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Older cancer patients are often excluded from clinical trials due to concerns about frailty and comorbidities. These same concerns about the viability of rendering treatment can spill over into clinical practice, including in elderly (ages ≥65) lung cancer patients.

In a "" article in JCO Oncology Practice, Chintan Shah, MD, of the University of Florida in Gainesville, and colleagues explored real-world trends in the use of antineoplastics in older patients diagnosed with extensive-stage small cell lung cancer (ES-SCLC) from 2001 to 2013, evaluating predictors of utilization, survival, and Medicare expenditure using NCI's Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

Highlights of the study included the following:

• Among over 15,000 patients with newly diagnosed ES-SCLC from 2001-2013, 43.38% received antineoplastics and 56.61% received supportive care only

• Every year since 2001, the percentage of patients receiving antineoplastics decreased (45.8% in 2001 to 36.6% in 2013)

• Factors associated with less chance of receiving antineoplastics were advanced age, living in high-poverty or rural areas, being non-Hispanic black or Hispanic, and having a higher Charlson Comorbidity Index (CCI)

• Mean Medicare spending per patient decreased over the study period for patients treated with antineoplastics and for those receiving supportive care only ($34,197 in 2001 and $25,265 in 2013)

• Although the SEER-Medicare database did not provide information on why antineoplastics were not delivered to older patients, the authors offered some possible reasons, such as the fact that elderly patients tend to have more smoking-related and other comorbidities, making them ineligible to receive potentially toxic antineoplastics. Also, despite 3 decades of advances in other solid cancers, there are still "limited therapeutic advances in SCLC, and relatively toxic platinum-based chemotherapy still remains the treatment of choice, which can make an elderly patient with more comorbidities actually opt not to receive palliative chemotherapy," Shah and colleagues stated

• The database does not currently have data on the use of immunotherapies, such as nivolumab (Opdivo), which was FDA approved for relapsed SCLC in these patients, the researchers noted

In the following interview, Shah, a hematology/oncology fellow, discussed the implications of the study.

What are the take-home messages from your group's study for lung cancer specialists?

Shah: We found that a significant proportion of elderly Medicare patients with ES-SCLC didn't receive potentially beneficial antineoplastic therapy. We also found that the proportion of such patients receiving antineoplastic agents continued to decline for the duration of our study period of 2001 to 2013. This is likely due to an increase in physiologic age with higher comorbidities.

For instance, we found that 9.6% of patients had CCI ≥3 in 2001 versus 15.6% in 2013. Effectively managing these comorbidities may make some patients eligible to receive antineoplastics.

Moreover, we also found that a proportion of patients from rural areas and high-poverty areas didn't receive antineoplastics despite having insurance -- this suggests poor access to healthcare. We also found that a significantly lower proportion of African-American or Hispanic patients did not receive antineoplastics, suggesting racial disparities.

Access to cancer care is an issue in . How could public health officials and cancer care specialists use the data from your group's study to potentially ?

Shah: About 19% of the U.S. population resides in rural areas. Proper cancer care requires not only medical oncologists, but also surgeons, radiation oncologists, and various support staff.

Moreover, we believe optimum cancer care also demands support from various other subspecialties and primary care providers [PCPs] to control and manage other comorbidities as well as various cancer treatment-related side effects.

As we found in our analysis, we are seeing more and more patients with a higher number of comorbidities than we did in the past. Without optimally controlling these comorbidities, patients are likely to suffer more life-threatening side effects or may not be eligible to receive antineoplastic therapy at all.

At this point, only 6% to 7% of oncology practices serve rural areas, and this makes access to cancer care in rural areas difficult. In April 2019, ASCO launched the . The goal is to identify opportunities to close the rural cancer care gap and implement strategies to improve rural cancer care in the U.S.

In my opinion, one of the most important roles of this task force is provider education and training ... to equip all members of the cancer care team -- including oncologists, PCPs, advanced practice providers, and other non-oncology specialists -- with specialized training and support so they are prepared to care for patients throughout their cancer journey, from active cancer treatment through survivorship and end-of-life care.

While this is surely a great initiative, we also strongly believe that without better access to healthcare in general, and access to various other subspecialties, we will not be able to close these gaps.

The study also found that although not significantly different, the mean inpatient spending per patient was higher throughout the study period for the supportive care only group compared with the group that received antineoplastic therapy. How could the data inform the current on ways to deliver quality healthcare cost-effectively?

Shah: Slightly lower inpatient spending of the group receiving antineoplastics can be explained by the fact that the chemotherapy given to ES-SCLC patients is largely on an outpatient basis. On the contrary, slightly higher inpatient spending for supportive care group patients can be due to the higher number of comorbidities possibly leading to frequent hospitalization.

From the database, it is not possible to determine the exact reasons for this trend. Various reports suggest that the current healthcare model has several downsides and is not sustainable, and healthcare reform is necessary.

Our study of ES-SCLC patients between 2001 and 2013 doesn't encompass the period when newer expensive immunotherapy became available and approved for the treatment of ES-SCLC. Besides that, our study also doesn't compare the utilization of antineoplastics and expenditure of different insurance types.

These are the limitations to our study, which unfortunately doesn't inform much about the current debate on ways to deliver quality healthcare cost-effectively. However, newer treatment modalities are expensive, and future trends are likely to show a significant increase in total Medicare spending, but that will be true for other private insurances as well. I believe proper monitoring and control of antineoplastic agents is essential to control healthcare cost.

The study was not able to determine the reasons patients did not receive antineoplastics. In your experience, how common is it for to treatment?

Shah: In our practice, we don't commonly see patients refusing treatment without any specific reasons. In my experience, patients refuse treatments despite a strong recommendation because of prior bad experiences, either personally or because they have seen loved ones go through chemotherapy-related side effects.

At times, patients either refuse or simply can't make it to clinic or treatment appointments due to living in areas with poor access to healthcare and the inability to afford transportation.

Moreover, in the last 3 decades, we have witnessed limited therapeutic advances in SCLC, and relatively toxic platinum-based chemotherapy remains the treatment of choice with marginal benefit in survival, which can make an elderly patient opt not to receive palliative chemotherapy. This is especially important for SCLC, as these patients tend to have higher smoking-related comorbidities.

While more treatment options are becoming available now, such as immunotherapy, unless we can find a way to make it easily accessible, we are unlikely to see any significant benefit of these agents in a real-world setting.

Does your group plan to continue this research and/or possibly look at change in the SCLC treatment landscape in older patients after the approval of nivolumab for relapsed SCLC?

Shah: The field of oncology is rapidly evolving. Several newer agents certainly have shown benefits in clinical trials; the benefit in the real-world setting is yet to be determined. Besides that, the added cost of expensive newer agents and their impact on overall healthcare costs will also be an important factor moving forward. We certainly plan to continue our research to study the outcomes after approval of nivolumab in relapsed SCLC and also atezolizumab [Tecentriq] in the front-line setting.

Read the study abstract here and expert commentary about the clinical implications here.