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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue
Sarcoma: A Prospective Randomized Feasibility Trial</title><author><name sortKey="Brodowicz, Thomas" sort="Brodowicz, Thomas" uniqKey="Brodowicz T" first="Thomas" last="Brodowicz">Thomas Brodowicz</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Schwameis, Eva" sort="Schwameis, Eva" uniqKey="Schwameis E" first="Eva" last="Schwameis">Eva Schwameis</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Widder, Joachim" sort="Widder, Joachim" uniqKey="Widder J" first="Joachim" last="Widder">Joachim Widder</name><affiliation><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Amann, Gabriele" sort="Amann, Gabriele" uniqKey="Amann G" first="Gabriele" last="Amann">Gabriele Amann</name><affiliation><nlm:aff id="aff4"><addr-line>Department of Clinical Pathology</addr-line><addr-line>University Hospital</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Wiltschke, Christoph" sort="Wiltschke, Christoph" uniqKey="Wiltschke C" first="Christoph" last="Wiltschke">Christoph Wiltschke</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Dominkus, Martin" sort="Dominkus, Martin" uniqKey="Dominkus M" first="Martin" last="Dominkus">Martin Dominkus</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Windhager, Reinhard" sort="Windhager, Reinhard" uniqKey="Windhager R" first="Reinhard" last="Windhager">Reinhard Windhager</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Ritschl, Peter" sort="Ritschl, Peter" uniqKey="Ritschl P" first="Peter" last="Ritschl">Peter Ritschl</name><affiliation><nlm:aff id="aff5"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Orthopedic Hospital Gersthof</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Potter, Richard" sort="Potter, Richard" uniqKey="Potter R" first="Richard" last="Pötter">Richard Pötter</name><affiliation><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Kotz, Rainer" sort="Kotz, Rainer" uniqKey="Kotz R" first="Rainer" last="Kotz">Rainer Kotz</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Zielinski, Christoph C" sort="Zielinski, Christoph C" uniqKey="Zielinski C" first="Christoph C." last="Zielinski">Christoph C. Zielinski</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation><affiliation><nlm:aff id="aff6"><addr-line>Medical Experimental Oncology and Ludwig Boltzmann Institute for Clinical Experimental Oncology</addr-line><addr-line>Department of Medicine I</addr-line><addr-line>University Hospital</addr-line><addr-line>18-20 Waehringer Guertel</addr-line><addr-line>Vienna</addr-line><addr-line>A-1090</addr-line><country>Austria</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">18521295</idno><idno type="pmc">2395444</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2395444</idno><idno type="RBID">PMC:2395444</idno><idno type="doi">10.1080/13577140020025869</idno><date when="2000">2000</date><idno type="wicri:Area/Pmc/Corpus">000941</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000941</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue
Sarcoma: A Prospective Randomized Feasibility Trial</title><author><name sortKey="Brodowicz, Thomas" sort="Brodowicz, Thomas" uniqKey="Brodowicz T" first="Thomas" last="Brodowicz">Thomas Brodowicz</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Schwameis, Eva" sort="Schwameis, Eva" uniqKey="Schwameis E" first="Eva" last="Schwameis">Eva Schwameis</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Widder, Joachim" sort="Widder, Joachim" uniqKey="Widder J" first="Joachim" last="Widder">Joachim Widder</name><affiliation><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Amann, Gabriele" sort="Amann, Gabriele" uniqKey="Amann G" first="Gabriele" last="Amann">Gabriele Amann</name><affiliation><nlm:aff id="aff4"><addr-line>Department of Clinical Pathology</addr-line><addr-line>University