Skip to main content
Erschienen in: Investigational New Drugs 3/2020

15.11.2019 | PHASE II STUDIES

A pilot study on intermittent every other days of 5-dose Filgrastim compared with single Pegfilgrastim in breast Cancer patients receiving adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy

verfasst von: Byeong Seok Sohn, Jae Ho Jeong, Jin-Hee Ahn, Kyung Hae Jung, Jeong Eun Kim, Joo Hyuk Sohn, Su-Jin Koh, Jae Hong Seo, Keun Seok Lee, Sung-Bae Kim

Erschienen in: Investigational New Drugs | Ausgabe 3/2020

Einloggen, um Zugang zu erhalten

Summary

Aim To compare the efficacy and safety of intermittent every other days 5-dose filgrastim with single pegfilgrastim in patients with breast cancer receiving adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. Methods In this pilot study, Korean patients who had undergone complete resection for breast cancer and scheduled for adjuvant TAC chemotherapy were enrolled. Patients were randomized to receive either intermittent 5 doses of filgrastim (5 mcg/kg/day) or once-a-cycle pegfilgrastim (6 mg) as primary prophylaxis during the first three cycles of the TAC chemotherapy. Absolute neutrophil count (ANC) was analyzed as well. Results A total of 22 patients were randomly and equally divided into filgrastim or pegfilgrastim arms. Febrile neutropenia (FN) occurred in 1 patient in the pegfilgrastim arm (1 of 33 cycles) and none in the filgrastim arm. G3 neutropenia occurred in 1 patient (1 of 33 cycles) in the filgrastim arm and 2 patients (4 of 33 cycles) in the pegfilgrastim arm (P = 0.476). G4 neutropenia occurred in 11 patients (28 of 33 cycles) in the filgrastim arm and 9 patients (18 of 33 cycles) in the pegfilgrastim arm (P = 0.476). Except for on day 9 in cycle 3, there was no significant difference between the two groups in terms of ANC. Conclusion We observed no significant differences between the two methods of prophylaxis in terms of FN and G3/4 neutropenia incidence in patients receiving adjuvant TAC chemotherapy. Intermittent every other days 5-dose filgrastim may be available alternative to pegfilgrastim.
Literatur
1.
Zurück zum Zitat Eiermann W, Pienkowski T, Crown J et al (2011) Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 29:3877–3884. https://doi.org/10.1200/jco.2010.28.5437 CrossRefPubMed Eiermann W, Pienkowski T, Crown J et al (2011) Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 29:3877–3884. https://​doi.​org/​10.​1200/​jco.​2010.​28.​5437 CrossRefPubMed
6.
7.
Zurück zum Zitat Siena S, Piccart MJ, Holmes FA, Glaspy J, Hackett JRenwick JJ (2003) A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncol Rep 10:715–724PubMed Siena S, Piccart MJ, Holmes FA, Glaspy J, Hackett JRenwick JJ (2003) A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncol Rep 10:715–724PubMed
9.
Zurück zum Zitat Park KH, Sohn JH, Lee S et al (2013) A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer. Investig New Drugs 31:1300–1306. https://doi.org/10.1007/s10637-013-9973-4 CrossRef Park KH, Sohn JH, Lee S et al (2013) A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer. Investig New Drugs 31:1300–1306. https://​doi.​org/​10.​1007/​s10637-013-9973-4 CrossRef
10.
13.
Zurück zum Zitat Koumakis G, Vassilomanolakis M, Barbounis V, Hatzichristou E, Demiri S, Plataniotis G, Pamouktsoglou FEfremidis AP (1999) Optimal timing (preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology 56:28–35. https://doi.org/10.1159/000011926 CrossRefPubMed Koumakis G, Vassilomanolakis M, Barbounis V, Hatzichristou E, Demiri S, Plataniotis G, Pamouktsoglou FEfremidis AP (1999) Optimal timing (preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology 56:28–35. https://​doi.​org/​10.​1159/​000011926 CrossRefPubMed
14.
Zurück zum Zitat Martin M, Lluch A, Segui MA et al (2006) Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 17:1205–1212. https://doi.org/10.1093/annonc/mdl135 CrossRefPubMed Martin M, Lluch A, Segui MA et al (2006) Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 17:1205–1212. https://​doi.​org/​10.​1093/​annonc/​mdl135 CrossRefPubMed
22.
Zurück zum Zitat Rader M (2006) Granulocyte colony-stimulating factor use in patients with chemotherapy-induced neutropenia: clinical and economic benefits. Oncology (Williston Park) 20(5 Suppl 4):16–21 Rader M (2006) Granulocyte colony-stimulating factor use in patients with chemotherapy-induced neutropenia: clinical and economic benefits. Oncology (Williston Park) 20(5 Suppl 4):16–21
26.
Zurück zum Zitat Holmes FA, Jones SE, O'Shaughnessy J et al (2002) Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13:903–909. https://doi.org/10.1093/annonc/mdf130 CrossRefPubMed Holmes FA, Jones SE, O'Shaughnessy J et al (2002) Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13:903–909. https://​doi.​org/​10.​1093/​annonc/​mdf130 CrossRefPubMed
28.
Zurück zum Zitat von Minckwitz G, Raab G, Caputo A et al (2005) Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German breast group. J Clin Oncol 23:2676–2685. https://doi.org/10.1200/jco.2005.05.078 CrossRef von Minckwitz G, Raab G, Caputo A et al (2005) Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German breast group. J Clin Oncol 23:2676–2685. https://​doi.​org/​10.​1200/​jco.​2005.​05.​078 CrossRef
29.
Zurück zum Zitat Nabholtz JM, Cantin J, Chang J et al (2002) Phase III trial comparing granulocyte colony-stimulating factor to leridistim in the prevention of neutropenic complications in breast cancer patients treated with docetaxel/doxorubicin/cyclophosphamide: results of the BCIRG 004 trial. Clin Breast Cancer 3:268–275. https://doi.org/10.3816/CBC.2002.n.030 CrossRefPubMed Nabholtz JM, Cantin J, Chang J et al (2002) Phase III trial comparing granulocyte colony-stimulating factor to leridistim in the prevention of neutropenic complications in breast cancer patients treated with docetaxel/doxorubicin/cyclophosphamide: results of the BCIRG 004 trial. Clin Breast Cancer 3:268–275. https://​doi.​org/​10.​3816/​CBC.​2002.​n.​030 CrossRefPubMed
Metadaten
Titel
A pilot study on intermittent every other days of 5-dose Filgrastim compared with single Pegfilgrastim in breast Cancer patients receiving adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy
verfasst von
Byeong Seok Sohn
Jae Ho Jeong
Jin-Hee Ahn
Kyung Hae Jung
Jeong Eun Kim
Joo Hyuk Sohn
Su-Jin Koh
Jae Hong Seo
Keun Seok Lee
Sung-Bae Kim
Publikationsdatum
15.11.2019
Verlag
Springer US
Erschienen in
Investigational New Drugs / Ausgabe 3/2020
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-019-00863-8

