Tony Hagen

Because of the risk associated with the type of upfront treatment selected for patients with nonsmall cell lung cancer (NSCLC), testing for driver mutations is essential before beginning frontline therapy. Treatments could add to the toxicity of targeted therapies, as well as spark resistance to these therapeutic options, according to Suresh S. Ramalingam, MD, at the

&ldquo;Once you go in the wrong direction, there can be significant costs,&rdquo; said Ramalingam, the Roberto C. Goizueta Chair for Cancer Research; professor, Department of Hematology and Medical Oncology; and deputy director of the Winship Cancer Institute of Emory University.

In his presentation, Ramalingam highlighted current and emerging therapies for 6 key actionable driver mutations in NSCLC:

&ldquo;If you have to start treatment and you don&rsquo;t have time to wait [for next-generation sequencing (NGS) results], then I would suggest starting patients on a chemotherapy doublet alone,&rdquo; explained Ramalingam. &ldquo;By the time the results come back, if you have to shift gears and switch them to targeted therapy after [immunotherapy] exposure has already happened, there is a high incidence of regression no matter which targeted agent you&rsquo;re consideringsome more than others.&rdquo; Starting off with a less-than-ideal therapy can also complicate the toxicity picture, he added.

For patients with actionable mutations, targeted therapy is the preferred frontline treatment &ldquo;regardless of PD-L1 expression levels,&rdquo; said Ramalingam.

-mutated NSCLC, osimertinib (Tagrisso) has shown potency in comparison with earlier-generation EGFR TKIs, Ramalingam noted. The phase III FLAURA trial randomized 556 patients with previously untreated

mutationpositive (exon 19 del or L858R) advanced NSCLC to receive either osimertinib or standard EGFR TKI therapy with gefitinib (Iressa) or erlotinib (Tarceva). In the primary analysis, median progression-free survival (PFS), the primary end point, was 18.9 months for osimertinib versus 10.2 months for standard EGFR TKIs (HR, 0.46; 95% CI, 0.37-0.57;

The trial was not powered for overall survival (OS), but Ramalingam noted that a nearly 7-month advantage in OS was seen with osimertinib. The median OS was 38.6 months for the osimertinib group versus 31.8 months for the comparator

Because crossover was allowed, &ldquo;The control group had one of the highest OS [rates] we have seen for the EGFR first-line setting, and despite this, we&rsquo;ve seen an overall improvement in survival with osimertinib,&rdquo; Ramalingam said.

Osimertinib is the preferred first-line treatment for

-positive NSCLC, according to the National Comprehensive Cancer Network guidelines.

Also in this setting, dacomitinib (Vizimpro) outperformed gefitinib with regard to median PFS benefit (14.7 months vs 9.2 months; HR, 0.59; 95% CI, 0.47-0.74;

<.0001) for the first-line treatment of patients with advanced

-positive NSCLC, according to data from the phase III ARCHER 1050 trial.

Data presented at the 2018 ASCO Annual Meeting demonstrated that at a median follow-up of 31.3 months, the median OS with dacomitinib was 34.1 months versus 26.8 months with gefitinib.

Looking ahead to potential therapeutic advances in this setting, Ramalingam noted that various trials are evaluating EGFR TKIs in combination with angiogenesis inhibitors. One such trial is EA5182 (NCT02803203), which is comparing osimertinib with osimertinib plus bevacizumab (Avastin) in untreated patients with metastatic

-positive NSCLC. Furthermore, studies of chemotherapy plus gefitinib have shown wide margins of improvement in median PFS and OS, Ramalingam added.

For example, in the phase III NEJ009 study, the median PFS for gefitinib versus chemotherapy plus gefitinib in advanced NSCLC with

mutations was 11.2 months versus 20.9 months, and the median OS was 38.8 months versus 52.2 months, respectively.

