Cystectomy Remains The Standard Option For Patients With Bcg
No established and effective intravesical therapies are available for patients whose tumors recur after BCG, representing a clinically important unmet need. Radical cystectomy provides cancer eradication in a significant number of HG NMIBC cases . In the series of Stein and coworkers , the 10-year recurrence-free survival for patients with lymph node-negative tumors was 86% for T0, 89% for Tis, 74% for Ta, and 78% for T1 tumors. Several studies since have shown the advantage of performing early cystectomy in high-risk NMIBC patients, particularly in the case of BCG failure. It remains the standard of care in the case of BCG-unresponsive patients following adequate BCG treatment .
However many patients are elderly, have significant comorbidities with a diminished performance status, and/or are unwilling to undergo radical extirpative surgery.
Study: Gemcitabine Helps Prevent Recurrence Of Low
Published On: May 16, 2018Shared by Rosanne Fohn
A multi-institution clinical trial involving researchers from UT Health San Antonio shows significantly lower recurrence of bladder cancer in patients who received the chemotherapy drug gemcitabine.
The results of the trial were published May 8, 2018, in the Journal of the American Medical Association. Robert Svatek, M.D., a UT Health San Antonio genitourinary oncologist, was the universitys study leader.
Dr. Svatek was not only involved with conducting this study, but he and his site , along with our site , were the two leading recruiting sites for patients, said Edward M. Messing, M.D., the national leader of the study.
In addition to his oncology practice, Dr. Svatek is an associate professor in the Department of Urology and chief of the Division of Urologic Oncology at UT Health San Antonio.
In the trial, 406 patients with newly diagnosed bladder cancer or low-grade bladder cancer that had not invaded the muscle wall were randomly assigned to one of two groups. One group received one treatment of gemcitabine and a saline solution and the other group received one treatment of only saline solution, both directly instilled into the bladder through a catheter within three hours following surgery. Gemcitabine is already approved by the U.S. Food and Drug Administration to treat several types of cancer.
The trial was supported by the National Cancer Institute as well as Eli Lilly and Company.
Does Bcg Damage The Bladder
Treatment with BCG can cause a wide range of symptoms. Its common to have flu-like symptoms, such as fever, achiness, chills, and fatigue. These can last for 2 to 3 days after treatment. It also commonly causes a burning feeling in the bladder, the need to urinate often, and even blood in the urine.
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Basic Clinical Data Of Patients
From January 2011 to December 2015, among 116 patients with NMIBC who underwent TURBT or partial cystectomy for the first time in our hospital, 22 of them were excluded as they did not meet the inclusion criteria. The mean follow-up time was 43.61 months. The clinical data of 94 patients are illustrated in Table 2. There were 75 males and 19 females , with an average age of 63.22 years old. Among these patients, 52 had a history of smoking and the number of patients with BMI24 and < 24 was 37 and 57 , respectively. Tumor grade was low grade in 58 and high grade in 36 patients. Pathological T-category was Ta in 67 and T1 in 27 patients. The primary tumor size was lower than 3 cm in 57 patients and equal and/or greater than 3 cm in 37 patients . The CONUT score was 0 in 26 patients , 1 in 23 patients , 2 in 22 patients , 3 in 12 patients , 4 in 6 patients , 5 in 2 patients , and 6 in 3 patients , respectively. The recurrence rate was 33/94 after five years of follow-up.
Table 2 Patient Characteristics
Table 3 Relationships Between the EORTC-GUCG Risk Scoring System and Clinicopathological Parameters of 94 Patients with NMIBC
What Is The Relative Survival Rate Of Bladder Cancer
A relative survival rate compares people with the same type and stage of bladder cancer to people in the overall population. For example, if the 5-year relative survival rate for a specific stage of bladder cancer is 90%, it means that people who have that cancer are, on average, about 90% as likely as people who dont have
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How Does Recurrence Of Bladder Cancer Affect Survival Rate
Recurrent bladder cancer is cancer that has returned after initial treatment. Recurrence rates for bladder cancer depend on the stage of the original tumor, with 5-year recurrence rates of approximately 65% in patients with non-invasive or in situ tumors and 73% in patients with slightly more advanced disease at first diagnosis.16
Many patients with non-invasive bladder cancer have recurrences that are typically not life threatening however, the prognosis is generally worse if the disease has spread into deeper layers of the bladder wall or beyond to the lymph nodes or other organs.
Treatment Options For Recurrent Bladder Cancer
Treatment options for patients with recurrent bladder cancer include the following:
Palliative radiation therapy should be considered for patients with symptomatic tumors.
Recurrent or progressive disease in distant sites or after definitive local therapy has an extremely poor prognosis, and clinical trials should be considered whenever possible.
