[Evaluation of the complementary drug Factor AF2 as a supportive agent in management of advanced urothelial carcinoma. Prospective randomized multicenter study].

Abstract	This is a prospective randomized multicenter trial for evaluation of the biological response modifier Factor AF2 in advanced urothelial cancer treated with chemotherapy. Main aim of the study was the analysis of supportive effects. Additionally patients were examined with regard to tumor response, time to progression and survival. 106 patients with advanced urothelial cancer received chemotherapy with cisplatin and methotrexate. They were randomized for additional Factor AF2 (500 mg i.v., given at days 0-3, 7-10 and 11-14). Myelotoxicity was more common and severe in the group without Factor AF2 reaching statistical significance. Gastrointestinal side effects occurred in both groups, though grade III to IV toxicity was more common without Factor AF2. Overall remission rate was 38%, median survival 33 weeks, mean time to progression 20 weeks. There was no significant difference between the two groups with or without Factor AF2.
Authors	S Krege, A Hinke, T Otto, H Rübben
Journal	Der Urologe. Ausg. A (Urologe A) Vol. 41 Issue 2 Pg. 164-8 (Mar 2002) ISSN: 0340-2592 [Print] Germany
Vernacular Title	Bewertung des Komplementärtherapeutikums Factor AF2 als Supportivum in der Behandlung des fortgeschrittenen Urothelkarzinoms. Prospektiv randomisierte Multicenterstudie.
PMID	11993095 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References	Tissue Extracts factor AF2
Topics	Aged Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use) Carcinoma, Transitional Cell (drug therapy, mortality, pathology) Combined Modality Therapy Complementary Therapies Disease Progression Female Humans Male Middle Aged Neoadjuvant Therapy Neoplasm Staging Prospective Studies Survival Rate Tissue Extracts (administration & dosage, adverse effects) Urinary Bladder Neoplasms (drug therapy, mortality, pathology)

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