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A phase Ib/II translational study of sunitinib with neoadjuvant radiotherapy in soft-tissue sarcoma

Identifieur interne : 002E27 ( Main/Merge ); précédent : 002E26; suivant : 002E28

A phase Ib/II translational study of sunitinib with neoadjuvant radiotherapy in soft-tissue sarcoma

Auteurs : J. Lewin [Australie] ; K K Khamly [Australie] ; R J Young [Australie] ; C. Mitchell [Australie] ; R J Hicks [Australie] ; G C Toner [Australie] ; S Y K. Ngan [Australie] ; S. Chander [Australie] ; G J Powell [Australie] ; A. Herschtal [Australie] ; L. Te Marvelde [Australie] ; J. Desai [Australie] ; P F M. Choong [Australie] ; S A Stacker [Australie] ; M G Achen [Australie] ; N. Ferris [Australie] ; S. Fox [Australie] ; J. Slavin [Australie] ; D M Thomas [Australie]

Source :

RBID : PMC:4264446

Abstract

Background:

Preoperative radiotherapy (RT) is commonly used to treat localised soft-tissue sarcomas (STS). Hypoxia is an important determinant of radioresistance. Whether antiangiogenic therapy can ‘normalise' tumour vasculature, thereby improving oxygenation, remains unknown.

Methods:

Two cohorts were prospectively enrolled. Cohort A evaluated the implications of hypoxia in STS, using the hypoxic tracer 18F-azomycin arabinoside (FAZA-PET). In cohort B, sunitinib was added to preoperative RT in a dose-finding phase 1b/2 design.

Results:

In cohort A, 13 out of 23 tumours were hypoxic (FAZA-PET), correlating with metabolic activity (r2=0.85; P<0.001). Two-year progression-free (PFS) and overall (OS) survival were 61% (95% CI: 0.44–0.84) and 87% (95% CI: 0.74–1.00), respectively. Hypoxia was associated with radioresistance (P=0.012), higher local recurrence (Hazard ratio (HR): 10.2; P=0.02), PFS (HR: 8.4; P=0.02), and OS (HR: 41.4; P<0.04). In Cohort B, seven patients received sunitinib at dose level (DL): 0 (50 mg per day for 2 weeks before RT; 25 mg per day during RT) and two patients received DL: −1 (37.5 mg per day for entire period). Dose-limiting toxicities were observed in 4 out of 7 patients at DL 0 and 2 out of 2 patients at DL −1, resulting in premature study closure. Although there was no difference in PFS or OS, patients receiving sunitinib had higher local failure (HR: 8.1; P=0.004).

Conclusion:

In STS, hypoxia is associated with adverse outcomes. The combination of sunitinib with preoperative RT resulted in unacceptable toxicities, and higher local relapse rates.


