Impact of anemia management with EPO on psychologic distress in cancer patients: results of a multicenter patient survey.

AIM: We investigated the role of erythropoietin (EPO) in reducing anemia and preventing the development of psychological distress in patients treated with chemotherapy. PATIENTS & METHODS: This prospective observational study enrolled 591 adult patients receiving EPO at a dose of 30,000 IU administered once weekly for chemotherapy-induced anemia (mean baseline hemoglobin [Hb] level was 9.55 g/dl) over a 12-month period. RESULTS: The majority of patients (371 [71%] patients) achieved a Hb increase >2 g/dl after 4 weeks of treatment. Interestingly, the nonresponder group had a statistically significant deterioration of their psychological conditions as indicated by psychological distress score (p = 0.01). However, within the group of responders to EPO, the Psychological Distress Inventory score remained unchanged. In the present study, severe side effects associated with EPO were not recorded. CONCLUSION: Hb increase, induced by EPO, ameliorates the psychological conditions of cancer patients.

Emergencies in oncology: an overview and practical suggestions.

Oncologic emergencies are clinical situations that can lead to death in a short time (24-48 hours) if not quickly faced. In the clinical practice of the medical oncologist, such situations do not infrequently occur. The onset of oncologic emergencies may depend on the presence of cancer itself, the therapies carried out to counteract cancer, or the patient's predisposition to develop such events. Mediastinal syndrome, spinal cord compression, endocranial hypertension, pancytopenia, metabolic syndromes, deep vein thrombosis, pulmonary thromboembolism, disseminated intravascular coagulation and the massive pericardial effusion are the main medical emergencies in oncology occurring in clinical practice. It is essential to recognize the aforementioned situations early in order to treat them promptly, thus avoiding serious consequences. This paper is aimed at presenting an overview on the topic, offering practical suggestions useful in daily clinical practice.

Sequential docetaxel followed by epirubicin-vinorelbine as first-line chemotherapy in advanced breast cancer.

BACKGROUND: This phase II study evaluated the efficacy and the tolerability of a sequential regimen of docetaxel followed by epirubicin-vinorelbine combination as first-line chemotherapy in advanced breast cancer. PATIENTS AND METHODS: Twenty-seven patients received docetaxel 100 mg/m2 (4 cycles) followed by 4 cycles of epirubicin 90 mg/m2 (day 1) combined with vinorelbine 25 mg/m2 (days 1 and 5), with cycles repeated every 3 weeks. G-CSF was administered during epirubicin-vinorelbine treatment. RESULTS: There were 1 (3.7%) CR and 14 (51.9%) PR, for an overall response rate of 55.6% (95% CI, 36.9%-74.3%). Median time to response, time to progression and overall survival were 2, 9 and 25 months, respectively. The dose-limiting toxicity was neutropenia (grade 3 to 4 in 85% of the patients). There was one toxic death due to neutropenic fever. Gastrointestinal side-effects were generally mild According to the Simon two-stage design the response rate was considered unsatisfactory and patient accrual was terminated. CONCLUSION: This sequential regimen appears to be moderately effective; possibly, a modulation of the treatment based on objective responses instead of a fixed number of cycles may be more appropriate in order to obtain better results.

External beam radiotherapy in bone metastatic prostate cancer: impact on patients' pain relief and quality of life.

Bone metastases are a severe problem in oncology, since they usually are associated with pain. External beam radiation therapy (EBRT) has been, for many years, an important component of the treatment regimen to relieve pain. We have performed a clinical study to evaluate the relationship of response to EBRT in terms of pain relief and improvement in quality of life (QoL). We were also interested in the incidence of acute toxicity with EBRT. We have prospectively evaluated 75 patients (median age 68 years, range 64-79 years) with bone metastases from prostate cancer treated with EBRT, radiographically documented from June 1999 to September 2000. Additional therapies in these patients included: second-line hormonal therapy (HT) in 20 patients, chemotherapy (CT) in 25 patients, biphosphonates in 45 patients. For all patients a pain and narcotic evaluation was done before entering the study. Assessment of response was carried out by evaluating pain relief. QoL was measured by using the EORTC QLQ-C30 questionnaire. Toxicity analysis was based on the ROTG grading system. Survival was calculated by Kaplan-Meier estimate from the start of EBRT treatment until the last follow-up or death. A total of 61 out of 75 patients (81%) experienced some type of pain relief after treatment. The complete response rate was 23%. No significant difference in the response rates was found between the group treated with EBRT alone versus the groups treated with EBRT + CT or EBRT + HT. We noted a significant improvement in some of the scales of the considered EORTC-QLQC30 questionnaire. As expected all treatment-related complications were either grade 1-2 acute or subacute and transitory in nature. The group treated with EBRT + CT experienced slightly higher toxicity rates. There were no treatment-related fatalities. Forteen patients of 61 (23%) responders was alive at 12 months. Our results confirm the ability of EBRT to relieve bony pain in the majority of the cancer patients treated as measured by prospective analysis of pain scales prior to and after EBRT. Minimal side effects were experienced and QoL improved as shown by the results of the specific questionnaire.

Zoledronic acid in the treatment of bone metastases by hepatocellular carcinoma: a case series.

