Current Oncology

Background: In the ATLANTIS study, second-line lurbinectedin/doxorubicin did not improve overall survival (OS), however patients with a chemotherapy-free interval (CTFI) of ≥180 days had an improved progression free survival (PFS). The objective of this retrospective study was to identify the proportion of real-world small cell lung cancer (SCLC) patients who are suitable for lurbinectedin-based therapy based on these criteria. Methods: A retrospective study of all SCLC referred to BC Cancer between 2012 and 2017 was conducted. Patient demographics, staging, treatment, and survival data were collected retrospectively. Baseline characteristics were compared using descriptive statistics. OS was calculated using Kaplan–Meier curves. Statistically significant p-value was <0.05. Results: A total of 1048 patients were identified. Baseline characteristics: median age 68 years, 47% male, 61% current smoking status, 68% extensive disease. Best supportive care was received by 22%. First-line systemic therapy was platinum doublet for 71% of the population. Second-line systemic therapy was delivered to 22%. Of the 219 patients who received second-line systemic therapy after platinum doublet, 183 patients had a CTFI of ≥90 days and 107 patients had a CTFI of ≥180 days. Patients originally treated as limited stage disease, received platinum doublet as second line, received thoracic radiation (RT) or prophylactic cranial irradiation (PCI) were more likely to have a CTFI of ≥90 and ≥180 days. Conclusion: In our real-world SCLC population, only 21% of the SCLC population received second-line therapy after platinum doublet with 17% achieving CTFI of ≥90 days and 10% CTFI of ≥180 days. Based on this retrospective review, only a small fraction of platinum-treated patients would be preferentially offered lurbinectedin in the second-line setting. Full article

(Background) Radiation failure for localized prostate cancer is seen in 20–60% of patients who do not undergo extirpative surgery. Though potentially curative, salvage prostatectomy (SS) has not been frequently performed historically due to high rates of complications and postoperative incontinence. With the advent of robotic-assisted radical prostatectomy, these rates appear to be improved. Retzius-sparing approaches have additionally been shown to improve continence outcomes in the index setting, and may further improve continence outcomes in salvage cases while maintaining oncologic integrity. (Methods) We performed a literature review and qualitative analysis of published papers on salvage Retzius-sparing robotic-assisted radical prostatectomy (SRS). Three studies met criteria and were included in analysis. (Results) There were more patients with Gleason Grade Group 1 disease after initial treatment in the SRS group vs. SS (22% vs. 8%). Patients most frequently underwent external beam radiation therapy in both groups (52% vs. 49%). 30-day complication rates were 10% and 26% for SRS and SS, respectively. Continence outcomes were significantly improved in SRS with 59% of continence (based on study criteria) compared to 38% in SS. Time to continence was similarly improved for SRS. Positive surgical margins and biochemical recurrence were not significantly different between SRS and SS in any study. (Conclusions) SRS is a safe and feasible option for salvage treatment of localized prostate cancer and may improve postoperative continence outcomes. Positive surgical margin and biochemical recurrence rates are similar to those reported in SS. Full article

A cancer diagnosis can have a substantial impact on a patient’s mental health and quality of life. The aim of this study was to investigate the prevalence of fatigue, emotional distress, and uncertainty and examine the predictive value they have on the quality of life of advanced cancer patients. A prospective, multicenter study was conducted between February 2020 and May 2021 of individuals diagnosed with an advanced, unresectable neoplasm prior to initiating systemic antineoplastic treatment. Participants completed questionnaires to quantify fatigue, emotional distress, disease uncertainty, and quality of life. A linear regression analysis was performed to study the predictive QoL variables. The study population comprised 508 patients, 53.7% of whom were male and had a mean age of 54.9 years. The most common cancers were digestive (40.6%), bronchopulmonary (29.1%), and breast (8.5%); the most frequent histology was adenocarcinoma (63%); and most were stage IV (79.7%). More than half (55.7%) suffered fatigue, and 47.7% exhibited emotional distress; both were more prevalent among women. Fatigue, emotional distress, and disease uncertainty all correlate with diminished quality of life. Similarly, ECOG performance status and the demographic variables of age, sex, and comorbidities impacted quality of life. This patient sample displayed a high prevalence of fatigue and emotional distress, together with illness uncertainty, which are clearly linked to waning quality of life. To decrease the experience of fatigue and improve mental health treatment in cancer patients, interventions based on a biopsychosocial model must be intensified. Full article

Objectives: Rare tumors (RT) collectively account for one quarter of all malignancies in Italy. The low frequency and the large heterogeneity in natural history and outcome of individual diseases, together with a scarcity of epidemiological information make them a challenge for clinical practice, as well as for public healthcare organizations. We conducted a retrospective study to quantify the burden of hospitalization in a real-word setting in patients diagnosed with these diseases in an Italian region. Methods: RT patients were tracked along all hospital stays from 2000 to 2019 using hospital discharge records. Frequency of hospitalizations, average time spent in hospital and median timespan between consecutive admissions were considered. Re-hospitalization rates were analyzed through a multivariable negative binomial regression analysis to adjust for confounding and allowing for over-dispersion in count data. Results: As a whole, 57,329 patients were identified at first stay for all studied tumors. A total of 183,959 admissions were retrieved, along a median of 3 hospitalizations per patient. Median timespan between hospitalizations shortened in the course of the study years (12.5 months in 2000–2004 to 5.4 months in 2015–2019). The overall re-hospitalization rate increased from 0.92 per patient/year (95% CI = 0.81–1.04) in 2000–2004 to 2.17 (95% CI = 1.90–2.47) in 2015–2019. Conclusions: Overall, the hospitalization rate of patients with a RT increased in the twenty years since the 2000 and particularly doubled starting from 2015. A higher burden of hospitalizations was found for tumors of the central nervous system, thoracic cavity, digestive tract and sarcomas. To the best of our knowledge this is the first paper related to access to Italian healthcare facilities of patients with these tumors. Full article

Purpose: Biomarker discordances and alterations can be encountered between tru-cut biopsy and residual tumor in breast cancer treated with neoadjuvant chemotherapy (NACTx). We aimed to investigate the effect of NACTx on major biomarker expression (ER, PR, HER2, Ki-67) and tumor grade, the frequency and causes of receptor discordances, and the clinical significance of changes in terms of adjuvant therapy need and chemosensitivity. Methods: In this retrospective study, ER, PR, HER2, and Ki-67 expression and tumor grades were compared between pre- and post-NACTx tumor samples using the Wilcoxon signed-rank test. The frequencies of receptor discordances and the need for new adjuvant therapy due to discordances were calculated. The effect of patient and tumor characteristics and NACTx regimens on discordances was investigated using multivariate analysis. Using histopathological examinations, residual tumors were divided into chemotherapy-responsive and chemotherapy-unresponsive tumors. Biomarker changes in both groups were analyzed for predictability of chemosensitivity. Results: Of the 169 patients who received NACTx, 102 patients having enough residual tumors in the surgical pathology specimen were enrolled in the study. Histopathologically, about 70% of tumors were partially responsive to NACTx and 30% were unresponsive (chemo-resistant). The concordance and discordance rates were 95.1% versus 4.9% for ER (p = 0.180), 97.1% versus 2.9% for PR (p = 0.083), and 89.2% versus 10.8% for HER2 (p = 0.763), respectively. In addition, 15% of hormone receptor (HR)-negative patients became HR(+) and 5.7% of HER2(−) patients became HER2(+) in the residual tumors, requiring adjuvant endocrine or anti-HER2 therapy. In particular, 18% of triple-negative patients became HR(+) and 12% became HER2(+). HER2 loss was detected in 40% of HER2(+) patients. Multivariate logistic regression analysis revealed that lower estrogen expression (p = 0.046), a smaller tumor size (p = 0.029), and anti-HER2 therapy (p < 0.001) have independent efficacy on ER discordance, PR discordance, and HER2 discordance, respectively. Ki-67 and PR expression significantly decreased in chemotherapy-responsive tumors (p = 0.001 and p = 0.004), and the tumor grade increased in chemotherapy-unresponsive tumors (p = 0.034). Conclusions: Approximately 3–5% of HR discordance and about 10% of HER2 discordance can be observed in breast cancer after currently used NACTx regimens. Discordances are bi-directional (from positive to negative and vice versa), and their causes are multifactorial; they should be assessed accordingly. The NACTx effect alone cannot explain observed discordances but can cause biomarker alterations. The change in receptor status from positive to negative, especially HER2 loss, is mainly associated with the NACTx effect. However, the shift from negative to positive is thought to be primarily related to intratumoral heterogeneity. Receptor statuses becoming positive are of more clinical importance due to adjuvant therapy requirements. Biomarker alterations in PR, Ki-67, and tumor grade can provide predictive information about tumor chemosensitivity. Full article

