CTIT患者IL-11、TPO、TPO-RAs、咖啡酸片等有效率差异、同种肿瘤治疗方式差异及年龄、肝肾功能、合并症的影响

Cancer therapy-induced thrombocytopenia (CTIT) is a common complication in patients with solid tumors during their cancer treatment. The sole therapeutic agents approved for this indication are recombinant human interleukin-11 (rhIL-11) or recombinant human thrombopoietin (rhTPO). Romiplostim-N01 is a novel thrombopoietic agent launched in China in 2024, which has demonstrated preliminary therapeutic efficacy in the management of CTIT. This retrospective study compared romiplostim-N01 with rhIL-11 or rhTPO for CTIT management. Ninety-two matched consecutive patients with grade ≥2 CTIT (platelet [PLT] count < 75 × 109/L) were grouped into either the romiplostim-N01 group or the rhIL-11/rhTPO group. The primary endpoint was the proportion of treatment-marked responders, defined as patients who reached a PLT count of ≥100 × 109/L and at least 30 × 109/L higher than the pretreatment baseline within 7 days of treatment. Propensity score matching and a multivariate logistic regression model were used to estimate the treatment effects of the 2 drugs on CTIT. The 7-day marked response rate was significantly higher in the romiplostim-N01 group compared with the control group (58.7% vs 28.3%, P < .05), whereas the 14-day overall response rate was comparable between the 2 groups (89.1% vs 89.1%, P > .05). The median duration of chemotherapy delay was significantly shorter in the romiplostim-N01 group compared with the rhIL-11/rhTPO group (5.5 vs 9.5 days, P < .001). Multivariate regression analysis confirmed that romiplostim-N01 was independently associated with an elevation in PLT count. These findings position romiplostim-N01 as a favorable alternative to rhIL-11 or rhTPO in CTIT, given its enhanced early PLT response and reduced risk of chemotherapy disruption.

ABSTRACT Objective This real‐world study aimed to investigate the cancer therapy‐induced thrombocytopenia (CTIT) profile and evaluate the efficacy and safety of recombinant human interleukin‐11 (rhIL‐11) in its management. Methods Retrospective analysis included 12,431 CTIT patients treated with rhIL‐11 across 58 Chinese centers (July 2023–June 2024). Multivariate logistic regression analysis identified CTIT risk factors. Treatment outcomes and adverse events (AEs) were assessed. Results Independent CTIT risk factors included advanced age, medical history, prior myelosuppression, tumor type, bone marrow involvement, and previous anti‐tumor therapy. RhIL‐11 demonstrated significant thrombopoietic effects, with a mean treatment duration of 6.79 ± 2.59 days. Platelet (PLT) recovery to 50 × 109/L and 100 × 109/L was 4.60 ± 4.40 days and 7.68 ± 5.09 days, respectively. Hematologic malignancy patients required longer treatment and slower PLT recovery compared to those with solid tumors. Urologic and head/neck malignancy patients had faster recovery, while uterine, colorectal, and liver cancer patients exhibited poorer outcomes. Fluoropyrimidine monotherapy delayed PLT recovery compared to platinum‐, taxane‐, anthracycline‐based regimens, or gemcitabine/platinum combinations (all p < 0.05). Furthermore, patients with “impaired” PLT recovery capacity or grade IV CTIT demonstrated longer treatment and PLT recovery times, while grade I/III CTIT was associated with higher PLT recovery response rates. AEs occurred in 28.9% of patients, primarily mild fatigue (15.3%) and edema (7.5%). COVID‐19 infection correlated with prolonged treatment duration and delayed PLT normalization. Conclusion This large‐scale real‐world study confirms the efficacy and safety of rhIL‐11 in CTIT management. Treatment responses vary slightly across patient subgroups, but tolerability remains acceptable. Findings emphasize individualized CTIT strategies and proactive AEs monitoring.

… of cancer therapy induced thrombocytopenia (CTIT) after … 3 Comparison of response rates before and after treatment … Avatrombopag for chemotherapy-induced thrombocytopenia …

Cancer treatment-induced thrombocytopenia (CTIT) is a common adverse effect in malignant tumor patients, significantly increasing the risk of bleeding and negatively impacting treatment efficacy and quality of life. Current treatment options for CTIT primarily include platelet transfusion, recombinant human interleukin-11 (rhIL-11), recombinant human thrombopoietin (rhTPO) and thrombopoietin receptor agonists (TPO-RAs). However, these methods have their limitations; for instance, platelet transfusions may cause adverse reactions, and the efficacy and safety of rhTPO and TPO-RAs remain controversial. This review aims to summarize the current treatment landscape for CTIT and explore new therapeutic advancement, including the potential role of traditional Chinese medicine, in order to provide more effective treatment strategies for clinical practice.

