Found 5 Presentations For Request "Benedetta Pellegrino"
145P - High-risk breast cancer patients with RAD51-low tumors are characterized by good prognosis
- Benedetta Pellegrino (Parma, Italy)
Abstract
Background
Triple-negative breast cancer (TNBC) that do not achieve pathological complete response (pCR) have unfavorable prognosis. The RAD51 score is a functional assay able to identify Homologous Recombination Repair (HRR)-deficient tumors. In this setting, it may add prognostic value and guide post-neoadjuvant treatments.
Methods
We quantified RAD51 and BRCA1 foci by immunofluorescence, content of tumor-infiltrating lymphocytes (TIL) and expression of immune markers on diagnostic biopsies of 26 high-risk breast cancer (BC) patients (pts), namely TNBC or early onset BC (≤ 35 yo) or g
Results
RAD51 was successfully scored in 26/29 (90%) samples. 16/26 (62%) tumors were RAD51-low (HRD). 14 pts presented HRR alterations: 4 g
Conclusions
The RAD51 test is able to identify HRR-altered tumors, beyond g
Legal entity responsible for the study
The authors.
Funding
B.P. was supported by ESMO with a Clinical Translational Fellowship aid supported by Roche. This work was supported by the project ERAPERMED2019-215.
Disclosure
B. Pellegrino: Non-Financial Interests, Institutional, Sponsor/Funding: Novartis; Financial Interests, Institutional, Writing Engagements: BMS; Non-Financial Interests, Institutional, Sponsor/Funding: Lilly. V. Serra: Non-Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Sponsor/Funding: Abbie. A. Musolino: Non-Financial Interests, Institutional, Research Grant: EISAI; Non-Financial Interests, Institutional, Research Grant: Ltd.; Financial Interests, Personal, Sponsor/Funding: Roche; Financial Interests, Personal, Sponsor/Funding: MacroGenics; Financial Interests, Personal, Sponsor/Funding: Merck; Financial Interests, Personal, Sponsor/Funding: Lilly; Non-Financial Interests, Institutional, Research Grant: Pfizer. All other authors have declared no conflicts of interest.
1587P - SARS-CoV-2 infection risk and COVID-19 prevalence in cancer patients during the first wave of COVID-19 pandemic in a Northern Italy’s virus epicenter area
- Antonino Musolino (Parma, Italy)
Abstract
Background
Patients (pts) with cancer are purported to be more vulnerable to coronavirus disease 2019 (COVID-19). However, cancer encompasses a spectrum of heterogenous tumor subtypes. The aim of this study was to investigate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection risk and COVID-19 prevalence according to tumor subtype in the resident cancer population of the Province of Parma (Emilia Romagna Region, Nothern Italy) during the first wave of COVID-19 pandemic in Italy.
Methods
We analyzed data from the Parma Province Cancer Registry, COVID-19 hospital medical records, and local surveillance system of all laboratory-confirmed cases tested positive for SARS-CoV-2 from the beginning of the outbreak (February, 20) to July 19, 2020. All the Parma resident cancer population was classified as either “active” or “inactive” according to the evidence of any referral to health services, for any reason, during the observation period. Study analyses were adjusted for patient demographics, tumor subtype and period of cancer diagnosis.
Results
40,148 cancer pts (mean age 68; 57.8% females; 45.1% active) were analyzed. The cumulative risk of SARS-CoV-2 infection was 11.2% for cancer pts vs. 7% for non-cancer subjects (P < 0.0001). The overall COVID-19 attack rate was 2.2% (95% CI, 2.0-2.4) and 2.6% (95% CI, 2.4-2.9) for inactive and active cancer pts, respectively. The cumulative incidence of COVID-19 was higher in active vs. inactive cancer subjects (HR 1.18,
Conclusions
In our study, cancer pts were more susceptible to SARS-CoV-2 infection. The cumulative incidence of COVID-19 was higher in active vs. inactive cancer subjects. However, cancer is a heterogeneous group of diseases and pts with different tumor types had differing susceptibility to COVID-19 phenotypes. COVID-19 fatality rates for subgroups will be reported at the meeting.
Legal entity responsible for the study
University Hospital of Parma.
Funding
Has not received any funding.
Disclosure
A. Musolino: Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Macrogenics; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Seagen. B. Pellegrino: Financial Interests, Personal, Research Grant: Roche. All other authors have declared no conflicts of interest.
