Real world outcomes with neoadjuvant chemo-immuno-metronomic therapy in advanced head and neck squamous cell carcinoma (NeoLOCUS-Retro).

Abstract

236 Background: Patients with stage IVA–IVB head and neck squamous cell carcinoma (HNSCC) ineligible for upfront surgery or definitive chemoradiation have poor 5-year survival of 30% to 40%. The prospective NeoLOCUS study showed high response and conversion rates with a regimen combining chemotherapy, low-dose immunotherapy (LD-IO), and oral metronomic therapy (OMT). Here, we report real-world outcomes with the same. Methods: Single-center retrospective study of stage IVA–IVB HNSCC treated with neoadjuvant platinum–taxane chemotherapy plus LD-IO and OMT (erlotinib, methotrexate, celecoxib). Primary endpoint was conversion to radical-intent local therapy. Secondary endpoints were radiologic response, event-free survival (EFS), overall survival (OS), and grade ≥3 adverse events. Results: Forty-three patients were included (Characteristics in Table). After a median 4 (Range 1- 6) neoadjuvant cycles, objective radiologic response was 62.8% (complete response 2.3%; partial response 60.5%, progressive disease 4.7%). Volumetric tumor reduction ≥65% occurred in 54.8%. Conversion to radical-intent therapy was achieved in 69.8%. At median follow-up of 16 months, median EFS was 10.5 months and OS 16.1 months. Thirteen deaths (30.2%) occurred. Median OS was 18.1 months in those receiving radical therapy versus 6.5 months in those who did not. Grade ≥3 adverse events occurred in 14.7%, most commonly anemia and thrombocytopenia (7% each). One grade 4 diarrhea with acute kidney injury required discontinuation. At disease progression, 20.9% received palliative systemic therapy, 2.3% palliative radiotherapy alone and others supportive care. Conclusions: NeoLOCUS regimen demonstrated encouraging response rates and enabled conversion to radical-intent local therapy in about two-thirds of patients with advanced stage IVA–IVB HNSCC, translating into improved survival in this challenging clinical setting. Baseline and treatment characteristics. Characteristic Value Median age, yr (IQR) 54 (45.5–60) Male sex, n (%) 33 (76.7) Stage IVA / IVB, n (%) 25 (58.1) / 18 (41.9) Oral vs non-oral primary, n (%) 28 (65.1) / 15 (34.9) Harmonised ICI dose mg/kg/2wks (IQR) 0.4 (0.2–0.4) Radical-intent local therapy, n (%) 30 (69.8) CTRT + Radical RT, n (%) 24 (55.8) Surgery, n (%) 6 (14.0) Palliative RT / No local therapy 3 (7.0) / 10 (23.3)