Robert L. Coleman, MD

Pharmacists have always been a vital member of the cancer care team, but the emergence of many new oral therapies is making their role in patient care a more prominent one. This is especially true in the treatment of lung cancer.

Targeted therapies have found great success for lung cancer, and there are many promising new targeted oral drugs in the pipeline. As these drugs come to market, pharmacists will be called upon to provide a higher level of care to patients than in the past.

A large national study focusing on patients with non–small cell lung cancer (NSCLC) is underway that may help better define the expanded role pharmacists will play in patient care as more oral therapies are approved. The MYLUNG Consortium—or Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium—will observe up to 12,000 community-based patients with metastatic NSCLC over a 5-year period in 1 of the first collaborative research endeavors in lung cancer. The MYLUNG Consortium unites providers and investigators in The US Oncology Network, US Oncology Research, and Ontada with life sciences companies, biopharmaceutical manufacturers, and patient advocacy groups. This joint effort will strive to advance precision medicine options in a community setting for patients with NSCLC.

 According to the American Cancer Society, NSCLC is the most common type of lung cancer and accounts for approximately 84% of all lung cancer cases.

The MYLUNG Consortium is employing 3 protocols over 5 years, ending in 2026.

Protocol 1 retrospectively examines data on roughly 3500 patients from Ontada’s iKnowMed electronic health records collected as patients were treated by providers in The US Oncology Network. The goal is to understand baseline data on molecular testing and identify barriers to testing and precision medicine in a community setting. Although the MYLUNG Consortuim has completed collecting the dataset from protocol 1, the mining of data is ongoing.

Protocol 2, now under way, is enrolling 1000 patients from 10 practices, monitoring them from presentation through first-line therapy, and focusing on how diagnostic biomarker information is gathered and utilized in decision-making. Protocol 3, involving up to 7500 patients recruited from 20 practices, will provide a foundation from which prospectively assessed interventional strategies in patient-engagement algorithms will be conducted. Individual clinical trials will integrate findings from previous protocols and investigate new processes and their outcomes, enabling providers to make the best treatment recommendations based on available data. The goal is to improve access to testing and appropriate therapies for patients with NSCLC.

Pharmacists contribute to many critical aspects of the MYLUNG Consortium study, including the following:

As pharmacists fill the orders written for patients with newly diagnosed NSCLC, they can help enroll eligible patients in the MYLUNG Consortium, playing an active role in recruitment.

After putting a patient on treatment, the second most important thing is ensuring the patient stays on treatment. The emergence of oral therapies is suddenly taking patients out of the infusion chair and sending them to the pharmacy. This creates a different way of handling not only medication delivery but the whole care management paradigm as well. As the MYLUNG Consortium moves forward into protocols 2 and 3 and more oral therapies are utilized, there will be some unique roles for pharmacists addressing adherence and how adverse events can be mitigated.

Each of the oral drugs in the different targeted therapy categories have their own unique set of adverse effects. Pharmacists will play a key role in making sure adverse effects are managed, ensuring patients are triaged appropriately and handled with lower grade interventions, reducing the need for physician or emergency department visits. Given their deep understanding of these new therapies and their frequent interactions with patients, pharmacists will excel, not only as key members of the care team, but in this newly expanded role of driving adherence.

With greater focus on tumor testing to align with new drugs, physicians may be using compounds they are not as experienced with, as they may have previously delegated the drug to a different patient population. Now they are dealing with a larger number of patients because the drug may be used earlier in the treatment line. This might potentially open it up to a broader spectrum of adverse events. The pharmacist will play a key role in educating providers about potential adverse events that may occur in this expanded population, while also addressing ongoing questions or concerns.

A major goal of the MYLUNG Consortium is to optimize therapy, and having expertise available on drug-to-drug interactions, the bio durability of the compound and dose modification strategies are essential. These are critical issues that may not have come up previously, but now must be understood. The pharmacist will be an important component of this process whenever a new oral therapy is released.

After the FDA approves a new treatment for marketing, postmarketing studies are required or agreed upon by the drug sponsor and the FDA. These studies gather additional information from clinics about a product’s safety, efficacy and optimal use. By collecting data on populations that were not necessarily studied in clinical trials because of previous treatment, comorbidities, or other disqualifying characteristics, a more accurate view of real-life experience can be ascertained regarding tolerance and other factors. Pharmacists in the MYLUNG Consortium will play a key role in gathering this important data, enhancing the knowledge base for these promising new drugs.

The MYLUNG Consortium is intended to provide a deeper understanding of the barriers and opportunities in molecularly guided therapies for lung cancer, as well as identifying the optimal use of resources to provide the best outcome. The results could possibly be extrapolated from the NSCLC study to the real-world environment for other cancers.

Protocol 1 recently concluded, and there is much more to come over the next 5 years with protocols 2 and 3. The deep expertise of pharmacists will be essential in these study phases. Always a vital member of the patient’s comprehensive care team, pharmacists will be embracing a larger role than ever before, educating providers, ensuring patient enrollment, driving adherence, mitigating adverse events, and managing other critical issues.

The expanded role of the pharmacist in the MYLUNG Consortium foreshadows what is to come in cancer care. Looking at the drug pipeline for oncology, an increasing percentage of oral therapies are on the way, not only for lung cancer but for many other cancers as well. Consequently, many regimens will become more complex, with a mixture of infused and oral therapies. This will require a higher level of care than the oncology pharmacist has previously provided as a member of the care team. It will be pharmacists’ time to step into the spotlight.

is chief scientific officer for US Oncology Research, The Woodlands, Texas.

is vice president of Operations for Ontada, The Woodlands, Texas.

An inside look at the MYLUNG consortium. McKesson. Accessed May 6, 2021. 

https://www.mckesson.com/Specialty/An-Inside-Look-at-MYLUNG/

About lung cancer: key statistics for lung cancer. American Cancer Society. Reviewed January 12, 2021. Accessed May 6, 2021. 

https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html

Articles

Pharmacists have always been a vital member of the cancer care team, but the emergence of many new oral therapies is making their role in patient care a more prominent one.