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Background <p>Immune checkpoint inhibitors (ICIs) have revolutionized the treatment and prognosis of a variety of solid tumors. However, exaggerated immune activation can lead to immune-related adverse events (irAEs), among which hematologic irAEs remain poorly characterized. This study evaluated the frequency, spectrum, and risk factors of treatment-emergent cytopenia in patients with melanoma, renal cell carcinoma (RCC), and urothelial carcinoma (UCC) treated with ICIs.</p> Methods <p>We retrospectively reviewed patients at the American University of Beirut Medical Center who received at least one dose of ICIs between January 2019 and January 2024. Clinical, treatment, and laboratory data were collected from electronic medical records. Binary logistic regressions assessed the relationships between potential predictors and development of treatment-emergent cytopenia. The primary outcome of interest was the incidence of at least one treatment-emergent cytopenia.</p> Results <p>We included 153 patients (median age 68.21 years, 64.7% male, mean BMI 27.6 ± 4.32 kg/m²) receiving ICIs for melanoma (27.45%), RCC (27.45%), or UCC (45.09%). Pembrolizumab (52.94%) and nivolumab (23.52%) were the most used ICIs, with 28.1% receiving combination therapy. Initially, 47.05% of patients had pre-treatment anemia (mostly grade 1), while thrombocytopenia was rare (5.9%, all grade 1), and no patients had neutropenia. Following initiation with ICIs, 61.43% (94/153) experienced at least one new-onset or worsening treatment-emergent cytopenia. Most common were anemia (46.4%), followed by thrombocytopenia (27.45%) and neutropenia (26.14%). Pancytopenia occurred in 15.6% and bicytopenia in 18.3%. Median time to first hematologic disturbance was 1.39 months (mean 4.71 months, IQR (Long et al., Ann Oncol, 35:1191-1199, 2024); (Motzer et al., N Engl J Med, 378:1277-1290, 2018); (Gupta et al., ESMO Open, 10:104506, 2025), ~ 5.8 cycles). Most treatment-emergent cytopenia were grade 1 (71.24%), fewer grade 2 (20.26%) and 3 (8.49%). There was no grade 4 or 5 events or hematology-related fatalities. Supportive treatment included transfusions in 22.22% and (granulocyte colony-stimulating factor (G-CSF) administration in 12.41%; no patient required steroids, IVIG, or treatment discontinuation due to hematologic irAEs. Univariate regression analysis evaluating the predictors of developing at least one treatment-emergent cytopenia showed that lower baseline hemoglobin and a history of anemia were significant factors (<i>p</i> &lt; 0.001; OR = 0.56 and <i>p</i> &lt; 0.002; OR = 6.50, respectively). Additionally, regression analysis showed that baseline hemoglobin (OR 0.42, <i>p</i> &lt; 0.001) and eosinophil count (OR 1.42, <i>p</i> = 0.004) were significant predictors of anemia and thrombocytopenia, respectively. On multivariable analysis, hemoglobin emerged as a significant predictor, with HGB showing an OR of 0.91 (95% CI: 0.869–0.963, <i>p</i> = 0.001).</p> Conclusion <p>Although usually rare in literature, we found treatment-emergent cytopenia to be common but mild and manageable with ICIs. Early monitoring and supportive care are key.</p>

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Hematologic toxicity of immune checkpoint inhibitors: real-world burden and risk profiles from a five-year cohort from the Middle East

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月28日

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  • Ali Awada,
  • Ali Tarhini,
  • Abbas Hammoud,
  • Mohammad Kassem,
  • Ali Ghais,
  • Nicole Charbel,
  • Amal El Masri,
  • Ali ElHadi Zreik,
  • Firas Kreidieh

摘要

Background

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment and prognosis of a variety of solid tumors. However, exaggerated immune activation can lead to immune-related adverse events (irAEs), among which hematologic irAEs remain poorly characterized. This study evaluated the frequency, spectrum, and risk factors of treatment-emergent cytopenia in patients with melanoma, renal cell carcinoma (RCC), and urothelial carcinoma (UCC) treated with ICIs.

Methods

We retrospectively reviewed patients at the American University of Beirut Medical Center who received at least one dose of ICIs between January 2019 and January 2024. Clinical, treatment, and laboratory data were collected from electronic medical records. Binary logistic regressions assessed the relationships between potential predictors and development of treatment-emergent cytopenia. The primary outcome of interest was the incidence of at least one treatment-emergent cytopenia.

Results

We included 153 patients (median age 68.21 years, 64.7% male, mean BMI 27.6 ± 4.32 kg/m²) receiving ICIs for melanoma (27.45%), RCC (27.45%), or UCC (45.09%). Pembrolizumab (52.94%) and nivolumab (23.52%) were the most used ICIs, with 28.1% receiving combination therapy. Initially, 47.05% of patients had pre-treatment anemia (mostly grade 1), while thrombocytopenia was rare (5.9%, all grade 1), and no patients had neutropenia. Following initiation with ICIs, 61.43% (94/153) experienced at least one new-onset or worsening treatment-emergent cytopenia. Most common were anemia (46.4%), followed by thrombocytopenia (27.45%) and neutropenia (26.14%). Pancytopenia occurred in 15.6% and bicytopenia in 18.3%. Median time to first hematologic disturbance was 1.39 months (mean 4.71 months, IQR (Long et al., Ann Oncol, 35:1191-1199, 2024); (Motzer et al., N Engl J Med, 378:1277-1290, 2018); (Gupta et al., ESMO Open, 10:104506, 2025), ~ 5.8 cycles). Most treatment-emergent cytopenia were grade 1 (71.24%), fewer grade 2 (20.26%) and 3 (8.49%). There was no grade 4 or 5 events or hematology-related fatalities. Supportive treatment included transfusions in 22.22% and (granulocyte colony-stimulating factor (G-CSF) administration in 12.41%; no patient required steroids, IVIG, or treatment discontinuation due to hematologic irAEs. Univariate regression analysis evaluating the predictors of developing at least one treatment-emergent cytopenia showed that lower baseline hemoglobin and a history of anemia were significant factors (p < 0.001; OR = 0.56 and p < 0.002; OR = 6.50, respectively). Additionally, regression analysis showed that baseline hemoglobin (OR 0.42, p < 0.001) and eosinophil count (OR 1.42, p = 0.004) were significant predictors of anemia and thrombocytopenia, respectively. On multivariable analysis, hemoglobin emerged as a significant predictor, with HGB showing an OR of 0.91 (95% CI: 0.869–0.963, p = 0.001).

Conclusion

Although usually rare in literature, we found treatment-emergent cytopenia to be common but mild and manageable with ICIs. Early monitoring and supportive care are key.