A dose-finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy
2001

Study on NESP for Treating Anaemia in Chemotherapy Patients

Sample size: 59 publication Evidence: moderate

Author Information

Author(s): Glaspy J, Jadeja J Singh, Justice G, Kessler J, Richards D, Schwartzberg L, Rigas J, Kuter D, Harmon D, Prow D, Demetri G, Gordon D, Arseneau J, Saven A, Hynes H, Boccia R, O'Byrne J, Colowick A B

Primary Institution: UCLA School of Medicine

Hypothesis

Is NESP safe and effective for treating anaemia in patients undergoing chemotherapy?

Conclusion

NESP is well tolerated and shows a dose-response relationship in improving haemoglobin levels in chemotherapy patients.

Supporting Evidence

  • NESP was administered once per week for up to 12 weeks.
  • Patients were monitored for adverse events and effects on haemoglobin.
  • No antibody formation to NESP was detected during the study.
  • Mean change in haemoglobin at end of treatment was 1.24, 1.73, and 2.15 g dl−1 for the three dose cohorts.

Takeaway

This study tested a new medicine called NESP to help people with low blood levels while they are getting cancer treatment, and it worked well without causing problems.

Methodology

The study was a sequential, unblinded, and dose-escalating trial with three dose cohorts.

Potential Biases

Potential bias due to the unblinded nature of the study.

Limitations

The study was unblinded and had a limited follow-up period.

Participant Demographics

Patients with solid tumours receiving multicycle chemotherapy.

Digital Object Identifier (DOI)

10.1054/bjoc.2001.1748

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