The second-generation ALK inhibitor alectinib (Alecensa) has become the preferred drug in the

-positive space and shows good tolerability, Ramalingam said. In the phase III ALEX trial, the median PFS was 11.1 months for crizotinib versus not yet reached for alectinib (HR, 0.47; 95% CI, 0.34-0.65;

<.001), and the number of adverse events was 102 (68%) versus 62 (41%), respectively.

Brigatinib has also shown strong activity in this space, particularly in patients who have received prior chemotherapy. In the phase III ALTA-1L trial, brigatinib was associated with a 51% lower risk of disease progression or death than crizotinib (HR, 0.49;

<.001) in patients with prior chemotherapy in the locally advanced or metastatic setting. For patients who did not receive chemotherapy, median PFS was not reached for brigatinib versus 9.8 months for crizotinib.

-positive NSCLC accounts for up to 2% of patients with actionable mutations in NSCLC, Ramalingam said. Crizotinib, 1 of 2 FDA-approved agents in this space, has demonstrated strong antitumor activity in patients with advanced

-positive NSCLC. According to findings reported in 2014, the objective response rate (ORR) was 72% (95% CI, 58-84) and the median PFS was 19.2 months (95% CI, 14.4-not reached). Notably, 44% of patients in the study had received 2 or more prior lines of therapy.

&ldquo;These results were impressive, and they have driven practice for a very long time,&rdquo; Ramalingam said.

More recently, entrectinib (Rozlytrek) received FDA approval for adult and pediatric patients &ge;12 years of age with solid tumors that harbor

fusions. The decision was based on findings from an integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and the phase I ALKA-372-001 trials, which showed a clinical benefit rate of 77.4% (95% CI, 63.8-87.7) in patients with

fusionpositive NSCLC. Patients responded whether or not they had central nervous system (CNS) disease, Ramalingam noted. For those with CNS disease at baseline (n = 23) versus those without CNS disease (n = 30), the ORR was 73.9% (95% CI, 51.6-89.8) versus 80.0% (95% CI, 61.4-92.3), respectively.

Oncologists should keep in mind that &ldquo;not all

-mutations are the same,&rdquo; Ramalingam stressed.

V600E mutations account for approximately 41% of mutations in this class but patients whose tumors harbor non-V600E mutations are not likely to respond to BRAF inhibitors, he noted. For patients with

V600E mutated NSCLC, dabrafenib (Tafinlar) in combination with trametinib (Mekinist) has shown to be an effective regimen. Data from an open-label, phase II trial showed that treatment with the combination led to a response rate of 63.2% (95% CI, 49.3-75.6), a median PFS of 14 months, and a median OS of 24 months.

Two key agents in development for treatment of patients with

-positive NSCLC include selpercatinib (LOXO-292), which has achieved an ORR of 77% (95% CI, 58%-90%);

and BLU-667, which induced an ORR of 50%.

Both agents have received breakthrough designations from the FDA.

&ldquo;They have very good tolerability&hellip;and we hope to have them available for our patients in the very near future,&rdquo; Ramalingam said.

fusionpositive cancers, the TRK inhibitors larotrectinib (Vitrakvi) and entrectinib (Rozlytrek) have both shown promise, added Ramalingam. For example, larotrectinib was found to induce an ORR of 80%, according to pooled trial results presented at the 2018 ESMO Congress.

Furthermore, entrectinib was found to induce an ORR of 57% (95% CI, 43-71) in efficacy-evaluable patients with

Ramalingam S. Choosing the best first-line therapy: oncogene-driven NSCLC. Presented at: 14th Annual New York Lung Cancers Symposium; November 9, 2019; New York, New York.

Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer.

. 2018;378(2):113-125. doi: 10.1056/NEJMoa1713137.

Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFRTKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): final overall survival analysis.

. 2019;30(suppl 5):mdz394.076. doi: 10.1093/annonc/mdz394.076.

Mok T, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib for the first-line treatment of advanced EGFR mutation positive non-small cell lung cancer (ARCHER 1050): a randomized, open-label phase III trial.