PURPOSE Chemotherapy-induced thrombocytopenia (CIT) is a challenging and common complication of cytotoxic chemotherapy in patients with GI cancers. There is no widely available approved treatment. Avatrombopag is a potent, second-generation oral thrombopoietin receptor agonist promising for CIT management. METHODS We conducted a multicenter, randomized, double-blind, investigator-initiated US trial of avatrombopag or placebo (1:1) in GI cancer patients with persistent CIT (platelets ≤85 × 109/L on day 1 of a chemotherapy cycle despite adequate time to recover from the prior cycle). The primary end point was successful correction of CIT and prevention of recurrence (defined as recovery of platelets to ≥100 × 109/L, no chemotherapy dose modification/delay, and prevention of CIT recurrence [platelets ≥100 × 109/L] at end of the on-study cycle). RESULTS The trial was closed to enrollment by the data and safety monitoring board at the planned interim analysis after meeting prespecified stopping criteria for efficacy. Sixteen of 23 patients (70% [95% CI, 47 to 87]) receiving avatrombopag achieved the primary end point versus 4/24 patients (17% [95% CI, 5 to 37]) receiving placebo (Z = 3.67, P < .001). The median (IQR) platelet count at the end of the on-cycle treatment period was 157 (136-202) × 109/L with avatrombopag versus 72 (68-134) × 109/L with placebo. Adverse events (AEs) and serious AEs occurred in 78% and 17% of patients receiving avatrombopag and 46% and 0% of patients receiving placebo, respectively. No serious AEs were study drug-related. There were no treatment-related AEs leading to death or discontinuation of study drug. CONCLUSION In this randomized, placebo-controlled trial, avatrombopag was efficacious in the management of persistent CIT in patients with GI cancers. These findings are promising for a common, challenging oncologic complication that prevents delivery of full-dose, on-time, cancer-directed therapy.

… of immune thrombocytopenia (ITP), chemotherapy-induced … registered clinical studies of CTIT and currently stands as the … agents demonstrate comparable overall efficacy, they diverge …

Background Cancer treatment-induced thrombocytopenia (CTIT) is a common adverse effect of cancer therapy. CTIT increases the risk of bleeding, prolongs hospital stays, raises medical costs, and can negatively impact anti-tumor treatment outcomes, potentially leading to patient death. Therefore, it is crucial to initiate platelet-boosting therapy in a timely manner based on the individual circumstances of patients experiencing CTIT. Methods Patients who developed cancer treatment-induced thrombocytopenia and received Rh-TPO treatment from January 2023 and December 2023 were obtained for establishing the dataset. With absolute platelets increase as the outcome variable, univariate analysis was performed to screen out statistically significant factors, and 18 clinical variables were selected as initial features. The least absolute shrinkage and selection operator (LASSO) regression analysis was then used to identify the most important features. Based on this, a stacking ensemble model was constructed using cross-validation with out-of-fold predictions to prevent information leakage, and the predictive performance of the model was evaluated. Finally, the SHapley Additive exPlanations (SHAP) algorithm was used to explain the model, and a visual analysis of the features was conducted. Results A total of 400 inpatients who developed cancer treatment-induced thrombocytopenia and received Rh-TPO treatment were included, of which 280 inpatients were assigned to the training set and 1,20 to the testing set. After LASSO regression screening, the study identified 7 key features: ethnicity, height, baseline serum creatinine, pre-chemotherapy platelet count, follow-up days after chemotherapy, platelet count before Rh-TPO, and duration of Rh-TPO treatment. We compared the performance of different machine learning models and selected the best three models as base models. Combined with Linear Regression as the meta-learner, we built a stacking ensemble model using 3-fold cross-validation with out-of-fold predictions. The stacking ensemble model showed best prediction ability compared to independent models with R² of 0.77 (training) and 0.74 (testing), MAE of 6.39 (training) and 8.34 (testing), MSE of 62.17 (training) and 97.70 (testing), RMSE of 7.88 (training) and 9.88 (testing), and MAPE of 0.09 (training) and 0.12 (testing). SHAP analysis showed that pre-chemotherapy PLT value and the follow-up days after chemotherapy were the important features affecting the prediction results. Conclusion The predictive model developed in this study could be beneficial for accurately predicting the improvement in platelet count in patients with CTIT who use Rh-TPO, facilitating timely assistance for patients in avoiding the risks caused by a drop in platelet count in a timely manner.

Background: Cancer therapy-induced thrombocytopenia (CTIT) is a common complication of anti-tumor therapy, leading to treatment delays or interruptions, increased bleeding risk and compromised outcomes. In the present study, we aimed to evaluate the efficacy and safety of hetrombopag, an oral thrombopoietin receptor agonist, for managing and preventing CTIT in patients with breast cancer. Methods: In this multi-center, randomized phase II clinical trial (NCT05394285), breast cancer patients with platelet counts &lt;50×10⁹/L during anti-tumor treatment (Cycle 1) were enrolled. Those patients were randomly assigned (1:1)to receive either hetrombopag or subcutaneous recombinant human thrombopoietin (rhTPO) until their platelet counts &gt;100×10⁹/L, which was defined as the thrombocytopenia treatment phase (TTP). During the secondary prevention phase (SPP), all cases as self-control received hetrombopag for 14 days starting on day 1 of the subsequent anti-tumor treatment cycle (Cycle 2). The primary endpoint was the response rate of the SPP. Secondary endpoints comprised the response rate of TTP (key secondary endpoint), other platelet-related parameters, and safety outcomes. Results: Between September 2022 and May 2025, 67 patients with breast cancer were enrolled. After excluding one patient who withdrew informed consent, 66 patients were randomized. During the trial, 6 patients discontinued participation in the SPP, the remaining 60 patients constituted the per-protocol set (PPS). The majority of patients in the PPS (n=47) received antibody-drug conjugates (ADCs) treatment. For the primary endpoint, the response rate was 85.0% (51/60) in the PPS, and 89.4% (42/47) among patients receiving ADCs. Regarding the key secondary endpoint during the TTP, the response rates were 87.9% (29/33) in patients receiving hetrombopag and 81.8% (27/33) in those receiving rhTPO. No treatment-emergent severe adverse events were observed. Conclusions: Hetrombopag represents a promising and well-tolerated strategy for the secondary prevention and management of CTIT in breast cancer patients, particularly in patients received ADCs.

