Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma
BACKGROUND This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patient...
Gespeichert in:
| Veröffentlicht in: | Cancer 2015-04, Vol.121 (7), p.1128-1137 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1137 |
|---|---|
| container_issue | 7 |
| container_start_page | 1128 |
| container_title | Cancer |
| container_volume | 121 |
| creator | Herman, Joseph M. Chang, Daniel T. Goodman, Karyn A. Dholakia, Avani S. Raman, Siva P. Hacker‐Prietz, Amy Iacobuzio‐Donahue, Christine A. Griffith, Mary E. Pawlik, Timothy M. Pai, Jonathan S. O'Reilly, Eileen Fisher, George A. Wild, Aaron T. Rosati, Lauren M. Zheng, Lei Wolfgang, Christopher L. Laheru, Daniel A. Columbo, Laurie A. Sugar, Elizabeth A. Koong, Albert C. |
| description | BACKGROUND
This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer (LAPC).
METHODS
A total of 49 patients with LAPC received up to 3 doses of GEM (1000 mg/m2) followed by a 1‐week break and SBRT (33.0 gray [Gy] in 5 fractions). After SBRT, patients continued to receive GEM until disease progression or toxicity. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) and pancreatic cancer‐specific QLQ‐PAN26 module before SBRT and at 4 weeks and 4 months after SBRT.
RESULTS
The median follow‐up was 13.9 months (range, 3.9‐45.2 months). The median age of the patients was 67 years and 84% had tumors of the pancreatic head. Rates of acute and late (primary endpoint) grade ≥2 gastritis, fistula, enteritis, or ulcer toxicities were 2% and 11%, respectively. QLQ‐C30 global quality of life scores remained stable from baseline to after SBRT (67 at baseline, median change of 0 at both follow‐ups; P>.05 for both). Patients reported a significant improvement in pancreatic pain (P = .001) 4 weeks after SBRT on the QLQ‐PAN26 questionnaire. The median plasma carbohydrate antigen 19‐9 (CA 19‐9) level was reduced after SBRT (median time after SBRT, 4.2 weeks; 220 U/mL vs 62 U/mL [P |
| doi_str_mv | 10.1002/cncr.29161 |
| format | Article |
| fullrecord | <record><control><sourceid>wiley_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4368473</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>CNCR29161</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4611-a8e05a508d310e60184ff0960ad47f3d4362b4906de1c821425b659e47c5c7393</originalsourceid><addsrcrecordid>eNp9kd9qFDEUh4NY7LZ64wNIroWpycxk_twIslQtFC2i4F04k5zZjWSSJclsmTsfwbfwvXySZl0tetObhHC-8yUnP0Kec3bBGStfKafCRdnzhj8iK876tmC8Lh-TFWOsK0RdfT0lZzF-y8e2FNUTcloKUXWM9yvy82YLEWlJp9km8-v7D-NiMmlOxjuwNAWTV9yDnSEZt6EbnJRJMBiHFJymMWFAn0Alo-jg9UIDaOPTFgPsFjr6QHe5E12K9NakLbVegbULBb0Hp1DT2QWMqLLTYmbzLAgHGWh0mQ3KOD_BU3Iygo347M9-Tr68vfy8fl9cf3x3tX5zXai64byADpkAwTpdcYYN4109jqxvGOi6HStdV0051D1rNHLVlfmbxNCIHutWCdVWfXVOXh-9u3mYUKv88ABW7oKZICzSg5H_V5zZyo3fy2zu6rbKgpdHgQo-xoDjfS9n8hCXPMQlf8eV4Rf_3naP_s0nA_wI3BqLywMquf6w_nSU3gE_Jqd6</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Wiley Online Library Free Content</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Herman, Joseph M. ; Chang, Daniel T. ; Goodman, Karyn A. ; Dholakia, Avani S. ; Raman, Siva P. ; Hacker‐Prietz, Amy ; Iacobuzio‐Donahue, Christine A. ; Griffith, Mary E. ; Pawlik, Timothy M. ; Pai, Jonathan S. ; O'Reilly, Eileen ; Fisher, George A. ; Wild, Aaron T. ; Rosati, Lauren M. ; Zheng, Lei ; Wolfgang, Christopher L. ; Laheru, Daniel A. ; Columbo, Laurie A. ; Sugar, Elizabeth A. ; Koong, Albert C.</creator><creatorcontrib>Herman, Joseph M. ; Chang, Daniel T. ; Goodman, Karyn A. ; Dholakia, Avani S. ; Raman, Siva P. ; Hacker‐Prietz, Amy ; Iacobuzio‐Donahue, Christine A. ; Griffith, Mary E. ; Pawlik, Timothy M. ; Pai, Jonathan S. ; O'Reilly, Eileen ; Fisher, George A. ; Wild, Aaron T. ; Rosati, Lauren M. ; Zheng, Lei ; Wolfgang, Christopher L. ; Laheru, Daniel A. ; Columbo, Laurie A. ; Sugar, Elizabeth A. ; Koong, Albert C.</creatorcontrib><description>BACKGROUND
This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer (LAPC).