Weitere Artikel der Ausgabe 3/2020

Investigational New Drugs 3/2020 Zur Ausgabe

Adjuvante Immuntherapie verlängert Leben bei RCC

25.04.2024 Nierenkarzinom Nachrichten

Nun gibt es auch Resultate zum Gesamtüberleben: Eine adjuvante Pembrolizumab-Therapie konnte in einer Phase-3-Studie das Leben von Menschen mit Nierenzellkarzinom deutlich verlängern. Die Sterberate war im Vergleich zu Placebo um 38% geringer.

Alectinib verbessert krankheitsfreies Überleben bei ALK-positivem NSCLC

25.04.2024 NSCLC Nachrichten

Das Risiko für Rezidiv oder Tod von Patienten und Patientinnen mit reseziertem ALK-positivem NSCLC ist unter einer adjuvanten Therapie mit dem Tyrosinkinase-Inhibitor Alectinib signifikant geringer als unter platinbasierter Chemotherapie.

Bei Senioren mit Prostatakarzinom auf Anämie achten!

24.04.2024 DGIM 2024 Nachrichten

Patienten, die zur Behandlung ihres Prostatakarzinoms eine Androgendeprivationstherapie erhalten, entwickeln nicht selten eine Anämie. Wer ältere Patienten internistisch mitbetreut, sollte auf diese Nebenwirkung achten.

ICI-Therapie in der Schwangerschaft wird gut toleriert

Müssen sich Schwangere einer Krebstherapie unterziehen, rufen Immuncheckpointinhibitoren offenbar nicht mehr unerwünschte Wirkungen hervor als andere Mittel gegen Krebs.

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.