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Thread: (F) Treatment Decisions Comparisons Trends

  1. #121
    Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology [May, 2019, Full Text]

    The NCCN Guidelines for Prostate Cancer include recommendations regarding diagnosis, risk stratification and workup, treatment options for localized disease, and management of recurrent and advanced disease for clinicians who treat patients with prostate cancer. The portions of the guidelines included herein focus on the roles of germline and somatic genetic testing, risk stratification with nomograms and tumor multigene molecular testing, androgen deprivation therapy, secondary hormonal therapy, chemotherapy, and immunotherapy in patients with prostate cancer.
    See the Full Text.

  2. #122
    Survival after radiotherapy vs. radical prostatectomy for unfavorable intermediate-risk prostate cancer [2019]



    • There was no difference in survival between radical prostatectomy (RP) and EBRT + BT.
    • RP had better survival compared to EBRT alone and brachytherapy alone.
    • There was no significant difference in survival between RP and brachytherapy plus ADT or EBRT >7920 cGy and ADT.


    The optimal treatment for unfavorable intermediate-risk prostate cancer is unknown. Given the lack of randomized evidence, large comparative studies may be useful in guiding clinical decision-making.

    We queried the National Cancer Database for patients with unfavorable intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network. We compared overall survival between patients treated with radical prostatectomy (RP), external beam radiation therapy (EBRT), brachytherapy, and EBRT plus brachytherapy (EBRT+BT) using Cox proportional hazards models and propensity score matching.

    A total of 10,439 patients were analyzed. There was no statistically significant difference in overall survival between RP and EBRT+BT (hazard ratio [HR] = 1.24; 95% confidence interval [CI] 0.58–2.65). RP was associated with higher survival when compared to EBRT (HR = 2.30, 95% CI 1.70–3.20) and brachytherapy (HR = 2.90, 95% CI 1.40–6.20). When accounting for androgen deprivation therapy (ADT), there was no statistically significant difference in survival between RP and brachytherapy with ADT (HR = 3.08; 95% CI 0.62–15.27) or EBRT to a dose of ≥7920 cGy with ADT (HR = 2.6, 95% CI 0.50–13.20).

    We found no statistically significant difference in survival between RP and EBRT+BT. EBRT and brachytherapy had higher mortality, respectively, compared to RP. When including only radiotherapy patients who received ADT and, in the case of EBRT, a total dose ≥ 7920 cGy, there was no statistically significant difference in survival when comparing RP to EBRT or brachytherapy. These findings should be prospectively studied.

  3. #123
    Cost-Effectiveness of Active Surveillance, Radical Prostatectomy, and External Beam Radiotherapy for Localized Prostate Cancer: An Analysis of the ProtecT Trial



    Despite increasing emphasis on value-based care, the cost-effectiveness of prostate cancer (PCa) management options has not been compared using prospective clinical trial data. The prostate testing for cancer and treatment (ProtecT) trial demonstrated no difference in survival for patients randomized to active surveillance (AS), external beam radiotherapy (RT), or radical prostatectomy (RP). Herein, we compare the cost-effectiveness among the arms of ProtecT.

    A Markov model compared the cost-effectiveness of AS, RP, and RT based on ProtecT outcomes; specifically, 6-year quality of life data and 10 year oncologic data. Costs were based on 2017 Medicare reimbursement while utility values were assigned from the literature. Univariable and multivariable sensitivity analyses were performed.

    At 6 years after randomization, mean costs per patient were $12,143 (AS), $17,781 (RP), and $29,238 (RT). The incremental cost-effectiveness ratio relative to AS was $133,314/QALY for RP and $389,915/QALY for RT. At 10 years after randomization, both RP ($5,627/QALY) and RT ($78,291/QALY) were found to be more cost-effective than AS. The model was sensitive to the metastasis rate on AS, with a threshold of 2.4% at 10 years, below which AS was more cost-effective than RP. On multivariable sensitivity analysis at 10 years, using a willingness-to-pay threshold of $100,000/QALY, the most cost-effective strategy was RP in 45%, RT in 30%, and AS in 25% of model micro-simulations.

    Although AS represents a cost-effective management strategy for localized PCa during the initial several years after diagnosis, the relative cost-effectiveness of treatment emerges with extended follow up.

  4. #124
    Heterogeneity in Definitions of High-risk Prostate Cancer and Varying Impact on Mortality Rates after Radical Prostatectomy



    Multiple definitions of high-risk prostate cancer (PC) exist in clinical practice. Prior studies have primarily evaluated the variability in prediction of biochemical recurrence.

