Esophageal squamous cell carcinoma is an aggressive malignancy with histologic variability depending on where in the world it is diagnosed, with most of these cancers occurring in China and other parts of Asia. Previous studies with cytotoxic chemotherapy combinations led to a plateau median overall survival of approximately 10 to 12 months, as well as a need for more effective treatment options. Cytotoxic chemotherapy served as the control arm in 3 studies that evaluated the safety and efficacy of immunotherapy + chemotherapy versus chemotherapy alone; in all 3 prospective randomized trials, the addition of immunotherapy resulted in a survival benefit in the first-line relapsed/metastatic setting. Data support these immunotherapy regimens as new standard-of-care systemic therapy options for unresectable, locally advanced, recurrent or metastatic esophageal cancers, and these regimens have now been incorporated into the NCCN Guidelines.
Presented by: Michael K. Gibson
Rebecca A. Nelson, Enrique Soto-Perez-de-Celis, Rowan T. Chlebowski, Mara Schonberg, Joanne Mortimer, Kathy Pan, Lifang Hou, Marian L. Neuhouser, Kerryn W. Reding, Nazmus Saquib, Jean Wactawski-Wende, Emily Wolfson, Mina S. Sedrak, and Laura Kruper
Background: When treating older women with breast cancer, life expectancy is an important consideration. ASCO recommends calculating 10-year mortality probabilities to inform treatment decisions. One useful tool is the Schonberg index, which predicts risk-based all-cause 10-year mortality. We investigated the use of this index in women aged ≥65 years with breast cancer in the Women’s Health Initiative (WHI). Methods: We calculated 10-year mortality risk scores for 2,549 WHI participants with breast cancer (“cases”) and 2,549 age-matched breast cancer–free participants (“controls”) using Schonberg index risk scoring. Risk scores were grouped into quintiles for comparisons. Risk-stratified observed mortality rates and 95% confidence intervals were compared across cases and controls. Observed 10-year mortality rates in cases and controls were also compared with Schonberg index–based predicted 10-year mortality rates. Results: Compared with controls, cases were more often white (P=.005), had higher income and education levels (P<.001 for both), more often lived with their husband/partner (P<.001), scored higher on subjective health/happiness (P<.001), and needed less assistance in activities of daily living (P<.001). Participants with breast cancer had similar risk-stratified 10-year mortality rates compared with controls (34% vs 33%, respectively). Stratified results showed that cases had slightly higher mortality rates than controls in the lowest risk quintile and lower mortality rates in the 2 highest risk quintiles. Observed mortality rates in cases and controls were similar to Schonberg index–predicted mortality, with model c-indexes of 0.71 and 0.76, respectively. Conclusions: Among women aged ≥65 years with incident breast cancer, the Schonberg index–based risk-stratified 10-year mortality rates were similar to those in women without breast cancer, demonstrating a similar performance of the index among both populations. Along with other health measures, prognostic indexes can help predict survival among older women with breast cancer and support geriatric oncology guidelines that promote using life expectancy calculation tools for shared decision-making.
Michael P. Douglas, Meera V. Ragavan, Cheng Chen, Anika Kumar, Stacy W. Gray, Collin M. Blakely, and Kathryn A. Phillips
Background: Circulating tumor DNA (ctDNA) is used to select initial targeted therapy, identify mechanisms of therapeutic resistance, and measure minimal residual disease (MRD) after treatment. Our objective was to review private and Medicare coverage policies for ctDNA testing. Methods: Policy Reporter was used to identify coverage policies (as of February 2022) from private payers and Medicare Local Coverage Determinations (LCDs) for ctDNA tests. We abstracted data regarding policy existence, ctDNA test coverage, cancer types covered, and clinical indications. Descriptive analyses were performed by payer, clinical indication, and cancer type. Results: A total of 71 of 1,066 total policies met study inclusion criteria, of which 57 were private policies and 14 were Medicare LCDs; 70% of private policies and 100% of Medicare LCDs covered at least one indication. Among 57 private policies, 89% specified a policy for at least 1 clinical indication, with coverage for ctDNA for initial treatment selection most common (69%). Of 40 policies addressing progression, coverage was provided 28% of the time, and of 20 policies addressing MRD, coverage was provided 65% of the time. Non–small cell lung cancer (NSCLC) was the cancer type most frequently covered for initial treatment (47%) and progression (60%). Among policies with ctDNA coverage, coverage was restricted to patients without available tissue or in whom biopsy was contraindicated in 91% of policies. MRD was commonly covered for hematologic malignancies (30%) and NSCLC (25%). Of the 14 Medicare LCD policies, 64% provided coverage for initial treatment selection and progression, and 36% for MRD. Conclusions: Some private payers and Medicare LCDs provide coverage for ctDNA testing. Private payers frequently cover testing for initial treatment, especially for NSCLC, when tissue is insufficient or biopsy is contraindicated. Coverage remains variable across payers, clinical indications, and cancer types despite inclusion in clinical guidelines, which could impact delivery of effective cancer care.
