Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study.

PURPOSE: To assess the activity and toxicity of lenalidomide for patients with advanced hepatocellular cancer (HCC) previously treated with sorafenib. MATERIALS AND METHODS: Patients with advanced HCC who progressed on or were intolerant to sorafenib were eligible. Patients received lenalidomide 25 mg orally for 1 to 21 days in a 28-day cycle until disease progression or unacceptable toxicities. RESULTS: Forty patients were enrolled and were classified according to the Child-Pugh score: 19 were Child-Pugh A, 16 patients were Child-Pugh B, and 5 were Child-Pugh C. Seventeen patients had extrahepatic disease. Grade 4 neutropenia occurred in 1 of 40 patients (2.5%). Grade 3 fatigue (n=3) and rash (n=4) were the most common nonhematologic toxicities attributable to lenalidomide. Six of 40 patients (15%) had a partial response. Two patients (5%) have not progressed at 36 and 32 months. The median progression-free survival was 3.6 months and the median overall survival was 7.6 months. CONCLUSIONS: Lenalidomide can be administered to patients with advanced HCC and hepatic dysfunction. Promising, and in a small percentage of patients, durable activity has been demonstrated. Investigations are needed to explore the mechanism of action of lenalidomide in HCC.

Long-term adjustment of survivors of early-stage breast carcinoma, 20 years after adjuvant chemotherapy.

BACKGROUND: The long-term impact of breast carcinoma and its treatment was assessed in 153 breast carcinoma survivors previously treated on a Phase III randomized trial (Cancer and Leukemia Group B [CALGB 7581]) a median of 20 years after entry to CALGB 7581. METHODS: Survivors were interviewed by telephone using the following standardized measures: Brief Symptom Inventory (BSI), PostTraumatic Stress Disorder Checklist with the trauma defined as survivors' response to having had cancer (PCL-C), Conditioned Nausea, Vomiting and Distress, European Organization for Research and Treatment of Cancer QLQ-C30 (quality of life), Life Experience Survey (stressful events), MOS Social Support Survey, comorbid conditions (Older Americans Resources and Services Questionnaire), and items developed to assess long-term breast carcinoma treatment side effects and their interference with functioning. RESULTS: Only 5% of survivors had scores that were suggestive of clinical levels of distress (BSI), 15% reported 2 or more posttraumatic stress disorder (PTSD) symptoms (PCL-C) that were moderately to extremely bothersome, 1-6% reported conditioned nausea, emesis, and distress as a consequence of sights, smells, and tastes triggered by reminders of their treatment, 29% reported sexual problems attributed to having had cancer, 39% reported lymphedema, and 33%, reported numbness. Survivors who reported greater lymphedema and numbness that interfered with functioning had significantly worse PTSD (PCL-C; P = 0.008) com- pared with survivors who reported less lymphedema and numbness. Survivors with a lower level of education (P = 0.026), less adequate social support (P = 0.0033), more severe negative life events (P = 0.0098), and greater dissatisfaction with their medical care (P = 0.037) had worse PTSD compared with other survivors. CONCLUSIONS: Twenty years after the initial treatment, the impact of breast carcinoma on survivors' adjustment was minimal. However, the higher prevalence of PTSD symptoms in response to having had cancer is indicative of continuing psychologic sequelae long after treatment completion. Findings related to lymphedema and numbness and continued symptoms of PTSD suggest that the long-term psychologic and medical sequelae on adjustment may be underrecognized. To establish in more detail whether survivors' overall psychologic state is any different from that of individuals without cancer, a population of community residents without cancer would need to be studied.