IMPRESS-Norway: improving public cancer care by implementing precision medicine in Norway; inclusion rates and preliminary results.

BACKGROUND AND PURPOSE: In Norway, comprehensive molecular tumour profiling is implemented as part of the public healthcare system. A substantial number of tumours harbour potentially targetable molecular alterations. Therapy outcomes may improve if targeted treatments are matched with actionable genomic alterations. In the IMPRESS-Norway trial (NCT04817956), patients are treated with drugs outside the labelled indication based on their tumours molecular profile. PATIENTS AND METHODS: IMPRESS-Norway is a national, prospective, non-randomised, precision cancer medicine trial, offering treatment to patients with advanced-stage disease, progressing on standard treatment. Comprehensive next-generation sequencing, TruSight Oncology 500, is used for screening. Patients with tumours harbouring molecular alterations with matched targeted therapies available in IMPRESS-Norway, are offered treatment. Currently, 24 drugs are available in the study. Primary study endpoints are percentage of patients offered treatment in the trial, and disease control rate (DCR) defined as complete or partial response or stable disease in evaluable patients at 16 weeks (W16) of treatment. Secondary endpoint presented is DCR in all treated patients. RESULTS: Between April 2021 and October 2023, 1,167 patients were screened, and an actionable mutation with matching drug was identified for 358 patients. By the data cut off 186 patients have initiated treatment, 170 had a minimum follow-up time of 16 weeks, and 145 also had evaluable disease. In patients with evaluable disease, the DCR was 40% (58/145). Secondary endpoint analysis of DCR in all treated patients, showed DCR of 34% (58/170). INTERPRETATION: Precision cancer medicine demonstrates encouraging clinical effect in a subset of patients included in the IMPRESS-Norway trial.

Survival after docetaxel for metastatic castration-resistant prostate cancer in a rural health care setting.

Introduction: The aim of this study was to evaluate overall survival of men who received systemic therapy with docetaxel for metastatic castration- resistant prostate cancer (MCRPC) in rural Nordland County, Norway. Prognostic factors related to treatment and other variables were evaluated. Material and methods: Overall, 132 pa- tients were included in this retrospective study covering the years 2009-2022. Uni- and multivariate survival analyses were performed. Results: In this elderly cohort (median age 72 years), weekly low-dose docetaxel was the preferred regimen (44%). Seventy-three percent were treated in the first line. Only 11 patients (8%) were pre-exposed to docetaxel in the hormone-sensitive phase. Median survival was 14.3 months. Prognostic factors for longer survival included higher hemoglobin, lower lactate dehydrogenase, administration of docetaxel as first-line MCRPC treatment, and use of fewer prescription drugs for comorbidity. Pre-exposure to docetaxel did not play a major role, p = 0.76. Conclusions: In this rural health care setting, survival after docetaxel was shorter than reported by other groups. Blood test results were confirmed as important prognostic factors. In the present era of evolving treatment sequences, we recommend monitoring of real-world treatment results.

Palliative appropriateness criteria: external validation of a new method to evaluate the suitability of palliative radiotherapy fractionation.

BACKGROUND: Recently, the palliative appropriateness criteria (PAC) score, a novel metric to aid clinical decision-making between different palliative radiotherapy fractionation regimens, has been developed. It includes baseline parameters including but not limited to performance status. The researchers behind the PAC score analyzed the percent of remaining life (PRL) on treatment. The latter was accomplished by calculating the time between start and finish of palliative radiotherapy (minimum 1 day in case of a single-fraction regimen) and dividing it by overall survival in days from start of radiotherapy. The purpose of the present study was to validate this novel metric. PATIENTS AND METHODS: The retrospective validation study included 219 patients (287 courses of palliative radiotherapy). The methods were identical to those employed in the score development study. The score was calculated by assigning 1 point each to several factors identified in the original study and using the online calculator provided by the PAC developers. RESULTS: Median survival was 6 months and death within 30 days from start of radiotherapy was recorded in 13% of courses. PRL on treatment ranged from 1 to 23%, median 8%. Significant associations were confirmed between online-calculated PAC score, observed survival, and risk of death within 30 days from the start of radiotherapy. Patients with score 0 had distinctly better survival than all other groups. The score-predicted median risk of death within 30 days from start of radiotherapy was 22% in our cohort. A statistically significant correlation was found between predicted and observed risk (p < 0.001). The original and present study were not perfectly concordant regarding number and type of baseline parameters that should be included when calculating the PAC score. CONCLUSION: This study supports the dual strategy of PRL and risk of early death calculation, with results stratified for fractionation regimen, in line with the original PAC score study. When considering multifraction regimens, the PAC score identifies patients who may benefit from shorter courses. Additional work is needed to answer open questions surrounding the underlying components of the score, because the original and validation study were only partially aligned.

