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American Society of Clinical Oncology, Journal of Clinical Oncology, 16_suppl(40), p. 1574-1574, 2022

DOI: 10.1200/jco.2022.40.16_suppl.1574

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PRECISE CURATE.AI: A prospective feasibility trial to dynamically modulate personalized chemotherapy dose with artificial intelligence.

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

1574 Background: Most treatment guidelines recommend chemotherapy at maximum tolerated doses, which does not always lead to optimal efficacy, but implicitly results in toxicity. To overcome this challenge, we developed CURATE.AI, a small data, AI-derived platform that harnesses only a patient’s own prospectively/longitudinally acquired data to dynamically identify their own optimal and personalized doses. We subsequently harnessed CURATE.AI to dynamically modulate individualized chemotherapy doses for patients in a prospective clinical trial. Methods: We conducted an open-label, multi-center, single-arm, prospective feasibility trial in patients diagnosed with advanced solid tumors and treated with single-agent capecitabine, XELOX or XELIRI (+/- biologics) (NCT04522284). The standard-of-care (SOC) capecitabine dose was 1000 mg/m2, unless adjusted by clinician to account for patient’s comorbidities and organ dysfunction. Using an AI-discovered second-order correlation between patient-specific variation of capecitabine doses and corresponding tumor marker (CEA, CA19-9 or CA-125) readouts for each cycle, CURATE.AI generated individualized patient digital avatars and recommended bespoke dose for the subsequent cycle. The clinicians were permitted to accept CURATE.AI dose recommendations, or reject the recommendations and dose based on clinical judgement. Results: Since August 2020 we recruited ten patients: single-agent capecitabine (n = 1), XELOX (n = 6), and XELIRI (n = 3). As of 20 Jan 2022, one patient remains on the trial. The prescribed dose was on average reduced by 20 % (± 13.8 %) as compared to the projected SOC dose. The nine reported patients completed 3.9 cycles (± 2.2 cycles), with the longest participation lasting 8 cycles. CURATE.AI recommendations were considered in 27 out of 40 total dosing decisions and accepted for prescription in 26 of those decisions. The reasons for not considering CURATE.AI included insufficient time from patient recruitment to the first dose administration and complex medical circumstances at the time of the dosing decisions. Conclusions: CURATE.AI has been successfully incorporated into the clinical workflow of dynamic dose selection in the treatment of solid tumors under a clinical trial. Prospective validation of CURATE.AI led to a reduction of an average prescribed capecitabine dose, which alongside additional preliminary findings may eventually play an important role in improving patient response rates and durations compared to SOC. Results from the PRECISE CURATE.AI trial support the initiation of a randomized clinical trial and potential expansion towards other oncologic indications. Clinical trial information: NCT04522284.