In recent years, a dynamic development of oncology has been observed, resulting from the increasingly frequent occurrence of neoplasms and therefore, increasing population of patients. The most effective form of therapy for cancer patients is complex multidisciplinary specialized disease management, including nephro-oncology care. Different forms of renal function impairment are frequently diagnosed in cancer patients. They are caused by different co-morbidities existing before starting the oncologic treatment as well as the direct undesirable effects of this therapy which may cause temporary or irreversible damage of the urinary system—especially kidneys. According to different therapeutic programs, in such cases the degree of renal damage is often crucial for the possibility of further anti-cancer treatment. Medical personnel responsible for delivering care to oncology patients should be properly educated on current methods of prevention and treatment of renal complications resulting from anti-cancer therapy. The development of oncologic medicines design, including especially immuno-oncological agents, obliges us to learn new patomechanisms determining potential adverse effects, including renal complications. This publication is focused on the most important undesirable nephrotoxic effects of the frequently used anti-cancer drugs. Full article

Over five million cases of skin cancer are diagnosed each year in the United States with melanoma the third most common cancer in young adults. While publications have shown that sunburns increase the risk of developing melanoma throughout the lifetime including in adolescence and adulthood showing the importance of altering sun exposing behaviors throughout the lifetime, use of sun protection in college students remails low. In Fall 2019, an online survey of undergraduate students living on campus at a large southwestern university was conducted to determine the frequency of recent sunburns as well as sun protective behaviors and perceived knowledge of and barriers to sun protection. Associations between knowledge, behaviors, and barriers with self-reported sunburn were evaluated using logistic regression. Over 46% of 458 students reported at least one sunburn in the past three months and 21% reported having multiple sunburns in that period. Furthermore, 53% reported that they intentionally tanned their skin outdoors occasionally or more frequently, while 6.4% reported using an indoor tanning bed occasionally or more. Adjusted for skin sensitivity, recent sunburn history was associated with higher tanning activity scores and with high agreement that tanning was attractive (p < 0.01). This information can inform a more targeted series of intervention programming on the university campus. Full article

