A110
Phase II study of pegylated liposomal doxorubicin Caelyx chemotherapy as palliative systemic treatment in locally advanced, recurrent and metastatic head and neck squamous cell carcinoma
Hui Woon Loo, Werner Dobrowsky, Sanjoy Chatterjee, Charles Kelly
Northern Centre for Cancer Care, Newcastle, UK
Background
Systemic chemotherapy is accepted as the standard treatment in patients with locally advanced, recurrent and metastatic head and neck squamous cell carcinoma (HN-SCC) who are not amenable to surgery or radiotherapy, for symptom palliation. Platinum and 5-fluorouracil combination is commonly used first line chemotherapy with response rate of 30%. The purpose of this study is to evaluate the antitumour efficacy, tolerability and safety of single agent pegylated liposomal doxorubicin Caelyx.
Method
Treatment consisted of Caelyx 40mg/m2 in 1 hour infusion. Treatment was repeated 3 weekly. Repeat CT scan was carried out after the third and sixth cycle of chemotherapy. Patients were reviewed 3 weekly for assessment of performance status, physical examination, monitoring of tumour related symptoms and treated-related toxicities. Patients quality of life was assessed every 3 weekly using University of Washington quality of life questionnaire version 4 (UW-QoL v4).
Results
Fifteen patients entered the trial, all were evaluable for survival. Ten patients were evaluable for tumour response. The patients median age was 57 years. Median time from diagnosis to first relapse was 10.74 months. All patients received radical treatment to loco-regional disease after initial diagnosis. Eight patients had carboplatin and 5-fluorouracil palliative chemotherapy prior to entering the trial. On average each patient received 2.7 cycles of Caelyx. Three patients had stable disease and 7 patients had progressive disease. Caelyx was generally well tolerated with no treated related mortality. Quality of life questionnaires failed to demonstrate improvement with Caelyx chemotherapy. Median duration of survival from time of enrolment to study and death is 4.14 months.
Conclusion
This phase II non-comparative trial on Caelyx palliative chemotherapy used in locally advanced, recurrent or metastatic HN-SCC failed to demonstrate clinical benefit in relation to tumour response, median survival and quality of life, although toxicities profile of treatment was acceptable.
