Systemic Treatment Of Metastatic Cancer Research Articles

Tenets for Implementing Electronic Patient-Reported Outcomes for Remote Symptom Monitoring During Cancer Treatment.

Symptoms are common in patients receiving systemic treatment for metastatic cancer. Monitoring patients with electronic patient-reported outcomes (ePROs) detects severe and worsening symptoms early, enabling care teams to intervene and prevent downstream complications and thereby improving outcomes. The Centers for Medicare & Medicaid Services will require patient-reported outcome (PRO) monitoring in the upcoming Enhancing Oncology Model, and many practices will likely attempt to implement PROs in patient care for the first time. To assist practices with the design and implementation of ePRO remote symptom monitoring programs, tenets were drawn from prior ePRO program experiences and research. Successful implementation requires a quality improvement approach to change management with attention to software functionality, measured outcomes, personnel deployment, leadership and culture, workflow, equity, and patient engagement. Specific approaches in each of these areas can optimize program participation and effectiveness. Continuous program monitoring to identify and address barriers is essential to success. Initial challenges with personnel acceptance and patient participation are common and can be overcome by using these tenets. Remote symptom monitoring with ePROs is a key component of quality cancer care and population health management that requires organizational commitment and a deliberate approach by practices using established tenets to assure successful implementation.

Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

The combination of radiation therapy and immunotherapy for genitourinary cancer treatment: rationale, current evidence, and prospects

Targeted immunotherapy has emerged as a potentially effective systemic treatment for metastatic cancer in the past decade. However, a significant fraction of patients will either not respond or develop resistance to immunotherapy due to the immune-evasive properties of cancer. Radiation therapy can augment immunotherapy to modulate the immune suppressive tumor microenvironment and promote specific tumor targeting by the adaptive immune system. In this review, we will discuss the rationale for combining radiation therapy with immunotherapy and describe clinical studies using this combination strategy to improve the treatment response by inducing synergistic and abscopal effects. We will discuss ongoing prospective clinical trials that employ the combination of radiation therapy and immunotherapy in the treatment of genitourinary malignancies. Further advances in these combination therapy strategies are expected to improve the clinical response and disease course while further providing insight to the complex interactions and regulations between the immune system and cancer cells. Multiple additional clinical trials will be required to find routine application of this concept to the clinic.

Back to the Future: Are Tumor-Targeting Bacteria the Next-Generation Cancer Therapy?

Cancer patients infected with various bacteria were reported, for at least two centuries, to have spontaneous remission. W.B. Coley, of what is now the Memorial Sloan-Kettering Cancer Center, pioneered bacterial therapy of cancer in the clinic with considerable success beginning in the late nineteenth century. After Coley died in 1936, bacterial therapy of cancer essentially ended. Currently there is much excitement in developing bacterial therapy for treating cancer using either obligate or facultative anaerobic bacteria. This chapter will demonstrate the potential and strategy of Salmonella typhimurium A1-R, an engineered tumor-targeting variant for the systemic treatment of metastatic cancer. A new concept using Salmonella typhimurium A1-R for cell cycle "decoy" chemotherapy of metastatic cancer is also described.

A multicenter phase 2 clinical trial testing a combination of oxaliplatin, bolus 5-fluorouracil, leucovorin and capecitabine in patients with metastatic colorectal cancer (MCRC)

14526 Introduction: The combination of oxaliplatin (OX) with bolus and infusional 5FU has shown high activity in MCRC. Substituting capecitabine (CAPE) for 5FU in a novel high-dose schedule designed to mimic FOLFOX-6 is a feasible and well tolerated treatment (Hegeman, ASCO, 2005, #2058). A multicenter phase 2 study of this combination was performed to evaluate efficacy in first-line treatment of MCRC. Methods: Eligible patients have ECOG PS 0–2, no grade 2 or higher neuropathy, and no prior systemic treatment for metastatic cancer. Patients are treated with OX 100 mg/m2, leucovorin (LV) 20 mg/m2 and 5FU 400 mg/m2 IV bolus followed by CAPE 1500 mg/m2 PO Q8H x 6 doses, repeated every two weeks. The primary endpoint was confirmed antitumoral response. Patients were allowed to come off study to pursue surgical resection, if feasible. Results: 36 out of a planned 45 patients have been enrolled since 6/04. Survival (OS) and time to progession (TTP) data are available for all 36 patients. Toxicity and efficacy data is available for 33 patients. The median age of enrolled patients is 65.5 years (range 42–78). 16 (44%) of patients are male. 94% of patients are ECOG PS 0 or 1. Toxicity data is presented in the table . 14/33 (42%) of patients had a grade 3/4 toxicity (see table ). The response rate was 33% (95% confidence interval [CI] 18–52%): 11 patients achieved a partial response (33%), 14 (42%) had stable disease, and 8 (24%) had progressive disease. Median overall survival was 17.1 months (M) (CI 0.7+-27.5+ M). The one-year survival rate was 67%. The median TTP/TTF was 4.1 M (CI 0.3–14.3 M). Four (11%) patients have come off of the study protocol to pursue metastatectomy. Conclusion: OX, infusional 5FU, LV and CAPE is active and well tolerated in MCRC. This regimen had fewer episodes of grade 3–4 hand-foot syndrome and mucositis than prior regimens including longer durations of capecitabine. Study supported by sanofi-aventis. [Table: see text] [Table: see text]