Background: Type 2 Diabetes (DM2) and the consecutively daily use of antidiabetic medication are characterized by a frequent prevalence worldwide and were shown to impact the initiation and progression of malignant diseases. While these effects were observed in a variety of malignancies, comprehensive data about the role of DM2 and antidiabetic drugs in the outcome of head and neck melanoma (HNM) patients are missing. Methods: This retrospective population-based cohort study included 382 HNM patients from Eastern Bavaria having received tumor resection to negative margins between 2010 and 2017. Recurrence-free survival (RFS) was evaluated with regard to DM2 and routine metformin intake. Statistical analysis was performed by uni- and multivariate analyses. The median follow-up time was 5.6 years. Results: DM2 was diagnosed in 68 patients (17.8%), routine metformin intake was found in 39 cases (10.2%). The univariate survival analysis revealed impaired 5-year RFS in HNM patients with DM2 compared to non-diabetic controls (p = 0.016; 64.0% and 74.5%, respectively). The multivariate Cox regression substantiated this effect (HR = 1.980, 95% CI = 1.108–3.538, p = 0.021). In detail, the cumulative locoregional recurrence rate displayed the most far-reaching negative effect on the RFS of diabetic HNM patients (HR = 4.173, 95% CI = 1.628–10.697, p = 0.003). For metformin intake, a profound positive effect on the RFS in multivariate statistics was observed, both in the complete cohort (HR = 0.396, 95% CI = 0.177–0.884, p = 0.024) as well as in the cohort of diabetic HNM patients (HR = 0.352, 95% CI = 0.135–0.913, p = 0.032). Conclusions: This study emphasizes that DM2 is a relevant comorbid condition in HNM patients, impairing patient survival. Metformin intake was associated with a favorable outcome in HNM patients, providing possible therapeutic implications for future adjuvant treatment regimes. Full article

Background: Lung cancer (LC) is the leading cause of cancer-related mortality. In Ontario, Canada, there are significant survival differences for patients with newly diagnosed LC across the 14 provincial regions. Methods: A population-based retrospective cohort study using ICES databases from 01/2007–12/2017 identified patients with newly diagnosed LC through the Ontario Cancer Registry and those with LC as the cause of death. Descriptive data included patient, disease, and system characteristics. The primary outcome was 5-year survival by region. Results: 178,202 patient records were identified; 101,263 met inclusion criteria. LC incidence varied by region (5.6–14.6/10,000), as did histologic subtype (adenocarcinoma: 27.3–46.1%). Five-year cancer-specific survival was impacted by age, rurality, pathologic subtype, stage at diagnosis, and income quintile. Timely care was inversely related to survival (fastest quintile: HR 3.22, p < 0.0001). Adjusted 5-year cancer-specific survival varied across regions (24.1%, HR 1.12; 34.0%, HR 0.89, p < 0.001). Conclusions: When adjusting for confounders, differences in survival by health region persisted, suggesting a complex interplay between patient, disease, and system factors. A single approach to improving patient care is likely to be ineffective across different systems. Quality improvement initiatives to improve patient outcomes require different approaches amongst health regions to address local disparities in care. Full article

CDK4/6 inhibitors have revolutionized the treatment algorithm of luminal metastatic breast cancer, becoming the recommended first-line therapy in association with endocrine therapy. However, due to its theoretically greater and more rapid tumor shrinkage, the upfront use of chemotherapy is considered in some clinical situations like visceral crisis. At the state of the art level, a paucity of data is available about the use of CDK4/6 inhibitors in patients presenting with visceral crisis or with life-threatening conditions since this population was historically excluded from clinical trials. In addition, data regarding direct comparison between combinations of chemotherapy and CDK4/6 inhibitors in terms of efficacy, rapidity of responses and long-term outcomes are lacking. We report the case of a 68-year-old woman with luminal metastatic breast cancer presenting at diagnosis with a critical and potentially life-threatening condition. The patient was treated with first-line Abemaciclib plus letrozole and achieved a rapid partial response with sudden clinical stabilization. Although the patient did not technically present with a visceral crisis, this case presentation also endorsed the upfront use of CDK4/6 inhibitor combinations in critical clinical situations in the absence of severe organ dysfunction and after multidisciplinary discussion. Full article

