Safety and efficacy of weekly versus three-weekly paclitaxel plus platinum neoadjuvant chemotherapy in patients with locally advanced squamous cell head and neck carcinoma: A pilot study.

Background: Squamous cell carcinoma of head and neck (SCCHN) is one of the most common cancers seen in India and also the world. Majority of patients present in locally advanced (LA) disease where neoadjuvant combination chemotherapy with a taxane plus platinum with/without 5-Fluorouracil is the standard of care treatment. There are no/few prospective trials of weekly paclitaxel in SCCHN in spite of convincing evidence regarding safety and tolerability in other solid tumors such as breast, ovary, and lung carcinoma. In the present study, we prospectively assessed the safety and efficacy of weekly versus three-weekly paclitaxel plus platinum neoadjuvant chemotherapy in patients with LA-SCCHN.

Materials and Methods: We included 50 newly diagnosed patients of LA-SCCHN in the study and randomized them into two groups to receive either low-dose weekly (80 mg/sq. m) or standard three-weekly (175 mg/sq. m) paclitaxel along with standard dose carboplatin (AUC 5) and assessed response rates and toxicities.

Results: Age and sex were evenly matched in both groups. Oral and oropharyngeal cancers were the most common sites. Hematological toxicities were significantly more in the three-weekly group. Nonhematological toxicities, especially neuropathy, were also more in this group. The overall response rate (complete response + partial response) in the three-weekly arm was 36% versus 52% in the weekly arm.

Conclusion: Data from our small study suggest that weekly paclitaxel plus platinum neoadjuvant chemotherapy may be superior to the standard every 3 weeks' administration in terms of safety as well as efficacy in patients with LA-SCCHN.