Early Discontinuation of Lenalidomide in Patients with Relapsing or Refractory Multiple Myeloma: Predictive Factors for Stopping in the Real Life

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4504-4504 ◽  
Author(s):  
Aureliano Pistone ◽  
Marie Maerevoet ◽  
Sebastian Wittnebel ◽  
Marie Vercruyssen ◽  
Chloé Spilleboudt ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Multivariate Analysis ◽  
Disease Progression ◽  
Dose Reduction ◽  
Predictive Factors ◽  
Real Life ◽  
Roc Curves ◽  
Hematological Toxicity ◽  
Triple Combination ◽  
Early Discontinuation

Abstract Introduction: The immunomodulatory drug lenalidomide (Len) is a major drug in myeloma treatment. It has been reported that continuous treatment with Len until disease progression or unacceptable toxicity is associated with a better outcome. Although an early Len stop is associated with a decrease of progression free survival and overall survival, there is few published data on the reasons of early discontinuation beside disease progression. The aim of this study is to evaluate, in the real life, the reason of early Len discontinuation in patients with relapsed or refractory multiple myeloma. Methods: We retrospectively reviewed relapsing or refractory myeloma patients who received a Len based treatment in our center from January 2008 to December 2015. We collected data on toxicity, treatment discontinuation and dose modifications from the start of Len therapy until treatment discontinuation. We analyzed the baseline characteristics of the patients and their treatment. Results: 78 patients received a Len therapy for a total of 107 lines of treatment. The median age was 62 (38-84) years. The treatment was a combination of Len and low dose dexamethasone (dex) in 71% of the cases (n=75) and a triple combination in 29% (n=32) including a majority of Len-dex-cyclophosphamide (n=17) and Len-dex-bortezomib (n=12). The treatment was discontinued for toxicity in 39% (n=34) of the patients. Main reasons for early discontinuation of Len were: hematological toxicity in 38% (n=13), general symptoms (malaise, asthenia) in 32% (n=11), gastro intestinal toxicity in 9% (n=3). 47% of the pts (n=16) stopped treatment due to more than one toxicity. The median duration of treatment was 5.8 months for patients stopping Len for toxicity reasons compared to 11, 7 months in patients stopping Len for disease progression. Discontinuation for hematological toxicities was usually preceded by dose reduction. In a multivariate analysis, predictive factors for early Len discontinuation were: age (OR : 1,08 (1,03 - 1,11) ; p = 0,004) and a triple combination (OR : 4,84 (1,71 - 13,71) ; p = 0,003). Receiver operating characteristic (ROC) curves identified an age threshold of 69 predictive of early arrest for another cause than progression with an area under the ROC curves of 0,67 (0,55 - 0,79). The presence of comorbidities was not associated with a risk of dose reduction or early arrest of therapy. A reduction of the Len dose was done in 31% of the 107 lines (n=33). In 81 % of these 33 lines, we observed ≥ 2 toxicities (median of 3; range 1-9). The most frequently reported toxicities were: general symptoms in 84% (n=27), GI toxicity in 53% (n=17), infection in 13%. Hematological toxicity was reported in 87% although it motivated a dose reduction in only 22% of the lines (n=7). The only predictive factor for dose reduction in multivariate analysis was sex (OR : 3,63 (1,37 - 10,59) ; p = 0,007) with 76% of dose reduction in males comparing to 24% in females. In 75% of the cases (n=29) the dose reduction was followed by an early discontinuation of treatment for toxicity. Conclusion In our survey, Len-related non hematological toxicity is observed more frequently than expected from the literature and Len therapy modification was frequently due to multiple toxicities. In our analysis, age and Len-dex based triple combination are predictive factors for early Len discontinuation. Sex was a predictive factor for Len dose reduction. This has previously not been reported and may be due to the small sample size of this study. On the other hand this may be explained by variable pharmacokinetics in male and female. Interestingly, a dose reduction was followed in 75% of the cases by an early discontinuation of Len suggesting that - in patients at high risk of discontinuation of Len (e.g. older males) - Len could be started at lower dose and progressively increased according to the tolerance. Disclosures Meuleman: Takeda: Consultancy; Bristol-Myers-Squibb: Consultancy; Amgen: Consultancy; Celgene: Consultancy.

