Perioperative Systemic Therapy safe for Resectable Colorectal Peritoneal Metastases

It was an open-label, parallel-group phase 2 randomized clinical trial of 79 patients from 9 Dutch tertiary centres for the surgical treatment of CPM. They were randomized to perioperative systemic therapy (n = 37) or CRS-HIPEC (n = 42) alone. The major outcome assessed was proportions of macroscopic complete CRS-HIPEC and Clavien-Dindo grade 3 or higher postoperative morbidity. The researchers also assessed the rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment.

Key findings of the study were:

• Upon analysis, the researchers found no significant difference in the experimental and control arms regarding the proportions of macroscopic complete CRS-HIPEC (33 of 37 [89%] vs 36 of 42 [86%] patients; risk ratio, 1.04) and Clavien-Dindo grade 3 or higher postoperative morbidity (8 of 37 [22%] vs 14 of 42 [33%] patients; risk ratio, 0.65).
• They observed no treatment-related deaths.
• They noted that the objective radiologic and major pathologic response rates of CPM to neoadjuvant treatment were 28% (9 of 32 evaluable patients) and 38% (13 of 34 evaluable patients).

The authors concluded, "In this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial."

For further information:

https://jamanetwork.com/journals/jamasurgery/article-abstract/2780041