Pegteograstim prophylaxis for chemotherapy-induced neutropenia and febrile neutropenia: a prospective, observational, postmarketing surveillance study in Korea.

Abstract

PURPOSE:

This observational study aimed to evaluate the safety and efficacy of pegteograstim prophylaxis in patients with lymphoma and solid malignancies.

METHODS:

This study was conducted at 18 sites in Korea between November 2015 and August 2018.

RESULTS:

In total, 611 patients (female, 61.2%) with a median age of 58 (range, 18-88) years were included. Most patients had lymphomas (n = 371, 60.7%) and breast cancer (n = 230, 37.6%) and were administered R-CHOP21 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone per 21 days) (n = 284, 46.5%) and AC (doxorubicin and cyclophosphamide) (n = 177, 29.0%). The total pegteograstim dose in the 611 patients was 14,970 mg (2495 doses), with each patient receiving an average daily dose of 6.0 mg. Neutropenia grade 4 occurred in 97 patients (15.9%), and febrile neutropenia (FN) occurred in 31 patients (5.1%). Among the 611 patients, 267 patients (43.7%) developed 882 adverse events (AEs), and 11 patients (1.8%) experienced 18 adverse drug reactions (ADRs). There were 62 patients (10.2%) who experienced 81 cases of serious adverse events (SAEs), with FN and pneumonia being the most frequent at 14 and 13 episodes, respectively, in 13 patients (2.1%). Meanwhile, 1 patient (0.2%) developed 2 episodes of serious ADRs (grade 1 and grade 2 hypotension). No safety concerns in the elderly and patients with liver and/or renal disease were identified.

CONCLUSION:

The prophylactic use of pegteograstim might have good overall safety and efficacy in patients with lymphomas and solid malignancies in routine clinical practice, even in those who are elderly and have liver and renal diseases.

• Authors: Jaekyung Cheon, Hyeon-Su Im, Ho-Jin Shin, Inho Kim, Won Sik Lee, Kyung-Hun Lee, Seong Kyu Park, Min Kyoung Kim, Un Jong Choi, Jung Han Kim, IlKyun Lee, Jae-Cheol Jo
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 29 Issue 9 Pg. 5383-5390 (Sep 2021) ISSN: 1433-7339 [Electronic] Germany
• PMID: 33683460 (Publication Type: Journal Article, Observational Study)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Chemical References

• Antineoplastic Agents
• Granulocyte Colony-Stimulating Factor
• Doxorubicin
• Cyclophosphamide

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Breast Neoplasms (drug therapy)
• Chemotherapy-Induced Febrile Neutropenia (epidemiology, prevention & control)
• Cyclophosphamide (adverse effects)
• Doxorubicin (therapeutic use)
• Female
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Male
• Middle Aged
• Prospective Studies
• Republic of Korea
• Young Adult