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Results for “phase 3”

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PubMed2003

Cancer and Leukemia Group B (CALGB) 90203: a randomized phase 3 study of radical prostatectomy alone versus estramustine and docetaxel before radical prostatectomy for patients with high-risk localized disease.

The purpose of The Cancer and Leukemia Group B (CALGB) 90203 trial is to determine which of 2 treatment strategies is superior in treating men with high-risk, clinically localized adenocarcinoma of the prostate (stage T1 to T3a NX M0), defined as a predicted probability < or =60% of remaining free from disease recurrence for 5 years after surgery. Patients with a > or =10-year life expectancy will be randomized to either radical prostatectomy (RP) alone versus estramustine and docetaxel before RP. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be appropriate candidates for RP. Eligible patients will be stratified according to their predicted probability of remaining free from disease recurrence at 5 years after surgery (0% to 20%, 21% to 40%, and 41% to 60%) and randomized. Neoadjuvant chemotherapy will be 6 cycles (1 cycle = 21 days) of estramustine (280 mg tid, days 1 to 5) and docetaxel (70 mg/m2 on day 2). Warfarin (2 mg/day orally) will be given for prophylaxis against deep venous thrombosis. Bilateral pelvic lymph node dissection and RP will be performed within 60 days of registration/randomization for men randomized to the surgery-alone arm. For men randomized to receive preoperative chemotherapy, the surgical procedure will be performed within 60 days of completion of chemotherapy. Patients will be monitored with history review, physical examination, and serum prostate-specific antigen (PSA) levels every 3 months for the first 3 years after surgery, every 6 months for the next 3 years, and annually thereafter. Biochemical disease recurrence will be defined as a serum PSA level >0.4 ng/mL on 2 consecutive occasions > or =3 months apart after RP. The time of biochemical failure is measured from the date of randomization to the time of the first PSA level <0.4 ng/mL that is confirmed on the second serial PSA. The primary study end point is to determine if early systemic treatment with neoadjuvant estramustine and docetaxel before RP in patients with high-risk prostate cancer will decrease 5-year recurrence rates when compared with RP alone. Secondary outcomes will include (1) the safety and tolerability of neoadjuvant estramustine and docetaxel before RP; (2) the impact of this neoadjuvant strategy on pathologic tumor stage, including lymph node and surgical margin status; (3) time to clinically apparent disease recurrence; and (4) overall survival. The impact of RP with and without neoadjuvant estramustine and docetaxel on the patient's quality of life from pretreatment through year 3 will be assessed. Frozen prostate tissue will be obtained from men undergoing prostatectomy who are enrolled in either the treatment or control arms of the trial. These samples will be analyzed for their RNA expression patterns in order to build outcome prediction models. Furthermore, using array-based methods of expression analysis, the sensitivity to chemotherapeutic agents and response to chemotherapy may likewise be predicted. The trial will enroll approximately 700 men during a 48-month period. Patients will be observed for 84 months after study closure. The power to detect a 36% decrease in 5-year recurrence rates is 90%.

Adenocarcinoma↗

PubMed2003

A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: a trial by the Eastern Cooperative Oncology Group.

The optimal induction for older adults with acute myeloid leukemia (AML) is unknown. Several anthracyclines have been proposed, but the data remain equivocal. Additionally, few prospective trials of priming with hematopoietic growth factors to cycle leukemia cells prior to induction chemotherapy have been conducted. Three hundred and sixty-two older adults with previously untreated AML were randomized to either daunorubicin, idarubicin or mitoxantrone with a standard dose of cytarabine as induction therapy. In addition, 245 patients were also randomized to receive granulocyte-macrophage colony-stimulating factor (GM-CSF) or placebo beginning 2 days prior to induction chemotherapy and continuing until marrow aplasia. No difference was observed in the disease-free overall survival or in toxicity among patients receiving any of the 3 induction regimens or among those receiving growth factor or placebo for priming. However, the complete remission rate for the first 113 analyzable patients, who did not participate in the priming study and started induction therapy 3 to 5 days earlier than those who did, was significantly higher (50% versus 38%; P =.03). None of the anthracyclines is associated with improved outcome in older adults. Priming with hematopoietic growth factor did not improve response when compared with placebo. Furthermore, delaying induction therapy in older adults may lead to a lower complete remission rate.

