medigraphic.com
ISSN 2225-4676 (Electronic)

2015, Number 2

<< Back Next >>

Rev Cubana Neurol Neurocir 2015; 5 (2)

Security and effectiveness of nimotuzumab in patients with malign glial tumors

Saurez MG, Salva CSN, Piedra SP, Iglesias CB, Toledo JC, Solomón CMT, Santiesteban ÁE, Figueredo MJ, de la Torre SA, Quintanal CNE, Selva IJC, González FS, Uranga PR, Lage DA

Language: Spanish
References: 33
Page: 123-132
PDF size: 303.55 Kb.


ABSTRACT

Objective: To evaluate usage patterns for nimotuzumab, safety and effectiveness in terms of survival in patients with high–grade gliomas.
Methods: A cohort prospective, longitudinal, multicenter study was designed in adult patients with histological confirmation of high grade malignant glioma newly diagnosis to receive nimotuzumab according to prescription recommendations. Patients were followed for 3 years. We collected data on patterns of use, dosage and time of exposure to nimotuzumab. Reported adverse events were classified according to type, intensity and seriousness and also it was evaluated the survival time in months.
Results: Between December 2005 and August 2012, seventy patients received nimotuzumab grouped according to histology in 44 glioblastoma, 24 astrocytoma, anaplastic and 2 anaplastic oligoastrocytoma. All patients received nimotuzumab in combination with radiation, mostly concurrent (78.6 %); the remainder received it sequentially (21.4 %). Completed the induction phase planned 94.3 % of patients and continued in maintenance beyond 1 year 21.4 %. The events related to nimotuzumab were 24.1%. The most common were fever, chills, and cutaneous erythema of light and moderate intensity. It was founded no association between toxicity and therapeutic modality, neither with the number of doses received. Patients with anaplastic astrocytoma had a survival at diagnosis over 45 months and with glioblastoma of 14.8 months; with a survival rate at 3 years the 50.8 % and 20.2 % respectively.
Conclusions: The results of this observational study accompaniment those described in controlled studies. Nimotuzumab can be a therapeutic alternative safe, advantageous and feasible as part of conventional treatment in health care conditions.


REFERENCES

  1. Dubrow R, Darefsky AS. Demographic variation in incidence of adult glioma by subtype, United States, 1992–2007. BMC Cancer. 2011;11:325.

  2. Lawrence YR, Shi W, Dicker AP. From survival to survivorship: late side effects become an issue in high–grade glioma. Expert Rev Neurother. 2010;10(10):1493–5.

  3. Stupp R, Tonn JC, Brada M, Pentheroudakis G. High–grade malignant glioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow–up. Ann Oncol. 2010;21 (Suppl 5):v190–3.

  4. Lorenzoni J, Torrico A, Villanueva P, Gederlini A, Torrealba G. Surgery for high–grade gliomas in a developing country: survival estimation using a simple stratification system. Surg Neurol. 2008;70(6):591–7.

  5. Scott CB, Scarantino C, Urtasun R, Movsas B, Jones CU, Simpson JR, et al. Validation and predictive power of Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis classes for malignant glioma patients: a report using RTOG 90–06. Int J Radiat Oncol Biol Phys. 1998;40(1):51–5.

  6. Extra JM, Antoine EC, Vincent–Salomon A, Delozier T, Kerbrat P, Bethune–Volters A, et al. Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study. Oncologist. 2010;15(8):799–809.

  7. Campiglio M, Bufalino R, Sasso M, Ferri E, Casalini P, Adamo V, et al. Effect of adjuvant trastuzumab treatment in conventional clinical setting: an observational retrospective multicenter Italian study. Breast Cancer Res Treat. 2013;141(1):101–10.

  8. Oerlemans S, Issa DE, van den Broek EC, Nijziel MR, Coebergh JW, Huijgens PC, et al. Health–related quality of life and persistent symptoms in relation to (R–)CHOP14, (R–)CHOP21, and other therapies among patients with diffuse large B–cell lymphoma: results of the population–based PHAROS–registry. Ann Hematol. 2014;93(10):1705–15.

  9. Hurwitz HI, Bekaii–Saab TS, Bendell JC, Cohn AL, Kozloff M, Roach N, et al. Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin((R)) Registry – Investigation of Effectiveness and Safety (ARIES) observational cohort study. Clin Oncol (R Coll Radiol). 2014;26(6):323–32.

  10. Grothey A, Flick ED, Cohn AL, Bekaii–Saab TS, Bendell JC, Kozloff M, et al. Bevacizumab exposure beyond first disease progression in patients with metastatic colorectal cancer: analyses of the ARIES observational cohort study. Pharmacoepidemiol Drug Saf. 2014;23(7):726–34.

  11. Hofer S, Elandt K, Greil R, Hottinger AF, Huber U, Lemke D, et al. Clinical outcome with bevacizumab in patients with recurrent high–grade glioma treated outside clinical trials. Acta Oncol. 2011;50(5):630–5.

