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Evaluating the role of FAMIly history of cancer and diagnosis of multiple neoplasms in cancer patients receiving PD-1/PD-L1 checkpoint inhibitors: the multicenter FAMI-L1 study.

ABSTRACT: Background: We investigate the role of family history of cancer (FHC) and diagnosis of metachronous and/or synchronous multiple neoplasms (MN), during anti-PD-1/PD-L1 immunotherapy. Design: This was a multicenter retrospective study of advanced cancer patients treated with anti-PD-1/PD-L1 immunotherapy. FHC was collected in lineal and collateral lines, and patients were categorized as follows: FHC-high (in case of cancer diagnoses in both the lineal and collateral family lines), FHC-low (in case of cancer diagnoses in only one family line), and FHC-negative. Patients were also categorized according to the diagnosis of MN as follows: MN-high (>2 malignancies), MN-low (two malignancies), and MN-negative. Objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and incidence of immune-related adverse events (irAEs) of any grade were evaluated. Results: 822 consecutive patients were evaluated. 458 patients (55.7%) were FHC-negative, 289 (35.2%) were FHC-low, and 75 (9.1%) FHC-high, respectively. 29 (3.5%) had a diagnosis of synchronous MN and 94 (11.4%) of metachronous MN. 108 (13.2%) and 15 (1.8%) patients were MN-low and MN-high, respectively. The median follow-up was 15.6 months. No significant differences were found regarding ORR among subgroups. FHC-high patients had a significantly longer PFS (hazard ratio [HR] = 0.69 [95% CI: 0.48-0.97], p = .0379) and OS (HR = 0.61 [95% CI: 0.39-0.93], p = .0210), when compared to FHC-negative patients. FHC-high was confirmed as an independent predictor for PFS and OS at multivariate analysis. No significant differences were found according to MN categories. FHC-high patients had a significantly higher incidence of irAEs of any grade, compared to FHC-negative patients (p = .0012). Conclusions: FHC-high patients seem to benefit more than FHC-negative patients from anti-PD-1/PD-L1 checkpoint inhibitors.

SUBMITTER: Cortellini A

PROVIDER: S-EPMC6959456 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Evaluating the role of FAMIly history of cancer and diagnosis of multiple neoplasms in cancer patients receiving PD-1/PD-L1 checkpoint inhibitors: the multicenter FAMI-L1 study.

Cortellini Alessio A Buti Sebastiano S Bersanelli Melissa M Giusti Raffaele R Perrone Fabiana F Di Marino Pietro P Tinari Nicola N De Tursi Michele M Grassadonia Antonino A Cannita Katia K Tessitore Alessandra A Zoratto Federica F Veltri Enzo E Malorgio Francesco F Russano Marco M Anesi Cecilia C Zeppola Tea T Filetti Marco M Marchetti Paolo P Botticelli Andrea A Cappellini Gian Carlo Antonini GCA De Galitiis Federica F Vitale Maria Giuseppa MG Rastelli Francesca F Pergolesi Federica F Berardi Rossana R Rinaldi Silvia S Tudini Marianna M Silva Rosa Rita RR Pireddu Annagrazia A Atzori Francesco F Iacono Daniela D Migliorino Maria Rita MR Gelibter Alain A Occhipinti Mario Alberto MA Martella Francesco F Inno Alessandro A Gori Stefania S Bracarda Sergio S Zannori Cristina C Mosillo Claudia C Parisi Alessandro A Porzio Giampiero G Mallardo Domenico D Fargnoli Maria Concetta MC Tiseo Marcello M Santini Daniele D Ascierto Paolo A PA Ficorella Corrado C

Oncoimmunology 20200107 1

<b>Background</b>: We investigate the role of family history of cancer (FHC) and diagnosis of metachronous and/or synchronous multiple neoplasms (MN), during anti-PD-1/PD-L1 immunotherapy. <b>Design</b>: This was a multicenter retrospective study of advanced cancer patients treated with anti-PD-1/PD-L1 immunotherapy. FHC was collected in lineal and collateral lines, and patients were categorized as follows: FHC-high (in case of cancer diagnoses in both the lineal and collateral family lines), FH ...[more]