. 2017;35(suppl 18, abstr LBA9007). doi: 10.1200/JCO.2017.35.18_suppl.LBA9007.

Mok TS, Cheng Y, Zhou X, et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations.

. 2018;36(22):2244-2250. doi: 10.1200/JCO.2018.78.7994.

Nakamura A, Inoue A, Morita S, et al. Phase III study comparing gefitinib monotherapy (G) to combination therapy with gefitinib, carboplatin, and pemetrexed (GCP) for untreated patients (pts) with advanced non-small cell lung cancer (NSCLC) with EGFR mutations (NEJ009).

. 2018;36(suppl 15, abstr 9005). doi: 10.1200/JCO.2018.36.15_suppl.9005.

Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC.

. 2018;36(suppl 15, abstr 9043). doi: 10.1200/JCO.2018.36.15_suppl.9043.

Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer.

. 2018;379(21):2027-2039. doi: 10.1056/NEJMoa1810171.

Shaw AT, Ou SH, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer.

. 2014;371(21):1963-1971. doi: 10.1056/NEJMoa1406766.

Barlesi F, Drilon A, De Braud F, et al. Entrectinib in locally advanced or metastatic ROS1 fusion-positive nonsmall cell lung cancer (NSCLC): Integrated analysis of ALKA-372-001, STARTRK-1 and STARTRK-2. Presented at: 2019 European Lung Cancer Congress; April 11 to 13, 2019; Geneva, Switzerland. Abstract 109O.

Planchard D, Besse B, Groen HJM, et al. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicenter phase 2 trial.

. 2016;17(7):984-993. doi: 10.1016/S1470-2045(16)30146-2.

Drilon AE, Subbiah V, Oxnard GR, et al. A phase 1 study of LOXO-292, a potent and highly selective RET inhibitor, in patients with RET-altered cancers.

. 2018;36(suppl 15; abstr 102). doi: 10.1200/JCO.2018.36.15_suppl.102.

Subbiah V, Taylor M, Lin J, et al. Highly potent and selective RET inhibitor, BLU-667, achieves proof of concept in a phase I study of advanced, RET-altered solid tumors. Presented at: AACR Annual Meeting 2018; April 14-18, 2018; Chicago, IL. Abstract CT043.

Lassen UN, Albert CM, Kummar S, et al. Larotrectinib efficacy and safety in TRK fusion cancer: an expanded clinical dataset showing consistency in an age and tumor agnostic approach.

. 2018;29(suppl 8). doi: 10.1093/annonc/mdy279.397.

Demetri GD, Paz-Ares L, Farago AF, et al. Efficacy and safety of entrectinib in patients with NTRK fusion-positive tumors: pooled analysis of STARTRK-2, STARTRK-1 and ALKA-372-001. Presented at: 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA17.

Articles

Testing for driver mutations is essential before initiating therapy in patients with non&ndash;small cell lung cancer, because there is a risk that the type of upfront treatment chosen could add to the toxicity of, and spur resistance to, targeted therapy options, Suresh S. Ramalingam, MD, said at the 14th Annual New York Lung Cancers Symposium.

Genetic Testing is Essential in NSCLC Prior to Induction Therapy

Noeadjuvant therapy for lung cancer provides significant benefits compared with adjuvant therapy, according to Jamie E. Chaft, MD. In a presentation at the&nbsp;

, Chaft explained why neoadjuvant therapy is beneficial even though adjuvant therapy is still the standard of care at a number of cancer centers.

Preoperative treatment allows for earlier treatment of micrometastatic disease, reductions in surgical risk, improved tolerability and compliance with therapy, and also affords opportunities for use of surrogate endpoints and to study adaptive adjuvant therapy in nonresponders, said Chaft, who is an associate attending physician at Memorial Sloan Kettering Cancer Center.

