Patients with recurrent squamous cell carcinoma of the head and neck have a poor prognosis. Thalidomide(Drug information on thalidomide) (Thalomid) has antitumor and antiangiogenic properties. We conducted a phase II trial to determine toxicity, response rate, and survival in patients with recurrent squamous cell carcinoma of the head and neck. Eligibility criteria included recurrent and/or metastatic squamous cell carcinoma of the head and neck, measurable disease, and two or fewer prior chemotherapy regimens.
Thalidomide was administered at a starting dose of 200 mg nightly and increased by 200 mg every week to a goal dose of 1,000 mg nightly. Women of childbearing potential and pregnant women were excluded. Of 17 patients enrolled in the study to date, there are 12 males (71%) and 5 females (29%); the median age is 56 years. Patients received extensive prior treatments: 94% chemotherapy, 88% radiation therapy, and 77% surgery.
The most frequent toxicities included fatigue in 94% of patients (grade 3/4 in 19%), nausea/vomiting in 41% (grade 3/4 in 14%), edema in 53% (grade 3/4 in 22%), constipation in 35% (grade 3/4 in 0%), sensory neuropathy in 47% (grade 3/4 in 0%), pain in 35% (grade 3/4 in 0%), and skin reaction in 24% (grade 3/4 in 0%).
The median duration of treatment on protocol was 1.25 months. Of 17 patients treated, 16 (94%) have shown progressive disease and 1 (6%) was inevaluable due to early death. The median survival time for the 17 patients is 5.4 months. A subset of patients underwent baseline and posttreatment tumor biopsies to assess correlative biology. Currently, analysis of biopsies for angiogenic assays is underway and will be presented at the meeting.
CONCLUSION: We found that thalidomide is well tolerated in this population of heavily pretreated patients with recurrent squamous cell carcinoma of the head and neck, with a minority experiencing grade 3/4 toxicity. Thus far, the response rate for thalidomide in this population of patients is low, with median survival similar to that of historical controls.