Improvements in clinical benefit with vinorelbine in the treatment of hormone-refractory prostate cancer: A phase II trial

Fields-Jones, S.; Koletsky, Alan J.; Wilding, George; O’Rourke, Mark Allen; O’Rourke, Timothy J.; Eckardt, John R.; Yates, Barbara B.; McGuirt, Chip; Burris, Howard A.

doi:10.1023/a:1008315106697

Cited by 49 publications

(24 citation statements)

References 9 publications

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“…The median duration of the palliative response was about 10 months, which is similar to that recently observed with the use of mitoxantrone + prednisone or taxotere, and longer than that found with prednisone alone, vinorelbine or paclitaxel (Tannock et al, 1996;Fields-Jones et al, 1999;Trivedi et al, 2000;Savarese et al, 2001). The palliative response was accompanied by an improvement in a number of the quality of life dimensions, particularly a reduction in pain and an improvement in functional scales.…”

Section: Discussionsupporting

confidence: 82%

Weekly epirubicin in patients with hormone-resistant prostate cancer

et al. 2002

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The aim of this study was to investigate the benefit of weekly epirubicin in the treatment of metastatic hormone-resistant prostate cancer. One hundred and forty-eight patients with metastatic hormone-resistant prostate cancer received weekly 30-min intravenous infusions of epirubicin 30 mg m 2 of body surface area. The primary end-point was palliative response, defined as a reduction in pain intensity and an improvement in performance status. The secondary end-points were the duration of the palliative response, quality of life and survival. Fifty-seven (44%) of the 131 evaluable patients met the primary criterion of palliative response after six treatment cycles and 73 (56%) after 12 cycles; the median duration of the response was 9 months (range 1 -11). The median global quality of life improved in 52% of the patients after six cycles and in 68% after 12 cycles. The 12-and 18-month survival rates were respectively 56 and 31%, with a median survival of 13+ months (range 1 -36). The treatment was well tolerated: grade 3 neutropenia was observed in 8% of the patients, grade 3 anaemia in 7%, and grade 3 thrombocytopenia in 3%. None of the patients developed grade 4 toxicity or congestive heart failure. Weekly epirubicin chemotherapy can lead to a rapid and lasting palliative result in patients with metastatic HRPC, and have a positive effect on the quality of life and survival.

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Section: Discussionsupporting

confidence: 82%

Weekly epirubicin in patients with hormone-resistant prostate cancer

et al. 2002

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“…The median survival of patients with HRPC remains, however, at 9 -12 months despite medical advances and new approaches. Chemotherapy in patients with HRPC has been shown to decrease the serum levels of prostate-specific antigen (PSA), to shrink soft tissue metastases, to improve bone scans and, most importantly, to enhance aspects of quality of life (QL), especially pain (Tannock et al, 1996;Fields-Jones et al, 1999). Prolongation of survival by chemotherapy, however, has not been demonstrated in phase III trials conducted to date (Tannock et al, 1996;Hudes et al, 1999;Kantoff et al, 1999), although adequately powered randomised trials are now underway comparing mitoxantrone/prednisone with newer treatments including docetaxel alone or in combination with estramustine.…”

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confidence: 99%

Capecitabine in hormone-resistant metastatic prostatic carcinoma – a phase II trial

