Virtual On-Treatment Visits: Implementation, Patient Perspectives, Barriers, Limitations, Benefits, and Opportunities.

PURPOSE: This study aimed to report our initial experience with weekly tele-video "virtual" on-treatment visits (vOTVs), describe the logistics of implementation, report the results of patient and physician surveys, and discuss the barriers, limitations, and benefits of vOTVs during the COVID-19 pandemic. METHODS AND MATERIALS: vOTVs were piloted at 2 centers and within 1 week were expanded to 4 additional centers. Patients participating in vOTVs were surveyed about their satisfaction with vOTVs, the quality of vOTVs, and confidence in their physician's ability to manage their care through vOTVs, as well as their support of and preferences related to vOTVs. Participating physicians were surveyed about their comfort and satisfaction with vOTVs. Medical directors at nonparticipating centers within our network were surveyed regarding their reasoning for not using vOTVs. RESULTS: In week 1, 72 of 81 patients between 2 pilot centers were seen using vOTVs. In week 2, 189 of 211 patients were seen using vOTVs at 6 centers. Patient satisfaction with and confidence in their physician's ability to address their concerns through the vOTV was high at 4.75 on a 5-point scale. Patients were overall very supportive (4.67) and found the quality of the visits to be as good as or better than their prior in-person weekly on-treatment visit (3.75). Physicians participating in the vOTVs felt very comfortable in their ability to manage patients through this platform (5.0) and on average did not report any difference in terms of efficiency of visits (3.0). CONCLUSIONS: vOTVs were easy to implement and well received by patients and participating physicians. Our experience suggests that vOTVs can be implemented rapidly using available technology and with a high degree of patient and physician satisfaction during this pandemic with similar efficiency to in-person on-treatment visits.

Trends in the outcomes for patients with limited stage small cell lung cancer: An analysis of the Surveillance, Epidemiology, and End Results database.

We used the Surveillance, Epidemiology, and End Results (SEER) database to examine the outcomes of patients with limited stage small cell lung cancer (LS-SCLC) over time and to determine if any trends were present with respect to the publication of significant clinical trials. We assembled a cohort of 6271 patients aged 21 years and older with LS-SCLC diagnosed from 1983 to 1998 and followed through 2005. Potential covariates included patient age at diagnosis, sex, race, year of diagnosis, laterality, tumor size, and location (upper lobe, middle lobe, lower lobe, or main bronchus). In multivariate analysis, older age, male sex, African American race, and main bronchus location were all associated with a statistically significant increase in the mortality hazard. When compared to patients diagnosed in 1983-1987 who did not receive radiotherapy, the hazard for mortality was significantly reduced for patients diagnosed in 1988-1992 regardless of whether they received radiotherapy (HR=0.59; CI 0.52-0.65; p<0.0001) or not (HR=0.67; CI 0.60-0.75; p<0.0001). Patients who were diagnosed in 1993-1998 and received radiotherapy had similarly improved survival (HR=0.53; CI 0.47-0.58; p<0.0001), which was better than patients from the same time era who did not receive radiotherapy (HR=0.77; CI 0.69-0.85; p<0.0001). In conclusion, the survival for patients with LS-SCLC has improved over time. Many factors are likely involved, however we believe that part of this improvement was the result of clinical trials which investigated and subsequently defined chemoradiotherapy as the standard of care. In order to continue to improve clinical outcomes, clinical trials investigating new treatment paradigms are needed.

Symptom clusters in patients with newly-diagnosed brain tumors.

A symptom cluster comprises three or more concurrent symptoms. There is a paucity of symptom cluster research in cancer patients. Data from a previously conducted clinical trial were analyzed to search for symptom clusters. This phase III, placebo-controlled, double-blind, prospective, randomized clinical trial of 66 patients assessed the effect of prophylactic d-threo-methylphenidate (d-MPH) on quality of life (QOL) in newly diagnosed brain tumor patients receiving brain radiation therapy. Patients received 5-15 mg of d-MPH or placebo twice daily starting on week 1 of radiation therapy and continuing for 8 weeks post radiotherapy. QOL data were collected at baseline; the end of radiation therapy; and 4, 8, and 12 weeks following radiation therapy using the Functional Assessment of Cancer Therapy (FACT), the FACT-Brain subscale, and the Center for Epidemiologic Studies Depression Scale. Exploratory factor analysis, multidimensional scaling (MDS), and cluster analysis were used to search for symptom clusters. The trial failed to show a treatment effect; patients receiving d-MPH or placebo were analyzed together to search for clusters. Two symptom clusters were identified using exploratory factor analysis--a language cluster including difficulty reading, writing, and finding the right words and a mood cluster including feelings of sadness, anxiety, and depressed mood; these clusters were supported by MDS and cluster analysis. Our results suggest that interventions that target both cognitive function and mood should be considered in this patient population. Further research on symptom clusters in brain tumor patients is needed.

