Malignant Pleural Effusion Research Articles

Mortality after treatment of malignant pleural effusions with indwelling pleural catheters versus chemical pleurodesis: a population-based study.

Little is known about patient outcomes following treatment of malignant pleural effusions (MPE) in the real-world setting. We aimed to compare post-procedure all-cause mortality between individuals who received indwelling pleural catheter (IPC) insertion versus chemical pleurodesis for managing MPEs. We performed a retrospective population-based study using provincial health administrative data (Ontario, Canada) of adults with a MPE who underwent IPC insertion or chemical pleurodesis between 2015 and 2019. Individuals were followed until death or March 31, 2021. Difference in post-procedure mortality was calculated using inverse probability of treatment weighting (IPTW)-adjusted Cox proportional hazard regression analysis to balance potential confounders at baseline. We identified 4,790 (77.3%) individuals who received an IPC and 1,407 (22.7%) who had chemical pleurodesis for MPE. IPC insertions are increasing and chemical pleurodesis procedures are decreasing. The majority of IPCs were inserted in outpatients (61%), by pulmonologists (64.2%) and at sites with higher annual IPC volume, while chemical pleurodesis procedures were generally done by thoracic surgeons (74%) and at sites with higher annual pleurodesis volumes. In unadjusted comparison median time from initial cancer diagnosis to intervention was significantly longer in the IPC group (244 days, interquartile range [IQR]:33-903) compared to pleurodesis group (81 days, IQR:10-737; p < 0.0001). Unadjusted median time from index procedure to death was significantly longer in the pleurodesis group (165[IQR:48-457] days vs. 81[IQR:29-256] days, p < 0.0001), however the difference between groups became insignificant after the IPTW was applied (HR 1.27, 95%CI 0.95-1.69). 35% of IPCs were removed prior to death or end of follow-up. After adjusting for differences in baseline characteristics there was no difference in post-procedure mortality between IPC and chemical pleurodesis groups. In the real world, there are significant differences in the characteristics of patients who receive these two procedures and notable regional practice variation between procedure use. Future research should evaluate these variations in care and their effect on patient outcomes.

Renal Cell Carcinoma Presenting As Isolated Malignant Pleural Effusion: A Case Report

Renal Cell Carcinoma Presenting As Isolated Malignant Pleural Effusion: A Case Report

Pigtail catheter alternative option for malignant pleural effusion other than pleurodesis: a case series

Pigtail catheter alternative option for malignant pleural effusion other than pleurodesis: a case series

Beyond diagnosis: maximizing the role of medical thoracoscopy in pleural disease treatment.

Medical thoracoscopy has been extensively utilized in the diagnosis of pleural disease, yet its potential therapeutic applications remain underutilized. This article presents a comprehensive overview of the various uses of medical thoracoscopy in managing pleural diseases. It has been employed to facilitate thoracic drainage and reduce hospitalization duration of patients with complicated parapneumonic effusions and empyema. Additionally, medical thoracoscopic occlusion therapy can be used for bronchoscopic closure and refractory pneumothorax. However, there is currently a lack of standardized protocols for utilizing medical thoracoscopy to reduce the volume of giant emphysematous bullae. Furthermore, medical thoracoscopy allows for pleurodesis or photodynamic therapy in patients with malignant pleural effusion. Nevertheless, further high-quality clinical research is needed to validate these findings.

Challenges and strategies toward oncolytic virotherapy for leptomeningeal metastasis.

Meningeal metastasis (LM) is commonly seen in the advanced stages of cancer patients, often leading to a rapid decline in survival time and quality of life. Currently, there is still a lack of standardized treatments. Oncolytic viruses (OVs) are a class of emerging cancer therapeutics with the advantages of selectively replicating in cancer cells, delivering various eukaryotic transgenes, inducing immunogenic cell death, and promoting anti-tumor immunity. Some studies applying OVs intrathoracically or intraperitoneally for the treatment of malignant pleural and peritoneal effusions have shown promising therapeutic effects. If OVs could be applied to treat LM, it would bring significant survival benefits to patients with LM. In this review, we analyzed past research on the use of viruses to treat meningeal metastasis, summarized the efficacy and safety demonstrated by the research results, and analyzed the feasibility of oncolytic virus therapy for meningeal metastasis. We also summarized the existing data to provide guidance for the development of OVs that can be injected into the cerebrospinal fluid (CSF).