Morant¹,

Bernhard

Dietrich

et al. 2004

Br J Cancer

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The objective of the trial is to evaluate the efficacy of capecitabine in patients with metastatic hormone-resistant prostate carcinoma (HRPC), in terms of prostate-specific antigen (PSA) response and clinical benefit (decrease of pain or analgesic score) and its safety profile. In all, 25 patients with HRPC were enrolled on a phase II trial of capecitabine (Xeloda s ) at a dose of 1250 mg m À2 orally twice daily on days 1 -14 every 21 days. The inclusion criteria were PSA serum levels 43 Â upper limit of normal, a WHO performance status 0 -2, age o85 years and adequate bone marrow, liver and renal function. In patients with grade 2 or higher haematological toxicity on day 1 of the treatment cycle, therapy was first delayed, and then continued at a lower dose. Trial end points were PSA response and clinical benefit defined by quality of life (QL) data and analgesic consumption. The median age of patients was 70 years (range 54 -85 years). A median of three cycles of capecitabine was administered (range 1 -8). PSA response was observed in three patients (12%, 95% CI 3 -31%), with times to tumour progression of 18, 21 and 35 weeks, respectively. In these patients, the response durations were 12, 17 and 32 weeks, respectively. Minor PSA regression was also seen in two further patients. The median time to tumour progression of all patients was 12 weeks (95% CI 9 -15 weeks). Haematological toxicity was minor, with leukopenia grade 3 observed in one patient. There were three deaths during trial treatment, respectively, due to sepsis following mucositis and leukopenia, presumed sepsis with mucositis induced by chemotherapy and concomitant radiotherapy and cerebral dysfunction progressing to coma. Hand -foot syndrome grades 2 and 3 were observed in four patients each. Clinical benefit was observed in five patients (20%, CI 7 -41%). Based on toxicity data, we recommend a lower starting dose of 1000 mg m À2 orally twice daily. While capecitabine has some activity in HRPC, as suggested by observed PSA responses, we conclude that it is not worthwhile to investigate capecitabine monotherapy in a phase III trial. Combinations of capecitabine with other agents, such as vinorelbine or docetaxel, may prove to be more effective.

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“…In a phase II trial performed by Fields-Jones et al [64], it Autorino/Di Lorenzo/Damiano/ De Placido/D'Armiento showed a durable clinical benefit (response rate 39%) as defined by improvement in pain index and performance status. Encouraging results have been obtained, more recently, by Oudard et al [65] in a phase II study using vinorelbine on an outpatient weekly schedule.…”

Section: Vinca Alkaloidsmentioning

confidence: 98%

Role of Chemotherapy in Hormone-Refractory Prostate Cancer

Autorino¹,

Lorenzo

Damiano³

et al. 2003

Urol Int

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Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation and for which nonhormonal approaches are required, can be precisely defined as hormone-refractory prostate cancer (HRPC). Until recently, there has been no standard chemotherapeutic approach for HRPC. In this article recent advances in the treatment of HRPC using chemotherapeutic regimens are critically reviewed. We performed a MEDLINE search of the published reports from 1995 to 2002 including chemotherapy in the treatment of HRPC. We critically reviewed a total of 84 clinical trials, of which only 6 were phase III trials, most of the studies being phase II trials. Various chemotherapeutic agents have been used. To date, the major benefits of chemotherapy in the treatment of HRPC are palliative in nature, in terms of reduction of pain and use of analgesics and improvement of performance status, as followed in the most recent trials. There is a promising activity of new drug combinations, such as vinca alkaloids and taxanes in association with estramustine. Mitoxantrone, although with a limited activity, has been shown to provide improvement in pain and quality of life for the patients. Several studies suffer from methodological deficits, such as small number of patients, heterogeneity of enrolled groups or no definitive response criteria. Further phase III studies are necessary to better evaluate the efficacy of the different regimens.

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Improvements in clinical benefit with vinorelbine in the treatment of hormone-refractory prostate cancer: A phase II trial

Abstract: These findings indicate that vinorelbine is well tolerated in men with hormone-refractory prostate cancer and produces durable clinical benefit as defined by improvement in pain index and performance status.

Cited by 49 publications

References 9 publications

Weekly epirubicin in patients with hormone-resistant prostate cancer

Weekly epirubicin in patients with hormone-resistant prostate cancer

Capecitabine in hormone-resistant metastatic prostatic carcinoma – a phase II trial

Role of Chemotherapy in Hormone-Refractory Prostate Cancer

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