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The 2021 American Society of Gynecological Oncology (SGO) Annual Meeting will be held in the form of an online meeting on March 19-25.
As a global event in the field of gynecological oncology, the SGO conference brought together top experts and scholars in the field of gynecological oncology to discuss the latest research progress and best clinical practice in the field of gynecological oncology.
This article counts the heavy research progress (LBA abstract) in related fields that was first announced at this SGO conference.
The efficacy of single antiangiogenic drugs is comparable to combination therapy [1] Background Cancer Genome Atlas (TCGA) and related studies have shown that endometrial cancer may be sensitive to DNA repair inhibitors.
Preclinical studies have shown that PARP inhibitors alone or in combination with other targeted drugs have shown preliminary anti-tumor activity in endometrial cancer.
In other tumor types, PARP inhibitors combined with anti-angiogenic drugs have shown synergistic anti-tumor effects and good tolerance.
Cediranib is a tyrosine kinase inhibitor targeting VEGFR.
The study aims to explore the efficacy and safety of olaparib, olaparib+cediranib versus cediranib as a single agent for endometrial cancer patients.
Methods This is a phase II clinical study.
The enrolled patients with recurrent endometrial cancer were randomly assigned to receive cediranib or olaparib or cediranib + olaparib at 1:1:1.
Eligible patients have received at least one or two platinum-containing chemotherapy regimens in the past.
Cediranib, olaparib, cediranib+olaparib are administered in 30 mg (PO daily), 300 mg (PO BID), 20 mg (PO daily) + 300 mg (PO BID), respectively, 28 days as a cycle.
The primary endpoint is progression-free survival (PFS), and stratification factors include histological status.
Results A total of 120 patients were enrolled in the study, of which 109 received treatment.
There were 34 cases, 39 cases in the cediranib group (group C), olaparib group (group O), and cediranib+ olaparib group (group OC), respectively.
36 patients.
The median age was 66 years, 51.
7% (62 cases) of patients had endometrioid adenocarcinoma, and 6.
7% (8 cases) of patients had mixed tissue types.
The results showed that the median PFS of the cediranib group, the olaparib group, and the cediranib+olaparib group were 3.
8 months, 2.
0 months, and 5.
5 months, respectively (O vs.
CP=0.
935, HR=1.
45; C vs.
OC, P=0.
064, HR=0.
7).
No new adverse events were found.
Conclusion Cediranib + olaparib showed certain anti-tumor activity in patients with recurrent and metastatic endometrial cancer, but compared with cediranib alone, it did not show a significant difference in efficacy.
The combination therapy is safe.
Single-agent olaparib is not effective in such patients.
Voice of China APPROVE study: Apatinib + liposomal adriamycin for platinum-sensitive recurrent ovarian cancer, the disease control rate reached 82.
0%! [2] Background anti-angiogenic drugs combined with chemotherapy can improve the survival benefit of platinum-sensitive patients with recurrent ovarian cancer.
The APPOVE study aims to evaluate apatinib (an oral tyrosine kinase inhibitor targeting VEGFR-2) + liposomal adriamycin (PLD) or PLD for platinum-sensitive relapsed or refractory ovarian cancer Efficacy and safety.
Chinese scholars announced the results of APPROVE research at this SGO conference.
Methods Patients eligible for enrollment were non-sticky ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that had progressed through platinum-containing chemotherapy confirmed by histology.
There is at least one measurable and/or non-measurable lesion, which can be accurately assessed by computed tomography/magnetic resonance imaging at baseline.
Patients were randomly assigned to receive PLD monotherapy (40mg/m2 IV Q4W up to 6 cycles) (PLD group) or PLD+apatinib (250mg PO) (A-PLD group) according to 1:1 until the disease progressed or appeared unacceptable Toxicity or patient withdrawal.
Stratification factors include whether it is platinum-sensitive recurrence and platinum-free interval (3 months vs 3-6 months).
The primary endpoint was PFS in the ITT population.
The secondary endpoints were OS, objective response rate (ORR), disease control rate (DCR), and safety.
Results From March 22, 2018 to November 16, 2020, a total of 152 patients were enrolled and randomly grouped into A-PLD group (n=78) and PLD group (n=74).
At a median follow-up time of 8.
1 months, the median PFS of the A-PLD group and PLD group were 5.
8 months and 3.
