Evaluation of the N Latex free light chain assay in the diagnosis and monitoring of AL amyloidosis

Mollee, Peter; Tate, Jill; Pretorius, Carel J.

doi:10.1515/cclm-2013-0361

Cited by 25 publications

(22 citation statements)

References 17 publications

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“…Overall response rates/CR rates in patients with high vs low baseline dFLC (.124.2 vs #124.2 mg/L, cutoff per the median baseline dFLC) after cycles 1, 2, and 4, and at EOT were 39%/3% vs 40%/9%, 50%/ 8% vs 52%/18%, 70%/5% vs 54%/21%, and 43%/18% vs 58%/32%, respectively (Table 3). Similar results were obtained using baseline dFLC cutoffs of 180 (previously validated to be of prognostic importance in AL) 27 and 50 mg/L (per the definition of measurable disease in AL) 28 (supplemental Table 2). Ongoing on treatment, n 1 1 2 ‡ Alive, n (%) 11 (61) 22 (65) 9 (50) KPS, Karnofsky performance status.…”

Section: Response To Treatmentsupporting

confidence: 75%

“…Higher overall and complete response rates at EOT were observed in patients with low vs high baseline dFLC (using 3 different cutoffs for patient dichotomization: 124. 28 ) and high vs low percentage dFLC decrease at the end of cycle 1 (using cutoffs for patient dichotomization of 59% [median] and 50% [validated cutoff defining dFLC PR] 29 ). The former association may reflect a deeper impact of treatment in patients with lower disease burden at baseline.…”

Section: Discussionmentioning

confidence: 99%

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Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis

Reece

Hegenbart

Sanchorawala

et al. 2014

Blood

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• Single-agent bortezomib produces durable hematologic responses and promising long-term overall survival in relapsed AL patients.• Once-weekly bortezomib is better tolerated and produces similar responses to twiceweekly bortezomib in relapsed AL patients.CAN2007 was a phase 1/2 study of once-and twice-weekly single-agent bortezomib in relapsed primary systemic amyloid light chain amyloidosis (AL) amyloidosis. Seventy patients were treated, including 18 and 34 patients at the maximum planned doses on the once-and twice-weekly schedules. This prespecified final analysis provides mature response and long-term outcomes data after 3-year additional follow-up since the last report. In the once-weekly 1.6 mg/m 2 and twice-weekly 1.3 mg/m 2 bortezomib groups, final hematologic response rates were 68.8% and 66.7%; 80% of patients in each group sustained their response for ‡1 year. One-year progression-free rates were 72.2% and 76.8%. Median overall survival (OS) was 62.1 months and not reached; 4-year OS rates were 75.0% and 63.0%. Low baseline difference in k/l free light-chain level was associated with higher hematologic complete response rates and longer OS. At data cutoff, 40 (57%) patients had received subsequent therapy, including 19 (27%) retreated with bortezomib, 11 (58%) of whom achieved complete or partial hematologic responses. Four patients received prolonged bortezomib for between 3.5 and 5.6 years, with no new safety concerns, highlighting the feasibility of long-term therapy. Single-agent bortezomib produced durable hematologic responses and promising long-term OS in relapsed AL amyloidosis. This trial was registered at www.clinicaltrials.gov as #NCT00298766. (Blood. 2014;124(16):2498-2506 IntroductionPrimary systemic amyloid light chain amyloidosis (AL) is a protein misfolding disorder in which a clonal plasma cell dyscrasia results in excessive production of abnormal immunoglobulin light chains.1-4 Extracellular deposition and toxicity of these fibril-forming abnormal light chains can lead to end-organ damage, particularly in the kidneys and heart, 1-4 and death. Suppression of the plasma cell dyscrasia and reduction or elimination of the production of amyloidogenic immunoglobulin light chains is the aim of AL treatment.1 Amyloid deposits can be resorbed and organ function restored on elimination of plasma cells secreting the abnormal light chains.1 Achievement of a hematologic response to therapy, particularly complete response (CR), is associated with improved organ function and prolonged survival. 5-8The plasma cell dyscrasia in AL is similar to that in multiple myeloma (MM).3,9 Thus, therapies that are effective in MM are typically used to treat AL.1 High-dose melphalan followed by stem cell transplantation (HDM-SCT) is highly effective in AL; however, many patients may be transplantation ineligible 10,11 due to age, poor performance status, and multiple organ involvement. Despite improvements in the management of transplantation in AL patients in recent years, the observed transplantation-associa...

