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At the 2020 ASCO conference, Professor Zang Rongyu from Zhongshan Hospital of Fudan University announced the results of the SOC-1 study in an oral presentation for the first time.
Corresponding to the German phase III DESKTOP study, the SOC-1 study once again confirmed that the second cytoreductive surgery can bring progression-free survival (PFS) benefits for patients with platinum-sensitive recurrent ovarian cancer.
Recently, the full text of the SOC-1 study was published in The Lancet Oncology[1].
Research background About 80% of patients with advanced ovarian cancer will relapse after first-line chemotherapy and targeted maintenance therapy.
The clinical application of secondary cytoreductive surgery is widespread, but whether it can be used for platinum-sensitive recurrent ovarian cancer is still controversial.
Recent studies have shown that secondary tumor cytoreductive surgery can improve the prognosis and prolong the survival of patients.
However, due to the recurrence of ovarian cancer, extensive metastasis to the pelvis and abdominal cavity often occurs.
The surgical removal of the cancer lesions requires extremely high requirements for the surgeon.
It is difficult to achieve a complete second operation (R0); and it does not achieve complete resection (R1).
/R2) surgery is not good for the treatment of ovarian cancer, which is the main reason why most patients with recurrent ovarian cancer cannot benefit from surgery.
Therefore, an effective scoring system is needed to screen patients suitable for surgery.
At present, there are two relatively systematic and mature scoring systems in the world.
One is the AGO scoring system proposed by the German Gynecological Oncology Clinical Research Cooperative Group (AGO) (verified in the Phase II DESKTOP study) [2]; This is the iMODEL (International Cooperative Fitting Model) risk scoring system for recurrent ovarian cancer proposed by the team of Professor Zang Rongyu from Zhongshan Hospital Affiliated to Fudan University.
More and more evidences show that 18F-FDG PET/CT can predict the sensitivity and specificity of complete resection of recurrent ovarian cancer.
Professor Zang Rongyu’s team combined iMODEL scoring with PET-CT imaging to establish a new scoring system and patient selection criteria to screen suitable patients who can benefit from secondary cytoreductive surgery.
Currently, there are three randomized controlled studies on secondary tumor cytoreductive surgery: AGO DESKTOP (Germany), GOG-0213 (U.
S.
), Shanghai Gynecological Oncology Group (SGOG) SOC-1 (China), aiming to explore the secondary Whether cytoreductive surgery can become the standard treatment for patients with recurrent ovarian cancer.
The SOC-1 study was officially launched in 2011 to confirm the efficacy and safety of secondary cytoreductive surgery for recurrent ovarian cancer.
In this study, Professor Zang Rongyu’s team published the PFS results of the SOC-1 study and the pre-set OS interim analysis results, and analyzed the cumulative treatment-free survival (TFSa) for the first time.
Research method SOC-1 is an open-label, randomized controlled, phase III clinical study conducted in 4 centers in China.
Enrolled patients with platinum-sensitive recurrent epithelial ovarian cancer aged 18 years and older who have a platinum-free interval of at least 6 months after the end of first-line platinum-containing treatment.
According to the results of iMODEL score and PET-CT examination, it is predicted that the recurrent lesions can be completely removed.
The iMODEL score is derived from the sum of the scores of 6 variables (FIGO staging, residual lesions after initial surgery, platinum-free interval, ECOG PS score, serum CA125 level at relapse, ascites).
In general, iMODEL score ≤4.
7 points indicate complete resection The possibility is higher.
Eligible patients were randomly assigned to receive second cytoreductive surgery sequential chemotherapy (intravenous paclitaxel [175 mg/m²] or docetaxel [75 mg/m²] in a 1:1 ratio, 6 cycles, every 3 Once a week) (surgery group) combined with carboplatin (5 mg/ml/min) or chemotherapy only (no surgery group).
The common primary endpoint is PFS and OS, and the secondary endpoint is TFSa.
Research results From July 19, 2012 to June 3, 2019, a total of 357 patients were included in the study, and they were randomly assigned to the surgery group (n=182) and the no surgery group (n=175).
The two groups were finally included 172 and 158 patients (Figure 1).
The baseline characteristics of the patients are shown in Table 1.
Figure 1 Test flow chart Table 1 Patient baseline characteristics At the time the database was locked on December 17, 2019, 130 patients in the no-operation group had relapsed.
The median follow-up time of the surgery group and the no-surgery group were 36 months and 33.
9 months, respectively.
The median PFS of the two groups were 17.
4 months and 11.
9 months, respectively (HR=0.
58, P<0.
0001, Figure 2).
The 2-year PFS rates of the group were 38% and 22%, respectively.
The post-event subgroup analysis is shown in Figure 3.
Figure 2 PFS analysis results of the ITT population Figure 3 Subgroup analysis results The median OS of the surgery group and the no-surgery group were 58.
1 months and 53.
9 months, respectively (HR=0.
82).
