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CC BY-NC-ND 4.0 · South Asian J Cancer
DOI: 10.1055/s-0045-1809351
Original Article

Evaluation of the Efficacy of Romiplostim in Management of Chemotherapy-Induced Thrombocytopenia in Indian Patients: A Retrospective Study

Vikas Talreja 
1   Department of Medical Oncology, Regency Hospital Ltd, Kanpur, Uttar Pradesh, India
,
Sangeeta Khatwani
2   Department of Pediatrics, Rama Hospital and University, Kanpur, Uttar Pradesh, India
,
Priyanka Subhagan
3   Department of Medical Affairs, Alkem Laboratories Ltd, Mumbai, Maharashtra, India
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Abstract

Introduction

Chemotherapy-induced thrombocytopenia (CIT) is a frequent complication of antineoplastic therapy. The incidence of CIT varies with cancer type and regimen used. CIT can result in chemotherapy delays, dose reductions, and discontinuation, leading to reduced survival rates· Romiplostim is a thrombopoietin receptor agonist that is effective for the treatment of CIT.

Aim

This article evaluates the efficacy and safety of romiplostim in patients with CIT in a real-world setting

Methodology

The study was a retrospective, single-center study, which enrolled patients with solid tumors or hematological malignancies with persistent thrombocytopenia who had been treated with romiplostim.

Results

A total of 100 patients with CIT were categorized into three treatment groups: romiplostim 500 mcg (N = 56), romiplostim 500 mcg + 1-unit random donor platelets (RDP) (N = 35), and romiplostim 500 mcg + 2-unit RDP (N = 9). The most common malignancies were gallbladder carcinoma in the romiplostim 500 mcg group, breast cancer in the romiplostim 500 mcg + 1-unit RDP group (31.4%), and gallbladder and head and neck carcinoma in the romiplostim 500 mcg + 2-unit RDP group. Chemotherapy regimens varied, with gemcitabine + cisplatin (26.7%), Adriamycin + cyclophosphamide (31%), and paclitaxel + carboplatin (22%) being the most used in each group, respectively. Grade I thrombocytopenia was most frequent with Capox (22.2%), grade II with gemcitabine + cisplatin (42.3%), grade III with paclitaxel + carboplatin and gemcitabine + cisplatin (17.02%), and grade IV with paclitaxel + carboplatin (44.4%). Romiplostim significantly increased platelet counts across all groups (p < 0.001), demonstrating its effectiveness in managing CIT across all severity grades.

Conclusion

Romiplostim was effective in increasing platelet counts regardless of the grade of thrombocytopenia. Romiplostim use for the management of CIT will help in correcting CIT and allow resumption of chemotherapy without recurrence of CIT in most patients undergoing cancer chemotherapy.


 

Keywords

cancer - chemotherapy-induced thrombocytopenia - malignancies - romiplostim - tumor
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Vikas Talreja

Introduction

Chemotherapy-induced thrombocytopenia (CIT) is a common complication of cytotoxic and targeted therapies, leading to treatment delays, dose reductions, and increased bleeding risk.[1] [2] [3] Despite its clinical impact, no Food and Drug Administration- or European Medicines Agency-approved therapies exist for CIT, and management has traditionally relied on platelet transfusions and chemotherapy modifications.[2] [4] Thrombopoietin receptor agonists (TPO-RAs), particularly romiplostim, have shown promise in increasing platelet counts and allowing chemotherapy continuation.[5] [6] Romiplostim, a second-generation TPO-RA, stimulates platelet production without inducing thrombopoietin autoantibodies, making it a viable treatment option.[7] This study evaluates the efficacy and safety of romiplostim in managing CIT in Indian patients, providing real-world insights into its role across various tumor types and thrombocytopenia grades.[2] [8]


 

Aim

This article evaluates the efficacy and safety of romiplostim in patients with CIT in a real-world setting.


 

Methodology

The study was a retrospective, single-center study conducted in Regency Hospital Ltd., Kanpur, Uttar Pradesh, India. The criteria for including patients from the database of cancer hospital included patients with solid tumors or hematological malignancies with thrombocytopenia who had been treated with romiplostim. Patients enrolled had undergone diverse chemotherapy regimens and had been treated with romiplostim. Patients enrolled had persistent thrombocytopenia defined as platelet cutoff of 50 to 100 × 109/L if lasting ≥ 3 to 4 weeks.


 

Results

Patients were categorized into three groups based on the treatments they had received. These included romiplostim 500 mcg (N = 56), romiplostim 500 mcg + 1-unit random donor platelets (RDP) (N = 35), and romiplostim 500 mcg + 2-unit RDP (N = 9). The mean age of patients in the romiplostim 500 mcg group was 53.70 ± 16.88 years, in the Romiplostim 500 mcg + 1-unit RDP group was 46.77 ± 12.28 years, and in the romiplostim 500 mcg + 2-unit RDP group was 61.22 ± 9.15 years.

