Conclusions
For resectable PDAC, perioperative G+E is feasible. Further evaluation of neoadjuvant strategies in resectable PDAC is warranted with more active systemic regimens.</description><subject>Adenocarcinoma</subject><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>BIOPSY</subject><subject>Cancer therapies</subject><subject>CARCINOMAS</subject><subject>Chemotherapy</subject><subject>Combined Modality Therapy</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Erlotinib Hydrochloride - therapeutic use</subject><subject>Female</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>HYPOTHESIS</subject><subject>Inhibitor drugs</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>PANCREAS</subject><subject>Pancreatic cancer</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - surgery</subject><subject>Pancreatic Tumors</subject><subject>Pancreaticoduodenectomy</subject><subject>PATIENTS</subject><subject>RADIOLOGY AND NUCLEAR MEDICINE</subject><subject>Response rates</subject><subject>SURGERY</subject><subject>Surgical Oncology</subject><subject>Targeted cancer therapy</subject><subject>TOXICITY</subject><subject>Tumors</subject><subject>Veins & arteries</subject><issn>1068-9265</issn><issn>1534-4681</issn><issn>1534-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ks1u1DAUhSMEoqXwAiyQBZsiFPB_EhZIo1EZRqo0IygbNpbjue64SuypnVTqji1PwPvxJHhIKYUFC8s_97vH9tEpiqcEvyaUizeJYM54iUlT4krWoiT3ikMi8hGXNbmf11jWZUOlOCgepXSBMakYFg-LA0Y4qQnDh8X3NUQXdhD14K4ALaA3btCt8_Dj67dXeZzELgzOuxatuzGhtfYmQoZN2IxhAx7MEPprZENEHyHlnW47uIOhWYaC0dE4H3r9Fs3mq0-rBfoiMCfoeNZ1LrPwEq23OgFaLtFZdLp7XDywukvw5GY-Kj6_PzmbfyhPV4vlfHZaGk4kKS3BrRGaUWPqVnC5kYLqTWOZICwXLDYEaqk5qzG2lZW2gUrTymqLWypZw46Kd5Pubmx72BjwQ9Sd2kXX63itgnbq74p3W3UerpSsZZ3NzAIvJoGQBqdSdg_M1gS_N0ZR2tCKV1Wmjm-uieFyhDSo3iUDXac9hDFlsBJUYsn36PN_0IswRp9N2FNMMNLIDNEJMjGkFMHevphgtQ-HmsKhcjjUr3Aokpue3f3rbcvvNGSATUDKJX8O8c_V_5H9Cbj1x4U</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Wei, Alice C.</creator><creator>Ou, Fang-Shu</creator><creator>Shi, Qian</creator><creator>Carrero, Xiomara</creator><creator>O’Reilly, Eileen M.</creator><creator>Meyerhardt, Jeffrey</creator><creator>Wolff, Robert A.</creator><creator>Kindler, Hedy L.</creator><creator>Evans, Douglas B.</creator><creator>Deshpande, Vikram</creator><creator>Misdraji, Joseph</creator><creator>Tamm, Eric</creator><creator>Sahani, Dushyant</creator><creator>Moore, Malcolm</creator><creator>Newman, Elliot</creator><creator>Merchant, Nipun</creator><creator>Berlin, Jordan</creator><creator>Goff, Laura W.</creator><creator>Pisters, Peter</creator><creator>Posner, Mitchell C.</creator><general>Springer International Publishing</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>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</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>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>OTOTI</scope><scope>5PM</scope></search><sort><creationdate>20191201</creationdate><title>Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial</title><author>Wei, Alice C. ; Ou, Fang-Shu ; Shi, Qian ; Carrero, Xiomara ; O’Reilly, Eileen M. ; Meyerhardt, Jeffrey ; Wolff, Robert A. ; Kindler, Hedy L. ; Evans, Douglas B. ; Deshpande, Vikram ; Misdraji, Joseph ; Tamm, Eric ; Sahani, Dushyant ; Moore, Malcolm ; Newman, Elliot ; Merchant, Nipun ; Berlin, Jordan ; Goff, Laura W. ; Pisters, Peter ; Posner, Mitchell C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4161-f10bc5a32cc8b546d652ad9f3513bc5f0c1e86a43800f7f6f9e7a27faf0b26393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adenocarcinoma</topic><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>BIOPSY</topic><topic>Cancer therapies</topic><topic>CARCINOMAS</topic><topic>Chemotherapy</topic><topic>Combined Modality Therapy</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Erlotinib Hydrochloride - therapeutic use</topic><topic>Female</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>HYPOTHESIS</topic><topic>Inhibitor drugs</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>PANCREAS</topic><topic>Pancreatic cancer</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - surgery</topic><topic>Pancreatic Tumors</topic><topic>Pancreaticoduodenectomy</topic><topic>PATIENTS</topic><topic>RADIOLOGY AND NUCLEAR MEDICINE</topic><topic>Response rates</topic><topic>SURGERY</topic><topic>Surgical Oncology</topic><topic>Targeted cancer therapy</topic><topic>TOXICITY</topic><topic>Tumors</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wei, Alice C.</creatorcontrib><creatorcontrib>Ou, Fang-Shu</creatorcontrib><creatorcontrib>Shi, Qian</creatorcontrib><creatorcontrib>Carrero, Xiomara</creatorcontrib><creatorcontrib>O’Reilly, Eileen M.</creatorcontrib><creatorcontrib>Meyerhardt, Jeffrey</creatorcontrib><creatorcontrib>Wolff, Robert A.</creatorcontrib><creatorcontrib>Kindler, Hedy L.</creatorcontrib><creatorcontrib>Evans, Douglas B.</creatorcontrib><creatorcontrib>Deshpande, Vikram</creatorcontrib><creatorcontrib>Misdraji, Joseph</creatorcontrib><creatorcontrib>Tamm, Eric</creatorcontrib><creatorcontrib>Sahani, Dushyant</creatorcontrib><creatorcontrib>Moore, Malcolm</creatorcontrib><creatorcontrib>Newman, Elliot</creatorcontrib><creatorcontrib>Merchant, Nipun</creatorcontrib><creatorcontrib>Berlin, Jordan</creatorcontrib><creatorcontrib>Goff, Laura W.