3 months, respectively (HR=0.
41, P=0.
0001).
Among the population with evaluable diseases, the ORR of the A-PLD group and the PLD group were 37.
7% (23/61) and 9.
5% (6/63) (P = 0.
0002), and the DCR of the two groups were 82.
0% (50/ 61) and 58.
7% (37/63) (P = 0.
0050).
OS data is not yet mature.
Hypertension and hand-foot syndrome were more common in the apatinib group.
Conclusion Apatinib+PLD can significantly improve PFS in patients with platinum-resistant or recurrent ovarian cancer.
The joint program also improved ORR and DCR.
Adverse events are similar to those of previously known single-agent adverse events.
ENPAC study: triple therapy for endometrial cancer, ORR reached 71%! [3] Background Compared with estrogen receptor or progesterone receptor, androgen receptor is more widely expressed in endometrial cancer (including endometrioid subtypes which account for up to 90%).
Enzalutamide can bind to the androgen receptor and undergo nuclear translocation, thereby blocking the binding of AR to DNA.
ENPAC is a phase II study aimed at exploring the efficacy and safety of paclitaxel + carboplatin + enzalutamide in advanced or recurrent endometrial cancer.
Methods Patients eligible for enrollment were patients with advanced or recurrent endometrial cancer who had not undergone chemotherapy, had measurable lesions, and had good organ function.
Before starting the three-drug therapy, the patient received enzalutamide (160mg) infusion therapy for 28 days.
Obtain biopsy samples before and after single-drug treatment to evaluate the effects of molecular markers, including androgen receptor expression and activation, androgen-related gene or protein expression, DNA copy number changes, etc.
The patient was subsequently treated with carboplatin (AUC 6 IV Q3W) + paclitaxel (175 mg/m2) + enzalutamide (160 mg daily).
The response is evaluated every 3 cycles, up to 9 cycles.
Evaluable patients receive at least 6 cycles of three-drug therapy.
The primary endpoint is PFS.
Results A total of 81 patients were screened in the study, of which 49 patients received treatment, with a median age of 64 years, 53.
1% of patients were histologically graded 2, 81.
6% of patients had recurrent disease, and no dose was observed during the safe lead-in period.
Limit toxicity.
There were 3 patients, 2 patients, 2 patients, and 1 patient who did not receive chemotherapy due to rapid progress during the enzalutamide monotherapy stage, unrelated death, withdrawal from the study, and unrelated stroke.
The median PFS of the total population was 11.
47, and the 6-month PFS rate was 77%.
Among the 35 evaluable patients, the determined ORR was 71%, the 6-month PFS rate was 83%, and the median PFS was 14.
42.
The most common adverse events included neutropenia (20%), anemia (18%), fatigue (18%), neuropathy (10%), hyperglycemia (14%), nausea (8%), thrombocytopenia (8%).
Conclusion Paclitaxel + carboplatin + enzalutamide is well tolerated and shows promising anti-tumor activity in patients with advanced or recurrent endometrial cancer who have not been chemotherapy.
Research is further analyzing the predictors of response and resistance to androgen inhibitor therapy.
Clinical trial information: NCT02684227.
The KEYNOTE-158 study vulvar squamous carcinoma cohort study data are published [4] Background advanced vulvar cancer affects the quality of life of elderly patients, and treatment options are limited.
The Phase Ib KEYNOTE-028 study showed that pembrolizumab showed certain anti-tumor activity in PD-L1-positive vulvar cancer patients with an ORR of 6%.
KEYNOTE-158 (NCT02628067) is a large-scale, non-randomized, multicenter, open-label Phase II study to evaluate the efficacy and efficacy of pembrolizumab in treated advanced patients (regardless of PD-L1 expression) safety.
At this meeting, the researchers announced the efficacy and safety of pembrolizumab in the vulvar cancer cohort.
Methods The study included patients 18 years of age and older with histologically/cytologically confirmed advanced vulvar squamous cell carcinoma who had failed previous treatment and had measurable lesions.
The ECOG PS score is 0 or 1.
There are enough samples for biomarker analysis.
The PD-L1 IHC 22C3 pharmDx detection method was used to determine the level of PD-L1.
A positive PD-L1 is defined as PD-L1 CPS≥1.
The enrolled patients received pembrolizumab treatment (200mg W3Q) until the disease progressed, or unacceptable toxicity appeared, or 35 treatment cycles were completed.
