Vinorelbine and Prednisone in older Cancer Patients with Hormone-Refractory Metastatic Prostate Cancer a Phase II Study

Tralongo, Paolo; Bollina, R.; Aiello, R.; Mari, Anna Di; Moruzzi, G.; Beretta, G; Mauceri, G.; Conti, G.

doi:10.1177/030089160308900106

Cited by 13 publications

(7 citation statements)

References 31 publications

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“…It is a mitotic inhibitor with better therapeutic index and lower neurotoxicity with respect to other vinca alkaloids, due to the lower axonal degradation associated with its use. Use of vinorelbine in the treatment of prostate cancer, although limited, has been shown to be effective: several studies 7 , 8 , 28 , 29 previously showed clinical response rate and pain control. Specifically, clinical response was reported to range between 20–40% with 20% reduction of PSA levels.…”

Section: Discussionmentioning

confidence: 99%

“…Specifically, clinical response was reported to range between 20–40% with 20% reduction of PSA levels. 7 , 8 , 28 , 29 …”

Section: Discussionmentioning

confidence: 99%

“…Several data have shown the safety and efficacy of vinorelbine in the treatment of elderly patients with mCRPC. 7 , 8 Most of these studies have been implemented when the oral formulation of vinorelbine has been available in order to exploit the easiest route of administration compared with intravenous drugs and evaluated the patients preferences of administration. 9 …”

Section: Introductionmentioning

confidence: 99%

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Chemotherapy in frail elderly patients with hormone-refractory prostate cancer: A “real world” experience

Tralongo

Bordonaro

Mari

et al. 2016

Prostate International

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BackgroundIn elderly patients affected by metastatic castration-resistant prostate cancer (mCRPC) chemotherapic treatment may be the choice if one considers not only the chronological age, but also the clinical status, the functional reserve, and the vulnerability of patients. Several studies have confirmed the survival benefit of docetaxel and vinorelbine among every class of age. Most CRP elderly patients are defined as frail, maybe due to comorbidities: these patients, who are unable to be candidates for a standard treatment, should be candidates for a more tolerable treatment.MethodsTwenty-six elderly, frail patients were evaluated. The patients were affected by mCRPC and were receiving chemotherapy with intravenous weekly docetaxel (12 patients) or oral metronomic vinorelbine (14 patients). Safety and efficacy were investigated evaluating clinical and objective response and tolerability. The level of patient satisfaction with treatment was assessed through a questionnaire.ResultsNo significant difference was found between groups in terms of 6-month progression-free survival: 57.1% for patients treated with oral metronomic vinorelbine versus 58.3% for patients treated with docetaxel. Median progression free survival was 8.6 months (95% confidence interval: 7.1–9.4 months), and 8.2 months (95% confidence interval: 6.9–9.3 months) for patients treated with oral metronomic vinorelbine and socetaxel, respectively. Oral metronomic vinorelbine was associated with increased patient satisfaction with respect to docetaxel administration. The most frequent side effect associated with oral metronomic vinorelbine was anemia and vomiting, with similar frequency compared to patients treated with docetaxel.ConclusionWeekly docetaxel and oral metronomic vinorelbine are equally effective and well tolerated in elderly unfit and frail patients affected by mCRPC. Metronomic vinorelbine treatment is associated with higher patient compliance and satisfaction.

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Section: Discussionmentioning

confidence: 99%

“…Specifically, clinical response was reported to range between 20–40% with 20% reduction of PSA levels. 7 , 8 , 28 , 29 …”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Chemotherapy in frail elderly patients with hormone-refractory prostate cancer: A “real world” experience

Tralongo

Bordonaro

Mari

et al. 2016

Prostate International

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“…Please use proper citation format when citing this article including the DOI, publisher reference, volume number and page location. mustine and docetaxel (11)(12)(13)(14). These observations DOX was diluted in 500 cc of a saline solution and administered by IV infusion over 2 h, followed by an prompted us to consider three aspects of the problem.…”

Section: Introductionmentioning

confidence: 99%

Weekly Administration of Docetaxel and Epirubicin as First-Line Treatment for Hormone-Refractory Prostate Carcinoma