Clinical and Molecular Features of Malignant Pleural Effusion in Non-Small Cell Lung Cancer (NSCLC) of a Caucasian Population

Background and Objectives: The diversity of patients with malignant pleural effusion (MPE) due to non-small cell lung cancer (NSCLC) as well as the variability in mutations makes it essential to improve molecular characterization. Objective: Describe clinical, pathological, and molecular characteristics MPE in a Caucasian population. Materials and Methods: Retrospective study of patients with NSCLC diagnosis who had undergone a molecular study from 1 January 2018–31 December 2022. Univariate analysis was performed to compare patient characteristics between the group with and without MPE and molecular biomarkers. Results: A total of 400 patients were included; 53% presented any biomarker and 29% had MPE.PDL1, which was the most frequent. EGFR mutation was associated with women (OR:3.873) and lack of smoking (OR:5.105), but not with MPE. Patients with pleural effusion were older and had lower ECOG. There was no significant difference in the presence of any biomarker. We also did not find an association between the presence of specific mutations and MPE (22.4% vs. 18%, p = 0.2), or PDL1 expression (31.9% vs. 35.9%, p = 0.3). Being younger constituted a protective factor for the presence of MPE (OR:0.962; 95% CI 0.939–0.985, p = 0.002), as well as ECOG ≤ 1 (OR:0.539; 95% CI 0.322–0.902, p = 0.01). Conclusions: This is the first study that describes the clinical, pathological, and molecular characteristics of MPE patients due to NSCLC in a Caucasian population. Although overall we did not find significant differences in the molecular profile between patients with MPE and without effusion, EGFR mutation was associated with a tendency towards pleural progression.

Malignant Pleural Effusion: Diagnosis and Treatment—Up-to-Date Perspective

Malignant pleural effusion is the presence of malignant cells within the pleural fluid, representing the second most common cause of pleural exudate. Although diagnostic methods and management techniques for malignant pleural effusion have dramatically improved over the decades, the current treatment is still palliative, aiming to remove pleural fluid, possibly prevent its recurrence, and alleviate symptoms through a wide range of available procedures. Treatment should be tailored to the individual patient, considering comorbidities, size of the effusion, rate of fluid accumulation, underlying cardiac or respiratory conditions, rate of recurrence, presence of loculations or trapped lung, tumor characteristics, cancer type, and patient preferences. This manuscript aims to review the available literature and to present the latest evidence on malignant pleural effusion management in order to provide an updated perspective on its diagnosis and treatment.

Prognostic Role of Pleural Fluid SUVpeak Value obtained from 18F-FDG PET/CT in patients with Malignant Pleural Effusion

PurposeAssessing the prognosis of patients with malignant pleural effusion (MPE) is cruical to manage the treatment. We aimed to investigate the role of pleural fluid SUVpeak value in predicting mortality. MethodsIn our single center, prospective cohort study, we enrolled 158 patients with MPE. PET/CT was independently evaluated by two nuclear medicine physicians. To identify independent predictors of 90-day mortality, we conducted both univariate and multivariate Cox regression analyses. Furthermore, we assessed the discriminatory ability of these predictors compared to the LENT score using the DeLong statistic. ResultsIn our study, we enrolled 158 patients with a mean age of 66.29±12.6 years, of whom 100 (63.3%) were male. The majority of patients (84.9%) had primary lung cancer, while 24 (15.1%) had metastases from extrapulmonary malignancies. Among the followed-up patients, 51 (32%) died within 90 days, with a median survival of 30 (17-61) days. LENT score (HR: 1.52, 95% CI: 1.14-2.03), pleural fluid albumin value (HR: 0.92, 95% CI: 0.87-0.97), pleural fluid SUVpeak value (HR: 1.39, 95% CI: 1.15-1.69), and pleural effusion size (HR: 1.01, 95% CI: 1.001-1.02) were found to be significant predictors. Furthermore, in assessing the predictive performance for 90-day mortality, ROC curve of a combination of the independent predictors was significantly higher than that of LENT score alone. ConclusionOur study revealed that the metabolic characteristics of pleural fluid might predict 90-day mortality in patients with MPE. We established that the incorporation of pleural fluid SUVpeak value into the LENT score has the potential to enhance its discriminative ability.