An imaging evaluation was performed every 9 weeks for 1 year, and then an imaging evaluation every 12 weeks.
The primary end point was ORR, and the secondary end points included DOR, PFS, OS, and safety.
Results A total of 101 patients were included in the study.
As of October 5, 2020, the median follow-up time was 36 months, the median age was 64 years, and 8.
9% of the patients had not received treatment before, 56.
4%, 22.
8%, and 10.
9, respectively.
% Of patients have previously received first-line, second-line, third-line and above treatment. 83.
2%, 6.
9%, and 9.
9% of patients were PD-L1 positive, negative, and non-evaluable, respectively.
Overall, the ORR was 10.
9%, of which 1 patient had a complete remission and 10 patients had a partial remission.
Among PD-L1 positive tumors, 9.
5% (8/84) patients achieved complete or partial remission.
Among PD-L1 negative tumors, 28.
6% (2/7) patients achieved complete or partial remission.
Among patients in remission, the median DOR was 20.
4 months.
Among all enrolled patients, the median PFS and median OS were 2.
1 months and 6.
2 months, respectively.
Fifty-one patients (50.
5%) had treatment-related adverse events, of which 12 patients (11.
9%) had grade 3~5 adverse events.
Conclusion Pembrolizumab showed a durable response in patients with vulvar squamous cell carcinoma, with an ORR of 10.
9% and a median DOR of 20.
4 months.
Whether in PD-L1 positive or negative patients, pembrolizumab single agent showed good anti-tumor activity.
References: 1.
Abstract 11636.
A Randomized, Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer2.
Abstract 11561.
Apatinib combined with pegylated liposomal doxorubicin (PLD) versus PLD for platinum-resistant recurrent ovarian cancer (APPROVE): A multicenter, randomized, controlled, open-label, phase II trial 3.
ENPAC: Phase II trial with safety lead of enzalutamide in combination with paclitaxel and carboplatin for advanced or recurrent endometrioid endometrial adenocarcinoma Presenting Author: Shannon Westin, MD.
Abstract 11584.
4.
Abstract 11603.
Pembrolizumab for vulvar squamous cell carcinoma: Results from the phase 2 KEYNOTE-158 study.
As a global event in the field of gynecological oncology, the SGO conference brought together top experts and scholars in the field of gynecological oncology to discuss the latest research progress and best clinical practice in the field of gynecological oncology.
This article counts the heavy research progress (LBA abstract) in related fields that was first announced at this SGO conference.
The efficacy of single antiangiogenic drugs is comparable to combination therapy [1] Background Cancer Genome Atlas (TCGA) and related studies have shown that endometrial cancer may be sensitive to DNA repair inhibitors.
Preclinical studies have shown that PARP inhibitors alone or in combination with other targeted drugs have shown preliminary anti-tumor activity in endometrial cancer.
In other tumor types, PARP inhibitors combined with anti-angiogenic drugs have shown synergistic anti-tumor effects and good tolerance.
Cediranib is a tyrosine kinase inhibitor targeting VEGFR.
The study aims to explore the efficacy and safety of olaparib, olaparib+cediranib versus cediranib as a single agent for endometrial cancer patients.
Methods This is a phase II clinical study.
The enrolled patients with recurrent endometrial cancer were randomly assigned to receive cediranib or olaparib or cediranib + olaparib at 1:1:1.
Eligible patients have received at least one or two platinum-containing chemotherapy regimens in the past.
Cediranib, olaparib, cediranib+olaparib are administered in 30 mg (PO daily), 300 mg (PO BID), 20 mg (PO daily) + 300 mg (PO BID), respectively, 28 days as a cycle.
The primary endpoint is progression-free survival (PFS), and stratification factors include histological status.
Results A total of 120 patients were enrolled in the study, of which 109 received treatment.
There were 34 cases, 39 cases in the cediranib group (group C), olaparib group (group O), and cediranib+ olaparib group (group OC), respectively.
36 patients.
The median age was 66 years, 51.
7% (62 cases) of patients had endometrioid adenocarcinoma, and 6.
7% (8 cases) of patients had mixed tissue types.
The results showed that the median PFS of the cediranib group, the olaparib group, and the cediranib+olaparib group were 3.
8 months, 2.
0 months, and 5.
5 months, respectively (O vs.
