What are the outcomes and recommendations of the OVijipec trial?

The OVijipec Trial: Outcomes and Recommendations

The OVijipec trial (M06OVH-OVHIPEC) demonstrated significant improvement in both recurrence-free survival and overall survival when hyperthermic intraperitoneal chemotherapy (HIPEC) was added to interval debulking surgery in patients with stage III ovarian cancer who underwent neoadjuvant chemotherapy. 1

Key Findings of the OVijipec Trial

• The trial was the largest (n=245) phase III prospective comparative study evaluating HIPEC in advanced ovarian cancer 1
• HIPEC improved both recurrence-free survival and overall survival in patients with FIGO stage III primary epithelial ovarian, fallopian tube, or peritoneal cancer who underwent neoadjuvant chemotherapy (NACT) due to extensive abdominal disease or suboptimal primary debulking surgery 1
• The effect of HIPEC was consistent across various subgroups including age, histologic type, prior surgery, extent of disease, and laparoscopy before surgery 1
• No significant differences in toxicity rates were observed between arms (grade 3-4 toxicities: 27% vs 25%) 1
• Quality of life metrics were similar between the HIPEC and control groups 1

Clinical Implementation Recommendations

• HIPEC should be considered at the time of interval debulking surgery (IDS) in patients with stage III disease treated with NACT 1
• HIPEC is appropriate for patients who have response or stable disease after NACT (3 cycles preferred, but 4-6 allowed) 1
• All patients treated with NACT and IDS (with or without HIPEC) should receive postoperative chemotherapy 1
• HIPEC is not recommended for patients treated with primary debulking surgery (no NACT) based on trial results showing no improvement in PFS or OS in this population 1
• Maximum effort should be made to achieve complete cytoreduction during IDS, regardless of whether HIPEC is planned 1

Technical Aspects of HIPEC Administration

• The recommended HIPEC agent is cisplatin at a dose of 100 mg/m² 1
• HIPEC is administered intraoperatively immediately after debulking (as part of the same procedure) 1
• Intraoperative administration may enable better perfusion of the peritoneal space because adhesions will not yet have formed 1
• The procedure time for debulking + HIPEC is longer than for debulking alone, but does not significantly impact hospital stay (median 10 vs 8 days) or timing of postoperative chemotherapy 1

Patient Selection Criteria

• HIPEC is most appropriate for patients with high-volume intraperitoneal disease (FIGO stage III) 1
• Particularly beneficial for those with peritoneal carcinomatosis who are at risk for widespread residual microscopic disease even after resection to no visible disease 1
• Patients with less extensive disease may not benefit as much because they are less likely to have widespread microscopic disease after debulking 1
• Patients with distant extra-abdominal metastases were often excluded from HIPEC studies due to concerns about effectiveness for extraperitoneal disease 1

Potential Complications and Safety Considerations

• Common major/severe complications include fistulas, abscesses, infections, surgical wound dehiscence, bowel perforation, ileus, hemorrhages, venous thromboembolism, myocardial infarction, pleural effusions, pneumothorax, and renal failure/insufficiency 1
• Historical mortality rates associated with HIPEC ranged from 0% to 7%, though more recent trials report no deaths related to the procedure 1
• Major/severe complications (≤30 days from surgery) occur in 9% to 40% of patients 1
• Additional procedures may be needed to manage complications 1

Current Guideline Position

• Based on the positive results of the OVijipec trial, NCCN Guidelines now include an option to consider HIPEC at the time of interval debulking surgery in patients with stage III disease treated with NACT 1
• The Gynecologic Cancer InterGroup (GCIG) consensus recommendations state that any form of IP therapy or HIPEC cannot be regarded as a reference treatment arm within clinical trials 1
• HIPEC remains an option to consider rather than a standard of care 1

Conclusion

The OVijipec trial provides important evidence supporting the use of HIPEC at the time of interval debulking surgery for patients with stage III ovarian cancer who have undergone neoadjuvant chemotherapy. The procedure shows survival benefits without significantly increasing toxicity or reducing quality of life, but should be reserved for appropriate patient populations and performed at centers with expertise in the technique.