Examples of using Labcc in English and their translations into Romanian
{-}
-
Colloquial
-
Official
-
Medicine
-
Ecclesiastic
-
Ecclesiastic
-
Computer
-
Programming
The majority of patients were male(57%);8% had mBCC whereas 92% had laBCC.
Figures 1 shows the best change in target lesion size for each patient with laBCC at the dose of 200 mg per central review.
For LaBCC, multiple punch biopsies were taken each time a response assessment was confounded by presence of lesion ulceration, cyst, and or scarring/fibrosis.
Of the 230 patients,16 had a diagnosis of Gorlin Syndrome(15 laBCC and 1 mBCC).
Of these 79 patients,66(83.5%) were laBCC patients(37[46.8%] with aggressive histology and 29[36.7%] with non-aggressive histology) and 13(16.5%) were mBCC patients.
Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
For patients with laBCC, the Independent Review Committee(IRC) Composite Overall Response was integrated from centrally evaluated MRI scans, digital clinical photographs and histopathology according to mRECIST.
Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
LaBCC was defined as cutaneous lesions that were inappropriate for surgery(inoperable, or for whom surgery would result in substantial deformity) and for which radiotherapy was unsuccessful or contraindicated.
Of patients who had a confirmed response(partial or complete), the median Duration ofResponse was 23.0 months(95% CI: 20.4, 26.7) in the laBCC cohort and 13.9 months(95% CI: 9.2, NE) in the mBCC cohort.
The majority of patients(laBCC 74%, mBCC 92%) had undergone prior therapies including surgery(laBCC 73%, mBCC 85%), radiotherapy(laBCC 18%, mBCC 54%) and antineoplastic therapies(laBCC 23%, mBCC 23%).
The secondary endpoints included duration of response, time to tumour response andprogression free survival(PFS) according to mRECIST in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Adult(≥18 years of age) patients with laBCC or mBCC who were not candidates for radiotherapy, surgery or other local therapies, were randomised to receive Odomzo at either 200 mg or 800 mg daily until disease progression or unacceptable toxicity.
The primary efficacy endpoint of the study was objective response rate according to modified Response Evaluation Criteria in Solid Tumours(mRECIST)in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
LaBCC patients had cutaneous lesions that were inappropriate for surgery(inoperable, multiply recurrent where curative resection deemed to be unlikely or for whom surgery would result in substantial deformity or morbidity) and for which radiotherapy was unsuccessful or contraindicated or inappropriate.
Among patients in the efficacy-evaluablepopulation with measurable and histologically confirmed disease, 68.5% and 36.9% responded to treatment in the laBCC and mBCC cohorts, respectively, by RECIST v1.1.
A patient was considered a responder in the laBCC cohort if at least one of the following criteria was met and the patient did not experience progression:(1)≥ 30% reduction in lesion size[sum of the longest diameter(SLD)], from baseline in target lesions by radiography;(2)≥ 30% reduction in SLD from baseline in externally visible dimension of target lesions;(3) Complete resolution of ulceration in all target lesions.
A post-approval, open-label, non-comparative, multicenter, phase II clinical trial(MO25616) was conducted in 1232 patients with advanced BCC,of whom 1215 patients were evaluable for efficacy and safety with laBCC(n= 1119) or mBCC(n= 96).
In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours(RECIST)version 1.0. In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging(where appropriate), and tumour biopsy.
A phase II, randomised double-blind study of two dose levels(200 mg or800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma(laBCC)(n=194) or metastatic basal cell carcinoma(mBCC)(n=36).