Lenalidomide as Salvage Therapy after Allogeneic Stem′Cell Transplantation in Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3704-3704
Author(s):  
Friederike Lehmann ◽  
Jean El-Cheikh ◽  
Tatjana Zabelina ◽  
Francis Ayuk ◽  
Christine Wolschke ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Dose Reduction ◽  
Cell Transplantation ◽  
Allogeneic Stem Cell Transplantation ◽  
Optimal Dose ◽  
Hematological Toxicity ◽  
Once Daily ◽  
Grade 3

Abstract Lenalidomide is an immunmodulatory drug, orally administered once daily, which is effective in relapsed multiple myeloma (MM). Here, we evaluated the efficacy and toxicity of lenalidomide in 24 MM patients with relapsed disease after allogeneic stem cell transplantation (allo-SCT). Median age was 59 (range, 37–70) years. The series included 8 females and 16 males. Prior to allo-SCT, all patients were heavily pretreated with a median of 6 chemotherapy cycles including autologous and allo-SCT in all patients. Also, prior to lenalidomide, salvage treatment included donor lymphocyte infusions (DLI) in 18 pts,, thalidomide in 11 pts and bortezomib in 13 pts. Lenalidomide was given at 15mg (n=4) or 25 mg (n=20) orally once daily on day 1–21 every 28 days and in 20 patients in combination with dexamethason.. No prophylactic anticoagulation was used. The median number of completed cycles was 5 (range 2–17). Myelotoxicity according NCI criteria was the primarily and major encountered side effect (leukopenia: 4% grade 4, 21% grade 3, 17% grade 2, thrombopenia: 17% grade 3, 29% grade 2) and led to dose reduction in 54% of the patients. Infectious complications were observed in 50%. Non-hematological toxicity consisted of cramps (n=9), fatique (n=5) and constipation (n=2). Thrombembolic complications (cerebral infarction) were observed in one patient, who received concomitant corticosteroid treatment for acute graft-vs.-host disease (GvHD), but neurological symptoms resolved completely. GvHD of the skin under lenalidomide treatment was seen in 3 patients (one grade 2, and 2 grade 1), with one case occurring shortly after an additional DLI.. Objective remission was achieved in 66% of the patients (CR: 8%, VGPR: 8%, PR: 50%) and stable disease (SD) in 13% of the patients, while in 21% progressive disease was noted. Prior treatment with thalidomide or with bortezomib did not influenced the rate of CR/PR. Surprisingly, patients with del 13q14 achieved a higher CR/PR rate than those without del 13q14 (p=0.02). The median time to progression was 9.7 months (95% CI: 7.5–11.9) and the median overall survival was 19.9 months (95% CI: 17.3–22.5). Lenalidomide is effective in relapsed patients with MM after allo-SCT. Major toxicity is myelotoxicity, which required dose reduction in the majority of patients. The optimal dose of lenalidomide after allo-SCT has to be investigated.

Longer Duration of Treatment and Maintenance of Best Response with Lenalidomide and Dexamethasone Prolongs Overall Survival in Patients with Relapsed or Refractory Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3702-3702 ◽  
Author(s):  
Jesús F San Miguel ◽  
Meletios A Dimopoulos ◽  
Edward A. Stadtmauer ◽  
S. Vincent Rajkumar ◽  
David Siegel ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Adverse Events ◽  
Disease Progression ◽  
Phase Iii ◽  
Duration Of Treatment ◽  
Early Discontinuation ◽  
Landmark Analysis ◽  
Best Response ◽  
The Impact

