Stage IIIA non-small cell lung cancer represents a relatively heterogeneous group of patients with metastatic disease to the ipsilateral mediastinal (N2) lymph nodes and also includes T3N1 patients. ...Presentations of disease range from apparently resectable tumors with occult microscopic nodal metastases to unresectable, bulky multistation nodal disease. This review explores the published clinical trials to make treatment recommendations in this controversial subset of lung cancer.
Systematic searches were made of MEDLINE, HealthStar, and Cochrane Library databases up to May 2006, focusing primarily on randomized trials, with inclusion of selected metaanalyses, practice guidelines, and reviews. Study designs and results are summarized in evidence tables.
The evidence derived from the literature now appears to support routine adjuvant chemotherapy after complete resection of stage IIIA lung cancer encountered unexpectedly at surgery. However, using neoadjuvant therapy followed by surgery for known stage IIIA lung cancer as a routine therapeutic option is not supported by current published randomized trials. Combination chemoradiotherapy, especially delivered concurrently, is still the preferred treatment for prospectively recognized stage IIIA lung cancer with all degrees of mediastinal lymph node involvement. Current and future trials may modify these recommendations.
Multimodality therapy of some type appears to be preferable in all subsets of stage IIIA patients. However, because of the relative lack of consistent randomized trial data in this subset, the following evidence-based treatment guidelines lack compelling evidence in most scenarios.
To investigate how communication among physicians, patients, and family/companions influences patients' decision making about participation in clinical trials.
We video recorded 235 outpatient ...interactions occurring among oncologists, patients, and family/companions (if present) at two comprehensive cancer centers. We combined interaction analysis of the real-time video-recorded observations (collected at Time 1) with patient self-reports (Time 2) to determine how communication about trial offers influenced accrual decisions.
Clinical trials were explicitly offered in 20% of the interactions. When offers were made and patients perceived they were offered a trial, 75% of patients assented. Observed messages (at Time 1) directly related to patients' self-reports regarding their decisions (2 weeks later), and how they felt about their decisions and their physicians. Specifically, messages that help build a sense of an alliance (among all parties, including the family/companions), provide support (tangible assistance and reassurance about managing adverse effects), and provide medical content in language that patients and family/companions understand are associated with the patient's decision and decision-making process.
In two urban, National Cancer Institute-designated comprehensive cancer centers, a large percentage of patients are not offered trials. When offered a trial, most patients enroll. The quality and quantity of communication occurring among the oncologist, patient, and family/companion when trials are discussed matter in the patient's decision-making process. These findings can help increase physician awareness of the ways that messages and communication behaviors can be observed and evaluated to improve clinical practice and research.
Background Several cancer therapies have been associated with cardiovascular harm in early‐phase clinical trials. However, some cardiovascular harms do not manifest until later‐phase trials. To limit ...interdisease variability, we focused on breast cancer. Thus, we assessed the reporting of cardiovascular safety monitoring and outcomes in phase 2 and 3 contemporary breast cancer clinical trials. Methods and Results We searched Embase and Medline records for phase 2 and 3 breast cancer pharmacotherapy trials. We examined exclusion criterion as a result of cardiovascular conditions, adverse cardiovascular event reporting, and cardiovascular safety assessment through cardiovascular imaging, ECG, troponin, or natriuretic peptides. Fisher's exact test was utilized to compare reporting. Fifty clinical trials were included in our study. Patients were excluded because of cardiovascular conditions in 42 (84%) trials. Heart failure was a frequent exclusion criterion (n=31; 62% trials). Adverse cardiovascular events were reported in 43 (86%) trials. Cardiovascular safety assessments were not reported in 23 (46%) trials, whereas natriuretic peptide and troponin assessments were not reported in any trial. Cardiovascular safety assessments were more frequently reported in industry‐funded trials (69.2% versus 0.0%; P <0.001), and in trials administering targeted/immunotherapy agents compared with only hormonal/conventional chemotherapy (78.6% versus 22.7%, P <0.001). Conclusions Our findings demonstrate significant under‐representation of patients with cardiovascular conditions or prevalent cardiovascular disease in contemporary later‐phase breast cancer trials. Additionally, cardiovascular safety is not routinely monitored in these trials. Therefore, contemporary breast cancer clinical trials may possibly underestimate the cardiovascular risks of cancer pharmacotherapy agents for use in clinical practice.
Lung cancer continues to be the leading cause of cancer death, and although most lung cancer is attributable to cigarette smoking, underlying genetic susceptibility is suggested by studies ...demonstrating familial aggregation. The first family linkage study of lung cancer has identified linkage of lung, laryngeal, and pharyngeal cancer in families to a region on chromosome 6q23-25. Because lung cancer and chronic obstructive pulmonary disease (COPD) are known to aggregate in families beyond shared risk associated with smoking, the linkage results are compared and contrasted with results from genomewide linkage and association studies and candidate gene studies searching for genes for lung cancer, lung function, and COPD. Linkage on chromosome 6q to both lung cancer and lung function, and on 12 to lung cancer, COPD, and lung function, together with overlap in candidate genes for these outcomes, suggests that future research into underlying genetic mechanisms of lung disease would benefit from broadening the collection of family history data and better defining the "high risk" population. As familial risk of lung disease is better defined, referral into screening programs and prevention trials can be better targeted to reach families with both a history of lung cancer and COPD.
