A randomised phase II study on neo-adjuvant chemotherapy for ‘high-risk’ adult soft-tissue sarcoma
The aim of this study was to examine the strategy, feasibility and outcome of neo-adjuvant chemotherapy, with doxorubicin and ifosfamide, in adult patients with ‘high-risk’ soft-tissue sarcomas. Patients with ‘high-risk’ soft-tissue sarcomas, defined as tumours ⩾8 cm of any grade, or grade II/III tu...
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| Veröffentlicht in: | European journal of cancer (1990) 2001-06, Vol.37 (9), p.1096-1103 |
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| container_title | European journal of cancer (1990) |
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| creator | Gortzak, E Azzarelli, A Buesa, J Bramwell, V.H.C van Coevorden, F van Geel, A.N Ezzat, A Santoro, A Oosterhuis, J.W van Glabbeke, M Kirkpatrick, A Verweij, J |
| description | The aim of this study was to examine the strategy, feasibility and outcome of neo-adjuvant chemotherapy, with doxorubicin and ifosfamide, in adult patients with ‘high-risk’ soft-tissue sarcomas. Patients with ‘high-risk’ soft-tissue sarcomas, defined as tumours ⩾8 cm of any grade, or grade II/III tumours |
| doi_str_mv | 10.1016/S0959-8049(01)00083-1 |
| format | Article |
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Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group ; E.O.R.T.C. Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group</creatorcontrib><description>The aim of this study was to examine the strategy, feasibility and outcome of neo-adjuvant chemotherapy, with doxorubicin and ifosfamide, in adult patients with ‘high-risk’ soft-tissue sarcomas. Patients with ‘high-risk’ soft-tissue sarcomas, defined as tumours ⩾8 cm of any grade, or grade II/III tumours <8 cm, or grade II/III locally recurrent tumours, or grade II/III tumours with inadequate surgery performed in the previous 6 weeks and therefore requiring further surgery, were randomised between either surgery alone or three cycles of 3-weekly doxorubicin 50 mg/m2 intravenous (i.v.) bolus and ifosfamide 5 g/m2 (24 h infusion) before surgery. The type of surgery had to be planned at randomisation. Tumours were to be amenable to surgery by amputation, compartmental resection, wide or marginal excision. If chemotherapy was given, surgery had to be performed within 21 days after the last chemotherapy. Patients received postoperative radiotherapy in cases of marginal surgery, microscopically incomplete resection and no further possibility for surgery, and in cases of surgery because of local recurrence. 150 patients were entered into the study and 134 were eligible, 67 in each arm. The most frequent side-effects of chemotherapy were alopecia, nausea and vomiting (95%), and leucocytopenia (32%). One patient died of neutropenic fever after the first cycle of chemotherapy. Chemotherapy did not interfere with planned surgery and did not affect postoperative wound healing. Limb-salvage was achieved in 88%, amputation was necessary in 12% (all according to the plan at randomisation). The trial was closed after completion of phase II, since accrual was too slow to justify expanding the study into the scheduled phase III study. At a median follow-up of 7.3 years, the 5 year disease-free survival is estimated at 52% for the no chemotherapy and 56% for the chemotherapy arm (standard error: 7%) (P=0.3548). The 5 year overall survival for both arms is 64 and 65%, respectively (standard error 7%) (P=0.2204). Neo-adjuvant-chemotherapy with doxorubicin and ifosfamide at these doses and with this schedule was feasible and did not compromise subsequent treatment, surgery with or without radiotherapy. Although not powered to draw definitive conclusions on benefit, but with an at least 7 year median follow-up, the results render it less likely that major survival benefits will be achieved with this type of chemotherapy.