XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy

Leukemia and Lymphoma

Volumn 50, Issue 3, 2009, Pages 374-379

  Engert, Andreas ^a   Griskevicius, L ^b   Zyuzgin, Y ^c   Lubenau, H ^d   del Giglio, A ^e,f  

^a UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^b VILNIUS UNIVERSITY   (Lithuania)

^c Leningrad Regional Clinical Hospital   (Russian Federation)

^d BioGeneriX AG   (Germany)

^e FACULDADE DE MEDICINA DO ABC   (Brazil)

^f HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

Author keywords

Chemotherapy; G CSF; Neutropenia; Non Hodgkin lymphoma; XM02

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; PREDNISOLONE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; UNCLASSIFIED DRUG; VINCRISTINE SULFATE; XM 02;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; BONE PAIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLU LIKE SYNDROME; HALF LIFE TIME; HOT FLUSH; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG TOXICITY; FEMALE; FEVER; FILGRASTIM; GRANULOCYTE COLONY STIMULATING FACTOR, RECOMBINANT; HUMANS; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; NEUTROPENIA; TREATMENT OUTCOME; YOUNG ADULT;

EID: 67650879442     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.1080/10428190902756081     Document Type: Article

References (12)

1. Holmes, F. A., O'Shaughnessy, J. A., Vukelja, S., Jones, S. E., Shogan, J. Savin, M. et al. (2002) Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol, 20, pp. 727-731.
2. Smith, T. J., Khatcheressian, J., Lyman, G. H., Ozer, H., Armitage, J. O. Balducci, L. et al. (2006) American Society of Clinical Oncology. 2006 update of recommendations for the use of white blood cell growth factors: An evidence-based, clinical practice guideline. J Clin Oncol, 24, pp. 3187-3205.
3. Aapro, M. S., Cameron, D. A., Pettengell, R., Bohlius, J., Crawford, L. Ellis, M. et al. (2006) EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer, 42, pp. 2433-2453.
4. Dale, D. C. (2002) Colony-stimulating factors for the management of neutropenia in cancer patients. Drugs, 62, pp. 1-15.
5. Martin-Christin, F. (2001) Granulocyte colony stimulating factors: How different are they? How to make a decision. Anti-cancer Drugs, 12, pp. 185-191.
6. George, S., Yunus, F., Case, D., Yang, B. B., Hackett, J. Shogan, J. E. et al. (2003) Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with Non-Hodgkin's lymphoma. Leuk Lymphoma, 44, pp. 1691-1696.
7. Grigg, A., Solal-Celigny, P., Hoskin, P., Taylor, K., McMillan, A. Forstpointner, R. et al. (2003) Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with Non-Hodgkin's lymphoma. Leuk Lymphoma, 44, pp. 1503-1508.
8. Crawford, J., Ozer, H., Stoller, R., Johnson, D., Lyman, G. Tahbara, I. et al. (1991) Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med, 325, pp. 164-170.
9. Lubenau, H., Bias, P. Maly, A. et al. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim NeupogenTM: Single-blind, randomised, cross-over trial. BioDrugs
10. Lubenau, H., Sveikata, A., Gumbrevicius, G., Macijauskiene, J., Fokas, V. Kazlauskas, S. et al. Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharm Ther
11. Eldar-Lissai, A., Cosler, L. E., Culakova, E. and Lyman, G. H. (2008) Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health, 11, pp. 172-179.
12. Ozer, H., Armitage, J., Bennett, C., Crawford, J., Demetri, G. D. Pizzo, P. A. et al. (2000) American Society of Clinical Oncology. 2000 Update of recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based, clinical practice guidelines. J Clin Oncol, 18, pp. 3558-3585.