Other inclusion criteria included key Ded at least a measurable response L version After evaluation criteria in solid tumors, ? Years, Eastern Cooperative Oncology Group performance XL880 status of zero to two K Body and ad Quate bone marrow function. Patients U back to a previous dose of fulvestrant were suitable, but who U two doses or more was new, f Rderf compatibility available. Exclusion criteria Patients with immunodeficiency che, Such as HIV, chemotherapy for metastatic disease or treatment with an FTI, gr Ere surgery or radiotherapy in the last few weeks, peripheral neuropathy grade and also metastasize to the presence of rapidly progressive, not life-threatening or Komorbidit th embroidered Lees, and a gastrointestinal disorder that t the active motility or absorption ver has changed.
The study was reviewed, approved and emotion Promoted by the Cancer Therapy Evaluation Program at the National Cancer Institute. The local ethics committee at each participating institution approved the protocol. All patients gave written informed Einverst ndnis. Fostamatinib Patients in the treatment plan were mg with fulvestrant Into a single im injection ml t possible to change the treatment was defined as a cycle. Patients also again U tipifarnib twice t Resembled consecutive days every day. Each tipifarnib dose was ingested with food. Is on each monthly visit, the patients have a history k, Rperliche examination, complete blood count, serum creatinine, electrolytes, liver enzymes, and the assessment of performance status, adverse events and liability. The treatment was without interruption until disease progression, severe toxicity t or unertr Resembled or withdrawal of consent continues.
Approved together with a bisphosphonate, bisphosphonate approved for patients with bone metastases. Assessment of response and toxicity t All patients underwent a CT scan of the thorax and abdomen and bone scintigraphy in the weeks after registration. Tumor response evaluated every three cycles of CT with RECIST and bone scans were was repeated if the bone scan was positive or original progressive bone metastases was suspected. The toxicity Was t have carried out according to the terminology of the National Cancer Institute H INDICATIVE side effects, version for patients, the toxicity of t scores, tipifarnib was up to the resolution and high instead of classes, then in the same cycle or the n Next cycle taken graded with a reduction in the dose amount.
Day Neurotoxizit t Degrees or degrees toxicity t h permanent Dermatological required permanent discontinuation of tipifarnib. Fulvestrant has not occurred, if allowed for tipifarnib toxicity t and held without dose reduction of fulvestrant. Patients t due to toxicity Heavy tipifarnib or unertr Possible sequel set fulvestrant alone until disease progression. The primary statistical considerations re endpoint was the CBR, which hung as an objective response or stable disease or sufficient Erh for PD in the sum of l longest diameter was defined qualify, with l as reference the smallest sum longest diameter since the start of treatment in the absence of new L emissions. For at least a few weeks. If the protocol was launched in April to life, it was expected that the study patients would both tamoxifen-resistant and resistant incurred Higer against AI diseases.
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