A phase II study of neoadjuvant gemcitabine plus doxorubicin in stage IIIB breast cancer: a preliminary report

• Published in: Seminars in oncology Vol. 28; no. 3 Suppl 10; p. 57
• Main Authors: Gomez, H, Kahatt, C, Falcon, S, Santillana, S, de Mendoza, F H, Valdivia, S, Vallejos, C, Otero, J, Pen, D L
• Format: Journal Article
• Language: English
• Published: United States 01.06.2001
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Breast Neoplasms - radiotherapy; Breast Neoplasms - surgery; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Doxorubicin - administration & dosage; Female; Humans; Middle Aged; Neoadjuvant Therapy
• ISSN: 0093-7754
• DOI: 10.1016/S0093-7754(01)80010-5

The purpose of this ongoing study is to determine the response and safety of a combination of gemcitabine (Gemzar; Eli Lilly and Company, Indianapolis, IN) plus doxorubicin as neoadjuvant therapy for stage IIIB breast cancer. Thirty-nine chemotherapy-naive patients were enrolled in the study. The median age was 54 years (range, 32 to 74 years), and the median Karnofsky performance status was 100. Gemcitabine 1,200 mg/m(2) was given on days 1 and 8, and doxorubicin 60 mg/m(2) on day 1, followed by surgery or radiotherapy. Ninety-seven of 117 cycles (83%) were administered at full dose. An overall response rate of 95% was obtained, with a complete response in 18% (seven patients) and a partial response in 77% (30 patients). Twenty-eight patients (72%) underwent breast surgery after a maximum of three cycles of neoadjuvant therapy. World Health Organization grade 3/4 toxicities included leukopenia in nine cycles (8%), neutropenia in 16 cycles (14%), febrile neutropenia in 11 cycles (9%), and anemia in two cycles (2%). The most important nonhematologic toxicity was grade 2/4 mucositis in 16 cycles (14%), and/or grade 2/3 diarrhea in 10 cycles (9%). Neoadjuvant therapy with gemcitabine plus doxorubicin results in a high tumor response rate with moderate oral and hematologic toxicity. Semin Oncol 28 (suppl 10):57-61.