A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer
Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT). Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins wa...
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| Veröffentlicht in: | Annals of oncology 2006-01, Vol.17 (1), p.50-56 |
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| creator | Glynne-Jones, R. Sebag-Montefiore, D. Maughan, T. S. Falk, S. J. McDonald, A. C. |
| description | Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT). Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins was unlikely received continuous capecitabine (500–825 mg/m2 twice daily, 7 days/week), oxaliplatin 2-h intravenous infusion (130 mg/m2 days 1 and 29) and pelvic radiotherapy (Monday–Friday for 5 weeks, total dose 45 Gy in 25 daily 1.8 Gy fractions). The MTD was the capecitabine dose causing dose-limiting toxicities (DLTs; treatment-related grade 3/4 toxicities) in one-third or more of patients treated per dose level. Results: Eighteen patients received three dose levels. The MTD was capecitabine 825 mg/m2 twice daily: DLTs occurred in two of six patients (grade 3 diarrhoea, rectal pain with local skin reaction). No DLTs occurred in six patients receiving capecitabine 650 mg/m2 twice daily. Grade 3/4 toxicity was rare, with minimal myelosuppression. Although predominantly a dose-finding study, XELOX-RT showed promising activity. Fourteen patients had histologically confirmed R0 resections and five had a pathological complete response. Conclusions: The recommended dose for further study is capecitabine 650 mg/m2 twice daily with oxaliplatin and radiotherapy. XELOX-RT showed promising antitumour activity. Further evaluation is underway. |
| doi_str_mv | 10.1093/annonc/mdj031 |
| format | Article |
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S. ; Falk, S. J. ; McDonald, A. C.</creator><creatorcontrib>Glynne-Jones, R. ; Sebag-Montefiore, D. ; Maughan, T. S. ; Falk, S. J. ; McDonald, A. C.</creatorcontrib><description>Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT). Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins was unlikely received continuous capecitabine (500–825 mg/m2 twice daily, 7 days/week), oxaliplatin 2-h intravenous infusion (130 mg/m2 days 1 and 29) and pelvic radiotherapy (Monday–Friday for 5 weeks, total dose 45 Gy in 25 daily 1.8 Gy fractions). The MTD was the capecitabine dose causing dose-limiting toxicities (DLTs; treatment-related grade 3/4 toxicities) in one-third or more of patients treated per dose level. Results: Eighteen patients received three dose levels. The MTD was capecitabine 825 mg/m2 twice daily: DLTs occurred in two of six patients (grade 3 diarrhoea, rectal pain with local skin reaction). No DLTs occurred in six patients receiving capecitabine 650 mg/m2 twice daily. Grade 3/4 toxicity was rare, with minimal myelosuppression. Although predominantly a dose-finding study, XELOX-RT showed promising activity. Fourteen patients had histologically confirmed R0 resections and five had a pathological complete response. Conclusions: The recommended dose for further study is capecitabine 650 mg/m2 twice daily with oxaliplatin and radiotherapy. XELOX-RT showed promising antitumour activity. Further evaluation is underway.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdj031</identifier><identifier>PMID: 16284060</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - radiotherapy ; Administration, Oral ; Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Capecitabine ; chemoradiation ; Combined Modality Therapy ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Dose-Response Relationship, Drug ; Female ; Fluorouracil - analogs & derivatives ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; locally advanced rectal cancer ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Neoplasm Staging ; Organoplatinum Compounds - administration & dosage ; Oxaliplatin ; Pelvis - radiation effects ; Pharmacology. Drug treatments ; Preoperative Care ; Rectal Neoplasms - drug therapy ; Rectal Neoplasms - radiotherapy ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Rate ; Tumors</subject><ispartof>Annals of oncology, 2006-01, Vol.17 (1), p.50-56</ispartof><rights>2006 INIST-CNRS</rights><rights>Copyright Oxford University Press(England) Jan 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c456t-ae561e68793db74c80d469a49204900db18b80e24a3cd71699f256e8bfc5d5203</citedby><cites>FETCH-LOGICAL-c456t-ae561e68793db74c80d469a49204900db18b80e24a3cd71699f256e8bfc5d5203</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,4009,27902,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17500304$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16284060$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Glynne-Jones, R.</creatorcontrib><creatorcontrib>Sebag-Montefiore, D.</creatorcontrib><creatorcontrib>Maughan, T. S.</creatorcontrib><creatorcontrib>Falk, S. J.</creatorcontrib><creatorcontrib>McDonald, A. C.</creatorcontrib><title>A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT). Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins was unlikely received continuous capecitabine (500–825 mg/m2 twice daily, 7 days/week), oxaliplatin 2-h intravenous infusion (130 mg/m2 days 1 and 29) and pelvic radiotherapy (Monday–Friday for 5 weeks, total dose 45 Gy in 25 daily 1.8 Gy fractions). The MTD was the capecitabine dose causing dose-limiting toxicities (DLTs; treatment-related grade 3/4 toxicities) in one-third or more of patients treated per dose level. Results: Eighteen patients received three dose levels. The MTD was capecitabine 825 mg/m2 twice daily: DLTs occurred in two of six patients (grade 3 diarrhoea, rectal pain with local skin reaction). No DLTs occurred in six patients receiving capecitabine 650 mg/m2 twice daily. Grade 3/4 toxicity was rare, with minimal myelosuppression. Although predominantly a dose-finding study, XELOX-RT showed promising activity. Fourteen patients had histologically confirmed R0 resections and five had a pathological complete response. Conclusions: The recommended dose for further study is capecitabine 650 mg/m2 twice daily with oxaliplatin and radiotherapy. XELOX-RT showed promising antitumour activity. Further evaluation is underway.