The OS results are still immature, and further follow-up is still needed.
The median to the first follow-up anti-tumor treatment time of the two groups were 18.
1 months and 13.
6 months (HR=0.
59), and the median to the second follow-up anti-tumor treatment time of the two groups were 33.
5 months and 28.
1 months, respectively (HR =0.
69).
The median TFSa of the surgery group and the no-surgery group were 46.
8 months and 42.
4 months, respectively.
The complete resection rate in the surgery group was 77% (132/177).
Patients with an iMODEL score greater than 4.
7 were assigned to surgery, with a complete resection rate of 61%; in contrast, 154 patients with an iMODEL score less than 4.
7 were assigned to surgery, with a complete resection rate of 79%.
In the surgical group, 9 patients (5%) had grade 3 or higher surgical complications at 30 days (Table 2).
The most common grade 3-4 adverse events during chemotherapy were neutropenia (surgery group [17%] vs no surgery group [12%]), leukopenia (9% vs 6%), and anemia (6% vs 6 %)(table 3).
Table 2 Complications at 30 days in the surgery group Table 3 Safety analysis, discussion and conclusion The results showed that compared with chemotherapy alone, sequential chemotherapy of secondary cytoreductive surgery is associated with prolonged PFS in patients with platinum-sensitive relapsed ovarian cancer, and patients should be actively involved The specific medical center consults whether a second cytoreductive surgery is acceptable.
Similar to the final analysis of the Phase III DESKTOP study (PFS HR=0.
66), the SOC-1 study showed that the second cytoreductive surgery + chemotherapy can prolong the PFS of patients by 5.
6 months (HR=0.
58).
The time to the first and second follow-up anti-tumor treatments is the key node between PFS and OS.
The time to the first and second follow-up anti-tumor treatments of the second cytoreductive surgery + chemotherapy is longer than that of the chemotherapy alone group.
The results of this study have innovated the diagnosis and treatment model for recurrent ovarian cancer, and provided higher-level evidence-based medical evidence for the secondary tumor cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.
It is expected to change the clinical practice of recurrent ovarian cancer in the future. References: [1]Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial.
https://doi.
org/10.
1016/ S1470-2045(21)00006-1.
[2] Heitz F, du Bois A, Kurzeder C, Pfisterer J, Barinoff J, Grabowski J, Hilpert F, Mahner S, Harter P.
Surgery for recurrent ovarian cancer.
Womens Health ( Lond).
2011 Sep;7(5):529-35.
doi: 10.
2217/whe.
11.
52.
PMID: 21879821.
Corresponding to the German phase III DESKTOP study, the SOC-1 study once again confirmed that the second cytoreductive surgery can bring progression-free survival (PFS) benefits for patients with platinum-sensitive recurrent ovarian cancer.
Recently, the full text of the SOC-1 study was published in The Lancet Oncology[1].
Research background About 80% of patients with advanced ovarian cancer will relapse after first-line chemotherapy and targeted maintenance therapy.
The clinical application of secondary cytoreductive surgery is widespread, but whether it can be used for platinum-sensitive recurrent ovarian cancer is still controversial.
Recent studies have shown that secondary tumor cytoreductive surgery can improve the prognosis and prolong the survival of patients.
However, due to the recurrence of ovarian cancer, extensive metastasis to the pelvis and abdominal cavity often occurs.
The surgical removal of the cancer lesions requires extremely high requirements for the surgeon.
It is difficult to achieve a complete second operation (R0); and it does not achieve complete resection (R1).
/R2) surgery is not good for the treatment of ovarian cancer, which is the main reason why most patients with recurrent ovarian cancer cannot benefit from surgery.
Therefore, an effective scoring system is needed to screen patients suitable for surgery.
At present, there are two relatively systematic and mature scoring systems in the world.
One is the AGO scoring system proposed by the German Gynecological Oncology Clinical Research Cooperative Group (AGO) (verified in the Phase II DESKTOP study) [2]; This is the iMODEL (International Cooperative Fitting Model) risk scoring system for recurrent ovarian cancer proposed by the team of Professor Zang Rongyu from Zhongshan Hospital Affiliated to Fudan University.
More and more evidences show that 18F-FDG PET/CT can predict the sensitivity and specificity of complete resection of recurrent ovarian cancer.
Professor Zang Rongyu’s team combined iMODEL scoring with PET-CT imaging to establish a new scoring system and patient selection criteria to screen suitable patients who can benefit from secondary cytoreductive surgery.
Currently, there are three randomized controlled studies on secondary tumor cytoreductive surgery: AGO DESKTOP (Germany), GOG-0213 (U.
S.
), Shanghai Gynecological Oncology Group (SGOG) SOC-1 (China), aiming to explore the secondary Whether cytoreductive surgery can become the standard treatment for patients with recurrent ovarian cancer.
The SOC-1 study was officially launched in 2011 to confirm the efficacy and safety of secondary cytoreductive surgery for recurrent ovarian cancer.