CP=0.
935, HR=1.
45; C vs.
OC, P=0.
064, HR=0.
7).
No new adverse events were found.
Conclusion Cediranib + olaparib showed certain anti-tumor activity in patients with recurrent and metastatic endometrial cancer, but compared with cediranib alone, it did not show a significant difference in efficacy.
The combination therapy is safe.
Single-agent olaparib is not effective in such patients.
Voice of China APPROVE study: Apatinib + liposomal adriamycin for platinum-sensitive recurrent ovarian cancer, the disease control rate reached 82.
0%! [2] Background anti-angiogenic drugs combined with chemotherapy can improve the survival benefit of platinum-sensitive patients with recurrent ovarian cancer.
The APPOVE study aims to evaluate apatinib (an oral tyrosine kinase inhibitor targeting VEGFR-2) + liposomal adriamycin (PLD) or PLD for platinum-sensitive relapsed or refractory ovarian cancer Efficacy and safety.
Chinese scholars announced the results of APPROVE research at this SGO conference.
Methods Patients eligible for enrollment were non-sticky ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that had progressed through platinum-containing chemotherapy confirmed by histology.
There is at least one measurable and/or non-measurable lesion, which can be accurately assessed by computed tomography/magnetic resonance imaging at baseline.
Patients were randomly assigned to receive PLD monotherapy (40mg/m2 IV Q4W up to 6 cycles) (PLD group) or PLD+apatinib (250mg PO) (A-PLD group) according to 1:1 until the disease progressed or appeared unacceptable Toxicity or patient withdrawal.
Stratification factors include whether it is platinum-sensitive recurrence and platinum-free interval (3 months vs 3-6 months).
The primary endpoint was PFS in the ITT population.
The secondary endpoints were OS, objective response rate (ORR), disease control rate (DCR), and safety.
Results From March 22, 2018 to November 16, 2020, a total of 152 patients were enrolled and randomly grouped into A-PLD group (n=78) and PLD group (n=74).
At a median follow-up time of 8.
1 months, the median PFS of the A-PLD group and PLD group were 5.
8 months and 3.
3 months, respectively (HR=0.
41, P=0.
0001).
Among the population with evaluable diseases, the ORR of the A-PLD group and the PLD group were 37.
7% (23/61) and 9.
5% (6/63) (P = 0.
0002), and the DCR of the two groups were 82.
0% (50/ 61) and 58.
7% (37/63) (P = 0.
0050).
OS data is not yet mature.
Hypertension and hand-foot syndrome were more common in the apatinib group.
Conclusion Apatinib+PLD can significantly improve PFS in patients with platinum-resistant or recurrent ovarian cancer.
The joint program also improved ORR and DCR.
Adverse events are similar to those of previously known single-agent adverse events.
ENPAC study: triple therapy for endometrial cancer, ORR reached 71%! [3] Background Compared with estrogen receptor or progesterone receptor, androgen receptor is more widely expressed in endometrial cancer (including endometrioid subtypes which account for up to 90%).
Enzalutamide can bind to the androgen receptor and undergo nuclear translocation, thereby blocking the binding of AR to DNA.
ENPAC is a phase II study aimed at exploring the efficacy and safety of paclitaxel + carboplatin + enzalutamide in advanced or recurrent endometrial cancer.
Methods Patients eligible for enrollment were patients with advanced or recurrent endometrial cancer who had not undergone chemotherapy, had measurable lesions, and had good organ function.
Before starting the three-drug therapy, the patient received enzalutamide (160mg) infusion therapy for 28 days.
Obtain biopsy samples before and after single-drug treatment to evaluate the effects of molecular markers, including androgen receptor expression and activation, androgen-related gene or protein expression, DNA copy number changes, etc.
The patient was subsequently treated with carboplatin (AUC 6 IV Q3W) + paclitaxel (175 mg/m2) + enzalutamide (160 mg daily).
The response is evaluated every 3 cycles, up to 9 cycles.
Evaluable patients receive at least 6 cycles of three-drug therapy.
The primary endpoint is PFS.
Results A total of 81 patients were screened in the study, of which 49 patients received treatment, with a median age of 64 years, 53.
1% of patients were histologically graded 2, 81.
6% of patients had recurrent disease, and no dose was observed during the safe lead-in period.
Limit toxicity.
