Change in serum prostate-specific antigen as a marker of response to cytotoxic therapy for hormone-refractory prostate cancer.

Smith, David C.; Dunn, Rodney L.; Strawderman, Myla; Pienta, Kenneth J.

doi:10.1200/jco.1998.16.5.1835

Cited by 193 publications

(72 citation statements)

References 15 publications

(4 reference statements)

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“…The primary end point of the trial was PSA response (Smith et al, 1998). In addition, clinical benefit, QL data and, if possible, tumour measurements were recorded.…”

Section: à2mentioning

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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“…The primary end point of the trial was PSA response (Smith et al, 1998). In addition, clinical benefit, QL data and, if possible, tumour measurements were recorded.…”

Section: à2mentioning

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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“…27,28 The assay is inexpensive and reproducible, and can provide a more objective assessment than imaging, because bone metastases predominate in many patients with advanced prostate cancer. PSA doubling time provides a useful means of monitoring progression of prostate cancer, 29 and thus reduction in doubling time following capecitabine treatment may predict clinical benefit.…”

Section: Resultsmentioning

confidence: 99%

Phase II study of oral capecitabine in patients with hormone-refractory prostate cancer

Spicer

Plunkett

Somaiah

et al. 2005

Prostate Cancer Prostatic Dis

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“…Post-therapy PSA levels have become widely accepted as a surrogate end point in the evaluation of treatment Defined as 450% fall in initial level maintained for at least 4 weeks from completion of chemotherapy. responses in hormone-refractory prostate cancer (Smith et al, 1998). One suggestion is that a decline of 50% or greater from baseline sustained over 2 months reflects a response (Kelly et al, 1993).…”

Section: Discussionmentioning

confidence: 99%

Epirubicin carboplatin and 5-fluorouracil (ECarboF) chemotherapy in metastatic hormone refractory prostate cancer

2004

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The aim of this study was to examine the efficacy and toxicity of the epirubicin, carboplatin and 5-fluorouracil (ECarboF) regime in patients aged 70 or less with metastatic prostate cancer resistant to LHRH analogues. The majority of patients had previously received steroids as part of their systemic management and had progressive disease on steroids. In total, 80 patients were treated over a 6-year period, with objective response rates (PSA or radiological) of 45% and median time to relapse of 9.5 months. Median survival of the group was 9.2 months. In all, 32% of patients were alive at 12 months. Grade 3/4 neutropenia occurred in 34% of patients with an 8.7% rate of neutropenic sepsis. Grade 3/4 nonhaematological toxicity occurred in 28% of patients. For a substantial minority of patients with hormone refractory prostate cancer, combination chemotherapy can induce remission of significant duration. While similar responses have been documented for systemic cytotoxic -steroid combinations, the responses in this study are likely to reflect the activity of cytotoxic drugs alone.

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Change in serum prostate-specific antigen as a marker of response to cytotoxic therapy for hormone-refractory prostate cancer.

Abstract: The PSA value after 8 weeks of this cytotoxic regimen does predict survival. A decrease in PSA level is associated with both survival and response in soft tissue lesions and should be incorporated into the response criteria and reporting of trials of cytotoxic agents in prostate cancer.

Cited by 193 publications

References 15 publications

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

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

Phase II study of oral capecitabine in patients with hormone-refractory prostate cancer

Epirubicin carboplatin and 5-fluorouracil (ECarboF) chemotherapy in metastatic hormone refractory prostate cancer

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