EORTC Gynecological Cancer Group conducts trials in ovarian, cervical and corpus tumours, including rare cancers.
With the help of established translational and imaging research processes, future EORTC studies in gynecological cancers will aim to provide molecular approaches to patient management. The greatest challenge is to discover clinically-useful predictive factors to identify subgroups of patients based on genomic patterns and activated pathways, and tailor clinical trials for them.
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- Presented results from the EORTC 1508 trial at ESMO. This trial included 122 patients with platinum-resistant ovarian cancer. 33 were randomised to bevacizumab (BEV); 11 to atezolizumab (ATE)+placebo (P); 13 to ATE +ASA; 32 to BEV+ ATE+P and 33 to BEV+ATE and treated until progression or unacceptable toxicity. The addition of ASA to BEV+ATE did not improve efficacy. Preliminary results of ATE+ASA may warrant exploration. Relative to BEV, the addition of ATE and ATE+ASA resulted in similar PFS-6 but prolonged time to first subsequent therapy and merits exploration. Translational analyses are ongoing with a grant from Roche to identify biomarkers of clinical benefit.
- EORTC 55092 1 phase I/II trial on pazopanib and weekly carboplatin and paclitaxel in patients with platinum-refractory/ resistant ovarian has been completed with final analysis expected in 2022. The primary objective was to assess progression-free survival rate at 1 year.
- EORTC 1212 2 (NiCCC) nintedanib trial was completed along with the final analysis. 93 ovarian and 9 endometrium patients were randomised. The main objectives were to assess the efficacy, safety and effect on quality of life of nintedanib compared to chemotherapy in women with relapsed clear cell carcinoma of the ovary or endometrium. The manuscript is in preparation.
- The EORTC 62113-55115 3 uterine sarcoma adjuvant trials has completed accrual. Follow-up is ongoing with 59 patients randomised. The primary objective is to assess progression-free survival (PFS) rate at four months after the last randomisation to cabozantinib or placebo. Data analysis and subsequent results are expected end 2022.
1 Phase IB-II, open label, multicenter feasibility study of pazopanib in combination with Paclitaxel and Carboplatin in patients with platinum- refractory/resistant ovarian, fallopian tube or peritoneal carcinoma.
2 NiCCC: A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium
3 A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment
Since 1977, EORTC has successfully conducted clinical research in ovarian, cervical, uterine and vulvar cancer. Many of these trials were unique and changed clinical practice.
The ACTION Study (EORTC 55904) investigated the role of adjuvant chemotherapy in early ovarian cancer. Original analysis showed that adjuvant chemotherapy improved recurrence-free survival (RFS) but not overall survival (OS).
The Interval Debulking Study in Ovarian Cancer (EORTC 55865) showed, and continues to show with over 10 years of follow up, that there is a significant survival advantage for patients who underwent interval debulking.
The EORTC 55971/NCIC-CTG OV13 trial showed that neoadjuvant chemotherapy followed by interval debulking surgery is a good alternative for primary debulking surgery in patients with extensive stage IIIc or IV ovarian carcinoma.
MRC 0VO5/EORTC 55955 This study found that in relapsed ovarian cancer, early treatment based on confirmed elevation of CA125 alone, versus delayed treatment based on clinical relapse, shows no evidence of a survival benefit or better quality of life. So there is no value in routinely measuring CA125 in the follow-up of ovarian cancer patients who attain a complete response after first-line treatment.
The first targeted agent maintenance trial at EORTC (EORTC 55041) compared two years of daily erlotinib versus observation. Although the results were negative, this trial was one of the first large randomised phase III trials in which targeted therapy was tested in ovarian cancer patients.
A recently-finished randomized phase III study of neoadjuvant chemotherapy followed by surgery versus concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa >4 cm or IIb cervical cancer (EORTC 55994) could provide important indications on best treatment modality in this early-stage population.
EORTC performed a randomised phase III trial in stage I and II uterine sarcomas to evaluate any potential benefit of adjuvant radiotherapy in this population. Over a 13-year period, this study recruited 224 patients including 103 with leiomyosarcomas (LMS) followed by 91 with carcinosarcomas (CS) and 28 with endometrial stromal sarcomas. The benefit in local control for CS (not seen in LMS) did not translate into any difference in OS between immediate postoperative pelvic radiotherapy and observation. These results clearly demonstrated that women with uterine sarcomas can be spared adjuvant radiotherapy. (REF ).
- ERP 261 – Computational modeling of ovarian cancer progression dynamics to suggest optimal treatment strategies. (project leader: Dr Neel)
The project will use data from the EORTC 55971 trial to validate an advanced model aimed at predicting treatment outcome between PDS and NACT patients and thereby improving current treatment strategy.
- ERP 255 – Development of a prognostic nomogram to predict progression-free survival in patients with ovarian cancer participating in maintenance therapy trials after the completion of 1st chemotherapy. (project leader Dr Lindeman).
The aim of this project is to use the EORTC 55041 data to develop 2 prognostic nomograms: one based on pre-maintenance treatment, disease and patient characteristics and their association with progression-free survival; the second on the characteristics that can predict therapeutic failure of NACT, where therapeutic failure of NACT is defined as death or disease progression during NACT prior to surgery, inability to receive surgery and presence of residual disease after surgery.
- ERP 236 – Transfusion utilization and effect on quality of life, progression free and overall survival in up front treatment of advanced epithelial ovarian cancer.(project leader: Dr Prescott).
Use the 55971 data to assess the impact of blood transfusion on overall survival (OS), progression free survival (PFS), Quality of Life (QoL) and adverse events of patients with epithelial ovarian cancer.
- ERP 244 – Applying novel markers to predict individualized risks of and benefits from treatment in patients with ovarian cancer. (project leader: Dr Parvin Tajik).
Use data from various studies including 55971 and 55041 to develop validated multi-marker rules, which allow a personalised choice of treatment. External validation of the two-marker rule for the choice of treatment in stage IIIC or IV ovarian cancer patients between primary surgery or neoadjuvant chemotherapy plus interval debulking surgery.
European Reference Networks (ERN) for rare solid tumours (EURACAN). EURACAN is involving references centers in Europe covering ten types of rare cancers. EURACAN will improve patient cares and facilitate research in rare cancers. EORTC is providing the clinical research infrastructure. (No website available yet)