Metastatic prostate cancer median survival,wilderness survival quiz pdf online,survival craft elevator link - Test Out

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Starting chemotherapy along with hormone therapy in men with newly diagnosed hormone-sensitive prostate cancer improved overall survival by more than 13 months in comparison with hormone therapy alone, a phase III study found. Contributor Deborah McBride, RN, PhD, CPON®, is a staff nurse IV at the Kaiser Permanente Oakland Medical Center and an assistant professor at Samuel Merritt University in Oakland, CA.
Have a pt with mets prostate ca who's been given low dose taxotere 3 wks on one wk off ,not on ADT. Investigation and Management of Prostate Cancer Mr C Dawson MS FRCS Consultant Urologist Edith Cavell Hospital, Peterborough. Cancers that are PSA detected have been shown to be clinically significant are frequently poorly differentiated or spread widely throughout the prostate when removed by radical surgery will often be upgraded or upstaged. Gleason Score Pathologist looks at two most common histological patterns under microscope Gives each a score from 1-5 1=Well differentiated ……….
In the late 1800s, a number of physicians including Stephen Paget and Thomas Ashworth,1, 2 hypothesized that tumor metastases were the result of tumor cells dislodging from the primary tumor, circulating in the peripheral bloodstream, and seeding distant sites. Depending on the type of cancer, approximately one-half of patients will present with either regional or distant clinically detectable metastases. Studies have suggested that tumors shed approximately 1 million circulating tumor cells per gram of tumor tissue.4 While this would seem to indicate that the metastatic process would progress quickly, the development of distant metastases is quite inefficient. The assay allows the capture and enumeration of tumor cells circulating in peripheral blood in a standardized format.7 Clinical trial studies have shown that this type of testing offers useful information for the physician to monitor progression of disease or response to treatment.
The CellSearch Circulating Tumor Cell system (Veridex LLC) uses a combination of immunomagnetic labeling and automated digital microscopy to identify and enumerate the number of circulating tumor cells in a peripheral blood specimen.
As noted above, the CellSearch system is FDA cleared for detection of circulating tumor cells in patients with metastatic breast, prostate, and colorectal cancer. In 2010, an estimated 209,060 new cases of breast cancer were diagnosed in the United States and there were approximately 40,230 deaths from this disease.11 Of newly diagnosed cases of breast cancer, 5% of patients will have metastatic breast cancer at diagnosis, and another 30% will ultimately develop metastatic disease. A multicenter, prospective, longitudinal clinical trial using the CellSearch system was conducted between 2001 and 2003, and the results published in 4 scientific publications.8,10,13,14 Results were used to determine whether the number of circulating tumor cells predicted disease progression and survival in metastatic breast cancer patients. Kaplan-Meier analyses were performed to determine whether circulating tumor cell counts could predict progression-free and overall survival. Monitoring circulating tumor cell levels during the course of treatment has also been shown to provide additional prognostic information. Several clinical and biomarker parameters were evaluated by univariate Cox regression analysis to determine which features were predictors of progression-free and overall survival at baseline. In 2010, an estimated 142,570 new cases of colorectal cancer were diagnosed in the United States with approximately 51,370 deaths due to colorectal cancer.11 Of the new cases, nearly 20% had metastatic colorectal cancer when diagnosed and nearly one-third will develop metastases during clinical follow-up. A multicenter, prospective clinical trial was conducted between 2004 and 2006 to determine whether circulating tumor cell enumeration could predict colorectal cancer disease progression and survival.16,17 Prior to initiation of a new line of therapy, 430 patients with measurable metastatic colorectal cancer were enrolled. The majority of patients (413 of 430) had a baseline blood draw, and a Kaplan-Meier curve was generated to evaluate progression-free and overall survival between 2 patient cohorts based on baseline circulating tumor cell counts. Monitoring circulating tumor cell levels during the course of treatment has also shown to provide additional prognostic information (Figure 6).
Similar to the clinical trial performed on metastatic breast cancer, several clinical and biomarker parameters were evaluated by univariate Cox regression analysis to determine which features at baseline were independent predictors of overall and progression-free survival. In the United States in 2010, there were approximately 217,730 new cases of prostate cancer with 32,050 deaths.11 Of the new cases, nearly 4% had evidence of metastatic disease at diagnosis.
