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Patients received recombinant human stem cell factor (Ancestim; Amgen, Thousand Oaks, CA, USA) 10 20 μg/kg subcutaneously for the first 7 days of cycle three only to examine the effect of recombinant human stem cell factor on the promotion of myelopoiesis (except one who had already achieved a complete remission by the completion of cycle two).
Resection of the primary tumor, if not completed at diagnosis, occurred after completion of cycle 4 or 5 and prior to high dose chemotherapy with stem cell rescue (HDC/SCR).
The patient represented two weeks later, upon completion of cycle 9 of chemotherapy, with a persistent complete left inferior altitudinal field defect.
Evaluable patients were defined as patients who either completed Cycle 1 or had a dose-limiting toxicity in Cycle 1, where completion of Cycle 1 was defined for the once weekly schedule as receiving one dose of trastuzumab and at least two doses of retaspimycin HCl.
Two patients discontinued the study before completion of cycle 1.
Patients in the placebo group switched to treatment with XM02 after completion of cycle 1.
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After completion of one cycle of standard dose and three cycles of HD-VIP chemotherapy the median Hb level dropped to 10.4 g dl−1 (range 8.2 14.5).
Linkage of glycolysis to the TCA cycle took place at approximately the same time as completion of the cycle itself.
Assuming 60% completion of one cycle, 50% two, and 45% completion of all three cycles, then simulations of size N = 10,000 yielded that approximately 21 patients were required at 5% significance and 80% power.
Fresh reducing agent was not needed till the completion of four cycles, but subsequent cycles required fresh BH4 -.
After completion of four cycles, two additional cycles of protocol treatment were proposed to all patients not showing disease progression.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com