Hospital</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Wiltschke, Christoph" sort="Wiltschke, Christoph" uniqKey="Wiltschke C" first="Christoph" last="Wiltschke">Christoph Wiltschke</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Dominkus, Martin" sort="Dominkus, Martin" uniqKey="Dominkus M" first="Martin" last="Dominkus">Martin Dominkus</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Windhager, Reinhard" sort="Windhager, Reinhard" uniqKey="Windhager R" first="Reinhard" last="Windhager">Reinhard Windhager</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Ritschl, Peter" sort="Ritschl, Peter" uniqKey="Ritschl P" first="Peter" last="Ritschl">Peter Ritschl</name><affiliation><nlm:aff id="aff5"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Orthopedic Hospital Gersthof</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Potter, Richard" sort="Potter, Richard" uniqKey="Potter R" first="Richard" last="Pötter">Richard Pötter</name><affiliation><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Kotz, Rainer" sort="Kotz, Rainer" uniqKey="Kotz R" first="Rainer" last="Kotz">Rainer Kotz</name><affiliation><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation></author><author><name sortKey="Zielinski, Christoph C" sort="Zielinski, Christoph C" uniqKey="Zielinski C" first="Christoph C." last="Zielinski">Christoph C. Zielinski</name><affiliation><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></nlm:aff></affiliation><affiliation><nlm:aff id="aff6"><addr-line>Medical Experimental Oncology and Ludwig Boltzmann Institute for Clinical Experimental Oncology</addr-line><addr-line>Department of Medicine I</addr-line><addr-line>University Hospital</addr-line><addr-line>18-20 Waehringer Guertel</addr-line><addr-line>Vienna</addr-line><addr-line>A-1090</addr-line><country>Austria</country></nlm:aff></affiliation></author></analytic><series><title level="j">Sarcoma</title><idno type="ISSN">1357-714X</idno><idno type="eISSN">1369-1643</idno><imprint><date when="2000">2000</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><italic>Purpose.</italic> The present prospective randomized adjuvant trial was
carried out to compare the toxicity, feasibility and efficacy of augmented chemotherapy
added to hyperfractionated accelerated radiotherapy after wide or marginal resection of grade
2 and grade 3 soft tissue sarcoma (STS).</p><p><italic>Patients and methods. </italic> Fifty-nine patients underwent primary surgery
by wide or marginal excision and were subsequently randomized to receive radiotherapy
alone or under the addition of six courses of ifosfamide (1500 mg/m<sup>2</sup>, days 1–4), dacarbazine
(DTIC) (200 mg/m<sup>2</sup>, days 1–4) and doxorubicin (25 mg/m<sup>2</sup>, days 1–2) administered in
14-day-intervals supported by granulocyte-colony stimulating factor (30 × 10<sup>6</sup>IU/day, s.c.)
on days 5–13. According to the randomization protocol, 28 patients received radiotherapy
only, whereas 31 patients were treated with additional chemotherapy.</p><p><italic>Results.</italic> The relative ifosfamide–doxorubicin–DTIC (IFADIC) dose
intensity achieved was 93%. After a mean observation period of 41±19.7 months
(range, 8.1–84 months), 16 patients (57%) in the control group versus 24 patients (77%) in the
chemotherapy group were free of disease (p>0.05).Within the control group, tumor relapses
occurred in 12 patients (43%;six patients with distant metastases, two with local relapse,
four with both) versus seven patients (23%; five patients with distant metastases, one with
local recurrence, one with both) from the chemotherapy group. Relapse-free survival (RFS)
(<italic>p</italic>=0.1), time to local failure (TLF) (<italic>p</italic>=0.09), time to distant failure (TDF) (<italic>p</italic>=0.17) as well as
overall survival (OS) (<italic>p</italic>=0.4) did not differ significantly between the two treatment groups.
