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Introduction
In Indian women, cervical cancer is among the most common malignancies, and is a major cause of mortality (1–3). India has a higher incidence of cervical cancer compared with the developed countries (1). The age-adjusted incidence rate of cervical cancer varies widely among Indian registries, from 4.91 to 23.07/100,000 populations; much higher than the world (7.9/100,000 population). Poor to moderate living standards, lack of proper screening, and a high (≥10% in women aged >30 years) prevalence of human papillomavirus infection could be the potential reasons responsible for the higher incidence in India (4).
The treatment of choice for early-stage cervical cancer is radical surgery, whereas, concurrent chemoradiation is preferred for locally advanced stages. However, the treatment options are very limited for patients with recurrent or metastatic cancers. In women with recurrent or limited metastatic disease, surgery or radiotherapy may be effective in only in few cases (5,6). After the clinical alert from the National Cancer Institute (NCI) in 1999 (7), concurrent chemoradiotherapy has become the standard of treatment for locally advanced cervical cancer (8); it enhances the radiosensitivity and local tumor efficacy of cytotoxic agents, with eradication of micrometastasis and ultimately improves the pelvic control and survival (9).
Chemotherapy with a platinum agent (carboplatin/cisplatin) and a taxane based regimen is considered the standard of care for cervical cancer in terms of longer overall survival (OS) and a better quality of life for the patients (5,7). Furthermore, carboplatin has advantages over cisplatin in terms of a better safety profile (low incidence of neuropathy, nephrotoxicity and emetogenesis) (10).
Docetaxel has dose limiting toxicities of acute hypersensitivity reactions, and fluid retention due to the excipients (polysorbate-80 and ethanol) used in the conventional formulations, which require corticosteroid premedication (11). DoceAqualip, a nanosomal docetaxel lipid suspension (NDLS), was developed with lipids generally recognized as safe (GRAS) by the US Food and Drug Administration (USFDA) and is devoid of polysorbate-80 and ethanol. DoceAqualip has been shown to be more effective than the conventional docetaxel in the treatment of breast cancer (12) and has demonstrated a promising overall response and safety without the need of corticosteroid in the treatment of breast cancer, advanced gastric adenocarcinoma, ovarian cancer, hormone refractory prostate cancer, and non-small cell lung cancer (11–13).
Here, we report a...