Table 4.
Clinical trials investigating the efficacy of induction therapy in HPV+ OPSCC
| Study | Study cohort | Treatment | Outcomes | Toxicity profile | Ref. |
|---|---|---|---|---|---|
| OPTIMA (2019) | 62 patients; divided into those with low-risk (≤T3 ≤N2b, ≤10 pack-year smoking history) or high-risk (T4 or ≥N2c or >10 pack-year smoking history) disease | Three cycles of carboplatin (AUC 6) plus nab-paclitaxel (100 mg/m2) followed by low-dose CRT (45 Gy plus three cycles of TFHX) or standard-dose CRT (75 Gy plus five cycles of TFHX) | 2-year PFS 95% in patients with low-risk disease, 94% in those with high-risk disease. | Grade ≥3 mucositis in 63% and 91%; grade ≥3 neutropenia in 30% and 18% and grade ≥3 dermatitis in 20% and 55% of patients in the low-risk and high-risk groups, respectively. All other grade ≥3 adverse events in ≤10% of patients. | 204 |
| E1308 (2017) | 80 patients; mostly with T1–3 N0–N2b disease, and a ≤10 pack-year smoking history | Three cycles of cetuximab (400 mg/m2 on day 1 followed by 250 mg/m2 weekly) plus IC followed by concurrent cetuximab with RT (54 Gy for patients with a CR or 69.3 Gy for those without a CR) | 2-year PFS 78%, 2-year OS 91% (100% for those with a CR at the primary site following IC). | Grade ≥3 mucositis in 30% and 47%; grade ≥3 dysphagia in 15% and 29%; grade ≥3 acneiform rash in 12% and 24% in patients who received low dose or high dose RT, respectively. | 205 |
| NCT02048020, NCT01716195 (2017) | 44 patients with stage III–IV disease | Two cycles of paclitaxel (175 mg/m2) and carboplatin (AUC 6) followed by IMRT: 54 Gy for those with a CR/PR or 60 Gy plus paclitaxel (30 mg/m2) for non-responders | 2-year PFS 92% | Grade 3 adverse events in 39% of patients, including dysphagia (9.1%), mucositis (9.1%) and dermatitis (6.8%). | 207 |
AUC, area under the curve; CR, complete response; CRT, chemoradiotherapy; HPV, human papillomavirus; IC, cisplatin (75 mg/m2 on day 1, paclitaxel 90 mg/m2 on days 1, 8 and 15); substitution of cisplatin with carboplatin was permitted; IMRT, intensity-modulated radiotherapy; OPSCC, oropharyngeal squamous cell carcinoma; OS, overall survival; PFS, progression-free survival; PR, partial response; TFHX, paclitaxel (100 mg/m2 on day 1), 5-fluorouracil (5-FU) (600 mg/m2 daily on days 0–5) and hydroxyurea (500 mg twice daily on days 0–5).