At the later presentation with ASI, two patients had deteriorated to grade C (8.7 %) and three had weakness grade D (13 %).
The majority of adverse events (81%) were Grade 1 or 2. One patient had generalized muscle weakness (Grade 3), which was deemed to be a dose-limiting toxicity.
Clinically relevant toxicities comprised grade 3 fatigue (n=2, concomitant with grade 4 neutropenic sepsis in one case), grade 3 vomiting, grade 3 diarrhoea, grade 3 hypersensitivity, grade 3 respiratory tract infection, grade 3 weakness and grade 4 pancytopenia (n=1).
Although a prospective study with biopsy before AS is appropriate to investigate the correlation between the growth rate of RCC and grade intuitively, biopsy has the weakness in grading renal tumors comparing with surgical specimens.
Neurologic examination showed hyporeflexic proximal muscle weakness of grade II I IV/Vin all limbs.
The neurologic examination demonstrated an intense pyramidal spasticity in the lower limbs and moderate weakness (Medical Research Council grade 3) of the proximal muscles.
The adverse effects profile was favorable with only two patients (one patient with fatigue and another with muscular weakness) experiencing grade ⩾3 toxicities.
All five patients had severe muscle weakness (Medical Research Council grade 3 or less) involving the proximal limb muscles and neck flexors with weakness of the muscles supplied by the motor cranial nerves confirming IMS.
Neurological symptoms were assessed daily by modified neurological scores (grade 0: normal; grade 1: tail weakness or tail paralysis; grade 2: hind leg paraparesis or hemiparesis; grade 3: hind leg paralysis or hemiparalysis; grade 4: complete paralysis (tetraplegia), moribund stage or death).
In brief, rats were clinically checked every day and evaluated according to neurological status (grade 0: normal; grade 1: tail weakness or tail paralysis; grade 2: hind leg paraparesis or hemiparesis; grade 3: hind leg paralysis or hemiparalysis; grade 4: complete paralysis (tetraplegia), moribund stage, or death).
