Various G-CSF Regimens to Prevent Infection During Chemotherapy

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious [1-3]. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia.

Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia.

The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear.

So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Ziekenhuis Maastricht
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development

Criteria

Inclusion Criteria:

• Breast cancer patients ≥18 years.

• Indication for 3-weekly chemotherapy.

• Considered fit enough to receive chemotherapy, with adequate renal and hepatic function.

• Planned a chemotherapy regime in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:

• Regimes with >20% risk of febrile neutropenia:

• e.g. TAC (docetaxel, adriamycin, cyclophosphamide)

• AT (adriamycin, docetaxel)

• Regimes with 10-20% risk of febrile neutropenia (e.g. AC, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of ≥1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue

• Prior chemotherapy

• ECOG performance status of 2 or more, grade 2 or higher liver function abnormalities).

• That is, patients starting with docetaxel as second part of FEC-D are eligible for the last 3 docetaxel cycles, if there is an increased risk of febrile neutropenia, e.g. by elderly age.

• Able to comply with the protocol.

• Written informed consent obtained prior to any study specific screening.

Exclusion Criteria:

• Active uncontrolled infection.

• Inadequate renal or hepatic function.

• Any evidence or history of hypersensitivity or other contraindications to G-CSF medication.

• Not recovered from acute toxicities of prior therapies.

• Absolute neutrophil count (ANC) <1.5 x 109/l, not caused by bone marrow involvement.