Chaft said there is powerful logic for addressing cancer earlier in development, when tumor size is smaller and the prognosis is better. At stage IA3, a resected nonsmall cell lung cancer (NSCLC) tumor the size of a quarter has a roughly 20% recurrence-mortality rate at 5 years; at stage IIA, a tumor the size of a golf ball has a recurrence-mortality rate of around 35% at 5 years. With lymph node involvement, mortality increases to 40% to 75% at 5 years, &ldquo;and that&rsquo;s just not acceptable. We need to do better,&rdquo; Chaft said.

In a meta-analysis of preoperative chemotherapy, including cisplatin and carboplatin, for patients with resectable NSCLC, investigators observed a 13% reduction in the relative risk of death (HR, 0.87; 95% CI, 0.78-0.96;

= .007), she noted. The analysis included 15 trials (n = 2385) and no evidence of difference was seen between trials (

The analysis demonstrated that preoperative chemotherapy in resectable NSCLC was a viable option for many of the patients, stage IB to IIIA, enrolled in these trials. Overall survival (OS), time to distant recurrence, and recurrence-free survival in resectable NSCLC were each significantly improved. &ldquo;We clearly see the efficacy of cisplatin-based chemotherapy either preoperatively or postoperatively,&rdquo; Chaft said.

She also noted a study of metastatic breast cancers in mice that she said demonstrated greater power of neoadjuvant versus adjuvant immunotherapies to eradicate distant metastases following primary resection. The combination of antiPD-1 and CD137-directed antibodies improved survival when given preoperatively but not postoperatively. &ldquo;I haven&rsquo;t seen anything more compelling,&rdquo; Chaft said. Authors of the study noted elevated and sustained peripheral tumor-specific immune responses, and speculated that blood sampling of tumor-specific CD8-positive T cells immediately before and after surgery may help to predict outcomes.

In the phase II NADIM trial, neoadjuvant chemoimmunotherapy with nivolumab (Opdivo) induced an 83% rate of pathologic response in patients (n = 34) with stage IIIA NSCLC, and the complete response rate was 59% (n = 24).

&ldquo;I think this is truly a game changer,&rdquo; Chaft commented. Progression-free survival (PFS) was 81% at 18 months in the intent-to-treat population.

By comparison, PFS in the PACIFIC trial was 52%, she noted, in which patients with locally advanced, unresectable NSCLC received durvalumab (Imfinzi) after &ge;2 cycles of platinum chemotherapy.

In the NATCH trial, chemotherapy before surgery for early-stage NSCLC led to moderately higher survival rates than surgery alone, but the findings were not statistically significant.

Chemotherapy before surgery for early-stage NSCLC led to moderately higher survival rates than surgery alone, but not enough to reach statistical significance. However, 90% of patients completed 3 cycles of preoperative paclitaxel and carboplatin.

&ldquo;Chemotherapy, we know from the NATCH study, is better tolerated preoperatively, there&rsquo;s greater compliance preoperatively, and we know there is benefit preoperatively versus postoperatively, so if it were me, I&rsquo;d want my systemic therapy preoperatively rather than postoperatively,&rdquo; Chaft said.

Although neoadjuvant treatment has potency in NSCLC, the potential for cure rests with surgery, and so &ldquo;We should not be giving therapies that are likely to interfere with that,&rdquo; she added. Patient selection is key to success with immunotherapies. &ldquo;The big push to give immunotherapy to all is well-intentioned, but we have to respect both absolute and relative contraindications for this patient population.&rdquo;

Low-grade toxicities should be observed but not treated, and all endocrinopathies should be investigated, particularly for thyroid dysfunction or adrenal insufficiency that could be exacerbated by the induction of anesthesia, she advised.

An ongoing trial slated to have practice-changing potential is the EA5142 study (NCT02595944) of nivolumab after surgery and chemotherapy in patients with stage Ib to stage IIIa NSCLC. The study, which Chaft is leading, will evaluate whether adjuvant therapy with nivolumab will result in improved OS and disease-free survival over standard observation following resection and standard adjuvant therapy. The trial just completed accrual and results will slowly read out over the next 7 years, Chaft said. &ldquo;The practicality of adjuvant versus neoadjuvant with all of these amazing new therapies out there is that it&rsquo;s going to take a really long time to understand how these drugs work.&rdquo;

She also discussed the value of surrogate endpoints as substitutes for clinical endpoints, such as pathologic response in the neoadjuvant setting and cell-free DNA in the adjuvant setting.

