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Clinical Studies

Phase I study of nab-paclitaxel-based induction followed by nab-paclitaxel-based concurrent chemotherapy and re-irradiation in previously treated head and neck squamous cell carcinoma



Recurrent head and neck squamous cell carcinoma (HNSCC) is associated with poor overall survival (OS). Prior studies suggested incorporation of nab-paclitaxel (A) may improve outcomes in recurrent HNSCC.


This Phase I study evaluated induction with carboplatin and A followed by concomitant FHX (infusional 5-fluorouracil, hydroxyurea and twice-daily radiation therapy administered every other week) plus A with cohort dose escalation ranging from 10–100 mg/m2 in recurrent HNSCC. The primary endpoint was maximally tolerated dose (MTD) and dose-limiting toxicity (DLT) of A when given in combination with FHX (AFHX).


Forty-eight eligible pts started induction; 28 pts started AFHX and were evaluable for toxicity. Two DLTs occurred (both Grade 4 mucositis) at a dose level 20 mg/m2. No further DLTs were observed with subsequent dose escalation. The MTD and recommended Phase II dose (RP2D) of A was 100 mg/m2.


In this Phase I study, the RP2D of A with FHX is 100 mg/m2 (AFHX). The role of re-irradiation with immunotherapy warrants further investigation.

Clinical trial information

This clinical trial was registered with identifier: NCT01847326.

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Fig. 1: Consort flow diagram.
Fig. 2: Progression-free survival.
Fig. 3: Overall survival.
Fig. 4: Overall survival for AFHX-treated patients.

Data availability

All data are available upon request.


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We would like to acknowledge support from Celgene (Bristol Myers Squibb). This trial was supported, in part, by the University of Chicago Medicine Comprehensive Cancer Center Support Grant (#P30 CA14599) and support from the V. and R.W Svendsen Foundation. This study was presented in part at the ESMO Annual Meeting 2021.


This study was funded by Celgene (Bristol Myers, Squibb).

Author information

Authors and Affiliations



Manuscript preparation: AJR and EEV. Study design: VMV, DJH and EEV. Patient data and study materials: AJR, ATP, JC, KR, VMV, TS, DJH and EEV. Data analysis and interpretation: AJR, JFC and EEV. Manuscript editing and review: all.

Corresponding author

Correspondence to Ari J. Rosenberg.

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Competing interests

AJR: consulting/advisory: EMD-Serono, Nanobiotix, Galectin Therapeutics, Privo Technologies. NA: stock options: Privo Technologies. ATP: consulting/advisory: Prelude, Abbvie, Elevar, Ayala; stock options: Privo Technologies; research funding: Abbvie, Kura Oncology. AJ: consulting: Isoray. Research funding: AstraZeneca. VMV: Stock: J&J. Research funding: Takeda. TS: research funding: BMS, AstraZeneca, Genentech, Nanobiotix, Merck. Honoraria: Merck, Nanobiotix. Consulting/advisory: Innate, Regeneron, Vir, Merck, Nanobiotix, BostonGene EEV: consulting/advisory: AstraZeneca, BeiGene, BioNTech, Eli Lilly, EMD-Serono, Genentech, GlaxoSmithKline, Novartis. The remaining authors declare no competing interests.

Ethics approval and consent to participate

This study was conducted in accordance with the Declaration of Helsinki and was approved by the University of Chicago institutional review board. Furthermore, written consent was obtained from all participants.

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Rosenberg, A.J., Agrawal, N., Pearson, A.T. et al. Phase I study of nab-paclitaxel-based induction followed by nab-paclitaxel-based concurrent chemotherapy and re-irradiation in previously treated head and neck squamous cell carcinoma. Br J Cancer (2022).

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