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.
Albumins
/ adverse effects
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Carboplatin
/ adverse effects
Carcinoma
/ drug therapy
Fluorouracil
/ adverse effects
Head and Neck Neoplasms
/ drug therapy
Humans
Hydroxyurea
Maximum Tolerated Dose
Neoplasm Recurrence, Local
/ drug therapy
Paclitaxel
Re-Irradiation
Squamous Cell Carcinoma of Head and Neck
/ drug therapy
Journal
British journal of cancer
ISSN: 1532-1827
Titre abrégé: Br J Cancer
Pays: England
ID NLM: 0370635
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
received:
22
03
2022
accepted:
29
07
2022
revised:
19
07
2022
pubmed:
10
8
2022
medline:
14
10
2022
entrez:
9
8
2022
Statut:
ppublish
Résumé
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/m 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/m In this Phase I study, the RP2D of A with FHX is 100 mg/m This clinical trial was registered with ClinicalTrials.gov identifier: NCT01847326.
Sections du résumé
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/m
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/m
CONCLUSIONS
In this Phase I study, the RP2D of A with FHX is 100 mg/m
CLINICAL TRIAL INFORMATION
This clinical trial was registered with ClinicalTrials.gov identifier: NCT01847326.
Identifiants
pubmed: 35945244
doi: 10.1038/s41416-022-01941-0
pii: 10.1038/s41416-022-01941-0
pmc: PMC9553920
doi:
Substances chimiques
130-nm albumin-bound paclitaxel
0
Albumins
0
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
Fluorouracil
U3P01618RT
Hydroxyurea
X6Q56QN5QC
Banques de données
ClinicalTrials.gov
['NCT01847326']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1497-1506Subventions
Organisme : NCI NIH HHS
ID : P30 CA014599
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.
Références
Mody MD, Rocco JW, Yom SS, Haddad RI, Saba NF. Head and neck cancer. Lancet. 2021;398:P2289–99.
doi: 10.1016/S0140-6736(21)01550-6
Brockstein B, Haraf DJ, Rademaker AW, Kies MS, Stenson KM, Rosen F, et al. Patterns of failure, prognostic factors and survival in locoregionally advanced head and neck cancer treated with concomitant chemoradiotherapy: a 9-year, 337-patient, multi-institutional experience. Ann Oncol. 2004;15:1179–86.
doi: 10.1093/annonc/mdh308
Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N. Engl J Med. 1993;328:184–94.
doi: 10.1056/NEJM199301213280306
Guo T, Qualliotine JR, Ha PK, Califano JA, Kim Y, Saunders JR, et al. Surgical salvage improves overall survival for patients with HPV-positive and HPV-negative recurrent locoregional and distant metastatic oropharyngeal cancer. Cancer. 2015;121:1977–84.
doi: 10.1002/cncr.29323
National Comprehensive Cancer Network. Head and Neck Cancers (Version 2.2020). https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf .
Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019;394:1915–28.
doi: 10.1016/S0140-6736(19)32591-7
Vokes EE, Panje WR, Schilsky RL, Mick R, Awan AM, Moran WJ, et al. Hydroxyurea, fluorouracil, and concomitant radiotherapy in poor-prognosis head and neck cancer: a phase I-II study. J Clin Oncol. 1989;7:761–8.
doi: 10.1200/JCO.1989.7.6.761
Haraf DJ, Weichselbaum RR, Vokes EE. Re-irradiation with concomitant chemotherapy of unresectable recurrent head and neck cancer: a potentially curable disease. Ann Oncol. 1996;7:913–8.
doi: 10.1093/oxfordjournals.annonc.a010793
Vokes EE, Haraf DJ, Mick R, McEvilly JM, Weichselbaum RR. Intensified concomitant chemoradiotherapy with and without filgrastim for poor-prognosis head and neck cancer. J Clin Oncol. 1994;12:2351–9.
doi: 10.1200/JCO.1994.12.11.2351
Salama JK, Vokes EE, Chmura SJ, Milano MT, Kao J, Stenson KM, et al. Long-term outcome of concurrent chemotherapy and reirradiation for recurrent and second primary head-and-neck squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2006;64:382–91.
doi: 10.1016/j.ijrobp.2005.07.005
Spencer SA, Harris J, Wheeler RH, Machtay M, Schultz C, Spanos W, et al. RTOG 96-10: reirradiation with concurrent hydroxyurea and 5-fluorouracil in patients with squamous cell cancer of the head and neck. Int J Radiat Oncol Biol Phys. 2001;51:1299–304.
