دورية أكاديمية
Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With BRCA -Mutated and/or BRCAness Phenotype: A Randomized Phase III Trial.
| العنوان: | Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With BRCA -Mutated and/or BRCAness Phenotype: A Randomized Phase III Trial. |
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| المؤلفون: | Lorusso D; Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy., Raspagliesi F; Fondazione IRCCS Istituto Nazionale Tumori Milan, Milan, Italy., Ronzulli D; Fondazione IRCCS Istituto Nazionale Tumori Milan, Milan, Italy., Valabrega G; Department of Oncology, Oncology Unit, University of Turin, Ordine Mauriziano Hospital, Turin, Italy., Colombo N; European Institute of Oncology IRCCS and Università degli Studi di Milano Bicocca, Milan, Italy., Pisano C; Department of Urology and Gynecology, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione G. Pascale, Naples, Italy., Cassani C; Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Unit of Obstetrics and Gynecology, University of Pavia, IRCCS San Matteo Hospital Foundation, Pavia, Italy., Tognon G; ASST Spedali Civili di Brescia, Università di Brescia, Brescia, Italy., Tamberi S; Ospedale degli Infermi-AUSL, Ravenna, Italy., Mangili G; IRCCS San Raffaele Hospital, Milan, Italy., Mammoliti S; IRCCS Ospedale Policlinico San Martino, Genova, Italy., De Giorgi U; IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy., Greco F; Oncology Unit, Mater Salutis Hospital, Ulss 9 Veneto Region, Legnago, Italy., Mosconi AM; Azenda Ospedaliera Perugia, Perugia, Italy., Breda E; MITO and Fatebenefratelli Hospital, Rome, Italy., Artioli G; Ulss 2 Marca Trevigiana, Treviso, Italy., Andreetta C; Department of Oncology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy., Casanova C; Department of Oncology, Ospedale Civile Santa Maria delle Croci, Ravenna, Italy., Ceccherini R; Department of Oncology, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy., Frassoldati A; S Anna University Hospital, Ferrara, Italy., Salutari V; Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Giolitto S; Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Scambia G; Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 May 01; Vol. 42 (13), pp. 1488-1498. Date of Electronic Publication: 2024 Feb 05. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Multicenter Study; Comparative Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Trabectedin*/therapeutic use , Trabectedin*/administration & dosage , Ovarian Neoplasms*/drug therapy , Ovarian Neoplasms*/genetics , Ovarian Neoplasms*/mortality , Mutation* , Neoplasm Recurrence, Local*/drug therapy, Humans ; Female ; Middle Aged ; Aged ; Adult ; Phenotype ; Prospective Studies ; BRCA2 Protein/genetics ; BRCA1 Protein/genetics ; Antineoplastic Agents, Alkylating/therapeutic use ; Antineoplastic Agents, Alkylating/adverse effects ; Antineoplastic Agents, Alkylating/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Aged, 80 and over ; Progression-Free Survival |
| مستخلص: | Purpose: Literature evidence suggests that trabectedin monotherapy is effective in patients with recurrent ovarian cancer (OC) presenting BRCA mutation and/or BRCAness phenotype. Methods: A prospective, open-label, randomized phase III MITO-23 trial evaluated the activity and safety of trabectedin 1.3 mg/m 2 given once every 3 weeks (arm A) in BRCA 1/2 mutation carriers or patients with BRCAness phenotype (ie, patients who responded to ≥two previous platinum-based treatments) with recurrent OC, primary peritoneal carcinoma, or fallopian tube cancer in comparison with physician's choice chemotherapy in the control arm (arm B; pegylated liposomal doxorubicin, topotecan, gemcitabine, once-weekly paclitaxel, or carboplatin). The primary end point was overall survival (OS) evaluated in the intention-to-treat population. Results: Overall, 244 patients from 21 MITO centers were randomly assigned (arm A = 122/arm B = 122). More than 70% of patients received ≥three previous chemotherapy lines and 35.7% had received a poly (ADP-ribose) polymerase inhibitor (PARPi) before enrollment. Median OS was not significantly different between the arms: arm A: 15.8 versus arm B: 17.9 months ( P = .304). Median progression-free survival was 4.9 months in arm A versus 4.4 months in arm B ( P = .897). Among 208 patients evaluable for efficacy, the objective response rate was 17.1% in arm A and 21.4% in arm B, with comparable median duration of response (5.62 v 5.66 months, respectively). No superior effect was observed for trabectedin in the prespecified subgroup analyses according to BRCA mutational status, chemotherapy type, and pretreatment with a PARPi and/or platinum-free interval. Trabectedin showed a higher frequency of grade ≥3 adverse events (AEs), serious AEs, and serious adverse drug reactions compared with control chemotherapy. Conclusion: Trabectedin did not improve median OS and showed a worse safety profile in comparison with physician's choice control chemotherapy. |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02903004 |
| المشرفين على المادة: | ID0YZQ2TCP (Trabectedin) 0 (BRCA1 protein, human) 0 (BRCA2 protein, human) 0 (BRCA2 Protein) 0 (BRCA1 Protein) 0 (Antineoplastic Agents, Alkylating) |
| تواريخ الأحداث: | Date Created: 20240205 Date Completed: 20240426 Latest Revision: 20240426 |
| رمز التحديث: | 20240427 |
| DOI: | 10.1200/JCO.23.01225 |
| PMID: | 38315944 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-7755 |
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| DOI: | 10.1200/JCO.23.01225 |