Pressurized Intraperitoneal Aerosol Chemotherapy (Oxaliplatin) for Unresectable Colorectal Peritoneal Metastases: A Multicenter, Single-Arm, Phase II Trial (CRC-PIPAC)
| Autor: | Gesina van Lijnschoten, Clément J. Huysentruyt, Max J. Lahaye, Maartje Los, Jacobus W. A. Burger, Joost Nederend, Robin J. Lurvink, Djamila Boerma, Simon W. Nienhuijs, Marinus J. Wiezer, Geert-Jan Creemers, Emma C. E. Wassenaar, Maarten J. Deenen, Ignace H. J. T. de Hingh, Koen P. Rovers |
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| Přispěvatelé: | RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Epidemiologie |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Abdominal pain
medicine.medical_specialty Chemotherapy Nausea business.industry medicine.medical_treatment Gastroenterology Oxaliplatin Clinical trial 03 medical and health sciences 0302 clinical medicine Oncology Interquartile range 030220 oncology & carcinogenesis Internal medicine Ascites medicine 030211 gastroenterology & hepatology Surgery medicine.symptom Adverse effect business medicine.drug |
| Zdroj: | Annals of Surgical Oncology, 28(9), 5311-5326. Springer, Cham |
| ISSN: | 1068-9265 |
| Popis: | Background Despite its increasing use, pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) has never been prospectively investigated as a palliative monotherapy for colorectal peritoneal metastases in clinical trials. This trial aimed to assess the safety (primary aim) and antitumor activity (key secondary aim) of PIPAC-OX monotherapy in patients with unresectable colorectal peritoneal metastases. Methods In this two-center, single-arm, phase II trial, patients with isolated unresectable colorectal peritoneal metastases in any line of palliative treatment underwent 6-weekly PIPAC-OX (92 mg/m(2)). Key outcomes were major treatment-related adverse events (primary outcome), minor treatment-related adverse events, hospital stay, tumor response (radiological, biochemical, pathological, ascites), progression-free survival, and overall survival. Results Twenty enrolled patients underwent 59 (median 3, range 1-6) PIPAC-OX procedures. Major treatment-related adverse events occurred in 3 of 20 (15%) patients after 5 of 59 (8%) procedures (abdominal pain, intraperitoneal hemorrhage, iatrogenic pneumothorax, transient liver toxicity), including one possibly treatment-related death (sepsis of unknown origin). Minor treatment-related adverse events occurred in all patients after 57 of 59 (97%) procedures, the most common being abdominal pain (all patients after 88% of procedures) and nausea (65% of patients after 39% of procedures). Median hospital stay was 1 day (range 0-3). Response rates were 0% (radiological), 50% (biochemical), 56% (pathological), and 56% (ascites). Median progression-free and overall survival were 3.5 months (interquartile range [IQR] 2.5-5.7) and 8.0 months (IQR 6.3-12.6), respectively. Conclusions In patients with unresectable colorectal peritoneal metastases undergoing PIPAC-OX monotherapy, some major adverse events occurred and minor adverse events were common. The clinical relevance of observed biochemical, pathological, and ascites responses remains to be determined, especially since radiological response was absent. |
| Databáze: | OpenAIRE |
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