Percent of remaining life on palliative radiation treatment: solely a function of fractionation?

Background: This study analyzed the percent of remaining life (PRL) on treatment in patients irradiated for bone metastases. Bone metastases were treated together with other target volumes, if indicated, e.g. a 10-fraction treatment course that included brain and bone metastases. PRL was determined by calculating the time between start and finish of palliative radiotherapy (minimum 1 day in case of a single-fraction regimen) and dividing it by overall survival in days from start of radiotherapy. Materials and methods: Different baseline parameters were assessed for association with dichotomized PRL (< 5% vs. ≥ 5%). The retrospective study included 219 patients (287 courses of palliative radiotherapy). After univariate analyses, multi-nominal logistic regression was employed. Results: PRL on treatment ranged from 1-23%. Single-fraction radiotherapy resulted in < 5% PRL on treatment in all cases. All courses with 10 fractions resulted in at least 5% PRL on treatment. Significant associations were found between various baseline parameters and PRL category. With fractionation included in the regression model, 3 parameters retained significant p-values: Karnofsky performance status (KPS), none-bone target volume and fractionation (all with p < 0.001). If analyzed without fractionation, none-bone target volume (p < 0.001), hemoglobin (p < 0.001), KPS (p = 0.01), lack of additional systemic treatment (p = 0.01), and hypercalcemia (p = 0.04) were significant. Conclusions: Fractionation is an easily modifiable factor with high impact on PRL. Patients with KPS < 70 and those treated for additional target types during the same course are at high risk of spending a larger proportion of their remaining life on treatment.

Ipilimumab in a real-world population: A prospective Phase IV trial with long-term follow-up.

Ipilimumab was the first treatment that improved survival in advanced melanoma. Efficacy and toxicity in a real-world setting may differ from clinical trials, due to more liberal eligibility criteria and less intensive monitoring. Moreover, high costs and lack of biomarkers have raised cost-benefit concerns about ipilimumab in national healthcare systems and limited its use. Here, we report the prospective, interventional study, Ipi4 (NCT02068196), which aimed to investigate the toxicity and efficacy of ipilimumab in a real-world population with advanced melanoma. This national, multicentre, phase IV trial included 151 patients. Patients received ipilimumab 3 mg/kg intravenously and were followed for at least 5 years or until death. Treatment interruption or cessation occurred in 38%, most frequently due to disease progression (19%). Treatment-associated grade 3 to 4 toxicity was observed in 28% of patients, and immune-related toxicity in 56%. The overall response rate was 9%. Median overall survival was 12.1 months (95% CI: 8.3-15.9); and progression-free survival 2.7 months (95% CI: 2.6-2.8). After 5 years, 20% of patients were alive. In a landmark analysis from 6 months, improved survival was associated with objective response (HR 0.16, P = .001) and stable disease (HR 0.49, P = .005) compared to progressive disease. Poor performance status, elevated lactate dehydrogenase and C-reactive protein were identified as biomarkers. This prospective trial represents the longest reported follow-up of a real-world melanoma population treated with ipilimumab. Results indicate safety and efficacy comparable to phase III trials and suggest that the use of ipilimumab can be based on current cost-benefit estimates.

