A phase II trial of a novel induction regimen: Polymeric micellar paclitaxel plus cisplatin for locally advanced head and neck squamous cell carcinoma.

Abstract

e18067 Background: Induction chemotherapy with the TPF regimen is recommended by international guidelines for locally advanced head and neck squamous cell carcinoma. However, its significant toxicities lead to generally poor patient tolerance, limiting its widespread clinical application, particularly among elderly or medically unfit patients. By encapsulating paclitaxel within micelles, pm-Pac enhanced permeability and retention effect, thereby improving pharmacokinetics and tumor-targeted delivery. This study evaluated the efficacy and safety of induction therapy with polymeric micellar paclitaxel plus cisplatin in LA-SCCHN, aiming to determine whether its pharmacologic advantages translate into clinical benefit. Methods: According to clinical trail the Eligible patients were stage III to IVB HNSCC received polymeric micellar paclitaxel 230 mg/m² (Day 1) plus cisplatin 70 mg/m² (Day 1–2) every three weeks for 2–4 cycles. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), safety, adverse events (AEs), and completion of subsequent definitive therapy. Results: Thirty patients were enrolled (median age, 66 years), including five HPV-positive cases (16.7%). After induction therapy, 5 patients achieved complete response (CR) and 11 achieved partial response (PR), yielding an ORR of 53.3% and a DCR of 93.3%. ORR reached 80% in HPV-positive patients versus 48% in HPV-negative/unknown patients. Common AEs included myalgia/limb pain (60%), neutropenia (26.7%), and bone marrow suppression (33.3%). Grade ≥3 AEs were mainly hematologic; no solvent-related hypersensitivity reactions occurred. Conclusions: Polymeric micellar paclitaxel plus cisplatin demonstrated promising antitumor activity, high disease control, and favorable tolerability in patients with LA-SCCHN, particularly among elderly or TPF-intolerant individuals. Clinical trial information: ChiCTR2500110591. Variable Number (n=30) Percentage (%) Age, years Median 66 (range 35–77) — <65 12 40.0 ≥65 18 60.0 Sex Male 23 76.7 Female 7 23.3 Primary Tumor Site Hypopharynx 9 30.0 Larynx 8 26.7 Oropharynx 6 20.0 Oral cavity 4 13.3 Other* 3 10.0 Clinical Stage II 2 6.7 III 13 43.3 IVA 14 46.7 IVB 1 3.3 HPV Status Positive 5 16.7 Negative/Unknown 25 83.3 Response Number (n=30) Percentage (%) Complete response (CR) 5 16.7 Partial response (PR) 11 36.6 Stable disease (SD) 12 40.0 Progressive disease (PD) 1 3.3 ORR (CR + PR) 16 53.3 DCR (CR + PR + SD) 28 93.3 Adverse Event All Grades Grade 3–4 Hematologic toxicity Bone marrow suppression 10 (33.3%) 6 (20.0%) Neutropenia 8 (26.7%) 5 (16.7%) Thrombocytopenia 2 (6.6%) 0 Febrile neutropenia 1 (3.3%) 1 (3.3%) Non-hematologic toxicity Limb pain / myalgia 18 (60.0%) 0 Gastrointestinal reactions (nausea/vomiting) 7 (27.3%) 0 Serious adverse events Pulmonary embolism 2 (6.7%) 2 (6.7%)