For the use of immunotherapy in metastatic non–small cell lung cancer (NSCLC), the NCCN Guidelines for NSCLC reflect the importance of assessing levels of PD-L1 expression to determine the best use of PD-1/PD-L1 inhibitors, whether alone or in combination with chemotherapy. Patients who lack a driver mutation and have tumor PD-L1 expression ≥50% are recommended to receive single-agent pembrolizumab, although combining with carboplatin/pemetrexed is also a reasonable choice, especially if there is higher burden of disease. For tumors with PD-L1 expression <50%, it is important to distinguish between nonsquamous and squamous cell carcinoma (SCC). For patients with non-SCC disease, pembrolizumab + carboplatin/pemetrexed is preferred. Alternately, a 4-drug regimen of carboplatin/paclitaxel/bevacizumab/atezolizumab is reasonable, especially for patients ineligible for pemetrexed. In patients with SCC, carboplatin + paclitaxel or nab-paclitaxel with pembrolizumab is a category 1 recommendation. Tumor mutational burden is emerging as a biomarker for efficacy but is not yet ready to be used in patient selection. Optimal management of the unique toxicities associated with immunotherapy, which can be more frequent with these combinations, is also critical for good outcomes.
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Matthew A. Gubens and Marianne Davies
Margaret A. Tempero
Outcomes for pancreatic cancer are becoming less discouraging with the refinement of molecular profiling, both germline and somatic, and beneficial effects seen with adjuvant chemotherapy. The NCCN Guidelines for Pancreatic Adenocarcinoma reflect these advances, and recommend that clinicians consider germline testing for all patients with pancreatic cancer and consider a molecular analysis for those with metastatic disease. The guidelines further recommend that clinicians consider adjuvant therapy with modified FOLFIRINOX (leucovorin/5-FU/irinotecan/oxaliplatin) for patients who are able to tolerate it.
Gary H. Lyman
Biosimilars are here to stay, but whether they will enjoy widespread uptake remains to be seen. The FDA sets a high bar for approval of biosimilar products, yet many clinicians remain skeptical about the efficacy and safety of these agents. Favorable experience with >30 biosimilars in Europe provides some reassurance that these agents are safe and effective and can be substituted for the reference product.
David M. O’Malley
After 3 to 4 decades of stagnation, several new options are available for the treatment of ovarian cancer, some of which produce longer survival compared with historical controls. Additionally, 3 new PARP inhibitors (olaparib, rucaparib, niraparib) have been approved for use in ovarian cancer, with different indications as maintenance therapy or treatment of recurrence. Indications for bevacizumab have been extended, and there are now multiple combination chemotherapy regimens that include bevacizumab as part of initial treatment and as an option for maintenance therapy in select patients, both for first-line primary/adjuvant chemotherapy and for treatment of recurrent or refractory disease.
Katy Winckworth-Prejsnar, James McCanney, Alyssa A. Schatz, Warren Smedley, Leonidas C. Platanias, Cecil M. Benitez, Lee N. Newcomer, C. Lyn Fitzgerald and Robert W. Carlson
Multiple factors are forcing the healthcare delivery system to change. A movement toward value-based payment models is shifting these systems to team-based integration and coordination of care for better efficiencies and outcomes. Workforce shortages are stressing access and quality of care for patients with cancer and survivors, and their families and caregivers. Innovative therapies are expensive, forcing payers and employers to prioritize resources. Patients are advocating for care models centered on their needs rather than those of providers. In response, payment policies have recently focused on the promotion of alternative payment models that incentivize coordinated, high-quality care with consideration for value and controlling the increasing overall costs associated with cancer and its treatment. Given the multitude of factors confounding cancer care, NCCN convened a multistakeholder working group to examine the challenges and opportunities presented by changing paradigms in cancer care delivery. The group identified key challenges and developed policy recommendations to address 4 high-visibility topics in cancer care delivery. The findings and recommendations were then presented at the NCCN Policy Summit: Policy Challenges and Opportunities to Address Changing Paradigms in Cancer Care Delivery in September 2018, and multistakeholder roundtable panel discussions explored these findings and recommendations along with additional items. This article encapsulates the discussion from the NCCN Working Group meetings and the NCCN Policy Summit, including multistakeholder policy recommendations on delivery issues in cancer care designed to help inform national policies moving forward.
Reith R. Sarkar, Katherine E. Fero, Daniel M. Seible, Neil Panjwani, Rayna K. Matsuno and James D. Murphy
Background: Pancreatic cancer is an aggressive disease characterized by early and relentless tumor spread, thus leading healthcare providers to consider it a “distant disease.” However, local pancreatic tumor progression can lead to substantial morbidity. This study defines the long-term morbidity from local and nonlocal disease progression in a large population-based cohort. Methods: A total of 21,500 Medicare beneficiaries diagnosed with pancreatic cancer in 2000 through 2011 were identified. Hospitalizations were attributed to complications of either local disease (eg, biliary disorder, upper gastrointestinal ulcer/bleed, pain, pancreas-related, radiation toxicity) or nonlocal/distant disease (eg, thromboembolic events, cytopenia, dehydration, nausea/vomiting/motility problem, malnutrition and cachexia, ascites, pathologic fracture, and chemotherapy-related toxicity). Competing risk analyses were used to identify predictors of hospitalization. Results: Of the total cohort, 9,347 patients (43.5%) were hospitalized for a local complication and 13,101 patients (60.9%) for a nonlocal complication. After adjusting for the competing risk of death, the 12-month cumulative incidence of hospitalization from local complications was highest in patients with unresectable disease (53.1%), followed by resectable (39.5%) and metastatic disease (33.7%) at diagnosis. For nonlocal complications, the 12-month cumulative incidence was highest in patients with metastatic disease (57.0%), followed by unresectable (56.8%) and resectable disease (42.8%) at diagnosis. Multivariable analysis demonstrated several predictors of hospitalization for local and nonlocal complications, including age, race/ethnicity, location of residence, disease stage, tumor size, and diagnosis year. Radiation and chemotherapy had minimal impact on the risk of hospitalization. Conclusions: Despite the widely known predilection of nonlocal/distant disease spread in pancreatic cancer, local tumor progression also leads to substantial morbidity and frequent hospitalization.
James L. Mohler, Emmanuel S. Antonarakis, Andrew J. Armstrong, Anthony V. D’Amico, Brian J. Davis, Tanya Dorff, James A. Eastham, Charles A. Enke, Thomas A. Farrington, Celestia S. Higano, Eric Mark Horwitz, Michael Hurwitz, Joseph E. Ippolito, Christopher J. Kane, Michael R. Kuettel, Joshua M. Lang, Jesse McKenney, George Netto, David F. Penson, Elizabeth R. Plimack, Julio M. Pow-Sang, Thomas J. Pugh, Sylvia Richey, Mack Roach III, Stan Rosenfeld, Edward Schaeffer, Ahmad Shabsigh, Eric J. Small, Daniel E. Spratt, Sandy Srinivas, Jonathan Tward, Dorothy A. Shead and Deborah A. Freedman-Cass
The NCCN Guidelines for Prostate Cancer include recommendations regarding diagnosis, risk stratification and workup, treatment options for localized disease, and management of recurrent and advanced disease for clinicians who treat patients with prostate cancer. The portions of the guidelines included herein focus on the roles of germline and somatic genetic testing, risk stratification with nomograms and tumor multigene molecular testing, androgen deprivation therapy, secondary hormonal therapy, chemotherapy, and immunotherapy in patients with prostate cancer.