Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer

K. J. O'Byrne, N. Dobbs, D. J. Propper, J. P. Braybrooke, M. I. Koukourakis, K. Mitchel, J. Woodhull, D. C. Talbot, Andrew V Schally, A. L. Harris

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

RC-160 (octastatin/vapreotide) is a potent octapeptide analogue of somatostatin with growth inhibitory activity in experimental tumours in vitro and in vivo, including breast cancer. We evaluated the efficacy and tolerability of high-dose RC-160, 3 mg day-1 on week 1 increased to 4.5 mg day-1 for weeks 2-4 and subsequently 6 mg day-1 until the end of treatment, administered by continuous subcutaneous infusion in the management of 14 women with previously treated metastatic breast cancer. The age range was 37-80 years (median 58.5 years) and performance status 0-2. The treatment was well tolerated with no dose reductions being required. No grade 3 or 4 toxicities were seen. Abscess formation developed at the infusion site in eight patients and erythema and discomfort was seen in a further three patients. A significant reduction in IGF-I levels occurred by day 7 and was maintained throughout the treatment. The lowest dose of RC-160 produced the maximal IGF-I response. Although there was no reduction in prolactin levels in patients whose baseline levels were normal, elevated prolactin levels found in three patients fell to within the normal range 7 days after commencing RC-160 treatment. A small but significant rise in fasting blood glucose levels was also recorded, the highest level on treatment being 7.6 mmol l-1. No objective tumour responses were observed, all patients showing disease progression within 3 months of commencing treatment. These findings demonstrate that high-dose RC-160, administered as a continuous subcutaneous infusion, can reduce serum levels of the breast growth factors IGF-I and prolactin but is ineffective in the management of metastatic breast cancer. Encouraging preclinical anti-tumour activity and the favourable toxicity profile in patients suggest the merit of future studies combining RC-160 with anti-oestrogen, cytotoxic and anti-angiogenic agents.

Original languageEnglish
Pages (from-to)1413-1418
Number of pages6
JournalBritish Journal of Cancer
Volume79
Issue number9-10
StatePublished - Mar 17 1999
Externally publishedYes

Fingerprint

Somatostatin
Breast Neoplasms
Insulin-Like Growth Factor I
Prolactin
Subcutaneous Infusions
Therapeutics
Neoplasms
vapreotide
Erythema
Abscess
Disease Progression
Blood Glucose
Fasting
Intercellular Signaling Peptides and Proteins
Estrogens
Reference Values
Breast
Growth
Serum

Keywords

  • Breast cancer
  • Insulin-like growth factor-I
  • Metastatic
  • Prolactin
  • RC-160
  • Somatostatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

O'Byrne, K. J., Dobbs, N., Propper, D. J., Braybrooke, J. P., Koukourakis, M. I., Mitchel, K., ... Harris, A. L. (1999). Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer. British Journal of Cancer, 79(9-10), 1413-1418.

Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer. / O'Byrne, K. J.; Dobbs, N.; Propper, D. J.; Braybrooke, J. P.; Koukourakis, M. I.; Mitchel, K.; Woodhull, J.; Talbot, D. C.; Schally, Andrew V; Harris, A. L.

In: British Journal of Cancer, Vol. 79, No. 9-10, 17.03.1999, p. 1413-1418.

Research output: Contribution to journalArticle

O'Byrne, KJ, Dobbs, N, Propper, DJ, Braybrooke, JP, Koukourakis, MI, Mitchel, K, Woodhull, J, Talbot, DC, Schally, AV & Harris, AL 1999, 'Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer', British Journal of Cancer, vol. 79, no. 9-10, pp. 1413-1418.
O'Byrne KJ, Dobbs N, Propper DJ, Braybrooke JP, Koukourakis MI, Mitchel K et al. Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer. British Journal of Cancer. 1999 Mar 17;79(9-10):1413-1418.
O'Byrne, K. J. ; Dobbs, N. ; Propper, D. J. ; Braybrooke, J. P. ; Koukourakis, M. I. ; Mitchel, K. ; Woodhull, J. ; Talbot, D. C. ; Schally, Andrew V ; Harris, A. L. / Phase II study of RC-160 (vapreotide), an octapeptide analogue of somatostatin, in the treatment of metastatic breast cancer. In: British Journal of Cancer. 1999 ; Vol. 79, No. 9-10. pp. 1413-1418.
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