Url:
DOI: 10.1038/bjc.2014.537
PubMed: 25321190
PubMed Central: 4264446

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PMC:4264446

Le document en format XML

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<name sortKey="Achen, M G" sort="Achen, M G" uniqKey="Achen M" first="M G" last="Achen">M G Achen</name>
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<institution>The Kinghorn Cancer Centre, Garvan Institute of Medical Research</institution>
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<country>Australia</country>
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<country xml:lang="fr">Australie</country>
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<name sortKey="Chander, S" sort="Chander, S" uniqKey="Chander S" first="S" last="Chander">S. Chander</name>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Powell, G J" sort="Powell, G J" uniqKey="Powell G" first="G J" last="Powell">G J Powell</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
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, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Herschtal, A" sort="Herschtal, A" uniqKey="Herschtal A" first="A" last="Herschtal">A. Herschtal</name>
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<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Te Marvelde, L" sort="Te Marvelde, L" uniqKey="Te Marvelde L" first="L" last="Te Marvelde">L. Te Marvelde</name>
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<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Desai, J" sort="Desai, J" uniqKey="Desai J" first="J" last="Desai">J. Desai</name>
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<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Choong, P F M" sort="Choong, P F M" uniqKey="Choong P" first="P F M" last="Choong">P F M. Choong</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff3">
<institution>Department of Orthopaedics, St. Vincent's Hospital</institution>
, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff4">
<institution>Department of Surgery, The University of Melbourne, St. Vincent's Hospital</institution>
, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Stacker, S A" sort="Stacker, S A" uniqKey="Stacker S" first="S A" last="Stacker">S A Stacker</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>Sir Peter MacCallum Department of Oncology, University of Melbourne</institution>
, Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Achen, M G" sort="Achen, M G" uniqKey="Achen M" first="M G" last="Achen">M G Achen</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>Sir Peter MacCallum Department of Oncology, University of Melbourne</institution>
, Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ferris, N" sort="Ferris, N" uniqKey="Ferris N" first="N" last="Ferris">N. Ferris</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Fox, S" sort="Fox, S" uniqKey="Fox S" first="S" last="Fox">S. Fox</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Slavin, J" sort="Slavin, J" uniqKey="Slavin J" first="J" last="Slavin">J. Slavin</name>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>The University of Melbourne, St Vincent's Hospital Campus</institution>
, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Thomas, D M" sort="Thomas, D M" uniqKey="Thomas D" first="D M" last="Thomas">D M Thomas</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Peter MacCallum Cancer Centre</institution>
, East Melbourne, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>The University of Melbourne, St Vincent's Hospital Campus</institution>
, Fitzroy, Victoria,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff6">
<institution>The Kinghorn Cancer Centre, Garvan Institute of Medical Research</institution>
, 370 Victoria Street, Darlinghurst, New South Wales 2010,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">British Journal of Cancer</title>
<idno type="ISSN">0007-0920</idno>
<idno type="eISSN">1532-1827</idno>
<imprint>
<date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass></textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background:</title>
<p>Preoperative radiotherapy (RT) is commonly used to treat localised soft-tissue sarcomas (STS). Hypoxia is an important determinant of radioresistance. Whether antiangiogenic therapy can ‘normalise' tumour vasculature, thereby improving oxygenation, remains unknown.</p>
</sec>
<sec>
<title>Methods:</title>
<p>Two cohorts were prospectively enrolled. Cohort A evaluated the implications of hypoxia in STS, using the hypoxic tracer
<sup>18</sup>
F-azomycin arabinoside (FAZA-PET). In cohort B, sunitinib was added to preoperative RT in a dose-finding phase 1b/2 design.</p>
</sec>
<sec>
<title>Results:</title>
<p>In cohort A, 13 out of 23 tumours were hypoxic (FAZA-PET), correlating with metabolic activity (
<italic>r</italic>
<sup>2</sup>
=0.85;
<italic>P</italic>
<0.001). Two-year progression-free (PFS) and overall (OS) survival were 61% (95% CI: 0.44–0.84) and 87% (95% CI: 0.74–1.00), respectively. Hypoxia was associated with radioresistance (
<italic>P</italic>
=0.012), higher local recurrence (Hazard ratio (HR): 10.2;
<italic>P</italic>
=0.02), PFS (HR: 8.4;
<italic>P</italic>
=0.02), and OS (HR: 41.4;
<italic>P</italic>
<0.04). In Cohort B, seven patients received sunitinib at dose level (DL): 0 (50 mg per day for 2 weeks before RT; 25 mg per day during RT) and two patients received DL: −1 (37.5 mg per day for entire period). Dose-limiting toxicities were observed in 4 out of 7 patients at DL 0 and 2 out of 2 patients at DL −1, resulting in premature study closure. Although there was no difference in PFS or OS, patients receiving sunitinib had higher local failure (HR: 8.1;
<italic>P</italic>
=0.004).</p>
</sec>
<sec>
<title>Conclusion:</title>
<p>In STS, hypoxia is associated with adverse outcomes. The combination of sunitinib with preoperative RT resulted in unacceptable toxicities, and higher local relapse rates.</p>
</sec>
</div>
</front>
<back>
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   |clé=     PMC:4264446
   |texte=   A phase Ib/II translational study of sunitinib with neoadjuvant radiotherapy in soft-tissue sarcoma
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Merge/RBID.i   -Sk "pubmed:25321190" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Merge/biblio.hfd   \
       | NlmPubMed2Wicri -a LymphedemaV1
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