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Section: Response To Treatmentsupporting

confidence: 75%

Section: Discussionmentioning

confidence: 99%

Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis

Reece

Hegenbart

Sanchorawala

et al. 2014

Blood

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“…More recently, a novel assay for FLC quantification (N latex FLC, Siemens) based on monoclonals, has been developed and introduced on the market [95]. The performance of the two assays for FLC quantification in AL amyloidosis patients has recently been compared [96,97]. The results showed that the assays have similar diagnostic sensitivity; however, they are not interchangeable and the dynamic range of the N Latex FLC assay is limited.…”

Section: Measurement Of the Amyloidogenic Precursormentioning

confidence: 99%

Biochemical markers in early diagnosis and management of systemic amyloidoses

Lavatelli

Albertini

Fonzo

et al. 2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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Systemic amyloid diseases are characterized by widespread protein deposition as amyloid fibrils. Precise diagnostic framing is the prerequisite for a correct management of patients. This complex process is achieved through a series of steps, which include detection of the tissue amyloid deposits, identification of the amyloid type, demonstration of the amyloidogenic precursor, and evaluation of organ dysfunction/damage. Laboratory medicine plays a central role in the diagnosis and management of systemic amyloidoses, through the quantification of the amyloidogenic precursor and evaluation of end-organ damage using biomarkers.

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“…However, CT-guided percutaneous needle biopsy or endoscopic ultrasound biopsy has the greater value in the diagnosis of these diseases [6,7]. So far, the gold standard for the diagnosis of amyloidosis is the histological examination of biopsy tissues through Congo red (pink or rose red) and methyl violet (red or purple) staining, and polarized light microscopy showing the characteristic yellow-green two-color of double refraction bodies [8].…”

Section: Discussionmentioning

confidence: 99%

18F-FDG-PET-CT with Little Value in Different Diagnosis between Pulmonary Malignancy and Amyloidosis

Song¹

2014

J Hematol Thrombo Dis

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Pulmonary amyloidosis is rare and is often misdiagnosed due a lack of general awareness of the condition. The role of PET-CT in the differential diagnosis between pulmonary amyloidosis and lung malignant tumors is still unclear. Herein, we describe a 61-year-old Chinese woman who presented with a right lower lobe pulmonary nodule, and right hilar and mediastinal lymph nodes shadows. On PET-CT examination, the patient was found to have right lower lung malignant lesions with multiple right hilar and mediastinal lymph node metastases. She was diagnosed with nephrotic syndrome with a history of pathologic type of amyloidosis over the previous two months. After performing right thoracotomy, a histopathologic diagnosis of pulmonary amyloidosis was made. The patient has done well postoperatively, showing no local recurrence in the lung or deterioration of her condition in a 12-month follow-up period. The pathology of nephrotic syndrome in patients with amyloidosis led to the diagnosis of systemic amyloidosis being made in this patient. From this case, combined with the domestic and international literature, we conclude that PET-CT is of little value for the different diagnosis between pulmonary amyloidosis and lung malignant tumors.

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Evaluation of the N Latex free light chain assay in the diagnosis and monitoring of AL amyloidosis

Abstract: Background: We compared a novel assay for free light chain (FLC) quantitation based on monoclonal antibodies (N-Latex, Siemens, Germany) to the established polyclonal antibody-based assay (Freelite

Cited by 25 publications

References 17 publications

Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis

Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis

Biochemical markers in early diagnosis and management of systemic amyloidoses

18F-FDG-PET-CT with Little Value in Different Diagnosis between Pulmonary Malignancy and Amyloidosis

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