897P - Nanosomal docetaxel lipid suspension (NDLS) or docetaxel based neoadjuvant therapy in Head and neck squamous cell carcinoma: Post hoc analysis of a prospective, randomized study

Background

TPF (Docetaxel, Platinum & 5-Fluorouracil) or TP regimen as neoadjuvant chemotherapy (NACT) in head and neck cancer are associated with a high rate of adverse events. Many of these adverse events are contributed by docetaxel. We wanted to analyze whether a change in formulation from conventional docetaxel to nanosomal docetaxel lipid suspension (NDLS, Doceaqualip) leads to decreased adverse events.

Methods

This was an exploratory analysis from the data of a prospective, single-center, phase 3 randomized study. The patients received either the TPF or TP regimen as a part of randomized study. The choice of docetaxel was at physician discretion. The adverse events rate during NACT were captured as per NCI- Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Out of 495 patients, data for adverse events and formulations was captured in 479 patients. Among these, we had 4 groups- Group-1 : NDLS in all cycles (192 (40.1%)), Group 2: docetaxel in all cycles ( 172(35.9%)), Group 3 : 1st cycle NDLS and rest docetaxel (64 (13.4%)) and Group 4: 1st cycle docetaxel and rest NDLS (51 (10.6%)). For this analysis we have restricted the comparison between group 1 & 2. A univariate analysis with Fisher's test was performed to study whether the different formulations had any impact on adverse event rate. The response rate and overall survival (OS) were compared between the 2 formulations.

Results

The use of NDLS led to a significant decrease in the incidence of mucositis and neutropenia (Table). The efficacy was statistically similar between group 1 and 2 with respect to response rates (24.7% versus 29.6%, P=0.301), and median OS (10.1 [8.526-11.674] versus 11.37 [10.320-12.414], P=0.07). Any Grade

Table: 897P

Conclusions

Use of NDLS formulation instead of conventional docetaxel leads to a decrease in adverse events like mucositis and neutropenia when used as neoadjuvant therapy in oral squamous cell carcinoma with similar efficacy.

Clinical trial identification

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.