    To examine the impact of different definitions on mortality after radical prostatectomy (RP).

    Design, setting, and participants
    Retrospective study of 6477 men with clinically localized disease undergoing RP at Barnes-Jewish Hospital (St. Louis, MO, USA) and Cleveland Clinic (Cleveland, OH, USA) between 1995 and 2007.

    Outcome measurements and statistical analysis
    Seven pretreatment definitions of high-risk PC (prostate-specific antigen [PSA] ≥20 ng/ml, biopsy Gleason score 8–10, clinical stage ≥T2c, cT3, D’Amico definition, National Comprehensive Cancer Network definition, Kattan nomogram) were evaluated. The Kaplan-Meier method was used to generate unadjusted survival estimates. Multivariable Cox proportional hazard regression models (controlling for age) were used to estimate the hazard ratio (HR) for PC-specific mortality (PCSM) and overall mortality (OM) in the high-risk group compared to men with lower risk not meeting that definition.

    Results and limitations
    6477 men were treated with RP from 1995 to 2007 and were followed for a median of 67 mo. Depending on the definition, patients with high-risk PC comprised between 0.7% (when using cT3 as the criterion) and 8.2% (when using the D’Amico criterion) of the population. The 10-yr PC survival estimates varied from 89.7% (PSA ≥20 ng/ml) to 69.7% (cT3) and overall survival ranged from 83.4% to 58.1%. On multivariable analysis, all high-risk definitions were associated with a higher risk of PCSM compared to lower risk (HR ranging from 4.38 for PSA ≥20 ng/ml to 19.97 for cT3; all p < 0.001). All definitions of high risk except for preoperative PSA ≥20 ng/ml were associated with a higher risk of OM (HR 1.72 for D’Amico to 3.31 for cT3; all p < 0.01).

    Heterogeneity in outcomes existed, depending on the pretreatment definition of high-risk PC. Clinical stage T3 and Gleason score 8–10 were most strongly associated with PCSM and OM.

    Patient summary
    There is variability in prostate cancer outcomes after surgery, depending on the definition of pretreatment high-risk disease used. Clinical stage T3 and high Gleason score were most strongly associated with prostate cancer–specific mortality and overall mortality.

  5. #125
    Long-Term Incidence of Secondary Bladder, Rectal Cancer in Patients Treated with Brachytherapy for Localized Prostate Cancer: A Large-Scale Population-Based Analysis



    We examined the incidence and time trends of secondary bladder cancer (BCa) and rectal cancer (RCa) after brachytherapy (BT) relative to radical prostatectomy (RP).

    Within the SEER database (1988-2015), we identified patients with localized PCa as only or first primary cancer, who underwent BT or RP. Cumulative incidence plots and multivariable competing-risks regression (CRR) models were used. Sensitivity analyses focused on patients age and years of diagnosis intervals and tested the effect of an unmeasured confounder.

    Of 318,058 localized PCa patients, 55,566 (18.4%) underwent BT. After PS-matching, 20-year secondary BCa incidence was 6.0% in BT vs. 2.4% in RP (p<0.001) patients and 20-year secondary RCa incidence was 1.1% in BT vs. 0.5% in RP (p<0.001) patients. In multivariable CRR models, BT predicted higher secondary BCa (hazard ratio [HR]: 1.58, p<0.001) and RCa (HR: 1.59, p<0.001) rates vs. RP. Sensitivity analyses replicated the same results after stratification according to age and showed HRs of decreasing magnitude in respectively historical, intermediate and contemporary years of diagnosis patients. An unmeasured confounder with an HR of 2 would render the effect of BT statistically insignificant if it affected RP patients with a ratio of 2 relative to BT patients. Finally, temporal trends showed a decrease of secondary 5-year BCa and RCa rates.

    BT predominantly increases the risk of secondary BCa and to lesser extent that of RCa. Thus, follow-up is required. It is encouraging that both secondary BCa and RCa rates have recently decreased, mostly for RCa.

  6. #126
    Combined external beam radiation therapy and brachytherapy versus radical prostatectomy with adjuvant radiation therapy for Gleason 9-10 prostate cancer



    It remains controversial whether external beam radiation therapy (EBRT) with brachytherapy boost (BT) provides equivalent oncologic outcomes compared with radical prostatectomy (RP) with or without adjuvant radiation therapy (ART) for men with Gleason 9-10 prostate cancer. We sought to compare ComboRT (EBRT+BT) to RP+ART for Gleason 9-10 prostate cancer in terms of overall survival (OS) and prostate cancer-specific mortality (PCSM) in two large national databases.

