Abstract 862P
Background
Surgery remains the only curative treatment for locally advanced oral cavity squamous cell carcinoma (OCSCC). For ‘Borderline resectable’ OCSCC, conversion to surgery has shown improved outcomes, but historical induction chemotherapy (IC) yields a mere 40% conversion rate. Addition of targeted agents like cetuximab has not yielded satisfactory outcomes. We report our outcomes with multi-agent IC in combination with low-dose nivolumab (LD-Nivo) for this clinical setting.
Methods
We prospectively enrolled 28 (26 male, 2 female) patients (pts) with OCSCC between April 2023 and March 2024, deemed ‘Borderline Resectable’ per pre-defined criteria in the Head and Neck Multidisciplinary Tumor Board (MDT). All pts received nab-paclitaxel 175mg/m2, carboplatin AUC 5, LD-Nivo (20mg or 40mg based on weight) along with triple oral metronomic therapy - Erlotinib 100mg OD, Celecoxib 200mg BD and 9mg/m2 weekly Methotrexate. After two 21-day cycles, reassessment imaging was discussed in MDT for feasibility of resectability. The primary endpoint was the proportion of pts undergoing R0 resection after two cycles of planned induction therapy. Secondary endpoints were objective response rates (ORR) and adverse events (AE).
Results
Baseline characteristics and AE are tabulated. ORR was 66.6% (18 partial response, 9 stable disease). One pt withdrew consent after cycle 1. After 2 cycles, 21/27 (77.7%) pts underwent surgery, all were R0 resection. Three pts (11.1%) had a pathological complete response. All 21 pts received adjuvant concurrent chemoradiation with weekly cisplatin. At a median 7.4 months follow-up, one pt had progression in lung. There were no treatment-related deaths. Table: 862P
Baseline characteristics and AE
| PARAMETER | VALUE |
| Median (IQR) Age | 44 (39-54) |
| PRIMARY SITE Buccal mucosa Oral tongue | 16 11 |
| BORDERLINE RESECTABILITY CRITERIA 1. Buccal mucosa primary with diffuse margins and peritumoral edema going up to the level of sigmoid notch of mandible but not above 2. Oral tongue primary with extension to posterior one-third of tongue or floor of mouth | 16 11 |
| STAGE III IVA IVB | 1 11 15 |
| GRADE 3 AE Anaemia Thrombocytopenia Infections Diarrhea Febrile neutropenia Acneiform rash | 3 3 3 2 1 1 |
| Grade 4 Acute Kidney Injury | 1 |
| IMMUNE-RELATED AE Grade 2 polyarthritis Reactivation of tuberculosis | 1 1 |
Conclusions
Preoperative multi-agent IC + LD-Nivo is feasible with a manageable safety profile. It has higher conversion rates to surgery than historical IC for ‘Borderline resectable’ OCSCC.
Clinical trial identification
CTRI/2023/04/051617.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
CMC Vellore Fluid Research Grant.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
870P - POPPY: A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients of performance status 2 with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC)
Presenter: Martin Forster
Session: Poster session 02
871P - Randomized phase II trial of nivolumab plus paclitaxel in subjects with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) unable for cisplatin (CP)-based chemotherapy (CT): NIVOTAX TTCC study
Presenter: Lara Iglesias Docampo
Session: Poster session 02
873P - Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA
Presenter: Andreas Dietz
Session: Poster session 02
874P - Preliminary outcomes from a phase Ib/II study of WX390 combined with toripalimab in patients with recurrent or metastatic head and neck squamous cell carcinoma
Presenter: Ye Guo
Session: Poster session 02
875P - A phase II clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)
Presenter: Dongmei Ji
Session: Poster session 02
876P - Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line (1L) treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)
Presenter: Xiaozhong Chen
Session: Poster session 02
878P - Final results of a phase II study of peltopepimut-S and cemiplimab in patients with relapsed/metastatic HPV16+ oropharyngeal cancer that progressed with prior anti-PD-1 therapy
Presenter: Anthony Kong
Session: Poster session 02
879P - VERSATILE-002: Survival with first-line treatment with PDS0101 therapeutic vaccine and pembrolizumab in HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Presenter: Jared Weiss
Session: Poster session 02