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  • 1
    Keywords: PROSTATE-CANCER ; MELANOMA PATIENTS ; COLONY-STIMULATING FACTOR ; RENAL-CELL CARCINOMA ; PULSED DENDRITIC CELLS ; REGULATORY T-CELLS ; tumor-antigen ; HIGH-FREQUENCIES ; MYELOID SUPPRESSOR-CELLS ; Peptide vaccine
    Abstract: IMA901 is the first therapeutic vaccine for renal cell cancer (RCC) consisting of multiple tumor-associated peptides (TUMAPs) confirmed to be naturally presented in human cancer tissue. We treated a total of 96 human leukocyte antigen A (HLA-A)*02(+) subjects with advanced RCC with IMA901 in two consecutive studies. In the phase 1 study, the T cell responses of the patients to multiple TUMAPs were associated with better disease control and lower numbers of prevaccine forkhead box P3 (FOXP3)(+) regulatory T (T(reg)) cells. The randomized phase 2 trial showed that a single dose of cyclophosphamide reduced the number of T(reg) cells and confirmed that immune responses to multiple TUMAPs were associated with longer overall survival. Furthermore, among six predefined populations of myeloid-derived suppressor cells, two were prognostic for overall survival, and among over 300 serum biomarkers, we identified apolipoprotein A-I (APOA1) and chemokine (C-C motif) ligand 17 (CCL17) as being predictive for both immune response to IMA901 and overall survival. A randomized phase 3 study to determine the clinical benefit of treatment with IMA901 is ongoing.
    Type of Publication: Journal article published
    PubMed ID: 22842478
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  • 2
    ISSN: 1365-2648
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Timing of quality of life (QoL) assessments as a source of error in oncological trials Aim of the study. To produce an empirical estimate of the nature and magnitude of the error produced by incorrect timing quality of life (QoL) measurements in patients receiving chemotherapy. Design. In a multicentre trial, 283 patients were randomized to receive either docetaxel (T) or sequential methotrexate and 5-fluorouracil (MF). The QoL was assessed at baseline and before each treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The study design was retrospective. Data were analysed using t-tests. Results. Erroneous timing affected the QoL findings in both treatment arms. At baseline, there were statistically significant differences in the MF group on the nausea/vomiting scale, with ill-timed assessment showing more symptoms, and in the T group on the physical functioning scale with ill-timed assessments indicating better QoL. The mean scores of correct vs. incorrect timings over the first 14 cycles showed statistically significant differences on several scales. In the MF group, ill-timed assessments indicated significantly worse physical functioning and global QoL, and significantly more of the following symptoms: fatigue, nausea/vomiting, insomnia, appetite loss, and constipation. In the T group, ill-timed assessment showed better physical functioning, less dyspnoea and more insomnia than correctly timed assessments. The reasons for erroneous timing were not always detectable retrospectively. However, in some cases the MF group, being in standard treatment, seemed to have followed a clinical routine not involving the active participation of the study nurse responsible, whereas patients in the experimental T group were more consistently taken care of by the study nurses. Conclusions. Incorrect timing of QoL assessments in oncological trials jeopardises both the reliability of the QoL findings within treatment and the validity of QoL outcome comparisons between treatments. This issue should be emphasized in the planning of both the study design and clinical routines.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1432-1335
    Keywords: Inflammatory breast cancer ; Immunotherapy ; Propionibacteria
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Nine 44- to 67-year-old patients with inflammatory breast carcinoma were treated over 2 weeks with intratumoral injections ofPrionibacterium granulosum KP-45 (KP). This period of immunotherapy was succeeded by four courses of chemoimmunotherapy (FAC: 5-fluorouracil, adriamycin, and cyclophosphamide + intratumoral KP). Inflammatory symptoms disappeared in three patients during immunotherapy and in the remaining six patients during the following chemoimmunotherapy. Finally, 3 to 4 months after starting the therapy, all nine patients were free from inflammatory symptoms and it became possible to perform radical (seven cases) or simple (two cases) surgery. Thereafter routine therapy (radiotherapy, fractionated dose of 5500 R, followed by 10 FAC courses + single injections of KP for each FAC course) was used. After 19 to 32 months observation time all patients are still in complete remission with no local recurrences. Only one patient showed distant metastases during the observation period.
    Type of Medium: Electronic Resource
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