Improving public cancer care by implementing precision medicine in Norway: IMPRESS-Norway.

BACKGROUND: Matching treatment based on tumour molecular characteristics has revolutionized the treatment of some cancers and has given hope to many patients. Although personalized cancer care is an old concept, renewed attention has arisen due to recent advancements in cancer diagnostics including access to high-throughput sequencing of tumour tissue. Targeted therapies interfering with cancer specific pathways have been developed and approved for subgroups of patients. These drugs might just as well be efficient in other diagnostic subgroups, not investigated in pharma-led clinical studies, but their potential use on new indications is never explored due to limited number of patients. METHODS: In this national, investigator-initiated, prospective, open-label, non-randomized combined basket- and umbrella-trial, patients are enrolled in multiple parallel cohorts. Each cohort is defined by the patient's tumour type, molecular profile of the tumour, and study drug. Treatment outcome in each cohort is monitored by using a Simon two-stage-like 'admissible' monitoring plan to identify evidence of clinical activity. All drugs available in IMPRESS-Norway have regulatory approval and are funded by pharmaceutical companies. Molecular diagnostics are funded by the public health care system. DISCUSSION: Precision oncology means to stratify treatment based on specific patient characteristics and the molecular profile of the tumor. Use of targeted drugs is currently restricted to specific biomarker-defined subgroups of patients according to their market authorization. However, other cancer patients might also benefit of treatment with these drugs if the same biomarker is present. The emerging technologies in molecular diagnostics are now being implemented in Norway and it is publicly reimbursed, thus more cancer patients will have a more comprehensive genomic profiling of their tumour. Patients with actionable genomic alterations in their tumour may have the possibility to try precision cancer drugs through IMPRESS-Norway, if standard treatment is no longer an option, and the drugs are available in the study. This might benefit some patients. In addition, it is a good example of a public-private collaboration to establish a national infrastructure for precision oncology. Trial registrations EudraCT: 2020-004414-35, registered 02/19/2021; ClinicalTrial.gov: NCT04817956, registered 03/26/2021.

The LabBM score is an excellent survival prediction tool in patients undergoing palliative radiotherapy.

BACKGROUND AND AIM: The prognostic assessment of patients referred for palliative radiotherapy can be conducted by site-specific scores. A quick assessment that would cover the whole spectrum could simplify the working day of clinicians who are not specialists for a particular disease site. This study evaluated a promising score, the LabBM (validated for brain metastases), in patients treated for other indications. MATERIALS AND METHODS: The LabBM score was calculated in 375 patients by assigning 1 point each for C-reactive protein and lactate dehydrogenase above the upper limit of normal, and 0.5 points each for hemoglobin, platelets and albumin below the lower limit of normal. Uni- and multivariate analyses were performed. RESULTS: Median overall survival gradually decreased with increasing point sum (range 25.1-1.1 months). When grouped according to the original three-tiered model, excellent discrimination was found. Patients with 0-1 points had a median survival of 15.7 months. Those with 1.5-2 points had a median survival of 5.8 months. Finally, those with 2.5-3.5 points had a median survival of 3.2 months (all p-values ≤ 0.001). CONCLUSION: The LabBM score, which is derived from inexpensive blood tests and easy to use, stratified patients into three very distinct prognostic groups and deserves further validation.

A Four-Tiered Prognostic Score for Patients Receiving Palliative Thoracic Radiotherapy for Lung Cancer.

Palliative radiotherapy improves lung cancer related symptoms. Prognosis should be taken into account when deciding about fractionation. In this study, prognostic factors derived from multivariate analysis were used to assign a point sum reflecting 6-month survival. Four prognostic groups were compared. Performance status, lactate dehydrogenase, C-reactive protein, liver/adrenal gland metastases, and extrathoracic disease status significantly predicted survival and formed the basis of the score. The four groups had a median survival of 0.8, 1.6, 3.3, and 10.5 months (6-month survival 0, 10, 30, 70%; 12-month survival 0, 0, 12, 40%; p = 0.0001), respectively. In the unfavorable group best supportive care might be preferable.

