PURPOSE: Patients with ovarian cancer often experience dose-limiting myelotoxicity, nephrotoxicity and anemia following treatment with platinum-based chemotherapy. PATIENTS AND METHODS: To investigate the ability of recombinant human erythropoietin (epoetin alfa) to prevent the development of anemia, 30 patients with advanced ovarian carcinoma receiving cisplatin or carboplatin were randomly assigned to treatment with subcutaneous epoetin alfa 300 IU/kg three times a week in addition to conventional supportive treatment, or conventional supportive treatment alone, for up to six chemotherapy cycles. The dose of epoetin alfa was reduced if hemoglobin concentration exceeded 15 g/dL. RESULTS: A highly significant difference in mean hemoglobin concentrations was observed between the two groups during the first cycle of chemotherapy due to a significant decrease in mean hemoglobin concentration in the control group. A maximal difference of 3.4 g/dL was achieved during cycle three. Fewer patients required blood or platelet transfusions in the epoetin alfa-treated group, although the difference was not significant compared to the control group. Epoetin alfa was well tolerated. CONCLUSION: Epoetin alfa appears to be effective and well tolerated in preventing hemoglobin decline in patients undergoing aggressive cyclic platinum-based chemotherapy for advanced ovarian carcinoma.

Adolescent↗

PubMedDate not supplied

Dexrazoxane cardioprotection in advanced breast cancer patients undergoing high-dose epirubicin treatment.

PURPOSE: We performed a randomized trial to evaluate the cardioprotective effect of dexrazoxane (DEX) in advanced breast cancer patients (ABC) treated with high single-dose epirubicin (EPI). A secondary objective was to determine the role of radioimmunoscintigraphy (RIS) in the assessment of epirubicin cardiotoxicity. PATIENTS AND METHODS: Ninety-five patients with ABC were treated with EPI 160 mg/m2 by i.v. bolus every 3 weeks with or without DEX, 1,000 mg/m2 i.v. Cardiac monitoring included multigated radionuclide (MUGA) scan with determination of resting left ventricular ejection fraction (LVEF), and RIS with 111-Indium antimyosin monoclonal antibodies. RESULTS: The overall response rate was 69% in the EPI arm and 67% in the EPI + DEX arm; median time to response and median time to progression were identical in both arms, being 2 and 8 months, respectively. Median survival was 19 months versus 29 months (p 0.21), respectively. DEX did not appear to contribute to extracardiac EPI toxicity. Congestive heart failure occurred only in the EPI arm (2 instances). LVEF significantly decreased from baseline only in the EPI group. An abnormal tracer uptake at RIS was observed early in both arms, but the increase in heart to lung ratio was much more evident in the control group. CONCLUSIONS: DEX significantly protects against the development of high dose epirubicin cardiotoxicity apparently without evidence of an adverse impact on antitumor activity and non cardiac toxicity. RIS is a very sensitive technique in detecting anthracycline cardiac damage, but its specificity is low and cannot be considered alone a primary test for guiding anthracycline treatment.

Aged↗

PubMedDate not supplied

Evaluation on serum 2'-5'oligoadenylate synthetase (2'-5'oligoAS) and beta 2 microglobulin (B2M) in patients with nodal metastases from cutaneous malignant melanoma treated with rIFN-alpha 2A.