A multicenter, prospective clinical trial was conducted between 2004 and 2006 to determine whether the number of circulating tumor cells predicted disease progression and overall survival.9,18 The patient sample in this trial consisted of patients with hormone-resistant, androgen-independent, or castration-resistant tumors. The clinical trial enrolled 231 patients with metastatic prostate cancer who, despite treatment, had an increase in prostate-specific antigen level.
Monitoring circulating tumor cells levels during the course of treatment has also shown to provide additional prognostic information.
Several clinical and biomarker parameters were evaluated by univariate Cox regression analysis to determine which features were predictors of overall and progression-free survival at baseline. These parameters, as well as prostate-specific antigen reduction from baseline (?30% versus <30%), were evaluated by multivariate Cox regression analysis again at 2 to 5 weeks, 6 to 8 weeks, 9 to 12 weeks, and 13 to 20 weeks after initiation of therapy. Circulating tumor cells play an important role in the metastatic disease process and our true understanding of their relevance is growing. Mayo Clinic has no equity in or license to Veridex, LLC, nor does Mayo Clinic receive any financial incentive from Veridex, LLC. Chambers AF, Groom AC, MacDonald IC: Dissemination and growth of cancer cells in metastatic sites.
Ross AA, Cooper BW, Lazarus HM, et al: Detection and viability of tumor cells in peripheral blood stem cell collections from breast cancer patients using immunocytochemical and clonogenic assay techniques. Allard WJ, Matera J, Miller MC, et al: Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Cristofanilli M, Budd GT, Ellis MJ, et al: Circulating tumor cells, disease progression, and survival in metastatic breast cancer. Hayes DF, Cristofanilli M, Budd GT, et al: Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival. Budd GT, Cristofanilli M, Ellis MJ, et al: Circulating tumor cells versus imaging--predicting overall survival in metastatic breast cancer. Cohen SJ, Punt CJ, Iannotti N, et al: Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer. Cohen SJ, Punt CJ, Iannotti N, et al: Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Naoe M, Ogawa Y, Morita J, et al: Detection of circulating urothelial cancer cells in the blood using the CellSearch System.
Okumura Y, Tanaka F, Yoneda K, et al: Circulating tumor cells in pulmonary venous blood of primary lung cancer patients.
Orteronel, an investigational oral therapy for prostate cancer, improved progression-free survival, but did not significantly improve overall survival in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).
Nivolumab Trumps Ipilimumab for Treatment-Naive Metastatic Melanoma: The phase III CheckMate 067 trial showed that nivolumab alone or in combination with ipilimumab doubled the median time to disease progression compared with ipilimumab monotherapy. Whole-Brain Radiation Therapy Improves Brain Metastases But Not Survival: A randomized study of 213 patients showed that the addition of whole-brain radiation therapy (WBRT) to stereotactic radiosurgery improved control of brain metastases in cancer patients, but did not result in a survival benefit.
Genomic Marker Predicted Anti–PD-1 Response in Colorectal Cancer: A phase II study found that 62% of colorectal cancer patients with mismatch repair deficiency responded to checkpoint blockade with the anti–programmed death 1 (PD-1) drug pembrolizumab. Adjuvant Chemotherapy Improves Survival in High-Risk Localized Prostate Cancer: The phase III RTOG 0521 trial showed a survival benefit in men with high-risk localized prostate cancer with the addition of docetaxel and prednisone to standard therapy (hormone and radiation therapy). Progression of HR-Positive Breast Cancer Delayed With Palbociclib Plus Fulvestrant: The combination of palbociclib plus the hormonal therapy fulvestrant more than doubled progression-free survival in women with previously treated hormone receptor (HR)-positive, HER2-negative metastatic breast cancer compared with fulvestrant alone. Eribulin Improves Survival in Advanced Sarcoma: A randomized trial showed that treatment with eribulin resulted in a survival improvement of 2 months in patients with two subtypes of soft-tissue sarcoma—leiomyosarcoma and liposarcoma—compared with patients treated with the standard therapy of dacarbazine. Elective Dissection of Lymph Nodes Improves Survival in Early Oral Cancer: A phase III study found that elective neck lymph node surgery for patients with early oral cancer reduced the risk of cancer recurrence and improved survival. Reduction in Late Mortality Improves Childhood Cancer Survival: The Childhood Cancer Survivor Study evaluated data of long-term health outcomes in 5-year survivors of childhood cancer and found that modern treatments have reduced long-term mortality rates, in part due to refined treatment approaches that reduced mortality related to secondary cancers, as well as heart and lung disease. Anastrozole Trumps Tamoxifen in DCIS: Treatment of postmenopausal women with ductal carcinoma in situ (DCIS) with the aromatase inhibitor anastrozole resulted in higher breast cancer–free survival rates compared with standard treatment with tamoxifen. To play the media you will need to either update your browser to a recent version or update your Flash plugin. Important developments that have contributed to decreased cancer morbidity and mortality include surgery, chemotherapy, radiotherapy, and screening programs that lead to earlier tumor detection. The availability of such tools improves our ability to monitor treatment in patients with metastatic cancer. The metastatic process is important to consider since most cancer deaths occur as a result of metastatic disease. A new method of monitoring patients with breast, colorectal, or prostate cancer includes screening for circulating tumor cells.
