Treatment patterns and outcomes in real-world transplant-ineligible patients newly diagnosed with multiple myeloma

Cejalvo, María J; Bustamante, Gabriela; González, Esther; Vázquez-Álvarez, J.; García, Ricarda; Ramírez-Payer, Ángel; Pérez‐Persona, Ernesto; Abella, Eugènia; Garzón, Sebastián; Garcia, Antoni; Jarque, Isidro; González, Marta Sonia; Sampol, Antònia; Motlló, Cristina; Martı́, Josep; Alcalá, Magdalena; Duro, Rafael; González, Yolanda; Sastre, J L; Sarrà, Josep; Lostaunau, G.; Lopez, Rocio; Rubia, Javier de la

doi:10.1007/s00277-021-04529-5

Cited by 11 publications

(22 citation statements)

References 27 publications

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“…Several studies have suggested that early transplantation can benefit patients with EMM (Bianchi et al, 2014;Li et al, 2014;Lee et al, 2015), which is opposite to the finding in other studies (Pérez-Simón et al, 2006;Minnema et al, 2008;Varettoni et al, 2010). Besides, many studies have shown that performance status is highly associated with survival in patients with MM (Kyle et al, 2003;Cook et al, 2019;Facon et al, 2020;Cejalvo et al, 2021). Our study also showed similar results to those of previous studies.…”

Section: Discussionsupporting

confidence: 65%

A prognostic model for patients with primary extramedullary multiple myeloma

Zhang

Chen²,

Wang³

et al. 2022

Front. Cell Dev. Biol.

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Background: Extramedullary disease is a manifestation of multiple myeloma, the prognosis of which remains poor even in the era of novel drugs. Therefore, we aimed to develop a predictive model for patients with primary extramedullary multiple myeloma (EMM).Methods: Clinical and laboratory data of patients diagnosed with primary EMM between July 2007 and July 2021 were collected and analyzed. Univariate and least absolute shrinkage and selection operation Cox regression analyses (LASSO) were used to select prognostic factors for overall survival (OS) to establish a nomogram prognostic model. The performance of the model was evaluated using concordance index which was internally validated by bootstraps with 1,000 resample, area under the curve (AUCs), and calibration curves.Results: 217 patients were included in this retrospective study. Patients with EMM had a higher rate of belonging to the male sex, age >50 years, advanced Durie–Salmon stage III, hypercalcemia, and low hemoglobin level. Compared with patients with bone-related extramedullary disease, those with extraosseous-related extramedullary disease had a higher frequency of advanced Durie–Salmon stage III, lower rate of hypercalcemia, and elevated prothrombin time. The OS and progression-free survival (PFS) of patients with bone-related extramedullary disease were significantly higher than those of patients with extraosseous-related extramedullary disease. After the univariate and LASSO analyses, six prognostic factors, including performance status, number of extramedullary involved sites, β2-microglobulin, lactate dehydrogenase, monocyte–lymphocyte ratio, and prothrombin time, were integrated to establish a nomogram. The model showed robust discrimination with a concordance index (C-index) of 0.775 (95% confidence interval [CI], 0.713–0.836), internally validated with the corrected C-index of 0.756, and excellent performance in time-dependent AUCs compared with other staging systems. The AUCs for 1-, 3-, and 5-year OS were 0.814, 0.744, and 0.832, respectively. The calibration curves exhibited good consistency between the observed and nomogram-predicted OS. The 5-year OS of patients in the high-risk group (23.3%; 95% CI, 13.9%–39.3%) was much worse than that in the low-risk group (73.0%; 95% CI, 62.5%–85.4%; p < 0.001).Conclusion: The nomogram predictive model based on six clinical variables showed good prognostic performance and could better predict individual survival in patients with EMM.

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Section: Discussionsupporting

confidence: 65%

A prognostic model for patients with primary extramedullary multiple myeloma

Zhang

Chen²,

Wang³

et al. 2022

Front. Cell Dev. Biol.

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“…Similarly, in another retrospective, multicenter, observational study of NTE patients conducted in Spain, the lenalidomide-based combinations, particularly Rd, were less used than the bortezomib-based combinations. Interestingly, patients treated with VMP and Rd showed lower survival rates than those in patients enrolled in clinical trials, since NTE patients in the RW tend to be older and present with higher risk and worse health status than those enrolled in randomized controlled trials (RCTs) ( 23 ). Moreover, in an analysis based on the Canadian Myeloma Research Group database (CMRG-DB), there was a clear preference for treating high-risk individuals with bortezomib-based triplets and, in particular, with bortezomib-cyclophosphamide-dexamethasone (VCd), which was the most widely used frontline bortezomib-containing regimen.…”

Section: Immunomodulatory Drugsmentioning

confidence: 99%

Beyond Clinical Trials in Patients With Multiple Myeloma: A Critical Review of Real-World Results

