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
4294 - The Patient Voice: An Irish Survey of Nutrition Attitudes & Access to Dietetic Care Throughout the Cancer Journey
Presenter: Erin Stella Sullivan
Session: Poster Display session 1
Resources:
Abstract
1925 - Homcology: home chemotherapy delivery in a simultaneous care project for frail advanced cancer patients
Presenter: Claudio Chini
Session: Poster Display session 1
Resources:
Abstract
4701 - Treatment-related adverse events and tolerability in patients with advanced non-squamous non-small cell lung cancer treated with first-line checkpoint inhibitors in combination with chemotherapy
Presenter: Ruth D'cunha
Session: Poster Display session 1
Resources:
Abstract
2985 - Clinical utility of a systematic toxicity assessment form (STAF) in patients with breast cancer receiving adjuvant or neoadjuvant therapy.
Presenter: Jwa Hoon Kim
Session: Poster Display session 1
Resources:
Abstract
2358 - Physicians’ satisfaction with Health-related quality of life (HRQoL) assessment in daily clinical practice using electronic patient-reported outcome (ePRO) for cancer patients.
Presenter: Guillaume Mouillet
Session: Poster Display session 1
Resources:
Abstract
5172 - Predictors of Survival in Patients with Incurable Cancer
Presenter: Erin Stella Sullivan
Session: Poster Display session 1
Resources:
Abstract
2281 - Patients and Physicians' Satisfaction with Telemedicine (TM) in Cancer Care and Factors that Correlate with a Positive Patient’s Experience
Presenter: Hurria Gondal
Session: Poster Display session 1
Resources:
Abstract
2193 - Adherence to ESMO 2014 guidelines on bone-targeting agent (BTA) initiation for breast and prostate cancer patients: real-world insights from practicing European physicians
Presenter: Alex Rider
Session: Poster Display session 1
Resources:
Abstract
2200 - Use of skeletal-related events preventive agents in patients with solid tumours and bone metastases in central Denmark
Presenter: Anders Boysen
Session: Poster Display session 1
Resources:
Abstract
2504 - Inadequacy of current definition and staging system of Medication-Related Osteonecrosis of Jaw (MRONJ) released by AAOMS : a Computed Tomography study in 151 cancer and myeloma patients
Presenter: Vittorio Fusco
Session: Poster Display session 1
Resources:
Abstract