Aged↗

PubMed2026

Therapeutic-drug-monitoring-based ATG Targeted Dosing Strategy in Unmanipulated Haploidentical Haematopoietic Stem Cell Transplantation: a randomized, multicenter, phase 3 clinical trial.

Anti-thymocyte globulin (ATG) has been a standard prophylaxis for graft-versus-host disease (GVHD). However, the pharmacokinetics of ATG in vivo vary significantly, and weight-based fixed dosing may not optimize efficacy while minimizing toxicity. We investigated the clinical results of a therapeutic-drug-monitoring (TDM)-based, dose-optimized ATG strategy versus weight-based fixed dosing in haploidentical haematopoietic stem cell transplantation (NCT05166967). Patients were randomly assigned in a 1:1 ratio to receive a targeted dose of ATG or a fixed dose of 10 mg/kg. The primary endpoint was the 365-day graft-versus-host disease-free and relapse-free survival (GRFS). From January 1, 2022, to January 16, 2024, 204 patients were enrolled, with 102 patients in each group. The 365-day GRFS was higher in the targeted dose group (66.7%) than in the fixed dose group (50.0%; hazard ratio [HR], 0.666; 95% confidence interval [CI], 0.4456 to 0.9954; P = 0.048). The cumulative incidence of moderate to severe chronic GVHD at day 365 was significantly lower in the targeted dose group (9.8%; 95% CI, 5.0 to 16.5) compared with the fixed dose group (22.5%; 95% CI, 15.0 to 31.1; P = 0.026). Fewer grade 3-5 infections were reported in the targeted dose group (44.1%) than in the fixed dose group (70.6%; P < 0.001). More patients in the targeted dose group achieved optimal ATG exposure (P = 0.007) and superior CD4+ T-cell reconstitution (P = 0.002). These findings support the clinical utility of a TDM-based individualized ATG dosing strategy that balances efficacy and toxicity for GVHD prophylaxis in allogeneic stem cell transplantation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05166967.

Humans↗

PubMed2003

What constitutes efficacy for a human immunodeficiency virus vaccine that ameliorates viremia: issues involving surrogate end points in phase 3 trials.

Initial human immunodeficiency virus (HIV) vaccines are unlikely to prevent acquisition of HIV in all recipients. Moreover, several HIV vaccines are under evaluation that are designed to reduce viremia after acquisition of infection. Such vaccines could provide important benefits to delay HIV progression and to reduce transmission. The decision to license a vaccine on the basis of observed effects on virus load and other postinfection surrogate end points in an efficacy trial is complicated by uncertainty about whether the vaccine effects will persist and reliably predict clinical effects, and by the challenge in interpreting the data posed by treatment of some seroconverters with antiretroviral drugs. Here, we evaluate how analyses of certain surrogate end points can be used for inferring clinically significant vaccine effects and propose end points that could be evaluated in efficacy trials to support licensure. The assessment suggests that a vaccine demonstrating moderately durable effects to delay therapy and to ameliorate viremia merits consideration for licensure.

AIDS Vaccines↗

PubMed2006

Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results.

OBJECTIVE: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 microg/ethinyl estradiol (EE) 20 microg (continuous LNG/EE). METHODS: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 microg/EE 20 microg daily for 12 months. RESULTS: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. CONCLUSIONS: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

Adolescent↗

PubMed2006

Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia.