Although evidence for neoadjuvant therapy is compelling, major international adjuvant antiPD-1/PD-L1 trials are fully enrolled or enrolling currently. &ldquo;In the next 3 years, we will have a plethora of data. Does that mean we should stop studying neoadjuvant chemotherapy and immunotherapy? Absolutely not,&rdquo; given all of the data, neoadjuvant therapy &ldquo;really is game-changing and probably better,&rdquo; Chaft concluded.

Chaft JE. Neoadjuvant or adjuvant. Presented at: 14th Annual New York Lung Cancers Symposium; November 9, 2019; New York, New York.

NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data.

2014;383(9928):1561-1571. doi: 10.1016/S0140-6736(13)62159-5.

Liu J, Blake SJ, Yong MC, et al. Improved efficacy of neoadjuvant compared to adjuvant immunotherapy to eradicate metastatic disease.

2016;6(12):1382-1399. doi: 10.1158/2159-8290.CD-16-0577.

Provencio M, Nadal E, Insa A, et al. Phase II Study of Neo-Adjuvant Chemo/ Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG.

2019;13(105):S320. doi: 10.1016/j.jtho.2018.08.236.

Felip E, Rosell R, Maestre JA, et al. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage nonsmall-cell lung cancer.

2010;28(19):3138-3145. doi: 10.1200/JCO.2009.27.6204.

Noeadjuvant therapy for lung cancer provides significant benefits compared with adjuvant therapy, according to&nbsp;Jamie E. Chaft, MD. In a presentation at the&nbsp;<em>14th Annual </em>New York Lung Cancers Symposium, Chaft explained why neoadjuvant therapy is beneficial even though adjuvant therapy is still the standard of care at a number of cancer centers.

Expert Discusses Benefits of Preoperative Therapy for NSCLC

Announced at the 2019 ASCO Annual Meeting, the FDA is rolling out a pilot program that will provide more information and assistance for acquiring expanded access (EA) to investigational therapies for both oncologists and patients. The program is being called Project Facilitate and will be run by the FDA Oncology Center of Excellence, and EA Navigator, which is operated by the Reagan-Udall Foundation for the FDA.

Expanded access or &ldquo;compassionate use&rdquo; programs make investigational drugs, biologics, and medical devices available to patients who have exhausted other options for treatment and do not qualify for clinical trials that would provide these agents. Richard Pazdur, MD, director of the Oncology Center of Excellence, said the joint program would streamline the process of gaining access to investigational agents while helping the FDA obtain information to improve the EA process and better understand investigational agents.

&ldquo;At the current time, the FDA doesn&rsquo;t know the number of patients requesting expanded access,&rdquo; Pazdur said in a presentation at the 2019 American Society of Clinical Oncology Annual Meeting.

&ldquo;Many times, the physician will go to the [drug] sponsor and the FDA is not aware if the sponsor denies these requests. We also do not know the reasons for drug sponsors&rsquo; denying these requests.&rdquo;

This pilot program is exclusively for improving EA for oncologics, Pazdur said. EA has been around, at least informally, since the 1960s, and was instrumental in efforts to broadly expand access for experimental treatments during the HIV/AIDs epidemic. Many EA requests, however, come from individual patients who are in extreme need and willing to try a therapy that has not been proven or may not have been cleared for marketing by the FDA. The agency, which must authorize requests for EA, receives about 1000 requests per year for participation in these programs.

Depending on the urgency, FDA approvals can be done over the phone, although follow-up is required.

