High dose epirubicin and cyclophosphamide in breast cancer stage IIIB

• Autores: José Aguiar Morales, D. Aguiar Bujanda, U. Bohn Sarmiento, Araceli Caballero Hidalgo
• Localización: Revista de oncología: Publicación oficial de la Federación de Sociedades Españolas de Oncología y del Instituto Nacional de Cancerología de México, ISSN 1575-3018, Vol. 6, Nº. 6, 2004, págs. 347-352
• Idioma: inglés
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• Resumen

  • Introduction. The aim of the study was to test the combination of high-dose 4-epiadriamycin (4-epi) with cyclophosphamide in treatment-naive, stage IIIB breast cancer patients.

    Material and methods. Between 1992 and 1994, 20 patients, 19 female and 1 male with locally-advanced (LA; n=9) and inflammatory (I; n=11) breast cancer were recruited. Mean age was 58 years (range 36-75 years). All patients had a Karnofsky performance status >80%. The treatment schedule was: 4-epi (120 mg/m2) and CTX (600 mg/m2) on day 1 every three weeks for three cycles. Those who achieved a complete response (CR) or a partial response (PR) underwent radical modified mastectomy, three cycles of 4-epi-cyclophosphamide (CTX), radiotherapy and tamoxifen (TMX). Patients with minor response (MR) or stable disease (SD) received hyperfractionated radiotherapy, three cycles of 4-epi-CTX and TMX.

    Results. All patients were evaluable for response and survival analysis. There were 19 (95%) overall responses (OR); CR+PR:12(60%); MR:7(35%); SD:1(5%). Three of twelve (25%) patients who underwent surgery achieved a pathological complete response (PCR). In the LA group were seen 6 (66.66%) relapses and 5 (55.55%) deaths and the inflamatory group showed 5 (45.45%) relapses and 6 (54.54%) deaths. In follow-up, the median progresion free survival (PFS) of the group was 32 months (95% CI: 0-72). The patients with CR had a median of 59 months (95% CI: 12-107) compared to 20 months (95% CI: 5-35) in the patients with PR (log-rank p=0.081). Overall survival (OS) was 44 months (95% CI: 0-98), with a median of 31 months (95% CI: 24-38) for the LA patients and 44 months (95% CI: 0-93) for the I group (log-rank p=0.9822).

    In general, the treatment was well tolerated, with grade 4 neutropenia in 6 (30%) patients and thrombocytopenia in 2 (10%). Nausea/vomiting grade 3-4 occurred in 4 (20%) patients and alopecia IV was 100% of patients.

    Conclusions. The combination of high-dose 4-epirubicin and cyclophosphamide is safe, with a high percentage of overall response (95%), well tolerated and without cardio-toxicity.