161P - Early phase cancer clinical trials: A viable treatment option for patients?

Background

The rising prevalence of cancer and swift development of anti-cancer therapies have driven changes in Early Phase Cancer Clinical Trials (EPCCTs). Modern EPCCTs often investigate response rates and survival outcomes alongside safety and tolerability. This study aimed to analyse a six-year EPCTT patient cohort to evaluate response rates.

Methods

A retrospective data analysis was performed on patients enrolled into EPCCTs at The Christie NHS Foundation Trust from Jan 2018 to Dec 2023. Data collected included demographics, prior systemic therapies, sites of disease, performance status, baseline bloods, type of trial therapy, best response, and duration of response. Statistical analyses were conducted on overall response rate (ORR), defined as partial response (PR) + complete response (CR), and disease control rate (DCR), defined as CR + PR + stable disease (SD).

Results

525 patients were treated on 98 EPCCTs. All patients received at least one dose of treatment with median of 4 cycles. 93% of patients were off trial at data collection, 73.1% due to progression, 11% from toxicity. 470 patients were evaluable for response. The ORR was 14.3% and DCR was 63.9%. Of the 238 patients with SD, 48.7% had duration of >6 months. The DCR in monotherapy (66.2%) and combination (62.8%) trials was similar. The difference in response rates due to sex (p 0.016), presence of liver metastasis (p=0.0001), Royal Marsden Hospital prognostic score (p=0.0001), Gustave Roussy Immune Score (p=0.0001), and LDH (p=0.0001) were all statistically significant. The median progression free survival was 4 months (SE 0.2, 95% CI 3.4-4.5) and median overall survival 10 months (SE 0.63, 95% CI 8.7-11.2). Patients with SD at 10 weeks have a 12-month survival probability of 0.53 (0.47-0.61) versus 0.12 (0.07-0.19) for PD. Table: 161P

Conclusions

EPCCTs are a valid treatment approach for patients with advanced cancer with two thirds of patients having DCR. Factors including LDH, presence of liver metastasis and sex contribute to the differences in response rates seen.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.