Pretherapeutic serological parameters play a predictive role in pathologic risk factors (PRF), which correlate with treatment and prognosis in cervical cancer (CC). However, the method of pre-operative prediction to PRF is limited and the clinical availability of machine learning methods remains unknown in CC. Overall, 1260 early-stage CC patients treated with radical hysterectomy (RH) were randomly split into training and test cohorts. Six machine learning classifiers, including Gradient Boosting Machine, Support Vector Machine with Gaussian kernel, Random Forest, Conditional Random Forest, Naive Bayes, and Elastic Net, were used to derive diagnostic information from nine clinical factors and 75 parameters readily available from pretreatment peripheral blood tests. The best results were obtained by RF in deep stromal infiltration prediction with an accuracy of 70.8% and AUC of 0.767. The highest accuracy and AUC for predicting lymphatic metastasis with Cforest were 64.3% and 0.620, respectively. The highest accuracy of prediction for lymphavascular space invasion with EN was 59.7% and the AUC was 0.628. Blood markers, including D-dimer and uric acid, were associated with PRF. Machine learning methods can provide critical diagnostic prediction on PRF in CC before surgical intervention. The use of predictive algorithms may facilitate individualized treatment options through diagnostic stratification. Full article

The possibility of positive psychological changes after cancer, namely, posttraumatic growth, is a growing field of research. Identifying personality traits and coping strategies related to posttraumatic growth may help find vulnerable individuals as well as promote helpful coping strategies to help more patients make positive changes at an early stage. The aim of this systematic literature review is to provide an overview of the quantitative data on coping strategies and personality traits associated with posttraumatic growth in patients with cancer and cancer survivors as well as the methods used in included studies. A systematic literature search was conducted using five databases (PubMed, PubPsych, PsycInfo, Web of Science, and PSYNDEXplus). The 70 reports of included studies assessed posttraumatic growth using questionnaires in a sample of patients with cancer or survivors. In addition, associations with a personality trait or coping strategy had to be examined cross-sectionally or longitudinally. All 1698 articles were screened for titles and abstracts by two authors, after which disputed articles were reviewed by a third author. Afterwards, articles were screened for full texts. Most studies had a cross-sectional design and used a sample of patients with breast cancer. Coping strategies have been researched more than personality factors. The personality traits of resilience, hardiness, dispositional positive affectivity, and dispositional gratitude seem to be related to posttraumatic growth, while the Big Five personality traits (openness to experience, conscientiousness, extraversion, agreeableness, neuroticism) have been less researched and/or seem to be unrelated. The use of social support, religious coping, positive reframing, and reflection during illness as coping strategies seems to be related to posttraumatic growth. The findings can be used for the development of interventions. Future studies should investigate associations longitudinally. Full article

Purpose: This paper aims to evaluate the safety and efficacy of the temporary redirection of blood flow of hepatoenteric collaterals using a balloon catheter in the common hepatic artery (CHA) to prevent the nontarget deposition of ⁹⁰Y microspheres. Materials and Methods: In this retrospective single-center study of patients who received ⁹⁰Y radioembolization (RE) from September 2010 to September 2015, diagnostic (67 patients) or treatment (72 patients) angiograms with the attempted use of a balloon catheter in the CHA to temporarily direct blood flow away from the hepatoenteric arteries were analyzed. SPECT/CT nuclear scintigraphy was performed after both diagnosis and treatment. Results: Overall, only 12 hepatoenteric arteries in 11 patients required embolization due to persistent hepatoenteric flow despite the use of the balloon occlusion technique in a total of 86 patients. Physicians performed the ⁹⁰Y RE using balloon occlusion with glass (n = 22) or resin (n = 50) microspheres. Over 80% administration of the prescribed ⁹⁰Y dose was accomplished in 34 (67%) resin and 20 (95%) glass microsphere patients. Post-treatment ⁹⁰Y RE scintigraphy confirmed the absence of extrahepatic activity in all patients. One grade 2 gastrointestinal ulcer was present after 90 days of follow-up. Conclusion: Temporary CHA occlusion with a balloon catheter is a reliable and reproducible alternative to the conventional coil embolization of hepatoenteric arteries during diagnostic Tc-99m macroaggregated albumin and therapeutic ⁹⁰Y RE delivery. Full article

