With advances in diagnostic technologies and screening leading to progressive tumor shrinkage at diagnosis, it becomes more difficult over time to evaluate the effects of treatment on overall survival. New treatments are often authorized based on early evidence, such as tumor response; disease-free, progression-free, meta-static-free, and event-free survival; and, less frequently, based on clinical endpoints, such as overall survival or quality of life. Standard guidelines so far are not available to approve pharmaceuticals.
People without breast cancer die also from other diseases and as such relative survival (RS) seems the best to evaluate the effect of treatment. Screening started in early 80’s as chemo- (8 drugs) and hormonotherapy (Nolvadex) becomes available. Between 1980 and 2000, RS increased from 75 to 90% attributed to treatment but omitted to analyse the tumor size, which decreased due to screening. Even 76 new drugs become available since 2000, we should have predicted the RS should rise up, but to our surprise the RS remain the same (+_ 1%). Does it mean that those “new” drugs are not effective? The problem is that those drugs were tested on patients younger than 65 with no co-morbidities which on it’s own have a negative impact but which can be increased by the drugs. All single drugs have
some cardio-toxicity and treatment schemes consist of multiple drugs increasing it as shown by American Heart Association (AHA) identifying a strong correlation and offered a thorough analysis of the notable areas of overlap between heart disease and breast cancer. Another significant issue that tends to be overlooked despite the wide array of new medications is medicaire conciliation. Pharmacists' monitoring revealed that over half of the prohibited drugs or closely watched drugs were initially overlooked by oncologists.
Despite the RS remain flat with all new drugs, we observe nonetheless that within the same period the number of local tumors increased and the regional ones decreased!
So matter of discussion is open to look to new approaches with an open mind, since hope on genes were great to predict outcome, but after 35 years we have so far still no treatment for tackling BRCA-1 and the question remains open what will be the value of the impact of looking to more genes.