359MO - Phase I dose-escalation study of nab-paclitaxel combined with cisplatin and capecitabin as induction chemotherapy followed by concurrent chemoradiotherapy in patients with nasopharyngeal carcinoma

Background

Nab-paclitaxel is a promising albumin-bound paclitaxel with a therapeutic index superior to that of docetaxel, but the optimal dose of nab-paclitaxel combined with cisplatin and capecitabine as induction chemotherapy followed by concurrent chemoradiotherapy for patients with locally advanced nasopharyngeal carcinoma remains unknown.

Methods

This was an open-label, single-arm study investigating the safety and efficacy of nab-paclitaxel+cisplatin+capecitabin as IC for three cycles, followed by cisplatin CCRT, conducted by using the standard “3 + 3” design in LA-NPC. If more than one-third of the patients in a cohort experienced dose-limiting toxicity (DLT), the dose used in the previous cohort was designated the maximum tolerated dose (MTD). The recommended phase 2 dose (RP2D) was defined as one level below the MTD.

Results

From 29 May 2021 to 17 March 2022, 19 patients with LA-NPC were enrolled, one patient withdrew informed consent. Two DLTs occurred in cohort 4 (grade 4 febrile neutropenia and grade 3 peripheral neuropathy), and an MTD was established as 225 mg/m². The most frequent grade 3 or 4 adverse events were neutropenia (16.7%), hypertriglyceridemia (16.7%), leukopenia (5.6%) and peripheral neuropathy (5.6%) during IC.

Conclusions

The RP2D is nab-paclitaxel 200 mg/m² on day 1, combined with cisplatin 75 mg/mg² on day 1 and capecitabin1000 mg/m² on days 1–14, twice a day, every 3 weeks, for three cycles as an IC regimen prior to CCRT.

Clinical trial identification

NCT04850235.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.