In the romiplostim 500 mcg group 55.4% were males, whereas in the romiplostim 500 mcg + 1-unit RDP group 37.1% were males as compared to 66.7% in the romiplostim 500 mcg + 2-unit RDP group.

Both males and females were enrolled in the three treatment groups.

Diagnosis of the Type of Cancer

In the romiplostim 500 mcg group, gallbladder carcinoma was the most common solid tumor; in the romiplostim 500 mcg + 1-unit RDP group, breast cancer was the most frequent cancer type (31.4%); and in the romiplostim 500 mcg + 2-unit RDP group, carcinoma of the gallbladder and carcinoma of head and neck were the most common cancers ([Table 1]).

Table 1

Types of cancer in patients enrolled

Type of Cancer

Romiplostim 500 mcg (N = 56)

Romiplostim 500 mcg + 1 unit RDP (N = 35)

Romiplostim 500 mcg + 2 units RDP (N = 9)

Carcinoma Breast

4 (7.1%)

11 (31.4%)

–

Carcinoma Cervix

1 (1.8%)

–

–

Carcinoma Colon

4 (7.1%)

–

1 (11.1%)

Carcinoma Colon with Liver Metastases

3 (5.4%)

1 (2.9%)

–

Carcinoma Gallbladder (all stages)

19 (33.9%)

7 (20.0%)

3 (33.3%)

Carcinoma Head & Neck

5 (8.9%)

3 (8.6%)

3 (33.3%)

Carcinoma Lung

5 (8.9%)

4 (11.4%)

1 (11.1%)

Carcinoma Oral Cavity

2 (3.6%)

2 (5.7%)

–

Carcinoma Prostate (including metastatic)

6 (10.7%)

–

1 (11.1%)

Carcinoma Rectum

5 (8.9%)

4 (11.4%)

–

Carcinoma Rectosigmoid

1 (1.8%)

1 (2.9%)

–

Carcinoma Stomach

1 (1.8%)

–

–

Non-Hodgkin Lymphoma (NHL)

–

1 (2.9%)

–

T-cell ALL

–

1 (2.9%)

–

Abbreviations: ALL, acute lymphoblastic leukemia; Ca, carcinoma; GB, gallbladder; Mets, metastases; NHL, non-Hodgkin lymphoma; RDP, random donor platelets.



 

Chemotherapy Regimens Prescribed

In the romiplostim 500 mcg group, the most commonly prescribed chemotherapy regimen was gemcitabine + cisplatin (26.7%), followed by FOLFOX (19.6%). In the romiplostim 500 mcg + 1-unit RDP group, AC (Adriamycin + cyclophosphamide) (31%) was the most frequently prescribed regimen. Among patients in the romiplostim 500 mcg + 2-units RDP group (N = 9), paclitaxel + carboplatin (22%) and gemcitabine + cisplatin (22%) were the most common regimens.


 

Grade of Thrombocytopenia

Grade I thrombocytopenia was observed the most in the Capox regimen (22.2%), while grade II was highest in gemcitabine + cisplatin (42.3%). Grade III was frequently seen with paclitaxel + carboplatin (17.02%) and gemcitabine + carboplatin (17.02%), whereas grade IV was most common with paclitaxel + carboplatin (44.4%) ([Table 2]).

Table 2

Grade of thrombocytopenia

Regimen

Thrombocytopenia

Grade I

(N = 18)

n (%)

Grade II

(N = 26)

n (%)

Grade III

(N = 47)

n (%)

Grade IV

(N = 9)

n (%)

A + C (Adriamycin and cyclophosphamide)

0 (0.0)

1 (3.85)

12 (3.91)

0 (0.0)

BFM-95

0 (0.0)

0 (0.0)

1 (2.13)

0 (0.0)

Cabazitaxel

2 (11.11)

1 (3.85)

0 (0.0)

0 (0.0)

Capox

4 (22.22)

1 (3.85)

1 (2.13)

0 (0.0)

Cabazitaxel + Carboplatin

0 (0.0)

0 (0.0)

1 (2.13)

0 (0.0)

Docetaxel

0 (0.0)

1 (3.85)

0 (0.0)

0 (0.0)

Docetaxel + Cabazitaxel

0 (0.0)

0 (0.0)

1 (2.13)

1 (11.11)

FOLFIRI

0 (0.0)

0 (0.0)

4 (8.51)

0 (0.0)

FOLFOX

3 (16.67)

5 (19.23)

6 (12.77)

0 (0.0)

Gemcitabine_Cisplatin

4 (22.22)

11 (42.31)

8 (17.02)

2 (22.22)

Gemcitabine + Carboplatin

0 (0.0)

1 (3.85)

0 (0.0)

0 (0.0)

Paclitaxel_Carboplatin

2 (11.11)

4 (15.38)

8 (17.02)

4 (44.44)

Paclitaxel + Cisplatin + Bevacizumab

2 (11.11)