Patient-reported symptoms before palliative radiotherapy predict survival differences.

BACKGROUND: Widely used prognostic scores, e. g., for brain or bone metastases, are based on disease- and patient-related factors such as extent of metastases, age and performance status, which were available in the databases used to develop the scores. Few groups were able to include patient-reported symptoms. In our department, all patients were assessed with the Edmonton Symptom Assessment System (ESAS, a one-sheet questionnaire addressing 11 major symptoms and wellbeing on a numeric scale of 0-10) at the time of treatment planning since 2012. Therefore, we analyzed the prognostic impact of baseline ESAS symptom severity. METHODS: Retrospective review of 102 patients treated with palliative radiotherapy (PRT) between 2012 and 2015. All ESAS items were dichotomized (below/above median). Uni- and multivariate analyses were performed to identify prognostic factors for survival. RESULTS: The most common tumor types were prostate, breast and non-small cell lung cancer, predominantly with distant metastases. Median survival was 6 months. Multivariate analysis resulted in six significant prognostic factors. These were ESAS pain while not moving (median 3), ESAS appetite (median 5), Eastern Cooperative Oncology Group (ECOG) performance status, pleural effusion/metastases, intravenous antibiotics at start or within 2 weeks before PRT and no systemic cancer treatment. CONCLUSIONS: Stronger pain while not moving and reduced appetite (below/above median) predicted significantly shorter survival. Development of new prognostic scores should include patient-reported symptoms and other innovative parameters because they were more important than primary tumor type, age and other traditional baseline parameters.

Tumor marker analyses in patients with brain metastases: patterns of practice and implications for survival prediction research.

This study aims to explore patterns of practice of tumor marker analyses and potential prognostic impact of abnormal markers in patients with brain metastases from solid tumors. Previously, lactate dehydrogenase (LDH) and albumin were identified as relevant biomarkers. We performed a retrospective analysis of 120 patients with known LDH and albumin treated with whole-brain radiotherapy (WBRT) in two different situations: (1) brain metastases detected at initial cancer diagnosis (n = 46) and (2) brain metastases at later time points (n = 74, median interval 13 months). Twenty-six patients (57 %) from group 1 had at least one tumor marker analyzed, and 11 patients (24 %) had abnormal results. Twenty-two patients (30 %) from group 2 had at least one tumor marker analyzed, and 16 patients (22 %) had abnormal results. When assuming that LDH and albumin would be standard tests before WBRT, additional potential biomarkers were found in 36 % of patients with normal LDH and albumin. Marker positivity rates were for example 80 % for carcinoembryonic antigen (CEA) in colorectal cancer and 79 % for CA 15-3 in breast cancer. Abnormal markers were associated with presence of liver metastases. CA 15-3 values above median predicted shorter survival in patients with breast cancer (median 1.9 vs. 13.8 months, p = 0.1). Comparable trends were not observed for various markers in other tumor types. In conclusion, only a minority of patients had undergone tumor marker analyses. Final group sizes were too small to perform multivariate analyses or draw definitive conclusions. We hypothesize that CA 15-3 could be a promising biomarker that should be studied further.

Oligometastatic non-small cell lung cancer: a significant entity outside of specialized cancer centers?

OBJECTIVE: To report the incidence, patterns of care, and outcomes of oligometastatic non-small cell lung cancer (NSCLC) in a rural practice setting in Norway. MATERIALS AND METHODS: A retrospective analysis was conducted of all patients with stage IV NSCLC at the initial diagnosis who received active treatment in the central part of Nordland, a rural county in northern Norway, during the period of 2006-2012. We analyzed overall survival and prognostic factors. RESULTS: The initial study population included 113 patients with stage IV disease who received active therapy; of these, 23 (20%) had oligometastatic spread (a maximum of 3 metastases to 1 organ). The median age was 71 years. Of the 23 patients, 16 (70%) did not receive radical or at least moderately aggressive local treatment for their thoracic disease. Of the remaining 7 patients, 4 (17.4%) did not receive systemic therapy. The median actuarial survival was 5.6 months in patients with more advanced metastases and 11.7 months in those with oligometastases (p = 0.03). Significant differences were also seen between the 2 oligometastatic patient groups with and without more intense thoracic treatment (median 19.7 vs. 7.6 months, p = 0.004). Further significant predictors of survival in patients with oligometastases were nodal stage (p = 0.028) and weight loss (p = 0.045). Trends were seen for T stage (p = 0.058) and performance status (p = 0.07). CONCLUSION: Oligometastatic NSCLC was diagnosed in a relevant proportion of patients; therefore, warranting prospective studies are recommended. Such studies are also needed to confirm the treatment-dependent survival differences observed in our patient population.

