617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER
Abstract Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. Methods: We randomly...
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| Veröffentlicht in: | Annals of oncology 2014-09, Vol.25 (suppl_4), p.iv210-iv211 |
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| creator | Singhal, M.K. Kapoor, A. Bagri, P.K. Narayan, S. Singh, D. Nirban, R.K. Singh, G. Maharia, S. Kumari, P. Jakhar, S.L. Beniwal, S. Sharma, N. Harsh, K. Kumar, H.S. Sharma, A. Bardia, M. |
| description | Abstract
Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods: We randomly assigned 310 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter on Day 1, 8 and 15, cycle repeated at 28 days for 6 cycles. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results: The median overall survival was 10.8 months in the FOLFIRINOX group as compared with 7.4 months in the gemcitabine group (hazard ratio for death, 0.48; 95% confidence interval [CI], 0.41 to 0.68; P < 0.001). Median progression-free survival was 5.6 months in the FOLFIRINOX group and 3.1 months in the gemcitabine group (hazard ratio for disease progression, 0.44; 95% CI, 0.29 to 0.49; P < 0.001). The objective response rate was 29.6% in the FOLFIRINOX group versus 8.3% in the gemcitabine group (P < 0.001). More adverse events were noted in the FOLFIRINOX group; 4.8% of patients in this group had febrile neutropenia. At 6 months, 29% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 59% in the gemcitabine group (hazard ratio, 0.45; 95% CI, 0.29 to 0.68; P < 0.001).
Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival benefit at the cost of increased toxicity. Thus, FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer having good performance status.
Disclosure: All authors have declared no conflicts of interest. |
| doi_str_mv | 10.1093/annonc/mdu334.3 |
| format | Article |
| fullrecord | <record><control><sourceid>oup</sourceid><recordid>TN_cdi_oup_primary_10_1093_annonc_mdu334_3</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/annonc/mdu334.3</oup_id><sourcerecordid>10.1093/annonc/mdu334.3</sourcerecordid><originalsourceid>FETCH-oup_primary_10_1093_annonc_mdu334_33</originalsourceid><addsrcrecordid>eNqVj0uLwjAURoMoWB9rt3c9UE1MrZNlJqZ6oS_SKO5C0RmYYaxiceG_tz7-gKvvwHc2h5ARo2NGBZ-UVXWsdpPD_sJ5MOYt4rFZKPxPGrA28aiYcn8-40GX9Or6j1IaiqnwiAvZPF9IyFey0ICIYA3KGFSW5NJguoQoiyNsKNvCRptiXcBSJwqt_MJUN6-BRFtZWGlRQS5TZfQDVYPaDEjnp_yvv4ev7ZOPSFu18o-Xkzudfw_l-eoYdfcE90xwzwTH-VvyDVoLR-c</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER</title><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Singhal, M.K. ; Kapoor, A. ; Bagri, P.K. ; Narayan, S. ; Singh, D. ; Nirban, R.K. ; Singh, G. ; Maharia, S. ; Kumari, P. ; Jakhar, S.L. ; Beniwal, S. ; Sharma, N. ; Harsh, K. ; Kumar, H.S. ; Sharma, A. ; Bardia, M.</creator><creatorcontrib>Singhal, M.K. ; Kapoor, A. ; Bagri, P.K. ; Narayan, S. ; Singh, D. ; Nirban, R.K. ; Singh, G. ; Maharia, S. ; Kumari, P. ; Jakhar, S.L. ; Beniwal, S. ; Sharma, N. ; Harsh, K. ; Kumar, H.S. ; Sharma, A. ; Bardia, M.</creatorcontrib><description>Abstract
Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods: We randomly assigned 310 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter on Day 1, 8 and 15, cycle repeated at 28 days for 6 cycles. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results: The median overall survival was 10.8 months in the FOLFIRINOX group as compared with 7.4 months in the gemcitabine group (hazard ratio for death, 0.48; 95% confidence interval [CI], 0.41 to 0.68; P < 0.001). Median progression-free survival was 5.6 months in the FOLFIRINOX group and 3.1 months in the gemcitabine group (hazard ratio for disease progression, 0.44; 95% CI, 0.29 to 0.49; P < 0.001). The objective response rate was 29.6% in the FOLFIRINOX group versus 8.3% in the gemcitabine group (P < 0.001). More adverse events were noted in the FOLFIRINOX group; 4.8% of patients in this group had febrile neutropenia. At 6 months, 29% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 59% in the gemcitabine group (hazard ratio, 0.45; 95% CI, 0.29 to 0.68; P < 0.001).
Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival benefit at the cost of increased toxicity. Thus, FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer having good performance status.
Disclosure: All authors have declared no conflicts of interest.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdu334.3</identifier><language>eng</language><publisher>Oxford University Press</publisher><ispartof>Annals of oncology, 2014-09, Vol.25 (suppl_4), p.iv210-iv211</ispartof><rights>European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2014</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>315,781,785,27929,27930</link.rule.ids></links><search><creatorcontrib>Singhal, M.K.</creatorcontrib><creatorcontrib>Kapoor, A.</creatorcontrib><creatorcontrib>Bagri, P.K.</creatorcontrib><creatorcontrib>Narayan, S.</creatorcontrib><creatorcontrib>Singh, D.</creatorcontrib><creatorcontrib>Nirban, R.K.</creatorcontrib><creatorcontrib>Singh, G.</creatorcontrib><creatorcontrib>Maharia, S.</creatorcontrib><creatorcontrib>Kumari, P.</creatorcontrib><creatorcontrib>Jakhar, S.L.</creatorcontrib><creatorcontrib>Beniwal, S.</creatorcontrib><creatorcontrib>Sharma, N.</creatorcontrib><creatorcontrib>Harsh, K.</creatorcontrib><creatorcontrib>Kumar, H.S.</creatorcontrib><creatorcontrib>Sharma, A.</creatorcontrib><creatorcontrib>Bardia, M.</creatorcontrib><title>617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER</title><title>Annals of oncology</title><description>Abstract
Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods: We randomly assigned 310 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter on Day 1, 8 and 15, cycle repeated at 28 days for 6 cycles. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results: The median overall survival was 10.8 months in the FOLFIRINOX group as compared with 7.4 months in the gemcitabine group (hazard ratio for death, 0.48; 95% confidence interval [CI], 0.41 to 0.68; P < 0.001). Median progression-free survival was 5.6 months in the FOLFIRINOX group and 3.1 months in the gemcitabine group (hazard ratio for disease progression, 0.44; 95% CI, 0.29 to 0.49; P < 0.001). The objective response rate was 29.6% in the FOLFIRINOX group versus 8.3% in the gemcitabine group (P < 0.001). More adverse events were noted in the FOLFIRINOX group; 4.8% of patients in this group had febrile neutropenia. At 6 months, 29% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 59% in the gemcitabine group (hazard ratio, 0.45; 95% CI, 0.29 to 0.68; P < 0.001).
Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival benefit at the cost of increased toxicity. Thus, FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer having good performance status.
