LymphedemaV1, Main, Exploration, bibRecord, 00A239

Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

Identifieur interne : 00A239 ( Main/Exploration ); précédent : 00A238; suivant : 00A240

Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

Auteurs : Thomas Brodowicz [Autriche] ; Eva Schwameis [Autriche] ; Joachim Widder [Autriche] ; Gabriele Amann [Autriche] ; Christoph Wiltschke [Autriche] ; Martin Dominkus [Autriche] ; Reinhard Windhager [Autriche] ; Peter Ritschl [Autriche] ; Richard Pötter [Autriche] ; Rainer Kotz [Autriche] ; Christoph C. Zielinski [Autriche]

Source :

Sarcoma [ 1357-714X ] ; 2000.

RBID : PMC:2395444

Abstract

Purpose. 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).

Patients and methods. 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/m², days 1–4), dacarbazine (DTIC) (200 mg/m², days 1–4) and doxorubicin (25 mg/m², days 1–2) administered in 14-day-intervals supported by granulocyte-colony stimulating factor (30 × 10⁶IU/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.

Results. 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) (p=0.1), time to local failure (TLF) (p=0.09), time to distant failure (TDF) (p=0.17) as well as overall survival (OS) (p=0.4) did not differ significantly between the two treatment groups. Treatment-related toxicity was generally mild in both treatment arms.

Conclusion. 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.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2395444

DOI: 10.1080/13577140020025869
PubMed: 18521295
PubMed Central: 2395444

Affiliations:

Autriche

Le document en format XML

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Sarcoma: A Prospective Randomized Feasibility Trial</title>
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<author><name sortKey="Widder, Joachim" sort="Widder, Joachim" uniqKey="Widder J" first="Joachim" last="Widder">Joachim Widder</name>
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<author><name sortKey="Potter, Richard" sort="Potter, Richard" uniqKey="Potter R" first="Richard" last="Pötter">Richard Pötter</name>
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<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Kotz, Rainer" sort="Kotz, Rainer" uniqKey="Kotz R" first="Rainer" last="Kotz">Rainer Kotz</name>
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<author><name sortKey="Zielinski, Christoph C" sort="Zielinski, Christoph C" uniqKey="Zielinski C" first="Christoph C." last="Zielinski">Christoph C. Zielinski</name>
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<addr-line>Vienna</addr-line>
<country>Austria</country>
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<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<affiliation wicri:level="1"><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>
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<country xml:lang="fr">Autriche</country>
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<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 wicri:level="1"><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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</author>
<author><name sortKey="Schwameis, Eva" sort="Schwameis, Eva" uniqKey="Schwameis E" first="Eva" last="Schwameis">Eva Schwameis</name>
<affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Widder, Joachim" sort="Widder, Joachim" uniqKey="Widder J" first="Joachim" last="Widder">Joachim Widder</name>
<affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Amann, Gabriele" sort="Amann, Gabriele" uniqKey="Amann G" first="Gabriele" last="Amann">Gabriele Amann</name>
<affiliation wicri:level="1"><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>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Wiltschke, Christoph" sort="Wiltschke, Christoph" uniqKey="Wiltschke C" first="Christoph" last="Wiltschke">Christoph Wiltschke</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Dominkus, Martin" sort="Dominkus, Martin" uniqKey="Dominkus M" first="Martin" last="Dominkus">Martin Dominkus</name>
<affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Windhager, Reinhard" sort="Windhager, Reinhard" uniqKey="Windhager R" first="Reinhard" last="Windhager">Reinhard Windhager</name>
<affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Ritschl, Peter" sort="Ritschl, Peter" uniqKey="Ritschl P" first="Peter" last="Ritschl">Peter Ritschl</name>
<affiliation wicri:level="1"><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>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Potter, Richard" sort="Potter, Richard" uniqKey="Potter R" first="Richard" last="Pötter">Richard Pötter</name>
<affiliation wicri:level="1"><nlm:aff id="aff3"><addr-line>Department of Radiotherapy and Radiobiology</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kotz, Rainer" sort="Kotz, Rainer" uniqKey="Kotz R" first="Rainer" last="Kotz">Rainer Kotz</name>
<affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Department of Orthopedic Surgery</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</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 wicri:level="1"><nlm:aff id="aff1"><addr-line>Clinical Division of Oncology</addr-line>
<addr-line>Vienna</addr-line>
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><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>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</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>
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<profileDesc><textClass></textClass>
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<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>
<affiliations><list><country><li>Autriche</li>
</country>
</list>
<tree><country name="Autriche"><noRegion><name sortKey="Brodowicz, Thomas" sort="Brodowicz, Thomas" uniqKey="Brodowicz T" first="Thomas" last="Brodowicz">Thomas Brodowicz</name>
</noRegion>
<name sortKey="Amann, Gabriele" sort="Amann, Gabriele" uniqKey="Amann G" first="Gabriele" last="Amann">Gabriele Amann</name>
<name sortKey="Dominkus, Martin" sort="Dominkus, Martin" uniqKey="Dominkus M" first="Martin" last="Dominkus">Martin Dominkus</name>
<name sortKey="Kotz, Rainer" sort="Kotz, Rainer" uniqKey="Kotz R" first="Rainer" last="Kotz">Rainer Kotz</name>
<name sortKey="Potter, Richard" sort="Potter, Richard" uniqKey="Potter R" first="Richard" last="Pötter">Richard Pötter</name>
<name sortKey="Ritschl, Peter" sort="Ritschl, Peter" uniqKey="Ritschl P" first="Peter" last="Ritschl">Peter Ritschl</name>
<name sortKey="Schwameis, Eva" sort="Schwameis, Eva" uniqKey="Schwameis E" first="Eva" last="Schwameis">Eva Schwameis</name>
<name sortKey="Widder, Joachim" sort="Widder, Joachim" uniqKey="Widder J" first="Joachim" last="Widder">Joachim Widder</name>
<name sortKey="Wiltschke, Christoph" sort="Wiltschke, Christoph" uniqKey="Wiltschke C" first="Christoph" last="Wiltschke">Christoph Wiltschke</name>
<name sortKey="Windhager, Reinhard" sort="Windhager, Reinhard" uniqKey="Windhager R" first="Reinhard" last="Windhager">Reinhard Windhager</name>
<name sortKey="Zielinski, Christoph C" sort="Zielinski, Christoph C" uniqKey="Zielinski C" first="Christoph C." last="Zielinski">Christoph C. Zielinski</name>
<name sortKey="Zielinski, Christoph C" sort="Zielinski, Christoph C" uniqKey="Zielinski C" first="Christoph C." last="Zielinski">Christoph C. Zielinski</name>
</country>
</tree>
</affiliations>
</record>

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Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

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Abstract

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