A group of 23 colorectal cancer patients were treated by a new type of active specific immunotherapy (ASI) following complete surgical resection of liver metastases (RO resection). For ASI treatment we used a vaccine consisting of 1 x 10(7) autologous, irradiated (200 Gy) metastases-derived tumor cells incubated with 32 hemagglutination units (HU) of Newcastle disease virus (NDV). The adjuvant vaccine therapy was started 2 weeks after surgery and was repeated five times at 14-days intervals followed by one boost 3 months later. The delayed-type hypersensitivity (DTH) skin reactions to the vaccine were measured as well as the DTH reactions to a challenge test of 1 x 10(7) non-virus-modified autologous tumor cells from liver metastases or 1 x 10(7) autologous normal liver cells. In addition 32 HU NDV alone and a standard antigen test (Merieux test) were applied pre- and post-vaccination. The vaccination was well tolerated. In 13 of 23 patients an increasing reactivity against the vaccine was observed during the vaccination procedure. Nine patients (40%) experienced an increased DTH reactivity against autologous tumor cells following vaccination, while 17% or fewer showed an increased reactivity to Merieux test antigens, NDV, or normal liver cells. The increased antitumor response was not correlated to responsiveness to NDV alone, autologous liver cells, enzymes and culture medium used for vaccine preparation or standard antigens (Merieux test). After a follow-up of at least 18 months 61% of the vaccinated patients developed tumor recurrence in comparison to 87% of a matched control groups from the same institution that had been only surgically treated. The results of this phase II trial are encouraging and should stimulate further prospective randomized studies.

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Sixteen patients with colorectal carcinoma Dukes' Stage B2, C, or D were treated with an autologous virus-modified tumor-cell vaccine after potential curative tumor resection (R0-Resection). An inoculum of 1 X 10(7) cells incubated with 32 hemagglutination units of nonirradiated Newcastle disease virus (NDV) was given intracutaneously up to four times at 10-day intervals. The delayed-type hypersensitivity (DTH) skin reaction was measured. The vaccination was well tolerated. In 11 of 16 patients an increasing reactivity against the vaccine was observed during the vaccination procedure. A challenge test using autologous tumor cells without NDV after the vaccination cycle revealed a specific antitumor sensibilization in 12 patients. The DTH response was not due to bacterial contamination or sensibility to the virus. Histologic examination of the vaccination site showed a dense infiltration of predominantly helper T-lymphocytes. We conclude that in most of the patients treated active, specific immunization led to a specific antitumor sensitivity.

Introduction: Psoriasis is a systemic inflammatory disease characterised by pruritic skin lesions that impair quality of life (QOL). Long-Term Documentation of the Utilization of Apremilast in Patients with Plaque Psoriasis under Routine Conditions (LAPIS-PSO; Clini-calTrials.gov: NCT02626793) was a 52-week, prospective, multicentre, observational cohort study conducted in real-world dermatology clinical settings in Germany. We evaluated physician-and patient-reported outcomes for QOL, effectiveness and tolerability in patients with moderate to severe psoriasis vulgaris in LAPIS-PSO. Methods: The primary endpoint was the percentage of patients achieving Dermatology Life Quality Index (DLQI) score B 5 or C 5-point improvement from baseline in DLQI score at visit 2 (* 4 months after baseline). Secondary endpoints included assessments of symptoms and disease severity. Tolerability was evaluated based on adverse events (AEs). A pre-defined subgroup analysis based on baseline Physician's Global Assessment (PGA) score (2 or 3 versus 4) was performed. Data were examined descriptively through visit 5 (* 13 months) using the lastobservation-carried-forward (LOCF) approach and data as observed.