Publications by authors named "Primo Lara"
Article Synopsis
- A study explored the relationship between body mass index (BMI) and overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), finding that higher BMI may lead to better survival outcomes.
- Out of 1,279 patients analyzed from the SWOG-1216 trial, survival rates increased with higher BMI categories, with the median OS being longest in the obese group at 6.8 years.
- The analysis suggests that these findings, indicating a lower risk of death among patients with higher BMI, need further validation in additional clinical trials.
Article Synopsis
- In men with metastatic hormone-sensitive prostate cancer (mHSPC), new treatments help many live longer, but how well each person does can be really different.
- Researchers are looking at a blood test that counts tiny cancer cells (CTCs) to see if it can help predict a patient’s survival.
- They studied 503 men to see if the number of CTCs in their blood was linked to how long they lived and how well their treatment worked.
Article Synopsis
- Pembrolizumab is an effective adjuvant therapy for patients with high-risk clear cell renal cell carcinoma (ccRCC) after surgery, particularly in those with completely resected metastatic disease (M1 NED), improving disease-free survival and overall survival compared to other treatments.
- A systematic review of trials up to January 2024 identified 9 studies that demonstrated that, aside from pembrolizumab, other adjuvant therapies did not significantly enhance survival for M1 NED patients following metastasectomy.
- The findings suggest that future research should focus on identifying which specific M1 NED patients may benefit most from adjuvant treatment, as the benefits of therapies other than pembrolizumab remain unclear.
JCO Mesenchymal-epithelial transition (MET) signaling pathway plays a role in the pathogenesis of selected patients with papillary renal cell carcinoma (PRCC). In the phase II PAPMET trial (ClinicalTrials.gov identifier: NCT02761057), cabozantinib significantly prolonged progression-free survival and improved objective response rate compared with sunitinib in patients with advanced PRCC.
View Article and Find Full Text PDFImportance: Clinical trial data on adjuvant therapy in patients with non-clear cell renal cell carcinoma (RCC) are scant.
Objective: To evaluate the effect of adjuvant everolimus after nephrectomy on recurrence-free survival (RFS) and overall survival (OS) in patients with localized papillary and chromophobe RCC.
Design, Setting, And Participants: This prespecified subgroup analysis of a phase 3 randomized clinical trial, EVEREST, included patients enrolled between April 1, 2011, and September 15, 2016.
Background: Immunotherapy-based combinations have emerged as standard therapies for patients with metastatic renal cell carcinoma (mRCC). Pembrolizumab, a PD-1 inhibitor, combined with epacadostat, an indoleamine 2,3-deoxygenase 1 selective inhibitor, demonstrated promising antitumor activity in a phase 1 study in advanced solid tumors, including mRCC.
Methods: KEYNOTE-679/ECHO-302 was a randomized, open-label, parallel-group, multicenter, phase 3 study (NCT03260894) that compared pembrolizumab plus epacadostat with sunitinib or pazopanib as first-line treatment for mRCC.
Objective: To evaluate the clinical significance of subtyping (type 1 vs 2) of papillary renal cell carcinoma (PRCC) in patients treated with targeted therapy, as well as the concordance, sensitivity and positive predictive value (PPV) of local review pathology review.
Methods: Patients with advanced refractory PRCC were randomised to receive sunitinib or cabozantinib, crizotinib or savolitinib, stratified by PRCC subtype (type 1, type 2, or not otherwise specified [NOS]/mixed) by local review. Central review was retrospectively conducted by three expert genitourinary pathologists who independently reviewed cases.
Article Synopsis
- Bone pain at diagnosis significantly impacts overall survival in patients with metastatic hormone-sensitive prostate cancer (MHSPC), with limited existing data on this relationship.
- The analysis focused on data from a phase 3 clinical trial, SWOG-1216, involving patients diagnosed with MHSPC, comparing outcomes based on the presence or absence of baseline bone pain.
- Out of 1279 participants, 23.5% reported baseline bone pain, revealing a need for further study on how pain influences survival outcomes and treatment effectiveness.
Purpose: Cabozantinib and nivolumab (CaboNivo) alone or with ipilimumab (CaboNivoIpi) have shown promising efficacy and safety in patients with metastatic urothelial carcinoma (mUC), metastatic renal cell carcinoma (mRCC), and rare genitourinary (GU) tumors in a dose-escalation phase I study. We report the final data analysis of the safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) of the phase I patients and seven expansion cohorts.
Methods: This is an investigator-initiated, multicenter, phase I trial.
Article Synopsis
- The study investigated the effectiveness of nivolumab, an immunotherapy drug, used before and after surgery in patients with high-risk renal cell carcinoma compared to traditional surgery alone.
- It was a randomized phase 3 trial involving 819 patients across multiple sites in the US and Canada, who were assigned to either the nivolumab plus surgery group or surgery only group.
- The primary outcome measured was recurrence-free survival, with safety being assessed for all patients who started treatment, and the trial has been officially closed to new participants.
