Treatment with nanosomal paclitaxel lipid suspension conventional paclitaxel in metastatic breast cancer patients - a multicenter, randomized, comparative, phase II/III clinical study.

Background: A novel nanosomal paclitaxel lipid suspension (NPLS), free from Cremophor EL (CrEL) and ethanol, was developed to address the solvent-related toxicities associated with conventional paclitaxel formulation.

Objective: To evaluate the efficacy and safety of NPLS CrEL-based paclitaxel (conventional paclitaxel) in patients with metastatic breast cancer (MBC).

Design: A prospective, open-label, randomized, multiple-dose, parallel, phase II/III study.

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension (NDLS) versus Conventional Docetaxel as Neoadjuvant and Adjuvant Therapy for Primary Operable Breast Cancer.

Objective: Nanosomal docetaxel lipid suspension (NDLS) is a novel formulation developed to overcome toxicity issues caused by excipients (polysorbate 80 and ethanol) present in commercially available docetaxel formulation. We conducted a prospective, observational study to compare the outcomes of nanosomal docetaxel lipid suspension (NDLS)-based versus conventional docetaxel-based chemotherapy in primary operable breast cancer.

Methods: Sixty adult women with newly diagnosed stage IIb-III breast cancer were included.

Safety, Tolerability, and Pharmacokinetics of a Novel Mitochondrial Modulator, TRC150094, in Overweight and Obese Subjects: A Randomized Phase-I Clinical Trial.

TRC150094, a novel mitochondrial modulator, can restore metabolic flexibility by improving insulin resistance in preclinical studies. This study primarily aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of oral TRC150094 after conducting two double-blind, randomized, Phase-I studies, single ascending dose (SAD) and multiple ascending dose (MAD), with = 46, in overweight/obese adult and elderly subjects. In addition, the effect of TRC150094 on pharmacodynamic (PD) efficacy markers was evaluated.

Efficacy and safety of nanosomal docetaxel lipid suspension based chemotherapy in gastric and gastroesophageal junction adenocarcinoma.

The current retrospective multicenter study evaluated the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS; DoceAqualip) based chemotherapy in patients with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The medical charts of patients with gastric and GEJ adenocarcinoma, who were treated with NDLS (50-75 mg/m; 3 weekly cycles) based chemotherapy and followed-up from April 2014 to September 2018, were analyzed. The study endpoints included overall response rate (ORR) and disease control rate (DCR) in neoadjuvant and metastatic settings.

Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study.

Purpose: The purpose of this study was to evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip)-based chemotherapy in breast cancer.

Methods: Medical charts of patients with breast cancer, who were treated and followed up with NDLS (75-100 mg/m; 3-week cycle)-based chemotherapy from August 2014 to September 2018, were analyzed in this multicenter, retrospective study. The study endpoints were overall response rate (ORR: complete response [CR]+partial response [PR]) and disease control rate (DCR: CR+PR+stable disease [SD]) in neoadjuvant and metastatic settings.

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study.

Objective: To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) based chemotherapy in patients with sarcoma.

Methods: In this retrospective, multicenter (6 centers), observational study, we analyzed the medical charts of adult patients of either sex, who were treated with NDLS (75 mg/m in 3-weekly cycles) based chemotherapy for the treatment of sarcoma. The efficacy outcomes were overall response rate (ORR: complete response (CR) + partial response (PR)) and disease control rate (DCR: CR + PR + stable disease (SD)) in patients who received NDLS-based chemotherapy in neoadjuvant and metastatic settings.

Management of primary squamous cell carcinoma of the pancreas with a nanosomal paclitaxel lipid suspension-based regimen: A case report.

Squamous cell carcinoma (SCC) of the pancreas is a rare tumor with only a few case reports available. It is an aggressive form of pancreatic cancer with a poor prognosis. The diagnosis and optimal management of SCC of the pancreas is poorly defined due to the lack of standard treatment or guidelines and owing to the rarity of this malignancy.

Novel formulations of docetaxel, paclitaxel and doxorubicin in the management of metastatic breast cancer.

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.

Efficacy and safety of DoceAqualip in a patient with locally advanced cervical cancer: A case report.

The standard of care for locally advanced cervical cancer has been the combination of a taxane with platinum based therapy. Conventional docetaxel is known to cause hypersensitivity reactions, fluid retention and other toxicities due to polysorbate-80 and ethanol. Corticosteroid premedication prior to docetaxel administration is required to prevent these toxicities, however, toxicities are still observed, sometimes fatal, despite premedication.

Successful downstaging of locally recurrent penile squamous cell carcinoma with neoadjuvant nanosomal docetaxel lipid suspension (NDLS) based regimen followed by curative surgery.

Penile squamous cell carcinoma (pSCC) is a relatively rare disease in Western world but is a significant health problem in developing countries like India. We report here a case of successful multimodality management of recurrent pSCC with pelvic lymphadenopathy in a 56-year-old male patient with poorly controlled diabetes. The patient presented with ulceroproliferative growth over the residual penile stump clinically involving root of penis and with right pelvic lymphadenopathy.

Kinetics of 14carbon dioxide excretion from 14C-urea by oral commensal flora.

Background And Aim: Previous studies have shown that while performing the (14)C-urea breath test ((14)C-UBT) for the detection of Helicobacter pylori (H. pylori), there is possibility of false-positive results due to the other urease producing bacteria present in oropharynx, if breath samples are obtained within 30 min after administration of non-capsulated (14)C-urea. Therefore, we have exclusively evaluated the kinetics of (14)carbon dioxide ((14)CO(2)) excretion by oral commensal flora to theoretically propose optimum breath collection timings for (14)C-UBT.