[Radiotherapy of keloids. Patterns of care study -- results]. / Strahlentherapie des Keloids in Deutschland Patterns-of-Care-Studie -- Ergebnisse einer Umfrage.

BACKGROUND: Keloids are benign diseases of the skin. Because of the high rate of relapses after operation often postoperative irradiation is used. Treatment modalities must be collected by Patterns of Care Studies before therapy advice may be given from DEGRO. PATIENTS AND METHOD: Dates of investigations with questionnaire on mail of 250 radiotherapy institutions in Germany in 1997/2000 were collected to know therapy modalities, results and side effects. Keloids were irradiated in 101 institutions. During a time up to 35 years 1672 patients were irradiated, 880 patients had a follow-up. RESULTS: Mostly radiotherapy was applied soon postoperatively with kilovoltage radiotherapy or electrons 4-12 MeV fractionated 3-5 times a week and single doses of 2-3 Gy up to total doses of 10-20 Gy. 101 relapses were seen, the frequency of 11.4% is in the range of literature. Relapses were seen in the interval of some weeks up to 2 years after therapy. Side effects of irradiation were low, no malignant transformation was reported. CONCLUSION: Postoperative radiotherapy for keloids is applied in Germany mostly under equal conditions. This therapy offers effective relapse prophylaxis with nearly no side effects. A follow-up for 2 years is necessary to see outcome and relapses of irradiation.

Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial.

PURPOSE: Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic radiotherapy? MATERIAL AND METHODS: Fifty-six patients with an indication for adjuvant pelvic irradiation after curative surgery were double-blind randomized. All patients took 3 x 4 capsules study medication daily during radiotherapy. Twenty-eight patients in the enzyme group (EG) received capsules containing papain, trypsin and chymotrypsin, 28 in the placebo group (PG) received placebo capsules. All patients were irradiated with 5 x 1.8 Gy weekly to 50.4 Gy using four-field-box technique after CT-based planning. Primary objective was the grade of diarrhea, nausea, vomiting, fatigue and epitheliolysis during radiotherapy. Secondary objectives were the number of supportive medications and treatment interruptions due to acute toxicity. RESULTS: None/mild diarrhea: 43% EG, 64% PG. Moderate/severe diarrhea: 57% EG, 36% PG (P = 0.11). Mean duration: 11 days in EG, 10 days in PG. None/mild nausea: 93% EG, 93% PG. Moderate/severe nausea: 7% EG, 7% PG. None/mild vomiting: 100% EG, 97% PG. None/mild fatigue: 82% EG, 93% PG. Moderate/severe fatigue: 18% EG, 7% PG (P = 0.23). None/mild epitheliolysis: 75% EG, 93% PG. Moderate/severe epitheliolysis: 25% EG, 7% PG (P = 0.16). Treatment interruption (mean days): 2.44 in EG, 1.46 in PG. Number of supportive medication: 29 in EG, 19 in PG. CONCLUSIONS: The prophylactic use of proteolytic enzymes does not reduce acute toxicities, treatment interruptions and number of supportive medication and therefore does not improve tolerance of adjuvant pelvic radiotherapy.