Background Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared. Background Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared.


Clover von Thrombophlebitis

N Engl J Med ; Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer.

We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer.

Full Text of Background We randomly assigned men to one of two treatments, Clover von Thrombophlebitis, each given in day cycles: The primary end point was overall survival; Clover von Thrombophlebitis end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen PSA levels.

Full Text of Methods Of eligible patients, were assigned to receive docetaxel and estramustine and to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and Clover von Thrombophlebitis than in the group given mitoxantrone and prednisone The median time to progression was 6. Pain relief was similar in both groups. Full Text of Results The improvement in median survival of nearly Clover von Thrombophlebitis months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.

Full Text of Discussion Men with newly diagnosed metastatic prostate cancer have a rapid response to surgical or medical castration, with improvement in bone pain, regression of soft-tissue metastases, and a decline in serum prostate-specific Clover von Thrombophlebitis PSA levels, Clover von Thrombophlebitis.

Chemotherapy for androgen-independent prostate cancer is ineffective 4: Clover von Thrombophlebitis studies have demonstrated that the antiapoptotic protein Bcl-2 is increased in metastatic cells from androgen-independent prostate tissue.

Eligibility required pathologically confirmed adenocarcinoma of the prostate and progressive metastatic disease stage D1 or D2 despite androgen-ablative therapy and cessation of antiandrogen treatment. Criteria for progressive disease were progression of a bidimensionally measurable lesion, as assessed within 28 days before study registration; progression of disease that could be evaluated but not measured e. To ensure continued androgen ablation, patients continued taking luteinizing-hormone—releasing hormone agonists throughout study treatment.

Patients were required to discontinue bisphosphonates at least 28 days before registration. Prior radiotherapy to less Clover von Thrombophlebitis 30 percent of the bone marrow only or one prior Clover von Thrombophlebitis therapy except with estramustine, taxanes, anthracyclines, Clover von Thrombophlebitis, or mitoxantrone was permitted if at least four weeks had elapsed since the completion of that therapy. Clover von Thrombophlebitis renal, hepatic, and cardiac function and a SWOG performance-status score of 0 to 2 a performance status of 3 was allowed if the score was due to bone pain were also required.

Patients were ineligible if they had received prior radioisotope or anticoagulant therapy excluding aspirinhad active thrombophlebitis or hypercoagulability, had a history of pulmonary embolus, or pleural effusions or ascites. Patients were classified at registration according to the following factors: Patients were randomly assigned to one of two treatments, each given in day cycles: Doses of docetaxel and mitoxantrone were increased to 70 mg per square meter and 14 mg per square meter, respectively, if no grade 3 or 4 adverse events were observed during the first cycle.

A report that prophylactic anticoagulation decreased estramustine-associated vascular effects prompted an amendment of the protocol on January 15,to include daily warfarin 2 mg plus aspirin mg in the group assigned to receive estramustine. The pretreatment evaluation included a history taking, a physical examination in which weight and performance Clover von Thrombophlebitis Varizen 1 EL recorded, Clover von Thrombophlebitis, computed tomography CT of the abdomen and pelvis, bone scanning, Clover von Thrombophlebitis, nuclear ventriculography multiple gated acquisition [MUGA] scanninga complete blood count, and measurement of serum PSA, serum creatinine, and serum testosterone.

MUGA scans were repeated every four cycles among patients in the group given mitoxantrone and prednisone. At every cycle, the pretreatment evaluation was repeated excluding MUGA scanning, measurement of serum testosterone, and baseline imaging studies.

Imaging studies were repeated every six cycles; if positive, they were repeated every three cycles. Objective responses were defined on the basis of the sum of bidimensional measurements of metastatic lesions.

Confirmed objective responses required a follow-up scan a minimum of four weeks later that demonstrated a continued response. Progression was defined Clover von Thrombophlebitis one of the following: A confirmed partial response of nonmeasurable disease was defined as a reduction by more than 50 percent over baseline in two or more PSA measurements obtained at least four weeks apart, Clover von Thrombophlebitis, with no evidence of disease progression on imaging.

