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Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial

医学 卡铂 紫杉醇 阿维鲁单抗 肿瘤科 打开标签 子宫内膜癌 内科学 化疗 随机对照试验 癌症 免疫疗法 顺铂 无容量
作者
Sandro Pignata,Giovanni Scambia,Clorinda Schettino,Laura Arenare,Carmela Pisano,Davide Lombardi,Ugo De Giorgi,Claudia Andreetta,Saverio Cinieri,Carmine De Angelis,Domenico Priolo,Cláudia Casanova,Marta Rosati,Filippo Greco,Elena Zafarana,Ilaria Schiavetto,Serafina Mammoliti,Sabrina Chiara Cecere,Vanda Salutari,Simona Scalone,Alberto Farolfi,Marilena Di Napoli,Domenica Lorusso,Piera Gargiulo,Daniela Califano,Daniela Russo,Anna Spina,Rossella De Cecio,Paolo Chiodini,Francesco Perrone,Valentina Accinno,Chiara Altavilla,Claudia Andreetta,Giovanna Antonelli,Laura Arenare,Grazia Artioli,Francesco Avola,Bonifacio Barbara,Valentina Barbato,Michele Bartoletti,Simona Bevilacqua,Roberto Bordonaro,Oriana Borghese,Gaetano Buonfanti,Daniela Califano,Floriana Camarda,Giuliana Canzanella,Maria Rita Carbone,Maria Rita Carbone,G Stella,Cláudia Casanova,Chiara Cassani,Fabrizio Castagna,Monica Cattaneo,Sabrina Chiara Cecere,Paolo Chiodini,M. Cinefra,Saverio Cinieri,Nicoletta Colombo,Serena Corsetti,Monia Dall’Agata,Maria Rosaria D’Amico,Gennaro Daniele,Carmine De Angelis,Rossella De Cecio,Ugo De Giorgi,Elvira De Marino,Giovanni De Matteis,Sabino De Placido,Gabriella Del Bene,Antonia Del Giudice,Francesca Del Monte,Michele Del Sesto,Marilena Di Napoli,Maddalena Donini,Giuliana Drudi,G Falcone,Alberto Farolfi,Adolfo Favaretto,Giulia Ferrera,Manuela Florio,Valeria Forestieri,Maria Stella Gallo,Ciro Gallo,Piera Gargiulo,Francesca Garibaldi,Fabiana Gerevini,Viola Ghizzoni,Maria Olga Giganti,Anna Gimigliano,Elena Giudice,Nicoletta Gnocchi,Adriano Gravina,Filippo Greco,Stefano Greggi,Maria Laura Iaia,Annalisa Ilardi,Gelsomina Iovine,Gabriella Ippoliti,Giulia Irollo,Ilenia Isidori,Mariateresa Lapresa,G. Lavenia,Davide Lombardi,Laura Longhitano,Domenica Lorusso,Bortot Lucia,Gabriella Luzi,Serafina Mammoliti,Sara Mariano,Valentina Marino,Giovanna Marrapese,Marilena Martino,Roberta Matocci,E. Mazzoni,Daniela Mercuri,Maria Mirto,Giovanna Mollo,A. Montinaro,Marta Moscatelli,Anna Maria Mosconi,Lucia Musacchio,Nicoletta Nanni,Pamela Natalucci,Milena S. Nicoloso,Michele Orditura,Gabriella Maria Parma,Rodolfo Passalacqua,Michela Pelone,Maria Teresa Perri,Francesco Perrone,Bruno Perrucci,A Piancastelli,Maria Carmela Piccirillo,Antonio Piccolo,Sandro Pignata,Carmela Pisano,Domenico Priolo,Stefania Rapisardi,Giorgia Ravaglia,Teresa Ribecco,Caterina Ricci,Marianna Roccio,Fiorella Romano,Marta Rosati,Daniela Russo,Vanda Salutari,Daniela Sambataro,Alfonso Savio,Ada Sbriglia,Cono Scaffa,Simona Scalone,Giovanni Scambia,Clorinda Schettino,Ilaria Schiavetto,Concetta Sergi,Francesca Sgandurra,Roberto Sorio,Anna Spina,Stefano Stabile,Gianna Tabaro,Margherita Tambaro,Stefano Tamberi,Angelica Tecchiato,Ángela Maria Trujillo,Eleonora Zaccarelli,Elena Zafarana
出处
期刊:Lancet Oncology [Elsevier]
卷期号:24 (3): 286-296 被引量:13
标识
DOI:10.1016/s1470-2045(23)00016-5
摘要

Summary

Background

Adding immunotherapy to first-line chemotherapy might improve outcomes for patients with advanced or recurrent endometrial cancer. We aimed to compare carboplatin and paclitaxel versus avelumab plus carboplatin and paclitaxel as first-line treatment with avelumab given concurrent to chemotherapy and as maintenance after the end of chemotherapy.

Methods

MITO END-3 is an open-label, randomised, controlled, phase 2 trial conducted at 31 cancer institutes, hospitals, and universities in Italy. Eligible patients were aged 18 years or older with histologically confirmed advanced (FIGO stage III–IV) or recurrent endometrial cancer, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, and no previous systemic anticancer therapy as primary treatment for advanced or metastatic disease. Participants were randomly assigned (1:1) using a computerised minimisation procedure stratified by centre, histology, and stage at study entry, to either receive carboplatin (area under the curve [AUC] 5 mg/mL × min) and paclitaxel (175 mg/m2; standard group) intravenously every 3 weeks for six to eight cycles or avelumab (10 mg/kg intravenously) added to carboplatin and paclitaxel (experimental group) every 3 weeks and then every 2 weeks as a single maintenance treatment after the end of chemotherapy until disease progression or unacceptable toxicity. Patients, treating clinicians, and those assessing radiological examinations were not masked to study treatment. The primary endpoint was investigator-assessed progression-free survival, measured in the intention-to-treat (ITT) population. Patients who received at least one dose of study drug were included in the safety analysis. Experimental group superiority was tested with 80% power and one-tailed α 0·20. This trial is registered with ClinicalTrials.gov (NCT03503786) and EudraCT (2016–004403–31).

Findings

From April 9, 2018, to May 13, 2021, 166 women were assessed for eligibility and 39 were excluded. 125 eligible patients were randomly assigned to receive carboplatin and paclitaxel (n=62) or avelumab plus carboplatin and paclitaxel (n=63) and included in the ITT population. The median follow-up was 23·3 months (IQR 13·2–29·6) and was similar between the two groups. 91 progression-free survival events were reported, with 49 events in 62 patients in the standard group and 42 events in 63 patients in the experimental group. The median progression-free survival was 9·9 months (95% CI 6·7–12·1) in the standard group and 9·6 months (7·2–17·7) in the experimental group (HR of progression or death 0·78 [60% CI 0·65–0·93]; one-tailed p=0·085). Serious adverse events were reported more frequently in the experimental group (24 vs seven events in the standard group); neutrophil count decrease was the most frequent grade 3–4 adverse event (19 [31%] of 61 patients in the experimental group vs 26 [43%] of 61 patients in the standard group). Two deaths occurred in the experimental group during treatment (one respiratory failure following severe myositis [possibly related to treatment] and one cardiac arrest [not related to treatment]).

Interpretation

Adding avelumab to first-line chemotherapy deserves further testing in patients with advanced or recurrent endometrial cancer, although consideration of mismatch repair status is warranted.

Funding

Pfizer.
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