The CellTracks AutoPrep system automates and standardizes the preanalytical specimen preparation step that captures and stains circulating tumor cells for analysis. A gallery of images is reviewed by a technologist who identifies tumor cells based on the circulating tumor cell phenotype showing positive DAPI and CK staining with an absence of CD45 staining (Figure 2a). The following sections will discuss the evidence that shows the clinical utility of the CellSearch system for each of these patient populations. Primary tumor metastasis is the leading cause of breast cancer-related death and detection of the presence of circulating tumor cells in the blood of cancer patients may be an important indicator of the potential for metastatic disease and poor prognosis. The trial included 177 patients with metastatic disease as defined by standard imaging techniques. The number of circulating tumor cells (<5 versus ? 5), line of therapy (first versus second), and type of therapy (chemotherapy versus hormonal, immunotherapy versus chemotherapy) were univariate predictors of progression-free survival. Unlike the metastatic breast cancer trial, which used a cutoff of ?5 circulating tumor cells to place patients in the unfavorable group, the metastatic colorectal cancer trial used a cutoff of ?3. The results from studies have shown that a reduction of circulating tumor cells to less than 3 after the start of therapy predicts a longer progression-free survival in metastatic colorectal cancer patients.
A patient with a castration-resistant tumor is defined as a prostate cancer patient who has had 2 consecutive increases in prostate-specific antigen values despite hormone treatment. Baseline circulating tumor cell counts were determined prior to initiation of a new line of therapy.
A Kaplan-Meier curve was generated to evaluate the difference in progression-free and overall survival between 2 groups of patients based on their baseline circulating tumor cell counts (Figure 7a and 7b). This information and other data within the same clinical trial led to FDA clearance of the CellSearch assay for the capture and enumeration of circulating tumor cells in metastatic prostate cancer patients in 2008. The results from studies have shown that a reduction of circulating tumor cells to below 5 after the start of therapy predicted longer progression-free survival in metastatic prostate cancer patients. Number of circulating tumor cells at baseline (<5 versus ?5), baseline ECOG status (0 versus 1 versus 2) (Table), baseline hemoglobin, baseline lactate dehydrogenase (LDH), line of therapy (first through sixth), and type of therapy (taxotere) were predictors of progression-free survival on univariate analysis.
The ability to capture and enumerate circulating tumor cells will play an increasingly important role in the management of patients with metastatic breast, colorectal, and prostate cancer. Metastasis: quantitative analysis of distribution and fate of tumor embolilabeled with 125 I-5-iodo-2’-deoxyuridine. Patients treated with orteronel also had favorable circulating tumor cell counts compared with those in the control arm at 12 weeks on the study (15% vs 9%, P = .00016)Adverse events that were more common in the orteronel arm included nausea, fatigue, constipation, and diarrhea. Patients and Methods: This Study included 106 consecutive Korean patients with mCRPC who were treated with a 3-weekly regimen of docetaxel plus prednisolone chemotherapy between 2005 and 2011.


Treatment outcome of docetaxel plus prednisolone for metastatic castration-resistant prostate cancer in Korea.
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. A review of the patterns of docetaxel use for hormone-resistant prostate cancer at the Princess Margaret Hospital.
Docetaxel chemotherapy of Korean patients with hormone-refractory prostate cancer: Comparative analysis between 1 st -line and 2 nd -line docetaxel.
Docetaxel plus prednisolone for the treatment of metastatic hormone-refractory prostate cancer: A multicenter Phase II trial in Japan.
Shifting paradigms in prostate cancer; docetaxel plus low-dose prednisone-finally an effective chemotherapy.
Weekly administration of docetaxel for symptomatic metastatic hormone-refractory prostate carcinoma. Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer.
