Integrating Metronomic Therapy With Standard Chemotherapy in Advanced Unresectable Head and Neck Cancer: A Randomized Trial Addressing Global Cancer Care Equity (METRO PLUS).
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Kapoor Akhil, Gupta Anuj, Sansar Bipinesh, Mishra Bal Krishna, Singh Arpita, Upadhyay Arvind, Pal Ankita, Kumari Rukmeena, Sisodia Natasha, Kumar Amit, Nanda Sambit Swarup, Mukherji Ashutosh, Kapoor Ankita Rungta, Choubey Ajay, Pradhan Satyajit, Mishra Aseem, Chowdhury Zachariah, Patne Shashikant, Dhal Ipsita, Singh Neha, Shukla Shreya, Singh Satyendra Narayan, Suresh Arvind, Dey Somnath, Vinayak Kunal Ranjan, Lakshman Praveen, Gupta Lokendra, Gavel Pratibha, Bajpai Vijeta, Bandekar Bhavesh, Banavali Shripad Dinanath, Patil Vijay Maruti, Noronha Vanita, Prabhash Kumar
Аннотация
PATIENTS AND METHODS: A total of 238 adults with histologically confirmed, unresectable advanced HNSCC eligible for palliative platinum-based chemotherapy were randomly assigned 1:1 after stratification by tumor site and Eastern Cooperative Oncology Group (ECOG) performance status. Arm A received PC plus OMCT; Arm B received PC alone. The primary end point was OS. Secondary end points included progression-free survival (PFS), quality of life (QoL; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Functional Assessment of Cancer Therapy-Head & Neck), and safety.
RESULTS: Among 238 patients (119 per arm), the median age was 47 years; 97.8% were male, and 78% had ECOG performance status (PS) 0-1. The median OS was 10 months (95% CI, 8.3 to 11.7) with PC + OMCT versus 5 months (95% CI, 3.9 to 6.1) with PC alone (hazard ratio [HR], 0.54 [95% CI, 0.41 to 0.72]; P < .001). The median PFS was 6 months versus 2 months, respectively (HR, 0.38 [95% CI, 0.28 to 0.50]; P < .001). QoL analyses demonstrated clinically meaningful preservation across multiple domains in the PC + OMCT arm. Grade ≥3 toxicities did not increase with the addition of OMCT.
CONCLUSION: In platinum-sensitive advanced HNSCC, the addition of triple OMCT to PC significantly improved OS and PFS with acceptable toxicity. PC + OMCT represents a feasible and cost-conscious first-line option in resource-constrained settings.