We previously reported the results of a double-blind, placebo-controlled study of Filgrastim in patients with de novo AML undergoing induction and consolidation chemotherapy. The study demonstrated that Filgrastim was effective and well tolerated and had no impact on complete remission or survival. We now report follow-up data on these patients, assessing long-term effects with emphasis on prognostic indicators. After a median follow-up of 7 years, 434 (83%) patients were dead, 73 (14%) were alive, and 14 (3%) were lost to follow-up. The proportions of deaths were similar in the Filgrastim (83%) and placebo (84%) groups. No differences in median time to death (1.04 years Filgrastim, 1.13 years placebo; P = 0.97) or median disease-free survival (0.86 years Filgrastim, 0.79 years placebo; P = 0.52) were evident. Proportional hazard modeling identified age, performance status, and French-American-British subtype as independent predictors for survival (P < 0.001, P = 0.005, and P = 0.036, respectively), whereas cytogenetic status was not (P = 0.118). Filgrastim had no effect on overall survival in any of these subgroup analyses as none of the treatment comparisons were statistically significant. These findings indicate that Filgrastim can be effectively used to support patients with AML undergoing induction and consolidation chemotherapy without worsening long-term disease outcome.

Acute Disease↗

PubMed2006

High incidence of unusual cysteine variants in gp120 envelope proteins from early HIV type 1 infections from a Phase 3 vaccine efficacy trial.

During the course of a large-scale HIV-1 vaccine field trial (VAX004), full-length gp120 sequences were determined for 349 new HIV-1 infections. The data collected represent the largest survey of full-length gp120 sequences from new HIV-1 infections ever assembled. Previous studies have shown that subtype B viruses typically possess 18 cysteine residues that are covalently linked to form 9 conserved disulfide bridges. However, in this study we found that approximately 20% of the trial participants possessed envelope proteins with an unusual number of cysteine residues that could very likely result in unusual protein structures. One class of variants included envelope proteins with two additional cysteine residues in close proximity, potentially yielding additional disulfide-bonded loops. Other classes of variants included envelope proteins where amino acid replacements increased or decreased the number of cysteine residues by one, resulting in molecules with either 19 or 17 cysteines, respectively. Initial functional analysis demonstrated that envelope proteins with 19 cysteine residues bind to CD4 and the CCR5 chemokine coreceptor, and are infectious. These results suggest that the protein structure of gp120 in newly transmitted viruses may be more heterogeneous than previously appreciated and potentially represent a new mechanism of virus variation. The disulfide variation that we report here may have important implications for HIV vaccine and drug development efforts.

AIDS Vaccines↗

PubMed2005

Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection.

BACKGROUND: A vaccine is needed to prevent human immunodeficiency virus type 1 (HIV-1) infection. METHODS: A double-blind, randomized trial of a recombinant HIV-1 envelope glycoprotein subunit (rgp120) vaccine was conducted among men who have sex with men and among women at high risk for heterosexual transmission of HIV-1. Volunteers received 7 injections of either vaccine or placebo (ratio, 2 : 1) over 30 months. The primary end point was HIV-1 seroconversion over 36 months. RESULTS: A total of 5403 volunteers (5095 men and 308 women) were evaluated. The vaccine did not prevent HIV-1 acquisition: infection rates were 6.7% in 3598 vaccinees and 7.0% in 1805 placebo recipients; vaccine efficacy (VE) was estimated as 6% (95% confidence interval, -17% to 24%). There were no significant differences in viral loads, rates of antiretroviral-therapy initiation, or the genetic characteristics of the infecting HIV-1 strains between treatment arms. Exploratory subgroup analyses showed nonsignificant trends toward efficacy in preventing infection in the highest risk (VE, 43%; n=247) and nonwhite (VE, 47%; n=914) volunteers (P=.10, adjusted for multiple subgroup comparisons). CONCLUSIONS: There was no overall protective effect. The efficacy trends in subgroups may provide clues for the development of effective immunization approaches.

AIDS Vaccines↗

PubMed1999

Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial.

