Pragmatic patient choice-driven radical treatment approach (PRAGRAD) for very advanced Unresectable Oral Cavity Cancers

Purpose: The treatment of locally advanced unresectable oral cavity cancers (OCCs) is challenging, with limited consensus on optimal management and poor outcomes. Our clinical practice identified a subset of unresectable OCC patients who respond favorably to aggressive alternate treatment with chemotherapy and radiation therapy. We propose a systematic design for optimal selection method that is patient choice-driven while attempting to managing unresectable OCC with radical therapy approach. Methods and Materials: This observational pragmatic patient choice-driven cohort study enrolled patients deemed palliative by the multidisciplinary team. Patients were offered a choice between upfront palliation (cohort UPA) or upfront radical (cohort URAD) treatment. After induction chemotherapy, URAD patients were further stratified as responders (R) or nonresponders (N) and offered a choice between radical chemoradiation therapy (responder radical [RRAD] and nonresponders radical) or palliative treatment (responders palliation [RPA] and nonresponders palliation). We compared the overall survival between the cohorts using the University of Washington quality of life version 4 scores. Results: A total of 103 patients were screened and 73 enrolled with buccal mucosa 37 (49%) and oral tongue 26 (36%) being major sites; majority 57 (78%) chose URAD and UPA included 16 (22%) patients. After induction chemotherapy, 35 (65%) patients were responders. Of these, 27 (77%) opted to continue radical treatment (RRAD) and 8 (23%) chose palliation (RPA). Among the nonresponders (n = 19), 8 (42%) opted for radical treatment (nonresponders radical) and 11 (58%) chose palliation (nonresponders palliation). Overall, quality of life scores for URAD improved significantly from baseline to postintervention (30-60; P < .05), compared with the UPA (17-25; P = .75) with pain scores being the best in URAD (26-80; P < .05). Following stratification, the RRAD cohort showed median overall survival of 37.9 (95% CI, 18.4-not reached) and RPA was 14.0 (5.0-15.0) months compared with UPA 6.0 (3.0-9.0) months. Conclusions: The study assessed the feasibility or futility of managing unresectable OCCs with radical approach instead of palliation. The proposed patient choice-driven stratification protocol showed significantly better quality of life in patients who were optimally selected to undergo aggressive treatment compared with palliative management, with a possible improved survival of at least 9 months.