AustralieFrV1, Main, Exploration, bibRecord, 00BC28

Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer

Identifieur interne : 00BC28 ( Main/Exploration ); précédent : 00BC27; suivant : 00BC29

Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer

Auteurs : Joachim Von Pawel [Allemagne, France, Royaume-Uni, Australie, États-Unis] ; Ulrich Gatzemeier ; Jean-Louis Pujol ; Lionel Moreau ; S. Bildat ; Malcolm Ranson ; Gary Richardson ; Claus Steppert ; Alain Riviere ; Ina Camlett ; Stephen Lane ; Graham Ross

Source :

Journal of clinical oncology [ 0732-183X ] ; 2001.

RBID : Pascal:01-0220432

Descripteurs français

Pascal (Inist)
- Carcinome petite cellule, Bronchopulmonaire, Voie administration, Topotécane, Inhibiteur enzyme, DNA topoisomerase, Essai clinique phase II, Voie orale, Anticancéreux, Chimiothérapie, Voie intraveineuse, Etude comparative, Traitement, Efficacité traitement, Toxicité, Complication, Homme, Pyrano indolizino quinoléine dérivé.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Antineoplastic agent, Bronchopulmonary, Chemotherapy, Comparative study, Complication, DNA topoisomerase, Enzyme inhibitor, Human, Intravenous administration, Oral administration, Phase II trial, Route of administration, Small cell carcinoma, Topotecan, Toxicity, Treatment, Treatment efficiency.

Abstract

Purpose: Topotecan, administered intravenously, is active in small-cell lung cancer (SCLC). In this study, the comparability of oral topotecan to IV topotecan was investigated. Patients and Methods: Patients with SCLC that had relapsed 90 days or more after cessation of initial chemotherapy were randomized to receive either oral topotecan (Hycamtin) 2.3 mg/m²/d x 5 (52 patients) or IV topotecan 1.5 mg/m²/d x 5 (54 patients), every 21 days. Results: Response rates in this phase II randomized study were 23% (12/52) in the oral topotecan arm and 15% (8/54) in the IV topotecan arm. All radiological responses were confirmed by an independent radiologist. Median survival was 32 weeks (oral) and 25 weeks (IV). Good symptom control, defined as sustained improvement or no deterioration, was evident in both treatment groups. Topotecan was generally well tolerated, with myelosuppression being the major toxicity. Grade 4 neutropenia occurred in 35.3% of patients on oral topotecan and in 67.3% of patients on IV topotecan, which was statistically significant (P = .001). Fever/infection more than or equal to grade 2 associated with grade 4 neutropenia, together with sepsis, occurred in only 5.1% of courses (oral) and 3.3% of courses (IV). Non-hematological toxicity consisted mainly of vomiting (oral: 36.5% of patients; IV: 31.5% of patients) and nausea (oral: 26.9% of patients; IV: 40.7% of patients). Conclusion: This study found oral topotecan to be similar in efficacy to IV topotecan in the treatment of patients with relapsed SCLC, sensitive to first-line chemotherapy, with less grade 4 neutropenia and greater convenience of administration.

