Table of Contents
Journal of Cancer Research
Volume 2014 (2014), Article ID 684936, 7 pages
http://dx.doi.org/10.1155/2014/684936
Clinical Study

A Phase IV Clinical Trial of Patients with Solid Tumors Receiving Lenograstim as Primary Prophylaxis for Chemotherapy-Induced Neutropenia, in a Docetaxel-Based Regimen

1Wilgers Oncology Centre, Wilgers Hospital, Denneboom Road, Pretoria, Gauteng 0081, South Africa
2Sanofi South Africa, 2 Bond Street, Grand Central Extension 1, Midrand, Gauteng 1682, South Africa
3GVI Oncology Port Elizabeth, 1 Mangold Street, Newton Park, Port Elizabeth, Eastern Cape 6055, South Africa

Received 8 January 2014; Revised 4 March 2014; Accepted 5 March 2014; Published 6 April 2014

Academic Editor: Norikazu Masuda

Copyright © 2014 Samuel J. Fourie et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.