Citations

Lay summaryImmunotherapy has changed the landscape of cancer treatment. However, the benefit of immunotherapy is seen only in some cases, with most patients experiencing cancer progression despite treatment with immunotherapy. To overcome this, combination immunotherapy treatments are being studied. Herein, we propose for a precision‐driven approach for patient selection to identify successful combinations of immunotherapy to improve outcomes for patients with cancer.

The NCCN Guidelines for Survivorship are intended to help healthcare professionals who work with survivors to ensure that the survivors’ complex and varied needs are addressed. The NCCN Guidelines provide screening, evaluation, and treatment recommendations for the consequences of adult-onset cancer and its treatment; recommendations to help promote physical activity, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes updates to the NCCN Guidelines pertaining to preventive health for cancer survivors, including recommendations about alcohol consumption and vaccinations.

This selection from the NCCN Guidelines for Rectal Cancer focuses on management of malignant polyps and resectable nonmetastatic rectal cancer because important updates have been made to these guidelines. These recent updates include redrawing the algorithms for stage II and III disease to reflect new data supporting the increasingly prominent role of total neoadjuvant therapy, expanded recommendations for short-course radiation therapy techniques, and new recommendations for a “watch-and-wait” nonoperative management technique for patients with cancer that shows a complete response to neoadjuvant therapy. The complete version of the NCCN Guidelines for Rectal Cancer, available online at NCCN.org , covers additional topics including risk assessment, pathology and staging, management of metastatic disease, posttreatment surveillance, treatment of recurrent disease, and survivorship.

The author of this essay uses his experience learning the complex planning and strategies of chess in childhood to illustrate the importance of informed strategy in the treatment of patients with cancer.

150 Background: Pancreatic neuroendocrine tumors (pNETs) comprise less than 5% of all pancreatic tumors and 7% of all neuroendocrine tumors (NETs). There has been considerable progress in understanding the biology of pNETs and numerous therapeutic options emerged, especially with the collaboration of various specialties in the multidisciplinary setting. In this this study, we sought to analyze the association of facility volume, treatment modalities offered, and different risk adjusted outcomes in pNETs. Methods: We extracted data from National Cancer Data Base (NCDB) that covers 70% of all newly diagnosed cancer cases in the U.S and Puerto Rico. Patients with pNETs diagnosed between 2004 & 2017 were included and classified into tertiles based on hospital volume. Volume–outcome relationship was determined by using Cox regression adjusting for patient demographics, comorbidities, tumor characteristics, insurance type and therapy received. Kaplan Meier estimates of OS were compared with log-rank test. The primary predictor of interest was the facility volume defined as number of pNETs treated/year. A total of 7202 patients with pathologically confirmed pNETS were treated at 840 facilities. The median annual facility volume was 5patients/year. Facilities were classified into (T:mean cases/year) T1: < 3; T2:4-8; T3:≥9 cases/year. Results: A total of 7202 pNET patients were treated at 840 facilities. The median annual facility volume was 5 patients/year. Facilities were classified into (T: mean cases/year) T1:<3; T2:4-8; T3:≥9 cases/year. The unadjusted median OS by facility volume was: T1: 71 months (m), T2: 136 m, and T3: not-reached (p < 0.001). On multivariable analysis, compared with patients treated at T3 facilities, patients treated at lower-tertile facilities had higher risk of death [T2 hazard ratio (HR), 1.17 (95% CI, 1.03-1.33); T1 HR, 1.45 (CI, 1.30-1.67), p < 0.0001] and such a difference in OS was more pronounced in stage IV disease (Table). Patients at T3 facilities (vs T1) were more likely to receive surgical resection of the primary tumor (75 vs 49%), lymph node dissection performed at the time of surgery (70 vs 42%), and a better R0 resection (72 vs 46%) (p < 0.01). Conclusions: Patients who were treated for pNETs at high-volume centers (> 9cases/year) had significantly higher OS and were more likely to receive surgical resection along with lymph node dissection and R0 resection. There was a 45% increased risk of death in patients treated at low volume centers (< 3/year) as compared to high-volume centers (> 9/year). While OS difference was noticed in all stages, the difference was more pronounced in stage IV disease demonstrating the importance of multi-disciplinary approach in pNETs management and incorporating such quality measures in low-volume facilities.[Table: see text]