There were 3 patients, 2 patients, 2 patients, and 1 patient who did not receive chemotherapy due to rapid progress during the enzalutamide monotherapy stage, unrelated death, withdrawal from the study, and unrelated stroke.
The median PFS of the total population was 11.
47, and the 6-month PFS rate was 77%.
Among the 35 evaluable patients, the determined ORR was 71%, the 6-month PFS rate was 83%, and the median PFS was 14.
42.
The most common adverse events included neutropenia (20%), anemia (18%), fatigue (18%), neuropathy (10%), hyperglycemia (14%), nausea (8%), thrombocytopenia (8%).
Conclusion Paclitaxel + carboplatin + enzalutamide is well tolerated and shows promising anti-tumor activity in patients with advanced or recurrent endometrial cancer who have not been chemotherapy.
Research is further analyzing the predictors of response and resistance to androgen inhibitor therapy.
Clinical trial information: NCT02684227.
The KEYNOTE-158 study vulvar squamous carcinoma cohort study data are published [4] Background advanced vulvar cancer affects the quality of life of elderly patients, and treatment options are limited.
The Phase Ib KEYNOTE-028 study showed that pembrolizumab showed certain anti-tumor activity in PD-L1-positive vulvar cancer patients with an ORR of 6%.
KEYNOTE-158 (NCT02628067) is a large-scale, non-randomized, multicenter, open-label Phase II study to evaluate the efficacy and efficacy of pembrolizumab in treated advanced patients (regardless of PD-L1 expression) safety.
At this meeting, the researchers announced the efficacy and safety of pembrolizumab in the vulvar cancer cohort.
Methods The study included patients 18 years of age and older with histologically/cytologically confirmed advanced vulvar squamous cell carcinoma who had failed previous treatment and had measurable lesions.
The ECOG PS score is 0 or 1.
There are enough samples for biomarker analysis.
The PD-L1 IHC 22C3 pharmDx detection method was used to determine the level of PD-L1.
A positive PD-L1 is defined as PD-L1 CPS≥1.
The enrolled patients received pembrolizumab treatment (200mg W3Q) until the disease progressed, or unacceptable toxicity appeared, or 35 treatment cycles were completed.
An imaging evaluation was performed every 9 weeks for 1 year, and then an imaging evaluation every 12 weeks.
The primary end point was ORR, and the secondary end points included DOR, PFS, OS, and safety.
Results A total of 101 patients were included in the study.
As of October 5, 2020, the median follow-up time was 36 months, the median age was 64 years, and 8.
9% of the patients had not received treatment before, 56.
4%, 22.
8%, and 10.
9, respectively.
% Of patients have previously received first-line, second-line, third-line and above treatment. 83.
2%, 6.
9%, and 9.
9% of patients were PD-L1 positive, negative, and non-evaluable, respectively.
Overall, the ORR was 10.
9%, of which 1 patient had a complete remission and 10 patients had a partial remission.
Among PD-L1 positive tumors, 9.
5% (8/84) patients achieved complete or partial remission.
Among PD-L1 negative tumors, 28.
6% (2/7) patients achieved complete or partial remission.
Among patients in remission, the median DOR was 20.
4 months.
Among all enrolled patients, the median PFS and median OS were 2.
1 months and 6.
2 months, respectively.
Fifty-one patients (50.
5%) had treatment-related adverse events, of which 12 patients (11.
9%) had grade 3~5 adverse events.
Conclusion Pembrolizumab showed a durable response in patients with vulvar squamous cell carcinoma, with an ORR of 10.
9% and a median DOR of 20.
4 months.
Whether in PD-L1 positive or negative patients, pembrolizumab single agent showed good anti-tumor activity.
References: 1.
Abstract 11636.
A Randomized, Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer2.
Abstract 11561.
Apatinib combined with pegylated liposomal doxorubicin (PLD) versus PLD for platinum-resistant recurrent ovarian cancer (APPROVE): A multicenter, randomized, controlled, open-label, phase II trial 3.
ENPAC: Phase II trial with safety lead of enzalutamide in combination with paclitaxel and carboplatin for advanced or recurrent endometrioid endometrial adenocarcinoma Presenting Author: Shannon Westin, MD.
Abstract 11584.
4.
Abstract 11603.
Pembrolizumab for vulvar squamous cell carcinoma: Results from the phase 2 KEYNOTE-158 study.