HYPOTHESIS: Perioperative administration of a supplemented enteral formula may reduce the rate of postoperative infections. DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: Department of surgery at a university hospital. PATIENTS: Two hundred six patients with neoplasm of colorectum, stomach, or pancreas. INTERVENTION: Patients were randomized to drink 1 L/d of either a control enteral formula (n = 104) or the same formula enriched with arginine, RNA, and omega3 fatty acids (n = 102) for 7 consecutive days before surgery. The 2 diets were isoenergetic and isonitrogenous. Jejunal infusion with the same formulas was started 6 hours after operation and continued until postoperative day 7. MAIN OUTCOME MEASURES: Rate of postoperative infectious complications and length of hospital stay. RESULTS: Both groups were comparable for age, sex, weight loss, Karnofsky scale score, nutritional status, hemoglobin level, duration of surgery, blood loss, and rate of homologous transfusion. Intent-to-treat analysis showed a 14% (14/102) infectious complication rate in the supplemented group vs 30% (31/104) in the control group (P = .009). In the eligible population, the postoperative infection rate was 11% (9/85) in the supplemented group vs. 24% (21/86) in the control group (P = .02). The mean +/- SD length of postoperative stay was 11.1+/-4.4 days in the supplemented group and 12.9+/-4.6 in the control group (P = .01). CONCLUSION: Perioperative administration of a supplemented enteral formula significantly reduced postoperative infections and length of stay in patients undergoing surgery for cancer.

Adolescent↗

PubMed2003

An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis.

BACKGROUND: Alefacept, human lymphocyte function-associated antigen 3/immunoglobulin 1 fusion protein, binds to CD2 molecules on the surface of activated T cells, selectively targeting memory-effector (CD45RO+) T cells, which comprise more than 75% of T cells in psoriatic plaques. OBJECTIVE: To examine the efficacy and tolerability of intramuscular alefacept. DESIGN: International, randomized, double-blind, placebo-controlled, parallel-group trial. PATIENTS: A total of 507 patients with chronic plaque psoriasis. INTERVENTION: Placebo, 10 mg of alefacept, or 15 mg of alefacept administered once weekly for 12 weeks followed by 12 weeks of observation. MAIN OUTCOME MEASURE: Psoriasis Area Severity Index (PASI). RESULTS: Alefacept treatment was associated with dose-related significant improvements in PASI from baseline. Throughout the study, a greater percentage of patients in the 15-mg group than in the placebo group achieved a significant reduction in PASI. Of patients in the 15-mg group who achieved at least 75% PASI reduction 2 weeks after the last dose, 71% maintained at least 50% improvement in PASI throughout the 12-week follow-up. There were no opportunistic infections and no cases of disease rebound. CONCLUSION: Intramuscular administration of alefacept was a well-tolerated and effective therapy for chronic plaque psoriasis and thus represents a convenient alternative to intravenous dosing.

Adolescent↗

PubMed2000

A randomized phase 3 study of intraoperative cavernous nerve stimulation with penile tumescence monitoring to improve nerve sparing during radical prostatectomy.

PURPOSE: We determine if mapping of the cavernous nerve during radical prostatectomy using intraoperative cavernous nerve stimulation with tumescence monitoring results in improved erectile potency compared to conventional nerve sparing. MATERIALS AND METHODS: A prospective, randomized, single blinded study was performed on 61 patients at 6 centers. Patients had elected to undergo nerve sparing prostatectomy and had normal preoperative erectile function documented by the Sexual Function Inventory Questionnaire (SFIQ) and RigiScan parallel testing. Patients were randomized between conventional nerve sparing and nerve sparing assisted by the CaverMap Surgical Aid. paragraph sign In all patients neural continuity was assessed immediately after prostate removal by proximal cavernous nerve stimulation. All patients were blinded according to their allocation cohort. RESULTS: At 1 year there was substantial improvement in erectile function in the CaverMap group as measured by RigiScan. This group had a mean of 15. 9 minutes of greater than 60% nocturnal tumescence compared to 2.1 minutes in the conventional nerve sparing group (p <0.024). By SFIQ there was a nonsignificant trend to improved potency in the CaverMap group (71% versus 62%, p = 0.17). Of patients who had bilateral, unilateral and no response to stimulation after resection erectile function assessed by SFIQ recovered in 68%, 27% and 0%, respectively (p = 0.016). CONCLUSIONS: CaverMap assisted prostatectomy led to improved erectile function as assessed by RigiScan testing with no associated adverse events. A response to stimulation immediately after removal of the prostate accurately predicted return of erectile function.