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/S0959-8049(01)00083-1</identifier><identifier>PMID: 11378339</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Chemotherapy ; Chemotherapy, Adjuvant ; Combined Modality Therapy - methods ; Disease Progression ; Disease-Free Survival ; Doxorubicin - administration & dosage ; Follow-Up Studies ; Humans ; Ifosfamide - administration & dosage ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoadjuvant chemotherapy ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - surgery ; Pharmacology. Drug treatments ; Preoperative Care - methods ; Randomised study ; Risk Factors ; Sarcoma - drug therapy ; Sarcoma - radiotherapy ; Sarcoma - surgery ; Soft-tissue sarcoma ; Tumors</subject><ispartof>European journal of cancer (1990), 2001-06, Vol.37 (9), p.1096-1103</ispartof><rights>2001 Elsevier Science Ltd</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-df8534e454bdbc6de960858259dc9048405ab99da2844660cb27d7599838b6953</citedby><cites>FETCH-LOGICAL-c390t-df8534e454bdbc6de960858259dc9048405ab99da2844660cb27d7599838b6953</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0959-8049(01)00083-1$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,782,786,3554,27933,27934,46004</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1024173$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11378339$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gortzak, E</creatorcontrib><creatorcontrib>Azzarelli, A</creatorcontrib><creatorcontrib>Buesa, J</creatorcontrib><creatorcontrib>Bramwell, V.H.C</creatorcontrib><creatorcontrib>van Coevorden, F</creatorcontrib><creatorcontrib>van Geel, A.N</creatorcontrib><creatorcontrib>Ezzat, A</creatorcontrib><creatorcontrib>Santoro, A</creatorcontrib><creatorcontrib>Oosterhuis, J.W</creatorcontrib><creatorcontrib>van Glabbeke, M</creatorcontrib><creatorcontrib>Kirkpatrick, A</creatorcontrib><creatorcontrib>Verweij, J</creatorcontrib><creatorcontrib>the E.O.R.T.C. Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group</creatorcontrib><creatorcontrib>E.O.R.T.C. Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group</creatorcontrib><title>A randomised phase II study on neo-adjuvant chemotherapy for ‘high-risk’ adult soft-tissue sarcoma</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>The aim of this study was to examine the strategy, feasibility and outcome of neo-adjuvant chemotherapy, with doxorubicin and ifosfamide, in adult patients with ‘high-risk’ soft-tissue sarcomas. Patients with ‘high-risk’ soft-tissue sarcomas, defined as tumours ⩾8 cm of any grade, or grade II/III tumours <8 cm, or grade II/III locally recurrent tumours, or grade II/III tumours with inadequate surgery performed in the previous 6 weeks and therefore requiring further surgery, were randomised between either surgery alone or three cycles of 3-weekly doxorubicin 50 mg/m2 intravenous (i.v.) bolus and ifosfamide 5 g/m2 (24 h infusion) before surgery. The type of surgery had to be planned at randomisation. Tumours were to be amenable to surgery by amputation, compartmental resection, wide or marginal excision. If chemotherapy was given, surgery had to be performed within 21 days after the last chemotherapy. Patients received postoperative radiotherapy in cases of marginal surgery, microscopically incomplete resection and no further possibility for surgery, and in cases of surgery because of local recurrence. 150 patients were entered into the study and 134 were eligible, 67 in each arm. The most frequent side-effects of chemotherapy were alopecia, nausea and vomiting (95%), and leucocytopenia (32%). One patient died of neutropenic fever after the first cycle of chemotherapy. Chemotherapy did not interfere with planned surgery and did not affect postoperative wound healing. Limb-salvage was achieved in 88%, amputation was necessary in 12% (all according to the plan at randomisation). The trial was closed after completion of phase II, since accrual was too slow to justify expanding the study into the scheduled phase III study. At a median follow-up of 7.3 years, the 5 year disease-free survival is estimated at 52% for the no chemotherapy and 56% for the chemotherapy arm (standard error: 7%) (P=0.3548). The 5 year overall survival for both arms is 64 and 65%, respectively (standard error 7%) (P=0.2204). Neo-adjuvant-chemotherapy with doxorubicin and ifosfamide at these doses and with this schedule was feasible and did not compromise subsequent treatment, surgery with or without radiotherapy. Although not powered to draw definitive conclusions on benefit, but with an at least 7 year median follow-up, the results render it less likely that major survival benefits will be achieved with this type of chemotherapy.