Introduction
Oncologists are at the front lines of cancer care. They navigate a complex landscape
of rapidly changing treatments, technologies, and patient expectations. In this dynamic
environment, it is essential for oncologists to carefully examine and share their
clinical data. This practice is not just an academic task; it is vital for fostering
a realistic understanding of cancer outcomes. It helps prevent undue influence from
market-driven innovations and ensures optimal patient-centered care. Such care focuses
on prevention and early intervention instead of resorting to last-minute technological
fixes that can often be misleading.
Validation for Real-World Outcomes
The primary reason for oncologists to conduct thorough data analysis and publication
is to build a grounded and realistic perspective on cancer outcomes. This perspective
should remain clear of theories and marketing hype from the pharmaceutical and medical
device industries. An oncologist's real-world data (RWD) provides a clear view of
treatment effectiveness within their specific patient population.[1]
The pharmaceutical and medical device industries are powerful innovators, but they
also respond to market forces. New drugs and technologies often launch with great
fanfare and impressive efficacy rates from highly controlled clinical trials. While
these trials are crucial for regulatory approval, they frequently operate under strict
criteria that might not apply to the diverse patient populations encountered in everyday
practice. Without solid internal data, oncologists risk being influenced by market
narratives, which could lead to an overly optimistic and unrealistic view of treatment
success for their patients. For example, a new targeted therapy might show excellent
response rates in a clinical trial. However, an oncologist who analyzes its own patient
group—made up of individuals with various health challenges, genetic differences,
or different levels of access to care—could discover that the actual outcomes are
less impressive.
While randomized controlled trials (RCTs) are considered the gold standard for evaluating
drug efficacy, real-world evidence (RWE) analyses are increasingly challenging their
findings, as seen in recent literature. For example, in clinical trials, sorafenib
was shown to substantially improve the overall survival of patients with advanced
hepatocellular carcinoma, extending it by 2 to 3 months compared to a placebo.[2]
[3] A later Surveillance, Epidemiology, and End Results (SEER)-Medicare database analysis
of patients receiving sorafenib in clinical practice, a less selective group, found
that their survival was much shorter.[4] Similarly, patients with castration-resistant prostate cancer who received docetaxel
plus prednisone in a clinical trial had considerably better outcomes, including improved
survival and less toxicity, than those who received the same treatment outside of
a trial.[5]
[6] Again, when cetuximab combined with radiotherapy was shown an alternate standard
of treatment for locally advanced head and neck squamous cell carcinoma with lesser
toxicity since the Bonner study (IMCL 9815).[7] But subsequent clinical practice showed inferior outcome with increased toxicities.[8]
[9] This was confirmed in recent trials not supporting the routine use of cetuximab
in a curative setting.[10] This finding supports the idea that the positive results from RCTs for new cancer
treatments may not be fully replicated in routine clinical practice, where patients
are less selected and can experience worse outcomes and more side effects.
This does not overlook the value of new therapies; it aims to provide a realistic
view of their effectiveness in real life. By publishing these real-world outcomes,
oncologists enrich the understanding of a drug's performance, highlighting potential
gaps between trial results and everyday practice. This openness encourages better
conversations with patients about their prognosis and treatment expectations, building
trust and enabling shared decision-making based on a complete, honest picture. Their
data acts as a reality check, helping oncologists stay grounded in their expectations
for their unique patient population instead of being swayed by theoretical maximums.
Prioritizing Prevention Over Futile Technological Interventions
The second important reason for oncologists to audit and share data is to improve
patient care. This approach helps prevent unnecessary toxicity and challenges the
dangerous misconception that technology can merely “fix anything” when problems arise.