Adult↗

PubMed2006

Partner-specific sexual behavioral differences between phase 3 HIV vaccine efficacy trial participants and controls: Project VISION.

OBJECTIVE: To assess and compare sexual behaviors using partner-specific data between HIV-negative men who have sex with men (MSM) recruited for an HIV vaccine efficacy trial and a control group. METHODS: HIV-negative MSM from an HIV vaccine trial (n = 525) and controls (n = 732) were recruited by similar strategies and interviewed about behaviors with the 3 most recent partners in the past 6 months, obtained by audio computer-assisted self-interview (A-CASI). RESULTS: Vaccine trial participants were more likely than controls to report an HIV-positive partner (24.7% and 14.1%, respectively) or an HIV-positive primary partner (16.1% and 6.8%, respectively) and were less likely to report occasional or single-time partners of unknown HIV status (51.6% and 63.2%, respectively; P < 0.05 for each comparison). Vaccine trial participants more often reported receptive unprotected anal intercourse (UAI) during their last sexual encounter with an HIV-positive partner (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI]: 1.0 to 7.9). Most believed their HIV-positive partners were receiving antiretroviral treatment (ART), however, and after adjustment for perceived ART use, the association between vaccine study participation and receptive UAI with an HIV-positive partner was not significant. CONCLUSIONS: High-risk sexual behavior was reported by many VAX004 participants and controls. Differences between vaccine trial and control participants in the highest risk per contact behavior, receptive UAI with HIV-positive partners, was partly accounted for by perceived ART use. Partner level data are useful in refining risk assessment, which is important in the evaluation of HIV vaccine and other prevention trials.

AIDS Vaccines↗

PubMed1996

[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 4)--Report on clinical usefulness in diagnosis of cerebrovascular diseases].

Single photon emission computed tomography (SPECT) using 123I-Iomanzenil (IMZ), a tracer which binds specifically to central-type benzodiazepine receptors, was performed in patients with cerebrovascular diseases (CVD) to determine the clinical signicigance of IMZ SPECT studies in evaluating the pathophysiology of CVD. IMZ SPECT images obtained three hours after administration of the tracer were compared with the images of cerebral blood flow (CBF) studies in 206 cases. In regions with decreased CBF, the uptake of IMZ was relatively preserved in patients with cerebral thrombosis in comparison with cerebral embolism, and in those with perforator branch infarction in comparison with cortical infarction. The uptake of IMZ decreased as a function of both the severity of the decrease in the CBF and the duration of illness in regions with a significantly decreased perfusion reserve. These results suggest that decreased IMZ binding in ischemic stroke reflects the neuronal damage caused by the cerebral ischemia. On the other hand, in patients with intracerebral hemorrhage, the cortical uptake of IMZ was relatively well-preserved in regions with decreased CBF, and the decrease in the uptake of IMZ was more profound as a function of the decrease in the CBF, especially in cases of putaminal hemorrhage. These results also suggest that the decreased cortical CBF is a remote effect caused by a neuronal disconnection, and neuronal damage may occur in regions with severely impaired CBF.

Brain↗

PubMed2007

Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON).