</description><subject>Adolescent</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>Chemotherapy</subject><subject>Chemotherapy, Adjuvant</subject><subject>Combined Modality Therapy - methods</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Doxorubicin - administration & dosage</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Ifosfamide - administration & dosage</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoadjuvant chemotherapy</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - surgery</subject><subject>Pharmacology. Drug treatments</subject><subject>Preoperative Care - methods</subject><subject>Randomised study</subject><subject>Risk Factors</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - radiotherapy</subject><subject>Sarcoma - surgery</subject><subject>Soft-tissue sarcoma</subject><subject>Tumors</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMFuFSEUhonR2OvVR9CwMKYuUBhggJVpmqo3adKFuiYMMA51ZrgC0-Tu-hj6en2Scntv1J2rs_nOf87_AfCS4HcEk_b9F6y4QhIzdYrJW4yxpIg8AisihUJY8uYxWP1BTsCznK8rJCTDT8EJIVRIStUK9GcwmdnFKWTv4HYw2cPNBuayuB2MM5x9RMZdLzdmLtAOfopl8Mlsd7CPCd7d_hrC9wGlkH_c3f6Gxi1jgTn2BZWQ8-JhNsnGyTwHT3ozZv_iONfg28eLr-ef0eXVp8352SWyVOGCXC85ZZ5x1rnOts6rtlaRDVfOKszq89x0SjnTSMbaFtuuEU5wpSSVXas4XYM3h9xtij8Xn4uuxawfR1OLLFkLLIUUtf4a8ANoU8w5-V5vU5hM2mmC9V6wfhCs9_Y0JvpBsN7vvToeWLrJu79bR6MVeH0ETLZm7KtdG_I_6Q0jglbswwHz1cZN8ElnG_xsvQvJ26JdDP_55B57X5kI</recordid><startdate>20010601</startdate><enddate>20010601</enddate><creator>Gortzak, E</creator><creator>Azzarelli, A</creator><creator>Buesa, J</creator><creator>Bramwell, V.H.C</creator><creator>van Coevorden, F</creator><creator>van Geel, A.N</creator><creator>Ezzat, A</creator><creator>Santoro, A</creator><creator>Oosterhuis, J.W</creator><creator>van Glabbeke, M</creator><creator>Kirkpatrick, A</creator><creator>Verweij, J</creator><general>Elsevier Ltd</general><general>Elsevier</general><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>7X8</scope></search><sort><creationdate>20010601</creationdate><title>A randomised phase II study on neo-adjuvant chemotherapy for ‘high-risk’ adult soft-tissue sarcoma</title><author>Gortzak, E ; Azzarelli, A ; Buesa, J ; Bramwell, V.H.C ; van Coevorden, F ; van Geel, A.N ; Ezzat, A ; Santoro, A ; Oosterhuis, J.W ; van Glabbeke, M ; Kirkpatrick, A ; Verweij, J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-df8534e454bdbc6de960858259dc9048405ab99da2844660cb27d7599838b6953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy</topic><topic>Chemotherapy, Adjuvant</topic><topic>Combined Modality Therapy - methods</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Doxorubicin - administration & dosage</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Ifosfamide - administration & dosage</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoadjuvant chemotherapy</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neoplasm Recurrence, Local - surgery</topic><topic>Pharmacology. Drug treatments</topic><topic>Preoperative Care - methods</topic><topic>Randomised study</topic><topic>Risk Factors</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - radiotherapy</topic><topic>Sarcoma - surgery</topic><topic>Soft-tissue sarcoma</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gortzak, E</creatorcontrib><creatorcontrib>Azzarelli, A</creatorcontrib><creatorcontrib>Buesa, J</creatorcontrib><creatorcontrib>Bramwell, V.H.C</creatorcontrib><creatorcontrib>van Coevorden, F</creatorcontrib><creatorcontrib>van Geel, A.N</creatorcontrib><creatorcontrib>Ezzat, A</creatorcontrib><creatorcontrib>Santoro, A</creatorcontrib><creatorcontrib>Oosterhuis, J.W</creatorcontrib><creatorcontrib>van Glabbeke, M</creatorcontrib><creatorcontrib>Kirkpatrick, A</creatorcontrib><creatorcontrib>Verweij, J</creatorcontrib><creatorcontrib>the E.O.R.T.C. 