261P - Survival outcomes of triple-negative breast cancer (TNBC) patients in the pre-immunotherapy age: An analysis of Gruppo Italiano Mammella (GIM) 14 BIOMETA study with a focus on biological subtypes
- Luigi Cerbone (Genova, Italy)
Abstract
Background
TNBC is a subtype of Breast Cancer (BC) associated with an overall survival (OS) of around 19 months (ms). Before immunotherapy, no specific systemic treatment apart from chemotherapy (CT) was available. ER low disease is characterized by low ER and PgR staining (both <10%) and negative Her2. It’s considered as having a survival and a biological behavior comparable to that of TNBC. Deleterious germline BRCA mutations were the only predictive biomarker available in the past years for TNBC.
Methods
Patients (pts) were identified within the GIM-14 study, an ambispective multicenter Italian study including pts with metastatic breast cancer diagnosed from 2000 to 2020. TNBC and ER low pts were eligible to this analysis. Pts demographics, disease characteristics and treatment patterns were obtained for each patients. OS and 1st line Time to Treatment Failure (TTF) were calculated. Statistical analysis was performed with SAS v 9.4.
Results
Overall, 195 pts were eligible (158 TNBC and 37 ER low pts). BRCA mutation was assessed in 35 pts (18%), of whom 16 were pos and 19 neg. Pts’ characteristics are summarized in the table. Median (m) OS was 22.6 ms (95% CI: 18.6-26.8); 84% and 57% of pts were alive at 1 and 2 years respectively. M TTF was 4.4 ms (95% CI: 3.8-5.1). MOS of TNBC pts was 20.2 ms (95% CI: 16.9-24.9) while for ER low pts was 26.8 ms (17.4-73 ms); p 0.07. First line mTTF was 4.3 ms (95% CI: 3.7-4.9) for TNBC and 5.5 ms (95% CI: 3.7-9.3) for ER low pts, p 0.1. mOS in BRCA pos pts was 35 ms (19.6-NR) while for BRCA neg 16.3 was ms (95 CI%: 9-32), p 0.03. TTF was 6.9 ms (95%CI: 2.1-8) for BRCA pos pts and 3.9 ms for BRCA neg pts (95%CI: 1.4-6.6), p 0.44.
N=195 58 N=121 N=121
Conclusions
In this analysis OS of TNBC pts was comparable to that previously reported in literature. BRCApos pts showed a better OS when compared to BRCAneg pts. A trend towards a better OS in ER low pts was found. Further prospective investigation in this subgroup of pts is warranted.
Clinical trial identification
NCT02284581.
Legal entity responsible for the study
Consorzio Oncotech.
Funding
Has not received any funding.
Disclosure
M. De Laurentiis: Financial Interests, Personal, Speaker’s Bureau: Novartis, Roche; Financial Interests, Personal, Advisory Role: Amgen; Celgene; Eisai; Genomic Health; Lilly; MSD Oncology; Novartis; Pfizer; Pierre Fabre; Roche; Financial Interests, Institutional, Funding: Eisai; Italfarmaco; Roche; Financial Interests, Personal, Other: Amgen; Celgene; Eisai; Genomic Health; Lilly; MSD Oncology; Novartis; Pfizer; Pierre Fabre; Roche . G. Arpino: Financial Interests, Personal, Other: Roche, Pfizer, AstraZeneca, Novartis, Celgene, Eli Lilly, Amgen, Eisai. A. Fabi: Financial Interests, Personal, Other: Roche, Celgene, AstraZeneca, Eli Lilly, Novartis, Pfizer, Eisai. C. Mulinelli: Non-Financial Interests, Personal, Other, honoraria: Novartis. M. Lambertini: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Eli-Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Theramex; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Speaker’s Bureau: Sandoz; Financial Interests, Personal, Speaker’s Bureau: Novartis. C. Bighin: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Pfizer. L. Del Mastro: Financial Interests, Personal, Invited Speaker: Roche, Novartis, Eli Lilly, MSD, Pfizer, Ipsen; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Roche, Novartis, Eli Lilly, MSD, Genomic Health, Pierre Fabre, Daiichi Sankyo, Seagen, astraZeneca, EIsai. All other authors have declared no conflicts of interest.
