Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane

• Published in: Cancer chemotherapy and pharmacology 2014-10, Vol.74 (4), p.799-808
• Main Authors: Park, Ji Soo, Jeung, Hei-Cheul, Rha, Sun Young, Ahn, Joong Bae, Kang, Beodeul, Chon, Hong Jae, Hong, Min Hee, Lim, Seungtaek, Yang, Woo Ick, Nam, Chung Mo, Chung, Hyun Cheol
• Format: Article
• Language: English
• Subjects: Anthracyclines - administration & dosage; Anthracyclines - adverse effects; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Combined Chemotherapy Protocols; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Bridged-Ring Compounds - administration & dosage; Bridged-Ring Compounds - adverse effects; Cancer Research; Capecitabine; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease Progression; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Screening Assays, Antitumor; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Gynecology. Andrology. Obstetrics; Hand-Foot Syndrome - etiology; Hand-Foot Syndrome - physiopathology; Hand-Foot Syndrome - prevention & control; Humans; Mammary gland diseases; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Neoplasm Recurrence, Local; Neoplasm Staging; Neutropenia - chemically induced; Neutropenia - physiopathology; Neutropenia - prevention & control; Oncology; Original Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Republic of Korea - epidemiology; Severity of Illness Index; Taxoids - administration & dosage; Taxoids - adverse effects; Treatment Outcome; Tumors
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-014-2551-4

Purpose We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m 2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m 2 capecitabine orally twice daily on days 1–14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8–12.1], and median OS was 25.1 months (95 % CI 18.2–32.1). Prominent toxicities were neutropenia and hand–foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034–0.826; P  = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017–0.559; P  = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.