Abstract 936P
Background
Advanced HNSCC patients with platinum-refractory disease have limited treatment options and poor outcomes, especially in resource-constrained settings. Triple metronomic therapy, a low-dose continuous chemotherapeutic strategy, has shown promise in phase 2 trials but requires further validation. We aimed to evaluate triple OMCT's efficacy in improving overall survival (OS) compared to physician-choice chemotherapy (PCC).
Methods
In this phase 3 open-label study, 214 advanced HNSCC patients previously treated with platinum-based chemotherapy (October 2021-August 2022) were randomized 1:1 to receive triple OMCT (Arm A) with Methotrexate 9 mg/m2 PO weekly, Celecoxib 200 mg twice daily and erlotinib 150 mg daily, or PCC (Arm B), stratified by age and performance status. Primary endpoint was OS, with secondary endpoints including progression-free survival (PFS), Quality of Life (QoL) assessments, and safety. OS and PFS were analyzed using Kaplan-Meier and log-rank tests, with hazard ratios estimated by Cox proportional hazard models. QoL was assessed using EORTC QLQ-C30.
Results
Table: 936P
Baseline characteristics of the patients
| Characteristics | Arm A (Triple OMCT) n (%) | Arm B (Physician Choice) n (%) | p-value (Chi-square) |
| Age (in years) <60 60 or more | 86 (80.4) 21 (19.6) | 85 (79.4) 22 (20.6) | 0.865 |
| Sex Female Male | 6 (5.6) 101 (94.4) | 4 (3.7) 103 (96.3) | 0.517 |
| Baseline Hemoglobin level (gm/dL) ≤ 12 > 12 | 68 (63.6) 39 (36.4) | 78 (72.9) 29 (27.1) | 0.142 |
| Comorbidities Yes No | 7 (6.5) 100 (93.5) | 16 (15.0) 91 (85.0) | 0.077 |
| ECOG Performace Status 1 2 | 68 (63.6) 39 (36.4) | 62 (57.9) 45 (42.1) | 0.401 |
| Site of Tumor Oral Cavity Others | 70 (65.4) 37 (34.6) | 71 (66.4) 36 (33.6) | 0.885 |
Most patients had ECOG PS 1 (60.7%) and tumor site in the oral cavity (65.9%). With a median follow-up of 11 months, the median OS was 9 months in Arm A and 5 months in Arm B (HR, 0.63; 95% CI, 0.47–0.83; p=0.00011). Median PFS was 4 months in Arm A and 2 months in Arm B (HR, 0.67; 95% CI, 0.52–0.87; p<0.0001). Multivariate analysis identified age, hemoglobin level, and comorbidity as significant OS prognostic factors. No significant QoL score differences were observed. Triple OMCT showed fewer grade 3 or higher adverse events than PCC (28.0% vs 39.3%, p=0.03).
Conclusions
Triple OMCT is an effective, safe treatment for advanced HNSCC patients previously treated with platinum-based chemotherapy, offering improved OS and tolerable side effects compared to physician-choice chemotherapy.
Clinical trial identification
Clinical Trial Registry-India CTRI/2021/09/036296.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Indian Cooperative Oncology Network (ICON) Trust.
Disclosure
All authors have declared no conflicts of interest.
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