METHODS
A total of 49 patients with LAPC received up to 3 doses of GEM (1000 mg/m2) followed by a 1‐week break and SBRT (33.0 gray [Gy] in 5 fractions). After SBRT, patients continued to receive GEM until disease progression or toxicity. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) and pancreatic cancer‐specific QLQ‐PAN26 module before SBRT and at 4 weeks and 4 months after SBRT.
RESULTS
The median follow‐up was 13.9 months (range, 3.9‐45.2 months). The median age of the patients was 67 years and 84% had tumors of the pancreatic head. Rates of acute and late (primary endpoint) grade ≥2 gastritis, fistula, enteritis, or ulcer toxicities were 2% and 11%, respectively. QLQ‐C30 global quality of life scores remained stable from baseline to after SBRT (67 at baseline, median change of 0 at both follow‐ups; P>.05 for both). Patients reported a significant improvement in pancreatic pain (P = .001) 4 weeks after SBRT on the QLQ‐PAN26 questionnaire. The median plasma carbohydrate antigen 19‐9 (CA 19‐9) level was reduced after SBRT (median time after SBRT, 4.2 weeks; 220 U/mL vs 62 U/mL [P<.001]). The median overall survival was 13.9 months (95% confidence interval, 10.2 months‐16.7 months). Freedom from local disease progression at 1 year was 78%. Four patients (8%) underwent margin‐negative and lymph node‐negative surgical resections.
CONCLUSIONS
Fractionated SBRT with GEM results in minimal acute and late gastrointestinal toxicity. Future studies should incorporate SBRT with more aggressive multiagent chemotherapy. Cancer 2015;121:1128–1137. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
To the authors' knowledge, the current study is the first prospective multi‐institutional trial evaluating the role of stereotactic body radiotherapy in patients with locally advanced pancreatic cancer. The results suggest that fractionated stereotactic body radiotherapy with gemcitabine achieves favorable toxicity, quality of life, and preliminary efficacy compared with historical data.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.29161</identifier><identifier>PMID: 25538019</identifier><language>eng</language><publisher>United States: BlackWell Publishing Ltd</publisher><subject>Adenocarcinoma - mortality ; Adenocarcinoma - pathology ; Adenocarcinoma - therapy ; Adult ; Aged ; Aged, 80 and over ; chemoradiation ; Combined Modality Therapy ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Disease Progression ; Dose Fractionation ; Female ; Follow-Up Studies ; Humans ; locally advanced ; Male ; Middle Aged ; Neoplasm Staging ; Original ; pancreatic cancer ; Pancreatic Neoplasms - mortality ; Pancreatic Neoplasms - pathology ; Pancreatic Neoplasms - therapy ; positron emission tomography ; Prognosis ; Prospective Studies ; Quality of Life ; Radiosurgery ; stereotactic body radiotherapy ; Survival Rate ; unresectable</subject><ispartof>Cancer, 2015-04, Vol.121 (7), p.1128-1137</ispartof><rights>2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society</rights><rights>2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.</rights><rights>2014 The Authors. published by Wiley Periodicals, Inc. on behalf of . 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4611-a8e05a508d310e60184ff0960ad47f3d4362b4906de1c821425b659e47c5c7393</citedby><cites>FETCH-LOGICAL-c4611-a8e05a508d310e60184ff0960ad47f3d4362b4906de1c821425b659e47c5c7393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcncr.29161$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcncr.29161$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25538019$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Herman, Joseph M.</creatorcontrib><creatorcontrib>Chang, Daniel T.</creatorcontrib><creatorcontrib>Goodman, Karyn A.</creatorcontrib><creatorcontrib>Dholakia, Avani S.</creatorcontrib><creatorcontrib>Raman, Siva P.</creatorcontrib><creatorcontrib>Hacker‐Prietz, Amy</creatorcontrib><creatorcontrib>Iacobuzio‐Donahue, Christine A.</creatorcontrib><creatorcontrib>Griffith, Mary E.</creatorcontrib><creatorcontrib>Pawlik, Timothy M.</creatorcontrib><creatorcontrib>Pai, Jonathan S.</creatorcontrib><creatorcontrib>O'Reilly, Eileen</creatorcontrib><creatorcontrib>Fisher, George A.</creatorcontrib><creatorcontrib>Wild, Aaron T.</creatorcontrib><creatorcontrib>Rosati, Lauren M.</creatorcontrib><creatorcontrib>Zheng, Lei</creatorcontrib><creatorcontrib>Wolfgang, Christopher L.</creatorcontrib><creatorcontrib>Laheru, Daniel A.</creatorcontrib><creatorcontrib>Columbo, Laurie A.</creatorcontrib><creatorcontrib>Sugar, Elizabeth A.</creatorcontrib><creatorcontrib>Koong, Albert C.</creatorcontrib><title>Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma</title><title>Cancer</title><addtitle>Cancer</addtitle><description>BACKGROUND
This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer (LAPC).