Beyond tradition: Exploring the potential of a novel drainage technique for indwelling pleural catheter.

There are guidelines recommending the use of Indwelling pleural catheter (IPC), but there is no established consensus or guidelines regarding the modality of drainage post-IPC insertion. We have devised a novel drainage technique that combines the advantages of both aggressive and symptom-guided drainage. This was a prospective intervention trial in which patients with malignant pleural effusion, drained with IPC, were initially given one week of 'high-intensity' drainage on an outpatient basis using a low-pressure suction pump, followed by symptom-based home drainage using vacuum bottles. Patients were assessed for improvement in breathlessness, the number of autos pleurodesis, and the number of vacuum bottles consumed. A total of 25 patients with malignant pleural effusion who satisfied the inclusion criteria were selected. The mean breathlessness as per the visual analogue scale (VAS) was 87 before the insertion of IPC, which decreased to 48.2 immediately after IPC insertion and drainage. The 'high-intensity' drainage was able to maintain this fall in VAS. Thirteen patients (52%) achieved pleurodesis, of which 10 achieved pleurodesis after 5 weeks of IPC insertion, and 3 achieved pleurodesis after 7 weeks of IPC insertion. Eleven patients (44%) had the IPC in situ until death. One patient had the IPC removed due to empyema. None of the 10 patients who achieved pleurodesis within 5 weeks of IPC insertion had to use vacuum bottles at home for 'symptom-guided' fluid drainage. This novel method of draining malignant pleural effusion brought about symptomatic improvement, increase auto-pleurodesis, and thereby reduce the number of vacuum bottles consumed in the study population.

Malignant pleural effusion risk based on a novel tool using homocysteine and carcinoembryonic antigen in pleural fluid: A multicenter study

IntroductionThis multicenter study aimed to evaluate the Malignant Pleural Effusion Risk (MPER) diagnostic accuracy in distinguishing between benign and malign pleural effusion. Methods: MPER is based on pleural fluid Homocysteine (HCY) and carcinoembryonic antigen (CEA) that were measured using three different methods. MPER was calculated by assessing a previously published probabilistic model: Probability (%) = 100× (1 + e-z)-1, where Z = 0.5471 × [HCY] + 0.3846 × [CEA]–8.2671. ResultsA total of 301 patients were included (140 MPE). MPER demonstrated a high AUC (0.891), sensitivity (84.3 %), and specificity (80.7 %) with a cut-off > 35.3 %. ConclusionsThe MPER model demonstrated a high diagnostic accuracy supporting its use as a novel and powerful tool.

The Cytological Diagnosis of a Malignant Effusion Is Independent of the Volume of Fluid Processed.

