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A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811).

ABSTRACT: Safety and efficacy of intrapericardial (i.p.c.) instillation of bleomycin (BLM) following pericardial drainage in patients with malignant pericardial effusion (MPE) remain unclear. Patients with pathologically documented lung cancer, who had undergone pericardial drainage for MPE within 72 h of enrolment, were randomised to either arm A (observation alone after drainage) or arm B (i.p.c. BLM at 15 mg, followed by additional i.p.c. BLM 10 mg every 48 h). The drainage tube was removed when daily drainage was 20 ml or less. The primary end point was survival with MPE control (effusion failure-free survival, EFFS) at 2 months. Eighty patients were enrolled, and 79 were eligible. Effusion failure-free survival at 2 months was 29% in arm A and 46% in arm B (one-sided P=0.086 by Fisher's exact test). Arm B tended to favour EFFS, with a hazard ratio of 0.64 (95% confidence interval: 0.40-1.03, one-sided P=0.030 by log-rank test). No significant differences in the acute toxicities or complications were observed. The median survival was 79 days and 119 days in arm A and arm B, respectively. This medium-sized trial failed to show statistical significance in the primary end point. Although ipc BLM appeared safe and effective in the management of MPE, the therapeutic advantage seems modest.

SUBMITTER: Kunitoh H

PROVIDER: S-EPMC2658533 | biostudies-literature | 2009 Feb

REPOSITORIES: biostudies-literature

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A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811).

Kunitoh H H Tamura T T Shibata T T Imai M M Nishiwaki Y Y Nishio M M Yokoyama A A Watanabe K K Noda K K Saijo N N

British journal of cancer 20090120 3

Safety and efficacy of intrapericardial (i.p.c.) instillation of bleomycin (BLM) following pericardial drainage in patients with malignant pericardial effusion (MPE) remain unclear. Patients with pathologically documented lung cancer, who had undergone pericardial drainage for MPE within 72 h of enrolment, were randomised to either arm A (observation alone after drainage) or arm B (i.p.c. BLM at 15 mg, followed by additional i.p.c. BLM 10 mg every 48 h). The drainage tube was removed when daily ...[more]

PMID: 19156149

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Project description:BackgroundMalignant pericardial effusion (MPE) is a serious complication in patients with advanced malignant tumors, which indicates a poor prognosis. However, its clinical manifestations lack specificity, making it challenging to distinguish MPE from benign pericardial effusion (BPE). The aim of this study was to develop and validate a scoring system based on a nomogram to discriminate MPE from BPE through easy-to-obtain clinical parameters.MethodsIn this study, the patients with pericardial effusion who underwent diagnostic pericardiocentesis in Taizhou Hospital of Zhejiang Province from February 2013 to December 2021 were retrospectively analyzed. The eligible patients were divided into a training group (n = 161) and a validation group (n = 66) according to the admission time. The nomogram model was established using the meaningful indicators screened by the least absolute shrinkage and selection operator (LASSO) and multivariate logistic regression. Then, a new scoring system was constructed based on this nomogram model.ResultsThe new scoring system included loss of weight (3 points), no fever (4 points), mediastinal lymph node enlargement (2 points), pleural effusion (6 points), effusion adenosine deaminase (ADA≦18U/L) (5 points), effusion lactate dehydrogenase (LDH>1033U/L) (7 points), and effusion carcinoembryonic antigen (CEA>4.9g/mL) (10 points). With the optimal cut-off value was 16 points, the area under the curve (AUC), specificity, sensitivity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR) for identifying MPE were 0.974, 95.1%, 91.0%, 85.6%, 96.8%, 10.56 and 0.05, respectively, in the training set and 0.950, 83.3%, 95.2%, 90.9%, 90.9%, 17.50, and 0.18, respectively, in the validation set. The scoring system also showed good diagnostic accuracy in differentiating MPE caused by lung cancer from tuberculous pericardial effusion (TPE) and MPE including atypical cell from BPE.ConclusionThe new scoring system based on seven easily available variables has good diagnostic value in distinguishing MPE from BPE.

Project description:Background: The feasibility and value of pericardial effusion as a liquid biopsy sample for actionable alteration detection in patients with non-small cell lung cancer (NSCLC) has not been adequately investigated. Here, we aim to reveal genomic alterations between pericardial effusion and paired tumor tissue, plasma (plasma cfDNA), and pleural effusion supernatant (PE-cfDNA) based on second-generation sequencing technology. Material and methods: A total of 26 advanced NSCLC patients were retrospectively studied. The following samples were collected and sequenced using two targeted next-generation sequencing panels: pericardial effusion (n = 26), matched tumor tissue (n = 6), plasma (n = 16), and pleural effusion supernatant (n = 5). Results: A total of 10 actionable alterations were identified in pericardial effusion of the NSCLC patients, including MET amplification, EGFR L858R, EGFR T790M, EGFR exon 19 deletion, EGFR L861Q, KRAS G12C, EML4-ALK (exon 18: exon 20) fusion, EML4-ALK (exon 20: exon 20) fusion, EML4-ALK (exon 6: exon 20) fusion, and ERBB2 exon 20 insertion. All these actionable alterations harbored multiple drug-sensitive targets as well as several drug-resistant targets, such as EGFR T790M. Compared to plasma cfDNA of 16 patients, paired pericardial effusion had higher number of actionable alterations (p = 0.08) as well as higher percentage of the population with actionable alterations (p = 0.16). Moreover, 8 out of 10 actionable alterations with single nucleotide variations (SNVs) or insertions/deletions (indels) had a higher variant allele frequency (VAF) in pericardial effusion than plasma cfDNA. In addition, we identified two actionable alterations in paired pericardial effusion, which were absence in PE-cfDNA. Clearly, 2 out of 3 actionable alterations with SNVs/indels in pericardial effusion had a higher VAF than those in PE-cfDNA. Our finding suggested the importance of pericardial effusion in the optimal selection of patients for targeted therapy. Conclusion: Among liquid biopsy specimens from the advanced NSCLC patients, pericardial effusion may be a better candidate for genomic profiling than plasma cfDNA, while it could serve as a supplement to PE-cfDNA in detecting actionable alterations. Therefore, pericardial effusion might provide a new alternative for selection of patients for better treatment management.

Dataset Information

A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811).

Publications

A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811).

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