Abstract

Temozolomide plus bevacizumab in elderly patients with newly diagnosed glioblastoma and poor performance status: An Αnocef phase II trial.

Author
person German Reyes-Botero Service de Neurologie 2-Mazarin, Groupe Hospitalier Pitié-Salpêtrière, Paris, France info_outline German Reyes-Botero, Jerôme Honnorat, Oliver L. Chinot, Luc Taillandier, Isabelle Catry-Thomas, Jerome Barriere, Jean Sebastien Guillamo, Michel Fabbro, Didier Frappaz, Alexandra Benouaich Amiel, Emilie Le Rhun, Chantal Campello, Isabelle Tennevet, François Ghiringhelli, Marie-Laure Tanguy, Karima Mokhtari, Jean-Yves Delattre
Full text
Authors person German Reyes-Botero Service de Neurologie 2-Mazarin, Groupe Hospitalier Pitié-Salpêtrière, Paris, France info_outline German Reyes-Botero, Jerôme Honnorat, Oliver L. Chinot, Luc Taillandier, Isabelle Catry-Thomas, Jerome Barriere, Jean Sebastien Guillamo, Michel Fabbro, Didier Frappaz, Alexandra Benouaich Amiel, Emilie Le Rhun, Chantal Campello, Isabelle Tennevet, François Ghiringhelli, Marie-Laure Tanguy, Karima Mokhtari, Jean-Yves Delattre Organizations Service de Neurologie 2-Mazarin, Groupe Hospitalier Pitié-Salpêtrière, Paris, France, Hopital Pierre Wertheimer, Lyon, France, Centre Hospitalier Universitaire La Timone, Marseille, France, Centre Hospitalier Universitaire Nancy, Nancy, France, Hopital Saint-Andre CHU, Bordeaux, France, Centre Antoine Lacassagne, Nice, France, Centre Hospitalier Universitaire Caen, Caen, France, Centre Val d'Aurelle, Montpellier, France, Centre Léon Bérard, Lyon, France, Centre Hospitalier Universitaire Rangueil, Toulouse, France, Centre Oscar Lambret, Lille, France, Centre Hospitalier Universitaire Nimes, Nimes, France, Centre Henri Becquerel CLCC, Rouen, France, Georges-François Leclerc Cancer Center, Dijon, France, APHP-CHU Pitié-Salpêtrière, Paris, France, Hôpital Pitié-Salpêtrière, Paris, France, Pitie-Salpetriere Hospital-Pierre et Marie Curie Paris VI University, Paris, France Abstract Disclosures Research Funding Other Background: The optimal treatment of glioblastoma multiforme (GBM) in elderly patients (age ≥70 years) with impaired functional status (Karnofsky performance status, KPS<70) remains to be established. A previous study using temozolomide (TMZ) alone suggested an increase in median overall survival (OS) compared to supportive care (25 weeks vs. 12-16 weeks, respectively). Median progression-free survival (PFS) was 16 weeks and 26% of patients became transiently capable of self-care (IK>70) ( J Clin Oncol. 2011; 29: 3050-5). The present clinical trial evaluated the efficacy and safety of the combination of TMZ with bevacizumab (BV) as an initial treatment for elderly patients with GBM and KPS<70. Methods: Patients aged ≥ 70 years with KPS < 70 and a newly supratentorial GBM diagnosed by biopsy were eligible for this multicentric, prospective and non-randomised phase II trial. The primary endpoint was the OS and secondary endpoints included median PFS, quality of life, safety and cognition. Treatment consisted of TMZ 130-150 mgs/m 2 /d for 5 days every 4 weeks plus BV 10mgs/kg every 2 weeks, until 12 cycles or tumoral progression. Neither surgical resection nor radiotherapy was performed. Follow-up included clinical assessment every 2 weeks and brain MRI every 8 weeks. Results: Between October 2010 and March 2012, 66 patients (median age, 77 years; median KPS, 60) were enrolled. Median OS was 24 weeks (95% CI, 19-27.6) and median PFS was 16 weeks (95% CI, 13.1–19.3). Twenty-five patients (38%) became transiently capable of self-care (IK>70). Grade 3 and 4 haematological toxicity occurred in 13(19.6%) cases, whereas non-haematological toxicities were reported in 21(32%), including high blood pressure in 7(10%), thromboembolic events in 3(4.5%), intracerebral haemorrhage in 2(3%) and intestinal perforation in 2(3%) cases. Conclusions: This study confirms that TMZ-based treatment is of help in elderly GBM patients with poor KPS. However, the addition of bevacizumab does not appear to be of benefit in term of PFS and OS.