A Phase II Study of CaelyxTM (Liposomal Doxorubicin) in Metastatic Carcinoma of the Prostate: Tolerability and Efficacy Modification by Liposomal Encapsulation

A single centre phase II study wasconducted to determine the toxicity andactivity of CaelyxTM in hormone refractorymetastatic prostate cancer. Doxorubicinis known to be active in this setting andliposomal encapsulation may enhance itstherapeutic efficacy and also reducetoxicity. Fourteen patients with hormonerefractory metastatic prostate cancer weretreated with CaelyxTM 50 mg/m2 onceevery four weeks. All patients hadradiologically proven bone metastases andthree also had soft tissue metastaticdisease. All patients were evaluable fortoxicity and response was assessable inthirteen cases. Three PSA responses weredocumented in patients with non-measurabledisease. No patient had an objectiveresponse in measurable disease. Thecommonest toxicity was cutaneous and thiswas dose limiting in two patients. Gastrointestinal upset was frequent butgenerally mild. One patient died shortlyafter an episode of neutropaenic sepsiswith associated grade 3 mucositis followinghis third cycle of chemotherapy. Weconfirmed the toxicity profile of CaelyxTMbut its modest antitumour efficacy in thisgroup of patients suggests little promisefor future study in metastatic prostatecancer.