Neri

Molinara²,

Pantaleo³

et al. 2009

oncol res

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Androgen-independent prostate carcinoma (AICP) is one of the tumors that continue to respond poorly to chemotherapy. Recently, protocols based on the use of docetaxel have significantly improved survival for patients in this disease. In other types of neoplastic disease, combined therapy with taxanes and anthracycline derivatives has been shown to produce additive effects in terms of growth inhibition, and superior tolerability when associated with weekly administration schedules. These findings prompted us to examine the tolerability and efficacy of weekly treatment of AICP with docetaxel (DOX) plus epirubicin (EPI). We enrolled 35 chemotherapy-naive men with AICP (mean age 72 years, range 68-77) and normal hepatic, renal, and cardiac function. The chemotherapy protocol provided for the IV administration of DOX (30 mg/m2) and EPI (30 mg/m2) on days 1, 8, and 15 every 28 days. Treatment was continued for 6 months or until disease progression and/or unacceptable toxicity was observed. Serum levels of prostate-specific antigen (PSA) were monitored in all patients, and reductions from baseline values of >50% were considered indicative of positive responses to treatment. Thirty-four patients were included in the analysis of toxicity, and objective responses to treatment were assessed in the 28 patients with measurable lesions. Nineteen patients (56%) experienced PSA reductions of >50% that persisted for more than 4 weeks. The response to therapy was classified as complete in 1 of the 28 patients (4%) with measurable disease (at the lymph node level). Thirteen others (13/28, 46%) had partial responses, in nine (32%) the disease remained unchanged, and progression was observed in the remaining five (18%); overall response rate was 50% (CR + PR). Of the 27 patients with pain at the time of enrollment, 16 (59%) experienced pain reduction during treatment. The median time to disease progression was 11.7 months (95% CI: 7.7-15.7) while the median survival time was 18.7 months (95% CI: 12.3-25.1). During the study, four patients developed grade 3 anemia and leukopenia, which was reversible in all cases. Lower grades of asthenia, nausea, vomiting, diarrhea, and peripheral edema were also observed. There were no cases of cardiotoxic effects. Alopecia was frequent but reversible in all cases. The results of this preliminary study indicate that the combined administration of DOX and EPI for treatment of AIPC is effective and well tolerated. The weekly administration of the drug combination appears to be a promising approach to the treatment of these tumors.

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“…It preferentially binds to the mitotic spindle and affects microtubules in neural structures to a lesser degree than the parental compound and, thus, it is associated with less neurotoxicity [1,2,3]. Vinorelbine is active against a broad range of solid tumors [4,5,6]. The oral formulation of vinorelbine is particularly interesting because it is rapidly absorbed, has an elimination half-life of 40 h, is highly bound to platelets, has a hepatic metabolism and an absolute bioavailability of 40%, being similar to that of the parental drug [7].…”

Section: Introductionmentioning

confidence: 99%

A Dose Escalation Study of Biweekly Oral Vinorelbine and Gemcitabine in Patients with Solid Tumors

Karampeazis

Vamvakas²,

Agelaki³

et al. 2006

Oncology

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Purpose: To determine the maximum tolerated doses (MTDs) and the dose-limiting toxicities of a biweekly administration of oral vinorelbine and gemcitabine in patients with advanced solid tumors. Patients and Methods: Twenty-eight patients with advanced stage solid tumors were enrolled, and 12 (42.9%) of them were chemotherapy naive. Escalating doses of vinorelbine (50–70 mg/m² per os) and gemcitabine (800–1,000 mg/m² as a 30-min intravenous infusion) were administered on days 1 and 15 in 4-week cycles. Results: MTDs were reached at 70 mg/m² p.o. for vinorelbine and 900 mg/m² for gemcitabine. Grade 4 neutropenia, febrile neutropenia, grade 4 nausea/vomiting and treatment delay due to grade 3 neutropenia were the dose-limiting events during the first cycle of chemotherapy. A total of 94 chemotherapy cycles were administered with only one episode of febrile neutropenia and no toxic deaths. Severe (grade 3–4) neutropenia occurred in 10% of cycles while non-hematological toxicity was mild with grade 2–3 asthenia occurring in 17 (18%) cycles. Objective responses were achieved in patients with prostate and non-small cell lung cancer. Conclusions: The combination of biweekly oral vinorelbine (70 mg/m²) and gemcitabine (900 mg/m²) is a well-tolerated regimen with promising results in patients with advanced solid tumors.

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Vinorelbine and Prednisone in older Cancer Patients with Hormone-Refractory Metastatic Prostate Cancer a Phase II Study

Abstract: 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.

Cited by 13 publications

References 31 publications

Chemotherapy in frail elderly patients with hormone-refractory prostate cancer: A “real world” experience

Chemotherapy in frail elderly patients with hormone-refractory prostate cancer: A “real world” experience

Weekly Administration of Docetaxel and Epirubicin as First-Line Treatment for Hormone-Refractory Prostate Carcinoma

A Dose Escalation Study of Biweekly Oral Vinorelbine and Gemcitabine in Patients with Solid Tumors

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