Biweekly DoceAqualip in mCRPC patients beyond 20 cycles: A case series.

INTRODUCTION: Docetaxel 75 mg/m2 every 3 weeks for up to 10 cycles is an accepted standard regimen in metastatic castration-resistant prostate cancer (mCRPC). We report our experience with >20 cycles of biweekly nanosomal docetaxel lipid suspension (NDLS) treatment in patients with mCRPC. CASE REPORTS: Cases with long-term treatment of NDLS treatment in mCRPC patients were identified from the medical records of Jawaharlal Nehru Cancer Hospital & Research Centre Bhopal, India. A total of three cases with >20 cycles of NDLS are presented here. MANAGEMENT AND OUTCOMES: Overall, the 3 patients received biweekly NDLS at a dose of 45 mg/m2 for 22, 36, and 40 cycles, respectively, except for one patient where NDLS was initiated at 50 mg/m2 and later reduced to 45 mg/m2. All the 3 patients reported prostate-specific antigen (PSA) response (>50% decline in PSA levels from baseline). The time to treatment failure (TTF) was 14.8, 18.2, and 20.6 months in these 3 patients, respectively. PSA nadir occurred after 14, 6 and 13 cycles, respectively. The OS was 21.6, 22.2 and 25.8 months, respectively. Anemia, lymphopenia, and neutropenia were the most common adverse events. NDLS treatment was overall well-tolerated without any new safety concerns. CONCLUSIONS: Biweekly NDLS for >20 cycles was effective and well-tolerated in patients with mCRPC. NDLS can potentially be used for long-term management, which may be a requirement for most patients with mCRPC.

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. Patients received NDLS-based (n=30) or docetaxel-based (n=30) chemotherapy. Patients received (1) four cycles of preoperative doxorubicin and cyclophosphamide (AC) followed by four cycles of NDLS or docetaxel (T) and surgery (neoadjuvant AC→NDLS [n=9], or neoadjuvant AC→T [n=10]), or (2) four cycles of preoperative AC followed by surgery and postoperative NDLS or T (neoadjuvant AC→adjuvant NDLS [n=14], or neoadjuvant AC→adjuvant T [n=15]), or (3) surgery followed by postoperative AC→NDLS or T (adjuvant AC→NDLS [n=7], or adjuvant AC→T [n=5]) regimens. The study outcomes were pathological complete response (pCR) rates, clinical overall response rates (ORR), disease-free survival (DFS), overall survival (OS), and adverse event (AE) profile. Results: For neoadjuvant AC→T (n=10) vs neoadjuvant AC→NDLS (n=9), the pCR rates were 100% each, and the ORR were 100% vs 88.9% (p=1.0). All patients were alive at 6 months, and the median OS was not reached. Three patients had progressive disease (T: n=2, NDLS: n=1) with a DFS of 12 weeks in all three patients. Grade 3 infusion-related reactions were seen in five patients (16.7%) in T vs none in NDLS arms. Conclusion: NDLS-based neo/adjuvant chemotherapy was efficacious in the treatment of primary operable breast cancer and showed comparable pCR, ORR, DFS and OS rates versus conventional docetaxel. NDLS was better tolerated than conventional docetaxel.

Research on National Disaster Life Support Course in China.

OBJECTIVES: To provide scientific, theoretical support for the improvement of medical disaster training, we systematically analyzed the National Disaster Life Support (NDLS) Course and established a training curriculum with feedback based on the current status of disaster medicine in China. METHODS: The gray prediction model is applied to long-term forecast research on course effect. In line with the hypothesis, the NDLS course with feedback capability is more scientific and standardized. RESULTS: The current training NDLS course system is suitable for Chinese medical disasters. After accepting the course training, audiences' capabilities were enhanced. In the constructed GM (1,1) model prediction, the developing coefficients of the pretest and the posttest are 0.04 and 0.057, respectively. In light of the coefficient, the model is appropriate for the long-term prediction. The predicted results can be used as the basis for constructing training closed-loop optimization feedback. It can indicate that the course system has a good effect as well. CONCLUSIONS: According to the constructed GM model, the NDLS course system is scientific, practical, and operational. The research results can provide reference for relevant departments and be used for the construction of similar training course systems.

