Abstract 60P
Background
PAOLA 1 trial reported an unprecedented benefit of 66% 5-year rate survival increase with olaparib + bevacizumab in Homologous Repairs Recombination (HRR) deficient population (HRD). Literature data report an HRD prevalence of 50% in patients with high-grade serous carcinoma (HGSOC) and endometrioid high grade carcinoma (HGEOC). In this scenario HRD testing should be offered to any HGSOC and HGEOC patients. Here we present a descriptive analysis of an Italian referral center.
Methods
Patients respecting PAOLA-1 criteria were profiled adopting SOPHiA DDM™ HRD solution. The assay encompasses somatic mutations in 26 HRR genes (including BRCA1 and BRCA2), identifying pathogenic variants, such as SNPs and Indels. Report’s result includes: a) HRR status (negative/positive), b) Genomic instability (GI) value (ranging from -20 to 20), c) BRCA status.
Results
From January 1st 2023 to December 31st 2023, 338 patients were evaluated and only in 7 patients (2%) HRD test was indeterminate. Among patients’ characteristics, summarized in the table, RT <0 and primary debulking surgery (PDS) were more observed in HRD group. At data cut off, 22 patients experienced disease progression (14 HRR proficient (HRP), 7 HRD, 1 indeterminate). Data on maintenance therapy is under collection and will be integrated. Table: 60P
| HRD 179 (53%) | HRP 152 (45%) | Indeterminate 7 (2%) | |
| Histology | |||
| HGSOC | 173 | 127 | 7 |
| HGEOC | 0 | 7 | 0 |
| Others | 6 | 18 | 0 |
| FIGO STAGE | |||
| IIIA | 15 | 9 | 0 |
| IIIB | 20 | 17 | 0 |
| IIIC | 70 | 60 | 5 |
| IV | 70 | 60 | 2 |
| Others | 4 | 6 | 0 |
| Surgery | |||
| Primary debulking | 103 | 65 | 7 |
| Interval debulking | 76 | 87 | 0 |
| Residual Tumor (RT) | |||
| 0 | 81 | 65 | 0 |
| >0 | 84 | 68 | 5 |
| Not available | 14 | 19 | 2 |
| Status GI | |||
| positive | 171 | 0 | 0 |
| negative | 8 | 152 | 0 |
| indeterminate | 0 | 0 | 7 |
| Indice GI | |||
| Range (min-max) | -6.8 to 18.9 | -20 to 0 | Not available |
| BRCA | |||
| mutated | 77 | 0 | 0 |
| Wild Type | 100 | 150 | 7 |
| indeterminate | 2 | 2 | 0 |
Conclusions
Our data confirm current literature on HRD prevalence in HGOSC and HGEOC patients. Despite the limited follow-up, the dimension of the cohort will provide valuable real world data insights.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Marchetti: Financial Interests, Personal, Advisory Board: Clovis, GSK, AstraZeneca. V. Salutari: Financial Interests, Personal, Sponsor/Funding: GSK, PharmaMar, AstraZeneca, Clovis. A. Fagotti: Financial Interests, Personal, Other, Travel grant: AstraZeneca, Johnson & Johnson, MSD, Fondazione Internazionale Menarini, GSK. G. Scambia: Financial Interests, Personal, Invited Speaker, Speaker: Baxter Healthcare, GSK, Intuitive Surgical Inc., AstraZeneca & MSD, Olympus Europa, GSK, AstraZeneca & MSD, Olympus Europa; Financial Interests, Personal, Expert Testimony, Trainer: Covidien AG (Medtronic company); Financial Interests, Institutional, Invited Speaker, ‘IsoMSLN’ in Ovarian Cancer and Malignant Pleural Mesothelioma: Kiromic; Financial Interests, Institutional, Invited Speaker, Roll-over study for patients who have completed a previous cancer study with olaparib and who the investigator believes can benefit from continued treatment - ROSY-O: AstraZeneca; Financial Interests, Institutional, Invited Speaker, CATCH-R: Roll-over study to provide continuous access to clinical therapy with rucaparib.: Clovis Oncology; Financial Interests, Institutional, Invited Speaker, Phase 3, multicenter, placebo-controlled clinical study comparing chemo-immunotherapy (paclitaxel-carboplatin-oregovomab) versus chemotherapy (paclitaxel-carboplatin-placebo) in patients with advanced epithelial ovarian, tubal cancer of fallopian or peritoneal (FLORA-5): Oncoquest Pharmaceuticals Inc.; Financial Interests, Institutional, Invited Speaker, Phase 2b randomized, open-label, active comparator, parallel-group, multicenter study designed to evaluate the efficacy and safety of three different doses of the P2X3 receptor antagonist (BAY 1817080) versus placebo and Elagolix 150 mg in women with symptomatic endometriosis: Bayer AG; Financial Interests, Institutional, Invited Speaker, Usability of ITE transducers for sending electric fields for tumor treatment (TTFields): Novocure Ltd; Financial Interests, Institutional, Invited Speaker, Phase III, multicentre, open-label extension trial to evaluate long-term safety and efficacy in patients with advanced cancers currently undergoing treatment or in follow-up in a pembrolizumab trial.: Merck. C. Nero: Financial Interests, Personal, Other, Travel grant: Illumina, MSD. All other authors have declared no conflicts of interest.