Docetaxel Case Study

BACKGROUND
• Docetaxel (Taxotere®), formulated with ethanol and polysorbate 80, is amongst the most active and widely used cytotoxic agents for the treatment of several types of cancer. Docetaxel in combination with other drugs is still a very good option against also used in treating several additional cancer types. 1-4
• Nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) is a novel formulation recently approved in India for various solid tumors. It was developed to improve the safety profile of docetaxel by eliminating polysorbate 80 and ethanol from its formulation.5
• With shorter infusion times and without premedication, NDLS has demonstrated good response rates and better tolerability than conventional docetaxel. However, its efficacy
• The secondary efficacy endpoint was the disease control rate (DCR, CR + PR + stable disease [SD]). Patients without a confirmed CR or PR or SD were considered as failure in computing the best overall response rates.
• The overall response was evaluated using battery of tests that include primary and CT, MRI, USG, Tumor Marker or Status (ovary-CA 125, Prostate – PSA), endoscopy (Ca Esophagus/Stomach). In these patients if CT / MRI were missing, the reasons were either assessment was done by other tests from the battery of tests OR patient had hypersensitivity with dye for CT, or patient had not provided consent for CT/MRI.
Safety
• Medical history, demography, physical examination and vital signs, body measurement, ECOG, hepatic screening, b-human chorionic gonadotropin test (serum), hematology biochemistry, and urine analysis were carried out as a part of safety evaluations.
• Incidences of adverse events (AEs) were recorded every cycle for the duration of the trial, and graded according to the National Cancer Institute Common Toxicity Criteria, version 4.02.
• Data on deaths and discontinuations were collected throughout the
• Patients receiving triplet chemotherapy (NDLS + Platinum derivative/5FU /Gemcitabine/Capecitabine) required GCSF support only after the evidence of neutropenia by lab testing, during the follow up period after each cycle. On average 2-3 doses of 300 µg Neukine was sufficient to maintain the counts at acceptable range.
• In one patient on doublet chemotherapy (Doceaqualip + Carboplatin) for non-small cell lung cancer, febrile neutropenia was encountered after the 3rd cycle chemotherapy. This patient recovered after receiving 6 doses of 300 µg Neukine on daily basis.
• Patients receiving doublet chemotherapy containing Gemcitabine 1000 - 1200 mg/m2 (N = 4) required 2 - 3 doses of 300 µg Neukine to keep the counts at acceptable range for subsequent administration of the chemotherapy cycle.
• Patients receiving NDLS with Capecitabine doublet did not receive GCSF support for first 2 cycles of chemotherapy (N = 3), following the 3rd cycle 300 µg of Neukine for 2 days was usually sufficient to maintain the counts at acceptable levels for further