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INTRODUCTION: The incidence of thrombosis associated with pancreatic cancer chemotherapy is high (22-36%), however the incidence in BDT is unknown. AIM: The aim of this study is to analyze the incidence of incidental and symptomatic VTE, and its chronological pattern, in patients with BDT receiving chemotherapy in ambulatory setting. MATERIALS AND METHODS: We conducted a retrospective study to determine the incidence of VTE in patients with BDT, treated at 6 hospitals of the Cancer & Thrombosis Working Group of the Spanish Society of Medical Oncology (SEOM). 136 consecutive patients diagnosed and treated with chemotherapy, were identified between January 2008 and December 2012 and included in this analysis. RESULTS: Clinical characteristics in Table 1. With a median follow up of 16.6 months (range 0.4-98.2), VTE was identified in 26 patients (19.1%): 10 pulmonary embolism, 9 deep vein thrombosis and 7 visceral vein thrombosis. All VTE occurred in patients with active tumor (2 locally advanced, 24 metastatic). 46% of the events were incidentally diagnosed. 62% of the events occurred in the first 6 months after diagnosis of cancer. Eight events were identified during the diagnostic workup of the neoplasm. Only 1 patient had a VTE recurrence (superficial venous thrombosis). A non-significant trend towards lower survival (OS) in patients with VTE (median OS 20.9 months vs 13.6 months; p=0.066) was observed. CONCLUSIONS: The incidence of VTE in patients undergoing chemotherapy for BDT in the ambulatory setting is high, but lower than that described in pancreatic cancer.
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BACKGROUND: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). PATIENTS AND METHODS: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). RESULTS: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03). CONCLUSIONS: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.