Abstract 1882
Background
Due to the rarity and heterogeneity of recurrent and/or metastatic head and neck non-squamous cell carcinoma (R/M HN non-SCC), no standard chemotherapy for this condition has yet been established. This multicenter phase II trial evaluated the efficacy and safety of docetaxel and cisplatin combination (DC) in R/M HN non-SCC.
Methods
Eligibility criteria were R/M HN non-SCC; progressive disease within the last 6 months; no prior systemic therapy, or interval of at least 24 weeks since the last induction chemotherapy or chemoradiotherapy with curative intent; measurable disease; and ECOG performance status of 0 or 1. Patients (pts) received docetaxel (75 mg/m2 on day 1) and cisplatin (75 mg/m2 on day 1), repeated every 21 days for 6 cycles. The primary endpoint was objective response rate (ORR).
Results
From Nov 2012 to Oct 2016, a total of 23 pts were enrolled, characterized as 15 females, median age 57 years (range, 32-76), and 96% metastatic. Among 22 evaluable pts, ORR was 45.5% (95% confidential interval [CI], 24.4-67.8%), and the lower bound of the 95% CI of 24.4% exceeded the predefined hypothesis of 10%. ORRs according to primary tumor site and histology are shown in the table below. With a median follow-up period of 18.8 months, median progression-free survival and overall survival were 6.7 and 20.1 months, respectively. Grade 3/4 adverse events included neutropenia (91%), febrile neutropenia (FN) (39%), anemia (22%), appetite loss (17%), and fatigue (13%). The FN rate was significantly lower in the pts with prophylactic antibiotics (57 vs 11%, P = 0.04). No treatment-related deaths were observed.Table: 1066P
Objective response rates according to primary tumor site and histology
| Adenoid cystic carcinoma | Aadenocarcinoma, not otherwise specified | Salivary duct carcinoma | Sebaceous carcinoma | Mucoepidermoid carcinoma | NUT midline carcinoma | Acinic cell carcinoma | Total | |
|---|---|---|---|---|---|---|---|---|
| Salivary gland | 2/4 | 2/3 | 2/3 | 0/1 | 6/11 | |||
| Nasal cavity/paranasal sinus | 1/3 | 1/3 | ||||||
| Ocular | 0/1 | 2/2* | 2/3 | |||||
| Oral cavity/lip | 1/1 | 0/1 | 1/2 | |||||
| Oropharynx | 0/1 | 0/1 | 0/2 | |||||
| Ear | 0/1 | 0/1 | ||||||
| Total | 3/10 | 2/4 | 2/3 | 2/2 | 1/1 | 0/1 | 0/1 | 10/22 |
complete response
Conclusions
This phase II study of DC met its primary endpoint. This DC regimen is effective and represents a new treatment option in the treatment of progressive R/M HN non-SCC, although prophylactic antibiotics for FN should be considered.
Clinical trial identification
UMIN000008333.
Legal entity responsible for the study
Kobe University Hospital.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4162 - ODM-207 - a novel BET bromodomain inhibitor with antitumor activity in nonclinical models of ER+ breast cancer
Presenter: Anu Moilanen
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
3747 - HER2-positive breast cancer resistance to trastuzumab is associated with metabolic switch.
Presenter: Roman Dubianski
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4688 - Combination treatment with the PARP inhibitor niraparib and chemotherapeutics in a preclinical model of KRAS/BRAF mutated colorectal cancer cell lines across the four Consensus Molecular Subtypes.
Presenter: Pietro Paolo Vitiello
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
498 - Exosomal microRNA-32-5p induces multidrug resistance in hepatocellular carcinoma via the PI3K/Akt pathway.
Presenter: Xiao Fu
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
3731 - Effect of the polymorphism rs2470893 of the CYP1A1 gene on ovarian and endometrial cancer in Mediterranean women
Presenter: Judith Begona Ramirez Sabio
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
1215 - Cisplatin in NIPEC or HIPEC?
Presenter: Ivan Alvovsky
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
2738 - Matrix metalloproteinase-mediated regulation of programmed-death ligand in the human head and neck squamous cell carcinoma microenvironment
Presenter: MARIKO HIRAI
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
2190 - Trametinib synergizes with dexamethasone in KRAS-mutant myeloma cell lines through modulation of NDRG1 and induction of apoptosis
Presenter: Priya Sriskandarajah
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4482 - Functional inhibition of TGF-_ in colorectal cancer cells and its interaction with AXL receptor
Presenter: Davide Ciardiello
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
624 - Isoform-specific AKT Inhibition Differentially Affects Cell Functions in Pancreatic Adenocarcinoma
Presenter: Hugo Arasanz
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract