Mercaptopurine primary efficacy analysis was based on the full analysis set

mercaptopurine static disease were included. The objectives of the trial were to determine progression-free survival (PFS) after 12 weeks (primary endpoint), PFS, overall survival (OS), response rate (according to RECIST criteria), clinical benefit response (CBR) and safety profile.The study was approved by the institutional review board and ethics committee of each participating centre, and informed consent was given by each patient according to the Declaration of Helsinki. The trial is registered with WHO primary register number DRKS00000600.Immunohistochemistry Immunohistochemistry was performed on adjacent deparaffinised freshly cut sections using the peroxidase- labelled streptavidin–biotin technique, Dako REAL detection system (Glostrup, Denmark) for HER2. All immunostaining was performed in strict accordance with the FDA-approved REAL detection system package (Dako).

Immunohistochemical results were scored independently by two pathologists ‘blind’ to all case data. Additional tissue controls were performed along with the included cell line Rutaecarpine controls. Detection of HER2 was performed with heat-induced epitope retrieval and the use of the anti-HER2 primary antibody. Immunohistochemical staining was performed using the Dako Autostainer.The retrospective testing used the HER2-SISH double labelling in situ hybridisation system, and the Ventana BenchMark XT automated slide staining system . Gene amplification was assessed according to the breast cancer scoring system. Tumour response was evaluated by CT or MRI every 2 cycles and classified as complete remission (CR), partial remission (PR), stable disease, progressive disease (PD) according to RECIST. Primary endpoint was the PFS rate 12 weeks after the start of treatment. Secondary endpoints were PFS time, OS time, time to response (CR/PR), duration of response, CBR 12 weeks after the start of treatment and quality of life (QOL) using the EORTC QLQ-C30 QOL Questionnaire.

Clinical benefit response is a composite endpoint assessing the improvement in pain. and purchase Imiquimod Karnofsky performance status as primary measures and integrating body weight as a secondary measure. Patients were classified as responders, if pain or Karnofsky performance status was improved or, in case of stability of pain and Karnofsky performance status, body weight was increased.PFS was defined as the time from beginning of chemotherapy to disease progression or death, whichever occurred first. Overall survival time was defined as the time from beginning of chemotherapy to death.The primary efficacy analysis was based on the full analysis set (FAS), including all patients for whom treatment was started.

An additional analysis was performed in the per protocol (PP) population with those patients who had received at least two complete cycles of chemotherapy, or had terminated treatment due to toxicity, early progression or death before day 43. The PFS order Imiquimod rate and the OS rate were estimated by the Kaplan–Meier method. The effect of CA 19-9 serum concentration was investigated with a Cox regression model.The safety analysis set (SAF) was defined as those patients who received at least one dose of chemotherapy. The SAF is identical to the FAS in this study, therefore no further distinction will be made. The incidence of toxicity and adverse events.

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