Phase II study of weekly paclitaxel/carboplatin in combination with prophylactic G-CSF in the treatment of gynecologic cancers: A study in 108 patients by the Belgian Gynaecological Oncology Group

Vergote, Ignace;Debruyne, Philippe;Kridelka, Frédéric;Berteloot, Patric;Laenen, Annouschka;et.al.
(2015) Gynecologic Oncology — Vol. 138, n° 2, p. 278-284 (2015)

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Authors
  • Vergote, Ignace
    Author
  • Debruyne, Philippe
    Author
  • Kridelka, Frédéric
    Author
  • Berteloot, Patric
    Author
  • Vuylsteke, PeterUCLouvain
    Author
  • D'Hondt, LionelUCLouvain
    Author
  • Laenen, Annouschka
    Author
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Abstract
Objective To investigate the addition of prophylactic G-CSF to each weekly paclitaxel/carboplatin course in patients with recurrent platinum-resistant ovarian (OC), or recurrent or advanced endometrial (EC) or cervical carcinoma (CC). Methods 108 patients were enrolled i.e. 36 in each cohort. Eighteen courses of paclitaxel (60 mg/m2) and carboplatin (AUC 2.7) were administered weekly. G-CSF (filgrastim) was given to all patients on day 5 (and if needed on day 6). Results For patients with OC, 91% had platinum-resistant and 9% platinum-refractory disease. Median number of prior chemotherapy lines was 3 for OC, 1 for EC, and 1 for CC. Grade 3-4 neutropenia was observed in 34% of patients (95% CI: 26%-44%, P < 0,0001) (OC 29%, EC 36%, CC 38%). This is lower compared to historical data in all cohorts (84%). Confirmed sepsis was observed in 5%, grade 3-4 thrombocytopenia in 41%, grade 2-3 peripheral neuropathy in 17% of patients. In 71% of patients dose was delayed. Dose reduction was necessary for carboplatin in 47% and paclitaxel in 18% of patients. ORR was 51% (OC 48%, EC 45%, CC 58%). Median (95% CI) PFS and OS was 7.1 (5.1-8.1) and 12.7 (10.2-16.3) months, respectively (OC 7 and 13, EC 6 and 19, CC 6 and 14). Conclusion Weekly paclitaxel/carboplatin with G-CSF is an effective treatment with acceptable toxicity in patients with platinum-resistant or platinum-refractory OC, advanced or recurrent EC and CC. The incidence of grade 3-4 neutropenia is lower with the addition of weekly G-CSF compared with earlier studies without routine use of prophylactic G-CSF. © 2015 Elsevier Inc. All rights reserved.
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Vergote, I., Debruyne, P., Kridelka, F., Berteloot, P., Amant, F., Honhon, B., Lybaert, W., Leunen, K., Geldhof, K., Verhoeven, D., Forget, F., Vuylsteke, P., D’Hondt, L., Huizing, M., Van Den Bulck, H., & Laenen, A. (2015). Phase II study of weekly paclitaxel/carboplatin in combination with prophylactic G-CSF in the treatment of gynecologic cancers: A study in 108 patients by the Belgian Gynaecological Oncology Group. Gynecologic Oncology, 138(2), 278-284. https://doi.org/10.1016/j.ygyno.2015.05.042 (Original work published 2015)