125 Background: The advent of immunotherapy (IO) has led to significant improvement in outcomes for patients (pts) with advanced non-small cell lung cancer (adv NSCLC). The rate of crossovers and receipt of post-protocol IO in pivotal trials leading to FDA approvals of IO in NSCLC has not been systematically evaluated. Here, we evaluate crossover rates and post protocol therapies for pts with adv NSCLC across multiple first-line (1L) IO monotherapy and chemotherapy/IO (chemo/IO) combination trials. Methods: We utilized the publicly available data from pivotal clinical trials leading to approvals of IO or chemo/IO regimens in 1L treatment of adv NSCLC. We extracted data on outcomes, rate of crossover from control arm to IO, proportion of pts in control arm receiving IO and the start dates of these clinical trials. The primary outcomes were the rates of crossover and the proportion of patients in control arms who received post-control IO. Results: The study included 4 trials with IO monotherapy and 12 trials with chemo/IO combinations in 1L adv NSCLC. The primary endpoints for these trials were PFS (25%), OS (19%), and both PFS and OS (56%). The crossover rate from control arm to experimental arm (with IO) ranged from 0-74% in IO monotherapy trials and 0-49% in chemo/IO trials. Two IO monotherapy trials and five chemo/IO trials did not allow crossover; among them, 3 trials had a PFS/OS co-primary endpoint, while others had OS as primary endpoint. Ten of 16 trials provided explicit information on use of subsequent post-protocol therapies in their publications. Among the two IO monotherapy trials which did not allow crossover, post-protocol IO was administered in only 20-30% of patients. Among the six chemo/IO trials with information on post-protocol therapies, 30%-59% patients on the control arm subsequently received some form of IO on progression. Nine of 12 trials started accrual after 10/2015, when nivolumab was approved in the United States as second-line (2L) therapy for adv NSCLC regardless of tumor PD-L1 expression. Conclusions: Despite the highly significant OS benefit from 2L IO, which was the standard of care (SOC) in the United States, the rates of crossover and post-protocol IO administration was distressingly low in 1L IO monotherapy and chemo/IO trials for 1L adv NSCLC. This low rate of 2L treatment with IO may have been due to limited global availability prior to widespread regulatory approval during the conduct of these trials. There is an increased need for consistency in reporting of crossover treatment and post-protocol treatments to allow adequate assessment of the true 1L benefit with IO. Control arms in pivotal trials require scrutiny to ensure confirmation with SOC to provide access to optimal treatments for patients and prevent magnification of observed benefits in experimental arms. The difficulty lies in the global conduct of large randomized clinical trials with differing regulatory approvals.

AbstractBackground and ObjectiveCurrently, computed tomography‐guided transthoracic biopsy (CTTB) is the most accurate diagnostic approach for pulmonary nodules suspected of malignancy. Traditional bronchoscopy has shown suboptimal diagnostic sensitivity, but the emergence of robotic‐assisted bronchoscopy (RAB) has the potential to improve diagnostic accuracy, maximize diagnostic yield and complete mediastinal and hilar staging in a single procedure. We aim to assess the efficacy and diagnostic performance of RAB compared to CTTB for diagnosing pulmonary nodules suspected of lung cancer.MethodsA multicenter retrospective review of consecutive patients who underwent RAB and CTTB for evaluating pulmonary nodules from January 2019 to March 2021 at Mayo Clinic Florida and Mayo Clinic Rochester, United States. Clinical and demographic information, nodule characteristics, outcomes and complications were compared between RAB and CTTB.ResultsA total of 225 patients were included: 113 in the RAB group and 112 in the CTTB group. Overall diagnostic yield was 87.6% for RAB and 88.4% for CTTB. For malignant disease, RAB had a sensitivity of 82.1% and a specificity of 100%, CTTB had a sensitivity of 88.5% and a specificity of 100%. Complication rate was significantly higher for CTTB compared to RAB (17% vs. 4.4%; p = 0.002).ConclusionRAB, when available, can be as accurate as CTTB for sampling pulmonary nodules with similar or reduced complications and should be considered as a means for nodule biopsy, particularly when mediastinal staging is also clinically warranted.