The true error lies not just in the technological design but in the serious mistake
of depending on a safety system to make up for ignoring established protocols. The
blind trust in technology or advanced interventions without fully understanding their
utility and potential may risk patients in real-time treatment.[11]
In oncology, the urge to use every available technological advancement or cutting-edge
drug, especially as a patient's condition worsens, can be overwhelming. Oncology today
features modern imaging, complex molecular diagnostics, advanced radiation systems,
and strong systemic therapies. While these advances are transformative, they can also
pose risks and lead to toxicities. Without carefully analyzing their clinical data,
oncologists may overly rely on these tools, mistakenly assuming that more technology
guarantees better outcomes, especially in critical situations. Importantly, we also
have strong supportive care options like intensive care units (ICUs), powerful antibiotics,
and advanced life support. These tools are vital and they can help within their established
limits.
However, problems occur when oncologists treat these supportive measures and advanced
technologies as an ultimate safety net, thinking they can rescue any situation without
considering the patient's vulnerabilities. Medical professionals sometimes push patients
to their physical limits. This may involve ignoring a patient's age or health issues,
missing early warning signs, and relying on rescue measures instead of prevention.
A systematic review showed underreporting of toxic deaths in clinical oncology trials
possibly due to low autopsy rates.[12] These might overestimate the effects of newer intervention while underreporting
toxic deaths. In a SEER database analysis of 7,366,229 patients, 241,575 noncancer
deaths (15.9%) were recorded in the first year following a cancer diagnosis. Patients
have a 2.34-fold higher risk of dying from noncancer causes, such as cardiovascular
and infectious diseases, compared to the general population. This risk is highest
in the first month following a cancer diagnosis.[13] These may suggest probable deaths related to cancer-directed therapies. The side
effects of cancer treatments should be prevented or detected early with monitoring,
not just addressed after they become severe. An oncologist who carefully tracks and
evaluates their patients' experiences with treatment side effects might notice trends
that enable earlier interventions or even proactive measures. Their data could show,
for example, that certain patient profiles face higher risks for specific adverse
events, leading to closer monitoring or different treatment plans from the beginning.
For example, by employing sepsis surveillance and the prompt use of antibiotics and
Granulocyte colony-stimulating factor (G-CSF), along with early hospitalization, when
necessary, reduced the occurrence of sepsis-related early deaths in patients with
head-and-neck undergoing chemoradiation.[14] This forward-thinking approach, driven by RWD, is far superior and kinder than depending
on ICU admission as a last resort. Another study examined the benefit of the audit
in decreasing 30-day mortality by considering factors that may be associated with
an increased risk of chemotherapy-related death.[15]
By sharing these real-world insights, especially about managing side effects, early
warning signs, and the appropriate boundaries of supportive care, the broader oncology
community gains greatly. It fosters sharing practical knowledge that reveals what
truly works and what can be an ineffective or even harmful technological illusion
when pushed too far.[14]
[15] Feliu et al developed and validated a highly accurate tool which can help physicians
making decisions in elderly patients with cancer planned for chemotherapy using simple
parameters like stage, Eastern Cooperative Oncology Group Performance Status, activities
of daily living, serum albumin, body mass index, and hemoglobin.[16] This shared understanding can help develop more effective, evidence-based guidelines
for preventing or managing crises, leading to safer, timely patient care focused on
true benefits instead of last-minute, misleading “fixes” born from overreliance on
an imagined safety net.
Ultimately, oncologists' commitment to examining and sharing their clinical data is
not just an academic task; it is a deep commitment to truth, realism, and patient
safety. By grounding themselves in their own data, they gain a realistic view of what
treatments can genuinely achieve. By recognizing limitations and potential for harm,
they avoid the illusion of technological perfection, focusing on prevention and early
intervention. This dedication to insights based on data empowers oncologists to provide
more transparent and effective patient-centered care, ultimately changing what it
means to practice optimally in the complex world of oncology. In this direction, the
U.S. Food and Drug Administration (FDA) had issued a document named “Framework for
FDA's Real-World Evidence Program” to evaluate and use RWE to support regulatory decisions
for drugs and biological products.[17] Also, to evaluate the potential use of RWE to help support the approval of new indications
for already-approved drugs or to satisfy postapproval study requirements.
