Oral vinorelbine may not induce acute pain at the tumor site.
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Administration, Oral↗
Biomedical subjects
Paolo Tralongo
Publications and source records attributed to Paolo Tralongo.
Efficacy and safety of cetuximab/irinotecan in chemotherapy-refractory metastatic colorectal adenocarcinomas: a clinical practice setting, multicenter experience.
BACKGROUND: This study was designed to evaluate the efficacy and safety of irinotecan/cetuximab administered as third- or fourth-line therapy in a retrospective series of patients with metastatic colorectal cancer refractory to oxaliplatin and irinotecan. PATIENTS AND METHODS: Most patients (90%) had been previously treated with adjuvant 5-fluorouracil/leucovorin, and all had received oxaliplatin-based regimens before receiving irinotecan-based second-line treatment. Sixty patients with irinotecan-refractory colorectal cancer received a regimen comprising weekly irinotecan 120 mg/m2 as a 1-hour intravenous infusion and cetuximab 400 mg/m2 infused over 2 hours as the initial dose and 250 mg/m2 infused over 1 hour for the subsequent administrations. A single treatment cycle comprised 4 weekly infusions followed by 2 weeks of rest. RESULTS: According to an intent-to-treat analysis, a partial response was exhibited in 12 of 60 enrolled patients (20%; 95% confidence interval, 11%-32%) with a median duration of 5.1 months (range, 3-7.4 months). The tumor growth control rate was 50% (95% confidence interval, 37%-63%). Objective responses did not correlate with performance status, number of sites of disease, and pretreatments or epidermal growth factor receptor status. The median progression-free survival was 3.1 months (range, 1.2-9 months), whereas median overall survival was 6 months (range, 2-13 months). Both survival parameters correlated with performance status at the beginning of treatment. The main grade 3/4 toxicities were nausea (33%), diarrhea (27%), leukopenia (18%), asthenia (13%), and acne-like reaction (13%). CONCLUSION: Our data suggest that the weekly irinotecan/cetuximab regimen is feasible in an outpatient setting and tolerated by most patients. At present, combinations of chemotherapy with cetuximab are being evaluated in patients with earlier-stage disease in a number of ongoing studies.
Adenocarcinoma↗
Cognitive impairment, aromatase inhibitors, and age.
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Aged↗
Aromatase inhibitors and mental function.
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Aged↗
Safety of long-term administration of bisphosphonates in elderly cancer patients.
BACKGROUND: To evaluate the effectiveness and tolerability of the long-term treatment bone metastases with pamidronate in older patients. MATERIALS AND METHODS: Twenty-two ambulatory patients aged 70 or older were included in the study. The median age was 73 (range 70-77). Ten patients (46%) were affected by breast carcinoma, 7 (32%) by prostate carcinoma and 5 (22%) by multiple myeloma. Nine (40%) patients presented co-morbidity. All of the patients presented at least one metastatic lytic bone lesion measuring 1 cm or more in diameter; the median lesion number was 2 (range 1-4). Hormonal therapy or chemotherapy regimen, were allowed as clinically required. Patients were treated with a fixed dose of sodium pamidronate, 90 mg in 3 h infusion every 4 weeks. RESULTS: Partial response was shown in 6 (28%) patients, stable disease in 11 (50%), and progression (PD) in 5 (22%). 2 out of 5 patients with PD presented skeletal-related events (SREs) such as bone fracture. The median treatment duration was 19 months. The treatment was well tolerated; in 5 patients (23%) a GI fever was observed, in 3 patients (18%) G1 nausea, and in 3 patients (14) G1 diarrhea. Two cases (9%) of acute renal insufficiency (creatinine 1.7 and 1.6 mg/dl), and 3 cases (14%) of hypocalcemia (7.6, 7.5 and 7.8 mg/dl) were also registered. The renal dysfunction was reversible and without consequence. CONCLUSION: Our experience suggests that the bisphosphonates long-term administration is useful and did not cause significant side effects in elderly subjects. Low-grade pyrexia, nausea/vomiting, acute/reversible renal dysfunction and hypo-calcemia were the most frequent side effects reported. However, they were of low grade and in most cases, did not require dose modifications and/or hospitalization.
Aged↗
Fatigue and aging.
Fatigue is the most common chronic symptom of cancer and the symptom most likely to disrupt the patient's activity and to cause disability.Fatigue affects older cancer patients to the same order of magnitude as younger ones and appears to be related to different factors such as anemia, depression, and reduced neuromuscular energy production. Interestingly, some studies have suggested that the duration of fatigue may be age-related. In the elderly, fatigue may cause functional dependence; functional dependence may lead to interruption of treatment, decline in quality of life and expensive home care. Available interventions include reduction of centrally acting drugs, management of anemia and metabolic abnormalities, and management of depression, treatment of sleep disorders, correction of endocrine abnormalities and realistic exercise programmes.
Aged↗
The prevalence and correlates of fatigue in older cancer patients.
