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
2459 - Does bevacizumab increase joint pain ? Preliminary results of BEVARTHRALGIA Study
Presenter: Vauleon Enora
Session: Poster Display session 1
Resources:
Abstract
4913 - Prostatic cancer androgen deprivation therapy and bone health in carcinoma prostate.
Presenter: Gouri Shankar Bhattacharyya
Session: Poster Display session 1
Resources:
Abstract
1352 - Patterns of care for patients with metastatic bone disease in solid tumors – a cross-sectional study (SAKK 95/16)
Presenter: Michael Mark
Session: Poster Display session 1
Resources:
Abstract
6002 - Infection-Related Mortality in Different Types of Cancers
Presenter: Mohamed Gouda
Session: Poster Display session 1
Resources:
Abstract
5643 - Survival Trends in Critically ill Oncology Patients: impact of patient’s eligibility to post-ICU chemotherapy
Presenter: Edith Borcoman
Session: Poster Display session 1
Resources:
Abstract
3097 - Development and validation of a multivariable prediction model for 6-month mortality in older cancer patients: the GeriAtrIc-Tumor Score of PrEdiction for Early Death (GAIT SPEED)
Presenter: Angeli Angeli
Session: Poster Display session 1
Resources:
Abstract
856 - A Longitudinal Tracking and Quantitative Assessment of Paclitaxel-Induced Peripheral Neurotoxicity
Presenter: Ayumu Matsuoka
Session: Poster Display session 1
Resources:
Abstract
1662 - Efficiency of controlled cryotherapy in prevention of chemotherapy induced peripheral neuropathy (CIPN)
Presenter: Trudi Schaper
Session: Poster Display session 1
Resources:
Abstract
2766 - The Validity of Evaluations for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Presenter: Teppei Yamada
Session: Poster Display session 1
Resources:
Abstract
5683 - Prevention of chemoradiation-related mucositis in patients with head and neck cancer using dexamethasone-based mouthwash: A phase II randomized double-blind, placebo-controlled study
Presenter: Naiyarat Prasongsook
Session: Poster Display session 1
Resources:
Abstract