Isolated thoracic perfusion with chemofiltration for progressive malignant pleural mesothelioma

Our plain-English summary of Isolated thoracic perfusion with chemofiltration for progressive malignant pleural mesothelioma, by K.R. Aigner, E. Selak, S. Gailhofer (OncoTargets and Therapy, 2017).

The study

• Authors: K.R. Aigner, E. Selak, S. Gailhofer
• Journal: OncoTargets and Therapy
• Published: 2017;10:3049-3057
• Cited by: 9 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Introduction: Therapy of malignant pleural mesothelioma and especially the adequate role of surgery in this context remain the subject of controversial discussions. Radical surgery in particular, which is associated with substantial morbidity, failed to translate into a definite survival advantage. We report on interim results of an ongoing Phase II study of regional chemotherapy in terms of isolated thoracic perfusion with chemofiltration (ITP-F).

Patients And Methods: Twenty-eight patients (25 male, 3 female, mean age 63.4 years) with advanced pleural mesothelioma were included in this study. Isolation of the chest was achieved by insertion of a venous and arterial stop-flow balloon catheter via a femoral access. The aorta and inferior vena cava were blocked at the level of the diaphragm and the upper arms were blocked by pneumatic cuffs. Chemotherapy, consisting of 60 mg/m2 cisplatin and 15 mg/m2 mitoxantrone, was administered directly into the aorta. The isolated circuit was maintained for 15 minutes followed bŷ45 minutes of chemofiltration with a hemoprocessor until 5 L of filtrate were reached. The endpoints of the study were overall survival and quality of life (QoL).

Results: Out of 28 patients enrolled in the study, 5 had prior surgeries, 10 patients had systemic chemotherapy, and 5 patients additional irradiation. In all patients in restaging, clinical progress was noted. In all, 162 cycles were administered. Due to chemofiltration, toxicity was within tolerable limits, revealing World Health Organization grade I leucopenia and thrombocytopenia in 9 patients and mucositis grade I in 6 patients. The major surgical complication was inguinal lymphatic fistula in 40% of the cases. Gastrointestinal toxicity and/or neurotoxicity were never observed. One-year survival was 49%, 2-year and 3-year survival was 31%, and 5-year survival was 18%. Median overall survival was 12 months and progression-free survival 9 months.

Conclusion: ITP-F for patients with advanced pleural mesothelioma, progressive after standard therapies, is an effective and well-tolerated treatment modality, offering comparably long survival data at a good QoL.

In plain English

This article reported interim results of an ongoing Phase II study at a surgical oncology department in Burghausen, Germany. The study tested a regional chemotherapy method called isolated thoracic perfusion with chemofiltration (ITP-F) in 28 patients (25 men, 3 women; mean age 63.4 years) with advanced epithelioid malignant pleural mesothelioma that had progressed. Balloon catheters temporarily sealed off the chest's circulation, cisplatin and mitoxantrone were injected into the aorta, and the blood was then filtered. There was no comparison group, and the study did not examine asbestos exposure. In all, 162 cycles were given. Nine patients had stable disease and 13 responded. Median survival was 12 months. Survival was 49% at one year, 31% at two and three years, and 18% at five years. Low-grade drops in blood counts occurred in 9 patients, and groin lymphatic fistulas occurred in 40% of patients. No treatment-related deaths were reported. The authors concluded the treatment was feasible and well tolerated, with results encouraging but far from satisfactory, and called for a larger study. Some survival figures differ between sections of the article.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Interim report of an ongoing single-arm Phase II treatment study with no comparison group
• Who was studied: 28 patients with histologically proven epithelioid malignant pleural mesothelioma (25 male, 3 female; mean age 63.4 years, range 43 to 86). Twenty were stage IV and 8 were stage III. All had progressed on CT before the study. They were treated at the Department of Surgical Oncology, Medias Klinikum, Burghausen, Germany. Study dates are not given.
• Exposure: The study did not study asbestos exposure. The intervention was isolated thoracic perfusion with chemofiltration using 60 mg/m2 cisplatin and 15 mg/m2 mitoxantrone, repeated at 3-week intervals.
• Main results:
  • 162 treatment cycles were given to the 28 patients.
  • 9 of 28 patients (about 32%) had stable disease and 13 patients (46%) responded to therapy.
  • In 6 of 28 patients (21%), treatment was stopped after 2 cycles because of progressive disease (4 patients) or deterioration of performance status (2 patients).
  • For all 28 patients, median survival was 12 months. Survival was 49% at 1 year, 31% at 2 and 3 years, and 18% at 5 years.
  • Median progression-free survival was 9 months, and 1-year progression-free survival was 37.5%.
  • Grade I leucopenia and thrombocytopenia occurred in 9 patients, and grade I mucositis occurred in 6 patients.
  • Lymphatic fistulas (grade I surgical complications) occurred in 40% of patients and were the major therapy-related complication.
  • More than 95% of patients had hair loss.
  • There was no gastrointestinal toxicity, no neurotoxicity, and no treatment-related death.
• The authors' conclusion: The authors concluded that this locoregional chemotherapy was feasible and well tolerated. They called the data encouraging but far from satisfactory and called for investigation in a larger cohort.
• Limitations the authors state:
  • The patients were heterogeneous in their prior treatments.
  • Which patients benefit can only be determined in a larger study. The authors considered randomization after failure of all other strategies unethical and impractical.

Topics

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Chemotherapy, Diaphragm, Cisplatin, Overall Survival, Quality of Life, Median Overall Survival, Progression-Free Survival.

Related studies

• Treatment of primary peritoneal mesothelioma by continuous hyperthermic peritoneal perfusion (CHPP) — B.J. Park, H.R. Alexander, et al. (1999)
• Cytoreductive surgery and hyperthermic intrathoracic chemotherapy perfusion for malignant pleural tumours: perioperative management and clinical experience — M. Ried, T. Potzger, et al. (2013)
• Local and systemic exposure of cisplatin during hyperthermic intrathoracic chemotherapy perfusion after pleurectomy and decortication for treatment of pleural malignancies — M. Ried, T. Potzger, et al. (2013)
• Intraoperative hyperthermic chemotherapy perfusion for malignant pleural mesothelioma: an in vitro evaluation — R.B. Cameron, D. Hou (2013)
• Interim results of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion for patients with malignant pleural mesothelioma intolerable to extrapleural pneumonectomy — H. Ishibashi, M. Kobayashi, et al. (2015)
• Pharmacokinetic evaluation of intrapleural perfusion with hyperthermic chemotherapy using cisplatin in patients with malignant pleural effusion — H. Sakaguchi, H. Ishida, et al. (2017)

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