2022

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The current strategies for the treatment of multiple myeloma (MM) have improved, thanks to effective drug classes and combination therapies, for both the upfront and relapsed settings. Clinical trials for newly diagnosed transplant-ineligible patients led to the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs) in combination with anti-CD38 monoclonal antibodies (mAbs), to be administered during the induction phase before transplantation and during maintenance treatment, with lenalidomide recommended until relapse. In relapsed/refractory patients, the complex treatment scenario currently includes several options, such as triplets with anti-CD38 mAbs plus IMiDs or PIs, and novel targeted molecules. Comparisons among clinical trials and real-world data showed a good degree of reproducibility of some important results, particularly in terms of overall response rate, progression-free survival, and overall survival. This may help clinicians towards a proper selection of the best treatment options, particularly in real-world settings. However, as compared with the management of real-world settings, clinical trials have some pitfalls in terms of outcome and especially in terms of safety and quality of life. In fact, trials include younger and presumably healthier patients, excluding those with worst clinical conditions due to MM features (e.g., renal insufficiency or bone disease, which can impair the performance status) and comorbidities (e.g., cardiac and pulmonary disease), thus resulting in a possible lack of representativeness of data about the patients enrolled. In this review, we analyze comparable and discrepant results from clinical trials vs. real-world settings published in the last 10 years, focusing on different drugs and combinations for the treatment of MM and providing an overview of treatment choices.

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“…It can be seen that whether it can be reimbursed by medical insurance in China is a very critical factor influencing the treatment choices of physicians and patients in real-world practice. We also noticed that age might be a potential influence factor for MM patients to receive distinct frontline chemotherapies, and the treatment pattern of older MM was slightly different from other studies ( Chan et al, 2019 ; Al Saleh et al, 2021 ; Cejalvo et al, 2021 ; Jimenez-Zepeda et al, 2021 ). TD, BD, and BTD were frequent treatment regimens in both age subgroups.…”

Section: Discussionmentioning

confidence: 56%

Treatment attrition rates and relevant risk factors in multiple myeloma: A real-world study in China

Tang

Yang²,

Li³

et al. 2023

Front. Pharmacol.

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Background: For multiple myeloma (MM), the proportions of patients reaching the subsequent line of therapy (LOT) decline gradually and real-world data describing the attrition rates of LOT in Chinese MM were limited. Herein, we investigated the attrition rates by subsequent LOTs and their relevant risk factors in MM patients in China.Methods: MM patients who had been hospitalized and received at least one LOT from January 2008 to August 2019 in West China Hospital Sichuan University were retrospectively recruited. Demographic and clinical characteristic data were obtained from the “HemaTank” Chinese Multiple Myeloma Database. The Cox proportional hazards regression model was applied to analyze the risk factors of frontline treatment attrition.Results: A total of 1,255 newly diagnosed MM were enrolled, with 573 (45.7%) patients receiving only one LOT and 682 (54.3%) patients receiving more than one LOT. Thalidomide with dexamethasone/prednisone was the most common frontline treatment before 2017, while bortezomib-based regimens constituted the majority of frontline treatment in 2017 and beyond. The attrition rates from the first to the fifth LOT exhibited a gradual upward trend (45.7%, 48.7%, 58.9% and 62.5%, respectively). Meanwhile, 54.3%, 27.9%, 11.5%, and 4.3% of all the enrolled MM patients received a second, third, fourth and fifth LOT. MM who underwent autologous stem cell transplantation (ASCT) showed lower attrition rates across all LOTs (range 12%–56.8%) than MM without ASCT (range 49.1%–64.5%). The multivariate Cox regression model revealed that ISS stage III (HR 2.07, p < .001), elevated LDH (HR 1.47, p = .006), and comorbidities such as amyloidosis (HR 1.63, p = 0 .01), hepatic disease (HR 1.36, p = .022), pulmonary disease (HR 1.38, p = .022), and cardiac disease (HR 1.62, p = .004) were independent risk factors for MM patients attritted from the frontline treatment.Conclusion: In this study, the attrition rates were generally high and increased gradually across all LOTs. Nearly half of MM patients received only one LOT, and higher tumor burden and more comorbidities may be associated with fewer subsequent LOTs. The high attrition rates highlight the importance of applying the most optimal frontline treatment regimen rather than salvaging subsequent LOTs.

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Treatment patterns and outcomes in real-world transplant-ineligible patients newly diagnosed with multiple myeloma

Cited by 11 publications

References 27 publications

A prognostic model for patients with primary extramedullary multiple myeloma

A prognostic model for patients with primary extramedullary multiple myeloma

Beyond Clinical Trials in Patients With Multiple Myeloma: A Critical Review of Real-World Results

Treatment attrition rates and relevant risk factors in multiple myeloma: A real-world study in China

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