Good Doctor·Hyperthermic Perfusion | Literature Review and Analysis | (3) “A Controlled Study of Intracavitary Constant-Temperature Circulating Hyperthermic Perfusion Chemotherapy for Malignant Pleural Effusion”

[Abstract]

Case selection: The observation group comprised 25 patients aged 39–65 years, including 18 cases of lung cancer, 5 cases of pleural mesothelioma, and 2 cases of breast cancer; 15 were male and 10 were female. The control group consisted of 25 patients aged 38–68 years, with 16 cases of lung cancer, 6 cases of pleural mesothelioma, and 3 cases of breast cancer; 16 were male and 9 were female.

Methods: Fifty patients with malignant pleural effusion treated between January and December 2008 were randomly assigned to two groups. The observation group (n=25) underwent the establishment of a circulating double-lumen system using a conventional puncture needle; pleural lavage was performed first to replace the pleural fluid, followed by continuous pleural perfusion at a constant temperature (45–45.5°C). After 3–5 minutes of circulation, 60 mg of cisplatin was added to the circuit, and hyperthermic chemotherapy was maintained for 60 minutes. At the end of treatment, the infused solution was drained, leaving no less than 500 mL in the cavity. The control group (n=25) received a pleural drainage tube; initial pleural fluid drainage was performed, followed by instillation of 100 mL of fluid containing 60 mg of cisplatin. All patients completed three or more treatment cycles.

Results: Clinical efficacy: In the observation group, the overall response rate was 84% (21/25), with a complete remission rate of 32% (8/25); in the control group, the overall response rate was 52% (12/25), and the complete remission rate was 16% (4/25). These differences were statistically significant (P<0.05). Tumor markers showed a marked decrease. Adverse reactions: Both groups experienced mild adverse events, including nausea, vomiting, leukopenia, and chest pain; these symptoms resolved promptly with symptomatic management. Notably, patients in the observation group exhibited improved appetite and mental status, rather than deterioration, compared with the control group. No cases of pneumothorax or pleural infection occurred, and no patients developed hepatic or renal dysfunction.

Conclusion: Compared with conventional drainage and infusion chemotherapy, intrathoracic continuous hyperthermic circulatory chemotherapy significantly improves the efficacy of treating malignant pleural effusion, markedly reduces the recurrence of malignant effusion, and enhances the quality of life in patients with advanced cancer. The procedure is easy to master, cost‑effective, and well suited for implementation in primary‑care hospitals.

丨Article丨Source丨Core丨Background丨

“A Controlled Study of Intrathoracic Constant-Temperature Circulating Hyperthermic Perfusion Chemotherapy for Malignant Pleural Effusion” – Contemporary Medicine, Volume 16, Issue 19 (Wang Liufei, Li Wei)

Objective: To evaluate the efficacy of continuous hyperthermic intrathoracic perfusion chemotherapy at a constant temperature (42–43°C) for malignant pleural effusion.

[Keywords] Malignant pleural effusion; continuous constant-temperature circulating hyperthermic perfusion; chemotherapy

[Article ID] doi:10.3969/j.issn.1009-4393.2010.19.088

丨Expert丨Analysis丨

This study focused on malignant pleural effusion, a clinically challenging problem, and compared the efficacy, safety, and quality of life between thoracic hyperthermic intrathoracic chemotherapy with constant‑temperature circulation and conventional percutaneous instillation chemotherapy. The research topic precisely addressed a pressing clinical issue at the time: traditional single‑step aspiration and drug instillation often only provided symptomatic relief without addressing the underlying cause, leading to frequent recurrence of pleural effusion and poor patient quality of life. Published in 2010, the study was conducted when thoracic hyperthermic intrathoracic chemotherapy (HITHOC) was still in its exploratory and developmental phase. The findings of this clinical trial not only laid the groundwork for the early application of thoracic hyperthermic intrathoracic chemotherapy with constant‑temperature circulation but also provided practical, actionable guidance for optimizing treatment parameters, formulating clinical guidelines, and enabling grassroots medical institutions to implement this therapy.

