[Immune response to influenza vaccination among peritoneal dialysis patients]. / Risposta immune alla vaccinazione antiinfluenzale nei pazienti in dialisi peritoneale.

The influenza vaccination is considered useful in preventing influenza and its complications, but its efficacy is variable especially in uremia. The humoral efficacy in a group of 15 patients in peritoneal dialysis treatment has been evaluated. Antibody responses were measured before vaccination and at time intervals of 1-4 months after vaccination. A good response to viruses A (A/H3N2/Johannesburg 33/94, A/H1N1/Singapore 6/86), respectively 80% and 66.7% and an attenuated response (20%) to virus B (B/Beijing 184/93) was observed. For viruses A, the "non responders" were elder patients with a low count of lymphocytes. For virus B it is suggested that the low response is perhaps related to variable effectiveness of vaccine.

[Effectiveness of influenza vaccination in patients undergoing regular dialysis treatments]. / Efficacia della vaccinazione antifluenzale nei pazienti in trattamento dialitico regolare.

BACKGROUND: The influenza vaccination is considered useful in preventing influenza and its complications, but its efficacy is variable. Recent data on clinical effectiveness of influenza vaccination in renal patients are lacking. MATERIALS AND METHODS: The clinical efficacy in our Hemodialysis Unit during the last three years has been evaluated: 287 patients have been vaccinated. The rate of vaccination achieved has been of 81.3%. RESULTS: The efficacy has been of 46.7%. The difference of efficacy noted among young people (< 60 years) and elderly (> 60 years) in general population is not observed among our hemodialyzed patients. Bronchopulmonary complications (radiographically proven) have been low: 1.7%. No mortality increase has been observed. CONCLUSIONS: These findings suggest that influenza vaccine can reduce the incidence and severity of influenza virus infections also among hemodialyzed patients.

[Piperacillin and amikacin in the treatment of infections in neoplasm patients with granulocytopenia]. / Piperacillina ed amikacina nel trattamento delle infezioni in pazienti neoplastici in corso di granulocitopenia.

Infections are the most common cause of death in tumor patients. The risk of infection is progressively increased in relation to the severity of neutropenia. It is therefore essential to start empirical antibiotic therapy in these patients at the first sign of infection. Forty-three neutropenic tumor patients were entered into the above study when it was assumed that they had bacterial infections (temperature above 38.5 degrees C and/or signs and symptoms of infection). Patients with greater than 1000 neutrophils/mm3 were given piperacillin alone while those with more severe neutropenia (less than 1000/mm3) were given a combination of piperacillin plus amikacin. Of the 43 patients who had entered the study, 41 could be evaluated whereas the remaining two were considered dropouts either because of non-compliance with the study protocol or because the infection was found to be non-bacterial. In both groups of patients (greater than 1000 and less than 1000 neutrophils/mm3) infection resolved completely in a large percentage of cases (92% and 82%, respectively). The efficacy of piperacillin was therefore reconfirmed for the management of infection in oncologic patients with neutropenia, and proved to be an effective therapeutic resource in patients with both slight and severe neutropenia.

Phase II study of divided-dose vinblastine in advanced cancer patients.

A better therapeutic index has been obtained in breast cancer patients when vinblastine is given by a 5-day continuous infusion program than by i.v. bolus; the continuous infusion pharmacokinetics has been reproduced by an iv divided bolus at 0 and 48 h, which may be more easily applied to outpatients. We performed a broad phase II study in 97 advanced cancer patients in which vinblastine was administered by i.v. divided bolus at 0 and 48 h at the starting dose of 3.5-4 mg/m2, every 3 weeks. Our aim was to confirm the results achieved by continuous infusion and to investigate the toxicity pattern of this novel administration schedule. Neurotoxicity and myelosuppression were the main side effects: constipation and peripheral neurotoxicity respectively developed in 28% and 38% of patients and were severe in 5% and 1%. Leukopenia and thrombocytopenia respectively occurred in 70% and 40% of patients and were severe in 11% and 4%. Four partial responses, 38 no changes and 42 progression were obtained out of 84 evaluable patients. Responses were seen in tumors of breast, lung, and head and neck. Our results do not support the use of vinblastine in divided doses in advanced cancer patients.

Lonidamine versus polychemotherapy in advanced non-small-cell lung cancer. A preliminary analysis.