METHODS
A total of 49 patients with LAPC received up to 3 doses of GEM (1000 mg/m2) followed by a 1‐week break and SBRT (33.0 gray [Gy] in 5 fractions). After SBRT, patients continued to receive GEM until disease progression or toxicity. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) and pancreatic cancer‐specific QLQ‐PAN26 module before SBRT and at 4 weeks and 4 months after SBRT.
RESULTS
The median follow‐up was 13.9 months (range, 3.9‐45.2 months). The median age of the patients was 67 years and 84% had tumors of the pancreatic head. Rates of acute and late (primary endpoint) grade ≥2 gastritis, fistula, enteritis, or ulcer toxicities were 2% and 11%, respectively. QLQ‐C30 global quality of life scores remained stable from baseline to after SBRT (67 at baseline, median change of 0 at both follow‐ups; P>.05 for both). Patients reported a significant improvement in pancreatic pain (P = .001) 4 weeks after SBRT on the QLQ‐PAN26 questionnaire. The median plasma carbohydrate antigen 19‐9 (CA 19‐9) level was reduced after SBRT (median time after SBRT, 4.2 weeks; 220 U/mL vs 62 U/mL [P<.001]). The median overall survival was 13.9 months (95% confidence interval, 10.2 months‐16.7 months). Freedom from local disease progression at 1 year was 78%. Four patients (8%) underwent margin‐negative and lymph node‐negative surgical resections.
CONCLUSIONS
Fractionated SBRT with GEM results in minimal acute and late gastrointestinal toxicity. Future studies should incorporate SBRT with more aggressive multiagent chemotherapy. Cancer 2015;121:1128–1137. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
To the authors' knowledge, the current study is the first prospective multi‐institutional trial evaluating the role of stereotactic body radiotherapy in patients with locally advanced pancreatic cancer. The results suggest that fractionated stereotactic body radiotherapy with gemcitabine achieves favorable toxicity, quality of life, and preliminary efficacy compared with historical data.</description><subject>Adenocarcinoma - mortality</subject><subject>Adenocarcinoma - pathology</subject><subject>Adenocarcinoma - therapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>chemoradiation</subject><subject>Combined Modality Therapy</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Disease Progression</subject><subject>Dose Fractionation</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>locally advanced</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Original</subject><subject>pancreatic cancer</subject><subject>Pancreatic Neoplasms - mortality</subject><subject>Pancreatic Neoplasms - pathology</subject><subject>Pancreatic Neoplasms - therapy</subject><subject>positron emission tomography</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Radiosurgery</subject><subject>stereotactic body radiotherapy</subject><subject>Survival Rate</subject><subject>unresectable</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp9kd9qFDEUh4NY7LZ64wNIroWpycxk_twIslQtFC2i4F04k5zZjWSSJclsmTsfwbfwvXySZl0tetObhHC-8yUnP0Kec3bBGStfKafCRdnzhj8iK876tmC8Lh-TFWOsK0RdfT0lZzF-y8e2FNUTcloKUXWM9yvy82YLEWlJp9km8-v7D-NiMmlOxjuwNAWTV9yDnSEZt6EbnJRJMBiHFJymMWFAn0Alo-jg9UIDaOPTFgPsFjr6QHe5E12K9NakLbVegbULBb0Hp1DT2QWMqLLTYmbzLAgHGWh0mQ3KOD_BU3Iygo347M9-Tr68vfy8fl9cf3x3tX5zXai64byADpkAwTpdcYYN4109jqxvGOi6HStdV0051D1rNHLVlfmbxNCIHutWCdVWfXVOXh-9u3mYUKv88ABW7oKZICzSg5H_V5zZyo3fy2zu6rbKgpdHgQo-xoDjfS9n8hCXPMQlf8eV4Rf_3naP_s0nA_wI3BqLywMquf6w_nSU3gE_Jqd6</recordid><startdate>20150401</startdate><enddate>20150401</enddate><creator>Herman, Joseph M.</creator><creator>Chang, Daniel T.</creator><creator>Goodman, Karyn A.</creator><creator>Dholakia, Avani S.</creator><creator>Raman, Siva P.</creator><creator>Hacker‐Prietz, Amy</creator><creator>Iacobuzio‐Donahue, Christine A.</creator><creator>Griffith, Mary E.</creator><creator>Pawlik, Timothy M.</creator><creator>Pai, Jonathan S.