Why in the news? 

Physicians have expressed the necessity to categorize Cancers based on their genetic characteristics.

Context:

• An updated classification system could aid patients in comprehending the reasoning behind their treatment.
• While two individuals may share the same type of cancer, their therapies could vary due to differences in the biological mechanisms driving their tumors.

What motivates the need for change?

•  Not limited to cancers of a single organ: With technological improvements, doctors are also able to find which genetic mutations are responsible for a tumor in many cases and target them with drugs.
  • All cancers from the same organ don’t always share the same mutations, and these mutations aren’t limited to cancers of a single organ
• Access life-saving drugs sooner: This development in precision oncology requires cancers to be classified based on their molecular and genetic characteristics rather than the organ in which they originate, a team of researchers from France has written in a paper.
  • This way, according to them, cancer patients can also access life-saving drugs sooner. Oncologists spend a lot of time testing new drugs in clinical trials in a sequential manner, leading to “delay in treatment access”.

Has sequential testing caused delays? 

• • A 2012 clinical trial conducted in the U.S. explored the efficacy of the drug nivolumab across various cancer types, including melanoma and kidney cancer. Nivolumab targets a specific protein receptor found in certain tumors, and it showed promising results by alleviating symptoms in individuals with tumors expressing this protein

• Challenges Due to Traditional Organ-Based Classification-

• • Hindered by the traditional classification-Despite promising outcomes, the next logical step of testing nivolumab in individuals with tumors expressing the protein, regardless of cancer origin, was hindered by the traditional classification of cancers based on their organ of origin (e.g., breast, kidney, lung).
  • Multiple trials needed: As a consequence, researchers were compelled to conduct separate trials for each type of cancer, leading to significant delays in drug accessibility for patients with tumors expressing the targeted protein.
  • Time taking trails: Each trial requires substantial time and resources, from recruitment to data analysis, prolonging the process of drug approval and availability for specific cancer subtypes.

Significance of categorizing cancers based on their genetic characteristics-

• Faster drug development and availability: By targeting specific genetic mutations rather than specific cancer types, clinical trials for drugs can encompass all cancer types with those mutations. This approach potentially expedites the trial process, leading to faster drug development and availability.
• Reduces confusion among the patient: The revamped classification system not only accelerates clinical trial timelines but also enhances patient understanding of treatment rationale. Patients often receive different therapies for the same cancer due to diverse underlying biological mechanisms. Aligning cancer names with biological mechanisms reduces confusion and helps patients comprehend the reasoning behind their treatment plans.
• Personalized treatment: Physicians, including Dr. Jobanputra, emphasize the importance of educating patients about the molecular characteristics of their cancers. As the approach to cancer treatment becomes more personalized, understanding these molecular aspects becomes crucial as they directly impact prognosis and treatment costs.
• Reducing the timing in trial-naming cancers based on their biological characteristics rather than their anatomical origin can significantly reduce the time required to conduct clinical trials. This shift eliminates the need for separate trials for each cancer type defined by organ of origin, streamlining the research process

Challenges in Implementing the Proposed Cancer Classification Change:

• Limited Access to Genetic Testing: The accessibility and affordability of genetic testing are major hurdles, particularly in regions like India where many patients cannot afford these tests.
  • Without widespread access to such tests, implementing a classification system based on molecular alterations becomes impractical.
• Financial Barriers to Genetic Testing: The cost of genetic testing in Indian labs and abroad is prohibitively high for many patients, further exacerbating the issue of limited access.
  • Addressing these financial barriers is crucial for ensuring equitable access to precision oncology.
• Lack of Patients in Clinical Trials: Clinical trials based on molecular signatures require a significant number of patients with each type of cancer to produce meaningful results.
  • Without adequate representation across cancer types, there is a risk of generalizing results, limiting the effectiveness of precision oncology approaches.
• Time-taking Process: Transitioning to a new diagnostic nomenclature based on molecular alterations will likely occur gradually and require careful implementation.
  • While the proposed change has the potential to improve drug accessibility, its full realization will take time and concerted effort to overcome various challenges.

Conclusion: Categorizing cancers based on genetic characteristics can streamline treatment, improve drug accessibility, and enhance patient understanding. However, challenges like limited access to genetic testing and lack of patient representation in trials must be addressed.

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