Abstract
Docetaxel-based chemotherapy regimens have substantially improved survival and recurrence rates for cancer patients. Safety profile of docetaxel regimens includes toxicities, particularly a high risk of neutropenia and febrile neutropenia. Granotax was a prospective, open label, multicentre, national phase IV study that evaluated the incidence and severity of neutropenia in adult patients with solid tumors being treated with a docetaxel-based regimen while receiving the GCSF lenograstim. Among the 394 enrolled patients the incidence of grade 3-4 neutropenia was 16.2% and of febrile neutropenia was 1.5%, far lower than the reported 85–100% and 30–40% incidence without G-CSFs. A total of 68 patients (17.3%) were reported to have experienced at least one grade 3-4 adverse event during the study. Two (0.5%) patients and 32 (8.1%) patients had dose delayed due to febrile neutropenia and neutropenia, respectively. Four (1.0%) patients and 32 (8.1%) patients had a dose changed due to febrile neutropenia and neutropenia, respectively. The low incidence of adverse effects and chemotherapy dose changes, delays, and withdrawals supports the use of lenograstim as effective primary prophylaxis in South African patients being treated with a docetaxel-based regimen. Furthermore, lenograstim may increase the patient’s exposure to chemotherapy allowing patients to receive optimal dosing and duration of treatment, benefitting survival.
Highlights
South Africa is ranked 50th on the World Cancer Research Fund’s list of countries with the highest cancer prevalence [1] and has recently been predicted to have a 78% increase in cancer cases by 2030 [2]
The primary outcome of the Granotax study found the incidence of clinically important grade 3-4 neutropenia to be 16.2% in adult patients being treated for a solid tumor with a docetaxel-based chemotherapy regimen and using lenograstim as primary prophylaxis
In the BCIRG001 study conducted in 1491 women with node-positive breast cancer patients treated with adjuvant TAC versus FAC without the use of primary prophylactic granulocyte-colony stimulating factors (G-CSFs), the incidence of grade 3 or 4 neutropenia was 65.5% and the incidence of febrile neutropenia was 24.7% in treatment group treated with TAC [15]
Summary
South Africa is ranked 50th on the World Cancer Research Fund’s list of countries with the highest cancer prevalence [1] and has recently been predicted to have a 78% increase in cancer cases by 2030 [2]. A recent meta-analysis of data from 44,000 early breast cancer patients showed that the addition of a taxane such as docetaxel in anthracycline regimens reduces mortality by an average of ∼33% This is largely independent of age, nodal status, tumor diameter or differentiation, estrogen receptor status, or tamoxifen use [7]. G-CSFs have been shown to reduce overall mortality risk [8, 11], reduce the incidence of other adverse events (grade 2 or greater anaemia, asthenia, anorexia, myalgia, nail disorders, and oral mucositis) associated with docetaxel-based chemotherapy regimens, and increase health related quality of life and treatment compliance [8, 12]. Further nonhematological secondary objectives included evaluating the incidence and severity of asthenia, anorexia, myalgia, nail changes, and oral mucositis adverse events and recording neutropenia/FN associated days in hospital, infections, use of anti-infectives, and chemotherapy dose changes, withdrawals, or treatment delays
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