Randomized, paired comparison of No-Sting Barrier Film versus sorbolene cream (10% glycerine) skin care during postmastectomy irradiation.

PURPOSE: Postmastectomy irradiation provides an excellent model for irradiated skin care practices because of the relatively uniform surface and radiation compared with other situations in which radiation-induced moist desquamation is common. We designed a study to test the effect of prophylactic 3M Cavilon No-Sting Barrier Film (No-Sting) on the rates of moist desquamation compared with sorbolene cream (with 10% glycerin). METHODS AND MATERIALS: The irradiated chest wall was divided into medial and lateral halves. Sixty-one women were randomized to have No-Sting applied to either the medial or lateral half, with the alternate half treated with sorbolene. RESULTS: For all patients, the skin toxicity, calculated as the area under the curve, mean No-Sting and sorbolene score was 8.1 vs. 9.2, respectively (p = 0.005, Wilcoxon signed rank test). The total number of weeks of moist desquamation for the 61 patients was 40 vs. 45, equating to a mean of 0.65 week vs. 0.74 week per patient in the No-Sting and sorbolene-treated areas, respectively. The rates of moist desquamation were 33% vs. 46% (p = 0.096, McNemar's Exact test). For 58 fully assessable patients (minimum of 7 weekly observations), the area under the curve and rates of moist desquamation were significantly different statistically (p = 0.002 and 0.049, respectively). No statistically significant differences were noted in the pain scores. The pruritus scores were significantly reduced in the No-Sting area (area under the curve, p = 0.011). CONCLUSION: No-Sting reduces the duration and frequency of radiation-induced moist desquamation.

A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01.

PURPOSE: A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01. METHODS AND MATERIALS: A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less than 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters. RESULTS: Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores. CONCLUSIONS: The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies.

Interim analysis of toxicity and response in phase 1 trial of systemic targeted alpha therapy for metastatic melanoma.

PURPOSE: The aim is to assess toxicity and response of systemic alpha therapy for metastatic melanoma. EXPERIMENTAL DESIGN: This is an open-labelled Phase 1 dose escalation study to establish the effective dose of the alpha-immunoconjugate (213)Bi-cDTPA-9.2.27 mAb (AIC). Tools used to investigate the effects were physical examination; imaging of tumors; pathology; GFR; CT and changes in tumor marker. Responses were assessed using RECIST criteria. RESULTS AND DISCUSSION: Twenty-two patients with stage IV melanoma/in-transit metastasis were treated with activities of 55-947 MBq. Using RECIST criteria 50% showed stable disease and 14% showed partial response. One patient (6%) showed near complete response and was retreated because of an excellent response to the initial treatment. Another patient showed response in his tumor on mandible and reduction in lung lesions. Overall 30% showed progressive disease. The tumor marker melanoma inhibitory activity protein (MIA) showed reductions over eight weeks in most of the patients. The disparity of dose with responders is discussed. No toxicity was observed over the range of administered activities. CONCLUSION: Observation of responses without any toxicity indicates that targeted alpha therapy has the potential to be a safe and effective therapeutic approach for metastatic melanoma.