  12. Sarosi V, Losonczy G, Francovszky E, Tolnay E, Torok S, Galffy G, et al. Effectiveness of erlotinib treatment in advanced KRAS mutation–negative lung adenocarcinoma patients: Results of a multicenter observational cohort study (MOTIVATE). Lung Cancer. 2014;86(1):54–8.

  13. Reichert JM. Marketed therapeutic antibodies compendium. MAbs. 2012;4(3):413–5.

  14. Crombet–Ramos T, Rak J, Perez R, Viloria–Petit A. Antiproliferative, antiangiogenic and proapoptotic activity of h–R3: A humanized anti–EGFR antibody. Int J Cancer. 2002;101(6):567–75.

  15. Ramos TC, Figueredo J, Catala M, Gonzalez S, Selva JC, Cruz TM, et al. Treatment of high–grade glioma patients with the humanized anti–epidermal growth factor receptor (EGFR) antibody h–R3: report from a phase I/II trial. Cancer Biol Ther. 2006;5(4):375–9.

  16. Solomon MT, Selva JC, Figueredo J, Vaquer J, Toledo C, Quintanal N, et al. Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial. BMC Cancer. 2013;13:299.

  17. Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Versio3.0; DCTD, NCI, NIH, DHHS August 9, 2006 ed2003.

  18. Requerimientos para la notificación y el reporte de eventos adversos graves e inesperados en los ensayos clínicos. Regulación No. 45–2007 [Internet] 2007 [citado 21.012015]. Disponible en: http://www.cecmed.cu/Docs/RegFarm/DRA/EvalDC/Reg/Reg_45–07.pdf

  19. Requisitos para la comunicación expedita y periódica de reacciones, eventos adversos, intoxicaciones, defectos de calidad y actividad fraudulenta a medicamentos durante la comercialización. Regulación 51–2008 [Internet] 2008 [citado 21.01.2015]. Disponible en: http://www.cecmed.cu/Docs/RegFarm/DRA/VigPC/Reg/Reg_51–08.pdf

  20. Perez R, Moreno E, Garrido G, Crombet T. EGFR–Targeting as a Biological Therapy: Understanding Nimotuzumab’s Clinical Effects. Cancers Journal 2011; 3:2014–31.

  21. Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27(28):4733–40.

  22. Vredenburgh JJ, Desjardins A, Reardon DA, Friedman HS. Experience with irinotecan for the treatment of malignant glioma. Neuro Oncol. 2009;11(1):80–91.

  23. Diaz–Miqueli A, Martinez GS. Nimotuzumab as a radiosensitizing agent in the treatment of high grade glioma: challenges and opportunities. Onco Targets Ther. 2013;6:931–42.

  24. Qi WX, Sun YJ, Shen Z, Yao Y. Risk of anti–EGFR monoclonal antibody–related skin rash: an up–to–date meta–analysis of 25 randomized controlled trials. J Chemother. 2014;26(6):359–68.

  25. Rogne SG, Konglund A, Scheie D, Helseth E, Meling TR. Anaplastic astrocytomas: survival and prognostic factors in a surgical series. Acta Neurochir (Wien). 2014;156(6):1053–61.

  26. Arvold ND, Reardon DA. Treatment options and outcomes for glioblastoma in the elderly patient. Clin Interv Aging. 2014;9:357–67.

  27. Mariniello G, Peca C, De Caro Mdel B, Giamundo A, Donzelli R, Maiuri F. Glioblastoma in the elderly: the impact of advanced age on treatment and survival. J Neurol Surg A Cent Eur Neurosurg. 2014;75(4):276–81.

  28. Tanaka S, Meyer FB, Buckner JC, Uhm JH, Yan ES, Parney IF. Presentation, management, and outcome of elderly patients with newly–diagnosed anaplastic astrocytoma. J Neurooncol. 2012;110(2):227–35.

  29. Rogers LR. Chemotherapy and immunotherapy of brain tumors: what the epileptologist must know. Epilepsia. 2013;54 (Suppl 9):105–8.

  30. Bruna J, Miro J, Velasco R. Epilepsy in glioblastoma patients: basic mechanisms and current problems in treatment. Expert Rev Clin Pharmacol. 2013;6(3):333–44.

  31. Bode U, Massimino M, Bach F, Zimmermann M, Khuhlaeva E, Westphal M, et al. Nimotuzumab treatment of malignant gliomas. Expert Opin Biol Ther. 2012;12(12):1649–59.

  32. Nimotuzumab en el tratamiento de tumores de alto grado de malignidad. Estudio de seguridad y efectividad. [Internet] 2007 [citado 2015.01.21]. Disponible en: http://registroclinico.sld.cu/ensayos/RPCEC00000146–Sp

  33. Evaluación de la efectividad y seguridad del anticuerpo monoclonal hR3 (Nimotuzumab) para el tratamiento de pacientes con tumores gliales de alto grado de malignidad. [Internet] 2007 [citado 2015.01.21]. Disponible en: http://registroclinico.sld.cu/ensayos/RPCEC00000087–Sp




2020     |     www.medigraphic.com