Evaluating the value of number of cycles of docetaxel and prednisone in men with metastatic castration-resistant prostate cancer. A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: A TAX327 study analysis. Docetaxel, low-dose estramustine, and doxifluridine in hormone-refractory metastatic prostate cancer. Oncological outcome of docetaxel-based chemotherapy for Japanese men with metastatic castration-resistant prostate cancer. Efficacy and safety of docetaxel plus prednisolone chemotherapy for metastatic hormone-refractory prostate adenocarcinoma: Single institutional study in Korea.
Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: A phase II study in Caucasian and Asian patients.
Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: An update and review of the literature. The group who received adjuvant chemotherapy had a 93% 4-year overall survival rate compared with 89% among the standard therapy alone group. The trial is the first phase III trial to show a survival benefit of a novel therapy over the current standard for soft-tissue sarcoma patients. The trial randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. The results were reported at the American Society of Clinical Oncology 2014 annual meeting.The trial compared early chemotherapy plus androgen deprivation therapy (ADT) to ADT alone in men with metastatic prostate cancer. Since that time cancer researchers have demonstrated the critical role that these cells play in metastasis.
Currently, the only US Food and Drug Administration (FDA)-cleared system for detecting circulating tumor cells in peripheral blood is the CellSearch system (Veridex LLC). Cancer metastasis consists of a series of separate, yet related, steps that must occur in order for a tumor cell to metastasize.3 As a tumor begins to form, nutrients are initially supplied by simple diffusion through the cell wall. The CellSearch Circulating Tumor Cell assay is the first and only assay to date cleared by the FDA to use circulating tumor cell analysis to determine prognosis in patients with metastatic disease. Therefore, recent efforts that focus on the ability of an assay that can be performed on a peripheral blood sample to consistently enumerate, track, and characterize circulating tumor cells in cancer patients holds promise to determine patient prognosis and to monitor response to treatment. A baseline circulating tumor cell count was determined prior to start of new therapy and a follow-up count was determined approximately 3 to 4 weeks after the start of therapy. The favorable group (n = 90) represented patients with a baseline circulating tumor cell count <5, while the unfavorable group (n = 87) represented patients with a baseline count ? 5.
Imaging methods were determined for each patient as per the current standard of care defined by the patient’s physician. The favorable group (n = 305) in the metastatic colorectal cancer trial consisted of patients with a <3 circulating tumor cell count at baseline, while the unfavorable group (n = 108), consisted of patients with a cell count ?3. When these features were evaluated in a multivariate model, all 7 parameters were independent predictors of progression-free survival. Most patients (221 of 231) had 1 or more blood draws to monitor circulating tumor cell counts and prostate-specific antigen levels every 4 to 6 weeks after baseline.
The favorable group (n = 94), consisted of patients with <5 circulating tumor cells identified at baseline. These 6 parameters and baseline alkaline phosphatase were also univariate predictors of overall survival.
However, the high-grade adverse event rate and discontinuation rate were higher in the combination arm. Additionally, patients with mismatch repair deficiency in other tumors such as stomach, small bowel, endometrial, and bile duct had a 60% objective response rate.
The 5-year disease-free survival rate was 73% in docetaxel-treated patients and 66% in patients treated with standard therapy alone (P = .05). Efficacy and safety results from a phase III trial of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067). From 2006–2012, 790 men were randomly assigned to a maximum of six cycles of docetaxel plus ADT or ADT alone. There were approximately 51,000 colorectal-, 40,000 breast-, and 32,000 prostate-cancer deaths in 2010 and almost all were due to the development of metastatic disease.
The system is FDA cleared for the detection of circulating tumor cells in patients with metastatic breast, prostate, and colorectal cancer. Proliferation of the mass continues through the secretion of angiogenic factors that allow for the growth of a capillary network to supply the tumor’s increasing need for nutrients. Blood is collected using the Circulating Tumor Cell Collection Kit (supply T630) and the specimen must be promptly shipped to assure processing within 96 hours of collection. Progression-free survival was determined from the time of the baseline blood draw to identifiable disease progression based on CT scans or clinical indications.
Interestingly, patients with ?5 circulating tumor cells at baseline, which decreased to <5 at the end of treatment had significantly longer median progression-free and overall survival than patients who maintained counts of at least 5 at all time points (Figure 4a and 4b).
