Idarubicin-loaded Beads for Chemoembolization of Hepatocellular Carcinoma: The IDASPHERE II Single-Arm Phase II Trial.

Aged Aged, 80 and over Antibiotics, Antineoplastic / administration & dosage Carcinoma, Hepatocellular / therapy Chemoembolization, Therapeutic / methods Female Humans Idarubicin / administration & dosage Liver Neoplasms / therapy Male Middle Aged

Journal

Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260

Informations de publication

Date de publication:
06 2019
Historique:
pubmed: 1 5 2019
medline: 28 1 2020
entrez: 1 5 2019
Statut: ppublish

Résumé

Background A prior in vitro study showed that idarubicin was the most cytotoxic agent for hepatocellular carcinoma (HCC) cell lines. Idarubicin-loaded beads for transarterial chemoembolization (TACE) were previously evaluated for the appropriate dose in a phase I dose-escalation study. Purpose To evaluate objective response rate (ORR), safety, and survival after TACE by using idarubicin-loaded beads for unresectable HCC. Materials and Methods This prospective single-arm phase II study was conducted between January 2015 and January 2017. Participants with unresectable HCC were included in the trial and underwent TACE with idarubicin-eluting beads. The primary end point was 6-month ORR assessed with independent central review by using modified Response Evaluation Criteria in Solid Tumors. Secondary end points were best ORR during the first 6 months, overall survival, progression-free survival, time to progression, and safety. A two-stage Fleming statistical design was used. Results Forty-six study participants (mean age, 71.2 years ± 10.2; six women and 40 men) were included; 44 participants underwent at least one TACE session. The 6-month ORR was 52% (23 of 44). The best ORR achieved was 68% (30 of 44). Fourteen of 44 (32%) participants underwent a curative treatment after TACE. Median progression-free survival, time to progression, and overall survival were 6.6 months, 9.5 months, and 18.6 months, respectively. TACE was discontinued for toxicity in four of 44 (9%) participants. The most frequent grade 3-4 adverse events were elevated aspartate aminotransferase (14 of 44, 32%), elevated γ-glutamyl transpeptidase (eight of 44, 18%), hyperbilirubinemia (seven of 44, 16%), elevated alanine aminotransferase (seven of 44, 16%), and pain (seven of 44, 16%). Conclusion Idarubicin-eluting beads showed a good safety profile and promising objective response rate and time to progression when used as part of a transarterial chemoembolization regimen for unresectable hepatocellular carcinoma. © RSNA, 2019 See also the editorial by Padia in this issue.

Identifiants

DOI: 10.1148/radiol.2019182399 PMID: 31038408
pubmed: 31038408
doi: 10.1148/radiol.2019182399
doi:

Substances chimiques

Antibiotics, Antineoplastic 0
Idarubicin ZRP63D75JW

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

801-808

Commentaires et corrections

Type : CommentIn

Auteurs

Boris Guiu (B)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0003-1277-3054

Patrick Chevallier (P)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0002-2229-229X

Eric Assenat (E)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0002-8958-2793

Emilie Barbier (E)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Philippe Merle (P)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Antoine Bouvier (A)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Jérôme Dumortier (J)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Eric Nguyen-Khac (E)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0001-8672-4146

Jean Gugenheim (J)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0002-2624-3014

Agnès Rode (A)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Frédéric Oberti (F)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Pierre-Jean Valette (PJ)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Thierry Yzet (T)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Olivier Chevallier (O)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0002-3888-3174

Jean-Claude Barbare (JC)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0001-8228-4542

Marianne Latournerie (M)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).

Mathieu Boulin (M)

From the Saint-Eloi University Hospital, 80 avenue Augustin Fliche, 34295 Montpellier, France (B.G., E.A.); Archet University Hospital, Nice, France (P.C., J.G.); Biostatistics, Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Burgundy & Franche-Comté University Dijon, France (E.B.); Croix Rousse University Hospital, Lyon, France (P.M., A.R.); Hôtel Dieu University Hospital, Angers, France (A.B., F.O.); Edouard Herriot University Hospital, Lyon, France (J.D., P.J.V.); University Hospital, Amiens, France (E.N.K., T.Y., J.C.B.); and Dijon University Hospital, EPICAD INSERM LNC-UMR1231, Burgundy & Franche-Comté University, Dijon, France (O.C., M.L., M.B.).
ORCID: 0000-0002-3504-7250

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Sujet âgé de 80 ans ou plus › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Antinéoplasiques › Antibiotiques antinéoplasiques › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies du foie › Tumeurs du foie › Carcinome hépatocellulaire › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Thérapeutique › Occlusion thérapeutique › Embolisation thérapeutique › Chimioembolisation thérapeutique › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Glucides › Hétérosides › Aminosides › Anthracyclines › Daunorubicine › Idarubicine › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies du foie › Tumeurs du foie › Idarubicin-loaded Beads for Chemoembolization...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Idarubicin-loaded Beads for Chemoembolization...