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/m2; 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. Overall survival (OS) and safety were evaluated for all settings. RESULTS: Of 91 patients (neoadjuvant: 12, adjuvant: 61, metastatic: 18), efficacy evaluation in 29 patients (neoadjuvant: 12/12, metastatic: 17/18) demonstrated an ORR and DCR of 100%, respectively, in the neoadjuvant setting, and an ORR of 64.7% and DCR of 70.6%, respectively, in the metastatic setting. At a median follow-up of 21.6 months (range: 2.1 to 49.9 months), median OS was not reached in neoadjuvant and adjuvant settings, and it was 30.4 months in metastatic settings. At least one adverse event (AE) was reported in 59.3% of patients. Anemia, thrombocytopenia, lymphopenia, and neutropenia were the most common hematological AEs reported while hyperglycemia and alteration in liver function tests were the most common non-hematological AEs. NDLS-based treatment was well tolerated without any new safety concerns. CONCLUSION: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer. Further, NDLS is being evaluated prospectively in patients with triple-negative breast cancer (ClinicalTrials.gov: NCT03671044).

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/m2; 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. Overall survival (OS) and safety were also evaluated. Of the 43 patients with gastric (n=39) and GEJ (n=4) adenocarcinoma, efficacy evaluation was available in 35 (neoadjuvant, 17/18 patients; metastatic, 18/25 patients). In the neoadjuvant setting, an ORR of 58.82% and a DCR of 94.11% were observed, whereas in the metastatic setting, the ORR was 77.77% and the DCR was 83.33%. In the neoadjuvant setting, at a follow-up ranging from 0.7 to 41.2 months, the median OS was not reached. In the metastatic setting, the median OS was 31.9 months at a follow-up ranging from 0.2 to 50.3 months. At least one adverse event (AE) was reported in 24 patients. Anemia, lymphopenia and thrombocytopenia were the most common hematological AEs, while nausea, vomiting and weakness were the most common non-hematological AEs. NDLS based treatment was well-tolerated without any new safety concerns. Overall, NDLS-based chemotherapy was effective and well-tolerated in the management of gastric and GEJ adenocarcinoma.

Nanosomal docetaxel lipid suspension based chemotherapy in a pregnant MBC patient - a case report.

The current report presents a case of a pregnant woman with breast cancer metastasized to liver and lungs. The standard of care for breast cancer in pregnancy is anthracycline/taxane-based chemotherapy regimens. Docetaxel has shown a favorable toxicity profile during the second and third trimesters of pregnancy. A novel nanosomal docetaxel lipid suspension (NDLS) (DoceAqualip), with a proven efficacy and tolerability profile, has been approved in India for the treatment of advanced solid tumors since 2013. We present here a case of a pregnant woman with metastatic breast cancer managed with NDLS based TAC regimen showing a partial response after six cycles. The patient delivered a healthy male child with normal Apgar score and weight at the 32nd week of gestation.

Basic Disaster Life Support (BDLS) Training Improves First Responder Confidence to Face Mass-Casualty Incidents in Thailand.

BACKGROUND: Medical response to mass-casualty incidents (MCIs) requires specialized training and preparation. Basic Disaster Life Support (BDLS) is a course designed to prepare health care workers for a MCI. The purpose of this study was to evaluate the confidence of health care professionals in Thailand to face a MCI after participating in a BDLS course. METHODS: Basic Disaster Life Support was taught to health care professionals in Thailand in July 2008. Demographics and medical experience were recorded, and participants rated their confidence before and after the course using a five-point Likert scale in 11 pertinent MCI categories. Survey results were compiled and compared with P<.05 statistically significant. RESULTS: A total of 162 health care professionals completed the BDLS course and surveys, including 78 physicians, 70 nurses, and 14 other health care professionals. Combined confidence increased among all participants (2.1 to 3.8; +1.7; P<.001). Each occupation scored confidence increases in each measured area (P<.001). Nurses had significantly lower pre-course confidence but greater confidence increase, while physicians had higher pre-course confidence but lower confidence increase. Active duty military also had lower pre-course confidence with significantly greater confidence increases, while previous disaster courses or experience increased pre-course confidence but lower increase in confidence. Age and work experience did not influence confidence. CONCLUSION: Basic Disaster Life Support significantly improves confidence to respond to MCI situations, but nurses and active duty military benefit the most from the course. Future courses should focus on these groups to prepare for MCIs. Kuhls DA , Chestovich PJ , Coule P , Carrison DM , Chua CM , Wora-Urai N , Kanchanarin T . Basic Disaster Life Support (BDLS) training improves first responder confidence to face mass-casualty incidents in Thailand. Prehosp Disaster Med. 2017;32(5):492-500 .

