Anne Chiang, MD, PhD, associate professor​, Yale School of Medicine, chief network officer and deputy chief medical officer​, Smilow Cancer Network, discusses the management of ​immune-related adverse effects (irAEs) in lung cancer. 

It is critical to conduct a thorough toxicity evaluation in patients with lung cancer who are receiving immunotherapy, Chiang says. This is commonly done in the clinical trial setting, and it should also be a part of everyday practice, says Chiang. 

Common ​irAEs include diarrhea and skin toxicities. To quantify irAEs, ​it may be beneficial for patients to keep a diary that patients can refer to in follow-up appointments, Chiang notes.

Notably, it’s important to keep ​irAEs in mind when a patient presents with an ailment such as low blood pressure​. In some cases, more serious irAEs such as adrenal insufficiency, hypophysitis, or encephalitis can be mistaken for dehydration, Chiang concludes. 

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Anne Chiang, MD, PhD, discusses the management of ​immune-related adverse effects in lung cancer. 

Dr. Chiang on the Management of Immune-Related AEs in Lung Cancer  

Every day, researchers conduct hundreds of clinical trials in cancer, yielding data about how the latest treatment advances impact the disease. Clinicians look at the results to determine which potential new treatments may or may not be good options for patients. But there are also other assessments that may help determine this: how do patients actually 

 when they’re taking a medicine? We can get some of these answers from the patient perspective through patient-reported outcomes, or PROs.

While PRO data have historically been analyzed by the US Food and Drug Administration (FDA) during the drug approval process, they have been largely inaccessible to the public. As a result, cancer patients are often left in the dark over how other patients feel and function on treatment – for example, the impact of a therapy on activities of daily functioning, disease symptoms, and symptomatic side effects.

Fortunately, a new FDA program is giving patients and providers first-time access to PRO data from cancer clinical trials of marketed treatments. The FDA’s Oncology Center of Excellence (OCE) launched 

, a pilot website that will evolve to include a list of cancer trials that have available PRO data taken from patient questionnaires. The first cancer trial PRO data being piloted on the site were provided by AstraZeneca.

The pilot website will display a table of patient-reported data collected over time, showing symptoms at baseline and at multiple time points during cancer treatment. The information can give patients and healthcare providers a deeper understanding of the patient experience during cancer trials to help inform treatment decisions.

Project Patient Voice is not meant to replace the clinician-reported safety information that is available as part of a drug's labeling. Data from Project Patient Voice should not substitute for advice from a health care professional. Rather, Project Patient Voice serves as a complement to FDA patient labeling and patient information, not a sole source of information on which to make decisions about medical care. Patients should ask their health care provider if they have any questions about their cancer treatment.

For the first phase of the Project Patient Voice website, AstraZeneca is contributing data from the first clinical trial to report data using the PRO-CTCAE

 patient questionnaire. PRO-CTCAE is a rigorous measurement tool for patients to rate the frequency, severity, interference, or presence/absence of symptomatic adverse events (AEs) that they may experience during a cancer trial. The questionnaire, developed by the 

, asks questions on various AEs, including pain, fatigue, nausea, and other symptoms that can be meaningfully reported from the patient’s perspective during a clinical trial while on an oncology therapy.

Improving Cancer Care Through the Patient Experience

As patient-centric healthcare has grown in recent years, more attention is being paid to PRO in cancer trials. With Project Patient Voice, the FDA is aiming to build a publicly accessible repository of PRO data, making it simpler for patients and providers to access and share important information about the patient’s treatment experience.

, co-hosted with the American Society of Clinical Oncology, seeking feedback on the website from stakeholders from across the cancer ecosystem. I invite my fellow healthcare providers to share feedback on the website and data.

The future of PRO in cancer research is exciting. The more it becomes a standard part of cancer clinical trials, the greater the opportunity for it to integrate into clinical practice and help shape cancer care, which may result in better patient outcomes.

Articles

A new FDA program is giving patients and providers first-time access to patient-reported outcome data from cancer clinical trials of marketed treatments.

Project Patient Voice: A Milestone in Cancer Patient Empowerment

Consolidation of community oncology practices with hospital-based cancer centers is an accelerating trend that will affect future healthcare delivery models.

 This year, the Community Oncology Alliance reported hospital acquisitions and corporate mergers among 55% of 1338 community oncology practices surveyed, representing a 20% increase over the previous year’s results.

Primary drivers of this trend include declining physician reimbursements for cancer treatment and care outside the hospital setting, increasing overhead for care delivery, and mounting shortages of medical oncologists available to care for a growing cancer patient population. Hospitals are motivated to acquire physician practices to expand their referral base, optimize payer relationships, and to maintain and/or grow pricing power for medical services.

