Safety Profile of 5-Aminolevulinic Acid as a Surgical Adjunct in Clinical Practice

e13024 Background: Hertraz, the first trastuzumab biosimilar was approved in Morocco in 2017. Real world data on trastuzumab biosimilars are very limited or not available. HERLife is a prospective, non-interventional phase IV study program that investigated the experience of using Hertraz, a biosimilar for trastuzumab (Herceptin), under routine clinical practice conditions in Morocco. The primary aim of this study was to confirm the acceptable safety and tolerability of Hertraz. Methods: Ninety-nine patients with HER2-positive breast cancer treated with Hertraz were enrolled from 8 public and private sector hospitals and followed up for 12 months as part of this non-interventional study. Cardiac events (LVEF) and other unexpected or serious adverse events were monitored. The study arms consisted of patients with early breast cancer (Arm 1, n=70) and metastatic breast cancer (Arm 2, n=29) whose median age was 53 years in both groups. Results: Switching from Herceptin to Hertraz was observed in 45% of 29 MBC patients and 27% of 70 EBC patients. Switching was done at a median of 4th cycle. Pertuzumab was used in combination with Hertraz in 69% and 19% of patients in the metastatic and neoadjuvant settings, respectively. Two patients had a decline in LVEF. One patient treated with Hertraz alone and one patient treated with Hertraz and pertuzumab developed a decrease in LVEF requiring a three-week treatment discontinuation of Hertraz. Treatment of Hertraz was continued after 1 skipped cycle without occurrence of new side effects. No other trastuzumab related adverse events was observed. Four patients in the metastatic group and 2 patients in the early breast cancer arm had a relapse in the 12 months of clinical follow-up. Conclusions: The management of HER2+ breast cancer in Morocco follows the international recommendations. This is the first real world safety data of Hertraz from Morocco. The 12-month follow-up treatment with Hertraz showed an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Hertraz or Hertraz combined with pertuzumab, the safety profile was similar to that previously reported in other studies.

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Rationale for use mefloquine for COVID-19 treatment

Kachestvennaya klinicheskaya praktika ◽

10.37489/2588-0519-2020-s4-103-105 ◽

2020 ◽

pp. 103-105

Author(s):

V. A. Otdelenov ◽

K. B. Mirzaev ◽

A. V. Dmitriev ◽

V. V. Poroikov ◽

D. A. Sychev

Keyword(s):

Clinical Practice ◽

Safety Profile ◽

Efficacy And Safety ◽

Scientific Justification

Currently, the use of mefloquine in patients with COVID-19 does not have sufficient scientific justification and, given the unfavorable efficacy and safety profile, cannot be considered for routine use in clinical practice.

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Results of the first interim analysis of the CARMA study to investigate efficacy and safety profile of catumaxomab in clinical practice.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e13100 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e13100-e13100

Author(s):

Volker Kunzmann ◽

Jalid Sehouli ◽

Barbara Schmalfeldt ◽

Pauline Wimberger ◽

Christian M. Kurbacher ◽

...

Keyword(s):

Clinical Practice ◽

Safety Profile ◽

Interim Analysis ◽

Malignant Ascites ◽

Median Number ◽

Pivotal Trial ◽

Advanced Tumor ◽

Secondary Endpoints ◽

Study Population ◽

First Time

e13100^ Background: The trifunctional antibody catumaxomab is approved in the EU for intraperitoneal (i.p.) treatment of malignant ascites in patients (pts) with EpCAM-positive carcinomas. Clinical data for catumaxomab are based on the pivotal trial and several phase I/II trials. So far, the routine use of catumaxomab in clinical practice has not been evaluated systematically. Therefore, a large prospective observational study was started in 2010. The study investigates the administration of catumaxomab in a total of 160 pts with malignant ascites under routine conditions in daily clinical practice. Here we show the results of the first pre-planned interim analysis. Methods: The analysis included 49 pts with malignant ascites due to EpCAM-positive carcinomas treated with i.p. catumaxomab under routine conditions in clinical practice. Participating centres were hospitals and practices of oncologists in Germany. Primary endpoint was puncture-free interval (PFI), secondary endpoints included safety and overall survival (OS). Results: At inclusion into the study pts already had undergone a median number of 9 ascites punctures. Malignant ascites had been diagnosed for the first time 3.3 months before (median). Patients suffered from typical ascites symptoms as follows: swelling (79.6%), pain (44.9%), dyspnea (26.5%), anorexia (26.5%), obstipation (12.2%). 49 pts were treated with catumaxomab, of whom 30 pts received all 4 infusions (61.2%). Median PFI was 108 days (d), the median OS was 102 d. Most frequent adverse events were fever, nausea and diarrhoe. Conclusions: This is the first systematic report on routine use of catumaxomab in clinical practice.. Although The study population mainly comprised patients with advanced tumor diseaset a clinical benefit after catumaxomab therapy could be demonstrated. The treatment showed an acceptable safety profile Theseresults are consistent with the data of the pivotal trial. The data will be evaluated in further analyses including larger patient numbers.

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PP45. GEOGRAPHICAL INEQUALITIES OF ACCESS TO 5-AMINOLEVULINIC ACID IN THE UK – BARRIERS TO IMPLEMENTING RESEARCH FINDINGS INTO CLINICAL PRACTICE

Neuro-Oncology ◽

10.1093/neuonc/now293.045 ◽

2017 ◽

Vol 19 (suppl_1) ◽

pp. i13-i13

Author(s):

Mr Stephen Price

Keyword(s):

Clinical Practice ◽

Aminolevulinic Acid ◽

Geographical Inequalities ◽

Research Findings ◽

The Uk

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Aminolevulinic acid with gold nanoparticles: a novel theranostic agent for atherosclerosis

The Analyst ◽

10.1039/c4an02166e ◽

2015 ◽

Vol 140 (6) ◽

pp. 1974-1980 ◽

Cited By ~ 14

Author(s):

Karina de Oliveira Gonçalves ◽

Monica Nascimento da Silva ◽

Letícia Bonfante Sicchieri ◽

Flávia Rodrigues de Oliveira Silva ◽

Ricardo Almeida de Matos ◽

...

Keyword(s):

Gold Nanoparticles ◽

Clinical Practice ◽

Polyethylene Glycol ◽

Aminolevulinic Acid ◽

Theranostic Agent ◽

Theranostic Agents

5-Aminolevulinic acid gold nanoparticles functionalized with polyethylene glycol were synthesized and administered to rabbits to evaluate their use in clinical practice as theranostic agents for atherosclerosis.

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