0 (0.0)

0 (0.0)

0 (0.0)

Pemetrexed_ Carboplatin

1 (5.56)

1 (3.85)

4 (8.51)

2 (22.22)

R-CHOP

0 (0.0)

0 (0.0)

1 (2.13)

0 (0.0)

Abbreviations: A + C, Adriamycin (Doxorubicin) + Cyclophosphamide; BFM-95, Berlin-Frankfurt-Münster 95 protocol; Capox, Capecitabine + Oxaliplatin; FOLFOX, 5-Fluorouracil + Leucovorin + Oxaliplatin; FOLFIRI, 5-Fluorouracil + Leucovorin + Irinotecan; R-CHOP, Rituximab + Cyclophosphamide + Doxorubicin + Vincristine + Prednisolone.



 

Mean Change in Platelet Count

In all the three treatment groups, there was a significant increase in platelet count after treatment with romiplostim as compared to baseline (p < 0.001). In both grade III and grade IV thrombocytopenia a significant rise in platelet count was observed. Romiplostim was effective in increasing platelet counts regardless of the grade of thrombocytopenia ([Fig. 1]).

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Fig. 1 Mean change in platelet count.

 

 

Discussion

CIT is a frequent complication of cytotoxic chemotherapy, especially with gemcitabine- and platinum-based regimens. Different chemotherapy agents cause CIT through various mechanisms, such as stem cell suppression or impaired platelet production.[6] The National Cancer Institute's Common Terminology Criteria for Adverse Events classifies thrombocytopenia from grade I (< 75 × 109/L) to grade IV (< 25 × 109/L), with severe cases increasing bleeding risks. CIT often leads to chemotherapy dose reductions or interruptions, affecting survival.[6]

Until recently, therapy for CIT chiefly consisted of platelet transfusions and supportive care during severe, symptomatic nadirs. But platelet transfusion is a temporary, unreliable treatment option that is often impractical or impossible to continue for extended periods TPO-RAs like romiplostim have proven effective in clinical trials by stimulating platelet production, reducing bleeding, and minimizing chemotherapy disruptions.[2] In a retrospective study (153 solid tumors and 20 lymphoma/myeloma), 71% of patients responded to romiplostim, 79% avoided chemotherapy delays, and 89% did not require transfusions.[9] Another study showed platelet counts rising from 62,000/μL to 141,000/μL within 2 weeks, with 93% achieving platelet correction within 3 weeks. Long-term romiplostim use (> 1 year) was safe without evidence of resistance or increased risk of thrombosis.[5]

In the current study, the efficacy of romiplostim was evaluated regardless of the type of cancer and chemotherapy regimen used. Patients with diverse types of cancer were included, including carcinoma of the lung, liver, gallbladder, breast, cervix, stomach, rectum, colon, prostate, and patients with metastases. In the romiplostim 500 mcg group, the most commonly prescribed chemotherapy regimens were gemcitabine + cisplatin (26.7%), followed by FOLFOX (19.6%) and paclitaxel + carboplatin (8.9%). In the romiplostim 500 mcg + 1-unit RDP group A + C (31%) was the most commonly prescribed chemotherapy regimens. In the romiplostim 500 mcg + 2-unit RDP group (N = 9), paclitaxel + carboplatin (22%) and gemcitabine + cisplatin (22%) were the most commonly prescribed chemotherapy regimens. Grade I thrombocytopenia was observed the most in the Capox regimen (22.2%), while grade II was highest in gemcitabine + cisplatin (42.3%). Grade III was frequently seen with paclitaxel + carboplatin (17.02%) and gemcitabine + carboplatin (17.02%), whereas grade IV was most common with paclitaxel + carboplatin (44.4%).

Romiplostim significantly increased platelet counts across all groups (p < 0.001), regardless of thrombocytopenia grade, cancer type, or chemotherapy regimen. These findings confirm romiplostim's effectiveness in managing CIT.

The limitations of the current study include the retrospective nature of the study. The findings of this study need to be corroborated in large multicentric studies.


 

Conclusion

Treatment of CIT poses a treatment challenge. CIT can result in chemotherapy delays, dose reductions, and discontinuation, leading to reduced survival rates. In the current retrospective study, the efficacy of romiplostim was demonstrated in treating CIT regardless of the type of cancer and chemotherapy regimen used. Romiplostim was effective in increasing platelet counts regardless of the grade of thrombocytopenia. Romiplostim use for the management of CIT will help in correcting CIT and allow resumption of chemotherapy without recurrence of CIT in most patients undergoing cancer chemotherapy.


 

 

Conflict of Interest

None declared.


Address for correspondence

Vikas Talreja, MD, DM
Regency Hospital Ltd
Kanpur, Uttar Pradesh
India   

Publication History

Received: 03 March 2025

Accepted: 02 May 2025

Article published online:
18 June 2025

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Vikas Talreja
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Fig. 1 Mean change in platelet count.