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PubMed2002

The role of chemotherapy in advanced prostate cancer.

The development of hormone resistance is an unfortunate final common pathway in most patients with advanced prostate cancer, resulting in a narrowing of therapeutic options for the clinician, and limited median survival of 10-12 months for the patient. While cytotoxic chemotherapy has been utilized for many years, its efficacy has been disappointing. Quality of life assessments are increasingly used in assessing response in hormone-resistant prostate cancer (HRPC), and PSA has emerged as an important surrogate marker of response in both local and advanced disease. Estramustine and the taxanes have been investigated, as monotherapy and in combination, in the treatment of HRPC in phase 2 and 3 clinical trials, a number of which are ongoing. Substantial advances in the management of HRPC over the past decade have led to renewed optimism that improvement in survival can be achieved, and support the belief that chemotherapy plays a role in this pursuit. In tandem with the development of new agents, refined means of assessing response have been developed, and represent a key component of new research strategies in HRPC.

Antineoplastic Agents, Hormonal↗
PubMed2002

[Second cancer after starting treatment for prostate cancer].

The subjects for the present study were 270 patients with prostate cancer who underwent initial treatment at our hospital over the 14 years from 1986 to 1999. They were investigated to assess the relationship between their treatment and metachronous tumors. Sixteen patients (5.9%) developed cancer of other organs after starting treatment for prostate cancer. These metachronous tumors included gastric cancer in six patients as well as lung cancer, esophageal cancer, colorectal cancer, liver cancer, renal cancer, bladder cancer, skin cancer, leukemia, and mediastinal adenocarcinoma. Treatment for prostate cancer other than surgery included radiotherapy in eight patients, administration of estramustine phosphate sodium in nine patients, and LH-RH analogues in six patients. The chi-square test showed no significant difference in the incidence of metachronous cancer in relation to the presence/absence of these three therapies. The present study therefore ruled out the possible induction of other tumors by treatment for prostate cancer.

Aged↗
PubMed2002

[Hormonal chemotherapy for hormone-refractory prostate cancer].

To our knowledge, no standard chemotherapy for patients with hormone-refractory prostate cancer (HRPC) has been established. Since most patients with HRPC are elderly and have bone metastasis, cytotoxic chemotherapy causes them to be at high risk for myelosuppression. Therefore, chemotherapeutic agents with low toxicity and good compliance should be elected. We conducted three regimens for HRPC on an outpatient basis. Eligibility criteria were defined as serial rising PSA values on 3 or more occasions at least 2 weeks apart or radiological new or extensive lesions under hormonal therapy. The first regimen is comprised of cyclophosphamide (CPM), 100 mg/day, UFT, 400 mg/day, and estramustine phosphate (EMP), 560 mg/day in two daily fractions. The second regimen is comprised of an oral administration of dexamethasone (DEX) (0.5-2 mg/day). The third regimen is comprised of DEX, 1 mg/day, cyclophosphamide, 100 mg/day and UFT, 400 mg/day in two daily fractions. Post-therapy prostate-specific antigen (PSA) level in serum, objective response on bone scan or measurable disease, and symptomatic response on bone pain were assessed. All regimens showed clinical efficacy with mild toxicity. Indications and limitations of these regimens are discussed. Further, the combination trials of taxane and EMP in patients with HRPC are reviewed.

Aged↗
PubMed1992

[Clinical course of hormone refractory cancer of the prostate].

Analysis of the clinical progression of 61 patients with prostate cancer undergoing hormone therapy. PSA allowed early detection in 86.9% cases. In 25 patients no rescue treatment was instituted, and 36 patients were treated with estramustine phosphate resulting in decreased PSA levels in 58% and objective response in 36%. Of these, 82% showed decreased PSA levels for over six months. Survival rate was higher in respondent, treated patients and comparable in non-respondents, treated versus non treated patients.

Acid Phosphatase↗
PubMedDate not supplied

National randomized study of chemotherapeutic agents in advanced prostatic carcinoma: a progress report.

In the 36 months since its inception, the National Prostatic Cancer Project treatment subgroup has randomly assigned over 360 patients with progressive advanced prostatic cancer who were no longer responsive to endocrine manipulation to either one of four different clinical studies. The initial study demonstrated a clear superiority for 5-fluorouracil (5-FU) and cyclophosphamide over continued conventional therapy. Beneficial responses were documented and are associated with increased survival rates and relief from pain and other symptoms. A proportionately larger number of patients obtained clinical benefit (stable and partial regression) on cyclophosphamide than on standard or 5-FU therapy. The criteria for evaluation of patients are supported by the survival data, ie, responders have survived for a longer period of time than those patients who continued in progression. Preliminary data from the subsequent protocols have documented a 30% response (stable and partial regression) in patients receiving oral estramustine phosphate and definite responses in patients treated with DTIC; Too few patients have been treated with Leo 1031 to offer total response rates at this time, although the early results are promising. These clinical studies have firmly established a place for chemotherapy in the management of prostatic cancer. New trials will introduce single- and multiple-drug chemotherapy at earlier phases of the clinical course of prostatic cancer patients.