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Possible Side Effects Of Bcg
There are a number of things you can do to manage the side effects of BCG. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:
This medication can cause irritation to the bladder, including difficulty or painful urination , blood in the urine , and increased urgency , or frequency of urination. Patients are advised to increase fluid intake after administration of this medication to âflushâ the bladder. You should report any of the urinary symptoms listed above that last more that 48 hours to your healthcare team for further management instructions.
Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.
Your doctor or nurse can recommend medication and other strategies to relieve aches, pains, and generalized malaise.
BCG Infection Reaction
Bladder Cancer Recurrence After 5 Years
Demographic and epidemiologic characteristics
Although men are three to four times more likely to develop BC, several epidemiologic reports associated female gender with a more advanced disease and worse survival rates . Messer et al. confirmed that female gender, after adjusting to standard clinical and pathologic features, was associated with an increased risk for cancer-specific mortality and disease recurrence compared to male gender in patients undergoing open RC. In other studies, gender was not associated with outcomes in stage-adjusted analyses, whereas pathologic tumor stage remained the most powerful factor influencing the course of disease in both genders .
Elderly patients have more years to compound comorbidities. As such, they are associated with higher mortality after RC . In a retrospective analysis of 605 patients treated with open RC, Horovitz et al. reported that octogenarians had comparable RFS to the younger counterparts . Conversely, an overview of the Bladder Cancer Research Consortium reported that patients aged > 80 years had a significantly greater risk of disease recurrence than patients aged 60 years . However, the retrospective nature of the studies suffered of the selection bias related to the higher use of bladder-sparing techniques in older patients and to the lower use of both NAC and AC.
Pathologic patterns, tumor and node stage
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Enhanced Cystoscopy And Imaging For Follow
As mentioned above, white light cystoscopy has limitations with sensitivity for papillary tumors of 7080%, which is lower in case of CIS . These numbers are in trials, and for the studies performed with blue light in the setting of a transurethral resection, so in the operating room. Can we also use these techniques to improve our performance during outpatient follow-up, which usually is done with flexible instruments.
NBI is easy to perform in an outpatient setting, since it does not require additional preparation and the specific equipment can be used both in the clinical as well as in the outpatient setting. The real advantage of NBI, however, remains to be proven, since published data are limited and not in agreement. Mukherjee et al. showed in a randomized controlled trial NBI to be better in tumor detection and resection as compared to white light , whereas an earlier and larger study did not show a difference in recurrence rate after 1 year of follow-up .
The consequence of better tools in follow-up, in this case better cystoscopy, has been shown to result in more confidence and less anxiety among patients and urologists, resulting in longer intervals between cystoscopies . Another way to improve the sensitivity of cystoscopy might be the use of artificial intelligence , which was shown to improve both sensitivity and specificity resulting in a better bladder cancer detection and resection .
Working On A Manuscript
The characteristics of included studies and patient cohorts are summarized in Table 1. Only a minor part of the studies focused exactly on the role of smoking on NMIBC prognosis, whereas the remaining studies included smoking in uni- or multivariate analysis as a potential confounding factor, but the smoking status was not the main subject of these studies. Among all 64 included studies, patients age, tumour pathologic characteristics and additional intravesical treatment differed.
The conducted analyses included a different number of studies which provided data to investigate the association between smoking status and recurrence or progression. Necessary details, which explain the selection of studies for consecutive analyses were presented in Table 1.
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Failure Of Bcg Contact With The Target
Gradual waning of the immune response. Intravesical BCG instillations induce a transient peripheral immune activation against BCG antigens. Reactivation is observed in most cases after additional BCG courses. The absence of long-lasting immune activation after a single 6-week course of BCG could be related to the increased clinical efficacy observed with BCG maintenance instillations.12,13,14
Inadequate immune response. There is strong evidence that the success of BCG therapy might be due to a preferential induction of a TH-1 response .15,16 Although somewhat controversial, TH-2 responses detected either in the peripheral circulation or locally in the bladder are associated with poorer outcomes and might explain failure to respond to BCG therapy.17
Natural resistance-associated macrophage protein gene polymorphisms. The NRAMP1 gene has been implicated in susceptibility to infectious diseases and in response to BCG. Data suggest implication of the NRAMP1 gene in bladder cancer recurrence and response to BCG.18
Unresponsive tumour. Many recent investigations have determined whether biological markers might predict disease progression and/or response to treatment.19 An excellent review was provided a couple of years ago by Saint and colleagues.20
Bladder Cancer Recurrence: A Persistent Fear For Patients
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One of the hardest parts of living with bladder cancer is dealing with the risk of recurrence. For some, recurrences pop up every few months or years, and the relief of being “cancer-free” is short-lived. For others, bladder cancer is diagnosed, treated, and the person remains in remission but the fear that it could come back looms overhead. For others still, remission has yet to be achieved.
