Phase II Trial of Thalidomide in the Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Oncology, ONCOLOGY Vol 14 No 11, Volume 14, Issue 11

Patients with recurrent squamous cell carcinoma of the head and neck have a poor prognosis. 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 have a poor prognosis. 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.

Click here to read Wen-Jen Hwu's commentary on this abstract.