Optimal dose and timing of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy for aggressive non-Hodgkin lymphoma (NHL) is still an unresolved issue. We assessed whether dose intensifications with cyclophosphamide and doxorubicin might improve outcome in younger patients with intermediate-risk aggressive NHL. Previously untreated patients were assigned to receive either 8 courses of standard CHOP (n = 239) or 6 courses of intensified (I)-CHOP (n = 238). Although there was a tendency in favor of I-CHOP for overall survival (OS), disease-free survival (DFS), and event-free survival (EFS), the differences were not significant. However, although these analyses were not planned, when the intermediate-risk group was divided into low-intermediate- and high-intermediate-risk patients according to the International Prognostic Index (IPI), low-intermediate-risk patients had improved 6-year OS (67% vs 52%; P = .05), DFS (58% vs 45%; P = .06), and EFS (41% vs 30%; P = .21) when they were treated with I-CHOP compared with standard CHOP. On the other hand, high-intermediate-risk patients seem to have no benefit from I-CHOP. Although clinically relevant side effects occurred more often in the I-CHOP arm, treatment-related mortality was similar. These data suggest that I-CHOP might be preferable to standard CHOP in younger patients with low-intermediate-risk aggressive NHL.

Adolescent↗

PubMed2002

Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European Organisation for Research and Treatment of Cancer-Children's Leukemia Group phase 3 trial.

Asparaginase is an enzyme used in the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in children. It has minimal bone marrow toxicity. Its major side effects are anaphylaxis, pancreatitis, diabetes, coagulation abnormalities, and thrombosis, especially intracranial. It is derived from 2 different sources: Escherichia coli and Erwinia chrysanthemi. Nonrandomized clinical studies have suggested a similar efficacy of these 2 types of asparaginases and a lower toxicity for Erwinia-asparaginase. The European Organisation for Research and Treatment of Cancer-Children's Leukemia Group (EORTC-CLG) 58881 trial randomized 700 children with acute lymphoblastic leukemia or lymphoblastic lymphoma to either E coli- or Erwinia-asparaginase at the same dosage of 10 000 IU/m(2) twice weekly to compare toxicity and efficacy. Coagulation abnormalities were more frequent in the E coli-asparaginase than in the Erwinia-asparaginase arm of the study (30.2% versus 11.9%, P <.0001). The incidence of other toxicity was not significantly different. In the Erwinia-asparaginase arm, more patients failed to achieve complete remission (4.9% versus 2.0%; P =.038) and the relapse rate was higher, leading to shorter event-free survival (hazard ratio,1.59; 95% CI, 1.23-2.06; P =.0004). The estimate of event-free survival rate (SE) at 6 years was 59.8% (2.6%) versus 73.4% (2.4%). Overall survival rate at 6 years was also lower in the Erwinia-asparaginase arm at 75.1% (2.3%) versus 83.9% (2.0%), P =.002. With the dose scheduling used in this protocol, E coli-asparaginase induced more coagulation abnormalities but was superior to Erwinia-asparaginase for the treatment of childhood lymphoid malignancies.

Adolescent↗

PubMed1994

A phase 3 randomized trial of immediate combination chemotherapy vs delayed combination chemotherapy in patients with completely resected stage II and III non-small cell carcinoma of the lung.

The purpose of this trial (Lung Cancer Study Group [LCSG] 853) was to perform a comparative study of immediate combination chemotherapy (cyclophosphamide, doxorubicin, cisplatin [CAP]) vs delayed combination chemotherapy (CAP) administered at the time of first systemic relapse in patients with completely resected stage II and stage III non-small cell cancer of the lung. We randomly assigned 188 patients with resected stage II or stage III non-small cell lung cancer of the lung (squamous, 53%; nonsquamous, 47%) to receive either immediate or delayed combination chemotherapy. Careful intraoperative staging was performed in all patients. Before randomization, patients were stratified according to stage--II (hilar nodes positive) vs III (mediastinal nodes positive or T3)--and histologic features (squamous vs nonsquamous). Ninety-four patients were randomized to receive immediate CAP vs 94 patients randomized to receive delayed CAP. Prognostic variables such as extent of disease, histologic features, sex, race, TN status, and Karnofsky performance status were equally distributed between randomized groups. The treatment groups differed with respect to greater than 10% weight loss. Forty-one percent of patients had stage II disease and 59% of patients had stage III disease. Median time to recurrence (19.5 months) and survival (32.7 months) did not differ between treatment groups. Immediate combination chemotherapy was associated with a 12% reduction in risk of recurrence and an 18% reduction in risk of death, although these rates were not statistically significant. Histologic features, sex, race, Karnofsky performance status, nodal status, and weight change were associated with higher risks of recurrence.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

