The management of breast cancer with advanced disease or metastasis is a common problem in India and other countries. A panel of 13 oncology experts deliberated on the sidelines of the 35th Indian Cooperative Oncology Network Conference held in Mumbai to formulate an expert opinion recommendation on the novel drug delivery system (NDDS) formulations in the treatment of metastatic breast cancer (MBC). The survey comprised of 39 questions related to limitations of conventional formulations and therapeutic positioning of NDDS formulations of docetaxel, paclitaxel and doxorubicin in the management of MBC. The experts used data from published literature and their practical experience to provide expert opinion and recommendations for use by the community oncologists. The experts opined that the newer NDDS formulations should provide a significant efficacy advantage in terms of overall survival and progression-free survival, or demonstrate better tolerability when compared with conventional formulations. The newer NDDS formulations of taxanes should be considered in special circumstances such as diabetes, in patients who have had hypersensitivity reactions and in cases where steroids need to be avoided. The novel formulations of doxorubicin should be used in the elderly and in patients with borderline cardiac function.
Fulvestrant is an oestrogen-receptor antagonist that exerts selective oestrogen receptor downregulation, antiproliferative activity and induction of apoptosis. It is indicated for the treatment of postmenopausal women with locally advanced or metastatic breast cancer for disease relapse or progression on or after adjuvant anti-oestrogen therapy. Fulvestrant was initially approved at a dose of 250 mg, however, the results of the CONFIRM trial led to approval of 500 mg dose (i.e. 500 mg on days 0, 14 and 28, then 500 mg every 28 days).Fulvestrant has also shown superiority over anastrozole as first-line therapy in the phase II trial. There are contrasting data for its efficacy when used in combination with anastrozole. It is well tolerated, with no significant difference with respect to the toxicity profile of other hormonal therapies. Treatment with fulvestrant is not associated with any clinically significant effects on sex hormone levels, bone-specific turnover markers or endometrial thickening. 4 Both anastrozole and letrozole have proven superior to tamoxifen as five years' primary adjuvant therapy in early breast cancer, in addition to providing a number of tolerability benefits compared with the tamoxifen. 5 The selective oestrogen receptor modulator (SERM) tamoxifen is also used widely to treat both premenopausal and postmenopausal patients with advanced breast cancer as firstline treatment. 6 Other endocrine therapies include the progestins, such as megestrol acetate, high-dose oestrogens and androgens. However, these treatment options are being used less frequently as newer, more effective and better-tolerated therapies become available. Although adjuvant endocrine therapy is an effective treatment for breast cancer, most patients with advanced disease will eventually exhibit resistance to individual therapies. Nonetheless, an initial response to endocrine treatment is generally indicative of a positive response to further alternative endocrine agents.
Schizophreniais a heterogeneous, chronic, severe, and disabling brain disorder that has affected people throughout history. Schizophrenia is a severely debilitating psychiatric disorder observed worldwide, with a median lifetime prevalence of 0.7%-1.0%. Iloperidone possesses stronger affinity for serotonin (5-HT2A) than dopamine (D 2) receptors, and its efficacy is roughly comparable to that of other (nonclozapine) antipsychotics. In May 2009, the Food and Drug Administration approved iloperidone for the acute treatment of schizophrenia in adults. Iloperidone may be a useful and safe option for the treatment of schizophrenia. Several confirmatory trials of iloperidone reported to reduced the symptoms of schizophrenia at oral doses from 12 to 24 mg, which was more effective than placebo in reducing positive and negative syndrome total score and Brief Psychiatric Rating scale scores. Iloperidone was found to be as effective as haloperidol and risperidone in post-hoc analysis. In several clinical studies, most common adverse events reported were dizziness, dry mouth, dyspepsia and somnolence, with few extra pyramidal symptoms and metabolic changes in short and long-term studies in adults. As per adverse effect concern, akathisia was rare in case of iloperidone but prolongation of the corrected QT (QTc) interval was comparable to haloperidol and ziprasidone. Further comparative studies are needed to assess the benefit/risk profile of iloperidone and its role in the treatment of schizophrenia.
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.
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