On July 24, 2015, the FDA approved sonidegib (ODOMZO; Novartis) for the treatment of patients with locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiotherapy. The approval was based on data from one randomized, double-blind, noncomparative trial of two doses of sonidegib administered to 230 hedgehog inhibitor-naïve patients with metastatic basal cell carcinoma (mBCC, = 36) or laBCC ( = 194). Patients were randomized 2:1 to receive sonidegib 800 mg ( = 151) or 200 mg ( = 79) daily. The objective response rate (ORR) for patients with laBCC was 58% [95% confidence interval (CI), 45-70] in the 200 mg group and 44% (95% CI, 35-53) in the 800 mg group. The median duration of response for patients with laBCC was nonestimable (NE) in the 200 mg arm and 15.7 months (95% CI, NE) in the 800 mg arm. The ORR for patients with mBCC was 8% (95% CI, 0.2-36) and 17% (95% CI, 5-39) in patients treated with 200 and 800 mg, respectively. The most common adverse events occurring in ≥10% of patients were muscle spasms, alopecia, dysgeusia, nausea, fatigue, increased serum creatine kinase, decreased weight, and diarrhea. .
After completing this course, the reader will be able to:1. Describe the setting in which the use of peginterferon-alfa-2b is appropriate for melanoma patients.2. Define the expectations with regard to survival and side effect profile in patients with melanoma receiving peginterferon-alfa-2b.This article is available for continuing medical education credit at CME.TheOncologist.com. The relapse-free survival (RFS) interval, the primary efficacy endpoint, was significantly longer in PEG-IFNtreated patients. The median RFS times were 34.8 months and 25.5 months, respectively. There was no statistically significant difference in the overall survival time.
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ABSTRACTThe most common (>60%) grade 1-4 adverse reactions were fatigue, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST), pyrexia, headache, anorexia, myalgia, nausea, chills, and injec-
After completing this course, the reader will be able to:1. Discuss the results of the CAM 307 randomized trial of alemtuzumab in patients with B-cell chronic lymphocytic leukemia.2. Describe the pretreatment and prophylactic medications recommended for patients treated with alemtuzumab.3. Identify the most common toxicities seen with alemtuzumab treatment.Access and take the CME test online and receive 1 AMA PRA Category 1 Credit ™ at CME.TheOncologist.com CME CME
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