TY - JOUR
T1 - 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
T2 - a multicenter, non-randomized phase 2 trial
AU - Oppelt, Peter
AU - Ley, Jessica
AU - Daly, Mackenzie
AU - Rich, Jason
AU - Paniello, Randal
AU - Jackson, Ryan S.
AU - Pipkorn, Patrik
AU - Liu, Jingxia
AU - Gay, Hiram
AU - Palka, Kevin
AU - Neupane, Prakash
AU - Powell, Steven
AU - Spanos, William C.
AU - Gitau, Mark
AU - Zevallos, Jose
AU - Thorstad, Wade
AU - Adkins, Douglas
N1 - Funding Information:
The Siteman Cancer Center is supported in part by NCI Cancer Center Support (Grant number P30 CA91842). We acknowledge funding from Celgene for this project and the support of Tin Jin Ong MD, Kathy Amiri PhD, Jeff Eskew PhD, Monserrat Valles PhD, Jacqueline Jesse PharmD, and Daniel Read PhD. We thank the patients who participated, the head and neck research team at Washington University, Kim Trinkaus PhD, the Alvin Siteman Cancer Center (Washington University, St Louis, Missouri, USA) and Barnes-Jewish Hospital (St Louis) for use of the Tissue Procurement Center, and the Center for Biomedical Informatics.
Funding Information:
This work was supported in part by Grant funding from Celgene. Clinical trial sponsorship by Celgene and Siteman Cancer Center in part by NCI Cancer Center Support Award Number P30 CA91842.
Funding Information:
JL, MD, JR, RP, PP, JL, HG, PN, and MG have no disclosures to report. PO reports personal fees from Bristol Myers, Merck, and Eisai, outside the submitted work. RJ reports personal fees from Intuitive surgical, outside the submitted work. KP reports personal fees from Merck, Genetech, and Boehringer Ingelheim, outside the submitted work. RS reports consulting support from Bristol Myers and institutional research support from Merck, Bristol Myers, Pfizer, Vyriad, Incyte, Genentech, Actuate, and Novartis, outside the submitted work. WS reports consulting support from Bristol Myers and Regeneron, outside the submitted work. JZ reports personal fees from Summit Biolabs, Inc, outside the submitted work. WT reports other from Elekta, Inc (wife is employee. Radiotherapy hardware and software company. However, the department does not use those products). DA reports research funding from Celgene for the submitted work and consulting or scientific advisory board support from Pfizer, Eli Lilly, Merck, Celgene, Cue Biopharma, and institutional research support from Pfizer, Eli Lilly, Merck, Celgene/BMS, Novartis, AstraZeneca, Atara Bio, Blueprint Medicine, Celldex, Enzychem, Kura, Exelixis, Innate, Sensei, and Matrix Biomed, outside the submitted work.
Publisher Copyright:
© 2021, Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/4
Y1 - 2021/4
N2 - In locally advanced head and neck squamous-cell carcinoma (LA-HNSCC), clinical complete response (cCR) at the primary site, assessed by clinical examination, after induction chemotherapy predicts for a low relapse risk after subsequent chemoradiotherapy. Prior studies showed a cCR rate of 77% with induction nanoparticle albumin-bound (nab)-paclitaxel given with cisplatin and 5-fluorouracil (APF). The primary aims of this non-randomized phase 2 trial were to determine the cCR rate after induction nab-paclitaxel and cisplatin (Arm 1) and after nab-paclitaxel monotherapy (Arm 2). Eligibility required LA-HNSCC, T2-T4 stage classification, and suitable (Arm 1) or unsuitable (Arm 2) candidates for cisplatin. Arm 1 patients received nab-paclitaxel and cisplatin, then cisplatin with radiation. Arm 2 patients received nab-paclitaxel, then cetuximab with radiation. The primary endpoint was cCR after two cycles of induction chemotherapy. Each arm enrolled forty patients. cCR at the primary site occurred in 28 patients (70%) after nab-paclitaxel and cisplatin and in 8 patients (20%) after nab-paclitaxel monotherapy. The overall clinical response rate was 98% after nab-paclitaxel and cisplatin and 90% after nab-paclitaxel monotherapy. In subset analyses, cCR rates by T stage classifications (T2, T3, T4) were 54, 86, and 69% after nab-paclitaxel and cisplatin, and 14, 11, and 26% after nab-paclitaxel. cCR rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel. The cCR rate after nab-paclitaxel and cisplatin was similar to APF; however, the cCR rate after nab-paclitaxel monotherapy was lower. The trial was registered at ClinicalTrials.gov NCT02573493 on October 9, 2015.
AB - In locally advanced head and neck squamous-cell carcinoma (LA-HNSCC), clinical complete response (cCR) at the primary site, assessed by clinical examination, after induction chemotherapy predicts for a low relapse risk after subsequent chemoradiotherapy. Prior studies showed a cCR rate of 77% with induction nanoparticle albumin-bound (nab)-paclitaxel given with cisplatin and 5-fluorouracil (APF). The primary aims of this non-randomized phase 2 trial were to determine the cCR rate after induction nab-paclitaxel and cisplatin (Arm 1) and after nab-paclitaxel monotherapy (Arm 2). Eligibility required LA-HNSCC, T2-T4 stage classification, and suitable (Arm 1) or unsuitable (Arm 2) candidates for cisplatin. Arm 1 patients received nab-paclitaxel and cisplatin, then cisplatin with radiation. Arm 2 patients received nab-paclitaxel, then cetuximab with radiation. The primary endpoint was cCR after two cycles of induction chemotherapy. Each arm enrolled forty patients. cCR at the primary site occurred in 28 patients (70%) after nab-paclitaxel and cisplatin and in 8 patients (20%) after nab-paclitaxel monotherapy. The overall clinical response rate was 98% after nab-paclitaxel and cisplatin and 90% after nab-paclitaxel monotherapy. In subset analyses, cCR rates by T stage classifications (T2, T3, T4) were 54, 86, and 69% after nab-paclitaxel and cisplatin, and 14, 11, and 26% after nab-paclitaxel. cCR rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel. The cCR rate after nab-paclitaxel and cisplatin was similar to APF; however, the cCR rate after nab-paclitaxel monotherapy was lower. The trial was registered at ClinicalTrials.gov NCT02573493 on October 9, 2015.
KW - Cetuximab
KW - Cisplatin
KW - Head and neck squamous-cell carcinoma
KW - nab-paclitaxel
KW - Radiation
UR - http://www.scopus.com/inward/record.url?scp=85102605889&partnerID=8YFLogxK
U2 - 10.1007/s12032-021-01479-w
DO - 10.1007/s12032-021-01479-w
M3 - Article
C2 - 33683482
AN - SCOPUS:85102605889
VL - 38
JO - Medical Oncology
JF - Medical Oncology
SN - 1357-0560
IS - 4
M1 - 35
ER -