</creatorcontrib><creatorcontrib>Pisters, Peter</creatorcontrib><creatorcontrib>Posner, Mitchell C.</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>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>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>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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 China</collection><collection>MEDLINE - Academic</collection><collection>OSTI.GOV</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of surgical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wei, Alice C.</au><au>Ou, Fang-Shu</au><au>Shi, Qian</au><au>Carrero, Xiomara</au><au>O’Reilly, Eileen M.</au><au>Meyerhardt, Jeffrey</au><au>Wolff, Robert A.</au><au>Kindler, Hedy L.</au><au>Evans, Douglas B.</au><au>Deshpande, Vikram</au><au>Misdraji, Joseph</au><au>Tamm, Eric</au><au>Sahani, Dushyant</au><au>Moore, Malcolm</au><au>Newman, Elliot</au><au>Merchant, Nipun</au><au>Berlin, Jordan</au><au>Goff, Laura W.</au><au>Pisters, Peter</au><au>Posner, Mitchell C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial</atitle><jtitle>Annals of surgical oncology</jtitle><stitle>Ann Surg Oncol</stitle><addtitle>Ann Surg Oncol</addtitle><date>2019-12-01</date><risdate>2019</risdate><volume>26</volume><issue>13</issue><spage>4489</spage><epage>4497</epage><pages>4489-4497</pages><issn>1068-9265</issn><issn>1534-4681</issn><eissn>1534-4681</eissn><abstract>Background
There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC.
Methods
A multicenter, cooperative group, single-arm, phase II trial was conducted between April 2009 and November 2013 (ACOSOG Z5041). Patients with biopsy-confirmed PDAC in the pancreatic head without evidence of involvement of major mesenteric vessels (resectable) were eligible. Patients (
n
=
123) received an 8-week cycle of G+E before and after surgery. The primary endpoint was 2-year overall survival (OS), and secondary endpoints included toxicity, response, resection rate, and time to progression. Resectability was assessed retrospectively by central review. The study closed early due to slow accrual, and no formal hypothesis testing was performed.
Results
Overall, 114 patients were eligible, consented, and initiated protocol treatment. By central radiologic review, 97 (85%) of the 114 patients met the protocol-defined resectability criteria. Grade 3+ toxicity was reported in 60% and 79% of patients during the neoadjuvant phase and overall, respectively. Twenty-two of 114 (19%) patients did not proceed to surgery; 83 patients (73%) were successfully resected. R0 and R1 margins were obtained in 67 (81%) and 16 (19%) resected patients, respectively, and 54 patients completed postoperative G+E (65%). The 2-year OS rate for the entire cohort (
n
=
114) was 40% (95% confidence interval [CI] 31–50), with a median OS of 21.3 months (95% CI 17.2–25.9). The 2-year OS rate for resected patients (
n
=
83) was 52% (95% CI 41–63), with a median OS of 25.4 months (95% CI 21.8–29.6).
Conclusions
For resectable PDAC, perioperative G+E is feasible. Further evaluation of neoadjuvant strategies in resectable PDAC is warranted with more active systemic regimens.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>31418130</pmid><doi>10.1245/s10434-019-07685-1</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1068-9265 |
| ispartof | Annals of surgical oncology, 2019-12, Vol.26 (13), p.4489-4497 |
| issn | 1068-9265 1534-4681 1534-4681 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6868305 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adenocarcinoma Adenocarcinoma - drug therapy Adenocarcinoma - surgery Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - therapeutic use BIOPSY Cancer therapies CARCINOMAS Chemotherapy Combined Modality Therapy Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Erlotinib Hydrochloride - therapeutic use Female Gemcitabine Humans Hypotheses HYPOTHESIS Inhibitor drugs Male Medicine Medicine & Public Health Middle Aged Oncology PANCREAS Pancreatic cancer Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - surgery Pancreatic Tumors Pancreaticoduodenectomy PATIENTS RADIOLOGY AND NUCLEAR MEDICINE Response rates SURGERY Surgical Oncology Targeted cancer therapy TOXICITY Tumors Veins & arteries |
| title | Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-05T16%3A50%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Perioperative%20Gemcitabine%E2%80%89+%E2%80%89Erlotinib%20Plus%20Pancreaticoduodenectomy%20for%20Resectable%20Pancreatic%20Adenocarcinoma:%20ACOSOG%20Z5041%20(Alliance)%20Phase%20II%20Trial&rft.jtitle=Annals%20of%20surgical%20oncology&rft.au=Wei,%20Alice%20C.&rft.date=2019-12-01&rft.volume=26&rft.issue=13&rft.spage=4489&rft.epage=4497&rft.pages=4489-4497&rft.issn=1068-9265&rft.eissn=1534-4681&rft_id=info:doi/10.1245/s10434-019-07685-1&rft_dat=%3Cproquest_pubme%3E2275260647%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=227353196&rft_id=info:pmid/31418130&rfr_iscdi=true |