    We identified patients diagnosed with clinical T1-T3N0M0, Gleason 9-10, prostate-specific antigen (PSA) 0-40 ng/mL prostate cancer managed with either ComboRT or RP+ART using the National Cancer Database (N=4,367) and Surveillance, Epidemiology, and End Results (SEER) database (N=2,276). We compared OS and PCSM in the two databases using inverse probability of treatment-weighted multivariable Cox proportional hazards regression modeling after accounting for clinical and demographic factors.

    Median follow-up in the NCDB and SEER cohorts were 6.0 years and 5.8 years, respectively. Within the NCDB cohort, there was no significant difference in 5-year OS between RP+ART versus ComboRT (86.7% vs 87.0%, adjusted hazard ratio [AHR] 1.10, 95% confidence interval [CI] 0.95-1.27, p=0.220). Results were unchanged when including only those who received hormonal therapy. Within the SEER cohort, there was no difference in 5-year PCSM (6.0% vs 5.7%, AHR 1.22, 95% CI 0.0.88-1.71, p=0.234). There was no significant interaction between age (>=65 versus <65 years) and treatment modality for the NCDB or SEER cohorts.

    For patients with Gleason 9-10 prostate cancer, multi-modality surgical therapy is equivalent to ComboRT.
    [Emphasis mine]

  7. #127
    Ten-year outcomes of high-dose intensity-modulated radiation therapy for nonmetastatic prostate cancer with unfavorable risk: early initiation of salvage therapy may replace long-term adjuvant androgen deprivation
    [2019, Full Text]



    The optimal timing of salvage androgen deprivation therapy (ADT) following definitive radiation therapy for prostate cancer (PCa) is unknown. This study evaluated the efficacy of early initiation of salvage-ADT (S-ADT) based on predetermined timing among patients with unfavorable PCa treated with high-dose intensity-modulated radiation therapy (IMRT).

    Materials and methods
    High-risk (HR) and very-high-risk (VHR) PCa patients treated with IMRT at our institution between September 2000 and December 2010 were analyzed retrospectively. Treatment consisted of high-dose IMRT (78 Gy/39 fractions) combined with 6 months of neoadjuvant-ADT (NA-ADT). S-ADT was initiated when prostate-specific antigen levels exceeded 4.0 ng/mL.

    In total, 268 (184 HR and 84 VHR) patients were analyzed. The median follow-up period was 114.4 months. The 10-year overall survival (OS), PCa-specific survival (PCSS), biochemical failure (BF), and clinical failure (CF) rates were 82.8%, 97.1%, 27.3%, and 12.8% among the HR PCa patients and 79.4%, 87.9%, 56.2%, and 26.7% among the VHR PCa patients (p = 0.839, = 0.0377, < 0.001, and < 0.001), respectively. The 10-year cumulative incidence rates of urinary and rectal (grades 2–3) toxicities were 22.6% and 5.8%, respectively. No grade 4 or higher toxicities were observed.

    High-dose IMRT combined with short-term NA-ADT resulted in long-term disease-free status, with acceptable morbidity among approximately three-fourths of the HR PCa patients and nearly half of the VHR PCa patients. Moreover, excellent survival outcomes were achieved by the early S-ADT initiation. This approach may be a promising alternative to uniform provision of long-term ADT.

  8. #128
    Trends in the use of proton beam therapy among newly diagnosed cancer patients in the United States



    Background: Proton Beam Therapy (PBT) is a potentially superior radiotherapy technology for tumors with complex anatomy surrounded by sensitive tissues and for childhood cancers where sparing surrounding normal tissue is better achieved than with photon radiotherapy. The first conditions for payment of PBT claims went into effect in 2009. In 2014, the American Society of Radiation Oncology categorized PBT clinical indications into Group 1, for which health insurance coverage is recommended, and Group 2, for which coverage is recommended only if additional requirements are met. Methods: We evaluated 21,920 newly diagnosed patients in the National Cancer Database (NCDB) who received PBT between 2004 and 2016. Joinpoint analyses were used to evaluate the Annual Percent Change (APC) in the number and characteristics of patients treated with PBT. Results: The number of patients treated with PBT in NCDB facilities increased from 1,114 in 2004 to 3,173 in 2016 (APC = 8.78, p < .001), due mainly to increases in Group 1 cancers after 2010 (from 271 patients in 2010 to 1,124 in 2016, APC = 26.4, p < .001). The number of Group 2 patients treated with PBT increased slower (from 937 in 2004 to 2,049 in 2016, APC = 6.1, p < .05). Breast and prostate cancers were most common, although trends varied substantially by cancer site. Between 2010 and 2016, receipt of PBT increased for breast cancer patients from 40 in 2010 to 405 in 2016 (APC = 48.5, p < .001), but decreased for prostate cancer patients from 1,205 in 2011 to 680 in 2016 (APC = -14.06, p < .001). While most of Group 1 patients had private insurance coverage (59.3% of patients treated in 2016), Medicare was the most common primary insurance type among Group 2 patients (50% of patients treated in 2016). Conclusions: The number of newly diagnosed cancer patients treated with PBT has increased between 2004 to 2016 in the US, with a sharp increase for cancers with clinical indications for health insurance coverage since 2010. While most of these patients have private insurance coverage, the steady increase in the number of patients being treated with PBT for cancers with additional requirements for health insurance coverage is primarily in those with Medicare coverage.