All lesions seen at baseline were followed using the same method for all successive studies, either CT or MRI of the chest, abdomen, and pelvis.
Based on the baseline cell counts, Kaplan-Meier analyses were performed in the 2 patient cohorts. Progression-free survival was determined by identifying continued increases in prostate-specific antigen values, radiologic imaging evidence of disease progression, or other clinical signs.
The unfavorable group (n = 125), consisted of patients with a ?5 circulating tumor cells count.
Several trials are currently under way, including one from the Southwest Oncology Group, SWOG-S0500 trial,25 which is investigating a strategy of changing or maintaining therapy based on circulating tumor cell levels in patients with metastatic breast cancer. According to Cancer Statistics in Korea 2009, the five leading primary cancer sites in men include prostate and the mortality rates of PCa have also continued to increase. Adjuvant docetaxel was also associated with a statistically significant reduction in distant metastases.
This review will discuss how the system works and how it can be used to provide prognostic information and monitor treatment of metastatic cancer. Migration through the body occurs when the mass reaches a lymphatic channel or blood vessel, and then tumor cells detaches from that mass and enter the lymphatic or blood vessel. Once in the laboratory, the whole blood specimen is centrifuged and placed on the CellTracks AutoPrep system (Figure 1). Circulating tumor cell enumeration was also shown to be a predictive marker of overall survival. A baseline circulating tumor cell count was established prior to the start of therapy and follow-up counts were determined every 3 to 4 weeks. The results of this study showed that progression-free and overall survival were significantly higher in patients in the favorable group.
Overall survival was determined from baseline draw until time of death or until last contact with the patient. Since circulating tumor cell counts and prostate-specific antigen reduction rates have been shown to predict overall survival during the course of treatment, Kaplan-Meier analyses were performed to determine whether a combination of circulating tumor cell analysis and prostate-specific antigen reduction rates could better predict overall survival during treatment. These trials should answer the question of whether changing treatment based on an elevated or increasing circulating tumor cell count alone is warranted. One seizure was reported in the trial in the enzalutamide-treated group and none in the bicalutamide-treated group. Once in circulation, the tumor cells are transported throughout the body, finally coming to rest against a vessel wall.
The plasma is aspirated to waste and the remaining cellular component is mixed with buffer and ferrofluid reagent conjugated with monoclonal epithelial cell adhesion molecule (EpCAM) antibodies. Since circulating tumor cell counts at baseline and prior to the first imaging studies have been shown to predict overall and progression-free survival, this analysis may provide a more accurate assessment of prognosis when used in conjunction with surveillance imaging techniques as compared with imaging alone. Progression-free survival was measured from the time of baseline blood draws until the time of detectable disease progression based on CT or MRI scans and clinical findings.
Bevacizumab therapy was the only feature to be a strong independent predictor of better overall survival (HR = 0.68). The results from this analysis showed that patients with ?5 circulating tumor cells at any time point after initiation of therapy were much more likely to have shorter overall survival than those with <5 circulating tumor cells, regardless of their prostate-specific antigen reduction measurement from baseline.
The regimen of docetaxel plus ADT was beneficial in all subgroups analyzed. Six percent of men receiving the chemohormonal regimen experienced febrile neutropenia, 1% experienced significant effects on sensory nerves, and 1% had significant effects on motor nerves.
The tumor cells seep into the surrounding tissue through events similar to those in the migration process.
The data from this clinical trial led to FDA clearance in 2004 of the CellSearch assay for the capture and enumeration of circulating tumor cells in metastatic breast cancer patients.
Overall survival was determined from the time of baseline blood draws to the time of death. The information from this clinical trial led to FDA clearance of the CellSearch assay in 2007 for the capture and enumeration of circulating tumor cells in metastatic colorectal cancer patients. Since circulating tumor cell counts at baseline and prior to the first imaging studies were shown to predict overall and progression-free survival, this analysis may provide a more accurate assessment of prognosis when used in conjunction with routine surveillance imaging techniques compared to imaging alone.


This analysis also showed that a reduction in prostate-specific antigen from baseline was predictive of overall survival and circulating tumor cell analysis was much more accurate than prostate-specific antigen reduction measurements (Figure 8a and 8b). Metastases, particularly to the bone and lymph nodes, are frequent in men with CRPC, leading to pain, other symptoms, and impairment in the quality of life (QOL).
