Phase II trials in cancer: present status and analysis methods

Sixty-seven recent phase II studies are reviewed with respect to their design, conduct and analysis. The review shows that in the majority of studies: (i) eligibility criteria are not clearly defined; (ii) no statistical method is applied in interpreting the results; (iii) not all the patients are considered evaluable. Negative conclusions are drawn from two-thirds of the studies. Very few studies give any statistical rationales for their design, and only nine studies are randomized studies. A review of all 17 phase II studies in breast cancer, reported in Cancer Treatment Reports between 1981 and 1983, shows that: (i) all the studies with 20 or more patients are negative; (ii) all the inconclusive studies are of small size; (iii) the distribution of patients according to prior chemotherapy is not comparable or the terminology used for prior therapy is not uniform. Review of all 19 studies in colorectal cancer, reported in Cancer Treatment Reports between 1981 and 1983, reveals, in addition to the above problems, that the 20% response rate to 5-FU in previously untreated patients is not supported. Proposals are made to improve the design, conduct and analysis of phase II studies. Methods for analysing phase II study data are reviewed and two-stage designs appropriate for phase II trials in cancer are discussed.     

Reversible electroencephalogram changes associated with administration of baclofen in a quadriplegic patient: case report

We present the case of a spastic quadriplegic who developed mental symptoms which resolved when his Baclofen was discontinued. Of interest was the presence of EEG abnormalities similar to those described in cats receiving this drug. These abnormalities, previously unreported in humans, resolved upon discontinuing Baclofen therapy.     

A clinically "silent" pheochromocytoma with spontaneous hemorrhage

We report a case of an abdominal mass that had hemorrhaged spontaneously into the retroperitoneal space and presented as an acute abdominal catastrophe. The pathological diagnosis was pheochromocytoma, although the patient had no suggestive symptoms preoperatively. The management of this silent pheochromocytoma and its atypical presentation are discussed.     

Initial two-year results of the Oregon Liver Transplantation Program

During the first 24 months of the Oregon Liver Transplantation Program, which began in October 1988, 94 patients were formally evaluated and 47 adults underwent 54 liver transplantations. Thirty-four percent of patients were veterans. The recipient operation lasted a mean of 7.4 hours (range: 4 to 16 hours). Veno-venous bypass was used routinely at first but selectively later (7 of the last 26 cases), resulting in reduced operating time. Hepatic artery reconstruction was end-to-end anastomosis in 52 cases and iliac conduit in 2. No arterial thrombosis occurred. Biliary reconstruction was choledochocholedochostomy in 83% and choledochojejunostomy in 17%. Biliary complications occurred in 28%. Operative mortality was 2%, and 1-year actual survival was 80%. Patients with hepatitis B fared worse, with four of six dying at a mean of 7.6 months. Overall, the median hospital stay was 30 days. Patients surviving more than 3 months had a mean Karnofsky score of 82%. No significant difference in outcome was noted in patients receiving prophylactic OKT3 monoclonal antibody (used in 45%) versus conventional immunosuppressive therapy. Overall, allograft rejection occurred in 55% of patients. Retransplantation was required in seven patients, three for primary graft nonfunction, two for uncontrolled rejection during induction therapy with OKT3, and two for graft failure secondary to recurrent hepatitis B.     

Localization of basic FGF-like immunoreactivity in the hypothalamo-hypophyseal neuroendocrine axis

We examined the localization of basic fibroblast growth factor (basic FGF) in the adult rat brain by immunohistochemical and Western blotting analysis using a specific antibody against a synthetic basic FGF fragment (N-terminal 12 residues). The antibody did not cross-react with acidic FGF. Basic FGF-like immunoreactivity was located exclusively in the neuronal elements and had very heterogenous distribution. Immunoreactive cell bodies were observed in the paraventricular, supraoptic and circular nuclei of the hypothalamus. Numerous immunoreactive neuronal processes originating from these basic FGF-positive cells extended lateroventrally and then caudally to the internal layer of the median eminence. In addition, the neurohypophysis contained a significant number of basic FGF-like immunoreactive fibers. Western-blotting analysis revealed that the hypothalamus and the hypophysis contained a main band of basic FGF immunoreactive with an apparent molecular weight of 17 kDa. These results show that the hypothalamo-hypophyseal neuroendocrine pathway contains basic FGF.     

Assessing hospital nursing staff retention and turnover. A life table approach.

This research applied the life table technique to nursing personnel data in two types of hospitals to illustrate how administrators can examine patterns of continued employment. Although a large proportion of nurses were short-stay employees, the teaching hospital was found to have a higher retention rate than the community hospital corporation. The retention patterns are examined by personal and professional characteristics, as well as by reason for termination. Implications of our findings are discussed with respect to policy concerns related to hiring, retention, productivity, and staff development.     

Multicystic peritoneal mesothelioma in a 29 year old male

A case of multicystic peritoneal mesothelioma in a 29 year old white male is reported. This is the second reported case of cystic peritoneal mesothelioma in a male and the first case of cystic mesothelioma reported in Australia. Clinical, histopathologic and ultrastructural findings are discussed together with a review of previous cases.     

Conversion of percutaneous ureteral stent to indwelling pigtail stent over guidewire

A ureteral stent placed percutaneously through a nephrostomy can be readily exchanged endoscopically for a ureteral indwelling pigtail stent over a percutaneous guide wire. Percutaneous antegrade stent placement can sometimes be accomplished when retrograde placement cannot. We report 10 successful conversions to indwelling stent in 11 cases. In 1 case the percutaneous guide wire could not be retrieved endoscopically because of a bleeding tumor in the bladder. No serious difficulties or complications were encountered. The percutaneous approach offers an alternative method of providing internal urinary diversion if retrograde ureteral indwelling stent placement has failed.