In this study, Professor Zang Rongyu’s team published the PFS results of the SOC-1 study and the pre-set OS interim analysis results, and analyzed the cumulative treatment-free survival (TFSa) for the first time.
Research method SOC-1 is an open-label, randomized controlled, phase III clinical study conducted in 4 centers in China.
Enrolled patients with platinum-sensitive recurrent epithelial ovarian cancer aged 18 years and older who have a platinum-free interval of at least 6 months after the end of first-line platinum-containing treatment.
According to the results of iMODEL score and PET-CT examination, it is predicted that the recurrent lesions can be completely removed.
The iMODEL score is derived from the sum of the scores of 6 variables (FIGO staging, residual lesions after initial surgery, platinum-free interval, ECOG PS score, serum CA125 level at relapse, ascites).
In general, iMODEL score ≤4.
7 points indicate complete resection The possibility is higher.
Eligible patients were randomly assigned to receive second cytoreductive surgery sequential chemotherapy (intravenous paclitaxel [175 mg/m²] or docetaxel [75 mg/m²] in a 1:1 ratio, 6 cycles, every 3 Once a week) (surgery group) combined with carboplatin (5 mg/ml/min) or chemotherapy only (no surgery group).
The common primary endpoint is PFS and OS, and the secondary endpoint is TFSa.
Research results From July 19, 2012 to June 3, 2019, a total of 357 patients were included in the study, and they were randomly assigned to the surgery group (n=182) and the no surgery group (n=175).
The two groups were finally included 172 and 158 patients (Figure 1).
The baseline characteristics of the patients are shown in Table 1.
Figure 1 Test flow chart Table 1 Patient baseline characteristics At the time the database was locked on December 17, 2019, 130 patients in the no-operation group had relapsed.
The median follow-up time of the surgery group and the no-surgery group were 36 months and 33.
9 months, respectively.
The median PFS of the two groups were 17.
4 months and 11.
9 months, respectively (HR=0.
58, P<0.
0001, Figure 2).
The 2-year PFS rates of the group were 38% and 22%, respectively.
The post-event subgroup analysis is shown in Figure 3.
Figure 2 PFS analysis results of the ITT population Figure 3 Subgroup analysis results The median OS of the surgery group and the no-surgery group were 58.
1 months and 53.
9 months, respectively (HR=0.
82).
The OS results are still immature, and further follow-up is still needed.
The median to the first follow-up anti-tumor treatment time of the two groups were 18.
1 months and 13.
6 months (HR=0.
59), and the median to the second follow-up anti-tumor treatment time of the two groups were 33.
5 months and 28.
1 months, respectively (HR =0.
69).
The median TFSa of the surgery group and the no-surgery group were 46.
8 months and 42.
4 months, respectively.
The complete resection rate in the surgery group was 77% (132/177).
Patients with an iMODEL score greater than 4.
7 were assigned to surgery, with a complete resection rate of 61%; in contrast, 154 patients with an iMODEL score less than 4.
7 were assigned to surgery, with a complete resection rate of 79%.
In the surgical group, 9 patients (5%) had grade 3 or higher surgical complications at 30 days (Table 2).
The most common grade 3-4 adverse events during chemotherapy were neutropenia (surgery group [17%] vs no surgery group [12%]), leukopenia (9% vs 6%), and anemia (6% vs 6 %)(table 3).
Table 2 Complications at 30 days in the surgery group Table 3 Safety analysis, discussion and conclusion The results showed that compared with chemotherapy alone, sequential chemotherapy of secondary cytoreductive surgery is associated with prolonged PFS in patients with platinum-sensitive relapsed ovarian cancer, and patients should be actively involved The specific medical center consults whether a second cytoreductive surgery is acceptable.
Similar to the final analysis of the Phase III DESKTOP study (PFS HR=0.
66), the SOC-1 study showed that the second cytoreductive surgery + chemotherapy can prolong the PFS of patients by 5.
6 months (HR=0.
58).
The time to the first and second follow-up anti-tumor treatments is the key node between PFS and OS.
The time to the first and second follow-up anti-tumor treatments of the second cytoreductive surgery + chemotherapy is longer than that of the chemotherapy alone group.
The results of this study have innovated the diagnosis and treatment model for recurrent ovarian cancer, and provided higher-level evidence-based medical evidence for the secondary tumor cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.
It is expected to change the clinical practice of recurrent ovarian cancer in the future. References: [1]Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial.
https://doi.
org/10.
1016/ S1470-2045(21)00006-1.
[2] Heitz F, du Bois A, Kurzeder C, Pfisterer J, Barinoff J, Grabowski J, Hilpert F, Mahner S, Harter P.
Surgery for recurrent ovarian cancer.
Womens Health ( Lond).
2011 Sep;7(5):529-35.
doi: 10.
2217/whe.
11.
52.
PMID: 21879821.