Carcinoma↗
PubMed1992

[The phase IV studies with Estracyt in prostatic cancer--supplementary report: results of long-term therapy].

Two hundred patients with prostatic cancer were enrolled in our previous study between 1984 and 1987. In this study, 96 patients of them were observed for 1 year or more after oral administration of Estracyt (estramustine sodium phosphate). Of these 96 cases, 33 patients were treated with Estracyt as primary treatment and 63 patient had been treated with other treatments before Estracyt treatment. Twelve patients were treated only with Estracyt and 84 patients also received other treatments. Thirty-eight patients were on primary therapy, 37 patients were on maintenance therapy, and 11 patients were on primary therapy, 37 patients were on maintenance therapy, and 11 patients were on the re-activated stage therapy and 10 patients were others. In conclusion, among the 67 cases in which the due judgement of the effect was possible, Estracyt was markedly effective in 10 cases (14.9%), effective in 16 cases (23.9%), slightly effective in 15 cases (22.4%) and ineffective in 26 cases (38.8%). The survival rate was 92.6% at the first year, 66.0% at the third year and 46.3% at the fifth year in the follow-up study. Adverse reactions were observed in 22 cases (22.9%), among which the administration was discontinued in 3 cases.

Aged↗
PubMed2004

Quantification of disseminated tumor cells in the bloodstream of patients with hormone-refractory prostate carcinoma undergoing cytotoxic chemotherapy.

Only very limited data are available on the presence of circulating tumor cells during cytotoxic chemotherapy for hormone-refractory prostate cancer. We analyzed 241 blood samples from 32 patients with hormone-refractory PCa under a chemotherapy schedule. The etoposide, estramustine phosphate and paclitaxel scheme as well as the mitoxantrone and prednisone schedule were used to treat patients with advanced prostate cancer. The pre-therapy serum PSA values were in the range from 1.4 ng/ml to 2,870.9 ng/ml (median 74.5 ng/ml). We isolated the CD45-negative cell population by immunomagnetic depletion from 16 ml of peripheral blood samples. These cells were stained for pan-cytokeratin and evaluated. Patients were observed for an average of 67 weeks (range 16-120). In 77 (32%) samples originating from 27 (84%) patients, tumor cells were detected at least once. Twenty of these patients had shown an initial response to therapy as indicated by a >/=50% decrease of the pre-therapy PSA value. Of these, 14 patients experienced a biochemical and/or a clinical progression. For 13 (93%) of them, circulating tumor cells were detectable during the time of PSA response, i.e. during the PSA decline and before a biochemical or clinical progression. However, we could not correlate the amount of circulating tumor cells with the observed PSA levels. This study demonstrates that circulating tumor cells are detectable during chemotherapy for hormone-refractory prostate cancer regardless of the degree of PSA response.

Adenocarcinoma↗
PubMed2005

[Chemotherapy for prostate cancer].

The clinical significance of chemotherapy for patients with hormone refractory prostate cancer(HRPC) is still controversial. Some randomized-controlled trials represented that mitoxantrone combined with prednisone (or hydrocortisone) provided palliative benefit to patients with HRPC. These treatments are well tolerated by elderly patients. On the other hand, the high PSA response rates have been observed in trials with both estramustine and taxane, however, higher toxicity was also recognized. The most relevant endpoint is not only palliative efficacy but also survival in these trials. Recently, the improvement of survival with docetaxel-based chemotherapy was reported. Further studies with chemotherapeutic agents will be needed to provide patients of HRPC good quality of life and longer survival.

Androgen Antagonists↗
PubMed2005

[Treatment of androgen-independent hormone refractory prostate cancer using docetaxel].

Although prostate cancer patients with metastatic lesion initially respond to androgen ablation therapy, almost patients develop to hormone-refractory states. The optimal treatment for men with hormone refractory prostate cancer (HRPC) has not been established. Docetaxel is a semisynthetic taxane that inhibit tumor growth by induction of microtubule stabilization and promotion of bcl-2 inactivation, which induce apoptosis. Docetaxel as single agent has significant anti-tumor effect in HRPC patients. Docetaxel combined with estramustine or other antimicrotubular agents have shown further significant cytotoxicity in HRPC patients. In the United States, Food and Drug Administration (FDA) approved docetaxel, injection in combination with prednisone for the treatment of patients with advanced metastatic prostate cancer in 2004.

Aged↗
PubMed2005

[Hormonoresistant metastatic prostate cancer: analysis of two phase III clinical studies].