UNLABELLED: IFN-alpha is a promising adjuvant agent in patients with regional melanomatous metastases (stage IIIB). The aim of this study was to verify whether serum evaluation of the interferon induced proteins 2'-5'oligoAS and B2M can predict the clinical response to rIFN-alpha 2A therapy. PATIENTS AND METHODS: Forty-two patients who had undergone radical dissection of nodal metastases were evaluated. All patients received adjuvant rIFN-alpha 2A (3 million units s.c. three times weekly) for 3 years or until progression. The patients were followed for a medium period of 43 months (range 19-46). During follow-up 22 of the 42 patients had disease progression. In all patients blood samples were obtained before starting adjuvant therapy and after 1 and 6 months of therapy with rIFN-alpha 2A. 2'-5' oligoAS and B2M were measured by radioimmunoassay. RESULT: During the first month of adjuvant therapy with rIFN-alpha 2A the serum levels of 2'- 5' oligoAS increased 10-fold, and this trend was maintained in the following 6 months. Similar results were obtained for B2M serum levels. However, we did not find any significant difference in AS and B2M serum levels between responders and non-responders. CONCLUSION: Our results, therefore, indicate that AS and B2M are markers of the biological activity of administered IFN but that they have little efficacy in predicting the clinical outcome of the treated patients.

2',5'-Oligoadenylate Synthetase↗

PubMedDate not supplied

[Sequential therapy with methotrexate and 5-fluorouracil in patients with advanced colorectal cancer pretreated with 5-fluorouracil plus folinic acid].

PURPOSE: To evaluate the efficacy and toxicity of a sequential low-dose methotrexate (MTX) and 5-fluorouracil (5FU) regimen in the palliative treatment of patients with advanced colorectal cancer. PATIENTS AND METHODS: Enrolled in the study were patients with advanced colorectal cancer, refractory to 5FU + FA. Patients were treated with MTX 40 mg/m2 i.v. bolus d 1 and 8, 5FU 700 mg/m2 i.v. bolus d 2 and 9 (24 hours after MTX bolus). The cycle was repeated every 4 weeks. RESULTS: 48 patients entered the study, and 45 are evaluable. The overall response rate was 15% with 1 complete response and 6 partial responses. Eight patients obtained disease stabilization. Median time to progression was 9 months. Toxicity was mild. Grade 3 stomatitis was observed in 7 (15%) patients. CONCLUSIONS: Sequential MTX/5FU is a well tolerated regimen with mild antitumor activity in refractory advanced colorectal patients.

Antineoplastic Combined Chemotherapy Protocols↗

PubMedDate not supplied

[Simultaneous infusion of vinorelbin and taxol as first-line chemotherapy in metastasized breast cancer].

PURPOSE: To evaluate the activity and toxicity of simultaneous infusion of vinorelbine (VNB) and paclitaxel (T) as first line chemotherapy in advanced breast cancer patients (pts). PATIENTS AND METHODS: 33 pts with histologically proven advanced breast cancer were treated with VNB 25 mg/m2 and T 150 mg/m2, both drugs given by i.v. infusion over 3 hours, with cycles repeated every 3 weeks. Granulocyte-colony-stimulating factor (G-CSF), 300 micrograms subcutaneously, was given on days 7 to 12 of each cycle in the first 10 patients. RESULTS: From October 1995 to July 1996, 33 untreated pts entered the study. Characteristics of the pts were the following: median age 53 years (29-71); median WHO performance status 1 (0-3); pre/postmenopausal 8/25; prior adjuvant chemotherapy 16; prior radiotherapy 8; dominant disease sites: soft tissue in 6; bone in 7, viscera in 19; number of metastatic sites: 1 in 18, 2 in 9, 3 in 6 pts. In 31 evaluable pts we observed: 1 CR (3%) and 14 PR (45%), for an overall response rate of 48%. Median time to response was 2 months; median time to progression and median survival were 7 and 22+ months, respectively. Median number of cycles was 6. Myelosuppression was the dose-limiting toxicity, with G 4 neutropenia occurring in 22% of the pts and neutropenic fever in 6% of the pts. Other toxicities were generally mild with nausea in 52% of the pts; mucositis in 15%; constipation in 12%; peripheral neuropathy in 46.5%. Alopecia was universal. CONCLUSIONS: Simultaneous infusion of VNB and T is well tolerated and active in untreated patients with advanced breast cancer. Median survival (22+ months) is similar to that reported with anthracycline-containing regimens, although response rate appears to be lower. It is likely that higher response rates may be achieved with a higher dose-intensity.

Adult↗