ancillaryservices such as free-standing diagnostic centers and even teleradiology.As cancers are detected earlier, there is an inverse pattern between increasing surgical care and decreasing(in relative terms) chemotherapy. In addition, as disease is caught at earlier and at less-symptomatic stages,the importance of drug safetywill also increase. All of these trends will continue.
Even back in the days of Richard Nixon and his “war on cancer” (and even before then), there have beendreams of a magic bullet that will kill onlycancer cells and preserve normal cells. For most people, cancerchemotherapy is associated with dreadful side effects from relatively benign but certainly concerning hairloss to severe bone-marrow suppression and fatal infections. A recent CNN article on Lance Armstrong’scancer crusade showed a galleryof cancer patients. All of them were bald from undergoing their respectivechemotherapies. Ironically, this picture is becoming less common with the new generation of targetedtherapiessuch asHerceptin,GleevecandErbitux.
The mechanism of action of these newer, more targeted drugs is not on inhibiting cell growth in general(with moderate levels of differentiation between cancerous and normal cells) but rather on affectingspecific functions and pathways unique to cancer cells. Even though these targeted drugs are darlings of the media and Wall Street and theystill onlyrepresent a small proportion of overall cancer chemotherapy,the industry implications have been profound. These new drugs have impacted longer survival and hencehave contributed to the concept of cancer in many cases now being a chronic disease. Another importanttrend has included a marked decrease in the level of in-patient cancer care (much of which is often relatedto the serious side effects of chemotherapy).
Personalized medicineis not specific to cancer as it represents a new paradigm in medicine in whichindividual genetic variations become relevant in fine-tuning the diagnosis and treatment. While people had“high cholesterol” just 20 years ago, theynow have various syndromes relating to subtypes of blood-bornecholesterol such as HDL, LDL and VLDL. Even more finely-tuned genetic subtypes are available forwhat was once a simple and monolithically defined syndrome. To some extent, the phenomenon of personalized medicine overlaps with the targeted therapies above. These targeted therapies are in somecases not just directed more effectively toward cancer cells but are also targeted by virtue of patient-specific genetic factors. Women with certain mutations in the BRCA1 gene, for example, have an 80percent lifetime risk of breast cancer. For these women, radical mastectomy is not such an extremetherapeutic (preventative) option. To a lesser extent than early detection and targeted therapies, thisnascent era of personalized medicine has likelyalso reduced death rates from cancer.The wider implicationss of personalized medicine for cancer care are still being explored and understood.Apart from the improvements in survival as suggested above, one absolutely critical impact is on howclinical trials for cancer are designed and constructed. As therapies become more personalized, the patientpool correspondinglygets smaller. This means the statistical power of large population-based clinical trialsis less or even not available for these highly personalized and targeted drugs. This is a problem that theFDAis addressing now. It will impact drug development and drug pipelines for years to come.
Minimally Invasive Surgery
In addition to earlier detection, the remarkable advances inminimally invasive surgical techniques– not just traditional “cutting” surgery but other approaches such as interventional radiology, endovascularmethods, lasers and radio-frequency ablation – have also raised the profile of surgery as a part of the careof many cancers. New minimally invasive techniques have caused a complete paradigm shift in theunderstanding of surgeryparticularlyas applied to cancer. In the traditional paradigm, surgerywas a “last-resort treatment” in which (generally speaking) only one, definitive operation was possible. t was literally“do or die”.Incremental surgeries can now be performed along with combination diagnostic/ therapeutic surgeries,second-look diagnostic procedures, drug-delivery system implants and repeat surgeries. A host of other
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