Abstract 3569
Background
Phase I clinical trials (Ph1) are crucial in the development of new anticancer therapies. New generation Ph1 investigating novel classes of drugs led to consistent improvements in response rates and clinical benefit in enrolled patients (pts). The aim of our study is to evaluate pts enrolled in Ph1 testing targeted therapies (TT), immunotherapy (IT), and their combinations.
Methods
Data of pts screened for enrollment in Ph1 in our institution were retrieved from clinical records. Primary objectives of the study were to determine overall response rate (ORR) and clinical benefit rate (CBR), according to RECIST 1.1 or iRECIST criteria (if applicable). Logistic regression analysis was performed to evaluate the impact of different variables on ORR and CBR.
Results
From December 2014 to November 2018, 723 pts were screened [median age 57 years (22-82)]. Primary tumor locations included breast (27.7%), biliary tract (15.5%), pancreas (8.9%), lung (6.8%), colorectal (6.5%), and ovary (4.8%). 275/723 (38.0%) pts had >2 metastatic sites; 304/723 (42.0%) received >2 lines of treatment in the metastatic setting. 481 patients (66.5%) resulted screen failure, mainly due to the absence of druggable molecular alteration(s) for biomarker- driven Ph1 (56.1%), abnormal lab results (12.7%), or poor performance status (11.4%). Conversely, the 242 (33.5%) eligible pts received IT (47.5%), TT (48.3%), or IT+TT combinations (4.2%). At time of data analysis, 209 (88.6%) patients experienced disease progression. ORR and CBR were 14.8% and 28.0%, respectively. No differences were found per age (>70y), sex or drug class. Pts with ≤2 metastatic sites had a higher CBR (OR 2.67, 95%, CI 1.39-5.10; Wald test p=.003), while pts who received ≤2 lines of treatment in the metastatic setting presented with higher ORR (OR 2.37; 95%, CI 1.03-5.44; Wald test p=.004).
Conclusions
Our results confirmed the consistent improvement in terms of CBR and ORR of the new generation Ph1 as compared to historical reported data. Better outcomes were observed in less pre-treated pts with lower burden of disease, suggesting that Ph1 should be proposed in earlier lines of therapy to derive a greater benefit. Further analyses on a larger cohort of Ph1 patients are currently ongoing.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Istituto Europeo di Oncologia.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4852 - Impact of routine screening and preemptive treatment on hepatitis B virus reactivation (HBVr) in patients receiving chemotherapy
Presenter: Celine Marty
Session: Poster Display session 1
Resources:
Abstract
5225 - The uptake, patient satisfaction and efficacy of scalp cooling among patients receiving chemotherapy in an Irish oncology day ward.
Presenter: William Maher
Session: Poster Display session 1
Resources:
Abstract
1901 - Placebo adverse events (AEs) in targeted and immune cancer therapy in the adjuvant and advanced setting: A systematic review and meta-analysis
Presenter: Diego Enrico
Session: Poster Display session 1
Resources:
Abstract
3258 - Reduced antibody levels and high seronegativity rates against vaccine preventable diseases pose a risk factor for infections in patients with solid and hematologic cancers
Presenter: Angela Guzek
Session: Poster Display session 1
Resources:
Abstract
3211 - Prognostic Factors Influencing Outcome After Therapy With Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin's Lymphoma
Presenter: Veselina Goranova - Marinova
Session: Poster Display session 1
Resources:
Abstract
4949 - Phase I Study of CC-90010 in Patients With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL)
Presenter: Victor Moreno
Session: Poster Display session 1
Resources:
Abstract
2271 - Pretreatment coagulation factors related to prognosis in patients with natural killer/T cell lymphoma
Presenter: Yue Chai
Session: Poster Display session 1
Resources:
Abstract
4335 - Diffuse large B cell lymphoma in the elderly. A retrospective analysis of standard versus alternative treatments
Presenter: Irene Sillero
Session: Poster Display session 1
Resources:
Abstract
5117 - MIPI as a superior prognostic tool in Mantle Cell Lymphoma compared to monocyte-lymphocyte, neutrophil-lymphocyte and platelet-lymphocyte ratios
Presenter: Filipa Macedo
Session: Poster Display session 1
Resources:
Abstract
5135 - Dose adjustment of chemotherapy in aggressive lymphoma using automated and standardized analysis and evaluation of DNA double strand breaks
Presenter: Julia Schröder
Session: Poster Display session 1
Resources:
Abstract