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Breaking! Intraperitoneal hyperthermic chemotherapy can extend the life of patients with advanced ovarian cancer by one year.
Based on the secondary analysis of the Gynecologic Oncology Group (GOG) 172 and the GOG172 trial, researchers found that the survival benefits of intraperitoneal chemotherapy for patients with advanced ovarian cancer can last for at least 10 years.
2018-11-16
Based on the secondary analysis of the American Gynecologic Oncology Group (GOG) 172 and the GOG172 trial, researchers found that the survival benefits of intraperitoneal chemotherapy for patients with advanced ovarian cancer can last for at least 10 years; for each additional intraperitoneal chemotherapy session, the mortality risk for ovarian cancer patients can be reduced by 12%, and this benefit is particularly significant for patients who have undergone optimal cytoreductive surgery.
Based on this research result, the NCCN, FIGO, and ESMO guidelines have all included intraperitoneal chemotherapy as one of the first-line treatment options for patients with advanced ovarian cancer after optimal tumor cytoreduction.
Ovarian Cancer Cytoreductive Surgery (CDS): Refers to the surgical treatment of advanced ovarian cancer, aiming to remove as much tumor tissue as possible, ensuring that the maximum diameter of residual lesions does not exceed 2 cm, to facilitate postoperative chemotherapy for long-term remission or even cure.
The surgical scope includes the entire uterus, bilateral adnexa, appendix, greater omentum, and other resectable metastatic lesions, and may even include partial resection of the bladder and intestines.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Involves rapidly infusing chemotherapy fluid at a constant temperature of 42-45°C into the abdominal cavity through a pre-implanted chemotherapy pump or abdominal puncture method, and then instructing the patient to change positions to ensure even distribution of the chemotherapy fluid. The essence of HIPEC is to provide intraperitoneal chemotherapy based on precise constant temperature, continuous perfusion, and filling the abdominal cavity.
HIPEC achieves precise temperature control for intraperitoneal hyperthermic chemotherapy through a sophisticated intraperitoneal perfusion treatment system, thereby preventing and treating peritoneal metastatic spread of malignant tumors. HIPEC has unique advantages in treating peritoneal metastasis from gastric cancer, colorectal cancer, and pseudomyxoma peritonei, as well as controlling malignant ascites.
The main mechanisms of action of HIPEC are as follows:
The physical effect of heat can directly kill tumor cells;
Intraperitoneal hyperthermic perfusion can increase the permeability of tumor cells to chemotherapy drugs;
Intraperitoneal hyperthermic chemotherapy can inhibit the repair and proliferation of tumor cell damage.
Numerous small-sample clinical trials have demonstrated that for both initial and recurrent ovarian cancer patients, intraperitoneal hyperthermic chemotherapy can improve overall survival compared to intravenous chemotherapy; for recurrent ovarian cancer, patients who received postoperative intraperitoneal hyperthermic chemotherapy followed by intravenous chemotherapy had a median survival time and three-year survival rate higher than those who received only intravenous chemotherapy, with statistically significant differences (Figures 1 and 2).
Figure 1 Comparison of median overall survival between intraperitoneal hyperthermic chemotherapy and intravenous chemotherapy in ovarian cancer.
Figure 2 Comparison of median progression-free survival between intraperitoneal hyperthermic chemotherapy and intravenous chemotherapy in ovarian cancer.
Although the above studies confirm that patients with advanced ovarian cancer can benefit from HIPEC treatment, the quality of this evidence is not high, mostly consisting of single-center small-sample studies or retrospective studies. Therefore, higher quality evidence needs to be validated through large-sample, multi-center, randomized controlled clinical trials of HIPEC treatment for advanced ovarian cancer.
The January 18, 2018 issue of the New England Journal of Medicine reported the results of the first multi-center, randomized controlled clinical trial of HIPEC treatment for stage III ovarian cancer, aimed at exploring whether adding intraperitoneal hyperthermic chemotherapy during cytoreductive surgery can improve the survival of patients with stage III ovarian cancer.
This trial enrolled 245 patients across 8 centers in two European countries, randomly assigned in a 1:1 ratio to the experimental group and the control group, with 122 patients in the cytoreductive surgery plus cisplatin chemotherapy group and 123 patients in the group without cisplatin chemotherapy. These patients had previously achieved at least stable disease after 3 cycles of carboplatin and paclitaxel treatment. The primary endpoint of the study was progression-free survival, and the key secondary endpoints were overall survival and side effects.
Figure 3 KM curve of median progression-free survival time in the HIPEC trial group and control group for ovarian cancer.
The study found that compared to the surgery-only group, the median progression-free survival time (Figure 3) and median overall survival time (Figure 4) for the surgery + HIPEC group were 14.2 months and 45.7 months, respectively, while the surgery group had 10.7 months and 33.9 months, extending the former by 3.5 months and 11.8 months, respectively.
There were no statistically significant differences in treatment-related side effects and quality of life between the two groups, with a similar proportion of patients experiencing grade 3 or higher adverse events, and over 90% of patients completed the entire treatment regimen. These findings suggest that HIPEC treatment is more acceptable than the regimen recommended by the GOG 172 study. Subgroup analysis results indicated that the surgery + HIPEC group outperformed the surgery-only group in all subgroups (Figure 5).
Figure 4 KM curve of median overall survival time in the HIPEC trial group and control group for ovarian cancer.
Figure 5 Subgroup analysis results of the HIPEC trial group and control group for ovarian cancer.
In this study, although postoperative HIPEC treatment significantly extended the overall survival time of patients, it did not show a significant advantage in median progression-free survival. Possible reasons include:
The number of patients enrolled in the trial was relatively small;
The temperature during HIPEC treatment was relatively low (40°C), while it is currently generally believed that 43°C is the optimal temperature for HIPEC thermal effects to kill tumor cells;
The efficacy of cisplatin monotherapy HIPEC is limited.
Based on a 2016 study comparing the efficacy of paclitaxel/cisplatin HIPEC for ovarian cancer, cisplatin combined with paclitaxel HIPEC treatment may achieve better efficacy and survival rates. Since the patients enrolled in this trial had poor prognoses and could not directly undergo CDS, all patients received 3 cycles of preoperative chemotherapy with paclitaxel and carboplatin, resulting in a high rate of optimal tumor reduction completion of 97% in both groups.
Combined with the results of two other clinical studies on neoadjuvant chemotherapy, the results of this trial further establish the important role of neoadjuvant chemotherapy in advanced ovarian cancer (with heavy tumor burden).
Although the results of this trial confirm that HIPEC treatment can extend progression-free survival and overall survival in patients with advanced ovarian cancer as Class I evidence, there are issues such as a small sample size, lower HIPEC temperatures, and the absence of combination chemotherapy drugs. Therefore, conducting clinical research protocols with more centers, larger sample sizes, more precise temperature control, and the use of platinum-based and paclitaxel combination chemotherapy during HIPEC will become an important way to clarify the clinical application value of HIPEC in advanced ovarian cancer, which will undoubtedly rewrite the clinical guidelines for ovarian cancer.
Key words:
Cancer degree,Tumor
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