Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial.
Kownoh ParkYoung-Kyung JeonJung Hoon KimYounak ChoiJae-Joon KimSang-Bo OhSo Yeon OhYun Jeong HongSeok Jae HuhIlhwan KimSeong Hoon ShinPublished in: Medicine (2023)
This study is a randomized, multicenter, open-label, investigator-initiated phase 3 study. Patients with adjuvant/neoadjuvant or first-line palliative chemotherapy comprising intensively myelosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled. The patients are assigned to the same-day arm or the next-day arm in a 1:1 ratio. The randomizations are stratified according to number of patient CIN risk factors (1 vs ≥2), chemotherapy setting (perioperative vs palliative), and interval (2-week vs 3-week). In the same-day arm, pegteograstim 6 mg is subcutaneously injected within 4 hours after completion of chemotherapy. In the next-day arm, pegetograstim is injected at 24 to 36 hours post-chemotherapy. A complete blood count test is performed daily from day 5 to 9 during the cycle 1. The primary endpoint is duration of Gr4 CIN (cycle 1), and secondary endpoints include incidence of Gr 3 to 4 CIN (cycle 1), severity of CIN (cycle 1), time to recovery absolute neutrophil count 1000/μL (cycle 1), incidence of febrile neutropenia, incidence of CIN-related dose delay, and dose intensity. In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group.
Keyphrases
- chemotherapy induced
- open label
- risk factors
- clinical trial
- locally advanced
- phase iii
- end stage renal disease
- chronic kidney disease
- ejection fraction
- newly diagnosed
- rectal cancer
- peritoneal dialysis
- study protocol
- double blind
- randomized controlled trial
- squamous cell carcinoma
- physical activity
- prognostic factors
- palliative care
- phase ii
- placebo controlled
- patient reported outcomes
- lymph node
- peripheral blood
- patients undergoing
- cardiac surgery
- patient reported
- urinary tract infection
- metastatic colorectal cancer