Abstract 673P
Background
Induction chemotherapy (ICT) is widely used in locally advanced squamous cell carcinoma of head and neck (SCCHN). Triweekly TPF (Docetaxel/Cisplatin/5FU) is most commonly used regimen but is associated with significant neutropenia. Hence, we conducted a phase II randomised prospective study to see if biweekly TPF regimen was associated with equal response rates with lesser toxicities in our setting.
Methods
Patients with locally advanced SCCHN with primary site being oral cavity/oropharynx/hypopharynx/larynx -Stage III/IVA/IVB (AJCC 8) were enrolled into two arms- arm A (biweekly TPF) and arm B (triweekly TPF). Arm A received ICT with docetaxel 50mg/m2, cisplatin 50mg/m2, leucovorin 250 mg/m2 and 5-fluorouracil 2500 mg/m2 (24hr continuous infusion) on day 1 biweekly for 3 cycles. Arm B received docetaxel 75mg/m2 and cisplatin 75mg/m2 on day 1, 5-FU 750mg/m2 (D1-D4 over 6hrs) triweekly for 2 cycles. Primary endpoint was response rate. Toxicity assessment was done as per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Results
One hundred and twenty patients were enrolled from march 2020 to february 2021 with 60 in each arm. Overall response rate was 89.8% (CR=25.4% PR=64.4%) in biweekly and 73.37% (CR=6.7% PR=66.7%) in triweekly arm (p=0.2). Stable disease (SD) was seen in 5.1% vs 11.7%, progressive disease (PD) in 5.1% vs 15% in biweekly and triweekly arm respectively. Toxicities are as tabulated below. Treatment delay and inter-chemotherapy admissions were seen in 20.3% vs 46.7% (p=0.003) and 16.7% vs 33.3% (p=0.057) in biweekly and triweekly arm. There were two deaths in biweekly and four in triweekly arm. There was trend towards better PFS and OS in biweekly arm however survival data is yet to mature. Table: 673P
| TOXICITIES | Biweekly arm | Triweekly arm | p values |
| Grade 3/4 neutropenia | 23.3% | 41.7% | p=0.05 |
| Febrile neutropenia | 10% | 16.7% | p=0.421 |
| Infection rate | 23.3% | 41.7% | p=0.23 |
| Grade 3/4 mucositis | 5% | 23.3% | p=0.007 |
| Grade 3/4 diarrhoea | 0% | 10% | p=0.027 |
Conclusions
Biweekly regimen had better response rates with lesser toxicities. Thus, biweekly TPF could be a feasible regimen in locally advanced SSCHN.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.