Article Synopsis
- The EVEREST trial investigated the effectiveness of adjuvant everolimus in patients with intermediate-high to very high risk of recurrence after kidney cancer surgery, showing a significant improvement in recurrence-free survival (RFS) but not in overall survival (OS).
- Of the 699 patients analyzed with very high-risk clear cell histology, those taking everolimus experienced a notable increase in RFS (HR 0.80) compared to placebo, although a high percentage (47%) of patients on everolimus discontinued treatment due to side effects.
- While everolimus improved RFS, the lack of statistically significant OS benefits suggests that further examination is needed to assess its long-term survival impact
Article Synopsis
- The study investigates how changes in prostate-specific antigen (PSA) levels at 3 and 7 months of androgen deprivation therapy (ADT) relate to overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
- Results show that a complete response (CR) in PSA at both 3 and 7 months significantly correlates with improved overall survival compared to no response, with specific statistical measures supporting this association.
- The findings suggest that monitoring PSA levels can help identify patients at higher risk of death, aiding in treatment decisions and the design of future clinical trials.
Background: Circulating biomarkers of bone metabolism are significantly associated with overall survival (OS) in men with advanced prostate cancer. In the SWOG S1216 phase III trial, we showed that elevated bone biomarkers are significantly associated with an increased risk of death in hormone-sensitive prostate cancer (HSPC) regardless of the status of bone metastases, identifying three risk groups with differential OS outcomes based on bone biomarker status. Here we report the association of bone biomarkers with OS in men with HSPC and documented skeletal metastases as part of a planned subset analysis of S1216.
View Article and Find Full Text PDFThe NCCN Guidelines for Kidney Cancer provide multidisciplinary recommendations for diagnostic workup, staging, and treatment of patients with renal cell carcinoma (RCC). These NCCN Guidelines Insights focus on the systemic therapy options for patients with advanced RCC and summarize the new clinical data evaluated by the NCCN panel for the recommended therapies in Version 2.2024 of the NCCN Guidelines for Kidney Cancer.
View Article and Find Full Text PDFArticle Synopsis
- Scientists are researching special molecules called microRNAs (miRNAs) to help treat lung cancer.
- They found three specific miRNAs, miR-22-3p, miR-9-5p, and miR-218-5p, that can stop cancer cells from growing by messing with how the cells use nutrients like folate.
- Among these, miR-22-3p was most effective in shrinking tumors in mice without causing harm, helping researchers understand how to use these miRNAs in future cancer treatments.
Importance: Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compared with White patients, possibly because of equitable access to care available in a clinical trial setting.
Objective: To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.
Article Synopsis
- The study investigated the effectiveness of everolimus, a drug that inhibits the mammalian target of rapamycin, in preventing disease relapse in patients who had surgery for renal cell carcinoma.
- Conducted as a randomized, double-blind trial, 1545 adult participants at high risk of recurrence were assigned to receive either everolimus or a placebo after their surgery, with a focus on measuring recurrence-free survival over a median follow-up of 76 months.
- Results showed that everolimus improved recurrence-free survival (5-year rates of 67% vs. 63%) but did not reach the statistical significance needed, while it was particularly beneficial for those in the very-high-risk category, although it was associated with significantly more
Unlabelled: Systemic targeted therapy in prostate cancer is primarily focused on ablating androgen signaling. Androgen deprivation therapy and second-generation androgen receptor (AR)-targeted therapy selectively favor the development of treatment-resistant subtypes of metastatic castration-resistant prostate cancer (mCRPC), defined by AR and neuroendocrine (NE) markers. Molecular drivers of double-negative (AR-/NE-) mCRPC are poorly defined.
View Article and Find Full Text PDFA survey of clinical research professionals @SWOG indicate that 80% of clinical trial offices are understaffed. Addressing this is critical so progress for people with cancer continues. Read more about lessons learned in the #COVID19 pandemic and how it informs a path forward.
View Article and Find Full Text PDFBackground: Bone biomarkers are strongly prognostic for overall survival (OS) in men with castration-resistant prostate cancer but not fully established for hormone-sensitive prostate cancer (HSPC).
Objective: Bone biomarkers in HSPC were prospectively evaluated as part of a phase 3 study of androgen deprivation therapy ± the CYP17 inhibitor orteronel.
Design, Setting, And Participants: Patients were randomly divided into training (n = 316) and validation (n = 633) sets.
The ataxia telangiectasia and Rad3-related (ATR) checkpoint kinase 1 (CHK1) pathway is intricately involved in protecting the integrity of the human genome by suppressing replication stress and repairing DNA damage. ATR is a promising therapeutic target in cancer cells because its inhibition could lead to an accumulation of damaged DNA preventing further replication and division. ATR inhibition is being studied in multiple types of cancer, including advanced urothelial carcinoma where there remains an unmet need for novel therapies to improve outcomes.
View Article and Find Full Text PDF