Optimal schedule for administering granulocyte colony-stimulating factor in chemotherapy-induced neutropenia in non-small-cell lung cancer

Soda, Hiroshi; Oka, M.; Fukuda, Masaaki; Kinoshita, Akitoshi; Sakamoto, Akira; Araki, Jun; Fujino, Satoru; Itoh, Naomi; Watanabe, Koichi; Kanda, Tomomasa; Hara, Kohei

doi:10.1007/s002800050440

Cited by 26 publications

(21 citation statements)

References 14 publications

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“…Koumakis et al [9] have shown that starting G-CSF administration within 24-72 h after chemotherapy provides good neutrophil recovery and decreases the number of febrile episodes and the antibiotic use. However, in other studies G-CSF not given until more than 72 h after chemotherapy was associated with a similar pattern of hematologic recovery and meant the total dose of G-CSF administered was smaller [5,17]. In our study, with lenograstim started on day 5, the incidence of severe neutropenia and febrile episodes was slight and the cost of treatment was lower.…”

Section: Discussioncontrasting

confidence: 48%

A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia

Juan

Campos

Carañana

et al. 2001

Supportive Care in Cancer

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The aim of this trial was to compare the severity of neutropenia, the frequency of hospital admission for fever or infection, and the use of antibiotics among patients treated with a standard dose of lenograstim (263 microg/day of Euprotin) and others treated with half of this dose (131.5 microg/day) and the cost-effectiveness of each of the two doses. In this single-center study, 44 patients with solid tumors, who were all receiving standard-dose chemotherapy regimens following previous neutropenia or were at high risk of neutropenia, were randomized to receive lenograstim at a dose of 263 microg or 131.5 microg daily in the first cycle and then crossed over to the alternate dose for the following cycle. Crossover to the alternate dose was repeated for patients who received more than two cycles. Lenograstim was administered from day +5 to day +14. The absolute neutrophil count (ANC) was assessed on days +5, +8, +12 and +15 of each cycle. Statistical analysis was performed using a general lineal model for repeated samples. In all, 120 cycles were administered, with a median of 3 cycles (range 1-6). Only 4 patients received only 1 cycle. No statistically significant difference (P=0.324) in ANC was observed between standard-dose (mean 5.3, 10.7, 8.3, 11.4 x 10(9)/l) and low-dose (5.0, 8.6, 5.4, 7.5 x 10(9)/l) treatment at days +5, +8, +12 and + 15. Neutropenia grade III-IV was more common in patients receiving the low than in those receiving the standard dose of lenograstim (20% vs 12%, respectively), but the difference did not reach statistical significance (P=0.1). The incidence of fever and frequency of hospital admission were not affected by the dose of lenograstim: 3 patients presented with fever with the standard dose (all of those were admitted to hospital) and 2 patients with the low dose (1 was admitted). ANC in both groups (standard and low doses) was independent of chemotherapy line (first versus second or more). Lenograstim at a dose of 131.5 microg/day is as effective as the standard dose in limiting the severity of neutropenia and in preventing episodes of fever and hospital admissions after chemotherapy for solid tumors. The lower dose of lenograstim is cost-effective in neutropenia prophylaxis. Starting its administration on day +5 reduces costs while maintaining efficacy.

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Section: Discussioncontrasting

confidence: 48%

A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia

Juan

Campos

Carañana

et al. 2001

Supportive Care in Cancer

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“…Consequently, "rules of thumb" or more sophisticated methods of determination of the most promising protocols should be applied. "Rules of thumb" appear to fail in such a question as whether or not and by how long to delay the initiation of G-CSF support post-chemotherapy, leading to controversial results [5], [11], [19], [21]. In this work we applied a physiologically-based mathematical model of human granulopoiesis [20] in conjunction with doxurubicin PK/PD model in order to evaluate improved protocols of chemotherapeutic and myelo-supportive treatment.…”

Section: Discussionmentioning

confidence: 99%

“…However, the latter tools falls short of clarifying which schedule of G-CSF is optimal with respect to chemotherapeutic drugs. This question is evaluated in costly clinical trials by an inefficient trial-and-error method, which lead to controversial results [5], [11], [19], [21]. It should be noted that G-CSF can cause unpleasant side effects such as bone pain.…”

Section: Introductionmentioning

confidence: 99%

Improving Cancer Therapy by Doxorubicin and Granulocyte Colony-Stimulating Factor: Insights from a Computerized Model of Human Granulopoiesis

Vainstein

Ginosar

Shoham

et al. 2006

Math. Model. Nat. Phenom.

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Abstract. Neutropenia is a significant dose-limiting toxicity of cancer chemotherapy, especially in dose-intensified regimens. It is widely treated by injections of Granulocyte ColonyStimulating Factor (G-CSF). However, optimal schedules of G-CSF administration are still not determined. In order to aid in identifying more efficacious and less neutropenic treatment protocols, we studied a detailed physiologically-based computer model of granulopoiesis, as affected by different treatment schedules of doxorubicin and/or Granulocyte ColonyStimulating Factor (G-CSF). We validated the model as evident from accurate prediction of clinical data on human granulopoiesis in healthy individuals and in doxorubicin-treated cancer patients, with or without G-CSF support. Based on our model, we suggest new G-CSF administration regimens. These regimens include reduced G-CSF doses, optimally timed post-chemotherapy. Application of these regimens can lead to minimization of G-CSF side effects, as well as more cost-effective and less myelotoxic protocols. Currently clinical trials are being designed in order to test these new treatment regimens.

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“…First, a double-blind RCT [52] comparing GM-CSF with placebo in 60 patients; second, a threearm RCT [53] using prophylactic G-CSF in two arms and therapeutic G-CSF in the third arm, in 33 non-small lung cancer patients; and last, a RCT [54] comparing G-CSF with placebo in 138 patients. Overall, these small RCTs showed a decreased duration of neutropenia in the CSF arms, but failed to show other clinical benefi ts.…”

Section: Use Of Csf In Afebrile Neutropeniamentioning

confidence: 99%

Spanish Society of Medical Oncology consensus for the use of haematopoietic colony-stimulating factors in cancer patients

et al. 2009

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Neutropenia is a common complication of cancer chemotherapy. Colony-stimulating factors (CSF) may be used to avoid neutropenia-associated complications. The Spanish Society of Medical Oncology (SEOM) recently constituted a working group to review the main issues concerning the use of CSF and carried out a consensus process about the use of CSF in cancer patients, held in Madrid on 26 May 2006. The group concluded the following recommendations: prophylactic use of CSF is recommended when a rate of febrile neutropenia (FN) higher than 20% is expected without the use of CSF or when additional risk factors for neutropenia exist; therapeutic use of CSF is recommended in order to treat FN episodes but not to treat afebrile neutropenic episodes. In addition, the use of CSF is considered effective when used to mobilise stem cells before high-dose chemotherapy and when used for chemotherapy schedule optimisation in dose-dense and in dose-intense regimens.

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Optimal schedule for administering granulocyte colony-stimulating factor in chemotherapy-induced neutropenia in non-small-cell lung cancer

Cited by 26 publications

References 14 publications

A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia

A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia

Improving Cancer Therapy by Doxorubicin and Granulocyte Colony-Stimulating Factor: Insights from a Computerized Model of Human Granulopoiesis

Spanish Society of Medical Oncology consensus for the use of haematopoietic colony-stimulating factors in cancer patients

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