Sex Differences in Presentation, Treatment, and Survival in Patients Receiving Palliative (Chemo)Radiotherapy for Non-Small Cell Lung Cancer.

BACKGROUND/AIM: The aim of this study was to analyze sex differences in a real-world cohort of patients who received palliative thoracic radiotherapy or chemoradiotherapy for non-small cell lung cancer. PATIENTS AND METHODS: Retrospectively, baseline, treatment, toxicity, and survival data from a single institution were analyzed. The study included 181 patients (82 females, 99 males). RESULTS: Despite borderline significant differences in disease presentation (T and N stage), final assignment to stage II, III or IV was similar. The same was true for target volume size. Neither radiotherapy parameters nor systemic treatment approaches were significantly different. Toxicity profiles and survival were similar too. Less than 1 out of 3 patients experienced high-grade toxicity, largely esophagitis. Median survival was 8.1 (males) versus 7.8 months (females) and the corresponding 2-year survival rates were 16 and 15%, respectively (p=0.78). CONCLUSION: Relevant sex differences were not observed in this study of common radiotherapy regimes such as 10 fractions of 3 Gy or 15 fractions of 2.8 Gy, the latter often combined with carboplatin/vinorelbine chemotherapy.

Best supportive care in patients with brain metastases and adverse prognostic factors: development of improved decision aids.

PURPOSE: This study aimed to develop a survival prediction model that might aid decision making when choosing between best supportive care (BSC) and brain radiotherapy (RT) for patients with brain metastases and limited survival expectation. METHODS: A retrospective analysis of 124 patients treated with BSC, whole brain radiotherapy (WBRT), or radiosurgery was conducted. All patients had adverse prognostic features defined as 0-1.5 points according to the diagnosis-specific graded prognostic assessment score (DS-GPA) or GPA if primary tumor type was not among those represented in DS-GPA. Kaplan-Meier survival curves were compared between patients treated with BSC or RT in different scenarios, reflecting more or less rigorous definitions of poor prognosis. If survival was indistinguishable and this result could be confirmed in multivariate analysis, BSC was considered appropriate. RESULTS: Irrespective of point sum examined, DS-GPA by itself was not a satisfactory selection parameter. However, we defined a subgroup of 63 patients (51 %) with short survival irrespective of management approach (only 5 % of irradiated patients survived beyond 6 months; they had newly diagnosed, treatment-naïve lung cancer), i.e., patients in whom foregoing RT was unlikely to compromise survival. These were patients with 0-1.5 points and aged ≥ 75 years, had Karnofsky performance status ≤ 50, or had uncontrolled primary tumor with extracranial metastases to at least two organs. CONCLUSIONS: BSC is a reasonable choice in patients with limited life expectancy. After successful external validation of the selection criteria developed in this analysis, identification of patients who are unlikely to benefit from WBRT might be improved.

Prognostic Factors and Independent Validation of a Risk Stratification Model in Octogenarian Patients Irradiated for Brain Metastases.