Progressive disease was defined as a 25 percent increase in the serum PSA level — to at least 5 ng per milliliter — over the last preregistration measurement, with confirmation of the increase at least four weeks later. For patients with a decrease in serum PSA levels during the trial, progressive disease was defined as a confirmed increase of 25 percent, to at least 5 ng per milliliter over the nadir. The Clover von Thrombophlebitis objective of the study was to compare overall survival in the two groups.

Assuming an exponential distribution of survival times, 3. Interim analyses were to be conducted when half the patients had been enrolled and again when enrollment was complete. The null and alternative hypotheses were to be tested at a one-sided P level of 0. The significance level for the final analysis, Clover von Thrombophlebitis, performed one year after study closure, was specified as a one-sided P value of 0.

However, Clover von Thrombophlebitis, in accordance with the policy of the Journal, only two-sided P values are reported. Secondary end points included progression-free survival, the objective-response rate, the rate of PSA response defined as a decline in the serum PSA level of at least 50 percentand adverse events. The data set was locked and analyzed on March 9, Kaplan—Meier curves were used to estimate rates of overall survival and progression-free survival.

Survival was defined from the date of randomization to the date of death from any cause or censored at the date of last contact. Progression-free survival was defined as the time from randomization to the first occurrence of Clover von Thrombophlebitis or PSA progression or death from any cause. The general chi-square test was used to compare rates of response objective and PSA and adverse events between the two treatment groups. All analyses were performed with the use of SAS software, version 9.

Aventis was allowed to review the protocol and make comments before enrollment began. Aventis had Clover von Thrombophlebitis access to the data but received a semiannual summary of enrollment and adverse events.

A total of patients were enrolled between October and January Ninety-six patients 12 percent were found to be ineligible: The baseline characteristics of the eligible patients in both treatment groups were similar Table 1 Table 1 Baseline Characteristics of the Patients. The sole evidence of disease progression was a rising PSA level in 18 percent of patients. There were 11 major protocol deviations. Six patients in the group given docetaxel and estramustine and four patients in the group given mitoxantrone and prednisone did not receive the assigned treatment and were not included in the evaluation of adverse events.

One patient in the latter group who received intermittent radiotherapy while receiving the assigned treatment, a major protocol deviation, was included in the evaluation of adverse events.

Six patients who discontinued treatment within one week after starting mitoxantrone and prednisone four men or docetaxel and estramustine two men were not included in the evaluation of adverse events; however, in the case of all these men, the reported results and statistical analyses are based on the treatment group to which the patients were assigned.

During a median follow-up of 32 months, of the patients in the Clover von Thrombophlebitis given docetaxel and estramustine died 64 percentas did of the patients in the group given mitoxantrone and prednisone 70 percent.

According to the intention-to-treat analysis, the median survival was A partial response in measurable disease occurred in 17 percent Clover von Thrombophlebitis patients in the group given Clover von Thrombophlebitis and estramustine 17 of4 unconfirmed and 11 percent of patients in the group given mitoxantrone and prednisone 10 of 93, 4 unconfirmed.

Patients with an inadequate assessment were assumed to have had no response. There was no significant difference Clover von Thrombophlebitis pain relief, Clover von Thrombophlebitis, as reported by the patients, between the two groups data not shown. As of Decemberall surviving patients had stopped the protocol treatment. Adverse events led to the withdrawal of 54 patients in the group assigned to docetaxel and estramustine 16 percent and 32 patients in the group assigned to mitoxantrone and prednisone 10 percent.

The rates of severe or life-threatening grade 3 or 4 and fatal grade 5 adverse events are summarized in Table 2 Table 2 Adverse Events. The rate of grade 3, 4, or 5 neutropenia in the group given mitoxantrone and prednisone did not differ significantly from that in the group given docetaxel and estramustine As compared with the group given mitoxantrone and prednisone, the Clover von Thrombophlebitis given docetaxel and estramustine had significantly higher rates of grade 3 or 4 neutropenic fevers 5 percent vs.