The Reagan-Udall Foundation will provide a searchable database that physicians and patients can use to establish whether any clinical trials are available for treatment with the investigational agents. The database will also provide information about EA programs, thereby offering physicians and patients a streamlined information search, according to Ellen V. Sigal, PhD, chair of the Reagan-Udall Foundation.

&ldquo;For the first time, those who need quick access to drug availability and expanded access options will find it in 1 place without having to visit site by site or sift through thousands of studies that don&rsquo;t [serve] their needs,&rdquo; she said.

After visiting the foundation&rsquo;s website, physicians would then turn to Project Facilitate, which is tasked with ushering physicians through the process of reaching out to drug companies for EA. FDA officials said this process would be more coordinated than in the past, as their current focus is broadening access and then following up with physicians about outcomes.

&ldquo;Experienced FDA oncology staff will be available to support physicians and other healthcare professionals with their questions, assist in filling out the appropriate paperwork, and [facilitate] the process,&rdquo; according to a statement from the agency.

Pazdur said the agency hopes the initiative can resolve inequities in access due to the lack of information about EA. He said the FDA is working to change a perception among physicians that the approvals process is burdensome.

Pazdur said information about outcomes gathered during the process may be shared with trial sponsors. &ldquo;Frequently we are unaware of patient outcomes such as benefits from the proposed therapy and adverse events associated with that therapy,&rdquo; he said. Physicians are required by law to provide that information but often they don&rsquo;t, he added.

Reasons why drug sponsors turn down EA requests likely also will be shared, Pazdur said. &ldquo;I&rsquo;m sure we&rsquo;ll publish it and make it publicly available in some fashion. We haven&rsquo;t really worked that aspect out.&rdquo;

EA can only happen if a drug company agrees to make a drug available outside of a clinical trial. Requests are sometimes turned down because only limited supplies of investigational drugs are available, and the FDA cannot require a company to make its drugs available through EA. Drug companies sometimes are concerned that EA may compromise their clinical trials. For example, there is a concern that adverse events (AEs) among unenrolled patients may lead to holds being placed on clinical trials.

However, a review of EA requests over a 10-year period demonstrated that only 2 drug development programs were ever placed on clinical hold due to AEs in patients receiving EA, and these were temporary.

Under the 21st Century Cures Act, companies were required to make information about their EA programs public. The Reagan-Udall Foundation component of this EA pilot is partly an attempt to broadly disseminate that information, Sigal said. &ldquo;So, this is a necessary tool and urgent for patients and physicians.&rdquo;

Pazdur R. Project Facilitate & EA Navigator. Presented at: 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL.

Jarow JP, Lurie P, Crowley Ikenberry S, Lemery S. Overview of FDA&rsquo;s expanded access program for investigational drugs.

2017;51(2):177-179. doi: 10.1177/2168479017694850.

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer [news release]. Silver Spring, MD: FDA; June 3, 2019. https://www.fda.gov/news-events/press-announcements/fda-announces-project-facilitate-assist-physicians-seeking-access-unapproved-therapies-patients.

Announced at the 2019 ASCO Annual Meeting, the FDA is rolling out a pilot program that will provide more information and assistance for acquiring expanded access (EA) to investigational therapies for both oncologists and patients. The program is being called Project Facilitate.

FDA Unveils Project Facilitate to Ease Expanded Access to Experimental Cancer Treatments

Details on a prototype system were released during the 2019 ASCO Annual Meeting by a&nbsp;consortium of cancer care institutions that was designed to use electronic health record (EHR) systems to provide real-world patient data that could guide research and improve cancer treatment.

Minimal Common Oncology Data Elements (mCODE) is an open source system designed to allow for interflow of common clinical data from patients within institutional EHR systems. Data is collecting on 6 core domains:&nbsp;patient characteristics and demographics; lab tests and vital signs; specific details regarding the cancer; genomics such as molecular characteristics; treatments including surgical, radiation, drug and other treatments; and outcomes, such as current cancer status and survival. Data can be subdivided into 27 types of patient profiles and include 73 distinct data elements that can provide critical information for clinical inquiry.