PMID: 32002308

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Project description:BACKGROUND:Recent evidence suggested a potential correlation between overweight and the efficacy of immune checkpoint inhibitors (ICIs) in cancer patients. PATIENTS AND METHODS:We conducted a retrospective study of advanced cancer patients consecutively treated with anti-PD-1/PD-L1 inhibitors, in order to compare clinical outcomes according to baseline BMI levels as primary analysis. Based on their BMI, patients were categorized into overweight/obese (≥ 25) and non-overweight (< 25). A gender analysis was also performed, using the same binomial cut-off. Further subgroup analyses were performed categorizing patients into underweight, normal weight, overweight and obese. RESULTS:Between September 2013 and May 2018, 976 patients were evaluated. The median age was 68 years, male/female ratio was 663/313. Primary tumors were: NSCLC (65.1%), melanoma (18.7%), renal cell carcinoma (13.8%) and others (2.4%). ECOG-PS was ≥2 in 145 patients (14.9%). PD-1/PD-L1 inhibitors were administered as first-line treatment in 26.6% of cases. Median BMI was 24.9: 492 patients (50.6%) were non-overweight, 480 patients (50.4%) were overweight/obese. 25.2% of non-overweight patients experienced irAEs of any grade, while 55.6% of overweight/obese patients (p < 0.0001). ORR was significantly higher in overweight/obese patients compared to non-overweight (p < 0.0001). Median follow-up was 17.2 months. Median TTF, PFS and OS were significantly longer for overweight/obese patients in univariate (p < 0.0001, for all the survival intervals) and multivariate models (p = 0.0009, p < 0.0001 and p < 0.0001 respectively). The significance was confirmed in both sex, except for PFS in male patients (p = 0.0668). CONCLUSIONS:Overweight could be considered a tumorigenic immune-dysfunction that could be effectively reversed by ICIs. BMI could be a useful predictive tool in clinical practice and a stratification factor in prospective clinical trials with ICIs.

Project description:BackgroundKRAS (Kirsten rat sarcoma viral oncogene homolog) gene mutation is one of the common driver gene mutations in non-small cell lung cancer (NSCLC) with poor prognosis. There are limited effective treatments for advanced NSCLC patients with KRAS mutation. This study aimed to evaluate the effectiveness of PD-1/L1 immune checkpoint inhibitors (ICIs) as a first-line immunotherapy for advanced NSCLC patients harboring KRAS oncogene mutation.MethodsThis multicenter retrospective real-world study was conducted from 2019 to 2024 at Shanghai Changzheng Hospital and Shanghai Municipal Hospital of Traditional Chinese Medicine, including 78 patients who received immunotherapy using PD-1/L1 ICIs, and 29 patients who received traditional platinum-doublet chemotherapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary endpoints included the objective response rate (ORR), disease control rate (DCR), and correlation of prognostic biomarkers with survival outcomes.ResultsNo significant difference in ORR and DCR was observed between the two groups. The median PFS in immunotherapy group was longer than that in chemotherapy group [7.9 months (95% CI: 5.3-10.5) vs. 6.0 months (95% CI: 3.8-8.2), P = 0.030], and there was no significant difference in OS between the two groups (16.2 vs. 19.2 months, P > 0.05). Multivariate analysis identified PD-L1 expression as an independent protective factor for PFS (HR = 0.397, 95% CI: 0.178-0.887, P = 0.024), and elevated CRP (HR = 1.005, 95% CI: 1.001-1.010, P = 0.022), CEA (HR = 1.008, 95% CI: 1.001-1.014, P = 0.030) and neutrophil-to-lymphocyte ratio (NLR) (HR = 1.105, 95% CI: 1.024-1.193, P = 0.010) were independent risk factors for progression.ConclusionThe first-line treatment with PD-1/PD-L1 ICIs showed numerically better clinical efficacy than the traditional double-agent chemotherapy in patients with KRAS-mutated NSCLC, especially in PFS. Additionally, PD-L1 expression, C reactive protein, CEA, and NLR could serve as markers for predicting the efficacy of immunotherapy in patients with KRAS-mutated NSCLC.

Dataset Information

Evaluating the role of FAMIly history of cancer and diagnosis of multiple neoplasms in cancer patients receiving PD-1/PD-L1 checkpoint inhibitors: the multicenter FAMI-L1 study.

Publications

Evaluating the role of FAMIly history of cancer and diagnosis of multiple neoplasms in cancer patients receiving PD-1/PD-L1 checkpoint inhibitors: the multicenter FAMI-L1 study.

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