Emma B. Holliday, Arjun Peddireddy, and Van K. Morris
Squamous cell carcinoma of the anus and anal canal is a rare malignancy with an increasing incidence in the United States. In the past 2 decades, the proportion of Americans diagnosed with incurable, metastatic anal cancer at the time of initial presentation has increased. Most cases are linked to prior infection with HPV. Although concurrent chemoradiotherapy has been the accepted standard treatment for patients with localized anal cancer over the past half century, therapeutic advances have increased options for patients with unresectable or incurable anal cancer over the past 5 years. Specifically, combination chemotherapy and immunotherapy with anti–PD-(L)1 antibodies has demonstrated efficacy in this setting. Greater understanding of molecular drivers of this viral-associated malignancy has provided critical insight into evolving biomarkers for the clinical management of anal cancer. The pervasiveness of HPV across cases of anal cancer has been leveraged for the development of HPV-specific circulating tumor DNA assays as a sensitive biomarker for prognosticating recurrence in patients with localized anal cancer who complete chemoradiation. For patients with metastatic disease, somatic mutations, well-characterized for anal cancer, have not shown utility in identifying patients who benefit from systemic treatments. Although the overall response rate to immune checkpoint blockade therapies is low for metastatic anal cancer, high immune activation within the tumor and PD-L1 expression may identify patients more likely to experience response. These biomarkers should be incorporated into the design of future clinical trials to personalize further treatment approaches in the evolving management of anal cancer.
Shawna L. Ehlers, Lisa M. Gudenkauf, Elizabeth L. Kacel, Sherrie M. Hanna, Pam S. Sinicrope, Christi A. Patten, Eleshia L. Morrison, Jill Snuggerud, Danielle Bevis, Janae L. Kirsch, Jeffrey P. Staab, Katharine A.R. Price, Andrea E. Wahner-Hendrickson, and Kathryn J. Ruddy
Background: Cancer distress management is an evidence-based component of comprehensive cancer care. Group-delivered cognitive behavioral therapy for cancer distress (CBT-C) is the first distress treatment associated with replicated survival advantages in randomized clinical trials. Despite research supporting patient satisfaction, improved outcomes, and reduced costs, CBT-C has not been tested sufficiently within billable clinical settings, profoundly reducing patient access to best-evidence care. This study aimed to adapt and implement manualized CBT-C as a billable clinical service. Patients and Methods: A stakeholder-engaged, mixed-methods, hybrid implementation study design was used, and the study was conducted in 3 phases: (1) stakeholder engagement and adaptation of CBT-C delivery, (2) patient and therapist user testing and adaptation of CBT-C content, and (3) implementation of practice-adapted CBT-C as a billable clinical service focused on evaluation of reach, acceptability, and feasibility across stakeholder perspectives. Results: A total of 40 individuals and 7 interdisciplinary group stakeholders collectively identified 7 primary barriers (eg, number of sessions, workflow concerns, patient geographic distance from center) and 9 facilitators (eg, favorable financial model, emergence of oncology champions). CBT-C adaptations made before implementation included expanding eligibility criteria beyond breast cancer, reducing number of sessions to 5 (10 total hours), eliminating and adding content, and revising language and images. During implementation, 252 patients were eligible; 100 (40%) enrolled in CBT-C (99% covered by insurance). The primary reason for declining enrollment was geographic distance. Of enrollees, 60 (60%) consented to research participation (75% women; 92% white). All research participants completed at least 60% of content (6 of 10 hours), with 98% reporting they would recommend CBT-C to family and friends. Conclusions: CBT-C implementation as a billable clinical service was acceptable and feasible across cancer care stakeholder measures. Future research is needed to replicate acceptability and feasibility results in more diverse patient groups, test effectiveness in clinical settings, and reduce barriers to access via remote delivery platforms.
Presented by: Ella A. Kazerooni, Jacob Sands, and Douglas E. Wood
The NCCN Guidelines for Lung Cancer Screening have evolved over time to reflect the latest evidence and expert consensus. These NCCN Guidelines have played a significant role in shaping clinical practice and policy, leading to increased payer coverage for lung cancer screening and decreasing lung cancer mortality. Continued research and advancements in early detection methods, along with the implementation of effective screening programs, will be crucial in the ongoing effort to reduce lung cancer mortality and improve the overall quality of life for patients affected by this disease.
Presented by: Kristin Dickinson, Halle C.F. Moore, Jennifer Schmitz, and Eric S. Zhou
Moderated by: Andrew T. Day
For many patients, sleep disorders (particularly insomnia), cancer-related fatigue, and cancer-related cognitive impairment are common and distressing symptoms of cancer and its treatment. At the NCCN 2023 Annual Conference, a panel of experts began with a personal account of a cancer survivor’s experience and discussed approaches to assess and manage these adverse effects of cancer and its treatment.
Presented by: Gregory J. Riely
The use of next-generation tyrosine kinase inhibitors has led to improved progression-free survival for patients with metastatic non–small cell lung cancer (NSCLC) and those with EGFR-mutant and ALK-positive tumors. Newer therapeutics can now target KRAS G12C mutations, EGFR exon 20 insertions, and ERBB2 (HER2) mutations. Patients with metastatic NSCLC should undergo molecular testing for these mutations as well as for BRAF mutations; MET exon 14 skipping alterations; and ROS1, RET, and NTRK gene rearrangements (fusions). Novel targeted therapeutics are emerging at a fast pace.
Presented by: Mitesh J. Borad
Hepatobiliary cancers are aggressive tumors that affect the liver and biliary tract and are responsible for nearly 550,000 deaths per year. The most common malignancy is hepatocellular carcinoma, and risk factors include viral hepatitis infection, nonalcoholic steatohepatitis, and excessive alcohol use. Other etiologies include Wilson’s disease, α1-antitrypsin deficiency, and cryptogenic cirrhosis. Clinicians should be aware of underlying conditions and how they influence treatment decisions.