Cytological Examination of Malignant Pleural Effusion in Breast Cancer

Diagnostic Yield of Cytological Examination of Malignant Pleural Effusion in Different Breast Cancer Pathologies

Malignant pleural effusion (MPE) is characterized by the presence of malignant cells. It can occur in 15% of patients with cancer and is a common manifestation in patients with metastatic disease.

Breast cancer (BC) is the second most common cause of MPE and MPE occurring in 2- 11% of patients with BC. Breast cancer is a heterogeneous disease of malignant tumors with diversified morphology, clinical course, biologic behavior and prognosis, and accurate tumor classification is critical for a patient's care.

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Diagnostic test: Thoracentesis

Detailed Description

The serous pleural cavity is an enclosed space covered by the parietal and visceral layers of serous membranes, which are lined by a monolayer of mesothelial cells supported on fibrous tissue rich in capillaries and lymphatic. Under physiological conditions, these two layers are in juxtaposition and only a small amount of fluid is Present inside these compartments, acting as a lubricant to avoid friction.

Many infectious, benign, and malignant diseases can cause pleural effusion. Approximately one-fourth of all pleural effusions and 30 - 70% of all exudative effusions in hospital settings are secondary to cancer.

Lung cancer is the most common metastatic tumor to the pleura in men, while breast cancer is the most common tumor in women.

Breast cancer is the most commonly diagnosed malignant tumor in women worldwide and the most common cause of malignancy- related deaths. Breast cancer patients constitute approximately 36% of all oncological patients. The incidence of breast cancer is gradually increasing worldwide.

Since breast cancer is a heterogeneous disease that varies from clinical course to molecular subtypes, it includes a wide spectrum of diseases with different presentations and morphological, biological, and clinical phenotypes. Therefore, the behavior and treatment success of breast cancer vary greatly from person to person, and, as a result, it is possible to encounter very different personalized prognosis processes in breast cancer patients.

Malignant pleural effusions are most commonly caused by carcinomas of lung, breast, gastrointestinal tract or ovary, and hematological malignancies. Diagnosis of pleural effusion is done by many maneuvers as simple aspiration for cytological examination, or using more invasive maneuvers as closed pleural biopsy and medical thoracoscopy. Large studies evaluated the sensitivity and specificity of conventional cytology for the detection of malignant cells in effusions, ranging from 40% to 80% and 89% to 98%, respectively.

Molecular classification of breast cancer was developed based on the use of complementary DNA microarrays to represent human genes. Breast cancer was divided into 4 intrinsic molecular subtypes: luminal A, luminal B, v-erb-b2 (ERBB2)/human epithelial growth factor receptor 2 (HER2) gene-overexpressing (HER2), and basal-like.

The presence of MPE in advanced cancer is associated with poor prognosis, and the range of overall survival (OS) time is from 5 to 13 months. MPE is most common in triple-negative breast cancer (TNBC), and TNBC phenotype is an unfavorable characteristic in patients with MPE, worsening the prognosis and reducing life expectancy. For symptomatic patients with MPE, it is recommended to use an indwelling pleural catheter or chemical pleurodesis combined with systemic treatment.

Several factors could be attributed to this great variability, such as different immune-cytochemical staining techniques, dilutions and type of antibody clone used, volume of sample, procedural technique and the experience of the examiner. In addition, lack of uniformity in reporting such specimens could also be a factor for such wide differences in overall values of sensitivity and specificity among studies, with no study yet, to the best of our knowledge, reporting risk of malignancy (ROM) of defined diagnostic categories in pleural fluids.

For the time being, no international recommendations have been made about the rationale of using anti-tumor therapy against standard palliative MPE treatment procedures. The clinical treatment response of MPE is poor in systemic anti-tumor therapy in most malignant conditions. Therefore, there is an urgent need to develop a viable and reliable method to improve therapeutic effects of BC patients with MPE.

Therefore, pleural effusion samples will be sampled, using a diagnostic system and reporting ROM for each defined category, as well as use of immunohistochemistry and overall sensitivity and specificity of cytology when compared to concomitant pleural biopsies.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mohamed AbdElmoniem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients are presented for thoracentesis with cytological examination of pleural effusion, if the appearance of visceral and parietal pleural was clearly and if malignant diagnosis of breast was confirmed on histological analysis of the biopsy material.

Description

Inclusion Criteria:

• Patients will be included if they are presented for thoracentesis with routine cytological examination of pleural effusion before biopsy or thoracoscopy, if the appearance of visceral and parietal pleural was clearly and if malignant diagnosis of breast was confirmed on histological analysis of the biopsy material.

Exclusion Criteria:

• Age <18 years.
• Patients diagnosed with malignant pleural mesothelioma (MPM)
• Contraindication for pleurocentesis; patient refusing, coagulopathy and active skin infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer breast; malignant pleural effusion in breast cancer	Diagnostic test: Thoracentesis; Aspiration of pleural effusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytological examination of pleural effusion in breast cancer ( cell/unit)	Diagnosis of pleural effusion by cytological examination	6 months

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Investigators: Principal Investigator: Mohamed AbdElmoniem, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2024
• Primary Completion (Actual): January 19, 2025
• Study Completion (Actual): April 19, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; malignant pleural effusion; Cytological examination
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Diseases; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: R.24.10.2828.R2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No