Efficacy and Safety of a Novel Nanosomal Docetaxel Lipid Suspension as an Anticancer Agent - A Retrospective Study

This retrospective study evaluated the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS; DoceAqualip®) in advanced solid tumors. Medical charts of adults with solid tumors treated with DoceAqualip® (75-100mg/m2 IV q3week) at Noora Hospital between June 2014 and June 2016 were analyzed. Of 69 patients, 54% were men; majority had stages III (47.82%) and IV (31.88%) cancer; gastric adenocarcinoma was most common (34.8%) type. Efficacy data was available for 56 patients, which showed best overall response in 58.9% (BOR; complete response [CR, 12.5%] + partial response [PR, 46.4%], p<0.0001), and disease control rate (DCR; CR+PR+stable disease) in 98.2% (p<0.0001); 1 patient had progressive disease (PD). Highest BOR (100%) was reported in urinary bladder cancer, and DCR (100%) in hormone refractory prostate cancer, urinary bladder cancer and soft tissue sarcoma. The efficacy evaluation for a pool of all 69 patients was: BOR 47.82% (CR, 10.14%+PR, 37.68%; p<0.0001), and DCR 79.71% (p<0.0001); 1 patient had PD and efficacy response was not available for 18.9% patients. At least 1 adverse events (≥1) was reported in 65% patients; 66 episodes of anemia+neutropenia (n=29), 47 neutropenia (n=17) and 15 anemia (n=5); nausea with vomiting (94 episodes) was most common nonhematological toxicity. DoceAqualip® monotherapy did not require granulocyte colony stimulating factor (G-CSF) support, whereas doublet/triplet chemotherapy required 2-3 doses of G-CSF to normalize counts. Overall, DoceAqualip® (75-100mg/m2) demonstrated a promising overall response and was well-tolerated in patients with different solid tumors.