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SAiL (MO19390): large phase IV trial confirms the efficacy(The capacity for beneficial change (or therapeutic effect) of a given intervention) and safety of first-line Avastin in real-life setting

Large, single-arm, open-label(A type of clinical trial in which both the researchers and participants know which treatment is being administered), multicentre trial evaluating the safety and efficacy of Avastin with standard chemotherapy in patients with untreated locally advanced, metastatic(Pertaining to the spread of a disease, usually cancer, from one organ or part to another non-adjacent organ or part) or recurrent non-squamous(Pertaining to cells not from squamous epithelium; relatively common, locally invasive and occasionally metastatic) NSCLC.1

Patients (n=2,212) received Avastin (7.5mg/kg or 15mg/kg) plus standard first-line chemotherapy for up to six cycles, followed by Avastin alone until PD (maintenance).

Primary endpoint

  • Safety: including incidence of serious AEs(Symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study) related to Avastin and AEs of special interest.

Secondary endpoints

  • OS(The time from trial entry to death from any cause).
  • TTP(The time from when a patient enters a study and the time that either the disease progresses (advances) or the patient dies).
  • Safety of Avastin in patients who develop CNS metastases during the treatment period, and for 6 months following treatment.

SAiL: remarkable efficacy results in the overall population

Final efficacy outcomes further confirm the benefit of Avastin used in combination with a wide range of chemotherapy regimens.

Of the 2,212 patients in the SAiL ITT(Usually pertaining to an analysis that is based on the initial treatment intent, not on the treatment eventually administered) population, 1,087 patients (49%) received carboplatin doublets, and 829 patients (37%) received cisplatin doublets.

Efficacy was consistent across major chemotherapy regimens.1

In the overall trial population

  • Median OS was 14.6 months.
  • Median TTP was 7.8 months.1

SAiL: proven efficacy in the elderly population

Approximately 28% of patients evaluable for safety were >65 years of age.

The median age for the elderly (>65 years) group was 70.

Compared with patients aged ≤65 years, elderly patients (>65 years) treated with first-line Avastin-based therapy

  • Had a similar incidence of AEs of special interest.
  • Had similar efficacy outcomes, with a remarkable median OS of 14.6 months in both populations.3

References

  1. Crinò L, Dansin E, Garrido P, et al. Lancet Oncol 2010;11:733–40.
  2. Crinò L, Franke F, Sadjadian P, et al. Ann Oncol 2010;21(Suppl. 8):viii142 (Abstract 427P).
  3. Reck M, Mazières J, Mark Z, et al. J Thorac Oncol 2010;5(Suppl.1):S83 (Abstract 211O).

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