Abstract Introduction: Multiple myeloma (MM) accounts for about 20% of deaths from hematological cancers and remains incurable despite conventional and high-dose chemotherapy. Two phase III trials in patients with relapsed or refractory MM (MM-009 and MM-010) showed that lenalidomide combined with dexamethasone resulted in significantly improved response rates and significantly prolonged median time to progression (TTP) and overall survival (OS) compared with dexamethasone alone. This current sub-analysis of lenalidomide plus dexamethasone therapy assessed whether there was a survival benefit in maintaining patients on therapy after achieving their best response and what the impact of early discontinuation on TTP and OS was. Methods: Of the 353 patients from MM-009 and MM-010 treated with lenalidomide plus dexamethasone, 32 did not respond. Of the remaining 321 responding patients, 214 had a partial response (PR) or better and 107 patients had stable disease (SD). In this post-hoc sub-analysis, we first assessed the outcome of continuing treatment for ≤10 months vs. >10 months in all 321 patients who achieved SD or better, after they achieved their best response. In this landmark analysis, OS was measured from the time of achieving best response to death from any cause or to last contact. In a second analysis, we assessed the impact of early discontinuation due to adverse events or withdrawn consent on OS and TTP in all patients who achieved SD or better. Therefore, we excluded patients who discontinued treatment due to disease progression, death, or lack of efficacy. Patients who achieved SD or better and who continued on therapy were compared with those who discontinued. OS and TTP were assessed from time of randomization. Results: In the landmark analysis, of the 321 responding patients (≥PR, n=214; SD, n=107), 223 patients received treatment for ≤10 months after achieving their best response and 98 patients for >10 months after achieving their best response. Patients who continued therapy for >10 months after achieving their first best response had significantly longer OS vs. those who received therapy for ≤10 months (not reached vs. 23.4 months; p<0.0001). At 24 months after achieving their best response, significantly more patients were alive if they continued therapy >10 months vs. ≤10 months (93.8% vs. 48.4%, p<0.0001). In the second analysis, in order to evaluate the impact of discontinuation in patients achieving SD or better, we excluded 134 patients due to disease progression, death, or lack of efficacy. Of the remaining 187 responding patients, 72 discontinued treatment for AE (n=42) or withdrew consent (n=30), while the remaining 115 patients continued treatment. Median OS and TTP were significantly longer for patients who continued vs. those who discontinued treatment (median OS: not reached vs. 29.5 months, p<0.0001; median TTP: not reached vs. 13.6 months, p<0.0001). Conclusions: In patients achieving SD or better, prolonged duration of treatment was associated with significantly longer OS and TTP. In contrast, early discontinuation of treatment led to reduced OS and TTP. Therefore, efforts should be made to manage adverse events while maintaining patients on therapy. Furthermore, maintaining treatment with lenalidomide and dexamethasone after achieving the optimal response ensures a significant improvement in OS for patients with relapsed or refractory MM.

Lenalidomide after Allogeneic Stem Cell Transplantation in Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4840-4840 ◽  
Author(s):  
Friederike Lehmann ◽  
El-Cheikh Jean ◽  
Tatjana Zabelina ◽  
Francis Ayuk ◽  
Christine Wolschke ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Dose Reduction ◽  
Cell Transplantation ◽  
Allogeneic Stem Cell Transplantation ◽  
Hematological Toxicity ◽  
High Dose ◽  
Once Daily ◽  
Grade 3