NCCTG N0574 (Alliance): A phase III randomized trial of whole brain radiation therapy (WBRT) in addition to radiosurgery (SRS) in patients with 1 to 3 brain metastases. Finally, the newly growing microtumor establishes a new vascular network through angiogenic processes and formation of a new tumor site is complete. Magnets then attract the ferrofluid-bound cells to the side of the tube, the remaining fluid and any unlabeled cells are aspirated and the magnets are removed. According to the researchers, the evidence is insufficient to recommend that patients with low-volume, hormone-sensitive disease undergo early docetaxel therapy. Relatively few men have metastatic prostate cancer at the time of initial diagnosis because prostate cancer screening blood tests typically detect the disease before it has spread. While these steps describe the most general overview of the metastatic process, many other factors may be involved including loss of cell to cell adhesion, motility of tumor cells, epithelial-mesenchymal transition, and heterogeneous cell populations in the primary tumor. However, screening is expected to become less common because a government advisory committee, the U.S. The CellSearch system uses 3 stains to help distinguish epithelial cells from contaminating leukocytes and nonspecific debris: 4’-6-diamidino-2-phenylindole (DAPI) stains the nuclei of cells and helps identify viable cells, phycoerythrin (PE)-labeled cytokeratin (CK) antibodies (CK 8, 18, and 19) recognize epithelial cells, allophycocyanin (APC)-labeled CD45 antibodies identify contaminating leukocytes.
LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. The resulting epithelial-enriched fluid is then placed in a cell presentation device (MagNest) that attracts the magnetically labeled epithelial cells to the surface of the cartridge.
Of several factors examined, multivariate analysis Identified good performance status and first-line setting predict longer OS. They cite findings that more men are harmed by unnecessary treatments for prostate cancer than are saved from death by screening. However, until now, there has been no equivalent standard for Korean patients with CRPC and few reports of long-term treatment with docetaxel in CRPC because of the limit of maximum of ten and twelve cycles in the TAX 327 and SWOG protocol respectively.We undertook this study to evaluate the efficacy and tolerability of the combination of docetaxel and prednisolone in Korean patients with CRPC.
The study is meaningful because of the larger number of patients and a longer follow-up period in Korean patients with CRPC than any other study reported to date. One hundred-thirteen CRPC patients who received docetaxel plus prednisolone chemotherapy fulfilled the eligibility criteria for enrollment into the study between January 2005 and December 2011 at a single institution. Finally, this study was performed with a total of 106 Korean patients with metastatic castration-resistant prostate cancer (mCRPC) who received docetaxel plus prednisolone chemotherapy. Patient records were retrospectively reviewed to determine the baseline characteristics of patients and the clinical efficacy and tolerability of docetaxel. All the patients had histologically confirmed adenocarcinoma of the prostate, evidence of metastasis, and progressive disease despite complete androgen blockade therapy, anti-androgen withdrawal, and an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. PALOMA3: A double-blind, phase III trial of fulvestrant with or without palbociclib in pre- and post-menopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on prior endocrine therapy. Progressive disease was defined by an increase in PSA levels as determined by two consecutive measurements at least 2 weeks apart, an increase in the size of a measurable lesion by computed tomography (CT), or any newly developed bony metastasis with hot uptake by bone scan. Bone scan was considered non-progressive if there were no new lesions in two scans at least 2 months apart.
Informed consent for toxicity was obtained prior to each therapy.Treatment and data collection Pretreatment evaluation included a complete medical history-taking, a physical examination, complete blood cell (CBC) count, serum chemistry profile, serum PSA, bone scan, CT of the pelvis and abdomen, and chest X-ray. Randomized, open-label, multicenter, phase III study of eribulin versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma (ADI). Patients who had not undergone orchiectomy were required to continue androgen blockade with a luteinizing hormone-releasing hormone analog. Patients underwent physical examination, CBC count, liver function test, and renal function test before docetaxel administration, and 7 days after each docetaxel administration. In patients with measurable disease, tumor assessments were performed every three cycles until progression or sooner, if possible.
Chemotherapy was continued until disease progression or unacceptable adverse events occurred. All patients received docetaxel treatment as an in-patient each cycle.End points and statistical analyses All patients were evaluated for PSA response, objective measurable disease response, time to progression, and survival.
A PSA response was defined as a reduction of ≥50% from the baseline maintained for at least 3 weeks. Elective versus therapeutic neck dissection in the clinically node negative early oral cancer: A randomised control trial (RCT). For patients with measurable disease, the best response also determined based on the modified response evaluation criteria in solid tumors (RECIST) criteria, version 1.0. Treatment with docetaxel was continued until disease progression, unacceptable adverse events, or patient refusal occurred.