PURPOSE: to assess the prevalence and correlates of fatigue in cancer patients aged 60 and older during outpatient treatment with chemotherapy or pamidronate. PATIENT AND METHODS: seventy-seven consecutive cancer patients with different tumors age 60+ served by the senior adult oncology program of the H. Lee Moffitt Cancer Center, were enrolled in the study. Inclusion criteria were: (1) age >-60 years; (2) histological diagnosis of malignancy; (3) no major psychiatric or neurological disorder that could interfere with the competition of the measures; (4) ability to understand and to speak English. Assessment included cognition, function, depression and fatigue. The instruments included geriatric depression scale, mini mental state examination and fatigue symptom inventory. The study used a cross-sectional design. RESULTS: Fifty-six patients (72.7%) reported fatigue at the time of the assessment; seventy-six patients (99%) in the past week. Forty patients (52%) rated their average fatigue as greater than 5. Forty-two patients (54%) reported that they felt fatigue all seven days, for any part of the day in the week before the assessment. Sixty five (84%) patients rated fatigue as interfering with their general level of activity. The fatigue disruptiveness was higher for women than for man (P<0.007). Marital status and educational level were not significantly related to fatigue severity or fatigue disruptiveness (P> or =0.33). A significant positive correlation between depressive symptoms and fatigue severity (r = 0.29, P<0.01) was recorded. Depression was also significantly related to fatigue disruptiveness (r = 0.44, P<0.01). Cognitive status was not correlated with fatigue severity or fatigue disruptiveness. A negative correlation between haemoglobin level and fatigue severity (r = -0.30, P<0.01) and between haemoglobin level and fatigue disruptiveness (r = -0.28, P<0.01) was found. Having had medical care or counselling in the past for anxiety and depression was positively correlated with fatigue disruptiveness (r = 0.29, P<0.01). CONCLUSION: Fatigue is a common symptom of older cancer patients treated with antineoplastic medical treatment. Female patient showed higher fatigue disruptiveness than male. In this study a positive correlation between depression and fatigue, and a negative correlation between haemoglobin and fatigue, were recorded.
Age Factors↗
Vinorelbine and prednisone in older cancer patients with hormone-refractory metastatic prostate cancer. A phase II study.
AIMS AND BACKGROUND: Prostate cancer is a common disease in older men. Since it is hormone resistant, no treatment may improve survival. In patients with hormone-refractory prostate cancer, clinical benefit is an important treatment end point. STUDY DESIGN: This study evaluated the efficacy and toxicity of a vinorelbine and prednisone combination in hormone-refractory prostate cancer patients. Vinorelbine was administered at the dose of 25 mg/m2 on days 1 and 8, every three weeks; prednisone was administered orally at the dose of 12 mg/day. Thirty consecutive patients, 65 years or older, with progressive (PSA increase or increase in bidimensionally measurable lesion) metastatic prostate adenocarcinoma were enrolled. Four patients (13%) had a partial response and 14 (46%) stable disease. Time to progression for the entire group was 4.5 months (range, 2-13) and 7.5 months for the group of responders (range, 3-13). A PSA decrease >50% was registered in 36% of the patients. Pain reduction was recorded in 44.4% of the patients and stability in 14.8%. RESULTS: The treatment was well tolerated and grade 3 toxicity was found in 2 cases of anemia and 2 cases of leukopenia without fever. CONCLUSIONS: The schedule is able to control the evolution of hormone-refractory prostate cancer and to give a clinical benefit. These results provide information for further clinical trials in a large series of elderly cancer patients.
Administration, Oral↗
Vinorelbine and 5-fluorouracil bolus and/or continuous venous infusion plus levofolinic acid as second-line chemotherapy for metastatic breast cancer: an analysis of results in clinical practice of the Gruppo Oncologico Italia Meridionale (GOIM).
BACKGROUND: This retrospective study evaluated the activity and toxicity profile of a regimen of vinorelbine and 5-fluorouracil with levofolinic acid, given to a large series of patients with recurrent or refractory metastatic breast cancer after first-line chemotherapy. PATIENTS AND METHODS: Overall, 286 evaluable patients were included in the analysis. Two chemotherapy schedules were reviewed: a) the bolus regimen consisted of levofolinic acid 100 mg/m2 and 5-fluorouracil 375 mg/m2, both administered i.v. on days 1,2 and 3, plus vinorelbine 25 mg/m2 i.v. bolus on days 1 and 8 every 3 weeks; b) the infusional regimen of levofolinic acid 100 mg/m2 given as a 2-hour infusion, followed by 5-fluorouracil 400 mg/m2 i.v. bolus and by 5-fluorouracil 600 mg/m2 administered as 22-hour continuous venous infusion (c.v.i) for 2 days, plus vinorelbine i.v. bolus on days 1 and 8. RESULTS: Overall, twelve patients achieved a complete response (4%; 95%CL 2%-7%) and 115 patients showed a partial response (40%, 95%CL 34%-46%), for an overall response rate of 44% (95CL 39%-50%). Sixty-one patients had stable disease (21%) and 98 patients progressive disease (34%). The tumor growth control rate was 63% (95%CL 60%-71%). Patients with soft tissue metastases as the dominant disease showed the highest response rate (56%), followed by viscera (48%) and bone (33%). The difference in response rate between patients with dominant visceral disease versus those with dominant bone disease was statistically significant (p=0.038). Patients treated with the bolus schedule achieved a 40% overall response rate with a 5% complete response rate, while those who received the infusional regimen had a 48% overall response rate with a 5% complete response rate. This difference was not statistically significant (p=0.164). The overall median duration of objective responses was 8.3 months (range 4-14 months), median time to progression of the all series was 6.1 months (range 2-24 months) and the median overall survival was 14.6 months (range 3-32). There was a statistically significant difference in survival among responder and non-responder patients (p=0.0009). CONCLUSION: The results of this large off-trial analysis confirmed the clinical activity and adverse-event profile reported in controlled clinical trials of the vinorelbine/ 5-fluorouracil with levofolinic acid regimen in clinical practice. This combination regimen was active with a low toxicity burden and, therefore, represents a good therapeutic choice for patients who require second-line chemotherapy.
Adult↗