BACKGROUND/AIM: This study aimed at validation of a prognostic model, originally developed by Rades et al., in an age-restricted, particularly vulnerable subgroup of patients with brain metastases, because international variations in clinical practice and survival outcomes may impact on the performance of survival prediction tools. PATIENTS AND METHODS: Retrospectively, data from a single institution were analyzed. The study included 50 patients managed with palliative whole-brain radiotherapy. The Rades et al. score was assigned and the resulting 3 prognostic strata compared. RESULTS: The 3-month survival rates for the 3 strata were 0, 35, and 41%, respectively (p<0.001 pooled over all strata, log-rank test for Kaplan-Meier curves). However, the prognostic impact of extracranial metastases suggested by Rades et al., together with the performance status and number of brain metastases in their study of 94 patients, was absent. In contrast, cancer type (better survival for breast and melanoma) and lack of steroid treatment were significant in the present study. CONCLUSION: The original Rades et al. score is a useful prognostic model in our validation database. However, additional factors, such as primary cancer type and need to prescribe corticosteroids, appear to play a role and might therefore be considered when performing future large-scale studies.

The LabPS score: Inexpensive, Fast, and Site-agnostic Survival Prediction.

OBJECTIVES: To provide a widely applicable, blood-biomarker-based and performance-status-based prognostic model, which predicts the survival of patients undergoing palliative non-brain radiotherapy. This model has already been examined in a cohort of patients treated for brain metastases and performed well. METHODS: This was a retrospective single-institution analysis of 375 patients, managed with non-ablative radiotherapy to extracranial targets, such as bone, lung, or lymph nodes. Survival was stratified by LabPS score, a model including serum hemoglobin, platelets, albumin, C-reactive protein, lactate dehydrogenase, and performance status. Zero, 0.5, or 1 point was assigned and the final point sum calculated. A higher point sum indicates shorter survival. RESULTS: The LabPS score predicted overall survival very well (median 0.6 to 26.5 mo, 3-month rate 0% to 100%, 1-year rate 0% to 89%), P =0.0001. However, the group with the poorest prognosis (4.5 points) was very small. Most patients with comparably short survival or radiotherapy administered in the last month of life had a lower point sum. Additional prognostic factors, such as liver metastases, opioid analgesic use, and/or corticosteroid medication, were identified. CONCLUSIONS: If busy clinicians prefer a general prognostic model rather than a panel of separate diagnosis-specific/target-specific scores, they may consider validating the LabPS score in their own practice. In resource-constrained settings, inexpensive standard blood tests may be preferable over imaging-derived prognostic information. Just like other available scores, the LabPS cannot identify all patients with very short survival.

Contribution of case reports to glioblastoma research: systematic review and analysis of pattern of citation.

INTRODUCTION: Research activity related to different aspects of diagnosis, epidemiology and treatment of glioblastoma has increased during recent years. Authors of scientific publications are able to choose between different formats including case reports. Little is known about their influence on advancement of the field or scientific merits. Do glioblastoma case reports attract attention or do they go largely unrecognized? METHODS: Different measures of impact, visibility and quality of published research are available, each with its own pros and cons. For the present evaluation (to the best of our knowledge the first one on this subject), article citation rate was chosen. The databases PubMed and Scopus were searched for articles that were published during the 5-year time period between 2006 and 2010. RESULTS: We identified 5831 articles dealing with glioblastoma. Of these, 286 (4.9%) reported on single patient cases and 15 (0.26%) were reports of two cases. The median number of citations was 1 (range 0-37). Stratified by year of publication, the median number ranged from 0 for those published in 2010 to 3 for those published in 2006. Citations appeared to gradually increase during the first 2-3 years after publication. As compared to other articles, case reports were significantly less likely to receive a large number of citations. CONCLUSION: Compared to other formats, the proportion of case reports was limited and few of them were highly cited. It cannot be excluded that case reports without citation provide interesting information to some readers. However, their educational value is difficult to quantify.

Towards improved prognostic scores predicting survival in patients with brain metastases: a pilot study of serum lactate dehydrogenase levels.

