Gastric Cancer with Peritoneal Metastases: Why Patient-Reported Outcomes Matter in Clinical Trials

Area of Science:

• Oncology
• Gastroenterology
• Clinical Trials

Background:

• Gastric cancer with peritoneal involvement is increasing, especially in younger patients with diffuse-type disease.
• This aggressive subtype significantly impacts quality of life (QoL) due to a high symptom burden.
• Emerging therapies include normothermic intraperitoneal and systemic chemotherapy (NIPS), pressurised intraperitoneal aerosol chemotherapy (PIPAC), and cytoreductive surgery with HIPEC.

Purpose of the Study:

• To evaluate the effectiveness of novel therapeutic strategies for gastric cancer with peritoneal metastases.
• To highlight the importance of patient-reported outcomes (PROs) in assessing treatment efficacy and patient experience.
• To advocate for the routine integration of PROs in clinical trial design for patient-centered care.

Main Methods:

• Review of existing clinical trials and therapeutic strategies for gastric cancer peritoneal metastases.
• Analysis of survival data from trials like DRAGON-01, PHOENIX-GC, PERISCOPE II, and PIPAC VER-ONE.
• Assessment of patient-reported outcome measures (PROMs) used in relevant studies, including EORTC QLQ-C30 and QLQ-STO22.

Main Results:

• Normothermic intraperitoneal and systemic chemotherapy (NIPS) demonstrated a significant overall survival benefit in the DRAGON-01 trial.
• Pressurised intraperitoneal aerosol chemotherapy (PIPAC) and cytoreductive surgery with HIPEC show promise but require further investigation in randomized studies.
• Patient-reported outcomes (PROs) are inconsistently captured across trials, with some studies (e.g., DRAGON-01) lacking QoL data, while others (e.g., PERISCOPE II) are incorporating PRO measures.

Conclusions:

• NIPS is currently the only strategy with proven overall survival benefit for gastric cancer with peritoneal metastases.
• Standardized and routine integration of PROs is crucial to ensure survival benefits translate into meaningful improvements in patient quality of life.
• Future trial designs must embed PROs to deliver value-based, patient-centered care for this patient population.