Abstract Background: Lenalidomide is an immunmodulatory drug, orally administered once daily, which is effective in relapsed multiple myeloma (MM). Here, we evaluated the efficacy and toxicity of lenalidomide in 16 MM patients with relapsed disease after allogeneic stem cell transplantation (allo-SCT). Methods: Median age was 57 (range 37–68) years. The series included 5 females and 11 males. Prior to allo-SCT, all patients were heavily pretreated with multiple lines of chemotherapy, including high dose therapy with autologous stem cell support. Also, prior to lenalidomide treatment, other salvage therapies included donor lymphocyte infusions (DLI) in 93% of cases, thalidomide in 63%, and bortezomib in 88%. NCI-criteria were used to define toxicity. Lenalidomide was given 25 mg orally once daily on day 1–21 every 28 days. No prophylactic anticoagulation was used. Results: The overall median number of completed cycles was 5 (range 1–10). Very good partial response (VGPR) was achieved in 13%, partial remission (PR) in 53%, and stable disease (SD) in 27% of the patients. During the follow up period, disease progression was observed in 50% of cases, and death in one patient. The median progression-free survival was 8 months, while the median overall survival was not yet reached. Hematotoxicity was the primarily and major encountered side effect (leukopenia: 6% grade 4, 19% grade 3, 19% grade 2, 38% grade 1; thrombopenia: 19% grade 3, 19% grade 2, 31% grade 1). This myelotoxicity led to dose reduction (usually 10 mg) in 44% of the patients. Infectious complications were observed in 25%. Non-hematological toxicity was also seen in 75% of cases (56% grade 1, 19% grade 2), consisting of cramps in the leg, constipation, symptomatic fatigue, nausea and progressing polyneuropathy (n=1). Thrombembolic complications (cerebral infarction) were observed only in one patient, who was receiving concomitant corticosteroid treatment for acute graft-versus-host disease (GvHD), but neurological symptoms resolved completely. GvHD of the skin under lenalidomide treatment was seen in 25% of cases (one grade 2, and 3 grades 1), with one case occurring shortly after an additional DLI. Conclusions: Lenalidomide is effective in relapsed patients with MM after allo-SCT. Major toxicity is myelotoxicity, which required dose reduction in a majority of patients. With this background, a dose-finding study to determine the optimal lenalidomide dose as maintenance therapy after allo-SCT has already started.

scholarly journals Next-generation immunomodulatory drugs in multiple myeloma

2019 ◽  
Vol 73 ◽  
pp. 791-802
Author(s):  
Anna Suska ◽  
Maciej Rafał Czerniuk ◽  
Artur Jurczyszyn
Keyword(s):  
Multiple Myeloma ◽  
Real Life ◽  
Cost Effective ◽  
Cross Resistance ◽  
Hematological Toxicity ◽  
Immunomodulatory Drugs ◽  
Effective Treatment Option ◽  
Cost Effective Treatment ◽  
Increased Risk ◽  
New Generation

Multiple myeloma (MM) is a hematological malignancy that mainly affects elderly patients, with the median age of 69 years at the time of diagnosis. Despite the recent increase in the number of drugs used in the antimyeloma therapy, the disease remains incurable, with remissions and subsequent relapses. Immunomodulatory drugs (IMIDs), known to have multiple mechanisms of actions, including direct anti-MM activity and immune-stimulatory properties, are currently the backbone in multidrug regimens. New generation IMIDs are recommended nowoby ESMO – lenalidomide is included in frontline therapy, while pomalidomide is accepted from the third line. Clinical trials proved lack of apparent cross-resistance between immunomodulatory agents, confirmed their high efficacy and acceptable safety profile in individuals with relapsed multiple myeloma (RRMM) refractory to proteasome inhibitors and lenalidomide, even with adverse cytogenetic abnormalities. Also, triplet pomalidomide-based combinations with bortezomib, carfilzomib, cyclophosphamide, daratumumab or elotuzumab were proved to be effective and safe in this group of patients. The most common adverse events of the new generation IMIDs are the following: hematological toxicity (neutropenia, thrombocytopenia, anemia), fatigue and, while administered with dexamethasone, infections. However, peripheral neuropathy, significantly limiting the use of first generation IMID - thalidomide, is much less frequently observed. Due to the increased risk of venous thromboembolism, thromboprophylaxis should be implemented in the whole course of IMID therapy. Data from real-life settings demonstrate that new generation IMIDs are a cost-effective treatment option in relapsed/ refractory myeloma. Currently, one drug program with the new IMIDs is available in Poland.

