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Once rhabdomyosarcoma (RMS) recurs, it is often insensitive to existing treatments, resulting in an overall survival rate of less than 20%
.
The main prognostic factors after recurrence are the type of recurrence, previous radiotherapy, initial tumor size, and time to recurrence after diagnosis
The VIT-0910 trial aims to evaluate the efficacy and safety of vincristine-irinotecan with or without temozolomide (VIT or VI) in the treatment of relapsed or refractory rhabdomyosarcoma
.
This is a randomized phase 2 trial.
RMS patients aged 0.
5-50 years received a 21-day course of vincristine + irinotecan ± temozolomide until the disease progressed or intolerable toxicity appeared
.
The primary endpoint is the objective response rate after two courses of treatment
Corrected PFS and OS for the two treatment groups
Corrected PFS and OS for the two treatment groupsA total of 120 patients (60 in each group) were recruited from 37 medical centers
.
The median age of the tested patients was 11 years (range 0.
The objective response rates of the VIT group and VI group were 44% vs 31%, respectively.
Toxic reaction and relative risk ratio of the two groups
Toxic reaction and relative risk ratio of the two groupsIn general, patients in the VIT group experienced more adverse events of grade 3 and above than those in the VI group (98% vs 78%; P=0.
009), and there were also significant differences in hematological toxicity (81% vs 61%; P= 0.
025)
.
In summary, the addition of temozolomide to the VI regimen can improve the chemotherapy effect of recurrent rhabdomyosarcoma , but the accompanying toxicity also increases
.
The VIT regimen is considered to be the new standard treatment for patients with pediatric soft tissue sarcoma in Europe
The addition of temozolomide to the VI regimen can improve the chemotherapy effect of recurrent rhabdomyosarcoma .
Original source:
Anne-Sophie Defachelles, et al.
Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial in this message