397 - Low doses of gemcitabine (G) with cisplatin (C) in treatment of metastatic breast cancer (mBC) progressing after anthracyclines, taxanes, capecitabi...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Presenter T. Y Semiglazova
Authors T..Y. Semiglazova1, M.L. Gershanovich1, D.H. Latipova1, L.V. Filatova1, V.A. Chubenko1, V.F. Semiglazov2, V.V. Semiglazov3, P.V. Krivorotko2, D.E. Matsko4, V.V. Klimenko3
  • 1Department Of Chemotherapy, N.N.Petrov Research Inst. of Oncology, 197758 - St. Petersburg/RU
  • 2Breast Cancer Department, N.N.Petrov Research Inst. of Oncology, 197758 - St. Petersburg/RU
  • 3Department Of Oncology, Pavlov Medical University, St. Petersburg/RU
  • 4Department Of Pathology, N.N.Petrov Research Inst. of Oncology, 197758 - St. Petersburg/RU

Abstract

Background

The highest synergism of G was registered with C, as G suppresses DNA reparation after its damage from C, which leads to apoptosis of tumor cell. The study of optimal doses of G and C combination continues for intensive pretreated MBC.

Purpose

Evaluate efficiency and tolerability of the low doses of G and C in 131 patients with MBC progressing after anthracyclines, taxanes, capecitabine and other antineoplastic agents.

Methods

G 600-750 mg/m2 and C 30 mg/m2 were administered on days 1 and 8 every 3 weeks in the 2nd line for 28 patients, in the 3rd for 54 patients and in the 4th for 49 patients. Groups were comparable in age, performance status (PS), ER/PgR and HER2 expressions, localization and number of metastatic sites prior to treatment.

Results

Total amount of cycles: 549, median 4.2 per patient (range: 2-12). The overall response (OR) of all patients was 27%, clinical benefit (OR + stable disease) – 71.7%, with median time to progression (TTP) 4.8 months (95% CI 3.9-5.7 months) and median overall survival (OS) 14.6 months (95% CI 12.1-17.1 months). The OR in the 2nd line was observed in 39.3%, in the 3rd – 27.8% and in the 4th– 18.4% (р < 0.05), clinical benefit – in 85.7, 59.3 and 77.6% (р > 0.05) respectively. Pain intensity reduction and improvement of PS were noted in patients in spite of the lines. Linear discriminant and regression analyses showed that OR, TTP and OS didn't depend on the ER/PgR and HER2 expressions, but ECOG 2-3, pain syndrome, metastases in the lymph nodes and liver were the factors of poor prognosis. The treatment-related adverse events were neutropenia, anemia, thrombocytopenia, alopecia, nausea, vomiting, peripheral neuropathy and fatigue. Toxicities with grade 3-4 intensity were neutropenia (31.6% of patients), vomiting (0.8%), anemia (2.3%), thrombocytopenia (3.1%). No febrile neutropenia and deaths related to the study treatment occurred.

Conclusions

The low doses of G with C are effective and tolerable in treatment of MBC progressing after antracycline, taxanes, capecitabine, other antineoplastic agents not only in the 2ndand 3rd, but also in the 4th lines and are suitable for outpatient therapy.

Disclosure

All authors have declared no conflicts of interest.