Immune checkpoint inhibitors (ICIs) have been widely adopted in the treatment of malignant tumors, and their durable antitumor effects have revolutionized cancer therapy. Immune checkpoint inhibitor‐induced thrombocytopenia (ICIIT) represents a rare but potentially severe or even fatal hematologic toxicity associated with immunotherapy. Therefore, it is imperative for healthcare professionals to recognize this potential adverse event and to understand its identification and management. However, the pathophysiological mechanisms underlying ICIIT remain incompletely understood, and both its diagnosis and treatment pose significant challenges. This review summarizes current knowledge on the epidemiology, prognosis, diagnosis, pathogenesis, and clinical management strategies of ICIIT. The findings of this review may serve as critical evidence to aid clinicians in the recognition and treatment of ICIIT and to inform future research efforts. Subsequent studies should aim to identify predictive biomarkers and develop novel therapeutic approaches to improve patient outcomes.

… Safety profiles were comparable between groups, with no rhTPO-related thromboembolic … risk CTIT (eg, those with a prior history of Grade 2 chemotherapy-induced thrombocytopenia or …

Renal dysfunction is common in patients with hematologic diseases and frequently emerges at diagnosis or during treatment. Acute kidney injury, chronic kidney disease, and glomerular involvement may arise from disease biology, antineoplastic therapy, infection, transplantation-related injury, or cumulative supportive exposures. In clinical practice, impaired kidney function rarely represents an isolated comorbidity; rather, it modifies therapeutic feasibility, dose intensity, supportive management, and long-term outcomes. Renal impairment affects delivery of conventional chemotherapy, targeted and immune-based therapies, complicates antimicrobial selection during immunosuppression, and influences eligibility and risk stratification for hematopoietic stem cell transplantation (HSCT). Beyond its immediate consequences, renal dysfunction carries prognostic significance and may reshape therapeutic goals as renal reserve evolves. Considering renal dysfunction as a modifier of hematologic management, rather than solely as a renal endpoint, clarifies its role in treatment planning across the disease continuum.

: Chemotherapy-induced anemia (CIA) is a multifaceted entity influenced by a variety of patient- and treatment-specific factors. Some sources of variation within CIA include chemotherapeutic agent as well as dose and administration schedule, type and stage of malignancy, baseline pretreatment hemoglobin, target hemoglobin, timing of intervention (red blood cell transfusion, iron, erythropoietin stimulating agent), nutritional status, renal function, age, and gender. The diversity of patient presentation and symptomatology within the broader spectrum of CIA contributes to the challenge of establishing universal criteria to govern optimal management therapies. This manuscript will review the development and evolution of CIA with an emphasis on assorted therapeutic interventions.

This review will discuss how 2 common and morbid conditions, renal disease and liver disease, alter platelet number and function. It will review the impact of thrombocytopenia on bleeding complications in patients with these disorders and whether the low platelet count actually correlates with bleeding risk. Emerging data also suggest that platelets are much more than bystanders in both renal and liver disease, but instead play an active role in the pathobiology of these disorders. This review will briefly cover the emerging information on novel roles of platelets in the biology of renal and liver disease.

Comorbidities are frequent in patients with lung cancer, who are often treated with systemic anticancer therapy. The purpose of the present review is to report the adaptations …

… As a measure of comorbidity, the Charlson comorbidity index (14) was calculated after … of post-chemotherapy sinusoidal injury with a poorer functional liver reserve and perioperative …

… increasing numbers of major comorbid conditions. This risk is … chemotherapy, baseline leukopenia, renal dysfunction, most … directly or indirectly through changes in platelets, monocytes, …

Bleeding and thrombotic complications are important causes of morbidity and mortality in critically ill patients with cancer. The prevalence of these complications has increased …

… with discontinuation of chemotherapy and plasmapheresis. … malignancy, significant medical comorbidities, or an inability to … count, platelet count, biochemical liver and renal function tests…

… have impairment in renal function due to age, comorbid conditions, and/or malignancy-associated factors, making the utilization of cisplatin-based chemotherapy … with a platelet count ≤ …

… of comorbid conditions, pre-existent liver disease and small … partial hepatic resection after systemic neoadjuvant chemotherapy … , pulmonary, hepatic or renal disease is pivotal as they …