</creator><creator>O'Reilly, Eileen</creator><creator>Fisher, George A.</creator><creator>Wild, Aaron T.</creator><creator>Rosati, Lauren M.</creator><creator>Zheng, Lei</creator><creator>Wolfgang, Christopher L.</creator><creator>Laheru, Daniel A.</creator><creator>Columbo, Laurie A.</creator><creator>Sugar, Elizabeth A.</creator><creator>Koong, Albert C.</creator><general>BlackWell Publishing Ltd</general><scope>24P</scope><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>5PM</scope></search><sort><creationdate>20150401</creationdate><title>Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma</title><author>Herman, Joseph M. ; Chang, Daniel T. ; Goodman, Karyn A. ; Dholakia, Avani S. ; Raman, Siva P. ; Hacker‐Prietz, Amy ; Iacobuzio‐Donahue, Christine A. ; Griffith, Mary E. ; Pawlik, Timothy M. ; Pai, Jonathan S. ; O'Reilly, Eileen ; Fisher, George A. ; Wild, Aaron T. ; Rosati, Lauren M. ; Zheng, Lei ; Wolfgang, Christopher L. ; Laheru, Daniel A. ; Columbo, Laurie A. ; Sugar, Elizabeth A. ; Koong, Albert C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4611-a8e05a508d310e60184ff0960ad47f3d4362b4906de1c821425b659e47c5c7393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adenocarcinoma - mortality</topic><topic>Adenocarcinoma - pathology</topic><topic>Adenocarcinoma - therapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>chemoradiation</topic><topic>Combined Modality Therapy</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Disease Progression</topic><topic>Dose Fractionation</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>locally advanced</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Original</topic><topic>pancreatic cancer</topic><topic>Pancreatic Neoplasms - mortality</topic><topic>Pancreatic Neoplasms - pathology</topic><topic>Pancreatic Neoplasms - therapy</topic><topic>positron emission tomography</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Radiosurgery</topic><topic>stereotactic body radiotherapy</topic><topic>Survival Rate</topic><topic>unresectable</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Herman, Joseph M.</creatorcontrib><creatorcontrib>Chang, Daniel T.</creatorcontrib><creatorcontrib>Goodman, Karyn A.</creatorcontrib><creatorcontrib>Dholakia, Avani S.</creatorcontrib><creatorcontrib>Raman, Siva P.</creatorcontrib><creatorcontrib>Hacker‐Prietz, Amy</creatorcontrib><creatorcontrib>Iacobuzio‐Donahue, Christine A.</creatorcontrib><creatorcontrib>Griffith, Mary E.</creatorcontrib><creatorcontrib>Pawlik, Timothy M.</creatorcontrib><creatorcontrib>Pai, Jonathan S.</creatorcontrib><creatorcontrib>O'Reilly, Eileen</creatorcontrib><creatorcontrib>Fisher, George A.</creatorcontrib><creatorcontrib>Wild, Aaron T.</creatorcontrib><creatorcontrib>Rosati, Lauren M.</creatorcontrib><creatorcontrib>Zheng, Lei</creatorcontrib><creatorcontrib>Wolfgang, Christopher L.</creatorcontrib><creatorcontrib>Laheru, Daniel A.</creatorcontrib><creatorcontrib>Columbo, Laurie A.</creatorcontrib><creatorcontrib>Sugar, Elizabeth A.</creatorcontrib><creatorcontrib>Koong, Albert C.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Herman, Joseph M.</au><au>Chang, Daniel T.</au><au>Goodman, Karyn A.</au><au>Dholakia, Avani S.</au><au>Raman, Siva P.</au><au>Hacker‐Prietz, Amy</au><au>Iacobuzio‐Donahue, Christine A.</au><au>Griffith, Mary E.</au><au>Pawlik, Timothy M.</au><au>Pai, Jonathan S.</au><au>O'Reilly, Eileen</au><au>Fisher, George A.</au><au>Wild, Aaron T.</au><au>Rosati, Lauren M.</au><au>Zheng, Lei</au><au>Wolfgang, Christopher L.</au><au>Laheru, Daniel A.</au><au>Columbo, Laurie A.</au><au>Sugar, Elizabeth A.</au><au>Koong, Albert C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2015-04-01</date><risdate>2015</risdate><volume>121</volume><issue>7</issue><spage>1128</spage><epage>1137</epage><pages>1128-1137</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><abstract>BACKGROUND
This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer (LAPC).