  9. #129
    Physician benefit-risk preferences for non-metastatic castration-resistant prostate cancer treatment (nmCRPC)



    Background: Second-generation androgen receptor inhibitors (SGARIs) are now available for the management of nmCRPC based on improvements in metastasis-free survival. We used a discrete choice experiment (DCE) to explore how U.S. oncologists and urologists may balance different SGARIs’ risks (i.e., adverse events [AEs]) against survival, when treating an otherwise asymptomatic patient population. Methods: We invited oncologists and urologists treating nmCRPC patients via online panels to participate. The survey included 14 treatment choice questions, each comparing 2 hypothetical medication profiles, which varied in terms of 5 safety and 2 efficacy attributes. These attributes were selected via qualitative interviews and pre-testing with physicians, patients, and caregivers. We described safety attributes (fatigue, skin rash, cognitive problems, falls, and fractures) in terms of severity and frequency and efficacy attributes (overall survival [OS] and time to pain progression) in terms of duration of effect. We used a main-effects random parameters logit model to estimate preference weights and importance scores for each attribute. Results: 74 oncologists and 75 urologists completed the survey. Among safety attributes, physicians were most concerned with cognitive problems, fractures, and fatigue. Physicians placed 36% more importance on reducing cognitive problems from severe to none compared to improving OS by 12 months instead of 3 months. On average, physicians were willing to trade off 7.1 months of OS for a reduction in fatigue severity from severe to mild/moderate and 0.8 months of OS for a reduction in fatigue from mild/moderate to none. Physicians were willing to trade off approximately 4.2 and 5.0 months of OS for reduction in fracture risk from 8% to 5%, and 5% to 0%, respectively. Conclusions: As shown in this DCE, physicians making treatment decisions for largely asymptomatic nmCRPC patients, were willing to trade substantial amounts of survival to avoid AEs. These results emphasize the importance of carefully balancing the risk-benefit profiles of SGARI therapy when treating this patient population, to ultimately optimize the overall quality of the patients’ survival.

  10. #130
    Circadian Rhythm Research Supports Timed Cancer Treatment
    [2019, Full Text]


    Our circadian rhythm is vital for far more than just a good night's sleep—it plays a crucial role in almost all of our body's physiological and behavioral activities. In fact, “even single neurons and fibroblasts harbor a conserved, cell-autonomous circadian clock,” according to researchers in the Perelman School of Medicine at the University of Pennsylvania.

    Disruption of this delicate internal clock can have significant negative effects and has been implicated in a number of disease states, including neurodegenerative disorders such as Huntington's and Parkinson's disease (Trends Endocrinol Metab 2016;27(4):192-203).

    In addition, “disrupted rhythms, which can occur in many ways, such as shift work and jet lag, were previously shown to increase susceptibility to cancer,” according to Amita Sehgal, PhD, Professor of Neuroscience and Director of Penn's Chronobiology Program. Research shows dysregulated circadian rhythms increase the risk of many cancers, including lung, breast, skin, oral, and prostate (Cancer Res 2004; doi:10.1158/0008-5472.CAN-04-0674). The fact that many different tumors are affected suggests basic cellular changes, yet little is known about the mechanisms driving the association between dysregulated circadian rhythms and tumorigenesis (Int J Genomics 2018; doi:10.1155/2018/8576890).

    Sehgal and her team recently used cell-based circadian desynchronization experiments to discover what exactly happens to basic cell function with circadian rhythm disruption (PLoS Biol 2019; doi: 10.1371/journal.pbio.300022 . They found chronic circadian desynchronization causes cell proliferation along several oncogenetic pathways. Their research also supports the potential efficacy of chronotherapy, or timed treatment. Both discoveries have lasting implications for researchers and practicing clinicians alike.


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