The initial set of standards and specifications for mCODE was released at the annual meeting by a collaboration including ASCO, its nonprofit subsidiary CancerLinQ, the MITRE Corporation, and the Alliance for Clinical Trials in Oncology Foundation (The Alliance Foundation).

The lack of interoperability and inability to share information among EHR systems smoothly has long been a concern among oncologists and an impediment to large-scale research efforts that depend on agglomerations of data that, when mined, filtered, and analyzed, yield insights into drug performance and patient experiences under treatment.

As many as 15 million individuals in the United States are living with cancer and much of the information about them is stored in EHRs of one kind or another. These systems have their own standards for classifying data and priorities for what kinds of data should be collected. This adds to the incompatibility between EHR systems, interferes with care coordination, and adds to administrative work and the costs of healthcare.

Through its common elements structure, mCODE can bypass many of the communication barriers posed by multiple different EHR systems and protocols used by the healthcare community.

This is partly accomplished by incorporation of Fast Healthcare Interoperability Resources (FHIR), a draft standard that establishes formats for data reporting and applies coding that facilitates the exchange of EHR information across systems. Investigators said when using mCODE, clinicians would be able to plug common clinical terms into a search engine and draw the data they need from institutional EHRs hooked into the system.

In fact, one of the core principles that will drive the success of mCODE is its adherence to standard, widely available medical terminologies, investigators said. Additionally, the system will be available free of charge. It is available for download at mCODEinitiative.org.

Investigators also said mCODE will be capable of capturing increasingly complex genomic data that is produced by new discoveries in molecular diagnostics and treatment.

"Progress and quality care for patients with cancer can hinge on our ability to seamlessly share patient data among doctors, hospitals, and researchers. But data sharing is much more difficult, if not impossible, when EHR systems contain incompatible information," said ASCO President Monica M. Bertagnolli, MD, FACS, FASCO. "With mCODE, we're bringing the oncology community together around common data standards that will bring us one step closer to our goal of learning from every patient with cancer."

The Alliance Foundation is initiating a research effort that will integrate patient data collected via EHRs with clinical trial information broadening the amount of information on treatment and patient population available for drawing conclusions about efficacy and treatment strategies.

"This work will validate the use of mCODE as a tool for clinical research and will also establish a platform for conducting research that includes many patients not currently represented in conventional prospective clinical trials," said Steven Piantadosi, MD, PhD, scientific director of the Alliance Foundation ICAREdata Project.

Jay J. Schnitzer, MD, PhD, noted that the huge base of information mCODE will make available will contribute enormously to advances in oncology. "Publishing mCODE is an important step towards realizing incredible insights into treatment that the 97% of cancer patients not participating in clinical trials could generate,&rdquo; said Schnitzer, who serves as MITRE's chief technology officer. "Through wide adoption and integration of cancer data standards, and the application of technologies like FHIR, shared treatment experiences could be turned into information that patients and clinicians can use to better navigate care options."

mCODE is currently being piloted at Partner's Healthcare in Boston and Intermountain Healthcare headquartered in Salt Lake City, among other cancer centers across the country. The results of these pilots will be used to improve the functioning of mCODE.

Bertagnolli MM. mCODE: Minimal Common Oncology Data Elements. Presented at: The American Society of Clinical Oncology Annual Meeting; June 1-4, 2019; Chicago, IL.

Details on a&nbsp;prototype system were released during the 2019 ASCO Annual Meeting by a&nbsp;consortium of cancer care institutions that was designed to use electronic health record systems to provide real-world patient data that could guide research and improve cancer treatment.

Tony Hagen | Authors

Articles

Genetic Testing is Essential in NSCLC Prior to Induction Therapy

Expert Discusses Benefits of Preoperative Therapy for NSCLC

FDA Unveils Project Facilitate to Ease Expanded Access to Experimental Cancer Treatments

Open-Source System Introduced to Guide, Improve Cancer Treatment Through EHR Systems