Disclosure: All authors have declared no conflicts of interest.</description><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid/><recordid>eNqVj0uLwjAURoMoWB9rt3c9UE1MrZNlJqZ6oS_SKO5C0RmYYaxiceG_tz7-gKvvwHc2h5ARo2NGBZ-UVXWsdpPD_sJ5MOYt4rFZKPxPGrA28aiYcn8-40GX9Or6j1IaiqnwiAvZPF9IyFey0ICIYA3KGFSW5NJguoQoiyNsKNvCRptiXcBSJwqt_MJUN6-BRFtZWGlRQS5TZfQDVYPaDEjnp_yvv4ev7ZOPSFu18o-Xkzudfw_l-eoYdfcE90xwzwTH-VvyDVoLR-c</recordid><startdate>20140901</startdate><enddate>20140901</enddate><creator>Singhal, M.K.</creator><creator>Kapoor, A.</creator><creator>Bagri, P.K.</creator><creator>Narayan, S.</creator><creator>Singh, D.</creator><creator>Nirban, R.K.</creator><creator>Singh, G.</creator><creator>Maharia, S.</creator><creator>Kumari, P.</creator><creator>Jakhar, S.L.</creator><creator>Beniwal, S.</creator><creator>Sharma, N.</creator><creator>Harsh, K.</creator><creator>Kumar, H.S.</creator><creator>Sharma, A.</creator><creator>Bardia, M.</creator><general>Oxford University Press</general><scope/></search><sort><creationdate>20140901</creationdate><title>617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER</title><author>Singhal, M.K. ; Kapoor, A. ; Bagri, P.K. ; Narayan, S. ; Singh, D. ; Nirban, R.K. ; Singh, G. ; Maharia, S. ; Kumari, P. ; Jakhar, S.L. ; Beniwal, S. ; Sharma, N. ; Harsh, K. ; Kumar, H.S. ; Sharma, A. ; Bardia, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-oup_primary_10_1093_annonc_mdu334_33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Singhal, M.K.</creatorcontrib><creatorcontrib>Kapoor, A.</creatorcontrib><creatorcontrib>Bagri, P.K.</creatorcontrib><creatorcontrib>Narayan, S.</creatorcontrib><creatorcontrib>Singh, D.</creatorcontrib><creatorcontrib>Nirban, R.K.</creatorcontrib><creatorcontrib>Singh, G.</creatorcontrib><creatorcontrib>Maharia, S.</creatorcontrib><creatorcontrib>Kumari, P.</creatorcontrib><creatorcontrib>Jakhar, S.L.</creatorcontrib><creatorcontrib>Beniwal, S.</creatorcontrib><creatorcontrib>Sharma, N.</creatorcontrib><creatorcontrib>Harsh, K.</creatorcontrib><creatorcontrib>Kumar, H.S.</creatorcontrib><creatorcontrib>Sharma, A.</creatorcontrib><creatorcontrib>Bardia, M.</creatorcontrib><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Singhal, M.K.</au><au>Kapoor, A.</au><au>Bagri, P.K.</au><au>Narayan, S.</au><au>Singh, D.</au><au>Nirban, R.K.</au><au>Singh, G.</au><au>Maharia, S.</au><au>Kumari, P.</au><au>Jakhar, S.L.</au><au>Beniwal, S.</au><au>Sharma, N.</au><au>Harsh, K.</au><au>Kumar, H.S.</au><au>Sharma, A.</au><au>Bardia, M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER</atitle><jtitle>Annals of oncology</jtitle><date>2014-09-01</date><risdate>2014</risdate><volume>25</volume><issue>suppl_4</issue><spage>iv210</spage><epage>iv211</epage><pages>iv210-iv211</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Abstract
Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods: We randomly assigned 310 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter on Day 1, 8 and 15, cycle repeated at 28 days for 6 cycles. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results: The median overall survival was 10.8 months in the FOLFIRINOX group as compared with 7.4 months in the gemcitabine group (hazard ratio for death, 0.48; 95% confidence interval [CI], 0.41 to 0.68; P < 0.001). Median progression-free survival was 5.6 months in the FOLFIRINOX group and 3.1 months in the gemcitabine group (hazard ratio for disease progression, 0.44; 95% CI, 0.29 to 0.49; P < 0.001). The objective response rate was 29.6% in the FOLFIRINOX group versus 8.3% in the gemcitabine group (P < 0.001). More adverse events were noted in the FOLFIRINOX group; 4.8% of patients in this group had febrile neutropenia. At 6 months, 29% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 59% in the gemcitabine group (hazard ratio, 0.45; 95% CI, 0.29 to 0.68; P < 0.001).
Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival benefit at the cost of increased toxicity. Thus, FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer having good performance status.
Disclosure: All authors have declared no conflicts of interest.</abstract><pub>Oxford University Press</pub><doi>10.1093/annonc/mdu334.3</doi></addata></record> |
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| title | 617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER |
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