A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy.

PURPOSE: The quality of life (QOL) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy (RT). We assessed the effect of prophylactic d-threo-methylphenidate HCl (d-MPH), a central nervous system (CNS) stimulant on QOL and cognitive function in patients undergoing RT. METHODS AND MATERIALS: Sixty-eight patients with primary or metastatic brain tumors were randomly assigned to receive d-MPH or placebo. The starting dose of d-MPH was 5 mg twice daily (b.i.d.) and was escalated by 5 mg b.i.d. to a maximum of 15 mg b.i.d. The placebo was administered as one pill b.i.d. escalating three pills b.i.d. The primary outcome was fatigue. Patients were assessed at baseline, the end of radiation therapy, and 4, 8, and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT-F) subscales, as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam. RESULTS: The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm (p = 0.61). At 8 weeks after the completion of brain RT, there was no difference in fatigue between patient groups. The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm (p = 0.64). Secondary outcomes were not different between the two treatment arms. CONCLUSIONS: Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL.

Managing the cognitive effects of brain tumor radiation therapy.

Postoperative radiation therapy (RT), either alone or in combination with chemotherapy, is the mainstay of treatment for primary and/or metastatic brain tumors. The majority of patients with brain tumors will have significant symptoms of their disease and of RT that will have a negative impact on their quality of life and neurocognitive function. The symptoms of brain tumors depend on tumor location. Radiation-induced brain injury is a complex and dynamic process involving all cells in the brain, including endothelial and oligodendroglial cells, astrocytes, microglia, neurons, and neuronal stem cells. The symptoms of radiation-induced brain injury may be acute, subacute, or chronic, occurring hours, days, weeks, months, and even years after exposure to radiation, the pathogenesis of which is oxidative stress and inflammation. At present, there are no effective preventive approaches for radiation-induced brain injury. Rather, the management of radiation-induced fatigue, changes in mood, and cognitive dysfunction involves a multidisciplinary approach using pharmacologic, behavioral, and rehabilitative therapies. Given the prevalence of brain neoplasms and the high incidence of the radiation-induced symptom cluster and brain injury, clinical research to address these important clinical problems is critical.

Irinotecan/gemcitabine followed by twice-weekly gemcitabine/radiation in locally advanced pancreatic cancer.

Early clinical studies combining irinotecan (CPT-11, Camptosar) and gemcitabine (Gemzar) have yielded encouraging results. Gemcitabine administered via a twice-weekly schedule results in an enhanced radiation-sensitizing effect. This multi-institution phase II trial of induction irinotecan/gemcitabine followed by twice-weekly gemcitabine and upper abdominal radiation has been initiated to determine the activity of this regimen in patients with unresectable pancreatic cancer. Patients received two cycles of induction irinotecan (100 mg/ m2 IV) and gemcitabine (1,000 mg/m2 IV) on days 1 and 8 of each 3-week cycle. Following the induction therapy, patients without disease progression received twice-weekly gemcitabine at 40 mg/m2 and radiation. Nine patients have been enrolled in the study to date. Median patient age was 71 years (range: 65-85 years). The major toxicity observed thus far was grade 3/4 neutropenia. Grade 3/4 nonhematologic toxicity was rarely observed and included dehydration (12%) and diarrhea (12%), which were likely related to the irinotecan. No treatment-related deaths have occurred. These preliminary data suggest that this regimen is well tolerated. Although the data are limited, tumor progression during the induction chemotherapy has not been observed thus far (radiographically or biochemically [CA-19-9]).