Perioperative Systemic Therapy safe for Resectable Colorectal Peritoneal Metastases

So far, no randomized clinical trials have investigated perioperative systemic therapy relative to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy alone for resectable colorectal peritoneal metastases (CPM). Therefore, Dr Koen P. Rovers and his team conducted a study to assess the feasibility and safety of perioperative systemic therapy in patients with resectable CPM and the response of CPM to neoadjuvant treatment.

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