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

Ari J. Rosenberg; Nishant Agrawal; Alexander T. Pearson; Zhen Gooi; Elizabeth Blair; Louis Portugal; John F. Cursio; Aditya Juloori; Jeffrey Chin; Kathryn Rouse; Victoria M. Villaflor; Tanguy Y. Seiwert; Evgeny Izumchenko; Mark W. Lingen; Daniel J. Haraf; Everett E. Vokes

doi:10.1038/s41416-022-01941-0

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

Ari J. Rosenberg, Nishant Agrawal, Alexander T. Pearson, Zhen Gooi, Elizabeth Blair, Louis Portugal, John F. Cursio, Aditya Juloori, Jeffrey Chin, Kathryn Rouse, Victoria M. Villaflor, Tanguy Y. Seiwert, Evgeny Izumchenko, Mark W. Lingen, Daniel J. Haraf, Everett E. Vokes

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Background: 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. Methods: 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). Results: 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. Conclusions: 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 ClinicalTrials.gov identifier: NCT01847326.

Original language	English (US)
Pages (from-to)	1497-1506
Number of pages	10
Journal	British journal of cancer
Volume	127
Issue number	8
DOIs	https://doi.org/10.1038/s41416-022-01941-0
State	Published - Nov 1 2022

ASJC Scopus subject areas

Oncology
Cancer Research

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10.1038/s41416-022-01941-0

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Rosenberg, A. J., Agrawal, N., Pearson, A. T., Gooi, Z., Blair, E., Portugal, L., Cursio, J. F., Juloori, A., Chin, J., Rouse, K., Villaflor, V. M., Seiwert, T. Y., Izumchenko, E., Lingen, M. W., Haraf, D. J., & Vokes, E. E. (2022). 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. British journal of cancer, 127(8), 1497-1506. https://doi.org/10.1038/s41416-022-01941-0

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. / Rosenberg, Ari J.; Agrawal, Nishant; Pearson, Alexander T. et al.
In: British journal of cancer, Vol. 127, No. 8, 01.11.2022, p. 1497-1506.

Research output: Contribution to journal › Article › peer-review

Rosenberg, AJ, Agrawal, N, Pearson, AT, Gooi, Z, Blair, E, Portugal, L, Cursio, JF, Juloori, A, Chin, J, Rouse, K, Villaflor, VM, Seiwert, TY, Izumchenko, E, Lingen, MW, Haraf, DJ & Vokes, EE 2022, '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', British journal of cancer, vol. 127, no. 8, pp. 1497-1506. https://doi.org/10.1038/s41416-022-01941-0

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title = "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",

abstract = "Background: 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. Methods: 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). Results: 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. Conclusions: 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 ClinicalTrials.gov identifier: NCT01847326.",

author = "Rosenberg, {Ari J.} and Nishant Agrawal and Pearson, {Alexander T.} and Zhen Gooi and Elizabeth Blair and Louis Portugal and Cursio, {John F.} and Aditya Juloori and Jeffrey Chin and Kathryn Rouse and Villaflor, {Victoria M.} and Seiwert, {Tanguy Y.} and Evgeny Izumchenko and Lingen, {Mark W.} and Haraf, {Daniel J.} and Vokes, {Everett E.}",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Nature Limited.",

year = "2022",

month = nov,

day = "1",

doi = "10.1038/s41416-022-01941-0",

language = "English (US)",

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T1 - 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

AU - Rosenberg, Ari J.

AU - Agrawal, Nishant

AU - Pearson, Alexander T.

AU - Gooi, Zhen

AU - Blair, Elizabeth

AU - Portugal, Louis

AU - Cursio, John F.

AU - Juloori, Aditya

AU - Chin, Jeffrey

AU - Rouse, Kathryn

AU - Villaflor, Victoria M.

AU - Seiwert, Tanguy Y.

AU - Izumchenko, Evgeny

AU - Lingen, Mark W.

AU - Haraf, Daniel J.

AU - Vokes, Everett E.

PY - 2022/11/1

Y1 - 2022/11/1

N2 - Background: 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. Methods: 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). Results: 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. Conclusions: 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 ClinicalTrials.gov identifier: NCT01847326.

AB - Background: 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. Methods: 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). Results: 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. Conclusions: 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 ClinicalTrials.gov identifier: NCT01847326.

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JO - British journal of cancer

JF - British journal of cancer

IS - 8

ER -

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

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