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PIPAC for the Treatment of Gynecologic and Gastrointestinal Peritoneal Metastases: Technical and Logistic Considerations of a Phase 1 Trial

  • Peritoneal Surface Malignancy
  • Published:
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Abstract

Background

Peritoneal metastases (PM) from ovarian, gastric, appendiceal, or colorectal origin can be treated via cytoreductive surgery with or without the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) for selected patients. Unfortunately, not all patients are candidates for aggressive surgical debulking. For these patients, pressurized intraperitoneal aerosolized chemotherapy (PIPAC) has emerged as an alternative method for intraperitoneal (IP) chemotherapy administration. This report presents the design and implementation of the first phase 1 trial to evaluate the safety and efficacy of PIPAC in the United States.

Methods

This is an ongoing prospective phase 1 clinical trial of PIPAC for patients who have histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with PM and have progressed to at least one evidence-based chemotherapeutic regimen. The trial has two clinical arms. The patients in arm 1 have gynecologic and gastric malignancies treated with IP cisplatin and doxorubicin, and the arm 2 patients have colorectal and appendiceal malignancies treated with intravenous fluorouracil and leucovorin followed by IP oxaliplatin. All the patients are monitored for dose-limiting toxicities and adverse events.

Results

Practical and technical considerations for the phase 1 PIPAC trial are presented. These considerations include patient selection, operating room setup, and technical details for successful aerosolized chemotherapy delivery. The phase 1 study results will be reported separately at completion of the trial.

Conclusions

The PIPAC treatment is a feasible, minimally invasive approach that permits IP delivery of chemotherapy. Once completed, the ongoing phase 1 trial will help to provide safety and initial efficacy data.

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Acknowledgments

The authors thank Nicola Welch, PhD, CMPP, for assistance editing the manuscript.

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Authors and Affiliations

  1. Division of Surgical Oncology, Department of Surgery, City of Hope National Medical Center (COH), Duarte, CA, USA

    Mustafa Raoof MD, Gautam Malhotra MD, PhD, Michael O’Leary MD, Thuy Tran MD, Yanghee Woo MD, Isaac B. Paz MD, Lorna Rodriguez-Rodriguez MD, PhD & Yuman Fong MD

  2. Division of Gynecologic Oncology, Department of Surgery, City of Hope Comprehensive Cancer Center (COH), Duarte, CA, USA

    Adrian Kohut MD & Thanh H. Dellinger MD

  3. Biostatistics Core, City of Hope Beckman Research Institute, Duarte, CA, USA

    Paul Frankel PhD

  4. Department of Medical Oncology, COH, Duarte, CA, USA

    Marwan Fakih MD, Joseph Chao MD, Dean Lim MD & Mihaela C. Cristea MD

  5. Department of Anesthesiology, COH, Duarte, CA, USA

    Michael Lew MD

  6. National Institute of Health, Bethesda, MD, USA

    Andrew Blakely MD

  7. Northwell Cancer Center, New York, NY, USA

    Richard Whelan MD

  8. Tuebingen Universitaet, Tübingen, Germany

    Marc A. Reymond MD

  9. Mayo Clinic, Jacksonville, FL, USA

    Amit Merchea MD

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  1. Mustafa Raoof MD
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Correspondence to Mustafa Raoof MD or Thanh H. Dellinger MD.

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Raoof, M., Malhotra, G., Kohut, A. et al. PIPAC for the Treatment of Gynecologic and Gastrointestinal Peritoneal Metastases: Technical and Logistic Considerations of a Phase 1 Trial. Ann Surg Oncol 29, 175–185 (2022). https://doi.org/10.1245/s10434-021-10505-0

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