A phase-II study of liposomal doxorubicin and docetaxel in patients with advanced pancreatic cancer.

BACKGROUND: Both liposomal doxorubicin (LD) and docetaxel (D) have a broad range of activity against solid tumors, including advanced pancreatic cancer (APC), as single agents, while their combination has produced encouraging response rates in the treatment of several malignancies. We have conducted a Phase-II study in order to evaluate the tolerance and efficacy of their combination as front-line treatment in patients with APC. PATIENTS AND METHODS: Twenty-one chemotherapy-naïve patients with unresectable, locally-advanced or metastatic pancreatic cancer were enrolled. These included 16 males and 5 females with median age 66 years (range 57-80). Performance status (PS) was 0 (n = 10 pts), 1 (n = 7 pts) and 2 (n = 4 pts). D (80 mg/m2), and LD (30 mg/m2) were administered on day 1, every 3 weeks. RhG-CSF s.c. was given to all patients. At the time of analysis, all included patients were evaluated for toxicity and for response. RESULTS: A total of 92 cycles were administered (4.38 cycles/patient). Partial response was achieved in 6 patients, with a median duration of response of 3 months. Stable disease was observed in 7 patients and progressive disease in 8 patients. The median duration of survival was 10 months (95% CI, 6-14 months) and the actuarial 1-year survival rate was 33.33%. With regard to toxicity, grades 3,4 neutropenia occurred in 8 (38%) patients and grades 3,4 thrombocytopenia in 4 (19%) patients. Non-hematological toxicity was recorded in 15 (71%) patients: grades 3,4 diarrhea (3 pts, 14%), hypersensitivity reactions (3 pt, 14%), grade 2 neurotoxicity (6 pts, 29%) and palmar-plantar erythrodysesthesia (9 pts, 43%). CONCLUSION: The doxorubicin and docetaxel combination was well-tolerated by these poor prognosis patients. Although both drugs have a marginal activity in pancreatic cancer, most patients experienced significant clinical improvement, with acceptable toxicity.

Effects of cefepime and meropenem on the gastrointestinal colonization of surgical patients by Candida albicans.

BACKGROUND: The study evaluated the effects of cefepime and meropenem on the gastrointestinal (GI) colonization of surgical patients by Candida albicans. PATIENTS AND METHODS: Twenty adult surgical patients who received intravenously either of these antibiotics as monotherapy for the treatment of an existing infection were studied prospectively. Ten patients received cefepime (2.0 g twice a day), and another ten meropenem (1.0 g every 8 h) for 7 days. Quantitative stool cultures for C. albicans were performed immediately before, at the end, and 1 week after the end of antibiotic treatment. RESULTS: Both antibiotics increased the GI colonization of patients by Candida. Meropenem caused a higher increase (2.0 log(10) CFU/g of stool) as compared to cefepime (1.7 log(10) CFU/g of stool). However, these increases were statistically not significant. CONCLUSION: Cefepime and meropenem when given to sensitive patients do not increase significantly the risk of Candida infection originating in the GI tract.

The prognostic significance of autoantibodies against dsDNA in patients with colorectal adenocarcinoma.

BACKGROUND: The tumors of the gastrointestinal system have been associated with various immune disorders. The goal of this study was to correlate the presence of the anti-dsDNA autoantibodies in the serum of patients with colorectal adenocarcinoma suffering from the prognosis of their disease. PATIENTS AND METHODS: We investigated 55 patients with colorectal adenocarcinoma, 26 patients with benign surgical disease and 40 healthy volunteers for the presence of anti-dsDNA autoantibodies pre-operatively and one month post-operatively, with an ELISA technique. RESULTS: The difference of prevalence of anti-dsDNA antibodies between the group of cancer patients and the two control groups was statistically significant (p < 0.001). After a 3-year follow-up, the difference of incidence of the recurrences between the positive and the negative group for anti-dsDNA autoantibodies of the CA patients was statistically significant (P < 0.01). CONCLUSION: The presence of anti-dsDNA autoantibodies in patients with colorectal cancer indicated a better outcome of the course of the disease.

Distant cutaneous metastasis from carcinoma of the uterus. A case report.

Cutaneous metastasis from intraabdominal carcinoma is relatively rare. When it is present it is usually located in the skin overlying the neoplasm [1]. Carcinoma of the uterus metastatic to the skin accounts for 9% of all cutaneous metastases. Distant metastasis is extremely rare. Such a metastasis to the skin of the big toe of the lower limb is presented.

Multiple cholesterol embolism: a case report.