PURPOSE: The survival of patients with hepatocellular carcinoma (HCC) has improved with advancements in various diagnostic tools and treatment modalities. Consequently, bone metastases from HCC are diagnosed more frequently. The aims of the present study was to describe the clinical features and treatment of HCC patients presenting with bone metastases. In particular, we evaluated the role of zoledronic acid in these patients especially with regard to pain reduction, analgesic drug consumption and safety. METHODS: Between December 2006 and July 2008, we recruited 17 (male:female, 12:5, median age, 68 years; age range, 62-85 years) consecutive patients. Spinal metastases were present in 11 patients (64.7%). Zoledronic acid was administered in all patients (total number of administrations, 107; mean number of administrations, 6.29). RESULTS: A total of 15 patients received at least three administrations of zoledronic acid and reported clinical benefit with pain reduction and tapering of analgesic drugs. Before starting treatment, the mean VAS for patients who received at least three administrations (15/17 patients) of zoledronic acid was 7.1 (+/-0.24), and after 3 months 5.3 (+/-0.20). This improvement was independent of the sex, the extent of metastasis and the concomitant anticancer treatment. No significant side effects were registered in this series of patients. Median survival was 10 months (CI 6,353-13,647). CONCLUSIONS: Zoledronic acid may be helpful in treating bone metastases in HCC patients. Patients regularly receiving zoledronic acid showed significant pain relief.

A phase II study of irinotecan alternated with a weekly schedule of oxaliplatin, high-dose leucovorin and 48-hour infusion 5-fluorouracil in patients with advanced colorectal cancer.

OBJECTIVES: To evaluate the safety and efficacy of irinotecan (CPT-11) alternated with a weekly treatment for 4 weeks of oxaliplatin (L-OHP), high-dose leucovorin (LV) and a 48-hour 5-fluorouracil infusion (5-FU 48 h) as first-line chemotherapy for patients with advanced colorectal cancer (ACC). PATIENTS AND METHODS: Previously untreated patients with ACC received chemotherapy consisting of a weekly treatment for 4 weeks of L-OHP (65 mg/m2), high-dose LV (150 mg/m2) followed by a 5-FU 48 h infusion (2,300 or 1,800 mg/m2) alternated with CPT-11 (350 mg/m2). A cycle was to be performed every 8 weeks. Treatment was continued up to tolerance, disease progression or patient refusal. Forty consecutive patients with measurable ACC, aged 26-70, performance status < or =2, entered our study. RESULTS: Six complete and 17 partial responses were observed (overall response rate, 57.5%; 95% confidence interval, CI: 38.8-71.1%); an additional 35% of the patients had stable disease. The median duration of response was 10.9 months (range, 6.5-30+ months). The median time to progression and the median overall survival time were 11.4 (95% CI: 10.4-12.3) and 20.3 (95% CI: 16.4-23.7) months, respectively. At the median follow-up period of 24 months, 17 patients (42.5%) are still alive. After a median number of 4 cycles, one toxic death occurred. The incidence of grade 3-4 toxicity per patient in any cycle was: stomatitis 7.5%, nausea/vomiting 2.5% and diarrhea 45% for the infusional part, neutropenia 37.5%, anemia 2.5%, thrombocytopenia 5%, alopecia 5% and diarrhea 10% for the CPT-11 part of the regimen. Gastrointestinal toxicity was different according to the dose of 5-FU. Serious adverse events occurred most frequently when 5-FU was given at a dose of 2,300 mg/m2 with a high incidence of grade 3-4 diarrhea (72.2%) and stomatitis (16.6%), and led to dose reduction of 5-FU in 13 of 18 patients (72.2%). For 22 patients who started 5-FU at a dose of 1,800 mg/m2, a dose reduction of 5-FU was necessary only 5 times (22.7%). No patient discontinued treatment because of severe neurotoxicity. CONCLUSIONS: The activity of our alternating regimen of L-OHP/LV/5-FU 48 h and CPT-11 for not previously treated ACC patients is counterbalanced by a high toxicity and a inconvenient schedule.

Weekly docetaxel and vinorelbine (VIN-DOX) as first line treatment in patients with hormone refractory prostate cancer.

BACKGROUND: The current study investigated the clinical benefit, the impact on biochemical and objective response and tolerability of weekly docetaxel with vinorelbine (VIN-DOX) in symptomatic patients with hormone refractory prostate cancer (HRPC). METHODS: Patients were treated with docetaxel 25 mg/m2 and vinorelbine 20 mg/m2, intravenously for 6 consecutive weeks followed by a 2 week rest repeatedly until disease progression. Clinical benefit evaluations, based on Karnofsky performance status (KPS) and pain measure, were assessed weekly during therapy. A clinical benefit response was defined as a sustained (> or =4 weeks) improvements in one of these parameters. Changes in prostate-specific antigen (PSA) levels, tumoral response and toxicity also were evaluated. RESULTS: 19 men (median age 68 years), were treated. Overall, 42% of patients achieved a KPS significant change and positive pain response; 47% achieved a 50% or greater reduction in PSA. The objective response rate was observed in 2 of 9 patients with measurable disease (22%). The most important toxicity was neutropenia (Grade 3 = 32%). CONCLUSIONS: The combination of weekly VIN-DOX appears to be feasible. VIN-DOX was found to be associated with improvement in clinical benefit response and biochemical response and well tolerated as first line treatment in HRPC.