FOLFOX-4 is an effective and well-tolerated regimen as a second-line treatment in advanced gall bladder cancer patients. Further studies are required, especially in the Indian subcontinent.

Purpose. To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) in patients with metastatic castration-resistant prostate cancer (mCRPC). Materials and Methods. In this multicenter, retrospective study, we analyzed the medical charts of mCRPC patients, who were treated with NDLS administered as 2-weekly (50 mg/m2) or 3-weekly regimens (75 mg/m2). The study endpoints were prostate-specific antigen (PSA) response (>50% PSA decline from baseline), PSA progression (PSA increase from baseline beyond 12 weeks: ≥25% and ≥2 ng/mL), median PSA decline, and time-to-treatment failure (TTF). Overall survival (OS) and safety were also evaluated. Results. Data of 24 patients with mCRPC were analyzed in this study. NDLS was administered as a 2-weekly regimen in 37.5% (9/24; all first-line) patients and as a 3-weekly regimen in 62.5% patients (15/24; first-line: 20% (3/15), second-line: 80% (12/15)). Overall, PSA response was reported in 66.7% (16/24) patients. The PSA response was 77.8% (7/9 patients) in the 2-weekly group and 60% (9/15 patients) in the 3-weekly group. The median decline in PSA was 96.31% in the 2-weekly group and 83.29% in the 3-weekly group; the median TTF was 6.7 and 6.5 months in the 2 weekly group and 3-weekly group, respectively. The median OS was 14.6 months (follow-up: 5.5–25.8 months) in the 2-weekly group whereas it was not reached in the 3-weekly group (follow-up: 7.9–15.6 months). The most common hematological AEs were anemia, lymphopenia, thrombocytopenia, and neutropenia whereas nausea, weakness, constipation, vomiting, and diarrhea were the most common (≥10%) nonhematological AEs. Overall, NDLS treatment was well tolerated without any new safety concerns. Conclusions. Nanosomal docetaxel lipid suspension (2-weekly or 3-weekly) was effective and well tolerated in patients with metastatic castration-resistant prostate cancer.

No abstract

enrolled. Relevant demographic data were recorded, including performance status (assessed by Karnofsky performance status [KPS] and European Cooperative Oncology Group [ECOG] scoring system). Epidermal growth growth factor receptor (EGFR) expression was estimated in serum using reverse transcriptase polymerase chain reaction (RT-PCR) at baseline and following four cycles of Carboplatin-Paclitaxel chemotherapy. Response was assessed using the RECIST 1.1 criteria. Objective response rate (ORR) was defined as Complete remission (CR) or partial response (PR) and Disease control rate (DCR) was defined as CR/PR/Stable disease (SD). Kaplan meier curve was used to compare the overall survival (OS) between subjects based on median EGFR expression level as the cutoff. Results: A total of 82 subjects were enrolled. These included 79 (96.3%) males with mean (SD) age of 61.9 (9.8) years and 48.8% having metastatic disease. Majority were current / former smokers (97.6%); 59.7% had KPS ranging between 40-70 and 48.1% had ECOG of 0/II. The baseline mean (± SD) serum EGFR expression was 17.8 ± 9.3 fold increase over control values, with median (min., max.) of 18.2 (4.4, 42.8). Following chemotherapy, ORR and DCR were 59.7% and 77.3% respectively. Significant reduction in EGFR expression was observed with median (min, max.) absolute and percentage reduction of 6.2 fold (−3.1, 33.6), and 54.2 % (−55.6, 78.4) respectively; p < 0.001. No significant association was observed between change in EGFR expression and age, gender, disease stage, performance status, ORR or DCR. Subjects with baseline EGFR expression of greater than 16.0 fold had significantly worse OS than those with <16.0 fold increase. Conclusions: EGFR is over-expressed in advanced squamous cell lung cancer and is significantly downregulated following chemotherapy; additionally, baseline expression is a useful marker of overall survival following chemotherapy. Legal entity responsible for the study: N/A