A plain language summary of patient preferences for treatments for multiple myeloma that has relapsed or is refractory to prior therapy
A multicenter, observational study to evaluate the safety of restarting antitumor therapy recovered from COVID-19
Cancer patients face a higher risk of adverse effects from coronavirus disease 2019 (COVID-19) compared to the general population. However, the safety of restarting antitumor therapy following COVID-19 recovery remains unclear.
BREAKWATER Phase III: results for encorafenib and cetuximab plus mFOLFOX6 in first-line V600E-mutant metastatic colorectal cancer
The BREAKWATER Phase III study investigated encorafenib and cetuximab plus mFOLFOX6 versus chemotherapy with or without bevacizumab for the treatment of patients with previously untreated V600E - mutant metastatic colorectal cancer. The study showed significantly improved objective response rate by blinded independent central review, and significantly longer progression-free survival by blinded independent central review and overall survival in patients treated with first-line encorafenib and cetuximab plus mFOLFOX6 compared with chemotherapy with or without bevacizumab. The safety profiles were consistent with those known for each agent. These results led to the approval of encorafenib and cetuximab plus mFOLFOX6 for the treatment of V600E-mutant metastatic colorectal cancer, including in the first line. This paradigm shift in metastatic colorectal cancer highlights the importance for early genomic testing to identify patients who would benefit from this new treatment option. We discuss the results from BREAKWATER - including progression-free survival by blinded independent central review, overall survival, objective response rate by blinded independent central review in all participants, and safety - and the meaning of these results for clinical practice as a new treatment option and the need for earlier genomic testing.: www.clinicaltrials.gov identifier is NCT04607421.
Real-world treatment patterns and attrition for non-driver mutation metastatic non-small cell lung cancer in the US
Programmed cell death protein-1/ligand-1 (PD-1/PD-L1) inhibitors (PD-[L]1) are standard of care for patients with metastatic non-small cell lung cancer (mNSCLC). This study examined real-world treatment patterns and attrition by lines of therapy (LOTs) among patients with non-driver mutation mNSCLC.
A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract
Real-world treatment and utilization of venetoclax for incident acute myeloid leukemia in a Medicare population
This study aimed to describe first-line venetoclax in the Medicare population and its impacts on treatment patterns, utilization, and costs.
Ponatinib in the treatment of acute lymphoblastic leukemia
Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) was historically associated with a very poor prognosis in the pre-tyrosine kinase inhibitors (TKIs) era. While consolidation with allogeneic hematopoietic cell transplantation (HCT) was associated with improved outcomes in patients with Ph+ ALL treated with chemotherapy alone, the advent of -targeting TKIs revolutionized the therapeutic landscape, enhancing response rates, increasing the proportion of patients proceeding to HCT, and improving survival. Compared to earlier generation TKIs, ponatinib, a third-generation TKI, is more potent and overcomes a broader array of preexisting and emerging resistant mutations, and clinical studies have illustrated superiority in attaining a negative measurable residual disease (MRD) state, leading to excellent long-term survival outcomes, even without the application of consolidative allogeneic HCT. Ponatinib has been successfully integrated into various treatment regimens, including both low- and high-intensity chemotherapy regimens, and in combination with blinatumomab, for adult patients with newly diagnosed Ph+ ALL. Herein, we summarize landmark trials, specifically their efficacy and toxicity profile, that established ponatinib as a standard of care for patients with newly diagnosed Ph+ ALL who are suitable medically for it.
ALIDHE phase 3b study design: ivosidenib + azacitidine in adults with newly diagnosed mutant acute myeloid leukemia
Ivosidenib is an inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1) that is approved alone or in combination with azacitidine in patients with mIDH1 acute myeloid leukemia (AML) that are ineligible to receive intensive chemotherapy.
Clinical outcomes and healthcare resource use in triple-class exposed patients with relapsed/refractory multiple myeloma
Immunomodulatory drugs (IMiDs), proteasome inhibitors, and monoclonal antibodies (MAbs) alone or in combination form the backbone of multiple myeloma (MM) treatment, yet MM remains incurable requiring further lines of therapy (LOT). This study investigated real-world treatment patterns, clinical outcomes, and healthcare utilization among triple-class exposed (TCE) patients initiating subsequent LOTs.
Trends in initial primary treatment approach and biomarker testing across social determinants of health in early-stage non-small cell lung cancer
To evaluate the impact of a comprehensive set of social determinants of health (SDOH) on treatments, timing, and key biomarker testing for early-stage non-small cell lung cancer (NSCLC).