Until now, mitoxantrone was the standard drug for hormone resistant prostate cancer (HRPC). Docetaxel has shown more than 50% of biological response rate in HRPC in several phase II studies. Recently, two phase III studies comparing mitoxantrone and docetaxel were reported. In the view of the results of these studies, it is likely that we will change the usual treatment policy. First one , TAX 327, compared docetaxel 75 mg/m2 every 3 weeks, docetaxel 35 mg/m2 weekly and mitoxantrone 12 mg/m2 every 3 weeks. 1,006 patients were included, overall survival was better in the docetaxel arm than in the mitoxantrone arm (18.7 vs. 16.9 months; p = 0.009). The SWOG study compared docetaxel-estramustine and mitoxantrone-prednisone. 770 patients were included, the difference in overall survival was significantly in favor of the docetaxel arm (17.5 vs. 15.6 months; p = 0.02). These results shows that docetaxel is now the standard treatment of HRPC and the standard arm for future studies in this disease.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

[Prostate cancer with penile metastasis: a case report].

A 77-year-old man presented with complaints of dysuria, nocturia and painless nodule on his penis. Laboratory examination revealed elevated serum prostate-specific antigen (PSA) and CA19-9. Pathological examinations on prostate and penile biopsy specimens revealed prostate adenocarcinoma with penile metastasis. The patient was diagnosed as having prostate cancer stage D2 (T4N1M1) with bone, lymph node and penile metastases. There was no response to initial hormonal therapy with the surgical castration and diethylstilbestrol. However, decrease of the tumor size, as well as PSA and CA19-9 values were achieved after the combined chemotherapy with Estramustine, Paclitaxel and Carboplatin.

Adenocarcinoma↗
PubMed2006

Current chemotherapeutic approaches for androgen-independent prostate cancer.

This review describes the current state of chemotherapy for androgen-independent prostate cancer. Landmark clinical trials, including TAX 327, a randomized trial comparing docetaxel and prednisone with mitoxantrone and prednisone, and SWOG 9916, a randomized clinical trial comparing docetaxel and estramustine with mitoxantrone and prednisone, are reviewed. Novel combination therapies, involving taxane administered with compounds such as calcitrol and thalidomide, newer cytotoxic agents, vaccine therapies, and targeted modalities are also detailed. This review mainly focuses on agents with activity in phase II/III clinical trials.

Antibodies, Monoclonal↗
PubMed1991

[The evaluation of the effect of Estracyt on prostatic cancer].

The clinical effect of Estracyt on untreated prostatic carcinoma was evaluated. The subjects consisted of 51 of 71 patients with prostatic carcinoma who were observed for 6 months or more after oral administration of 560 mg of estramustine phosphate. This drug was effective in all patients: markedly effective in 34 (66.6%), moderately effective in 13 (25.5%), and slightly effective in 4 (7.8%). During the observation period varying from 6 months to 2 years and 6 months, 7 patients had recurrence of progression. The interval between the drug administration and recurrence of progression varied from 6 months to 1 year and 10 months (mean, 15.8 months). Prostate acid phosphatase and gamma-seminoprotein remained normal between 3 and 15 months after the administration but became elevated due to recurrence of progression after 18 months or more in some patients. Blood testosterone, luteinizing hormone, and follicle stimulating hormone decreased while blood cortisol increased. Therefore, estrogen was acting effectively. Side effects were observed in 56.9% of the patients, the most frequent being mazoplasia in 33 patients (45.8%), and cardiovascular complications and apoplexy in 11 patients (15.3%). Estracyt was effective for untreated prostatic carcinoma but the problems such as recurrence of progression and side effects require further examination.

Adenocarcinoma↗
PubMed1987

[Hormone therapy of male genital cancer (prostatic cancer)].

Endocrine therapy for urological tumor includes estrogen therapy for prostatic carcinoma. This endocrine therapy is one of the most firmly established therapeutic methods in the field of clinical oncology. However, confusion exists about how long this treatment remains effective and whether it prolongs survival, since estrogen can create cardiovascular complications in patients with prostatic carcinoma. Recently, new endocrine agents have been developed to compensate for the problems of estrogen therapy and to make treatment more effective. Estramustine sodium phosphate is medicine for internal use prepared by combining estradiol with nitrogen mustard. This hormonal chemotherapeutic agent has proved effective in 98% of treated patients. Most of the side effects of this agent have been observed in the digestive organs. Chlormadinone acetate, a progestational agent, has proved more effective against early prostatic carcinoma than against late-stage disease. LHRH analogue, which is now drawing much attention as a "chemical castration" agent for prostatic cancer patients, exerts an effectiveness equal to medium-dose estrogen treatment. The above three agents for the treatment of prostatic carcinoma should become increasingly popular in the future.