Background: The Canadian Blood Services Cord Blood Bank (CBS CBB) was created to improve access to stem cell products for transplantation for patients across ethnic groups. An analysis of distributed units is needed to assess the effectiveness of the bank to meet the needs of patients from different ethnic groups. Methods: A descriptive analysis was performed on all cord blood units distributed from the CBS’ CBB as of 30 June 2022. Results: Distribution of the first 60 units based on CBS’ CBB inventory has been linear over time. A similar proportion of cord blood unit (CBU) recipients were pediatric or adult. More than half of the cord blood units (56.7%) were distributed to recipients outside of Canada, and CBUs were used to treat a broad range of hematologic and immune disorders. 43.3% of distributed CBUs were of non-Caucasian ethnicity and 18% were from donors self-reporting as multi-ethnic. The mean total nucleated cell counts and total CD34⁺ cell counts were 1.9 ± 0.1 × 10⁹ cells and 5.3 ± 0.5 × 10⁶ CD34⁺ cells, respectively. CD34⁺ cells per kg (recipient weight) varied significantly between pediatric (age 0–4), adolescent (age 5–17) and adult recipients (age 18 and older) (3.1 ± 0.5, 1.4 ± 0.5 and 0.9 ± 0.07 × 10⁵ CD34⁺ cells/kg, respectively). HLA matching was 6/6 (15%), 5/6 (47%) or 4/6 (38%). Conclusions: The CBS’ CBB has facilitated the utilization of banked units for patients across a broad range of ages, geographic distribution, ethnicity, and diseases. Distributed units were well matched for HLA alleles and contained robust cell counts, reflecting a high-quality inventory with significant utility. Full article

A positive surgical margin (PSM) is reported to have some connection to the occurrence of biochemical recurrence and tumor metastasis in prostate cancer after the operation. There are no clinically usable models and the study is to predict the probability of PSM after robot-assisted laparoscopic radical prostatectomy (RALP) based on preoperative examinations. It is a retrospective cohort from a single center. The Lasso method was applied for variable screening; logistic regression was employed to establish the final model; the strengthened bootstrap method was adopted for model internal verification; the nomogram and web calculator were used to visualize the model. All the statistical analyses were based on the R-4.1.2. The main outcome was a pathologically confirmed PSM. There were 151 PSMs in the 903 patients, for an overall positive rate of 151/903 = 16.7%; 0.727 was the adjusted C statistic, and the Brier value was 0.126. Hence, we have developed and validated a predictive model for PSM after RALP for prostate cancer that can be used in clinical practice. In the meantime, we observed that the International Society of Urological Pathology (ISUP) score, Prostate Imaging Reporting and Data System (PI-RADS) score, and Prostate-Specific Antigen (PSA) were the independent risk factors for PSM. Full article

Purpose: To review the successes and challenges of integrating systematic reviews (SRs) into the Rethinking Clinical Trials (REaCT) Program. Methods: All REaCT program SRs were evaluated and descriptive summaries presented. Results: Twenty-two SRs have been performed evaluating standard of care interventions for the management of: breast cancer (n = 15), all tumour sites (n = 4), breast and prostate cancers (n = 2), and prostate cancer (n = 1). The majority of SRs were related to supportive care (n = 14) and survivorship (n = 5) interventions and most (19/22, 86%) confirmed the existence of uncertainty relating to the clinical question addressed in the SR. Most SRs (15/22, 68%) provided specific recommendations for future studies and results were incorporated into peer-reviewed grant applications (n = 6) and clinical trial design (n = 12). In 12/22 of the SRs, the first author was a trainee. All SRs followed PRISMA guidelines. Conclusion: SRs are important for identifying and confirming clinical equipoise and designing trials. SRs provide an excellent opportunity for trainees to participate in research. Full article