Cholesterol embolism is an unusual but serious complication of intra-arterial procedure such as arterial catheterization, angiography, and angioplasty. In this short paper a case of fatal cholesterol embolisation after angiography is described. Histology examination revealed atheroembolic lesions in the kidneys, spleen and colon.

Fournier's gangrene: still highly lethal.

Five patients with necrotizing soft tissue infections of the perineum and scrotum are presented. There were one female and four male patients, aged from 35 to 70 years. Portals of entry were perirectal abscesses in four cases and a scrotal abscess in one case. All patients required extensive surgical debridement and intravenous broad-spectrum antibiotics. Operative debridement involved the scrotum, the perineal and inguinal area, the upper thighs and the anterior abdominal wall. One patient required transverse loop colostomy and one loop sigmoidostomy. One patient was reoperated on after inadequate drainage of a perirectal abscess. Three patients were referred to our unit after some delay, while one patient did not seek medical care until after being febrile for 2 weeks. Despite aggressive debridement, this last patient died of fulminant sepsis. Fournier's gangrene, which is not so rare as in generally considered, is still associated with a high mortality, which can be reduced only by improving medical awareness and early treatment both of the primary cause and of necrotizing fasciitis.

A randomized trial comparing adjuvant fluorouracil, epirubicin, and mitomycin with no treatment in operable gastric cancer.

Combination chemotherapy (CT) has, in some groups of patients with gastric cancer (GC), who are at a high risk for relapse, resulted in a small but measurable improvement in palliation and patient survival not reaching statistical significance and therefore remaining applicable in an investigational setting. Based on the above data, we studied adjuvant CT with FEM (5-fluorouracil (5-FU), epirubicin, mitomycin C) in a randomized study of patients with completely resected stage III GC and patients with stages T1-3 with a low histologic grade. CT was started 2-3 weeks after surgery. From August 1988 until February 1994, 84 patients with completely resected tumors and lymph nodes were randomized to either group A (FEM) or group B (no treatment). Patients were eligible for randomization if they had a Karnofsky score > 60, no postoperative evidence of residual tumor, and normal cardiac, hepatic and renal functions. Forty-two patients were randomized to each group, with no significant differences regarding: age distribution, group A 53 years (41-65), group B 57 years (35-66); sex, group A 32/10, group B 25/17 (men/women); site of primary tumor, group A 22/20, group B 25/17 (pylorus/antrum); histologic grade, group A 0/19/23, group B 0/25/17 (grades I/II/III); lymph node metastases, group A 30, group B 32, and surgical procedure, group A 33/9/6, group B 35/7/9 (total gastrectomy/partial gastrectomy/splenectomy). Group A received 5-FU 600 mg/m2/day i.v. on days 1, 8, 29 and 36, epirubicin 45 mg/m2/day i.v. on days 1 and 29, and mitomycin C 10 mg/m2 i.v. on day 1. The schedule was repeated every 56 days for 3 cycles. Group B received no treatment odd was only subjected to the regular follow-up. At the last follow-up at 66 months, 27/42 patients in group A (64%) had relapsed or died, compared to 34/42 patients in group B (81%). The differences in the relapse and the disease-free and the overall survival rates were not statistically significant. Only the subgroup of patients with histologic grade III tumors receiving adjuvant FEM demonstrated a trend towards improved survival (p = 0.085). Main therapy-related toxicities for the treatment group were grade I-II anemia, neutropenia, and throbocytopenia in 16, 45, and 22% of patients, respectively, and grade I-II nausea and vomiting in 29% of patients. Based on the present findings and those of previous studies, even if one considers the difference reaching statistical significance in the latter for histologic grade III tumors, it becomes evident that with current therapeutic modalities adjuvant therapy has no established role in the management of resectable GC. Studies of new-generation regimens, such as FAMTX (5-FU, Adriamycin and methotrexate) as well as ELF (etoposide, Leucoverin, and 5-FU), should be conducted in the adjuvant therapy setting with a nontherapy control group, in order to clarify the issue of adjuvant CT in resectable GC.

Vascular manifestations of Behçet's disease.

The purpose of this article is to present the spectrum of vascular disease accompanying Behçet's disease. Four cases of the disease with various vascular manifestations are presented. In the first case superior vena cava syndrome due to thrombosis was the presenting symptom. In the second case foot ischemia with toe necrosis was prevalent. In the third case the patient developed recurrent aneurysmal disease in large and medium size arteries requiring successive vascular surgery, and in the fourth case the patient had SVC thrombosis and ruptured femoral aneurysm. All four patients were young males. Although vascular complications of Behçet disease are uncommon they may pose serious therapeutic problems.