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Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group</aucorp><aucorp>E.O.R.T.C. Soft Tissue Bone Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group/Canadian Sarcoma Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomised phase II study on neo-adjuvant chemotherapy for ‘high-risk’ adult soft-tissue sarcoma</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2001-06-01</date><risdate>2001</risdate><volume>37</volume><issue>9</issue><spage>1096</spage><epage>1103</epage><pages>1096-1103</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>The aim of this study was to examine the strategy, feasibility and outcome of neo-adjuvant chemotherapy, with doxorubicin and ifosfamide, in adult patients with ‘high-risk’ soft-tissue sarcomas. Patients with ‘high-risk’ soft-tissue sarcomas, defined as tumours ⩾8 cm of any grade, or grade II/III tumours <8 cm, or grade II/III locally recurrent tumours, or grade II/III tumours with inadequate surgery performed in the previous 6 weeks and therefore requiring further surgery, were randomised between either surgery alone or three cycles of 3-weekly doxorubicin 50 mg/m2 intravenous (i.v.) bolus and ifosfamide 5 g/m2 (24 h infusion) before surgery. The type of surgery had to be planned at randomisation. Tumours were to be amenable to surgery by amputation, compartmental resection, wide or marginal excision. If chemotherapy was given, surgery had to be performed within 21 days after the last chemotherapy. Patients received postoperative radiotherapy in cases of marginal surgery, microscopically incomplete resection and no further possibility for surgery, and in cases of surgery because of local recurrence. 150 patients were entered into the study and 134 were eligible, 67 in each arm. The most frequent side-effects of chemotherapy were alopecia, nausea and vomiting (95%), and leucocytopenia (32%). One patient died of neutropenic fever after the first cycle of chemotherapy. Chemotherapy did not interfere with planned surgery and did not affect postoperative wound healing. Limb-salvage was achieved in 88%, amputation was necessary in 12% (all according to the plan at randomisation). The trial was closed after completion of phase II, since accrual was too slow to justify expanding the study into the scheduled phase III study. At a median follow-up of 7.3 years, the 5 year disease-free survival is estimated at 52% for the no chemotherapy and 56% for the chemotherapy arm (standard error: 7%) (P=0.3548). The 5 year overall survival for both arms is 64 and 65%, respectively (standard error 7%) (P=0.2204). Neo-adjuvant-chemotherapy with doxorubicin and ifosfamide at these doses and with this schedule was feasible and did not compromise subsequent treatment, surgery with or without radiotherapy. Although not powered to draw definitive conclusions on benefit, but with an at least 7 year median follow-up, the results render it less likely that major survival benefits will be achieved with this type of chemotherapy.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>11378339</pmid><doi>10.1016/S0959-8049(01)00083-1</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0959-8049 |
| ispartof | European journal of cancer (1990), 2001-06, Vol.37 (9), p.1096-1103 |
| issn | 0959-8049 1879-0852 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adolescent Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Chemotherapy Chemotherapy, Adjuvant Combined Modality Therapy - methods Disease Progression Disease-Free Survival Doxorubicin - administration & dosage Follow-Up Studies Humans Ifosfamide - administration & dosage Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoadjuvant chemotherapy Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - surgery Pharmacology. Drug treatments Preoperative Care - methods Randomised study Risk Factors Sarcoma - drug therapy Sarcoma - radiotherapy Sarcoma - surgery Soft-tissue sarcoma Tumors |
| title | A randomised phase II study on neo-adjuvant chemotherapy for ‘high-risk’ adult soft-tissue sarcoma |
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