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Temozolomide Plus Bevacizumab Chemotherapy in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status (KPS<70) (NCT02898012)

Roche Pharma AG
The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.
  • Drug: Temozolomide
    Temozolomide (TMZ) Temozolomide (TMZ) administered at 130-150 mg/m2 for 5 consecutive days every 4 weeks up to 12 cycles. IV or oral administration was allowed according to the clinical status. TMZ starts at 130 mgs/m2 and increase to 150 mgs/m2 during the second cycle in the absence of hematologic toxicity. In the case of grade 3 or 4 toxicity, the dose for the next cycle is decreased to 110 mg/m2. If the grade 3 or 4 toxicity persists at a dose of 110 mg/m2, treatment is discontinued.
    • Drug: Bevacizumab
      Bevacizumab (Bev) administered at a dose of 10 mgs/kg every 2 weeks. Bev was interrupted in cases of wound healing disturbances, gastrointestinal perforation, intestinal occlusion, fistula, uncontrolled hypertension, nephrotic syndrome, grade 4 or recurrent grade 3 thromboembolic events, arterial thrombosis, hemorrhage > grade 2, left ventricular failure, or posterior reversible leukoencephalopathy.
      Ages eligible for Study
      70 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Supratentorial Glioblastoma diagnosed by biopsy.
      • Patients aged ≥ 70 years
      • KPS >30 and < 70
      • Life expectancy > or = 8 weeks
      • Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy.
      • CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage.
      • Included to health social security system
      • Medical assessment previous to inclusion
      • Informed consent form
      Exclusion Criteria:
      • Previous treatment with Surgical resection, RT or chemotherapy to the tumor.
      • Hemoglobin level < 9 g%
      • Absolute neutrophil count < 1500
      • Platelet count < 100.000
      • ASAT or ALAT levels more than 3 times the upper limit of normal.
      • Bilirubin levels more than 2 times the upper limit of normal
      • Creatinin more than 1.5 times the upper limit of normal
      • Untreated high blood pressure >150/100 mmHg
      • Congestive cardiac failure
      • Proteinuria > 1 gr/24h
      • INR > 1.5 the upper limit of normal
      • Recent symptomatic haemorrhage
      • History of abnormal wound healing
      • Gastrointestinal fistula
      • Haemoptysis > grade 2 (NCI-CTC)
      • Intracranial abscess
      • Coagulation disorder
      • Active infection requiring intravenous antibiotics
      • Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months
      • Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer)
      • Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.
      Elderly patients aged 65 years and older account for approximately 45% of GBM patients, and this figure is expected to rise concurrently with the aging population of most countries. Unfortunately, few trials have been performed in this setting. In elderly patients with good functional status (KPS >70), radiotherapy (RT) prolongs overall survival (OS) without causing a detriment in quality of life compared with palliative care alone. Recently, it was shown that TMZ could be an alternative to RT. In elderly patients with poor functional status at symptom onset (KPS < 70), RT does not appear to be a satisfactory option in this frail population; however, investigators previously found that TMZ alone was associated with improvements in functional status in 1/3 of cases and appeared to increase survival compared with supportive care alone, especially in methylated MGMT promoter patients.

      Bevacizumab (Bev) is an antiangiogenic monoclonal antibody targeting VEGF (vascular endothelial growth factor) that is currently used in recurrent GBM, particularly in combination with alkylating agents. Its effect as first line treatment in combination with TMZ and RT is controversial.

      In this study, investigators evaluated the efficacy and safety of the upfront combination of TMZ + Bev as an initial treatment for elderly patients with GBM and impaired functional status (KPS <70).

      1 locations

      France (1)
      • Groupe Hospitalier Pitié-Salpêtrière
        Not specified
        Paris, France, 75013
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      30 September, 2010
      Updated:
      06 September, 2016
      Participants:
      70
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