Assessment of the Knowledge of Blast Injuries Management among Physicians Working in Tripoli Hospitals (Libya).

Introduction No study on hospital staff preparedness for managing blast injuries has been conducted in Libya. The internal conflict in Libya since 2011 and the difficulties faced by the hospitals has highlighted the need for such studies. Hypothesis Physicians working in Tripoli (capital city Libya) hospitals are inadequately prepared for the management of blast injuries. METHODS: A survey was conducted in all 13 hospitals in Tripoli between June 2014 and May 2015 by using interviews based on a questionnaire consisting of 29 questions covering physicians' education related to blast injury, hospital management of mass casualties, and aspects of hospital preparedness for such incidents. RESULTS: Of 3,799 physicians working in Tripoli hospitals, 607 physicians were interviewed (16.0%). All but one of the physicians reported that there was no disaster response plan, none of them had read such a plan, 496 (81.7%) reported that hospitals were not prepared, and 471 (77.6%) that hospitals were not equipped for blast injuries. Though 414 (68.2%) reported that radiological equipment was available, 597 (98.3%) revealed that hospitals do not adopt training for blast injury. Only 39 (6.4%) had received professional training, though 183 (30.1%) were seeing blast injury patients at least once a week in their daily practice. Nevertheless, 185 (30.5%) had previous knowledge and experience in blast injuries management and 338 (55.70%) were aware of the major physical findings, but only 75 (12.4%) were following specific guidelines. According to approximately one-third of the physicians (192; 31%), staff and patient safety were not priorities for the hospital administration. Almost all (606; 99.9%) revealed that personal protective equipment for chemical and nuclear accidents was not available. CONCLUSION: Preparedness for blast injuries in Tripoli hospitals is seriously deficient. Planning optimized blast and disaster management in Libya is essential. Oun AM , Hadida EM , Stewart C . Assessment of the knowledge of blast injuries management among physicians working in Tripoli hospitals (Libya). Prehosp Disaster Med. 2017;32(3):311-316.

Development of Mass-casualty Life Support-CBRNE (MCLS-CBRNE) in Japan.

This report outlines the need for the development of an advanced course in mass-casualty life support (MCLS) and introduces the course content. The current problems with education on disasters involving chemical agents, biological agents, radiation/nuclear attacks, or explosives (CBRNE) in Japan are presented. This newly developed "MCLS-CBRNE" program was created by a Ministry of Health, Labour, and Welfare (Tokyo, Japan) research group based on these circumstances. Modifications were then made after a trial course. Training opportunities for relevant organizations to learn how to act at a CBRNE disaster site currently are lacking. The developed course covers initial responses at a disaster site. This one-day training course comprises lectures, three tabletop simulations, and practical exercises in pre-decontamination triage and post-decontamination triage. With regard to field exercises conducted to date, related organizations have experienced difficulties in understanding each other and adapting their approaches. Tabletop simulations provide an opportunity for participants to learn how organizations working on-site, including fire, police, and medical personnel, act with differing goals and guiding principles. This course appears useful as a means for relevant organizations to understand the importance of developing common guidelines. The MCLS-CBRNE training is proposed to support CBRNE disaster control measures during future events. Anan H , Otomo Y , Kondo H , Homma M , Koido Y , Morino K , Oshiro K , Harikae K , Akasaka O . Development of mass-casualty life support-CBRNE (MCLS-CBRNE) in Japan. Prehosp Disaster Med. 2016;31(5):547-550.