Category: Lung

Hot Topics: Reports of Drug Side Effects Inconsistent

jackiewe Hot Topics in Research, Lung, Oncology, Pharmaceutical Sciences

Variation in toxicity reporting methods for early phase lung cancer treatment trials at oncology conferences

Simons EA, Smith DE, Gao D, Camidge DR. Variation in toxicity reporting methods for early phase lung cancer treatment trials at oncology conferences. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2020.04.020.

Introduction

Phase I and II trials provide the initial human safety and tolerability data for new drugs. However, the methods for presenting toxicity data are not standardized. Clinicians often first encounter these data at professional conferences. We sought to characterize how the burden of adverse events (AE) is reported at the largest professional conference in clinical oncology.

Methods

We collected toxicity data from all lung cancer-associated phase I and II trial presentations and posters at the American Society for Clinical Oncology annual meetings 2017-2019. We captured AE features including the minimum incidence utilized for reporting; whether AEs shown were treatment-emergent or treatment-related, grouped by organ system or separated by individual descriptors; whether combined or separated across dose levels when a dose escalation component was included; and whether dose-limiting toxicities, serious AE, dose reduction rules and denominators for laboratory tests were described.

Results

209 trials were analyzed. There was wide variability in toxicity reporting practices. Six different thresholds for reporting AE of any grade were used. Treatment-related AEs were reported twice as frequently as treatment-emergent AEs. Toxicities were as likely to be reported across dose level as by dose level. Terms such as dose-limiting toxicity and serious AE were rarely defined. Dose reduction rules and denominators for laboratory tests were never defined.

Conclusion

Standardization of methods for reporting toxicities could improve the quality and ease of comparability of data on adverse effects in early phase therapeutic trials. A minimal AE data disclosure template is proposed.

Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report

pjgrier Blood, Hot Topics in Research, Lung, Research Commentary

Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report
BACKGROUND: We update recommendations on 12 topics that were in the 9th edition of these guidelines, and address 3 new topics.
METHODS: We generate strong (Grade 1) and weak (Grade 2) recommendations based on high- (Grade A), moderate- (Grade B), and low- (Grade C) quality evidence.
RESULTS: For VTE and no cancer, as long-term anticoagulant therapy, we suggest dabigatran (Grade 2B), rivaroxaban (Grade 2B), apixaban (Grade 2B), or edoxaban (Grade 2B) over vitamin K antagonist (VKA) therapy, and suggest VKA therapy over low-molecular-weight heparin (LMWH; Grade 2C). For VTE and cancer, we suggest LMWH over VKA (Grade 2B), dabigatran (Grade 2C), rivaroxaban (Grade 2C), apixaban (Grade 2C), or edoxaban (Grade 2C). We have not changed recommendations for who should stop anticoagulation at 3 months or receive extended therapy. For VTE treated with anticoagulants, we recommend against an inferior vena cava filter (Grade 1B). For DVT, we suggest not using compression stockings routinely to prevent PTS (Grade 2B). For subsegmental pulmonary embolism and no proximal DVT, we suggest clinical surveillance over anticoagulation with a low risk of recurrent VTE (Grade 2C), and anticoagulation over clinical surveillance with a high risk (Grade 2C). We suggest thrombolytic therapy for pulmonary embolism with hypotension (Grade 2B), and systemic therapy over catheter-directed thrombolysis (Grade 2C). For recurrent VTE on a non-LMWH anticoagulant, we suggest LMWH (Grade 2C); for recurrent VTE on LMWH, we suggest increasing the LMWH dose (Grade 2C).
CONCLUSIONS: Of 54 recommendations included in the 30 statements, 20 were strong and none was based on high-quality evidence, highlighting the need for further research.
 
CHEST 2016; 149(2):315-352
Clive Kearon, MD, PhD; Elie A. Akl, MD, MPH, PhD; Joseph Ornelas, PhD; Allen Blaivas, DO, FCCP; David Jimenez, MD, PhD, FCCP; Henri Bounameaux, MD; Menno Huisman, MD, PhD; Christopher S. King, MD, FCCP; Timothy A. Morris, MD, FCCP; Namita Sood, MD, FCCP; Scott M. Stevens, MD; Janine R. E. Vintch, MD, FCCP; Philip Wells, MD; Scott C. Woller, MD; and COL Lisa Moores, MD, FCCP

Management of Pulmonary Nodules by Community Pulmonologists

pjgrier Hot Topics in Research, Lung, Oncology

Management of Pulmonary Nodules by Community Pulmonologists
BACKGROUND: Pulmonary nodules (PNs) are a common reason for referral to pulmonologists. Th e majority of data for the evaluation and management of PNs is derived from studies performed in academic medical centers. Little is known about the prevalence and diagnosis of PNs, the use of diagnostic testing, or the management of PNs by community pulmonologists. METHODS: Th is multicenter observational record review evaluated 377 patients aged 40 to 89 years referred to 18 geographically diverse community pulmonary practices for intermediate PNs (8-20 mm). Study measures included the prevalence of malignancy, procedure/test use, and nodule pretest probability of malignancy as calculated by two previously validated models. Th e relationship between calculated pretest probability and management decisions was evaluated. RESULTS: Th e prevalence of malignancy was 25% (n 5 94). Nearly one-half of the patients (46%, n 5 175) had surveillance alone. Biopsy was performed on 125 patients (33.2%). A total of 77 patients (20.4%) underwent surgery, of whom 35% (n 5 27) had benign disease. PET scan was used in 141 patients (37%). Th e false-positive rate for PET scan was 39% (95% CI, 27.1%-52.1%). Pretest probability of malignancy calculations showed that 9.5% (n 5 36) were at a low risk, 79.6% (n 5 300) were at a moderate risk, and 10.8% (n 5 41) were at a high risk of malignancy. Th e rate of surgical resection was similar among the three groups (17%, 21%, 17%, respectively; P 5 .69). CONCLUSIONS: A substantial fraction of intermediate-sized nodules referred to pulmonologists ultimately prove to be lung cancer. Despite advances in imaging and nonsurgical biopsy techniques, invasive sampling of low-risk nodules and surgical resection of benign nodules remain common, suggesting a lack of adherence to guidelines for the management of PNs.
CHEST2015; 148(6): 1405 – 1414