Abstract 867P
Background
Recurrent head and neck squamous cell carcinoma (HNSCC) is generally treated palliatively with immunotherapy-based treatment, yet survival remains poor. Re-irradiation is an aggressive but potentially curative salvage approach in this setting. This study evaluated nab-paclitaxel based re-induction and re-irradiation with concurrent nab-paclitaxel-based chemotherapy in recurrent HNSCC. We report the primary analysis and outcomes.
Methods
Eligible patients had recurrent or second primary HNSCC requiring locoregional therapy not amenable to surgical salvage in patients with previously irradiated HNSCC. Nab-paclitaxel and carboplatin re-induction were administered for 2 cycles. Complete response (CR), partial response (PR), or stable disease (SD) received nab-paclitaxel on day 1 (with cohort dose escalation) in combination with 5-fluorouracil (5-FU), and hydroxyurea with twice daily radiation on days 1-5 of a 14-day cycle for 5 cycles for a cumulative radiation dose of 75 Gy (FHX). PD with induction received palliative radiation. The primary endpoint was maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel when given in combination with FHX (AFHX). Secondary endpoints included progression free survival (PFS) and overall survival (OS).
Results
From March 2013 until January 2020, 48 patients (pts) were eligible and started re-induction, and 28 pts started AFHX. Median age was 60 (37-84), 71% male, 52% smoking history, 15% had second primary, 29% were p16+. Response following induction was CR 5%, PR 18%, SD 60%, and PD 18%. Four-year OS and PFS was 26% (95% CI 14,40) and 23% (95% CI 12,36), respectively. The MTD and RP2D of nab-paclitaxel in AFHX was 100mg/m2. Among pts who started re-irradiation with AFHX, 4-year OS and PFS were 45% (95% CI 26,63) and 38% (95% CI 20,56) respectively. There was no difference in survival observed between recurrent and second primary tumors.
Conclusions
Chemo-reirradiation is a curative salvage treatment for a subset of recurrent HNSCC. Response to re-induction enriches for favorable outcome. The role of chemo-reirradiation in the era of immunotherapy warrants investigation.
Clinical trial identification
NCT01847326.
Editorial acknowledgement
Legal entity responsible for the study
University of Chicago.
Funding
Celgene.
Disclosure
A. Rosenberg: Financial Interests, Personal, Advisory Board: EMD Serono; Financial Interests, Personal, Advisory Board: Nanobiotix. A.T. Pearson: Financial Interests, Advisory Board: Prelude Therapeutics. A. Juloori: Financial Interests, Institutional, Funding: AstraZeneca. E.E. Vokes: Financial Interests, Advisory Board: AbbVie; Financial Interests, Advisory Board: AstraZeneca; Financial Interests, Advisory Board: Beigene; Financial Interests, Advisory Board: BioNTech; Financial Interests, Advisory Board: Eli Lilly; Financial Interests, Advisory Board: EMD Serono; Financial Interests, Advisory Board: Genentech; Financial Interests, Advisory Board: GlaxoSmithKline; Financial Interests, Advisory Board: Merck; Financial Interests, Advisory Board: Novartis. All other authors have declared no conflicts of interest.