Clinical Characteristics and Predictive Factors of Peripheral Neurophaty in Multiple Myeloma Patients Treated with Bortezomib and/or Imids

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4056-4056
Author(s):  
Vincenzo Federico ◽  
Russo Eleonora ◽  
Andrea Truini ◽  
Anna Levi ◽  
Fabiana Gentilini ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Neuropathic Pain ◽  
Peripheral Neuropathy ◽  
Dose Reduction ◽  
Median Time ◽  
Predictive Factors ◽  
Neurological Examination ◽  
Clinical Characteristics ◽  
Douleur Neuropathique ◽  
Significant Difference

Abstract Abstract 4056 Background: Peripheral neuropathy (PN) and neuropathic pain are common and severe dose-limiting side effects of Bortezomib and/or IMIDs used in the management of multiple myeloma patients, which often requires dose reduction or interruption of treatment. Aims: We performed a monocentric prospective study to investigate the incidence, clinical characteristics and predictive factors of peripheral neuropathy and neuropathic pain in multiple myeloma patients treated with Bortezomib and/or IMIDs. Methods: All patients underwent clinical examination and were studied for the standard nerve conduction using the sural nerve action potential (SAP) trend. Neurological evaluation was performed monthly before, during and after Bortezomib and/or IMIDs treatment. Neuropathic pain was evaluated using the Douleur Neuropathique 4 (DN4) questionnaire and the Total Neuropathy Score reduced version. Results: Between January 2007 and June 2011, 145 consecutive patients, treated with Bortezomib and/or IMIDs, were prospectively studied. The clinical characteristics were: median age 60 years (range 32–78); 68 men and 77 women; 80 and 65 patients were, respectively, in Durie and Salmon stages I-II and III. Fifty-eight patients (40%) were treated with Bortezomib, 20 (14%) with Thalidomide, 37 (26%) with Lenalidomide and 30 (20%) with the Bortezomib-Thalidomide combination. After a median time of 3 months (range 1–22) from the start of our study, 100 patients (69%) developed a peripheral neuropathy during treatment; 78 (54%) patients had pain according to the DN4 questionnaire and 45 (31%) experienced neuropathic pain according to the Total Neuropathy Score. A significant difference (p<0.01) in terms of age and median time from diagnosis to the neurological examination was observed between patients with and without peripheral neuropathy. Patients with peripheral neuropathy were older and had a longer median time from diagnosis to the neurological examination: median age 59 vs 43 years (range 45–78 vs 32–62) and 45 vs 22 months (range 1–160 vs 1–36) from diagnosis. In addition, the different treatments were significantly associated with the development of peripheral neuropathy: the Bortezomib-Thalidomide combination and Bortezomib or Thalidomide alone were more frequently associated with peripheral neuropathy than Lenalidomide (p<0.05). No correlation between PN occurrence and cumulative dose of Bortezomib and IMIDs was observed. Among 30 patients (20%) treated with the Bortezomib-Thalidomide combination as first line of therapy, 22 (72%) experienced a peripheral neuropathy. In this group of patients, according to the SAP study, the neuropathy appeared after a median of 1.6 months of treatment and worsened after 3 months (Fig. 1). Sixteen patients continued Bortezomib-Thalidomide at the same dosage and 6 patients required a Bortezomib-Thalidomide dose reduction. An improvement of the neuropathy was observed after 4 months from the stop of treatment. Conclusions: Our data underline the clinical importance of peripheral neuropathy and pain in patients with multiple myeloma. Age, duration of disease and treatment are predictive factors of peripheral neuropathy development. The Douleur Neuropathique 4 (DN4) and Total Neuropathy Score questionnaires are useful tools to evaluate neuropathic pain. We also observed that a reduction of SAP occurs early in patients who developed a neuropathy that improves after the end of treatment. This finding could suggest the presence of biological factors predisposing to the development of neuropathy. Disclosures: Petrucci: Janssen, Celgene: Honoraria.

Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study

2020 ◽  
Vol 20 (11) ◽  
pp. 887-895 ◽  
Author(s):  
Martina Catalano ◽  
Giandomenico Roviello ◽  
Raffaele Conca ◽  
Alberto D’Angelo ◽  
Valeria Emma Palmieri ◽  
...  
Keyword(s):  
Performance Status ◽  
Real Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Hematological Toxicity ◽  
Free Survival ◽  
Grade 3 ◽  
Ecog Ps ◽  
Prognostic And Predictive Markers

Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice. Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed. Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients. Conclusions: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

scholarly journals Telomere Architecture Correlates with Aggressiveness in Multiple Myeloma

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1969
Author(s):  
Aline Rangel-Pozzo ◽  
Pak Yu ◽  
Sadhana LaL ◽  
Yasmin Asbaghi ◽  
Luiza Sisdelli ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Disease Progression ◽  
Genomic Instability ◽  
Clinical Decision Making ◽  
Three Dimensional ◽  
Clinical Decision ◽  
Response To Treatment ◽  
Average Intensity ◽  
Patient Response ◽  
Smoldering Multiple Myeloma

The prognosis of multiple myeloma (MM), an incurable B-cell malignancy, has significantly improved through the introduction of novel therapeutic modalities. Myeloma prognosis is essentially determined by cytogenetics, both at diagnosis and at disease progression. However, for a large cohort of patients, cytogenetic analysis is not always available. In addition, myeloma patients with favorable cytogenetics can display an aggressive clinical course. Therefore, it is necessary to develop additional prognostic and predictive markers for this disease to allow for patient risk stratification and personalized clinical decision-making. Genomic instability is a prominent characteristic in MM, and we have previously shown that the three-dimensional (3D) nuclear organization of telomeres is a marker of both genomic instability and genetic heterogeneity in myeloma. In this study, we compared in a longitudinal prospective study blindly the 3D telomeric profiles from bone marrow samples of 214 initially treatment-naïve patients with either monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with a minimum follow-up of 5 years. Here, we report distinctive 3D telomeric profiles correlating with disease aggressiveness and patient response to treatment in MM patients, and also distinctive 3D telomeric profiles for disease progression in smoldering multiple myeloma patients. In particular, lower average intensity (telomere length, below 13,500 arbitrary units) and increased number of telomere aggregates are associated with shorter survival and could be used as a prognostic factor to identify high-risk SMM and MM patients.

Predictive factors for ambulation in stroke patients in the rehabilitation setting: A multivariate analysis

2007 ◽  
Vol 109 (9) ◽  
pp. 763-769 ◽  
Author(s):  
Stefano Masiero ◽  
Renato Avesani ◽  
Mario Armani ◽  
Postal Verena ◽  
Mario Ermani
Keyword(s):  
Multivariate Analysis ◽  
Predictive Factors ◽  
Stroke Patients

Laboratory indicators predict axillary nodal pathologic complete response after neoadjuvant therapy in breast cancer

2021 ◽  
Author(s):  
Peng Chen ◽  
Tong Zhao ◽  
Zhao Bi ◽  
Zhao-Peng Zhang ◽  
Li Xie ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Neoadjuvant Therapy ◽  
Predictive Factors ◽  
Molecular Subtype ◽  
Treatment Options ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Breast Cancer Patients ◽  
Logistic Analysis

 The purpose was to integrate clinicopathological and laboratory indicators to predict axillary nodal pathologic complete response (apCR) after neoadjuvant therapy (NAT). The pretreatment clinicopathological and laboratory indicators of 416 clinical nodal-positive breast cancer patients who underwent surgery after NAT were analyzed from April 2015 to 2020. Predictive factors of apCR were examined by logistic analysis. A nomogram was built according to logistic analysis. Among the 416 patients, 37.3% achieved apCR. Multivariate analysis showed that age, pathological grading, molecular subtype and neutrophil-to-lymphocyte ratio were independent predictors of apCR. A nomogram was established based on these four factors. The area under the curve (AUC) was 0.758 in the training set. The validation set showed good discrimination, with AUC of 0.732. In subtype analysis, apCR was 23.8, 47.1 and 50.8% in hormone receptor-positive/HER2-, HER2+ and triple-negative subgroups, respectively. According to the results of the multivariate analysis, pathological grade and fibrinogen level were independent predictors of apCR after NAT in HER2+ patients. Except for traditional clinicopathological factors, laboratory indicators could also be identified as predictive factors of apCR after NAT. The nomogram integrating pretreatment indicators demonstrated its distinguishing capability, with a high AUC, and could help to guide individualized treatment options.

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