Novel chemotherapy regimens reduce the risk of postoperative recurrence in patients with hepatocellular carcinoma

Guangzhou, December 17 (Cai Minjie, Chen Gang) Sun Yat-sen University Cancer Center announced on the 17th that the center and the First Affiliated Hospital of Jinan University and other four centers jointly completed a clinical study
.
This study is the first in the world to confirm that adjuvant FOLFOX hepatic artery perfusion chemotherapy can reduce the risk of postoperative recurrence in people with liver cancer complicated with microvascular invasion, and has good safety, filling the gap
in this field at home and abroad.

This study was selected for poster discussion at the 2022 American Society of Clinical Oncology Annual Meeting and published online on December 16 under the title "The Role of Postoperative Adjuvant FOLFOX Hepatic Arterial Perfusion Chemotherapy in Patients with Hepatocellular Carcinoma with Microvascular Invasion: A Multicenter, Phase III Randomized Controlled Study" in the Journal of Clinical Oncology
, a top journal in oncology.

Liver cancer is one of the
most common malignant tumors worldwide.
Hepatocellular carcinoma is the most important pathological type of liver cancer, accounting for about 90% of all liver cancer, surgical resection is still the main means for patients with hepatocellular carcinoma to obtain radical treatment, but the high recurrence rate after surgery has always been a difficult problem in clinical practice
.

The incidence of microvascular invasion in hepatocellular carcinoma is about 30% to 50%, which has been recognized as a high-risk factor for recurrence of liver cancer after surgery, and there is still a lack of global consensus on postoperative adjuvant therapy strategies for patients with microvascular invasion
.

Hepatic artery perfusion chemotherapy, in which chemotherapy drugs are injected through the hepatic artery through the catheter, into the main blood supply artery of the tumor, is a new treatment method widely used in advanced liver cancer in recent years
.
Compared with systemic chemotherapy, hepatic artery perfusion chemotherapy can significantly increase the local drug concentration in tumor tissue, while reducing the distribution
of chemotherapy drugs in other organs.

In clinical practice, the team of Professor Guo Rongping and Wei Wei of the Cancer Center of Sun Yat-sen University realized that hepatic arterial perfusion chemotherapy has potential value
for killing micro-metastases that existed in the liver before surgery and reducing recurrence.

In this multicenter, prospective phase III.
randomized controlled clinical study, patients with hepatocellular carcinoma who were pathologically confirmed to have microvascular invasion after surgery were randomly assigned to the treatment group (receiving 1-2 postoperative adjuvant FOLFOX-HAIC) and the control group (routine follow-up)
according to randomized 1:1.
A total of 315 patients were enrolled in the intention-to-treat population and randomized to treatment and control groups
.
After excluding patients who did not conform to the protocol, a total of 286 patients were enrolled in the treatment and control groups
.

The results showed that the median tumor-free survival in the hepatic artery perfusion chemotherapy group and the control group was 20.
3 months and 10.
0 months, respectively, and the median tumor-free survival in the eligible population was 19.
3 months and 8.
9 months, respectively, which met the primary endpoint
of the study.

In the intention-to-treat population, the overall survival rates at 1-year, 2-year and 3-year hepatic arterial perfusion chemotherapy were 93.
8%, 86.
4%, and 80.
4%, respectively, and in the control group were 92.
0%, 86.
0%, and 74.
9
%, respectively.
Among the eligible population, the overall survival rates at 1-, 2-, and 3-year were 93.
9%, 85.
3%, and 80.
9% in the treatment group and 91.
8%, 84.
9%, and 72.
9%
in the control group, respectively.
Although the median overall survival rate of the treatment group showed a trend of improvement compared with that of the control group, no statistical difference was reached, and the reason may be related
to the rich treatment methods of liver cancer, and the patients after recurrence can be found in the regular review in time and receive effective comprehensive treatment.

In terms of toxic side effects, most of the adverse reactions associated with hepatic arterial perfusion chemotherapy of the FOLFOX regimen were observed to be grade 0-1, only 2 (1.
6%) patients developed grade 3 pain, and no treatment-related deaths were observed during the study period, confirming that this treatment model is safe and feasible
.

According to reports, the study of the above-mentioned professor's team confirmed for the first time that adjuvant FOLFOX regimen hepatic arterial perfusion chemotherapy is an effective strategy for postoperative adjuvant therapy in patients with liver cancer, which will help improve the efficacy of liver cancer surgery and is expected to rewrite the guidelines
.
(End)