METHODS
A total of 49 patients with LAPC received up to 3 doses of GEM (1000 mg/m2) followed by a 1‐week break and SBRT (33.0 gray [Gy] in 5 fractions). After SBRT, patients continued to receive GEM until disease progression or toxicity. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) and pancreatic cancer‐specific QLQ‐PAN26 module before SBRT and at 4 weeks and 4 months after SBRT.
RESULTS
The median follow‐up was 13.9 months (range, 3.9‐45.2 months). The median age of the patients was 67 years and 84% had tumors of the pancreatic head. Rates of acute and late (primary endpoint) grade ≥2 gastritis, fistula, enteritis, or ulcer toxicities were 2% and 11%, respectively. QLQ‐C30 global quality of life scores remained stable from baseline to after SBRT (67 at baseline, median change of 0 at both follow‐ups; P>.05 for both). Patients reported a significant improvement in pancreatic pain (P = .001) 4 weeks after SBRT on the QLQ‐PAN26 questionnaire. The median plasma carbohydrate antigen 19‐9 (CA 19‐9) level was reduced after SBRT (median time after SBRT, 4.2 weeks; 220 U/mL vs 62 U/mL [P<.001]). The median overall survival was 13.9 months (95% confidence interval, 10.2 months‐16.7 months). Freedom from local disease progression at 1 year was 78%. Four patients (8%) underwent margin‐negative and lymph node‐negative surgical resections.
CONCLUSIONS
Fractionated SBRT with GEM results in minimal acute and late gastrointestinal toxicity. Future studies should incorporate SBRT with more aggressive multiagent chemotherapy. Cancer 2015;121:1128–1137. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
To the authors' knowledge, the current study is the first prospective multi‐institutional trial evaluating the role of stereotactic body radiotherapy in patients with locally advanced pancreatic cancer. The results suggest that fractionated stereotactic body radiotherapy with gemcitabine achieves favorable toxicity, quality of life, and preliminary efficacy compared with historical data.</abstract><cop>United States</cop><pub>BlackWell Publishing Ltd</pub><pmid>25538019</pmid><doi>10.1002/cncr.29161</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0008-543X |
| ispartof | Cancer, 2015-04, Vol.121 (7), p.1128-1137 |
| issn | 0008-543X 1097-0142 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4368473 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Wiley Online Library Free Content; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adenocarcinoma - mortality Adenocarcinoma - pathology Adenocarcinoma - therapy Adult Aged Aged, 80 and over chemoradiation Combined Modality Therapy Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease Progression Dose Fractionation Female Follow-Up Studies Humans locally advanced Male Middle Aged Neoplasm Staging Original pancreatic cancer Pancreatic Neoplasms - mortality Pancreatic Neoplasms - pathology Pancreatic Neoplasms - therapy positron emission tomography Prognosis Prospective Studies Quality of Life Radiosurgery stereotactic body radiotherapy Survival Rate unresectable |
| title | Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-03T18%3A13%3A57IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-wiley_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%202%20multi%E2%80%90institutional%20trial%20evaluating%20gemcitabine%20and%20stereotactic%20body%20radiotherapy%20for%20patients%20with%20locally%20advanced%20unresectable%20pancreatic%20adenocarcinoma&rft.jtitle=Cancer&rft.au=Herman,%20Joseph%20M.&rft.date=2015-04-01&rft.volume=121&rft.issue=7&rft.spage=1128&rft.epage=1137&rft.pages=1128-1137&rft.issn=0008-543X&rft.eissn=1097-0142&rft_id=info:doi/10.1002/cncr.29161&rft_dat=%3Cwiley_pubme%3ECNCR29161%3C/wiley_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/25538019&rfr_iscdi=true |