The relationship between pleural fluid volume and cytological diagnosis of malignancy has been often investigated with conflicting conclusions on whether or not a minimum fluid volume should be defined. The primary objective of this retrospective investigation is to evaluate the relationship between fluid volume and cytological diagnosis of malignancy. A total of 511 body fluid specimen reports received between January 2018 and December 2019 were examined to investigate the relationship between diagnosis of malignancy to volume and biochemical properties. Pleural fluid (n = 252) and peritoneal fluid (n = 250) specimens were binned into two volume groups (< 75 mL, ≥ 75 mL). Pericardial fluid specimens (n = 9) were excluded due to small sample size. Prevalence of malignancy for pleural and peritoneal fluids was 20.2% and 20.08%, respectively, with no significant difference between the two volume groups. Malignant pleural effusions were associated with a serum to fluid protein ratio > 0.5 and malignant peritoneal effusions were associated with a serum ascites albumin gradient (SAAG) < 1.1 g/dL. Our study did not find a significant difference in the diagnosis of malignancy between volumes ≥ 75 mL and < 75 mL in either pleural or peritoneal fluid. Fluid volume is, therefore, not an adequacy criterion for detecting malignancy in either pleural or peritoneal fluid. Our analysis on the biochemical properties of each malignant fluid type was supportive of current use of Light's criteria and SAAG for effusion fluid evaluation.

Unveiling the Rarity: Pleural Metastasis of Papillary Thyroid Cancer – A Case Report and Clinical Implications

Papillary thyroid cancer (PTC) is an epithelial malignancy arising from the follicular cells within the thyroid, typically slow-growing with a benign course (5-year survival &gt;99% in locally contained malignancies). However, in unusual cases, this condition can spread to the pleura, leading to a malignant pleural effusion. The authors present a case of an 80-year-old female presenting with dyspnoea following treatment for suspected bacterial pneumonia. Imaging revealed a substantial left-sided pleural effusion. Despite interventions such as thoracentesis and intravenous antibiotics, the pleural effusion persisted. Subsequent video-assisted thoracic surgery revealed pleural biopsies positive for PTC, a disease previously believed to have been cured almost 6 decades ago. Pleural involvement in patients with PTC is exceptionally rare. A literature review conducted between 1992–2023 revealed merely seven published reports documenting PTC metastasis to the pleura. The authors’ case emphasises the significance of exploring various potential causes of a patient showing signs of subacute dyspnoea, particularly in individuals previously diagnosed with PTC, as it emphasises the possibilities of unforeseen recurrence, featuring the uncertainties and complexities of managing PTC.

A Case of CUP with Malignant Pleural Effusion: Overcoming Diagnostic and Therapeutic Hurdles with Chemotherapy

Introduction: Cancers of unknown primary (CUPs) present a diagnostic challenge as their origin is unidentified at diagnosis. Massive pleural effusion (MPE), indicative of lung metastasis in CUP, categorizes the condition into an unfavorable subset with a poor prognosis. Patients in this subset may exhibit a lower response to specific therapies. Case Presentation: A 62-year-old woman presented with cough, severe dyspnea, and MPE in the left lung. Thoracocentesis was performed, extracting 1,200 mL of hemorrhagic fluid, followed by the placement of an indwelling pleural catheter. The cytological examination of the pleural effusion indicated an adenocarcinoma, with immunohistochemistry revealing positive CK7 and negative CK20, Napsin A, and TTF-1. Additionally, elevated levels of Ca-125 (1,605 U/mL) and Ca 15-3 (242 U/mL) raised suspicion of gynecological malignancy. Thorax and abdominal CT scans, breast and thyroid ultrasounds showed no signs of malignancy, leading to the diagnosis of CUP. The patient’s performance status according to the Eastern Cooperative Oncology Group (ECOG) score was 4. Initial carboplatin 5 AUC and paclitaxel 175 mg/m2 administration resulted in improvement in performance status with ECOG score of 1, alleviation of dyspnea, reduction in pleural effusion 1 week after chemotherapy, with minimal effusion observed at 3 weeks, and Ca-125 levels decreased to 33.6 U/mL thereafter. Discussion: Empiric chemotherapy using carboplatin and paclitaxel is a feasible option for managing CUP with MPE mimicking gynecological malignancies with elevated Ca-125 and Ca 15-3 markers; initiating chemotherapy in poor performance status patients is beneficial with proper clinical judgment.

Bedside to bench and back again-translational research in interventional pulmonology.