Characteristics/Advantages of This Study

Outstanding value exploration

The results of this clinical study were officially published in 2010, at a time when hyperthermic intrathoracic chemotherapy (HITHOC) was still in its exploratory phase. In particular, the technique of percutaneous catheter placement under local anesthesia—enabling effective circulation and sustained‑temperature HITHOC treatment at the bedside of medical‑ward patients—represented a groundbreaking innovation within the global oncology hyperthermia community. This team pioneered the conduct of clinical trials demonstrating the efficacy of HITHOC without surgical intervention, an early initiative that not only advanced the field but also provided robust clinical evidence to inform the development of standardized operating protocols and expert consensus both domestically and internationally.

The experimental design is reasonable.

The study enrolled a total of 50 patients with pleural mesothelioma or malignant pleural metastases from various tumor histotypes, all presenting with malignant pleural effusion. Patients were randomly assigned to either the observation group or the control group, with comparable baseline characteristics between the two groups. The observation group received dual-channel, constant-temperature, circulating hyperthermic intrathoracic chemotherapy for 60 minutes, while the control group was administered the same chemotherapeutic agents at the same doses. All patients underwent three treatment cycles. With a single experimental variable, the design allowed for a straightforward comparison of the two therapeutic approaches, closely reflecting real-world clinical practice.

Comprehensive evaluation dimensions

The study assessed the efficacy of pleural fluid treatment according to WHO’s universal criteria, concurrently monitored tumor markers, and observed chemotherapy-related adverse effects, as well as patients’ appetite and mental status. Throughout the entire course, no severe complications such as pneumothorax, pleural infection, or organ injury occurred, thereby validating both the therapeutic effect and the safety and reliability of the percutaneous catheterization technique performed under local anesthesia. The findings fully demonstrate the effectiveness and safety of this treatment device—produced by Xi’an Good Doctor Medical Science and Technology Co., Ltd.—in controlling malignant pleural effusion. Furthermore, the article elucidates the therapeutic mechanism by integrating principles such as the differential heat tolerance between cancer cells and normal cells, the synergistic action of heat and chemotherapeutic agents, physical flushing and circulatory perfusion, and pleural repair, supported by robust evidence.

Highly practical for clinical use

This clinical trial leverages percutaneous puncture and catheterization techniques performed under local anesthesia to deliver effective HITHOC therapy at the bedside for patients across multiple departments, including medical oncology, respiratory medicine, and traditional Chinese medicine. The procedure is simple, cost‑effective, and can be readily mastered by frontline healthcare providers, making it well suited for widespread implementation.

This is an early clinical controlled study of intrathoracic hyperthermic perfusion chemotherapy. At a stage when industry standards and the underlying technology were still immature, the study used clinical data to demonstrate that hyperthermic perfusion chemotherapy with temperature control outperformed conventional regimens, offering superior control of pleural effusions, reduced recurrence, improved patient outcomes, and a favorable safety profile. The research not only provided early evidence supporting the clinical application of intrathoracic hyperthermic perfusion but also served as a practical reference for subsequent parameter optimization, guideline development, and the implementation of this therapy in primary‑care settings.

Expert Profile

Dr. Liu, M.D., Ph.D.

Professional Society Member:

• American Society for Cell Biology (2006–present)

• American Heart Association (2006–present)

• American Thoracic Society (1997–present)

• 2023–2025.5 Associate Professor, Department of Cardiology, University of Miami, USA

• 1999–2023 Assistant/Associate Professor, Division of Pulmonary and Critical Care Medicine, University of Nebraska Medical Center, USA

• 1996–1999 Postdoctoral Fellow, Department of Pulmonary and Critical Care Medicine, University of Nebraska Medical Center, USA

• 1992–1995: Master of Medicine, Department of Respiratory Medicine, Xijing Hospital, Fourth Military Medical University (under Professor Sun Bin)

• 1986–1992: Clinical Physician, Department of Respiratory Medicine, General Hospital of the Shenyang Military Region

• 1981–1986 Bachelor of Medicine, Department of Clinical Medicine, Fourth Military Medical University