Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

被引：7

作者：

Canova, S. ^{[1
]}

Ceresoli, G. L. ^{[2
,3
]}

Grosso, F. ^{[4
]}

Zucali, P. A. ^{[5
,6
]}

Gelsomino, F. ^{[7
]}

Pasello, G. ^{[8
,9
]}

Mencoboni, M. ^{[10
]}

Rulli, E. ^{[11
]}

Galli, F. ^{[11
]}

De Simone, I. ^{[11
]}

Carlucci, L. ^{[11
]}

De Angelis, A. ^{[4
]}

Belletti, M. ^{[4
]}

Bonomi, M. ^{[2
,12
]}

D'Aveni, A. ^{[2
,3
]}

Perrino, M. ^{[5
]}

Bono, F. ^{[1
]}

Cortinovis, D. L. ^{[1
,13
]}

机构：

[1] ASST HS Gerardo, SC Med Oncol, Monza, Italy

[2] Humanitas Gavazzeni, Bergamo, Italy

[3] ASST Valle Olona, Dept Oncol, Saronno Hosp, Saronno, VA, Italy

[4] Azienda Osped SS Antonio & Biagio & Cesare Arrigo, Mesothelioma Unit, Alessandria, Italy

[5] IRCCS Humanitas Res Hosp, Dept Oncol, Rozzano, Italy

[6] Humanitas Univ, Dept Biomed Sci, Rozzano, Italy

[7] IRCCS Azienda Osped Univ Bologna, Bologna, Italy

[8] Univ Padua, Dept Surg Oncol & Gastroenterol, Padua, Italy

[9] Ist Oncol Veneto IRCCS, Med Oncol 2, Padua, Italy

[10] ASL 3 Genovese Osped Villa Scassi, Genoa, Italy

[11] Ist Ric Farmacol Mario Negri IRCCS, Methodol Clin Res Lab, Milan, Italy

[12] ASST Cremona, Dept Oncol, Cremona, Italy

[13] ASST Monza San Gerardo Hosp, SC Med Oncol, Via Pergolesi 33, I-20900 Monza, Italy

来源：

ESMO OPEN | 2022年 / 7卷 / 06期

关键词：

malignant pleural mesothelioma; second line; durvalumab; immune checkpoint inhibitors; OPEN-LABEL; MULTICENTER; CHEMOTHERAPY; CISPLATIN; TRIAL; PEMBROLIZUMAB; 2ND-LINE;

D O I：

10.1016/j.esmoop.2022.100644

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Malignant pleural mesothelioma (MPM) is a cancer with a high mortality rate and few therapeutic options. After platinum-pemetrexed combination, no further promising drug seems to be effective. Immune checkpoint inhibitors may have some activity in pretreated patients and no data are available in this population about durvalumab. Materials and methods: DIADEM was a multicenter, open-label, single-arm, phase II trial aimed at evaluating the efficacy and safety of durvalumab. Patients with locally advanced/metastatic MPM who progressed after platinum-pemetrexed chemotherapy were enrolled to receive durvalumab (1500 mg, intravenously Q4W) for 12 months or until evidence of disease progression or unacceptable toxicity. The primary endpoint was the proportion of patients alive and free from progression at 16 weeks (PFS16wks) calculated from treatment initiation. Secondary endpoints were progression-free survival, overall survival, overall response rate, and safety. Results: Sixty-nine patients with a median age of 69 years (range 44-82 years) were enrolled; 62 patients (89.9%) had epithelioid histotype. As first-line treatment, all patients received platinum derivatives-pemetrexed combination (60.9% with carboplatin and 39.1% with cisplatin). As of March 2021, the median follow-up was 9.2 months (interquartile range 5.2-11.1 months). Six patients (8.7%) completed the 12-month treatment; 60 patients discontinued, of whom 42 for progressive disease, and 4 died. Seventeen patients (28.3%; 95% confidence interval 17.5% to 41.4%) were alive or free from progression at 16 weeks. Eleven patients (18.6%) had a grade 3 or 4 treatment-related adverse event (AE), and one (1.4%) had a grade >= 3 immune-related, treatment-related AE. There was one drug-related death. Conclusion: Durvalumab alone in pretreated non-selected MPM did not reach a meaningful clinical activity, showing any new major safety issue signals.

引用

页数：1

共 27 条

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