Phase I trial of intratumoral or intraperitoneal bromelain and NAC in patients with mucinous peritoneal tumors

In this Phase I trial, participants who had either declined surgery for, or were determined to be inoperable with, mucinous peritoneal tumors were administered a mixture of bromelain and NAC. Doses were based on estimated tumor volume as follows.

For people receiving intratumoral injection:

Bromelain 30mg and NAC 1500mg for tumor volume < 250mL

Bromelain 45mg and NAC 1500mg for tumor volume > 250mL or multiple treatment sites

For people receiving intraperitoneal injection:

Bromelain 45mg and NAC 1500mg for low tumor burden

Bromelain 60mg and NAC 2000mg for extensive tumor burden

A total of 20 patients underwent 28 treatments, with 13 receiving intratumoral treatment, and 7 receiving intraperitoneal treatment. The mean number of surgical procedures subjects had previously undergone was 3.8 (range 2-9). Primary tumor was appendiceal adenocarcinoma (N=10), mucinous ovarian tumor (N=3), colon cancer (N=1), or pseudomyxoma peritonei (N=6).

An objective response to Bromelain and NAC was seen in 30 of 41 treated sites (73.2%), in 85% of patients. Subjects received a mean of 4.2 doses. Adverse events occurred in 85% (N=17) of patients. There were a total of 88 adverse events, with 11 being serious treatment-related adverse events (12.5%). These included fever (35%) and grade II/III pain at drain site or during injection (30%).

This is the first trial of its kind examining such a protocol, with bromelain and NAC designed to essentially dissolve mucinous tumor masses, in humans.

Citation:

Valle et al. A novel treatment of bromelain and acetylcysteine (BromAc) in patients with peritoneal mucinous tumours: A phase I first in man study. European Journal of Surgical Oncology 2019 Oct 31. pii: S0748-7983(19)30913-8.

Link:

https://www.sciencedirect.com/science/article/pii/S0748798319309138