ENPNewswire-August 14, 2019--X-GEN Pharmaceuticals, Inc - The Release of Dactinomycin
for Injection, USP
powder for solution for injection; lot 3 etoposide concentrate for solution for infusion; lot no.
Those included were in-patients aged at least 18 years who had no communication problem, were using any of the agents leading to oral mucositis (alkylating agents such as busulfan, melphalan, cyclophosphamide that are used at high doses; antimetabolites such as methotrexate, 5-fluorouracil; antibiotics such as dactinomycin
, adriamycin, bleomycin, and alkaloids such as vinblastine), and who had no oral mucositis and provided informed written consent.
Positive results of cytogenetic studies, to the extent of the chromosomal aberrations analysis (peripheral lymphocytes), sister chromatid exchanges observations, micronucleus tests, the comet assay and the gene mutations assay, were described in respect of medical personnel, especially nurses exposed to different cytostatics (cisplatin, cyclophosphamide, ifosfamide, vincristine, doxorubicin, dactinomycin
, cytosine, methotrexate).
Based on the diagnosis of stage 3, favorable histology, Wilms' tumor, the patient was started on multidrug chemotherapy that consisted of doxorubicin, dactinomycin
, and vincristine.
RMS patients were given chemotherapy protocols with 'pirarubicin (25 mg/m 2, days 2 and 9) + vincristine (1.5 mg/m 2, days 1 and 8) + cyclophosphamide (300 mg/m 2, days 1-3) + cisplatin (90 mg/m 2, day 1)' or 'ifosfamide (1.5 g/m 2, day 1-5 + dactinomycin
(12-15 [micro]g/kg, day 1-5) + etoposide (100 mg/m 2, day 1-3) + vincristine (1.5 mg/m 2, day 1 and day 8)'.
Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin
with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonalrhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group.
For example, the guidelines recommend therapy with either methotrexate alone or alternating with leucovorin, or dactinomycin
alone for patients with confirmed low-risk GTN, defined as a prognostic score less than 7.
To minimize cardiotoxic side effects, doxorubicin was replaced by dactinomycin
when the maximal dose of doxorubicin was reached.
ES is a chemotherapy-sensitive disease, as demonstrated by various trials in the last decades evaluating VACA (vincristine, dactinomycin
, cyclophosphamide, and doxorubicin), VAC/IE (vincristine, doxorubicin, and cyclophosphamide alternating with ifosfamide-etoposide), VAIA (vincristine, dactinomycin
, ifosfamide, and doxorubicin), EVAIA (adding etoposide to VAIA), and VIDE (omitting dactinomycin
from EVAIA) [5-10].
A phase II clinical trial which was initiated in 2014 and completed in two and a half years, involved patients with refractory or relapsed NPM1-mutated AML treated with cycles of dactinomycin
at a dose of 15[micro sign]g per kilogram per day for five consecutive days (EudraCT number 2014-000693-18).
Results of the Intergroup Rhabdomyosarcoma Study Group D9602 Protocol, using vincristine and dactinomycin
with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: A report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group.