Professionally administered psychosocial interventions have been shown to improve the quality of life of cancer patients undergoing chemotherapy. The present study sought to improve access to ...psychosocial interventions during chemotherapy treatment by evaluating the efficacy and costs of a patient self-administered form of stress management training that requires limited professional time or experience to deliver.
Four hundred eleven patients about to start chemotherapy were randomly assigned to receive usual psychosocial care only, a professionally administered form of stress management training, or a patient self-administered form of stress management training. Quality-of-life assessments were conducted before randomization and before the second, third, and fourth treatment cycles. Intervention costs were estimated from both payer and societal perspectives.
Compared with patients who received usual care only, patients receiving the self-administered intervention reported significantly (P < or = .05) better physical functioning, greater vitality, fewer role limitations because of emotional problems, and better mental health. In contrast, patients who received the professionally administered intervention fared no better in terms of quality of life than patients receiving usual care only. Costs of the self-administered intervention were estimated to be 66% (from a payer perspective) to 68% (from a societal perspective) less than the average costs of professionally administered psychosocial interventions for patients starting chemotherapy.
Evidence regarding the efficacy and favorable costs of self-administered stress management training suggests that this intervention has the potential to greatly improve patient access to psychosocial intervention during chemotherapy treatment.
Develop a method for extracting smoking status and quantitative smoking history from clinician notes to facilitate cohort identification for low-dose computed tomography (LDCT) scanning for early ...detection of lung cancer.
A sample of 4,615 adult patients were randomly selected from the Multiparameter Intelligent Monitoring in Critical Care (MIMIC-III) database. The structured data were obtained by queries of the diagnosis tables using the International Classification of Diseases codes in use at that time. Unstructured data were drawn from clinician notes via natural language processing (NLP) using named entity recognition and our clinical data processing and extraction algorithms to identify two main clinical criteria for each smoking patient: (1) pack years smoked and (2) time from quit date (if applicable). A subset of 10% of the patient charts were manually reviewed for accuracy and precision.
The structured data revealed 575 (12.5%) ever smokers (current plus past use). None of these patients had quantification of their smoking history, and 4,040 (87.5%) had no smoking information in the diagnosis tables; consequently, a cohort of patients eligible for LDCT could not be determined. Review of the physician notes by NLP disclosed 1,930 (41.8%) ever smokers of whom 537 were active smokers and 1,299 former smokers, and in 94 cases, it could not be determined if they were active or former smokers. A total of 1365 patients (29.6%) had no smoking data recorded. When the smoking and the age criteria for LDCT were applied to this group, 276 were found to be eligible for LDCT using the USPSTF criteria. As determined by clinician review, our F-score for identifying patients eligible for LDCT was 0.88.
Unstructured data, obtained by NLP, can accurately identify a precise cohort that meets the USPSTF guidelines for LDCT.
Previous research has investigated patient question asking in clinical settings as a strategy of information seeking and as an indicator of the level of active patient participation in the ...interaction. This study investigates questions asked by patients and their companions during stressful encounters in the oncology setting in the USA. We transcribed all questions patients and companions asked the oncologist during 28 outpatient interactions in which “bad news” was discussed (
n
=
705
) and analyzed them for frequency and topic. Additionally, we analyzed the extent to which personal and demographic characteristics and independently obtained ratings of the oncologist-patient/companion relationships were related to question asking.
Findings demonstrated that at least one companion was present in 24 (86%) of the 28 interactions and companions asked significantly more questions than patients. The most frequently occurring topics for both patients and companions were treatment, diagnostic testing, diagnosis, and prognosis. In general, personal and demographic characteristics were unrelated to question asking, but older patients asked fewer questions, while more educated patients asked more questions. With regard to ratings of the quality of the dyadic relationships, results showed that “trust” between the physician and companions was positively correlated and “conversational dominance by physician” was negatively correlated with the frequency of companion questions. Additionally, positive ratings of the relationship between physicians and companions were correlated with fewer patient questions. This study demonstrates that companions are active participants in stressful oncology interactions. Future research and physician training in communication would benefit from expanding the focus beyond the patient–physician dyad to the roles and influence of multiple participants in medical interactions.
In recent years, there have been significant advances in the management of patients with lung cancer. This progress is associated with increased use of medical intensive care units (ICUs) for the ...management of a variety of complications related to cancer, its treatment, or comorbid illnesses. At the same time, there are advances in the care of critically ill patients in general. Over the last decade, there are several studies that report progressive improvement in the outcome of lung cancer patients admitted to the medical ICUs. On average, the ICU and hospital mortality rates of lung cancer patients are 36% and 51%, respectively. These rates are approaching those of critically ill general population. However, it is clear that not all lung cancer patients will benefit from this aggressive care. Although there are no absolute predictors, the current evidence suggests that advanced refractory cancer, poor baseline performance status, the need for mechanical ventilation, and multiple organ system failures are factors associated with worse ICU outcome. Further studies are needed to better triage patients who are going to benefit from ICU care; determine the optimal duration of this care; and assess the impact of this therapy on the long-term survival, cancer treatment, and quality of life of these patients.