Translational research in Interventional Pulmonology has made significant advances in recent years, ranging from novel biomarkers and imaging to practice-changing clinical trials in lung cancer and pleural disease. This review article aims to summarize key research studies in the field to understand the latest published evidence and to highlight areas of growing academic interest. In lung cancer, the role of novel imaging and biomarkers and their potential utility in early lung cancer diagnosis will be highlighted. In pleural disease, less invasive/conservative treatment in pneumothorax, early aggressive treatment in pleural infection along with novel biomarkers, and the shift beyond drainage strategies in malignant pleural effusion and mesothelioma will be discussed. This overview of translational research in the field of interventional pulmonology will ultimately help to highlight the gaps in current evidence to promote research in areas of clinical significance.

A Case of Malignant Pleural Effusion Complicated by Klebsiella rhinoscleromatis

A Case of Malignant Pleural Effusion Complicated by Klebsiella rhinoscleromatis

Prognostic significance of malignant pleural effusions in patients with advanced luminal B breast cancer

BackgroundThough the survival of breast cancer (BC) patients with malignant pleural effusion (MPE) has been studied, this has not been specifically studied in the luminal B subtype. Therefore, this study investigated the characteristics and survival of luminal B-BC patients presenting with MPE.MethodsWe retrospectively analyzed 141 patients diagnosed with postoperative advanced Luminal B breast cancer, including 54 cases with MPE and 87 cases without MPE at the Tianjin Cancer Hospital from January 2012 to January 2015. We assessed the clinical characteristics between the groups.ResultsThe mean age of all patients was 47 years, with no significant difference between the two groups. Altogether, 29 (33%), 24 (28%), 28 (32%), 45 (52%), and 10 (11%) patients had lung, liver, bone, lymph node, and chest wall metastases, respectively. In addition. The difference in overall survival between the two groups was not significant (P>0.05). However, cox regression analysis showed that only the tumor clinical stage at initial diagnosis was related to short overall survival. Further, we conducted a subgroup analysis and found that the higher the clinical stage at initial diagnosis in age < 50 years patients, the shorter the overall survival, while age > 50 years patients was not. (P < 0.05).ConclusionsThere was no difference in the overall survival between luminal B-BC patients with MPE and those without. Clinical stages at initial diagnosis were an independent prognostic factor for age < 50 years luminal B BC with MPE overall survival. Our results may help clinicians make positive decisions regarding personalized treatment of luminal B-BC with MPE.

Enhancing Intrapleural Hyperthermic Chemotherapy for Lung Cancer: Insights from 3D and PDX Models

Background/Objectives: Malignant pleural effusion (MPE) in lung cancer indicates systemically disseminated advanced lung cancer and is associated with poor survival. Intrapleural hyperthermic chemotherapy (IPHC) is a promising treatment for MPE; however, its biological basis is not fully understood. IPHC can enhance anticancer drug efficacy, particularly in drug-resistant cancers. This study investigated the effects of hyperthermia on cisplatin cytotoxicity in lung cancer cell lines, patient-derived tumor cells, and a patient-derived xenograft (PDX) model. Methods: Lung cancer cell lines (A549 and H2170) and patient-derived tumor cells were cultured in 2D/3D systems and treated with cisplatin under varying temperatures (37 °C, 43 °C, and 45 °C) and exposure times (5, 15, and 30 min). Antiproliferative effects were evaluated using LDH and CCK-8 assays. Optimal conditions identified in cell culture experiments were validated using a PDX model; tumor growth inhibition, delay, and protein expression were analyzed post-treatment. Results: Hyperthermia significantly enhanced the antitumor efficacy of cisplatin at 43 °C and 45 °C, with comparable effects under 15 and 30 min exposure. In the PDX model, IPHC showed increased tumor inhibition and necrosis and delayed tumor regrowth, particularly at higher cisplatin doses. Protein expression analysis revealed that hyperthermia decreased EGFR expression and increased levels of apoptosis-related proteins, including cleaved PARP and caspase-3. Conclusions: IPHC with cisplatin demonstrated enhanced antitumor efficacy in vitro models, particularly in drug-resistant lung cancer, indicating its potential as a valuable adjunct to existing treatment regimens for lung cancer and for improving patient outcomes in advanced lung cancer with MPE or pleural metastasis.