In keeping with this trend, the Smilow Cancer Hospital at Yale-New Haven acquired two large medical oncology practices operating in 10 discrete community locations. The acquisition, which occurred in 2011-2012, included 23 physicians and more than 150 staff, and Smilow is preparing to integrate additional practices.

Physician practices joining hospital-based programs must comply with federal, state, and accrediting body regulations established to ensure patient safety and care quality. Historically, private office practices have not been responsible for meeting these requirements, and the resulting gap in compliance with national and local patient safety mandates is oftentimes significant.

Customary practices in office settings, such as verbal orders, administration of medications and prescription renewals by unlicensed personnel, and the admixture of hazardous drugs in uncontrolled environments, are not permitted in hospital-based facilities. Patient identification processes are often loose, and targeted patient assessments, such as pain, nutritional status, distress levels, and fall risk, are typically not performed or are undocumented in office practices, whereas these elements are mandatory in hospital-based settings and/or for cancer program accreditation.

Similarly, while patient/family education is commonly delivered in office practices, documentation is often absent or limited. Regulatory noncompliance can result in loss of accreditation and reimbursement for services. Consequently, hospitals must incorporate regulatory compliance in merger agreements and establish clear methodologies for achieving alignment of candidate practices with regulatory body requirements and institutional standards.

Oncology nurses—because of their education, experience, and critical place on the healthcare team&mdash;are ideally suited to evaluate gaps, to design and implement strategies to promote compliance in newly acquired medical practices, and, ultimately, to ensure patient safety and quality care.

The Smilow community oncology integration project engaged 15 institutional teams, each focused on its specific area of expertise (eg, nursing, pharmacy, infection prevention, life safety) and coordinated by a steering committee. The teams participated in preliminary gap analyses, made recommendations for and implemented alignment plans, and conducted interval monitoring—not only to determine degree of compliance but also to reinforce practice changes designed to achieve alignment with institutional standards.

Assessment was accomplished through one-onone interviews and focus groups, onsite observations, and medical record reviews guided by structured instruments. Alignment strategies involved the integration of best practices, including unique telepharmacy technology, novel staff and physician engagement strategies and practice-based educational programming.

To ensure successful transformative practice and process change, transition planning incorporated understanding of restraining and driving forces and incorporated coalition building, targeted staff engagement strategies, consistent and clear communication, focused education, and reinforcement.

More than 50 practice and process changes in seven key areas, including patient safety, medication management, communication, environment of care, operations, infrastructure, and professional development, were implemented during a 7-month post-assessment period.

Top challenges experienced during the early transition phases included: (1) staff and physician resistance to the adoption of a new identity and different processes (especially with multiple changes happening simultaneously); (2) communication pattern disruptions associated with reporting decentralization, and (3) role restructuring to comply with scope of practice mandates. Adding a new discipline (ie, pharmacy) to the team to perform functions that were traditionally a primary nursing role was also difficult. However, with time and experience, these challenges have dissipated somewhat, and nurses have been able to integrate more comprehensive patient assessment and other best practices into their clinical practice repertoire.

At 12 and 18 months post -“Go Live,” process change continues to evolve for the two newly acquired practices as a new electronic medical record unifying all practice sites has been implemented. Going forward, opportunities for performance improvement include increasing clinical trial accrual, provision of supportive care services to identified patient subpopulations, development of electronic reporting of key processes, and communication enhancements.

Transitioning community oncology practices from office- to provider-based structures is a challenging project that offers opportunities for experienced oncology nurses to explore new roles as change champions and transition leaders. At Smilow, the nursing staff—together with their physician counterparts and leadership&mdash;made the network vision a true reality.

			Butcher L. Oncology landscape continues consolidation. 

			Forte GJ, Hanley A, Hagerty K, Kurup A, Neuss MN, Mulvey TM. American Society of Clinical Oncology national census of oncology practices: preliminary report. 

			Community Oncology Alliance. Community Oncology Practice Impact Report: The Changing Landscape of Cancer Care. http://glacialblog. com/userfiles/76/Community_Oncology_Practice_Impact_Report_6-25- 13F(1).pdf. Accessed June 27, 2013.

			Kocher R, Sahni NR. Hospitals’ race to employ physicians—the logic behind a money-losing proposition. 

			Appelbaum SH, Habashy S, Malo JL, Shafiq H. Back to the future: revisiting Kotter’s 1996 change model. 

Consolidation of community oncology practices with hospital-based cancer centers is an accelerating trend that will affect future healthcare delivery models. This year, the Community Oncology Alliance reported hospital acquisitions and corporate mergers among 55% of 1338 community oncology practices surveyed, representing a 20% increase over the previous year's results.

Anne Chiang, MD

Articles

Dr. Chiang on the Management of Immune-Related AEs in Lung Cancer

Project Patient Voice: A Milestone in Cancer Patient Empowerment

Merging Community Practices With an Academic Cancer Center