1633P - Why do cancer clinical trials (CT) discontinue prematurely in the era of COVID-19?
- Giovanni Maria Iannantuono (Rome, Italy)
Abstract
Background
The COVID-19 pandemic (C19P) is causing several detrimental effects on cancer care globally. CT are crucial to obtain high quality literature evidence and “poor accrual” is the most common reason for their early discontinuation (ED). At our best knowledge, no data are available on ED of cancer CT after the beginning of C19P.
Methods
ClinicalTrial.gov was queried for terminated (T), withdrawn (W) and suspended (S) CT for the following terms: “cancer”, “neoplasm”, and “tumor”. The search was made for all the CT available from the inception to 26th February 2021, without any restrictions. The following characteristics were extracted: reason for ED, study type (interventional [In]
Results
9990 CT were identified, but 765 CT were excluded as not related to cancer. Thus, 9225 CT were included (66% was T, 23% was W and 4% was S). Among CT classified as T, W and S, the frequency of In CT was 92%, 88% and 85% respectively, while the frequency of sponsored CT was 46%, 35% and 26% respectively. The most common reasons for ED were: “poor accrual” (29%), “lack of funding” (6%) and “sponsor decision” (5%). No reason for ED was available for 15% of CT. One hundred (1%) CT were discontinued due to C19P (27% was T, 7% was W and 66% was S). Comparing CT discontinued due to C19P with those discontinued due to other reasons, a lower rate of In-CT (73%
Conclusions
“Poor accrual” continues to be the main reason for ED of cancer CT, but C19P represents a new additional cause of ED. Sponsored trials showed less risk for ED. Further research is needed to maximize the expected benefit of cancer CT, reducing the anticipated risks.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
1712P - Safety and efficacy of influenza and pneumococcal vaccines in cancer patients on active therapy: A prospective study
- Nicla Maria La Verde (Milan, Italy)
Abstract
Background
Influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a higher morbidity and mortality rates. Limited data are available about safety, efficacy, immunogenicity and timing of influenza (I) and pneumococcal (P) vaccine (vax) in pts receiving active treatment. However, I and P vax in cancer pts and their family members (FMs) are reccomended.
Methods
This is a single institution prospective study conducted at L. Sacco Hospital (Milan, Italy) between Sept 20 and Apr 21. The aim was to assess efficacy and safety of vax. Cancer pts, age>18yo, in active antineoplastic treatment and FMs age>18yo were included. Each pt received I+P vax on the same day of therapy. Any local and systemic Adverse Event (AE), episode of Influenza Like Illness (ILI), pneumococcal infection (PI), access to Emergency Department (ED) or Hospital admission (HA) and delay of therapy (DoT) were recorded. The frequency of AEs, ILI episodes and PI among pts and age- and gender- matching FMs were compared.
Results
194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% ≥1 previous line of therapy; 38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: I-vax received for first time in 47% pts and 72% FMs. 100% pts and 49% FMs received I+P-vax. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01). P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11); the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DoT) and 3.6% FMs (p=0.04). No PI was recorded. In a logistic regression analysis type of therapy, previous treatment and the use of steroid don’t significantly impact on vax safety and efficacy.
Conclusions
Few ILI events were observed due to vax and probably to all measures adopted to prevent SARS-CoV-2 virus spread. Except for local I-vax AEs, no differences were observed in efficacy and safety between the 2 groups. During the observation time, >70% of cancer pts in active treatment received I and P vax, so the vaccination coverage was achieved, reducing the pressure on territorial healthcare system.
Clinical trial identification
Trial protocol n. 2020/ST/433 release by Local Ethic Committee.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
N.M. La Verde: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Speaker’s Bureau: Gentili; Financial Interests, Institutional, Funding: EISA. D. Dalu: Financial Interests, Personal, Invited Speaker: Gentili; Financial Interests, Personal, Other: MSD. A. Riva: Financial Interests, Personal, Other: MSD,; Financial Interests, Personal, Other: ViiV; Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Janseen; Financial Interests, Personal, Other: Cilag. S. Antinori: Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Merck. M. Galli: Financial Interests, Personal, Other: ViiV; Financial Interests, Personal, Other: BMS; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: AbbVie; Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Janssen; Financial Interests, Personal, Other: Roche. All other authors have declared no conflicts of interest.