"The Lancet·Tumor": The team from Zhongshan Hospital of Fudan University has made great achievements. The second tumor reduction surgery can reduce the risk of disease progression or death in patients with platinum-sensitive recurrent ovarian cancer by 42%|Clinical Discovery

Recently, Professor Zang Rongyu’s team from Zhongshan Hospital of Fudan University published important research results in the journal “The Lancet-Tumor”.
They found that in patients with platinum-sensitive recurrent ovarian cancer, chemotherapy and only treatment were performed after the second cytoreduction.
Compared with chemotherapy, the progression-free survival period is significantly longer.

The patient’s risk of disease progression or death was reduced by 42%.

Their research proved the survival benefits of secondary cytoreductive surgery, innovated the diagnosis and treatment model for recurrent ovarian cancer, and provided higher-level evidence-based medical evidence for secondary surgery for platinum-sensitive recurrent ovarian cancer, and hopefully Changing the clinical practice of recurrent ovarian cancer in the future.

▲ Screenshot of the homepage of the paper.
Ovarian cancer is one of the most important malignant tumors in gynecology.
Its fatality rate ranks first among gynecological malignancies.
Although its incidence is not high, the location of the disease is hidden and the symptoms are atypical.
Most patients are already Late.

About 80% of patients with advanced ovarian cancer will relapse after first-line chemotherapy and targeted maintenance therapy [1].

According to the patient’s sensitivity to platinum-based drugs, taking 6 months after the initial treatment (achieving clinical remission) as the boundary, recurrent ovarian cancer can be roughly divided into platinum-sensitive and drug-resistant types.
The recurrence lasted more than 6 months after the planned chemotherapy stopped [2].

At present, the diagnosis and treatment of ovarian cancer in my country is not standardized, and there is no universally accepted standard diagnosis and treatment model for recurrent ovarian cancer.
These have long troubled doctors and patients.

For patients with platinum-sensitive recurrent ovarian cancer, secondary cytoreductive surgery is a widely used but controversial option.
Its application principle in the treatment of ovarian cancer is similar to that of primary detumor surgery, and the success of the treatment depends on whether it is successful or not.
For the completeness of tumor resection [1,3].

Previous retrospective cohort studies have shown that the survival rate of patients with recurrent ovarian cancer is improved [4,5].

However, the survival benefit of secondary cytoreductive surgery has not been confirmed in randomized controlled trials.
This is also an important clinical problem that the international gynecological oncology field is looking forward to solving.

Germany (AGO Desktop III), the United States (GOG-0213) and China (SGOG SOC-1) have launched three randomized phase 3 clinical trials on secondary cytoreductive surgery.

Desktop III shows that secondary cytoreductive surgery for recurrent ovarian cancer can prolong progression-free survival and overall survival.

In contrast, the GOG-0213 study did not show the survival benefits of surgery.

The phase 3 clinical trial of SOC-1, led by Professor Zang Rongyu, was conducted in four research centers in China (Shanghai Fudan University Zhongshan Hospital, Hangzhou Zhejiang Cancer Hospital, Shanghai Fudan University Cancer Hospital, and Guangzhou Sun Yat-sen University Cancer Center).

The enrolled patients were ≥18 years old, had received standard first-line treatment in the past, and were predicted by iMODEL (International Cooperative Fitting Model) score combined with PET-CT examination results as recurring lesions that could be completely resected, and a platinum-free chemotherapy interval of ≥6 months Patients with ovarian cancer who recurred for the first time afterwards.

Between July 19, 2012 and June 3, 2019, a total of 357 patients were recruited.

After enrollment, the patients were stratified and randomly assigned to receive secondary cytoreductive surgery and then chemotherapy (surgery group, 182 cases) or chemotherapy alone (non-surgery group, 175 cases).

▲Trial design.
Patients in the surgery group will undergo surgery within 4 weeks after randomization.
The subsequent chemotherapy is usually performed 10-14 days after surgery, or wait until the patient recovers from the surgery.

Patients in the non-surgical group will receive chemotherapy within 4 weeks after grouping.

Both groups of chemotherapy regimens were platinum-based, and six 3-week cycles of paclitaxel (175 mg/m²) or docetaxel (75 mg/m²) combined with carboplatin (AUC 5) were injected intravenously.

The median follow-up time after treatment was 36 months, during which the CA125 concentration of the patient was measured and imaging examination was performed.

The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints were cumulative treatment-free survival (TFS), and adjusted overall survival (adjusted OS) after one-way treatment conversion.
The non-surgical group was transferred to the surgical group).

The researchers reported the final results of PFS and the interim analysis results of OS.

The median progression-free survival (PFS) of the surgical group was longer than that of the non-surgical group by nearly half a year, 17.
4 months and 11.
9 months, respectively (HR 0.
58, 95% CI 0.
45-0.
74, P<0.
0001).

This means that the risk of disease progression or death in the surgery group is reduced by 42%.

▲ The secondary cytoreductive surgery significantly prolonged PFS.
Because the research is still going on, the overall survival data is not yet mature.
From the reported interim analysis of overall survival, the median OS of the surgical group and the non-surgical group were 58.
1 respectively.
Months and 53.
9 months (HR 0.
82, 95% CI 0.
57 to 1.
19), there was no difference between the two groups, and there was no difference in quality of life between the surgical group and the non-surgical group.

The 60-day mortality rate of patients in both groups was 0%.

Although it will take about 2.
5 years for the overall survival data to mature, the current analysis shows that if the tumor cannot be removed by the second operation, it will be disadvantageous to the patient, and the effect of surgery will be inferior to chemotherapy.

The safety analysis of the study showed that the incidence of grade 3-4 complications in the surgical group 30 days after surgery was 5% (9/172).

The most common grade 3-4 complications during second-line chemotherapy include neutropenia (17% and 12% in the surgical and non-surgical groups, respectively), leukopenia (8% and 5%), and anemia (6% and 6 %).

The incidence of grade 3-4 chemotherapy-related adverse reactions in the surgical group and non-surgical group were 25% (41/166) and 20% (31/156), respectively.

It is worth mentioning that this phase 3 clinical study adopted clear patient selection criteria for the first time, which is not available in similar international research institutes.

The results of the study proved that for patients with platinum-sensitive recurrent ovarian cancer, secondary cytoreductive surgery significantly improved the progression-free survival time, affirmed the value of secondary cytoreductive surgery for recurrent ovarian cancer, and pointed out the population with the greatest benefit.

However, whether to choose surgery, it is recommended to consult qualified hospitals, whether secondary cytoreductive surgery becomes standard treatment, it still needs mature OS data support.

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20106 Responsible editorBioTalker