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Poster session 12

936P - Triple oral metronomic chemotherapy (OMCT) versus physician choice chemotherapy after failure of platinum-based therapy in advanced head and neck squamous cell cancer (HNSCC): A phase III randomized open-label study

Date

21 Oct 2023

Session

Poster session 12

Topics

Tumour Site

Head and Neck Cancers

Presenters

Akhil Kapoor

Citation

Annals of Oncology (2023) 34 (suppl_2): S554-S593. 10.1016/S0923-7534(23)01938-5

Authors

A. Kapoor¹, A. Gupta¹, B. Sansar¹, A. singh¹, L. Kashyap¹, R. Kumari¹, A. Kumar², S. Nanda³, A.R. Kapoor³, A. Mukherji³, A. Mishra⁴, A. Pal⁵, B. bandekar⁶, S.N. Singh⁷, K. Vinayak⁸, S. Dey⁸, V.M. Patil⁹, V. Noronha⁹, S. Banavali⁹, K. Prabhash⁹

Author affiliations

¹ Medical Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
² Medical Oncology, Homi Bhabha Cancer Hospital & Research Centre, Tata Memorial Centre, 221005 - Muzaffarpur/IN
³ Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
⁴ Head & Neck Surgery, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
⁵ Biostatistics, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
⁶ Clinical Research Secretariat, Mahamana Pandit Madan Mohan Malviya Cancer Centre, 221005 - Varanasi/IN
⁷ Radiology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
⁸ Pain And Palliative Medicine, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Tata Memorial Centre, 221005 - Varanasi/IN
⁹ Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, 400012 - Mumbai/IN

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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.