Why Is Adhering to Standard of Care So Elusive?

H. Jack West, MD


June 22, 2022

Over the past few years, one topic has continued to defy reason: the gulf between recommended molecular testing in the setting of advanced non–small cell lung cancer (NSCLC) and real-world practice in the United States.

In fact, I wrote about these shortcomings back in 2019, and then again last year. At both points, improvements were slower than we might have expected in such a dynamic field.

But there may be some hints as to why we're moving so slowly.

For one, molecular marker testing remains an area where standards of care are constantly changing, and consequently physicians have good reason to question whether next-generation sequencing will be covered by insurers. Another, potentially more compelling reason: New data reveal that we do quite poorly in following long-standing standards of care.

A recent analysis looking at delivery rates of adjuvant chemotherapy for resected early-stage NSCLC — the recommended standard of care for more than a decade — found that more than 40% of patients did not receive such care. The study, led by Kenneth L. Kehl, MD, MPH, evaluated patients enrolled on the intergroup study Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST), offered by multiple cooperative groups over many years. The analysis looked at patients with stage IB to IIIA NSCLC measuring at least 4 cm and/or with positive lymph nodes who did not enroll on a therapeutic trial.

This is precisely the group demonstrating a consistent survival benefit from adjuvant cisplatin-based chemotherapy — a treatment recommended by the National Comprehensive Cancer Network (NCCN). Yet only 57% of the 2833 patients included received any adjuvant chemotherapy, just 44% completed four cycles, and only 34% received a cisplatin-based chemotherapy. As one would expect, patients with stage II (58%) or IIIA (65%) NSCLC were much more likely to receive adjuvant chemotherapy than were those with stage IB NSCLC (38%).

However, because these patients were enrolled on a multicenter clinical trial, we can presume that these numbers are better than they would be in a broader population.

Indeed, evidence from a real-world database (ConcertAI Patient360) of patients' electronic medical records corroborate findings from the ALCHEMIST trial and highlight that numbers in clinical practice are even lower. In this analysis, my colleagues and I found that adjuvant chemotherapy was delivered to only a minority of patients who would be appropriate candidates — specifically, only 154 of 441 patients (34.9%). We also saw that adjuvant chemotherapy was administered to a much smaller proportion of patients with stage IB disease (15.7%) than those with stage II (42.1%) or stage IIIA disease (50.5%), and only 55% of the subgroup received a common cisplatin-based regimen.

Yet another example: A recent survey found that oncologists reported recommending consolidation durvalumab after chemoradiation to less than half of their new patients with unresectable stage III NSCLC.

This issue isn't isolated to drug treatment. Only 53% of patients enrolled in ALCHEMIST, for instance, received what NCCN criteria define as an adequate lymph node dissection.

The common theme here is the remarkable gap between the standard of care, as dictated by clinical trials, and actual practice, at least in thoracic oncology. Clearly, many patients are not receiving what the evidence indicates is optimal therapy.

Some of this gap may exist because patients in the broader community setting are older and have more comorbidities than those who receive treatment at larger centers and fulfill study eligibility requirements. Even so, the fact that so many more patients with stage II/IIIA NSCLC receive adjuvant chemotherapy than patients with stage IB NSCLC suggests that candidacy for treatment is just one potential contributing factor.

Patients and, probably, oncologists may question whether the recommendations emerging from clinical trial data are sufficient to apply broadly. In addition, barriers like cost, time away from other duties, and a lack of commitment to prolonged treatment may all contribute to guideline nonadherence.

But I think the most accurate answer to explain this gulf between optimal care and real-world practice is, "We just don't know." That, in large part, is because the oncology community has not dedicated enough attention to such practical matters.

The media, professional oncology organizations, and pharma-sponsored educational programs have successfully promoted a narrative of inexorable progress and miraculous gains in the field. Meanwhile, academic oncologists focus on developing new drugs that target mechanisms of acquired resistance. Yet collectively, we ignore an inconvenient truth, one that draws attention to a much less sexy topic that could have an exponentially greater impact: addressing why 50% of the lung cancer population isn't receiving treatments that we know improve survival.

Simply put, we need to direct more efforts toward how well we are delivering established treatments and to ensure that interventions developed in clinical trials can be reliably applied in practice. Cancer outcomes shouldn't depend on where a patient receives their treatment. We must ensure that we don't widen the gap between what is and is not feasible at certain centers.

What do you see as the leading limitations to providing standard of care? What explains these gaps in care? Let us know in the comment section.

H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, California, regularly comments on lung cancer for Medscape. Dr West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.