Phase 3 randomized trial evaluating second-line hormonal therapy versus docetaxel-estramustine combination chemotherapy on progression-free survival in asymptomatic patients with a rising prostate-specific antigen level after hormonal therapy for prostate cancer: an Eastern Cooperative Oncology Group (E1899), Intergroup/Clinical Trials Support Unit study.

Despite improvements in early detection of prostate cancer when it is clinically localized--and therefore most amenable to curative local therapies-- approximately 33% of men with early prostate cancer will develop biochemical failure with a rising prostate-specific antigen (PSA) during follow-up. The early use of androgen suppression in this group of men has changed the clinical picture of androgen-independent disease. Now, there are men on androgen suppression who will develop biochemical failure and remain free of clinical or radiographic evidence of metastatic disease for a period of time. There is no standard approach to this group of men, who have a rising PSA on androgen deprivation, because there are little or no data about strategies that may improve survival, delay time to progression, or improve quality of life. Therefore, current management of this population remains controversial. In an effort to determine which of these 2 approaches--second-line hormone therapy or chemotherapy--is optimal in delaying the time to progression, the Eastern Cooperative Oncology Group (ECOG) developed protocol E1899. Although both approaches offer the potential for response (reduction in PSA and prolonging the time to clinical progression), they have very different toxicity profiles, making impact on quality of life another important end point. This randomized trial evaluating second-line hormonal therapy using ketoconazole and hydrocortisone versus docetaxel and estramustine combination chemotherapy on progression-free survival in asymptomatic men with a rising PSA on androgen ablation for prostate cancer is the subject of this article.

Adenocarcinoma↗

PubMed2000

U.S. clinical investigation of the Artisan myopia lens for the correction of high myopia in phakic eyes. Report of the results of phases 1 and 2, and interim phase 3.

PURPOSE: The purpose of this article is to present the results of the U.S. Clinical investigation of the Artisan anterior chamber iris fixed lens implant for the correction of myopia in phakic eyes. METHODS: A prospective, multi-center, FDA-supervised trial was designed and undertaken in the United States by Ophtec USA, Inc., Boca Raton, Florida to determine the safety and efficacy of the Artisan lens as a potential refractive treatment for patients with high myopia. During the trial, two different models of the Artisan lens were used: one with a 5-mm optical zone (model 206) and the other with a 6-mm optical zone (model 204). RESULTS: The data presented comprise 176 enrolled subjects and 264 implant procedures. The most frequently chosen Artisan lens power was -13.00 D (average, -12.76 D; SD, 3.24). The postoperative results at 6 months for all eyes (n = 135) showed 100% of patients were 20/40 or better best-corrected while 72% gained one or more lines and 22% gained two or more lines regardless of degree of astigmatism or postoperative goal. Through the course of the study, intraocular pressure maintained a level with a mean below 16 mmHg. In general, total reported complications in the patient cohort decreased over time, dropping from 39% at the initial visit to 10% at visit four and 0% at visit seven. CONCLUSIONS: On the basis of the interim results of the U.S. Clinical Investigation of the Artisan Myopia Lens for the Correction of High Myopia in Phakic Eyes, the Artisan anterior chamber phakic IOL may offer an option for correction of high degrees of myopia. Refractive outcomes were exceptional and complications were minimal and amenable to treatment.

Adult↗