{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T22:52:58Z","timestamp":1761519178391},"reference-count":16,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[1999,11]]},"abstract":"<jats:p> PURPOSE: To assess the antitumor activity, safety, and hormone-suppressive effects of the irreversible aromatase inactivator, exemestane (Aromasin, Pharmacia &amp; Upjohn, Kalamazoo, MI), administered as third-line hormone therapy to postmenopausal women with metastatic breast cancer that is refractory to tamoxifen and megestrol acetate. <\/jats:p><jats:p> PATIENTS AND METHODS: Exemestane was administered at a dose of 25 mg\/d orally until patients experienced disease progression. The efficacy and safety of exemestane were clinically and radiographically evaluated. The impact of exemestane treatment on tumor-related signs and symptoms was assessed. The effect of exemestane on serum levels of estrogens and other steroidal hormones was determined. <\/jats:p><jats:p> RESULTS: Ninety-one patients were treated. There were four complete responses (CR) and eight partial responses (PR), for an objective response rate of 13% in the entire treated population. The overall success rate (CR, PR, or stable disease [SD]\u2009\u2265\u200924 weeks) was 30%. The median duration of response and overall success was 9 months and 8 months, respectively. Most patients with CR\/PR (83%; 10 of 12 patients) and SD \u2265 24 weeks (80%; 12 of 15 patients) had improved or stable tumor-related signs and symptoms. Mean levels of circulating estrone (E<jats:sub>1<\/jats:sub>), estradiol (E<jats:sub>2<\/jats:sub>), and estrone sulfate decreased to 11%, 22%, and 13% of baseline levels, respectively (at week 8 or 16 of treatment). One half of the patients had undetectable E<jats:sub>1<\/jats:sub> and E<jats:sub>2<\/jats:sub> levels during treatment, including at the time of disease progression. Mild nausea (20% of patients) and hot flashes (20%) were the most common drug-related adverse events and were generally grade 1. <\/jats:p><jats:p> CONCLUSION: Exemestane is an active and well-tolerated third-line hormonal therapy that represents a new treatment option for postmenopausal patients with advanced breast cancer that has become refractory to standard first- and second-line hormonal therapies. <\/jats:p>","DOI":"10.1200\/jco.1999.17.11.3418","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T06:06:07Z","timestamp":1487916367000},"page":"3418-3425","source":"Crossref","is-referenced-by-count":88,"title":["Multicenter, Phase II Trial of Exemestane as Third-Line Hormonal Therapy of Postmenopausal Women With Metastatic Breast Cancer"],"prefix":"10.1200","volume":"17","author":[{"given":"S.","family":"Jones","sequence":"first","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Vogel","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Arkhipov","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Fehrenbacher","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Eisenberg","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Cooper","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Honig","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Polli","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"Whaley","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"di Salle","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Tiffany","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Consonni","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Miller","sequence":"additional","affiliation":[{"name":"From the U.S. Oncology Research at Baylor-Sammons Cancer Center, Dallas, TX; Columbia Cancer Research Network, Miami, FL; Kaiser-Permanente, Vallejo, and Marin Oncology, Greenbrae, CA; University Hospital of Cleveland, Cleveland, OH; Georgetown University, Washington, DC; Pharmacia & Upjohn, Inc, Kalamazoo, and Trilogy Consulting Corp, Portage, MI; and Pharmacia & Upjohn, SpA, Milan, Italy."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"R2-3418","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.48.1.6"},{"key":"R3-3418","doi-asserted-by":"publisher","DOI":"10.1210\/jcem-36-2-207"},{"key":"R4-3418","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-198835060-00005"},{"key":"R5-3418","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.1983.tb00044.x"},{"key":"R6-3418","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1996.14.7.2000"},{"key":"R7-3418","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.2.453"},{"key":"R8-3418","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008226721932"},{"key":"R9-3418","doi-asserted-by":"publisher","DOI":"10.1016\/0022-4731(88)90129-X"},{"key":"R10-3418","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.1990.tb34309.x"},{"key":"R11-3418","doi-asserted-by":"publisher","DOI":"10.1016\/0960-0760(94)90270-4"},{"key":"R12-3418","unstructured":"Johannessen  DC,  Engan  T,  di Salle  E, et al: Endocrine and clinical effects of exemestane (PNU 155971), a novel steroidal aromatase inhibitor, in postmenopausal breast cancer patients: A phase I study.  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