Background.
Prostate cancer (PC) is the most commonly diagnosed noncutaneous malignancy in American men. PC, which exhibits a slow growth rate and multiple potential target epitopes, is an ideal candidate for immunotherapy. GVAX for prostate cancer is a cellular immunotherapy, composed of PC‐3 cells (CG1940) and LNCaP cells (CG8711). Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte‐macrophage colony‐stimulating factor. Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease, we initiated a phase II trial of neoadjuvant docetaxel and GVAX. For the trial, the clinical effects of GVAX were assessed in patients undergoing radical prostatectomy (RP).
Methods.
Patients received docetaxel administered at a dose of 75 mg/m2 every 3 weeks for 4 cycles. GVAX was administered 2–3 days after chemotherapy preoperatively for four courses of immunotherapy. The first dose of GVAX was a prime immunotherapy of 5×108 cells. The subsequent boost immunotherapies consisted of 3×108 cells. After RP, patients received an additional six courses of immunotherapy. Pathologic complete response, toxicity, and clinical response were assessed. The primary endpoint of the trial was a pathologic state of pT0, which is defined as no evidence of cancer in the prostate.
Results.
Six patients completed neoadjuvant docetaxel and GVAX therapy. No serious drug‐related adverse events were observed. Median change in prostate‐specific antigen (PSA) following neoadjuvant therapy was 1.47 ng/ml. One patient did not undergo RP due to the discovery of positive lymph nodes during exploration. Of the five patients completing RP, four had a downstaging of their Gleason score. Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP.
Conclusions.
Neoadjuvant docetaxel/GVAX is safe and well tolerated in patients with high‐risk locally advanced PC. No evidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted. These results justify further study of neoadjuvant immunotherapy.
In the vast literature on intracranial arachnoid cysts, communication of long-term follow-up is rare. Therefore, we studied the case histories of 60 children and juveniles operated on in our hospital since 1951. The most favorable cases were patients with temporal cysts: 93% recovered fully or with only slight deficits. In other locations (frontal, parietal, occipital, infratentorial), the percentages for a favorable course were lower. The reason cannot be attributed to the operation procedures. Independent of the surgical procedure, there were no postoperative deaths after 1969. Long-term follow-up revealed that, depending on the location of the arachnoid cyst, a high percentage (62%-93% of patients) had normal physical and social development with satisfactory quality of life.
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