Pragmatic Patient Choice-Driven Radical Treatment Approach (PRAGRAD) for Very Advanced Unresectable Oral Cavity...

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.

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.

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.

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.