No matter your experience, there are similar worries, milestones, and ways of coping. Our Bladder Cancer In America 2019 survey found the many ways by which bladder cancer recurrences affect our community.
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Ajcc Stage Groupings And Tnm Definitions
The American Joint Committee on Cancer has designated staging by TNM classification to define bladder cancer.
Can Bladder Cancer Be Cured
When detected at an early stage, bladder cancer can usually be treated successfully whereas later-stage cancers may present greater challenges for the patient and their healthcare team. As discussed later, people who have had bladder cancer are at risk for recurrence for the best chance of successfully treating recurrent cancer, early detection is again important.
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For Patients With A Urostomy
If you had a radical cystectomy and now have a urostomy, you might worry even about everyday activities at first. You might have to alter some of your daily routines because of changes in how you urinate. Other issues such as having sex might also cause concerns .
Its normal to have worries and concerns when adjusting to such a major change. But its important to know there are health care professionals who are specially trained to help people with their urostomies. They can teach you to take care of your urostomy and help you cope with the changes it brings. You can also ask the American Cancer Society about programs offering information and support in your area. For more information, see our Urostomy Guide.
Data Collection And Patient Follow
All patients received routine hematological examination, computed tomography, transabdominal ultrasound, urine cytology or tissue biopsy, cystoscopy prior to surgery in order to diagnose NMIBC, and finally confirmed by postoperative pathology. Pre-operative baseline clinical pathology and laboratory data such as age, gender, body mass index , smoking history, tumor size, pathological T stage, and grade were obtained through electronic medical records in the hospital and reviewed. All histopathology reports were based on the eighth edition of Tumor-Node-Metastasis staging system, and the grade was assessed based on the 2004 WHO grading system.18,19 Tumor size was the sum of the longest diameters of all postoperative pathological specimens. According to the blood test results , the preoperative serum albumin concentration, total cholesterol concentration and total peripheral lymphocyte count of all individuals were used to calculate the CONUT score. Based on the previous study,12 the scoring criteria of CONUT are illustrated in Table 1.
Table 1 The Scoring System for the Controlling Nutritional Status Scale
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Tumor Recurrence And Worsening Progression Rate In Entire Patient Population
The mean age of the patients was 62.9 years and the median follow-up interval was 101.5 months . Solitary/multiple tumors were seen in 114/76 patients, respectively. Tumor recurrence occurred in 82 patients . Most patients who had tumor recurrence could be diagnosed by the routine follow-up cystoscopic examination except for 3 patients who were detected due to gross hematuria. When we divided the patients into two groups, those with or without tumor recurrence, there were no significant differences in age, gender, IVI or smoking status between the two groups . The recurrence rate in multiple tumors was significantly higher than that in solitary tumors . Univariate and multivariate analyses demonstrated that multiple tumor and absence of IVI were significant risk factors for tumor recurrence . Kaplan-Meier curves demonstrated that the 5-year recurrence free survival rate for solitary tumors was significantly higher than that for multiple tumors , and also higher for patients receiving intravesical instillation .
Table 1 Clinical characteristics of all 190 patientsFigure 2
Ask Your Doctor For A Survivorship Care Plan
Talk with your doctor about developing a survivorship care plan for you. This plan might include:
- A suggested schedule for follow-up exams and tests
- A schedule for other tests you might need in the future, such as early detection tests for other types of cancer, or tests to look for long-term health effects from your cancer or its treatment
- A list of possible late- or long-term side effects from your treatment, including what to watch for and when you should contact your doctor
- Diet and physical activity suggestions
- Reminders to keep your appointments with your primary care provider , who will monitor your general health care.
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Recurrence Risk In Current Smokers And Former Smokers
Seventeen studies provided exact data on recurrences in the group of current smokers, former smokers and never smokers, respectively. The comparison between the risk of recurrence was also performed between the respective groups: current smokers vs former smokers and current vs never smokers . Current smokers were at 1.24 higher risk of recurrence compared to former smokers and former smokers had an increased risk compared to never .
Many studies did not provide comprehensive data on recurrence/ progression rates or numbers in the subgroups of smokers and non-smokers, but provided hazard ratios supplemented with 95% confidence interval and those were used for RFS and PFS analysis. Fifty studies were available for analyses of the pooled hazard ratio for recurrence and/or progression.
Type Of Studies And Quality Of The Evidence
For the analysis of the predictors of recurrence, 313 studies were retrospective, 14 were prospective and 27 were randomized clinical trials . Sample size ranged between 33 and 9064 patients. Most series involved multiple surgeons. For the analysis of recurrence rate, 29 studies were retrospective, 3 were prospective and 16 were RCTs. Sample size ranged between 110 and 9064 patients. Risk of bias evaluation is summarized in Supplementary Table 1.
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