Compassionate use program with FDT-TPI (trifluridine-tipiracil) in pre-treated metastatic colorectal cancer patients: Spanish real world data.

Abstract

e15019 Background: Trifluridine/tipiracil (FTD-TPI) is comprised of an antineoplastic nucleoside analog, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil. Compassionate use programs (CUPs) provide a treatment option for patients with unmet medical needs and an early opportunity to obtain data on efficacy, safety and use in a real-world setting. Methods: Patients were registered and approved to receive 2 cycles of trifluridine/tipiracil treatment, which could be renewed as necessary, we analysed baseline characteristics, safety results and exposure to the treatment with trifluridine/tipiracil (FTD-TPI) in the Spanish CUP. Results: A total 636 were registered in Spain and 538 received treatment with trifluridine/tipiracil. Median age was 64 years, of which 25% were older than 70 years old and 60% were male, 67% of pts were ECOG PS 1. Oral trifluridine/tipiracil was initiated at 35 mg/m2 bid. Most pts had received 2, 3, or ≥4 lines of prior treatment for metastatic disease (27%, 28%, and 38%, respectively); and 4% unknown. 275 (47%) patients had KRAS mutated and 209 (36%) had KRAS wild type. 35% received adjuvant chemotherapy and 20% of the patients were treated with regorafenib in previous lines. The main reasons for not initiating treatment included cancellation of request due to worsening condition and progressive disease. Treatment was generally well tolerated. A total of 173 AEs were reported in the Spanish CUP, the majority were myelosuppressive AEs; febrile neutropenia (grade ≥3) was reported in 6 pts (1.3%), grade _ > 3 neutropenia was reported in 56 (33%), grade 4 neutropenia in 16 (9%). Grade 3 anemia was reported in 8 (15% of the total AEs reported).The majority of pts 306 (56%) were allocated 3-4 cycle of treatment, 95(17.3%) 5-6 cycles, and 30(5. 5%) between 7-8 cycles. Conclusions: Thisreal-world data analysis is consistent with those reported in phase 3 trials of trifluridine/tipiracil (FDT-TP)in pretreated mCRC. The efficacy analyses of this population is planned.