PMID- 29540603 OWN - NLM STAT- MEDLINE DCOM- 20190920 LR - 20190920 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 23 IP - 7 DP - 2018 Jul TI - Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck. PG - 764-e86 LID - 10.1634/theoncologist.2017-0618 [doi] AB - LESSONS LEARNED: Chemotherapy for recurrent, metastatic squamous cell carcinoma of the head and neck need not be known for extreme toxicity.The weekly regimen studied here has been demonstrated to be tolerable and effective. BACKGROUND: The objective of this study was to establish the response rate, progression-free survival (PFS) and overall survival (OS), and safety profile of weekly docetaxel, platinum, and cetuximab (TPC) in patients with relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN). MATERIALS AND METHODS: Twenty-nine patients with metastatic or recurrent SCCHN with an Eastern Cooperative Oncology Group (ECOG) performance status <3 were enrolled in an institutional review board-approved phase II trial. This study permitted prior chemoradiation, radiation, and/or surgery, provided that 3 months had elapsed since the end of the potentially curative treatment. Patients received cisplatin 30 mg/m(2) or carboplatin area under the curve (AUC) 2, docetaxel 30 mg/m(2), and cetuximab 250 mg/m(2) weekly for 3 weeks, followed by a break during the fourth week, for a 28-day cycle. Planned intrapatient dose modifications were based on individual toxicity. RESULTS: Twenty-seven patients received TPC and were evaluable for response and toxicity. Rates of complete response (CR), partial response (PR), and confirmed PR were 3%, 52%, and 30%, respectively. The overall objective response rate was 56%. Estimated median PFS and OS were 4.8 and 14.7 months, respectively. The rates of grade 3 and 4 worst-grade adverse events (AEs) per patient were 85% and 7%, respectively. Dose density through cycle 4 was preserved for all patients; however, treatment beyond cycle 6 with the TPC regimen proved unfeasible. CONCLUSION: Weekly docetaxel, cisplatin, and cetuximab is an effective regimen for patients with metastatic or recurrent SCCHN. Response rates, PFS, and OS compare favorably with other combination chemotherapy treatments. Grade 4 toxicity rates observed in this study were substantially lower than those described with regimens using less frequent, higher-dose chemotherapy schedules. CI - (c)AlphaMed Press; the data published online to support this summary is the property of the authors. FAU - Trieu, Vanessa AU - Trieu V AD - Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA. FAU - Pinto, Harlan AU - Pinto H AD - Stanford University, Stanford, California, USA. FAU - Riess, Jonathan W AU - Riess JW AD - University of California Davis School of Medicine, Sacramento, California, USA. FAU - Lira, Ruth AU - Lira R AD - Stanford Cancer Institute, Stanford, California, USA. FAU - Luciano, Richard AU - Luciano R AD - Stanford Health Care, Stanford, California, USA. FAU - Coty, Jessie AU - Coty J AD - Stanford Health Care, Stanford, California, USA. FAU - Boothroyd, Derek AU - Boothroyd D AD - Stanford School of Medicine, Stanford, California, USA. FAU - Colevas, A Dimitrios AU - Colevas AD AD - Stanford University, Stanford, California, USA colevas@stanford.edu. LA - eng SI - ClinicalTrials.gov/NCT01437449 PT - Clinical Trial, Phase II PT - Journal Article DEP - 20180314 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 15H5577CQD (Docetaxel) RN - PQX0D8J21J (Cetuximab) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Cetuximab/administration & dosage/adverse effects MH - Cisplatin/administration & dosage/adverse effects MH - Docetaxel/administration & dosage/adverse effects MH - Drug Administration Schedule MH - Female MH - Head and Neck Neoplasms/*drug therapy/mortality/pathology MH - Humans MH - Male MH - Middle Aged MH - Palliative Care/methods MH - Progression-Free Survival MH - Squamous Cell Carcinoma of Head and Neck/*drug therapy/mortality/pathology MH - Young Adult PMC - PMC6058339 EDAT- 2018/03/16 06:00 MHDA- 2019/09/21 06:00 PMCR- 2018/03/14 CRDT- 2018/03/16 06:00 PHST- 2017/12/20 00:00 [received] PHST- 2018/01/15 00:00 [accepted] PHST- 2018/03/16 06:00 [pubmed] PHST- 2019/09/21 06:00 [medline] PHST- 2018/03/16 06:00 [entrez] PHST- 2018/03/14 00:00 [pmc-release] AID - theoncologist.2017-0618 [pii] AID - ONCO12399 [pii] AID - 10.1634/theoncologist.2017-0618 [doi] PST - ppublish SO - Oncologist. 2018 Jul;23(7):764-e86. doi: 10.1634/theoncologist.2017-0618. Epub 2018 Mar 14.