Hallo Forum,
Eine Frage von mir als „Neuling“:
Ich habe untenstehend einen Abstract gefunden, wonach ein Impfstoff gegen biochemisches Rezidiv helfen soll [keinWitz.]
Allerdings ist es eine Studie mit wenig Teilnehmern, und zwei Pharma-Unternehmen sind Mit-Autoren.
Soll man sowas ernst nehmen ? Oder wegklicken ?
Von Phase II – Studie bis Phase III Studie bis hin zur Leitlinie => Läßt sich das abschätzen wie lange das dauert ?
Danke für Rückmeldungen,
Barlaus
https://pubmed.ncbi.nlm.nih.gov/34762317/
Long-term first-in-man PhaseI/II study of an adjuvant dendritic cell vaccine in patients with high-riskprostate cancer after radical prostatectomy
Abstract Background: Patients with high-risk prostate cancer (PC) can experience biochemical relapse (BCR), despite surgery, and develop noncurative disease. The present study aimed to reduce the risk of BCR with a personalized dendritic cell (DC) vaccine, given as adjuvant therapy, after robot-assisted laparoscopic prostatectomy (RALP).
Methods: Twelve weeks after RALP, 20 patients with high-risk PC and undetectable PSA received DC vaccinations for 3 years or until BCR. The primary endpoint was the time to BCR. The immune response was assessed 7 weeks after surgery (baseline) and at one-time point during the vaccination period.
Results: Among 20 patients, 11 were BCR-free over a median of 96 months (range: 84-99). The median time from the end of vaccinations to the last follow-up was 57 months (range: 45-60). Nine patients developed BCR, either during (n = 4) or after (n = 5) the vaccination period. Among five patients diagnosed with intraductal carcinoma, three experienced early BCR during the vaccination period. All patients that developed BCR remained in stable disease within a median of 99 months (range: 74-99). The baseline immune response was significantly associated with the immune response during the vaccination period (p = 0.015). For patients diagnosed with extraprostatic extension (EPE), time to BCR was longer in vaccine responders than in non-responders (p = 0.09). Among 12 patients with the International Society of Urological Pathology (ISUP) grade 5 PC, five achieved remission after 84 months, and all mounted immune responses.
Conclusion: Patients diagnosed with EPE and ISUP grade 5 PC were at particularly high risk of developing postsurgical BCR. In this subgroup, the vaccine response was related to a reduced BCR incidence. The vaccine was safe, without side effects. This adjuvant first-in-man Phase I/II DC vaccine study showed promising results. DC vaccines after curative surgery should be investigated further in a larger cohort of patients with high-risk PC.
Long-term first-in-man PhaseI/II study of an adjuvant dendritic cell vaccine in patients with high-riskprostate cancer after radical prostatectomy
Eine Frage von mir als „Neuling“:
Ich habe untenstehend einen Abstract gefunden, wonach ein Impfstoff gegen biochemisches Rezidiv helfen soll [keinWitz.]
Allerdings ist es eine Studie mit wenig Teilnehmern, und zwei Pharma-Unternehmen sind Mit-Autoren.
Soll man sowas ernst nehmen ? Oder wegklicken ?
Von Phase II – Studie bis Phase III Studie bis hin zur Leitlinie => Läßt sich das abschätzen wie lange das dauert ?
Danke für Rückmeldungen,
Barlaus
https://pubmed.ncbi.nlm.nih.gov/34762317/
Long-term first-in-man PhaseI/II study of an adjuvant dendritic cell vaccine in patients with high-riskprostate cancer after radical prostatectomy
Abstract Background: Patients with high-risk prostate cancer (PC) can experience biochemical relapse (BCR), despite surgery, and develop noncurative disease. The present study aimed to reduce the risk of BCR with a personalized dendritic cell (DC) vaccine, given as adjuvant therapy, after robot-assisted laparoscopic prostatectomy (RALP).
Methods: Twelve weeks after RALP, 20 patients with high-risk PC and undetectable PSA received DC vaccinations for 3 years or until BCR. The primary endpoint was the time to BCR. The immune response was assessed 7 weeks after surgery (baseline) and at one-time point during the vaccination period.
Results: Among 20 patients, 11 were BCR-free over a median of 96 months (range: 84-99). The median time from the end of vaccinations to the last follow-up was 57 months (range: 45-60). Nine patients developed BCR, either during (n = 4) or after (n = 5) the vaccination period. Among five patients diagnosed with intraductal carcinoma, three experienced early BCR during the vaccination period. All patients that developed BCR remained in stable disease within a median of 99 months (range: 74-99). The baseline immune response was significantly associated with the immune response during the vaccination period (p = 0.015). For patients diagnosed with extraprostatic extension (EPE), time to BCR was longer in vaccine responders than in non-responders (p = 0.09). Among 12 patients with the International Society of Urological Pathology (ISUP) grade 5 PC, five achieved remission after 84 months, and all mounted immune responses.
Conclusion: Patients diagnosed with EPE and ISUP grade 5 PC were at particularly high risk of developing postsurgical BCR. In this subgroup, the vaccine response was related to a reduced BCR incidence. The vaccine was safe, without side effects. This adjuvant first-in-man Phase I/II DC vaccine study showed promising results. DC vaccines after curative surgery should be investigated further in a larger cohort of patients with high-risk PC.
Long-term first-in-man PhaseI/II study of an adjuvant dendritic cell vaccine in patients with high-riskprostate cancer after radical prostatectomy
- Department of Oncology, OsloUniversity Hospital HF, Oslo, Norway.
- 2Department of Urology, Oslo University Hospital HF, Oslo, Norway.
- 3Department of Urology, Akershus University Hospital HF, Oslo, Norway.
- 4Department of Pathology, Oslo University Hospital HF, Oslo, Norway.
- 5BioNTech IMFS GmbH, Idar-Oberstein, Germany.
- 6 Departmentfor Clinical Research, Oslo University Hospital HF, Oslo, Norway.
- 7Department of Molecular Oncology, Oslo University Hospital HF, Oslo, Norway.
- 8Department of Registration, Cancer Registry Norway, Oslo, Norway.
- 9Department of Research and Innovation, Møre and Romsdal Hospital Trust,Ålesund, Norway.
- 10 Medigene Immunotherapies GmbH, Munich,Germany.
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