Abstract 5613
Background
Addition of nimotuzumab to weekly cisplatin and radiation improves outcomes in head and neck cancer. HPV-negative oropharyngeal cancer has unsatisfactory treatment outcomes and is a candidate for escalation of treatment. Hence we wanted to determine whether the addition of nimotuzumab to cisplatin-radiation can improve outcomes in these subsets of poor-risk tumors.
Methods
This was a subgroup analysis of a phase 3 randomized study. In this study locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin (30 mg/m2 IV )- radiation (66-70 Gy) {CRT arm} or nimotuzumab (200 mg weekly) -weekly cisplatin (30 mg/m2)-radiation (66-70 Gy) {NCRT arm}. The data for HPV-negative oropharyngeal cancer was extracted from the database of this study for the current analysis. HPV testing was done with p16 IHC staining and reported according to the CAP criteria. The outcomes assessed were progression-free survival (PFS), disease-free survival (DFS), locoregional control (LRC), and overall survival (OS). Interaction test was performed between the study arms and HPV status prior to doing any HPV-specific analysis for each of the studied outcomes. Kaplan Meier estimates for 2-year OS with 95% CI is provided. The hazard ratio was calculated using Cox regression analysis.
Results
We had 187-HPV negative oropharyngeal cancers, 91-CRT arm and 96 in NCRT arm. The interaction test was significant for PFS (p = 0.000), locoregional control (p = 0.007) and overall survival (p = 0.002) but not for DFS (p = 0.072). The 2-year PFS was 31.5% (95%CI 21.5-42) in CRT arm versus 57.2% (95%CI 45.8-67.1) in NCRT arm (HR -0.54;95%CI 0.36-0.79, p = 0.002). While the 2-year LRC was 41.4 % (95%CI 29.8-52.6) in CRT arm versus in 60.4% (95%CI 48.7-70.2) in NCRT arm (HR -0.61;95%CI 0.4-0.94, p = 0.024). The addition of nimotuzumab also led to an improvement in OS from 39.0% (95%CI 28.4-49.6) to 57.6% (95%CI 46.3-67.4) (HR-0.63, 95%CI 0.43-0.92, p = 0.018).
Conclusions
The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV-negative oropharyngeal cancers.
Clinical trial identification
CTRI/2014/09/004980.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Biocon Ltd, TRAC.
Disclosure
K. Prabhash: Research grant / Funding (institution): Dr. Reddy’s Laboratories Inc; Research grant / Funding (institution): Fresenius Kabi India Pvt Ltd; Research grant / Funding (institution): Alkem Laboratories; Research grant / Funding (institution): Natco Pharma Ltd; Research grant / Funding (institution): BDR Pharmaceutics Intl Pvt Ltd; Research grant / Funding (institution): Roche Holding AG. V. Noronha: Research grant / Funding (institution): Dr. Reddy’s Laboratories Inc; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Sanofi Aventis. All other authors have declared no conflicts of interest.
Resources from the same session
2607 - Single cycle induction treatment with Cisplatin/Docetaxel plus Durvalumab/Tremelimumab in Stage III-IVB head and neck squamous cell cancer (CheckRad-CD8 trial)
Presenter: Markus Hecht
Session: Poster Display session 3
Resources:
Abstract
1388 - Radiotherapy plus cisplatin (CDDP) or cetuximab (C225) in human papilloma-virus (HPV)-associated oropharyngeal cancer (OPC)? A dillema finally resolved. An updated meta-analysis.
Presenter: Petar Suton
Session: Poster Display session 3
Resources:
Abstract
1478 - Treatment outcomes of head and neck cancer patients 70 years and older receiving different chemo-radiation combinations.
Presenter: Majd Issa
Session: Poster Display session 3
Resources:
Abstract
3985 - Brachytherapy and non-cancer mortality in patients with oral cavity and oropharynx SCCs
Presenter: Jovian Yu
Session: Poster Display session 3
Resources:
Abstract
4036 - Final results of a phase II study of induction chemotherapy (CT) with paclitaxel (PTX) and panitumumab (P) followed by radiotherapy (RT) and P in patients (pts) with locally advanced head and neck cancer (LAHNC) no candidates to platinum: study PANTERA
Presenter: Javier Martinez Trufero
Session: Poster Display session 3
Resources:
Abstract
4779 - Window of Opportunity for Durvalumab (MEDI4736) plus Metformin Trial in Squamous Cell Carcinoma of the Head and Neck (SCCHN): interim safety analysis
Presenter: Tony Richa
Session: Poster Display session 3
Resources:
Abstract
2757 - Severe Oral Mucositis (SOM) Mitigation by Genetically Modified Lactococcus Lactis Bacteria (LLB) Producing Human Trefoil Factor 1 (hTFF1; AG013) in Patients Being Treated With Concomitant Chemoradiation (CRT) for Oral and Oropharyngeal Cancers (OCOPC)
Presenter: Suraj Singh
Session: Poster Display session 3
Resources:
Abstract
5559 - Transcriptome signatures of treatment responses in a preoperative window of opportunity trial of nivolumab and tadalafil in resectable squamous cell carcinoma of the head and neck
Presenter: Sanket Shukla
Session: Poster Display session 3
Resources:
Abstract
3263 - Risk and Impact of Renal Impairment of Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Who Received Chemoradiotherapy with Cisplatin
Presenter: Thana Patimarattananan
Session: Poster Display session 3
Resources:
Abstract
3128 - Systemic bevacizumab for the treatment of recurrent respiratory papillomatosis: A retrospective analysis from an academic tertiary care center
Presenter: Sumita Trivedi
Session: Poster Display session 3
Resources:
Abstract