doi: 10.1016/S0360-3016(01)01745-X
Spencer SA, Harris J, Wheeler RH, Machtay M, Schultz C, Spanos W, et al. Final report of RTOG 9610, a multi-institutional trial of reirradiation and chemotherapy for unresectable recurrent squamous cell carcinoma of the head and neck. Head Neck. 2008;30:281–8.
doi: 10.1002/hed.20697
Villaflor VM, Melotek JM, Karrison TG, Brisson RJ, Blair EA, Portugal L, et al. Response-adapted volume de-escalation (RAVD) in locally advanced head and neck cancer. Ann Oncol. 2016;27:908–13.
doi: 10.1093/annonc/mdw051
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.
doi: 10.1093/jnci/92.3.205
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–81.
doi: 10.1080/01621459.1958.10501452
Seiwert TY, Foster CC, Blair EA, Karrison TG, Agrawal N, Melotek JM, et al. OPTIMA: a phase II dose and volume de-escalation trial for human papillomavirus-positive oropharyngeal cancer. Ann Oncol. 2019;30:1673.
doi: 10.1093/annonc/mdz171
Oppelt P, Ley J, Daly M, Rich J, Paniello R, Jackson RS, et al. nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2) for locally advanced head and neck squamous-cell carcinoma: a multicenter, non-randomized phase 2 trial. Med Oncol. 2021;38:35.
doi: 10.1007/s12032-021-01479-w
Weiss J, Gilbert J, Deal AM, Weissler M, Hilliard C, Chera B, et al. Induction chemotherapy with carboplatin, nab-paclitaxel and cetuximab for at least N2b nodal status or surgically unresectable squamous cell carcinoma of the head and neck. Oral Oncol. 2018;84:46–51.
doi: 10.1016/j.oraloncology.2018.06.028
Adkins D, Ley J, Oppelt P, Wildes TM, Gay HA, Daly M, et al. nab-Paclitaxel-based induction chemotherapy with or without cetuximab for locally advanced head and neck squamous cell carcinoma. Oral Oncol. 2017;72:26–31.
doi: 10.1016/j.oraloncology.2017.07.001
Rosenberg AJ, Agrawal N, Pearson A, Gooi Z, Blair E, Cursio J, et al. Risk and response adapted de-intensified treatment for HPV-associated oropharyngeal cancer: Optima paradigm expanded experience. Oral Oncol. 2021;122:105566.
doi: 10.1016/j.oraloncology.2021.105566
Langer CJ, Harris J, Horwitz EM, Nicolaou N, Kies M, Curran W, et al. Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation in recurrent squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Protocol 9911. J Clin Oncol. 2007;25:4800–5.
doi: 10.1200/JCO.2006.07.9194
Janot F, de Raucourt D, Benhamou E, Ferron C, Dolivet G, Bensadoun RJ, et al. Randomized trial of postoperative reirradiation combined with chemotherapy after salvage surgery compared with salvage surgery alone in head and neck carcinoma. J Clin Oncol. 2008;26:5518–23.
doi: 10.1200/JCO.2007.15.0102
Ward MC, Riaz N, Caudell JJ, Dunlap NE, Isrow D, Zakem SJ, et al. Refining patient selection for reirradiation of head and neck squamous carcinoma in the IMRT era: a multi-institution cohort study by the MIRI collaborative. Int J Radiat Oncol Biol Phys. 2018;100:586–94.
doi: 10.1016/j.ijrobp.2017.06.012
Ferris RL, Blumenschein G Jr., Fayette J, Guigay J, Colevas AD, Licitra L, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N. Engl J Med. 2016;375:1856–67.
doi: 10.1056/NEJMoa1602252
Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet 2019;393:156–67.
doi: 10.1016/S0140-6736(18)31999-8
Burtness B, Rischin D, Greil R, Soulieres D, Tahara M, de Castro G Jr, et al. Pembrolizumab alone or with chemotherapy for recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048: subgroup analysis by programmed death ligand-1 combined positive score. J Clin Oncol. 2022:JCO2102198.
Seiwert TY, Melotek JM, Blair EA, Stenson KM, Salama JK, Witt ME, et al. Final results of a randomized phase 2 trial investigating the addition of cetuximab to induction chemotherapy and accelerated or hyperfractionated chemoradiation for locoregionally advanced head and neck cancer. Int J Radiat Oncol Biol Phys. 2016;96:21–9.
doi: 10.1016/j.ijrobp.2016.04.030