B-314 Utility of he4 in differential diagnosis of pleural effusions

Abstract Background The usefulness of tumor markers in the differential diagnosis of cancer in patients with pleural effusions (PE) remains controversial. Few studies have reported the measurement of human epididymal protein 4 (HE4) in pleural fluid. HE4 is a tumor marker associated with different types of cancer. An elevated serum concentration has been observed in ovarian and lung cancers. Other benign pathologies can increase HE4 levels, which can be detect with different laboratory tests identified with adenosine deaminase (ADA), C-reactive protein (CRP), % polynuclear cell count (%PMN) and glomerular filtration rate (GFR) can be used in order to detect possible false positives. The objective of this study was to assess the diagnostic usefulness of HE4 in malignant pleural effusions by comparing HE4 concentrations between benign and malignant samples, while considering the causes of HE4 false positives. Methods HE4, ADA, differential leukocyte count, CRP and GFR concentrations were determined in 238 pleural effusion samples. Diagnostic efficacy analysis using receiver operating curves (ROC) identified the ability of HE4 to detect malignancy, searching for cut-off points with 100% specificity. Results HE4 concentrations showed significant differences (P&amp;lt;0.01) between malignant (median 1065pmol/L) and benign (median 699pmol/L) pleural effusions. Significant differences (P&amp;lt;0.01) were found in HE4 concentrations for gynecological and lung cancer origin (median 7397 pmol/L and 5150 pmol/L respectively) and other malignant pleural effusions (median 1065 pmol/L). Patients with benign diseases with renal failure showed a higher HE4 concentration (median 964pmol/L) than in patients without these pathologies (median 696pmol/L) identified with GFR&amp;lt;30 mL/min. No differences were demonstrated in HE4 concentration levels using ADA, differential leukocyte count or CRP, so only glomerular filtration rate was considered cause of false positives. A sensitivity of 23% was obtained for HE4, with a cut-off point of 3050pmol/L and a specificity of 100% for the whole group. In the potential false positive group, the sensitivity of HE4 was 28% with a cutoff point of 3050 pmol/L with a specificity of 100%. In the group without potential false positives, we obtained a sensitivity of 30% with a specificity of 100% for a cutoff point of 1992pmol/L. When we used a specific cut-off point for each group, we obtained a sensitivity of 38% with a specificity of 100%. Conclusions HE4 levels are higher in malignant pleural effusions compared to other pathologies. HE4 levels allow the identification of malignant pleural effusions with moderate sensitivity and maximum specificity. HE4 levels can differentiate between tumors of gynecological or lung origin and others. Glomerular filtration rate (GFR&amp;lt;30 mL/min) was considered the main cause of false positives. If we identify possible false positives, we can use specific cut-offs and improve sensitivity up to 38% with maximum specificity compared to using a single cut-off for all effusions.

