969P - Comparison of outcomes of weekly paclitaxel versus weekly cisplatin in oral cavity, oropharyngeal and hypopharyngeal cancer patients with concurrent radiation: A randomized controlled trial

Background

Head and neck cancer is the most common cancer in India. The standard of care in locally advanced head and neck cancer (LAHANC) is concurrent chemoradiation with cisplatin 100mg/m2 once every 3 weeks. As most of the patients have poor oral intake, their creatinine clearance will be low, resulting in the administration of sub-optimal doses of cisplatin and thereby affecting the response rates. Three weekly schedule had resulted in significant toxicities compared to the weekly schedule. Furthermore, the dosing of paclitaxel is not heavily dependent on creatinine clearance. So, we intended to compare the locoregional response rate and toxicity profile of weekly paclitaxel which showed better radiosensitization and good response rates in the recurrent and metastatic settings with weekly cisplatin in oral cavity, oropharyngeal and hypopharyngeal cancer in the concurrent setting.

Methods

Patients of LAHANC planned for radical concurrent chemoradiation were randomized to receive either weekly paclitaxel 40 mg/m² or weekly cisplatin 40 mg /m² with radiation of dose 66Gy in 33 fractions over 6-7 weeks. The response to the therapy was assessed six weeks after completion of treatment.

Results

50 patients (24 in paclitaxel arm and 26 in cisplatin arm) completed the intended course of treatment and follow up. The most common primary was the oral cavity (36%) followed by oropharynx (28%). The locoregional response rate in the paclitaxel group and cisplatin group was 87.5% and 80.8% respectively (P=0.704). The mucosal reactions were noted more in the paclitaxel group (P=0.018). Grade 3 dermatitis was seen more frequently in the paclitaxel group. However, hematological reactions (neutropenia and thrombocytopenia) were noted more in the cisplatin group though not statistically significant (P=0.491 and 0.520 respectively).

Conclusions

We conclude that weekly paclitaxel can be considered as an option in the concurrent setting in the treatment of LAHANC at the cost of increased mucosal and skin toxicity. However, a longer follow up and a bigger sample size are required to better characterize its role in the routine management of head and neck malignancies.

Clinical trial identification

CTRI/2017/09/009864.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

JIPMER, Puducherry, India.

Disclosure

All authors have declared no conflicts of interest.