Prospective evaluation of supportive care with or without CVD chemotherapy as a second-line treatment in advanced melanoma by patient's choice: a multicentre Dermatologic Cooperative Oncology Group trial.

This prospective, nonrandomized multicentre, phase III study compared best supportive care (BSC) alone with cisplatin, vindesine and dacabazine-based (CVD) chemotherapy and BSC in patients with advanced melanoma. A total of 117 pretreated patients with metastatic melanoma were evaluated, 34 patients in arm A (BSC) and 83 in arm B (BSC and CVD). Primary endpoint was overall survival and secondary endpoints were disease control rate and quality of life (European Organisation for Research and Treatment of Cancer QLQ-C30). Owing to sparse recruitment of patients for randomization, the protocol has been changed based on patients' choice. Baseline characteristics were imbalanced with respect to the Karnofsky Performance Index (P=0.001), the existence of brain metastases (P=0.035) and earlier application of chemoimmunotherapy (P=0.038). Disease control was observed in 8.8% of patients in arm A and in 28.9% of patients in arm B (P=0.028). Median overall survival time was 137 days in arm A and 229 days in arm B (P=0.014). Multivariate analyses could not ascribe this prognostic benefit to CVD treatment. No significant difference in the quality of life could be found. This study could not detect clear survival benefits for polychemotherapy with CVD compared with BSC alone in patients with advanced metastatic melanoma. Interestingly, having the choice of chemotherapy or BSC alone in a second-line situation, more than 70% of patients chose polychemotherapy.

Emerging drugs for actinic keratosis.

IMPORTANCE OF THE FIELD: Actinic keratoses (AK) represent a worldwide problem with continuously increasing incidence. AK are characterized by a proliferation of atypical keratinocytes limited to the epidermis, but they may develop into invasive squamous cell carcinoma. In this regard, novel treatment modalities have been developed that allow treatment of the whole actinically damaged field. AREAS COVERED IN THIS REVIEW: An overview about current treatment modalities for AK including, among others, their mechanism of action, application scheme and common side effects. Furthermore, recent developments in the field are described and future aspects are discussed. WHAT THE READER WILL GAIN: The reader of this review will be informed about all current treatment modalities for AK. Furthermore, the reader will gain knowledge about ongoing research in this field and novel topical drugs for the treatment of AK. TAKE HOME MESSAGE: Many treatment modalities are available for the treatment of AK. Recent developments have focused on the management of the whole actinically damaged field. In this regard, several topical drugs have been approved for AK, differing in clearance rates, side effects, application and cost. Research is continuing aiming in the development of the "ideal" treatment of AK which combines high clearance rates with few side effects, short treatment duration and low costs.

Treatment of multiple, multiform actinic keratoses on the head with imiquimod 5% cream.

The objective of this non-controlled interventional clinical study was to evaluate the efficacy of imiquimod in the treatment of fields with multiple, multiform AK. 180 office-based dermatological practices in Germany participated. Patients with clinically typical, visible AK lesions on the head were treated with 5% imiquimod cream 3 times per week for 4 weeks followed by a 4 week treatment pause. If lesions were still present, a second treatment course of treatment (COT) was given. Complete clearance rate, i.e. no clinically visible AK lesions in the treatment area, was the main outcome measure. 829 patients were enrolled. The complete clearance rate was 40.5% after the first COT and 68.9% overall. Altogether, 85.4% of the 7,427 baseline lesions were cleared. Patients with hyperkeratotic/hypertrophic lesions showed comparable responses. Local skin reactions were the most commonly reported adverse effects, causing discontinuation in only 4 patients. Severity of the local skin reactions was a strong predictor of the outcome. Patients with multiple multiform AK on the head can be successfully and safely treated with topical imiquimod in daily practice. Assurance of patient understanding that treatment success is closely correlated to proper drug administration is important.