The progression-free survival (PFS) and OS were defined as the time between first docetaxel administration and events. Reduction in late mortality among 5-year survivors of childhood cancer: A report from the Childhood Cancer Survivor Study (CCSS).
For univariate and multivariate analyses, Cox proportional hazards regression model was used. A total of 1180 cycles of treatment were administered to 106 patients (median 11 cycles; range, 2-32 per patient).
Forty-five patients (48.9%) experienced PSA response, considered to be a PSA decline of 50% from baseline that lasted for 4 weeks. Seventy-eight (73.6%) study subjects had measurable metastasis, revealed by radiographic examinations, which included CT and magnetic resonance imaging.
Most of the patients recovered with supportive care that included hydration and antibiotics. However, one patient (1.0%) had a treatment-related death for neutropenic fever during the observation period.
In terms of non-hematologic toxicities, grade 1-2 sensory neuropathies were most frequently found in 41 patients (39.4%). However, no patient developed a grade 3-4 non-hematologic toxicity, and all patients who developed a non-hematologic toxicity recovered with conservative management. To identify parameters associated with OS in patients treated with docetaxel plus prednisolone chemotherapy, univariate and multivariate analyses were performed using the Cox proportional hazard model [Table 4].
Of the several factors examined, ECOG PS, biopsy Gleason score, cycles of docetaxel, chemotherapy setting (first- or second-line), and PSA response were identified as significant factors associated with OS on univariate analysis. Of these five factors, only PS and chemotherapy setting appeared to be independent predictors of OS on multivariate analysis. Based on the results of TAX 327, ten cycles of docetaxel is generally used as the standard duration of therapy globally. The PSA response rate in the first-line group was 52.8%, which was similar to those found in the previous studies performed in Western countries. Other hematologic toxicity has been shown to be generally better than that of Japanese patients.
Identification of factors predicting the prognosis of men with mCRPC treated with docetaxel-based chemotherapy are needed, as are subgroup analyses comparing survival data with those of western countries. In the present study, biopsy Gleason score, cycles of docetaxel, and PSA response were statistically significant only in the univariate analysis. These findings indicate that lower biopsy Gleason score and more than ten cycles of docetaxel and prednisolone does not statistically enhance survival, supporting an earlier suggestion. Finally, ECOG PS and chemotherapy setting were revealed to be independently associated with OS and PSA response had a marginal statistical power in our survival analysis. Also, in data from TAX 327 trials, PS was identified by multivariate analysis as an independent prognostic factor. This OS outcome in the first-line setting was favorable compared with those of previous studies in other countries.
In the TAX 327 and SWOG 99-16 trials, the median survival in the groups assigned to docetaxel-based chemotherapy were less than 20 months. One Japanese retrospective study showed long median OS of 25.4 months in patients receiving docetaxel-based chemotherapy. However, patient demographics showed a large number of prior estramustine (63%) and secondary hormonal treatment (cyproterone acetate, 31%).This study targeted patients in a single-racial country. As far as we know, our study has the longest follow-up duration (median, 26.5 months) and includes the most homogenous population (especially in the subgroup analysis) of docetaxel plus prednisolone chemotherapy in Korean CRPC patients.
The studies for inter-individual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians were conducted by researchers in Singapore several years ago. They found that the response rate to docetaxel plus carboplatin chemotherapy was significantly higher in Asian patients than Caucasian patients. It is, therefore, possible that the observed difference in response rate reflects differences in response assessment between different races. Thus, studies of the differences of treatment outcome according to the race or ethnicity are necessary and important.Certain limitations must be considered when conclusions are drawn from our results. First is the inherent selection bias and potential data imperfection of the retrospective study design. Second, a sample size of 106 patients in such a common disease like mCRPC is not large enough. However, this is fairly large number in Korea when considering the low national incidence of PCa. Third, this study enrolled patients with variable degree of metastasis (from bone or lymph node only to vital organ) compared with TAX 327. The fourth limitation is the lack of examination of the validity of molecular markers in predicting disease prognosis in addition to conventional clinicopathologic parameters, since mCRPC Is characterized by unique biological features as well as heterogeneous genetic backgrounds. A well-designed prospective study including genetic background associated with the prognosis of mCRPC patients is required.




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