B-313 Assessment of β2-microglobulin concentration in pleural effusions

Abstract Background β2-microglobulin (β2-m) is a biomarker used in serum for different types of pathologies. It has been described that lymphocyte activation processes us tuberculosis infections, AIDS virus or cytomegalovirus infections, can produce an increase in the concentration of this marker. As a tumor marker is useful in lymphomas diagnosis. In the bibliography has reported that processes involving renal failure lead to a significant increase in its concentration. In patients with renal failure and treated with hemodialysis, have been described medians twenty times the upper reference limit. The objective is to assess whether the concentration of (β2-m) in pleural fluid is affected by the same factors as in serum. Methods We analyzed 303 pleural effusions (PE) samples from undiagnosed patients with pleural effusion. β2-microglobulin levels were prospectively measured by electrochemiluminescence (ECLIA) assays (Cobas c702, Roche Diagnostics®). Glomerular filtration rate (GFR) was calculated by CKD-EPI equation. The diagnostic performance of β2-microglobulin was evaluated by receiver operating characteristic (ROC) curve analysis. Statistical analyses were performed using SPSS software. Results Pleural fluid of 303 patients (104 female, 204 male) were collected. The median age was 72 ± 10,6 years. For all samples β2-m median concentration was 5,85 mg/L (IQR:3.4 -6.45).When we compared all results according to kidney failure values; GFR &amp;gt;60mL/min β2-m median concentration was 4,12mg/L and if GFR &amp;lt;60 mL/min, β2-m was 8,62g/L significant difference have found (p&amp;lt;0,001). Comparing results between malignant pleural effusions (MPE) (n=96) and benign pleural effusions (BPE) (n=207), MPE median concentration was 5.38 mg/L and 6.07mg/L significant difference (p&amp;lt;0,001). Benign pathologies associated with pleural effusions, tuberculosis samples had the highest concentration of β2-m. Tuberculosis samples (n=6) had a normal distribution, obtaining a value [mean (SD)] of 7.28 mg/mL (2,13) mg/mL. For tuberculosis samples and patients without renal failure (n=5) (GFR&amp;gt;60 mL/min), the area under the ROC curve was 0.98 (95% CI: 0.88-0.98) (p&amp;lt;0.005). For β2-m cut-off point was 5.150 mg/L, a sensitivity of 100%, specificity of 16%, positive predictive value (PPV) of 14% and negative predictive value (NPV) of 100% were obtained. Patients with lymphomas present the highest concentration in the group of malignant pleural effusions, but further investigations could not be performed due to the small sample size. Conclusions Based on the results obtained from our present study, it can be concluded that β2-microglobulin marker in pleural effusions has significant association with glomerular filtration rate, as well as occurs in serum. Higher concentrations were found in patients with GFR&amp;gt;60 mL/min and tuberculosis. Using 5,15 mg/L cut-off point, 100% of NPV was obtained.

Phase II study of ramucirumab and docetaxel for previously platinum-treated patients with non-small cell lung cancer and malignant pleural effusion (PLEURAM study).

The prognosis of patients with lung cancer and malignant pleural effusion (MPE) caused by carcinomatous pleurisy is poor. Chemical pleurodesis is commonly performed clinically, however, often has a high failure rate. Furthermore, prolonged sustained drainage and delayed introduction of systemic chemotherapy could increase the risk of worsening the Eastern Cooperative Oncology Group Performance Status (ECOG PS) in the treatment of patients with non-small cell lung cancer (NSCLC). Therefore, both systemic and local treatments are crucial to control MPE. Ramucirumab, an antibody targeting vascular endothelial growth factor receptor 2, is expected to be effective for treatment of MPE. However, there are no data supporting this hypothesis. Herein, we performed a prospective phase II study to evaluate the efficacy and safety of ramucirumab plus docetaxel in NSCLC patients with MPE. A single-arm phase II study was conducted to elucidate the efficacy and safety of ramucirumab plus docetaxel as a combined treatment for patients NSCLC and MPE previously treated with platinum-based chemotherapy. The primary endpoint was the MPE control proportion at eight weeks after protocol treatment initiation. The secondary endpoints of the study were objective response rate (ORR), progression-free survival (PFS), one-year survival rate, overall survival (OS), and toxicity profile. Between September 2019 and March 2022, 15 patients were enrolled. The pleural effusion control proportion at eight weeks was 100% [90% confidence interval (CI): 84.0-100%, and 95% CI: 78.4-100%], and the primary endpoint of this study was met. The ORR was 6.7% (95% CI: 0.2-32.0%), the median PFS was 6.3 months (95% CI: 1.9-6.9), and the median OS was 10.4 months (95% CI: 3.2-16.5). No Grade 5 or unexpected adverse events were observed. Ramucirumab plus docetaxel is a promising and safe treatment option for previously treated patients with NSCLC and MPE, showing a high pleural effusion control rate.