Communicating efficacy to oncologists

Over the past several years, the oncologists we have interviewed have repeatedly communicated a number of key informational challenges facing physicians in the community.

• The sheer volume of data deluging oncologists:  community oncologists are typically generalists and treat a wide variety of tumors in which the standard of care is constantly changing in the face of new data and studies.
• The economics of medicine in the US: pressure to see more patients and increasing volume of paperwork has lead to greater demands on oncologists’ time, leaving them with less time to keep up with the field.

Subtypes of many common tumor types have proliferated.  Non-small cell lung cancer is a case in point.  There are now multiple different subgroups based on histology and biomarker expression that are all treated differently.  In metastatic breast cancer, new subtypes (e.g., HER2-low or -ultralow, ESR1-positive, PIK3CA-positive), each with specific treatment approaches, have emerged in recent years[AW1] .  The number of treatment pathways and specific medications, many with unfamiliar or unique side effect profiles, has increased dramatically.

This situation is compounded by the fact that, in many cases, the data upon which oncologists base their decisions are not entirely clear-cut.

• The pace of advancements in oncology mean that the standard of care often changes faster than new trials are available, and novel regimens are thus compared with a standard of care that has become obsolete by the time the results are available.
• Multiple new trials may emerge at the same time or within a short period of time, all compared to the same standard of care rather than each other, requiring cross-trial comparisons, which are not rigorous (even if everyone does them anyway).

In these circumstances, oncologists rely on their experience, KOL guidance, parsing toxicity data, and looking at subgroup analyses to determine which therapeutic approach fits the goals and situation of a given patient.

Here, how companies position and communicate the value of their medications can be key.  Oncologists are looking for ways to cut through the morass of clinical data and to quickly understand where novel agents and regimens should be used.

Communications should be:

• Clinical: Messaging is more credible when couched in the language of the clinic rather than the language of marketing.
• Quantified:  Oncologists want to know exactly what outcomes they can expect from new medications or regimens.  Using words such as “superior” without numbers raises the question of just how superior a new approach is.  The classic example is one an oncologist reminded me of a couple of weeks ago: the approval of Tarceva (erlotinib) for pancreatic cancer on the basis of a statistically significant (and thus technically “superior”) survival advantage of less than two weeks.
• Concise and straightforward: All things being equal, oncologists tend to choose shorter, less wordy messages.

How the data are communicated should vary depending on the structure of the clinical trial and the setting.  When new therapies or regimens are compared to the current standard of care, the magnitude of improvement tends to be the most important factor.  When new therapies or regimens are compared to a standard of care that has since become obsolete, oncologists look for the absolute endpoint figures, since it does not matter how much better a new therapy is than a therapy that no one would use anymore.

Similarly, in the metastatic setting, oncologists prefer to see median figures for standard endpoints, whereas in curative settings (where five-year survival can be a proxy for cure) landmark analyses often carry more weight.