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TAXOTERE - Prostate cancer

Prostate cancer
Opinions on drugs - Posted on Jul 01 2020

Reason for request

New indication

  • Key points  

Favourable opinion for reimbursement in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).   

  •  What therapeutic improvement

 

TAXOTERE (docetaxel), in combination with ADT, provides a therapeutic improvement compared to ADT alone, in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

  •  Role in the care pathway?

The first-line treatment of metastatic hormone-sensitive prostate cancer is based on androgen deprivation therapy (ADT), in combination with docetaxel in patients eligible for chemotherapy, or on ADT plus abiraterone acetate in combination with prednisone or prednisolone. Both these strategies had demonstrated an improvement in overall survival compared to ADT alone. Apalutamide has recently been added to the therapeutic arsenal, having also demonstrated an improvement in terms of overall survival in this context. 

Role of TAXOTERE (docetaxel) in the care pathway: 

TAXOTERE (docetaxel) in combination with ADT represents a new first-line option in the treatment of patients with metastatic hormone-sensitive prostate cancer. 

In the absence of comparative data, the role of TAXOTERE (docetaxel) versus apalutamide or abiraterone acetate (in combination with prednisone or prednisolone) remains to be determined. 

According to the experts, the choice of treatment should take into account the patient’s age, comorbidities, the patient’s informed choice and the safety profile of each medicinal product. 


Clinical Benefit

Substantial

The clinical benefit of TAXOTERE is substantial in the MA indication. 


Clinical Added Value

minor

Considering: 

  • demonstration of a superiority of the TAXOTERE + ADT combination versus ADT alone, particularly in terms of overall survival (primary efficacy endpoint) in one study (57.6 months in the docetaxel group versus 44.0 months in the ADT alone group, i.e., an absolute increase of 13.6 months in favour of the docetaxel group (HR = 0.61, 95% CI [0.47; 0.80])), but without this benefit having been confirmed in a second study, introducing uncertainty with respect to the real benefit, 
  • the absence of demonstration of an improvement in quality of life, 
  • the cumulative safety profile marked by haematological (neutropenia and febrile neutropenia) and gastrointestinal (diarrhoea) toxicity. 

the Committee grants TAXOTERE, in combination with ADT, a minor clinical added value (CAV IV) versus ADT alone, in the indication “in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)”. 


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