Trastuzumab deruxtecan in the treatment of HER2-positive gastric cancer: a comprehensive review
Trastuzumab deruxtecan (T-DXd), a human epidermal growth factor receptor 2 (HER2)-targeted antibody - drug conjugate with a potent topoisomerase I inhibitor payload, has addressed considerable unmet needs in advanced HER2-positive gastric cancer or gastroesophageal junction cancer (GC/GEJC), particularly among patients showing disease progression following trastuzumab-based therapy. The present review summarizes the clinical development, real-world management, and future directions of T-DXd. The superiority of T-DXd was first demonstrated in the DESTINY-Gastric01 trial and subsequently confirmed in the recent global phase III DESTINY-Gastric04 trial, where it showed remarkable efficacy over chemotherapy, establishing it as the second-line standard of care. However, this efficacy must be balanced against its distinct safety profile, with interstitial lung disease representing most critical adverse event requiring vigilant monitoring and proactive management. Resistance mechanisms, including decreased HER2 expression and impaired internalization, remained the important challenges to overcome. Ongoing studies are exploring the role of T-DXd in first-line treatments, HER2-low tumors, and perioperative settings, with the aim of further expanding its therapeutic applications. These efforts hold promise for broadening the clinical utility of T-DXd and redefining the treatment algorithms for a wider population of GC/GEJC patients.
Patient involvement in the design of ALIDHE: a study of ivosidenib + azacitidine in newly diagnosed mutant AML
The ALIDHE study aims to supplement previous clinical trial data by evaluating the safety and tolerability of ivosidenib + azacitidine in adult patients with newly diagnosed mutant isocitrate dehydrogenase acute myeloid leukemia (AML).
A plain language summary of the EORTC 1333/PEACE-3 study of enzalutamide alone vs enzalutamide plus radium-223 in patients with metastatic castrationresistant prostate cancer (mCRPC) and bone metastases
Datopotamab deruxtecan versus docetaxel for non-small cell lung cancer: a plain language summary of the TROPION-Lung01 study
LIVER-R study protocol: a global real-world study of durvalumab-based regimens in patients with hepatobiliary cancers
Durvalumab-based regimens have improved outcomes compared with standard of care in unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancer (aBTC) clinical trials. Here we describe the protocol for the LIVER-R study, which will evaluate long-term outcomes with durvalumab-based regimens in patients with hepatobiliary cancers in real-world settings.
Trastuzumab deruxtecan in HER2-positive stomach or gastroesophageal junction cancer: a plain language summary of the DESTINY-Gastric02 study
Long-term safety and effectiveness of ruxolitinib in Japanese patients with polycythemia vera: a post-marketing study
This study evaluated the long-term safety and effectiveness of ruxolitinib in Japanese patients with polycythemia vera in clinical practice.
Osimertinib before and after chemoradiotherapy for unresectable stage III EGFR-mutated NSCLC: NEOLA Trial Protocol
ClinicalTrials.gov identifier is NCT06194448 (date of registration 5 January 2024).
Study design and rationale for the NeoTRACE trial: a multicenter phase II study of neoadjuvant sacituzumab govitecan plus zimberelimab followed by adjuvant zimberelimab with or without sacituzumab govitecan in patients with resectable non-small cell lung cancer
Perioperative chemoimmunotherapy improves pathological complete response (pCR), EFS, and OS in patients with resectable NSCLC versus chemotherapy, as shown in several phase-III-trials. However, approximately 17-22% of patients did not proceed to surgery, partly due to toxicity, highlighting the need for more efficacious and tolerable regimens. NeoTRACE is a phase II, multicenter, single-arm study to evaluate neoadjuvant sacituzumab govitecan (SG) and the PD-1 inhibitor zimberelimab (ZIM) in resectable stage II to IIIB (N2) NSCLC with no known EGFR/ALK alterations. The trial plans to enroll 50 participants, with neoadjuvant treatment administered for four cycles before resection, followed by adjuvant ZIM with/without SG at the physicians' discretion. The primary endpoint is the rate of pCR in tumor and lymph nodes. Secondary endpoints include major pathological response, surgical resection rate, disease-free survival, OS, safety, and quality of life. The study also explores circulating tumor DNA (ctDNA) dynamics, TROP2 expression, and spatial transcriptomics to identify biomarkers. NeoTRACE assesses a platinum-sparing approach in resectable NSCLC. Previous studies showed ADC and immunotherapy combinations are effective in advanced NSCLC, suggesting potential perioperative benefit. This study aims to improve pCR rate, reduce toxicity, enhance surgical eligibility, and personalize adjuvant treatment to improve long-term outcomes.: EudraCT: 2024-517561-16.
Combination of pan-immune-inflammation value and frailty index predicts the outcomes of elderly nasopharyngeal carcinoma treated by concurrent chemoradiotherapy
Nasopharyngeal carcinoma (NPC) is increasingly diagnosed in elderly populations. However, prognostic tools that incorporate both tumor biology and host vulnerability remain limited.
A deep learning radiomics model for predicting non-sentinel lymph node metastases in early-stage breast cancer patients
To develop and validate a deep learning radiomics model to predict non-sentinel lymph node (NSLN) metastases in early-stage breast cancer patients with 1-2 positive sentinel lymph node (SLN) metastases.