Buserelin↗
PubMedDate not supplied

Hormones in chemotherapy for pancreatic cancer, chemoagents or carriers?

The pancreas, particularly when inflicted with cancer, shelters sex hormones and their receptors more abundantly than some reproductive organs. In the laboratory, the anti-androgen cyproterone inhibits tumour growth while the anti-estrogen tamoxifen exhibits no effect. However, it is thought that the lack of effect from tamoxifen was due to the absence of nuclear estrogen receptors in the laboratory animals, which does not obtain in the human pancreas. Thus at least 4 phase II clinical trials with tamoxifen have been completed for CA pancreas. All but one resulted in at least doubling the average survival. On the other hand, because androgen receptors have only recently been identified in human pancreas, no clinical trial with androgens has been done. Also, quite recently, it has been found that the cytotoxic steroid estramustine binds in the pancreas to a protein with an affinity many times higher than that between the estrogens and their binding protein. However, promising results with tamoxifen from the phase II trials and the rareness of acute side-effects from the anti-estrogen promote the furthering of investigation with the agent. It has also been suggested that tamoxifen, while an anti-cancer agent itself in the pancreas, can simultaneously serve as a target specific carrier for other cytotoxic drugs.

Androgens↗
PubMedDate not supplied

[Hormonal treatment of cancer of the prostate].

We set forth the results obtained after application of a hormonal protocol in prostate carcinoma (P.C.) on 257 patients controlled between June 1976 and June 1987, of whom we have selected 160 who fulfilled the following requirements: under 80 years old, confirmed anatomopathological diagnosis, state equal to or above the T1 of the Union International contre le Cancer (U.I.C.C.) classification, tolerance of treatment applied, clinical, analytical and complete, systematic iconographic follow up and minimum survival of more than one year. We treated those patients with localised P.C. (they have no demonstrable metastases), who in our series numbered 78 (78/160), with Diethylethylbestrol (D.E.S.) at an orally administered dose of 1 mgr. a day. In these the plasma testosterone dropped below 100 nanograms/l. in 57 cases (57/79). In this case metastases appeared in 22 cases (22/78). We treated those patients with metastatized P.C., who in our series numbered 59 (59/160), with orally administered Estramustine Phosphate (Estracyt) at a dose of 560 mgr. every 24 h. in two goes. In these the plasma testosterone dropped below 100 nanograms/l. in 50 cases (50/59). In this group the metastases disappeared in 7 patients, became stabilized in 30 and worsened in the other 22 patients. We carried out surgical orchiectomy on 49 patients (49/160): in 17 cases due to associate vascular pathology, in 13 cases for sociocultural reasons, in 5 cases because of advanced age and in 14 cases it was conducted on patients with a poor response to D.E.S.

Adenocarcinoma↗
PubMed1988

[Tumor-oriented anti-cancer agent with estrogen as a carrier].

Tumor oriented anticancer agents with estrogen as a carrier have been extensively studied since 1950's. Only Estracyt and bestrabucil have been evaluated to be useful in clinical trials. Although the use of estrogen as a carrier for anticancer agents aimed at the development of the anticancer drug for the receptor mediated chemotherapy, these two drugs did not show any affinity to estrogen receptor. The history tells us that the development of anticancer agents for the estrogen receptor mediated chemotherapy is extremely difficult. Estracyt is reported to exert its anticancer effect on prostate cancer through the specific binding to the estramustine binding protein (EMBP) which is present only in the prostate gland and cancer. Bestrabucil shows the selective uptake by the various malignant cells and is indicated that bestrabucil exerts its anti-cancer effects on various malignant tumors including breast cancer and hematopoietic malignancy, through the affinity to malignant cells. The mechanism is unknown and to be elucidated.

Animals↗
PubMed1988

[Stage D1 prostatic cancer benefited by a single regimen of Estracyt].

One problem in the management of prostatic cancer is that about half of the patients with this disease have metastatic lesions at first diagnosis and therefore tend to be given palliative rather than radical therapy. We report here a patient with stage D prostatic cancer who was treated with a single regimen of estramustine phosphate (Estracyt). The patient was a 63-year-old man who was admitted to Keio University Hospital because of sudden onset of double vision. Under a presumptive diagnosis of brain tumor, he underwent thorough examination including brain CT, Ga and bone scan and basic blood tests, which revealed an extraordinarily high level of acid phosphatase. He was therefore referred to our urological division for investigation of possible prostatic cancer. On the basis of the results of urological examinations, a diagnosis of prostatic cancer, stage D, was confirmed. Accordingly, radical surgery was not indicated and instead he was started on oral Estracyt, to which he responded well. He has been enjoying a comfortable life to date, over one and a half years after initial referral.

Adenocarcinoma↗