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - radiotherapy</subject><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Capecitabine</subject><subject>chemoradiation</subject><subject>Combined Modality Therapy</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Fluorouracil - analogs & derivatives</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>locally advanced rectal cancer</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Oxaliplatin</subject><subject>Pelvis - radiation effects</subject><subject>Pharmacology. Drug treatments</subject><subject>Preoperative Care</subject><subject>Rectal Neoplasms - drug therapy</subject><subject>Rectal Neoplasms - radiotherapy</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Survival Rate</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkcFu1DAQhi0EotuFI1dkIYHgEDqOEyc-VqXQohVFUNCKi-XYjuolsYOdtN2n4hXxkhUrcfHYnu-fGc2P0DMCbwlweiKd806d9HoDlDxAC1IyntVQkIdoATynWVXS4ggdx7gBAMZz_hgdEZbXBTBYoN-neLiR0eBLrH0KJirZydF6h-M46S32LVbejdZNforYB9lhJQej7Cgb6wy2LuX7dJ1Fd3a8wf5ednbYlXFYOo0H091ahYPUdqZer89XV-vsy_WbnX5In8aNcRZ3Pk3QbbHUt9Ipo3EwavzbNb3CE_SolV00T_dxib69P78-u8hWVx8uz05XmSpKNmbSlIwYVlec6qYqVA26YFwWPIeCA-iG1E0NJi8kVboijPM2L5mpm1aVusyBLtGrue4Q_K_JxFH0NirTddKZtAiRk5wzSAYs0Yv_wI2fgkuzCcIZoxVNxxJlM6SCjzGYVgzB9jJsBQGxs1HMNorZxsQ_3xedmt7oA733LQEv94DcGdaGtBwbD1xVAlAoDo1tHM39v7wMPwWraFWKi_UP8ZHST-_I56_iO_0DJlC4ow</recordid><startdate>200601</startdate><enddate>200601</enddate><creator>Glynne-Jones, R.</creator><creator>Sebag-Montefiore, D.</creator><creator>Maughan, T. S.</creator><creator>Falk, S. J.</creator><creator>McDonald, A. C.</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>BSCLL</scope><scope>IQODW</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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>200601</creationdate><title>A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer</title><author>Glynne-Jones, R. ; Sebag-Montefiore, D. ; Maughan, T. S. ; Falk, S. J. ; McDonald, A. 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Abdomen</topic><topic>Humans</topic><topic>locally advanced rectal cancer</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Oxaliplatin</topic><topic>Pelvis - radiation effects</topic><topic>Pharmacology. Drug treatments</topic><topic>Preoperative Care</topic><topic>Rectal Neoplasms - drug therapy</topic><topic>Rectal Neoplasms - radiotherapy</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Survival Rate</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Glynne-Jones, R.</creatorcontrib><creatorcontrib>Sebag-Montefiore, D.</creatorcontrib><creatorcontrib>Maughan, T. S.</creatorcontrib><creatorcontrib>Falk, S. J.</creatorcontrib><creatorcontrib>McDonald, A. 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C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2006-01</date><risdate>2006</risdate><volume>17</volume><issue>1</issue><spage>50</spage><epage>56</epage><pages>50-56</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT). Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins was unlikely received continuous capecitabine (500–825 mg/m2 twice daily, 7 days/week), oxaliplatin 2-h intravenous infusion (130 mg/m2 days 1 and 29) and pelvic radiotherapy (Monday–Friday for 5 weeks, total dose 45 Gy in 25 daily 1.8 Gy fractions). The MTD was the capecitabine dose causing dose-limiting toxicities (DLTs; treatment-related grade 3/4 toxicities) in one-third or more of patients treated per dose level. Results: Eighteen patients received three dose levels. The MTD was capecitabine 825 mg/m2 twice daily: DLTs occurred in two of six patients (grade 3 diarrhoea, rectal pain with local skin reaction). No DLTs occurred in six patients receiving capecitabine 650 mg/m2 twice daily. Grade 3/4 toxicity was rare, with minimal myelosuppression. Although predominantly a dose-finding study, XELOX-RT showed promising activity. Fourteen patients had histologically confirmed R0 resections and five had a pathological complete response. Conclusions: The recommended dose for further study is capecitabine 650 mg/m2 twice daily with oxaliplatin and radiotherapy. XELOX-RT showed promising antitumour activity. Further evaluation is underway.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>16284060</pmid><doi>10.1093/annonc/mdj031</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - radiotherapy Administration, Oral Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Capecitabine chemoradiation Combined Modality Therapy Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Dose-Response Relationship, Drug Female Fluorouracil - analogs & derivatives Gastroenterology. Liver. Pancreas. Abdomen Humans locally advanced rectal cancer Male Maximum Tolerated Dose Medical sciences Middle Aged Neoplasm Staging Organoplatinum Compounds - administration & dosage Oxaliplatin Pelvis - radiation effects Pharmacology. Drug treatments Preoperative Care Rectal Neoplasms - drug therapy Rectal Neoplasms - radiotherapy Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Rate Tumors |
| title | A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer |
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