A Phase IV Clinical Trial of Patients with Solid Tumors Receiving Lenograstim as Primary Prophylaxis for Chemotherapy-Induced Neutropenia, in a Docetaxel-Based Regimen
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. 1. Introduction 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]. Breast cancer is the number one cancer diagnosed amongst South African women with a 1 in 29 lifetime risk [2, 3], while prostate cancer is the most prevalent in men [4]. Nevertheless, treatment options have substantially improved survival rates. Systemic adjuvant chemotherapy with anthracycline- and taxane-containing regimens has become the standard first line treatment for early and metastatic breast cancer [5], with large phase III randomized trials showing extremely high long-term disease-free survival and overall survival rates (resp., 80% and 90% at 5 years and 70% and 80% at 8 years) [6]. Indeed, 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%. Furthermore, this is largely independent of age, nodal status, tumor diameter or differentiation, estrogen receptor status, or
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