Multiple myeloma (MM) is a complex disease driven by numerous genetic and epigenetic alterations that are acquired over time. Despite recent progress in the understanding of MM pathobiology and the availability of innovative drugs, which have pronounced clinical outcome, this malignancy eventually progresses to a drug-resistant lethal stage and, thus, novel therapeutic drugs/models always play an important role in effective management of MM. Modulation of tumor microenvironment is one of the hallmarks of cancer biology, including MM, which affects the myeloma genomic architecture and disease progression subtly through chromatin modifications. The bone marrow niche has a prime role in progression, survival, and drug resistance of multiple myeloma cells. Therefore, it is important to develop means for targeting the ecosystem between multiple myeloma bone marrow microenvironment and chromatin remodeling. Extensive gene expression profile analysis has indeed provided the framework for new risk stratification of MM patients and identifying novel molecular targets and therapeutics. However, key tumor microenvironment factors/immune cells and their interactions with chromatin remodeling complex proteins that drive MM cell growth and progression remain grossly undefined. Full article

The standard of care for early-stage cervix cancer is radical hysterectomy with pelvic lymphadenectomy. Adjuvant radiotherapy (RT) or chemoradiotherapy may be administered to reduce the risk of recurrence in patients considered to be at elevated risk based on a combination of pathologic factors. We performed a retrospective review to determine oncologic outcomes in patients treated for early-stage cervix cancer and to determine if surgical approach impacted oncologic outcomes or the decision to use adjuvant therapy. In total, 174 women underwent radical hysterectomy and pelvic lymphadenectomy over the 15-year period. Most of these women (146) had open surgery and 28 had minimally invasive surgery (MIS). In total, 81 had adjuvant pelvic RT; 76 in the open surgery group (52%) and 5 in the MIS group (18%). Five-year PFS and OS, respectively, were 84% and 91%. Five-year PFS was significantly lower in patients who had MIS vs. open surgery, without a difference in 5-year OS, suggesting MIS should be avoided. Five-year PFS was the same with RT or with its omission, despite those treated with RT having higher risk disease. We have demonstrated excellent outcomes in patients with early-stage cervix cancer after primary surgery and selective use of RT, with few recurrences and excellent survival. Full article

In recent years, significant changes have occurred in metastatic hormone-sensitive prostate cancer (mHSPC) management, where docetaxel and new androgen receptor pathway inhibitors (ARPI) have been shown to improve overall survival (OS) compared to androgen deprivation therapy (ADT). Recent data could once again radically change mHSPC treatment. PEACE-1 and ARASENS trials demonstrated a survival benefit of the addition of ARPI to docetaxel and ADT combination (triplet therapy), compared to docetaxel and ADT. With multiple options to choose from, it is crucial to identify the patients who would benefit most from triplet therapy. In this meta-analysis, we evaluated the activity of the triplet therapy versus docetaxel plus ADT in mHSPC. A systematic review of PubMed/Medline, Embase, and the proceedings of major international meetings was performed. Five RCTs fulfilled the inclusion criteria. PEACE-1 and ARASENS studies reported disease-free survival (DFS) and OS. Post hoc analysis of three other trials evaluated the combination of ARPI, docetaxel and ADT. Globally, 2538 patients were included (1270 triplet therapy; 1268 docetaxel + ADT). Triplet therapy was associated with improved OS (hazard ratio (HR) 0.74; 95% confidence interval (CI), 0.66–0.83, p < 0.00001). A statistically significant benefit was shown in high-volume mHSPC patients (HR 0.76; 95% CI 0.59–0.97, p = 0.03) and in patients with de novo metastatic disease (HR 0.73; 95% CI, 0.64–0.82, p < 0.00001). The addition of ARPI to standard therapy was associated with DFS improvement (HR 0.41; 95% CI, 0.35–0.49, p < 0.00001). This metanalysis shows a significant OS benefit from concomitant administration of ARPI, docetaxel and ADT in high volume and de novo mHSPC. Full article