Treatment-related toxicity was generally mild in both treatment arms.</p><p><italic>Conclusion.</italic> We conclude that the safety profile of intensified IFADIC
added to radiotherapy was manageable and tolerable in the current setting. Inclusion
of intensified IFADIC was not translated into a significant benefit concerning OS, RFS,
TLF andTDF as compared with radiotherapy only, although a potential benefit of
chemotherapy for grade 3 STS patients needs to be validated in prospective randomized
trials including larger patient numbers.</p></div></front></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Sarcoma</journal-id><journal-title>Sarcoma</journal-title><issn pub-type="ppub">1357-714X</issn><issn pub-type="epub">1369-1643</issn><publisher><publisher-name>Hindawi Publishing Corporation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">18521295</article-id><article-id pub-id-type="pmc">2395444</article-id><article-id pub-id-type="pii">S1357714X00000219</article-id><article-id pub-id-type="doi">10.1080/13577140020025869</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue
Sarcoma: A Prospective Randomized Feasibility Trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Brodowicz</surname><given-names>Thomas</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Schwameis</surname><given-names>Eva</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Widder</surname><given-names>Joachim</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Amann</surname><given-names>Gabriele</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Wiltschke</surname><given-names>Christoph</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Dominkus</surname><given-names>Martin</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Windhager</surname><given-names>Reinhard</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Ritschl</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Pötter</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Kotz</surname><given-names>Rainer</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Zielinski</surname><given-names>Christoph C.</given-names></name><address><email>christoph.zielinski@akh-wien.ac.at</email></address><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff6">6</xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Clinical Division of Oncology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></aff><aff id="aff2"><label>2</label><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Vienna</addr-line><country>Austria</country></aff><aff id="aff3"><label>3</label><addr-line>Department of Radiotherapy and Radiobiology</addr-line><addr-line>Vienna</addr-line><country>Austria</country></aff><aff id="aff4"><label>4</label><addr-line>Department of Clinical Pathology</addr-line><addr-line>University Hospital</addr-line><addr-line>Vienna</addr-line><country>Austria</country></aff><aff id="aff5"><label>5</label><addr-line>Department of Orthopedic Surgery</addr-line><addr-line>Orthopedic Hospital Gersthof</addr-line><addr-line>Vienna</addr-line><country>Austria</country></aff><aff id="aff6"><label>6</label><addr-line>Medical Experimental Oncology and Ludwig Boltzmann Institute for Clinical Experimental Oncology</addr-line><addr-line>Department of Medicine I</addr-line><addr-line>University Hospital</addr-line><addr-line>18-20 Waehringer Guertel</addr-line><addr-line>Vienna</addr-line><addr-line>A-1090</addr-line><country>Austria</country></aff><pub-date pub-type="ppub"><month>12</month><year>2000</year></pub-date><volume>4</volume><issue>4</issue><fpage>151</fpage><lpage>160</lpage><permissions><copyright-statement>Copyright © 2000 Hindawi Publishing Corporation.</copyright-statement><copyright-year>2000</copyright-year><copyright-holder>Hindawi Publishing Corporation</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/"><p>This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p></license></permissions><abstract><p><italic>Purpose.</italic> The present prospective randomized adjuvant trial was
carried out to compare the toxicity, feasibility and efficacy of augmented chemotherapy
added to hyperfractionated accelerated radiotherapy after wide or marginal resection of grade
2 and grade 3 soft tissue sarcoma (STS).</p><p><italic>Patients and methods. </italic> Fifty-nine patients underwent primary surgery
by wide or marginal excision and were subsequently randomized to receive radiotherapy
alone or under the addition of six courses of ifosfamide (1500 mg/m<sup>2</sup>, days 1–4), dacarbazine
(DTIC) (200 mg/m<sup>2</sup>, days 1–4) and doxorubicin (25 mg/m<sup>2</sup>, days 1–2) administered in
14-day-intervals supported by granulocyte-colony stimulating factor (30 × 10<sup>6</sup>IU/day, s.c.)
on days 5–13. According to the randomization protocol, 28 patients received radiotherapy
only, whereas 31 patients were treated with additional chemotherapy.</p><p><italic>Results.</italic> The relative ifosfamide–doxorubicin–DTIC (IFADIC) dose
intensity achieved was 93%. After a mean observation period of 41±19.7 months
(range, 8.1–84 months), 16 patients (57%) in the control group versus 24 patients (77%) in the
chemotherapy group were free of disease (p>0.05).Within the control group, tumor relapses
occurred in 12 patients (43%;six patients with distant metastases, two with local relapse,
four with both) versus seven patients (23%; five patients with distant metastases, one with
local recurrence, one with both) from the chemotherapy group. Relapse-free survival (RFS)
(<italic>p</italic>=0.1), time to local failure (TLF) (<italic>p</italic>=0.09), time to distant failure (TDF) (<italic>p</italic>=0.17) as well as
overall survival (OS) (<italic>p</italic>=0.4) did not differ significantly between the two treatment groups.
Treatment-related toxicity was generally mild in both treatment arms.</p><p><italic>Conclusion.</italic> We conclude that the safety profile of intensified IFADIC
added to radiotherapy was manageable and tolerable in the current setting. Inclusion
of intensified IFADIC was not translated into a significant benefit concerning OS, RFS,
TLF andTDF as compared with radiotherapy only, although a potential benefit of
chemotherapy for grade 3 STS patients needs to be validated in prospective randomized
trials including larger patient numbers.</p></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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