A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI
- 166 Downloads
Practice patterns of same-day versus next-day pegfilgrastim vary in numerous practice settings across the country. Current utilization with same-day pegfilgrastim reduced overall visits and reduced treatment time for chemotherapy administration.
To assess the efficacy and safety of same-day versus next-day pegfilgrastim in patients with colorectal cancer.
Patient data was extracted through electronic health records (EHR) search of ICD-9 codes that matched patients with CRC and treated with FOLFOX or FOLFIRI from November 2013 to January 2016. The incidence rates of primary and secondary endpoints were estimated for patients who received either FOLFOX or FOLFIRI and same-day pegfilgrastim with 2-sided 95% confidence intervals. Fisher’s exact test for 2 × 2 contingency tables was used to compare the incidence of primary and secondary endpoints between the two study groups performed at the α = 0.05 significance level. A study by Hecht et al. served as a historical control for next-day pegfilgrastim.
A total of 109 out of an initial 330 patients with appropriate ICD-9 criteria were eligible for study inclusion. The primary endpoint of incidence of FN recorded over 4 chemotherapy cycles with either FOLFOX6 or FOLFIRI occurred in 3.7% of patients (95% CI, 1.1–9.4%). Secondary endpoints also occurred with a relatively low incidence: 13 patients developed grades 3/4 neutropenia (11.9%; 95% CI, 7.0–19.5%); 11 patients required dose reductions because of neutropenia or FN (10.1%; 95% CI, 5.6–17.3%); and 5 patients were hospitalized due to neutropenia or FN (4.6%; 1.7–10.6%). There were 4 reported events of FN (3.2%; 95% CI, 1.0–8.3%) for those who received next-day pegfilgrastim compared to 11 events in the placebo group (9.4%; 95% CI, 5.1–16.4%). The incidence of dose delays or dose reductions due to neutropenia or FN were 5 (4.1%, 95% CI, 1.5–9.4%) in the next-day pegfilgrastim group versus 26 (22.1%, 95% CI, 15.5–30.4%) in the placebo group.
The study was retrospective in design and utilized a historical control for the comparator.
Our study results suggest that same-day pegfilgrastim administration may be a safe and effective alternative to 24-h post-chemotherapy administration in patients with esophageal, gastric, appendiceal, or colorectal cancer undergoing treatment with FOLFOX or FOLFIRI.
KeywordsGastrointestinal cancers FOLFOX FOLFIRI Same-day pegfilgrastim Febrile neutropenia
- 4.de Gramont AD, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938–2947CrossRefPubMedGoogle Scholar
- 5.Douillard J, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355:1041–1047CrossRefPubMedGoogle Scholar
- 6.Hecht JR, Pillai M, Gollard R, Heim W, Swan F, Patel R, Dreiling L, Mo M, Malik I (2010) A randomized, placebo-controlled phase II study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer 9:95–101CrossRefPubMedGoogle Scholar
- 9.Crawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I, Kris M, Grous J, Picozzi V, Rausch G, Smith R, Gradishar W, Yahanda A, Vincent M, Stewart M, Glaspy J (1991) Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 325:164–170CrossRefPubMedGoogle Scholar
- 10.Vogel CL, Wojtukiewicz MZ, Carroll RR, Tjulandin SA, Barajas-Figueroa LJ, Wiens BL, Neumann TA, Schwartzberg LS (2005) First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 23:1178–1184CrossRefPubMedGoogle Scholar
- 11.Holmes FA, O’shaughnessy JA, Vukelja S et al (2002) Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20:727–731CrossRefPubMedGoogle Scholar
- 14.(2015) Neulasta ® [package insert]. Amgen Inc, Thousand OaksGoogle Scholar
- 15.Burris HA, Belani CP, Kaufman PA et al (2010) Pegfilgrastim on the same day versus next day of chemotherapy in patients with breast cancer, non–small-cell lung cancer, ovarian cancer, and non-Hodgkin’s lymphoma: results of four multicenter, double-blind, randomized phase II studies. J Oncol Pract 6:133–140CrossRefPubMedGoogle Scholar
- 16.Whitworth JM, Matthews KS, Shipman KA, Numnum TM, Kendrick JE, Kilgore LC, Straughn JM Jr (2009) The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies. Gynecol Oncol 112:601–604CrossRefPubMedGoogle Scholar
- 17.National Comprehensive Cancer Network. Myeloid growth factors (version 1. 2016). http://www.nccn.org/professionals/physican_gls/PDF/myeloiod_growth.pdf. Accessed 10 Mar 2016
- 18.Weycker D, Wu H, Hagiwara M et al (2014) Use of chemotherapy and same-day prophylaxis in US Clinical Practice. Blood 124:4825Google Scholar
- 19.Bilen MA, Cauley DH, Atkinson BJ, Chen HC, Kaya DH, Wang X, Vikram R, Tu SM, Corn PG, Kim J (2017) Safety of same-day pegfilgrastim administration in metastatic castration-resistant prostate cancer treated with cabazitaxel with or without carboplatin. Clin Genitourin Cancer 15:e429–e435CrossRefPubMedGoogle Scholar