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Results METEOR

 
 
results
 
 

: METEOR

 

Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma (NCT01865747)
 
 
 Sources: 
 Lancet Oncology, July 2016
 Ipsen Pharma, Germany, August 2016; 
 New England Journal of Medicine, November 2015

HOW MANY

people participated in the trial?

A total of 658 patients in 173 cancer centres in 26 countries worldwide took part in the trial.

STUDY

DESIGN

What did the study look like?

This phase 3 trial compared the efficacy and safety of cabozantinib versus everolimus in patients with advanced clear cell renal cell carcinoma in patients who had been previously been treated with at least ONE prior VEGFR TKI therapy.

All participating patients were randomly divided into two groups. After this randomisation a total of 658 patients received treatment. 330 patients were treated with cabozantinib, 328 patients were treated with everolimus:

  • cabozantinib (Cabometyx™) is an oral inhibitor of tyrosine kinases
  • everolimus (Afinitor™) is an oral mTor-inhibitor

1) cabozantinib was given as tablet once daily
2) everolimus was given as a tablet once daily.

For further information on the trial, please click here: clinicaltrials.gov/NCT01865747

RESULTS

of the study

The METEOR trial aimed to answer several questions:

Compared to an existing standard of care for treatment following disease progression on first-line VEGFR TKI therapy:

  1. Will the new treatment (cabozantinib) demonstrate a better overall survival? (Overall Survival was defined as the time from randomization on the trial to the date of death.)
  2. Will the new treatment (cabozantinib) demonstrate an improvement in the length of time that patients continue to respond to therapy? (Progression Free Survival was defined as the time from randomization on the trial untill the disease worsens as defined by RECIST criteria.)
  3. What percentage of patients will benefit? (Objective Response Rate was defined as a measurable response to each therapy as defined by RECIST criteria and assessed by an independent radiology review.)
  4. What are the different side effects of each therapy and how tolerable are they for patients?
The following could be observed:
  1. On average, patients in the group treated with cabozantinib had an overall survival (OS) benefit of approximately 4.9 months as compared to the average of patients in the group treated with everolimus.
  2. On average, patients in the group treated with cabozantinib had a median progression-free survival (stability) period of 7.4 months, compared to 3.8 months in the everolimus group. Stabilty of disease occurred in 65% in the cabozantinib group compared to 62% in patients treated with everolimus.
  3. The objective response rate with cabozantinib was 17% versus 3% with everolimus. In other words, approx. every 6th patient on the trial had a measurable response to the new therapy.
  4. Side effects for patients in both groups were different, but comparable in severity. The most common treatment-related adverse events among patients who received cabozantinib were: 
  • high blood pressure (49 patients, 15%)
  • diarrhoea (43 patients, 13%)
  • fatigue (36 patients, 11%),
  • hand-foot-syndrome (27 patients, 8%),
  • anaemia (19 patients, 6%)
  • high blood sugar (3, 1%)
  • hypomagnesaemia (low level of magnesium in the blood) (16 patients, 5%)
Severe treatment-related adverse events (grade 3 or worse) occurred in 68% of the patients treated with cabozantinib and in 58% of the patients treated with everolimus. One treatment-related death occurred in the cabozantinib group and two occurred in the everolimus group.
 
For those that want to read the full paper for theMETEOR study, please see here: Lancet Oncology, July 2016

CONCLUSION

 

The results of the METEOR trial show that for patients previously treated with one or more VEGFR TKI treatments, subsequent treatment with cabozantinib resulted in increased overall survival, delayed disease progression, and with comparable levels of toxicity as compared with similar patients treated with everolimus.

Based upon these results, cabozantinib has been approved in many countries as a treatment option for 2nd line advanced renal carcinoma.

SHARE

your experience 

Were you one of the patients on the METEOR trial? If you want to share your experience with others, please send us an e-mail to:This email address is being protected from spambots. You need JavaScript enabled to view it.

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Disclaimer: This is a patient-friendly summary of the results of this clinical trial which has been medically reviewed, but is provided for informational purposes only.
 
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