Do the chemotherapy drugs used during HIPEC matter for survival?
That’s the basis of a new clinical trial at the National Cancer Institute. Researchers are looking into whether changing the drugs used during HIPEC affects the results. HIPEC, the acronym for hyperthermic intraperitoneal chemotherapy, is the second step after cytoreductive surgery in prolonging survival with peritoneal mesothelioma.
Dr. Andrew Blakely is leading the trial and spoke with Mesothelioma Guide about the study. It’s accepting up to 60 people with a range of abdominal cancers, including peritoneal mesothelioma. Dr. Blakely, an assistant research physician and director of the surgical oncology research fellowship program, has clinical expertise in peritoneal mesothelioma.
Analyzing Reaction From Tissue Samples
The trial is currently enrolling participants. The goal is at least 10 peritoneal mesothelioma patients — 4‑6 in each arm — to get at least a sample size of response.
The basis is testing different combinations of chemotherapy drugs in HIPEC cancer treatment. There are four arms, and peritoneal mesothelioma fits in two of them. All patients will receive 75 mg of cisplatin for 60 minutes. The arms differ in the second drug used. Patients receive either doxorubicin or Mitomycin C.
“What we’re doing is taking some of the patient’s tumor tissue (during surgery) and testing it,” Dr. Blakely said.
The purpose is to analyze the tumors and histology, determining which patients respond to which chemotherapy drugs. This may help doctors individualize HIPEC treatment based on the tumor samples from biopsies.
“The next trial after this is doing a diagnostic laparoscopy, harvesting the tumor tissue, and exposing it to different chemotherapies,” Dr. Blakely said.
Patients also receive sodium thiosulfate, which is for kidney protection. It soaks up cisplatin and helps the kidneys flush out the drugs.
Dr. Blakely will analyze progression‑free and overall survival. He’ll also look at the proportion of tumor mass and the immunohistochemistry staining for aggressiveness. These before‑and‑after looks will help understand response to HIPEC.
“These are easy, intuitive ways to assess the tissue response,” he said. “Pathologists all over the world can replicate this.”
Why This Study Is Important
This study is another example of the push to “individualize” or “specialize” treatment for mesothelioma. There are few therapies — especially for peritoneal mesothelioma — and most involve the same methods, medications and dosages in all cases.
Dr. Blakely said differentiating treatment based on tumor analysis “makes sense.”
“We know how populations of patients respond to treatment. However, we don’t know how one individual patient responds to a treatment ahead of time,” he said. “The holy grail of personalized medicine has been talked about a lot.
“If we have a way of determining if a personalized treatment is more effective, then I think that helps support the pursuit of that and benefit of that.”
If you’d like to enroll in this study, contact our advocacy team. Registered nurse Karen Ritter can put you in touch with the team at National Cancer Institute. Email her at firstname.lastname@example.org.
Sources & Author
- Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies. Clinicaltrials.gov. Retrieved from: https://clinicaltrials.gov/ct2/show/NCT04847063. Accessed: 08/11/2021.
- Andrew M. Blakely, M.D. National Cancer Institute. Retrieved from: https://ccr.cancer.gov/staff-directory/andrew-m-blakely. Accessed: 08/11/2021.
Sources & Author