No clear evidence of survival benefit has been definitely shown by chemotherapy in advanced non-small-cell lung cancer. We evaluated in a randomized trial the activity of the new drug lonidamine (up to 1050 mg/day) versus MVP (mitomycin C, 10 mg/m2, vinblastine, 5 mg/m2, cisplatin, 100 mg/m2). The preliminary findings on 25 patients showed that lonidamine can be easily administered at these dose ranges, and main toxicity was represented by myalgia and testicular pain. Tolerance to combination chemotherapy (MVP) was superimposable to our prior experience. Responses were recorded in both arms, and no survival difference was apparent. The study is in progress.

Phase II study of divided-dose vinblastine in advanced breast cancer patients.

The pharmacokinetics of a 5-day, continuous infusion of vinblastine have been reproduced by an i.v. divided bolus at 0 and 48 h [10]; this schedule can be easily applied to outpatients. We treated 26 evaluable patients with refractory, advanced breast cancer with 3.5-4 mg/m2 vinblastine given i.v. by a divided bolus at 0 and 48 h of 21-day cycles. Neurotoxicity and myelosuppression were the main side effects: severe constipation and peripheral neurotoxicity developed in 14% and 3% of the patients, respectively; severe leukopenia and thrombocytopenia occurred in 24% and 10% of the patients, respectively. One partial response, 14 no changes, and 11 progressions were obtained. Our results do not support the use of vinblastine in divided doses in treating this disease.

Mitomycin C, vinblastine and cis-platin. An active regimen for advanced non-small cell lung cancer.

Fifty-one patients with advanced non-small cell lung carcinoma were treated with a combination of mitomycin C, vinblastine and cis-platin (MVP). Most cycles were given on an out-patient basis. Major side effects were leukopenia and peripheral neurotoxicity; one patient died of sepsis while leukopenic. In 44 evaluable patients the response rate was 50%, with one complete response. Overall median survival time was 280 days and median duration of responses was 232 days. A better performance status, disease limited to one hemithorax and no prior exposure to chemotherapy positively influenced the survival. MVP is an effective chemotherapy for non-small cell lung cancer and further experience with this combination is warranted.

4'-Deoxydoxorubicin, an inactive drug in small cell lung cancer.

4'-Deoxydoxorubicin was administered to 27 evaluable patients with refractory small cell lung cancer. The majority of patients had good initial performance status. One third of patients had never received doxorubicin before, and six had received a single drug alone (VM26). Myelotoxicity was the main side-effect, and leukopenia was more pronounced than thrombocytopenia. No significant non-hematological toxicity occurred apart from skin necrosis due to drug extravasation in one case. Two patients had partial response (7.4%; 95% confidence limits 0-17.2%). The low response rate obtained in this good prognosis patient population does not support further testing of this drug in small cell lung cancer.

Teniposide in the treatment of non-small cell lung carcinoma.

Forty-two evaluable patients with advanced non-small cell lung cancer were treated with teniposide at doses ranging from 120 to 180 mg/m2 on Days 1, 3, and 5 every 3 weeks. Thirty-four patients had received no prior chemotherapy. Seven partial responses (16.6%) were obtained (21% in chemotherapy-unexposed patients). Marrow toxicity was the main side effect: life-threatening thrombocytopenia occurred in 9% of patients, and 54.5% experienced severe leukopenia. Teniposide, at the doses and schedule employed, has moderate activity in non-small cell lung cancer.

Disorders of serum electrolytes and renal function in patients treated with cis-platinum on an outpatient basis.

Two hundred and eighty-one patients received 927 doses of cis-platinum, generally on an outpatient basis, at 55 mg/m2 every 3-4 weeks. Mannitol and 2.2501 of hydration with saline and 5% dextrose plus NaCl and KCl were given in 3-4 hr. No case of acute renal failure ensued and when azotemia occurred (3.5% of patients) it was easily reversible and controlled. An abnormal level of one or more electrolytes was detected in 194 patients (69%) during chemotherapy. K+, Na+, Ca2+ and Mg2+ values usually decreased in serum after DDP administration, but their depletion seldom caused symptoms. Hypomagnesemia developed in 20% of patients, but was symptomatic in only 1%. cis-Platinum, at the doses utilized, is safely given to outpatients, with the hydration program employed. Serum electrolyte decrease during chemotherapy must be expected, and rapidly corrected when symptoms develop.