At endpoint in approximately 14% of patients in each treatment group, retinopathy had progressed by three or more steps.
Children are expected to progress by two sublevels per school year and achieve a level 4c or above by the end of Year 6 (age 11).
Four patients (15%) progressed by clinical criteria after two, two, four, and six cycles of chemotherapy, respectively, and proceeded to immediate surgery.
Of the eight patients who had stable disease with no evidence of even a minor response after three cycles of MCF, five had progressed by the sixth cycle and only three maintained stability, raising the suggestion that in those patients without any demonstrable reduction in tumour size after three cycles, MCF should be discontinued.
Of the eight patients who had a partial response after three cycles, two had progressed by the end of the sixth cycle; in view of the lack of a confirmatory 1 month scan, the initial responses of these two patients were not included in the overall response rate.
Astigmatism progressed by 6 dpt within two years in one case and by 7 dpt within 11 years in the other [ 21, 22].
Of the 10 patients who had stable disease after three cycles, two subsequently achieved a partial response (both of whom had shown a minor response after three cycles), three maintained stable disease and five had progressed by completion of treatment.
The remaining patient progressed by clinical and radiological criteria after three cycles of FEC chemotherapy; she responded to four cycles of second-line docetaxel and had a near-complete pathological response at operation (1 mm residual invasive carcinoma).
However, sustaining the rapid progress over an extended period is challenging, as shown by the fact that only 13 study countries achieved rapid progress by two percentage points or more per year over a 15-year period.
All three placebo patients progressed by week-24 and were re-started on sorafenib; one experienced disease re-stabilisation.
