Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 4750
© 2004 American Society of Clinical Oncology

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Abstract

Neuroendocrine markers as predictor of octreotide acetate therapy in patients with hormone-refractory prostate cancer

Blekinge County Hospital, Karlskrona, Sweden; Department of Oncology, Karolinska Institute, Stockholm, Sweden; University Hospital MAS, Lund University, Malmö, Sweden; Department of Oncology. Lund University, Lund, Sweden; Statisticon, Uppsala, Sweden; Novartis, Täby, Sweden; Dept of Clin Chemistry, University of Uppsala, Uppsala, Sweden

4750

Background: Evidences of neuroendocrine differentiation in hormone-refractory prostate cancer has evoked expectations on new therapeutic options. Octreotide acetate has been used with varying results. In this pilot study the predictive value of Octreotide scintigraphy and/or serum Chromogranin-A (s-CrA) was investigated in patients treated with Octreotide acetate. Methods: Twenty patients with biopsy-proven prostate cancer and bone metastases and progressive disease during testosterone ablation therapy entered the trial. At base-line Octreotide scintigraphy, s-CrA, PSA, Alkaline phosohatase (ALP) was performed. Additionally two self-administered questionnaires EORTC QLQ C-30 (v3) and brief pain index were answered and a diary of pharmaceutical was started. The treatment consisted of Octreotide acetate 30 mg intra-muscular injection every month (Sandostatin LAR) after an initial run-in period of treatment with Octreotide acetate 100 µg subcutaneously injected three times a day for three days. The blood samples and questionnaires were repeated every month until the protocol was finished after three months. Results: Sixteen patients were treated per protocol, and 4 increased their global health score more than 10 units, with stable or decreased pain score without increase of analgesics. In 18 evaluable patients the PSA levels increased with an average from 259 to 542 µg/L during three months. Six patients responded with a reduction in ALP (median -26%, range -5 to -78%). Three patients were negative on Octreotide scintigraphy and 17 patients demonstrated positive lesions, generally of low intensity. At base-line s-CrA was elevated above normal range in 14 of the patients. In 6 of these patients s-CrA levels were normalized during treatment. No correlation was found between the result neither from Octreotide scintigraphy and therapy outcome nor between s-CrA and therapy outcome. Conclusions: Octreotide scintigraphy and s-CrA cannot identify those patients who responded on Octreotide acetate therapy with pain relief and improved health related quality of life using validated self assessed questionnaire.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis