Reporting of tobacco use and tobacco-related analyses in cancer cooperative group clinical trials: a systematic scoping review.

BACKGROUND: Continued smoking after a diagnosis of cancer negatively impacts cancer outcomes, but the impact of tobacco on newer treatments options is not well established. Collecting and evaluating tobacco use in clinical trials may advance understanding of the consequences of tobacco use on treatment modalities, but little is known about the frequency of reporting and analysis of tobacco use in cancer cooperative clinical trial groups. PATIENTS AND METHODS: A comprehensive literature search was conducted to identify cancer cooperative group clinical trials published from January 2017-October 2019. Eligible studies evaluated either systemic and/or radiation therapies, included ≥100 adult patients, and reported on at least one of: overall survival, disease/progression-free survival, response rates, toxicities/adverse events, or quality-of-life. RESULTS: A total of 91 studies representing 90 trials met inclusion criteria with trial start dates ranging from 1995 to 2015 with 14% involving lung and 5% head and neck cancer patients. A total of 19 studies reported baseline tobacco use; 2 reported collecting follow-up tobacco use. Seven studies reported analysis of the impact of baseline tobacco use on clinical outcomes. There was significant heterogeneity in the reporting of baseline tobacco use: 7 reported never/ever status, 10 reported never/ex-smoker/current smoker status, and 4 reported measuring smoking intensity. None reported verifying smoking status or second-hand smoke exposure. Trials of lung and head and neck cancers were more likely to report baseline tobacco use than other disease sites (83% versus 6%, P < 0.001). CONCLUSIONS: Few cancer cooperative group clinical trials report and analyze trial participants' tobacco use. Significant heterogeneity exists in reporting tobacco use. Routine standardized collection and reporting of tobacco use at baseline and follow-up in clinical trials should be implemented to enable investigators to evaluate the impact of tobacco use on new cancer therapies.

Impact of high-fidelity e-learning on knowledge acquisition and satisfaction in radiation oncology trainees.

Background: e-Learning is an underutilized tool in education for the health professions, and radiation medicine, given its reliance on technology for clinical practice, is well-suited to training simulation in online environments. The purpose of the present study was to evaluate the knowledge impact and user interface satisfaction of high-(hf) compared with low-fidelity (lf) e-learning modules (e-modules) in radiation oncology training. Methods: Two versions of an e-module on lung radiotherapy (lf and hf) were developed. Radiation oncology residents and fellows were invited to be randomized to complete either the lf or the hf module through individual online accounts over a 2-week period. A 25-item multiple-choice knowledge assessment was administered before and after module completion, and user interface satisfaction was measured using the Questionnaire for User Interaction Satisfaction (quis) tool. Results: Of 18 trainees, 8 were randomized to the lf module, and 10, to the hf module. Overall, knowledge assessment performance increased (11%, p < 0.05), with hf-group participants reporting a 13% improvement (p = 0.02), and senior participants reporting an almost 15% improvement (p < 0.01). Scores on the quis indicated that participants were satisfied with various aspects of the user interface. Conclusions: The hf e-module had a greater impact on knowledge acquisition, and users expressed satisfaction with the interface in both the hf and lf situations. The use of e-learning in a competency-based curriculum could have educational advantages; participants expressed benefits and drawbacks. Preferences for e-learning integration in education for the health professions should be explored further.

Surgery Versus Chemotherapy and Radiotherapy For Early and Locally Advanced Small Cell Lung Cancer: A Propensity-Matched Analysis of Survival.

BACKGROUND: The role of surgery in small cell lung cancer (SCLC) is controversial. Survival outcomes for resection of stage I-IIIA SCLC compared to chemotherapy-based non-surgical treatment (NST) were examined using propensity matching. METHODS: 29,994 clinical stage I-IIIA SCLC patients, including 2,619 undergoing surgery, were identified in the National Cancer Database. Stage-specific propensity scores for receipt of surgery were created. Resected patients were matched 1:1 to those undergoing NST. Overall survival (OS) was assessed using Kaplan-Meier and multivariable Cox models. A separate match was performed comparing Stage I/II patients aged <85 with a Charlson score of 0 who underwent lobectomy with adjuvant chemotherapy (and radiotherapy if node positive) to those treated with multiagent chemotherapy and concurrent chest radiotherapy (CRT) of at least 40 gray. RESULTS: 2,089 patients were matched, and cohorts were well balanced. Surgery was associated with longer survival for Stage I (median OS 38.6 months vs. 22.9 months, HR 0.62 95%CI 0.57-0.69, p<0.0001), but survival differences were attenuated for Stage II (median OS 23.4 months vs. 20.7 months, HR 0.84 95%CI 0.70-1.01, p=0.06) and IIIA (median OS 21.7 vs. 16.0 months, HR 0.71 95%CI 0.60-0.83, p <0.0001). In analyses by T and N stage, longer OS was observed in resected patients with stage T3/T4 N0 (median OS 33.0 vs. 16.8 months, p=0.008) and node positivity(N1+ 24.4 vs. 18.3 months p=0.03; N2+ 20.1 vs. 14.6 months p=0.007). In the subgroup analysis, 507 stage I/II patients receiving lobectomy and adjuvant chemotherapy were matched to patients receiving concurrent CRT. In this cohort, lobectomy with adjuvant chemotherapy was associated with significantly longer survival (median OS 48.6 vs. 28.7 months, p<0.0001). CONCLUSIONS: Surgical resection is associated with significantly longer survival for early SCLC. New randomized trials should assess trimodality therapy in stages I/II, and in node negative disease.

The prevalence and nature of supportive care needs in lung cancer patients.

PURPOSE: In the present work, we set out to comprehensively describe the unmet supportive care and information needs of lung cancer patients. METHODS: This cross-sectional study used the Supportive Care Needs Survey Short Form 34 (34 items) and an informational needs survey (8 items). Patients with primary lung cancer in any phase of survivorship were included. Demographic data and treatment details were collected from the medical charts of participants. The unmet needs were determined overall and by domain. Univariable and multivariable regression analyses were performed to determine factors associated with greater unmet needs. RESULTS: From August 2013 to February 2014, 89 patients [44 (49%) men; median age: 71 years (range: 44-89 years)] were recruited. The mean number of unmet needs was 8 (range: 0-34), and 69 patients (78%) reported at least 1 unmet need. The need proportions by domain were 52% health system and information, 66% psychological, 58% physical, 24% patient care, and 20% sexuality. The top 2 unmet needs were "fears of the cancer spreading" [n = 44 of 84 (52%)] and "lack of energy/tiredness" [n = 42 of 88 (48%)]. On multivariable analysis, more advanced disease and higher MD Anderson Symptom Inventory scores were associated with increased unmet needs. Patients reported that the most desired information needs were those for information on managing symptoms such as fatigue (78%), shortness of breath (77%), and cough (63%). CONCLUSIONS: Unmet supportive care needs are common in lung cancer patients, with some patients experiencing a very high number of unmet needs. Further work is needed to develop resources to address those needs.

Could molecular effects of Caulerpa racemosa metabolites modulate the impact on fish populations of Diplodus sargus?

The green alga Caulerpa racemosa is a non-native, invasive species in the Mediterranean, and an important stressor for several native organisms. The algal capacity to produce secondary metabolites has been suggested to modulate success of the C. racemosa invasion, although many of potentially involved biological pathways still remain unexplored. In this respect, the aim of the present study was to investigate some molecular and cellular effects in the white seabream Diplodus sargus, an ecologically key species, which included the alien C. racemosa in its diet. Organisms were sampled in 2 seasonal periods from 3 locations of Southern Italy, each characterized by different levels of algal abundance. The level of caulerpin, one of the main secondary algal metabolites, in fish tissues has been used as an indicator of the trophic exposure to the seaweed and related with molecular and cellular responses. Chemical analyses indicated that fish from invaded sites can accumulate caulerpin, with liver concentrations ranging from a few up to hundreds of µg/g. Biomarkers analyses revealed only limited alterations of the main antioxidant defences, such as glutathione reductase and levels of glutathione; on the other hand, increased enzymatic activities of cytochrome P450, glutathione S-transferases and acyl CoA oxidase, as well as enhanced gene transcription for peroxisome proliferator-activated receptor alpha, cytochrome P4501A and vitellogenin 1 were observed in fish more exposed to C. racemosa as indicated by liver concentrations of caulerpin higher than 50 µg/g. Despite a direct molecular relationship with this algal metabolite could not be established, our results suggest that a C. racemosa enriched diet can modulate biotransformation and fatty acids metabolism of D. sargus. Assessing whether similar effects represent short- or long-term effects will be of crucial importance to understand consequences on the general health status and reproductive performance of exposed key fish species in the Mediterranean region.

Outcomes of accelerated hypofractionated radiotherapy in stage i non-small-cell lung cancer.

PURPOSE: Outcomes after treatment with accelerated hypofractionated radiotherapy in stage i medically inoperable non-small-cell lung cancer (nsclc) patients were determined. METHODS: Our single-institution retrospective review looked at medically inoperable patients with T1-2N0M0 nsclc treated with accelerated hypofractionated curative-intent radiotherapy between 1999 and 2009. Patients were staged mainly by computed tomography imaging of chest and abdomen, bone scan, and computed tomography/magnetic resonance imaging of brain. Positron-emission tomography (pet) staging was performed in 6 patients. Medical charts were reviewed to determine demographics, radiotherapy details, sites of failure, toxicity (as defined by the Common Terminology Criteria for Adverse Events, version 3.0) and vital status. The cumulative incidence of local and distant failure was calculated. Overall (os) and cause-specific (css) survival were estimated by the Kaplan-Meier method. RESULT: In the 60 patients treated during the study period, the dose regimens were 50 Gy in 20 fractions (n = 6), 55 Gy in 20 fractions (n = 8), 60 Gy in 20 fractions (n = 42), and 60 Gy in 25 fractions (n = 4). All patients were treated once daily. The median follow-up was 27 months (range: 4-94 months). The os rates at 2 and 5 years were 61% [95% confidence interval (ci): 50% to 75%] and 19% (95% ci: 10% to 34%) respectively. The css rates at 2 and 5 years were 79% (95% ci: 68% to 91%) and 39% (95% ci: 24% to 63%) respectively. The cumulative incidence of local failure was 20% at 5 years. The cumulative incidence of distant failure was 28% at 5 years. No patients experienced grade 3 or greater pneumonitis or esophagitis. CONCLUSIONS: Accelerated hypofractionated regimens are well tolerated and provide good local control in medically inoperable patients with stage i nsclc. Such regimens may be a reasonable treatment alternative when stereotactic body radiation therapy is not feasible.