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<author><name sortKey="Gatzemeier, Ulrich" sort="Gatzemeier, Ulrich" uniqKey="Gatzemeier U" first="Ulrich" last="Gatzemeier">Ulrich Gatzemeier</name>
</author>
<author><name sortKey="Pujol, Jean Louis" sort="Pujol, Jean Louis" uniqKey="Pujol J" first="Jean-Louis" last="Pujol">Jean-Louis Pujol</name>
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<author><name sortKey="Moreau, Lionel" sort="Moreau, Lionel" uniqKey="Moreau L" first="Lionel" last="Moreau">Lionel Moreau</name>
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<author><name sortKey="Bildat, S" sort="Bildat, S" uniqKey="Bildat S" first="S." last="Bildat">S. Bildat</name>
</author>
<author><name sortKey="Ranson, Malcolm" sort="Ranson, Malcolm" uniqKey="Ranson M" first="Malcolm" last="Ranson">Malcolm Ranson</name>
</author>
<author><name sortKey="Richardson, Gary" sort="Richardson, Gary" uniqKey="Richardson G" first="Gary" last="Richardson">Gary Richardson</name>
</author>
<author><name sortKey="Steppert, Claus" sort="Steppert, Claus" uniqKey="Steppert C" first="Claus" last="Steppert">Claus Steppert</name>
</author>
<author><name sortKey="Riviere, Alain" sort="Riviere, Alain" uniqKey="Riviere A" first="Alain" last="Riviere">Alain Riviere</name>
</author>
<author><name sortKey="Camlett, Ina" sort="Camlett, Ina" uniqKey="Camlett I" first="Ina" last="Camlett">Ina Camlett</name>
</author>
<author><name sortKey="Lane, Stephen" sort="Lane, Stephen" uniqKey="Lane S" first="Stephen" last="Lane">Stephen Lane</name>
</author>
<author><name sortKey="Ross, Graham" sort="Ross, Graham" uniqKey="Ross G" first="Graham" last="Ross">Graham Ross</name>
</author>
</analytic>
<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2001">2001</date>
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<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>Bronchopulmonary</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Complication</term>
<term>DNA topoisomerase</term>
<term>Enzyme inhibitor</term>
<term>Human</term>
<term>Intravenous administration</term>
<term>Oral administration</term>
<term>Phase II trial</term>
<term>Route of administration</term>
<term>Small cell carcinoma</term>
<term>Topotecan</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Carcinome petite cellule</term>
<term>Bronchopulmonaire</term>
<term>Voie administration</term>
<term>Topotécane</term>
<term>Inhibiteur enzyme</term>
<term>DNA topoisomerase</term>
<term>Essai clinique phase II</term>
<term>Voie orale</term>
<term>Anticancéreux</term>
<term>Chimiothérapie</term>
<term>Voie intraveineuse</term>
<term>Etude comparative</term>
<term>Traitement</term>
<term>Efficacité traitement</term>
<term>Toxicité</term>
<term>Complication</term>
<term>Homme</term>
<term>Pyrano indolizino quinoléine dérivé</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Purpose: Topotecan, administered intravenously, is active in small-cell lung cancer (SCLC). In this study, the comparability of oral topotecan to IV topotecan was investigated. Patients and Methods: Patients with SCLC that had relapsed 90 days or more after cessation of initial chemotherapy were randomized to receive either oral topotecan (Hycamtin) 2.3 mg/m<sup>2</sup>
/d x 5 (52 patients) or IV topotecan 1.5 mg/m<sup>2</sup>
/d x 5 (54 patients), every 21 days. Results: Response rates in this phase II randomized study were 23% (12/52) in the oral topotecan arm and 15% (8/54) in the IV topotecan arm. All radiological responses were confirmed by an independent radiologist. Median survival was 32 weeks (oral) and 25 weeks (IV). Good symptom control, defined as sustained improvement or no deterioration, was evident in both treatment groups. Topotecan was generally well tolerated, with myelosuppression being the major toxicity. Grade 4 neutropenia occurred in 35.3% of patients on oral topotecan and in 67.3% of patients on IV topotecan, which was statistically significant (P = .001). Fever/infection more than or equal to grade 2 associated with grade 4 neutropenia, together with sepsis, occurred in only 5.1% of courses (oral) and 3.3% of courses (IV). Non-hematological toxicity consisted mainly of vomiting (oral: 36.5% of patients; IV: 31.5% of patients) and nausea (oral: 26.9% of patients; IV: 40.7% of patients). Conclusion: This study found oral topotecan to be similar in efficacy to IV topotecan in the treatment of patients with relapsed SCLC, sensitive to first-line chemotherapy, with less grade 4 neutropenia and greater convenience of administration.</div>
</front>
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<name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name>
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{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:01-0220432
   |texte=   Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer
}}

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les relations entre la France et l'Australie

Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer

Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer

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Abstract

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