Accurate prognostic information is desirable when counselling patients with brain metastases regarding their therapeutic options and life expectancy. Based on previous studies, we selected serum lactate dehydrogenase (LDH) as a promising factor on which we perform a pilot study investigating methodological aspects of biomarker studies in patients with brain metastases, before embarking on large-scale studies that will look at a larger number of candidate markers in an expanded patient cohort. For this retrospective analysis, 100 patients with available information on LDH treated with palliative whole-brain radiotherapy were selected. A comprehensive evaluation of different LDH-based variables was performed in uni- and multivariate tests. Probably, the most intriguing finding was that LDH kinetics might be more important, or at least complement, information obtained from a single measurement immediately before radiotherapy. LDH and performance status outperformed several other variables that are part of prognostic models such as recursive partitioning analyses classes and graded prognostic assessment score. LDH kinetics might reflect disease behaviour in extracranial metastatic and primary sites without need for comprehensive imaging studies and is a quite inexpensive diagnostic test. Based on these encouraging results, confirmatory studies in a larger cohort of patients are warranted.

Established Serum Biomarkers Are Prognostic Factors in Patients With Oligometastatic Cancer and Brain Involvement.

BACKGROUND/AIM: This study was designed to evaluate the prognostic impact of the previously validated LabBM score (serum lactate dehydrogenase, C-reactive protein, albumin, hemoglobin, platelets) in a new setting, namely patients with a limited number of brain metastases, arbitrarily defined as max. 4 brain lesions, from common tumor types such as lung and breast cancer. A total of 5 metastatic lesions overall were allowed to comply with current definitions of oligometastatic cancer. PATIENTS AND METHODS: For this retrospective single-institution analysis, 101 patients were identified from a previously described, prospectively maintained database. RESULTS: Twenty-one patients (21%) had extracranial metastases. Non-small cell and small cell lung cancer were the prevailing tumor types (78%). Forty-nine patients (49%) had normal blood test results (LabBM score 0 points). Their median survival (23 months) was significantly longer than that of patients with higher LabBM score. In multivariate analysis, LabBM score, performance status and single brain metastasis were associated with significantly better survival. Limited extracranial metastases did not impair prognosis. Patients with LabBM score 0 had a 5-year survival rate of 27% after surgery (n=24) and 39% after stereotactic radiotherapy (n=13), respectively (p=0.3). CONCLUSION: Blood biomarkers can be regarded as surrogate of the metastatic burden in the body, which is not always detectable by imaging methods. In contrast to circulating tumor cells and other emerging markers, the LabBM score is inexpensive. Patients with LabBM score >0 had a 2.8-fold increased risk of death. The score might be helpful in predicting survival improvement provided by ablative local treatment of oligometastases.

Feasibility and efficacy of early docetaxel plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer in a rural health care setting.

AIM/BACKGROUND: The aim of this study was to evaluate the feasibility and efficacy, in terms of overall survival, of intensified upfront systemic therapy in patients with metastatic hormone-sensitive prostate cancer who lived in rural Nordland County, Norway. PATIENTS AND METHODS: Overall 117 patients were included in this retrospective study. Three cohorts were created: early docetaxel and androgen deprivation therapy (ADT; the CHAARTED regimen; n = 37), ADT only during the same time period (2014-2020; n = 33), and ADT only in the years 2009-2014 (n = 47). RESULTS: Four patients (11%) did not complete 6 cycles of docetaxel, one of these due to early progression of cancer. During follow-up, 8 patients (22%) progressed to castration-resistant disease (mCRPC), compared to 24 (73%) with ADT only and 35 (75%) in the historical cohort, p = 0.000001. Such progression occurred within 12 months in 3 patients (8%) treated with docetaxel and 9 patients (27%) treated with ADT only during the same time period, p = 0.05. Median survival was 56 months (95% CI: 40-72 months), compared to 30 months in both other cohorts. 3-year survival rates were 79%, 38% and 37%, respectively (p = 0.016). In multivariate analysis, the CHAARTED regimen was associated with significantly improved survival. CONCLUSION: In this rural health care setting, early docetaxel was feasible and effective in reducing progression to mCRPC and prolonging survival. Median survival was very close to the 58 months reported in the CHAARTED trial.