ABSTRACT

INTRODUCTION: This open-label, phase 3 trial (ALTA-3; NCT03596866) compared efficacy and safety of brigatinib versus alectinib for ALK+ NSCLC after disease progression on crizotinib.

METHODS: Patients with advanced ALK+ NSCLC that progressed on crizotinib were randomized 1:1 to brigatinib 180 mg once daily (7-day lead-in, 90 mg) or alectinib 600 mg twice daily, aiming to test superiority. The primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS). Interim analysis for efficacy and futility was planned at approximately 70% of 164 expected PFS events.

RESULTS: The population (N=248; brigatinib, n=125; alectinib, n=123) was notable for long median duration of prior crizotinib (16.0-16.8 months) and low rate of ALK fusion in baseline circulating tumor DNA (ctDNA; 78/232 [34%]). Median BIRC-assessed PFS was 19.3 months with brigatinib and 19.2 months with alectinib (hazard ratio: 0.97 [95% confidence interval [CI]: 0.66-1.42]; p=0.8672]). The study met futility criterion. Overall survival was immature (41 events [17%]). Exploratory analyses pooled across treatment groups demonstrated median PFS of 11.1 versus 22.5 months in patients with versus without ctDNA-detectable ALK fusion at baseline (hazard ratio: 0.48 [95% CI: 0.32-0.71]). Treatment-related adverse events in >30% of patients (brigatinib/alectinib) were elevated blood creatine phosphokinase (70%/29%), aspartate aminotransferase (53%/38%), and alanine aminotransferase (40%/36%).

CONCLUSION: Brigatinib was not superior to alectinib for PFS in crizotinib-pretreated ALK+ NSCLC. Safety was consistent with the well-established and unique profiles of each drug. The low proportion of patients with ctDNA-detectable ALK fusion may account for prolonged PFS with both drugs in ALTA-3.

PMID:37574132 | DOI:10.1016/j.jtho.2023.08.010

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PubMed articles on: Cancer & VTE/PE

Commentary on the 2023 ASH guidelines for thrombophilia testing in VTE

Blood Adv. 2023 Aug 15:bloodadvances.2023011393. doi: 10.1182/bloodadvances.2023011393. Online ahead of print.

NO ABSTRACT

PMID:37581979 | DOI:10.1182/bloodadvances.2023011393

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PubMed articles on: Cancer & VTE/PE

Venous thromboembolism in multiple myeloma: Increasing evidence in support of direct oral anticoagulants

Br J Haematol. 2023 Aug 15. doi: 10.1111/bjh.19056. Online ahead of print.

ABSTRACT

Venous thromboembolism (VTE) continues to cause significant morbidity and excess mortality in patients with multiple myeloma. The report by Costa and colleagues demonstrates superiority of direct oral anticoagulants over aspirin in terms of VTE prevention, without increased bleeding complications seen. Commentary on: Costa et al. Direct oral anticoagulants versus aspirin for primary thromboprophylaxis in patients with multiple myeloma undergoing outpatient therapy: A systematic review and updated meta-analysis. Br J Haematol 2023 (Online ahead of print). doi: 10.1111/bjh.19017.

PMID:37581247 | DOI:10.1111/bjh.19056

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PubMed articles on: Cancer & VTE/PE

Giant breast phyllodes tumor with silent thromboembolism: A case report

Cancer Rep (Hoboken). 2023 Aug 14:e1865. doi: 10.1002/cnr2.1865. Online ahead of print.

ABSTRACT

BACKGROUND: Phyllodes tumor (PT) is a solid fibroepithelial breast lesion with proliferation of stromal and epithelial elements, usually presents with a rapidly expanding feature. Venous thromboembolism (VTE) have been reported to increase the burden in terms of mortality and morbidity of malignant tumor, and associate with worsened survival. However, benign PTs with silent thromboembolism that have not yet been reported, we report an unusual case of massive benign PT that grew on the left side of the breast in a cauliflower-shaped form and presented severe chronic blood loss and deep VTE.

CASE: A 37-year-old woman with uncontrolled pain presented a rapidly enlarging left breast mass, measuring approximately 30 × 20 × 15 cm3 that first started 25 years ago. color Doppler ultrasound showed a large mass lesion on the left breast and deep VTE, several enlarged lymph nodes in the left axilla and mediastinum, which presented a malignant character. However, the biopsies of the mass did not show evidence of malignancy and the pathology result was considered to be benign PT. The patient was treated with an inferior vena cava and anticoagulation, the operation was arranged according to the surgical procedure, the patient recovered very well after mastectomy.

CONCLUSION: This case is unique in that the giant breast mass presented with malignant character, was eventually pathologically confirmed to be benign PT, and it's rare that the benign tumor accompanied with silent thromboembolism. This finding describes the atypia features of giant benign PT and reminds the surgeon to consider the factor of VTE and risk when encountering ulcerative benign breast tumor and avoid excessive treatment.

PMID:37580942 | DOI:10.1002/cnr2.1865

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Venous thromboembolism and acute myeloid leukemia: risk factors and mortality in elderly white, black and Asian patients

Blood Coagul Fibrinolysis. 2023 Jul 7. doi: 10.1097/MBC.0000000000001226. Online ahead of print.

ABSTRACT

Risk factors for venous thromboembolism (VTE) in elderly patients with acute myeloid leukemia (AML) are not known by race. The aim of this study was to determine the association of VTE with known risk factors and the impact of VTE on mortality in elderly white, black and Asian patients with AML. The merged SEER-Medicare database (2000-2015) was used for patients aged at least 65 years diagnosed with AML. Multivariable logistic regression was used to examine the association of VTE with known risk factors and Cox proportional hazards regression was used to evaluate the association of VTE with mortality in white, black and Asian patients. Among 21 403 AML patients aged at least 65years, VTE was diagnosed in 10.6% of 18 731 white patients, 13.4% of 1362 black and 5.6% of 1310 Asian patients. Overall, the adjusted risk of VTE in black patients was similar to white patients, but Asian patients had a lower risk of VTE. Risk factors for VTE in white patients were age less than 75 years, female sex, chemotherapy and comorbid medical conditions, including hypertension, anemia, chronic kidney and lung disease, hyperlipidemia, heart failure and obesity. In black patients, hyperlipidemia, and heart failure and in Asian patients, age less than 75 years, female sex, chemotherapy and hypertension and myocardial infarction were associated with VTE. Central venous catheter placement was a predictor of VTE in all three races. Our study identified risk factors for VTE by race in elderly white, black and Asian AML patients.

PMID:37577858 | DOI:10.1097/MBC.0000000000001226

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Risk factors for pulmonary embolism in lung cancer patients with lower limb deep venous thrombosis: a case-control study

Transl Lung Cancer Res. 2023 Jul 31;12(7):1539-1548. doi: 10.21037/tlcr-23-346. Epub 2023 Jul 19.