Zoladex as primary therapy in advanced prostatic cancer. A French cooperative trial

• Published in: American journal of clinical oncology Vol. 11 Suppl 2; p. S112
• Main Authors: Metz, R, Namer, M, Adenis, L, Audhuy, B, Bugat, R, Colombel, P, Couette, J E, Grise, P, Khater, R, LePorz, B
• Format: Journal Article
• Language: English
• Published: United States 1988
• Subjects: Acid Phosphatase - analysis; Aged; Aged, 80 and over; Buserelin - administration & dosage; Buserelin - adverse effects; Buserelin - analogs & derivatives; Buserelin - therapeutic use; Delayed-Action Preparations; Follicle Stimulating Hormone - blood; France; Goserelin; Humans; Injections, Subcutaneous; Luteinizing Hormone - blood; Male; Middle Aged; Multicenter Studies as Topic; Neoplasm Metastasis; Neoplasms, Hormone-Dependent - drug therapy; Neoplasms, Hormone-Dependent - enzymology; Prospective Studies; Prostate - enzymology; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - enzymology; France
• ISSN: 0277-3732
• DOI: 10.1097/00000421-198801102-00027

From April 1984 to May 1986, 129 patients with prostate cancer entered a prospective trial with a new LH-RH agonist, Zoladex. Mean age was 72 years (range of 45-94 years) and, in most cases, patients had metastatic disease, not previously treated by chemotherapy or hormone therapy. Patients received a monthly injection of 3.6 mg. Serum testosterone was lowered into the range of castrate levels after 4 weeks of treatment. In 105 evaluable patients at 3 months, a 65% partial response (PR) rate was observed, with 11% stable and 24% progressive disease. Median time to progression was 37 weeks. Analysis of objective criteria revealed 30% PR for prostate volume and 51% CR-PR for prostatic acid phosphatases. Seventeen percent of lytic metastases had recalcified. One hundred twenty-nine patients were evaluable for toxicity. Endocrinological side effects were common: decrease in libido, 92%; impotence, 86%; hot flushes, 48%; and breast swelling or tenderness, 9%. Nonendocrinologic side effects were rare. The treatment is generally well accepted by patients owing to the convenient depot formulation and to the minor side effects.