There were eight treatment-related deaths in the group given docetaxel and estramustine: Four patients had grade 5 adverse events attributed to mitoxantrone and prednisone. Three died within 30 days of receiving protocol treatment, and another died from a respiratory tract infection and grade 4 anorexia. Vascular complications Clover von Thrombophlebitis their relationship to prophylactic warfarin treatment in the group Clover von Thrombophlebitis docetaxel and estramustine are shown in Table 3 Table 3 Adverse Events among Patients Receiving Docetaxel and Estramustine, According to Whether They Were Receiving Prophylactic Anticoagulation, Clover von Thrombophlebitis.

This randomized trial demonstrated that the treatment of androgen-independent metastatic prostate cancer with estramustine and docetaxel results in a longer Clover von Thrombophlebitis survival than treatment with mitoxantrone and prednisone The hazard ratios for death 0. Although we did not meet our primary aim of detecting a 33 percent improvement in median survival with estramustine and docetaxel, this trial had reasonable power to detect smaller differences in survival.

Relative to mitoxantrone and prednisone, docetaxel and estramustine reduced the mortality rate by 20 percent 95 percent confidence interval, Clover von Thrombophlebitis, 3 to 33 percent. The rates of reduced PSA levels and progression-free survival were significantly higher in the Clover von Thrombophlebitis given docetaxel and estramustine than in the group given mitoxantrone and prednisone.

The survival estimate of the group given estramustine and docetaxel in our trial fell within the confidence intervals of smaller phase 1 and 2 studies of this combination. The median survival of This difference may be due in part to the use of different eligibility criteria, in particular the requirement for symptomatic disease in the studies by Tannock et al.

In contrast, in a randomized trial of asymptomatic men with a rising serum PSA level, Berry et al. The median PSA level at entry 87 ng per milliliter was somewhat lower than in the studies by Kantoff et al.

Crossover treatment may also partially account for the small difference in survival between the two treatment groups, Clover von Thrombophlebitis. Of all the patients we treated, about half received at least one other antineoplastic regimen after having had no response to the assigned treatment. It is difficult to judge the effect of these additional treatments on overall survival, because multiple variables influence response and survival after crossover treatment.

Continuous corticosteroid treatment can reduce serum PSA levels by at least 50 percent in 20 to 74 percent of men with hormone-refractory prostate cancer, 20 but the regimen of premedication with dexamethasone 60 mg every three weeks that we used is unlikely to have affected the results.

In a phase 2 study, the same dose and schedule of dexamethasone that we used were employed Clover von Thrombophlebitis the serum PSA level rose at least 25 percent over baseline levels or clinical progression occurred, at which point docetaxel and estramustine were given. None of the patients treated with dexamethasone had a decline in PSA of at least 50 Clover von Thrombophlebitis the level actually increased by a median of 47 percent, Clover von Thrombophlebitis.

After progression during dexamethasone therapy, 92 percent of patients treated with docetaxel and estramustine had a decline in serum PSA levels of at least 50 percent. In phase 2 studies, estramustine was associated with an increased risk of nausea, thromboembolic events, and cardiovascular events, Clover von Thrombophlebitis.

However, this difference was not associated with an increased rate of treatment-related deaths or discontinuation of treatment in the former group. In conclusion, treatment with estramustine and docetaxel moderately increases survival at the cost of an increased rate of adverse events.

These factors must be balanced when one is considering the use of docetaxel and estramustine as first-line therapy for men with metastatic androgen-independent prostate cancer, Clover von Thrombophlebitis.

Petrylak and Taplin report having received grant support, Clover von Thrombophlebitis, lecture fees, and consulting fees from Aventis; Dr. Hussain consulting fees and lecture fees from and having equity in Aventis; Dr.

Lara lecture fees from Aventis and AstraZeneca; Dr.


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