Complementary Medicine Use Amongst Patients with Metastatic Cancer Enrolled in Phase III Clinical Trials

BackgroundComplementary medicines (CM) are frequently used by patients with cancer. Controversy exists over the effectiveness and risk that CM may add to conventional cancer therapy. The incidence of CM use among patients enrolled in phase III clinical trials is unknown.MethodsMedication lists from 6 international phase III clinical trials were retrospectively reviewed to identify patients using CM. Patients had metastatic breast, colorectal, or lung cancers. Quality of life, adverse events, overall survival, and progression-free survival were compared between CM users and non-users. Baseline differences between groups were adjusted with propensity score matching groups.ResultsSeven hundred and six of 3446 patients (20.5%) used at least one CM. CM use was highest among patients with breast cancer (35.6%). CM users had more favorable baseline prognostic factors (ECOG 0-1, non-smoking status, younger age, and fewer metastases). CM use was associated with lower rates of adverse events (50% vs. 62%, P = .002) and quality of life was similar between both groups. After adjustment with propensity score matching, CM use was also associated with longer overall survival in patients with lung cancer (adjusted hazard ratio 0.80, 95%CI, 0.68-0.94, P =.0054). However, several key control variables like EGFR status were not available.ConclusionOne in 5 patients in phase III clinical trials report using CM. CM was not associated with worse cancer-specific outcomes. However, CM users had more favorable baseline prognostic factors, and likely other confounders that may have contributed to improved outcomes observed in the lung cohort. Physicians should monitor for CM use and potential interactions with clinical trial drugs.     

Cost–effectiveness of community-based practitioner programmes in Ethiopia,Indonesia and Kenya

Objective

To assess the cost–effectiveness of community-based practitioner programmes in Ethiopia, Indonesia and Kenya.

Methods

Incremental cost–effectiveness ratios for the three programmes were estimated from a government perspective. Cost data were collected for 2012. Life years gained were estimated based on coverage of reproductive, maternal, neonatal and child health services. For Ethiopia and Kenya, estimates of coverage before and after the implementation of the programme were obtained from empirical studies. For Indonesia, coverage of health service interventions was estimated from routine data. We used the Lives Saved Tool to estimate the number of lives saved from changes in reproductive, maternal, neonatal and child health-service coverage. Gross domestic product per capita was used as the reference willingness-to-pay threshold value.

Findings

The estimated incremental cost per life year gained was 82 international dollars ($)in Kenya, $999 in Ethiopia and $3396 in Indonesia. The results were most sensitive to uncertainty in the estimates of life-years gained. Based on the results of probabilistic sensitivity analysis, there was greater than 80% certainty that each programme was cost-effective.

Conclusion

Community-based approaches are likely to be cost-effective for delivery of some essential health interventions where community-based practitioners operate within an integrated team supported by the health system. Community-based practitioners may be most appropriate in rural poor communities that have limited access to more qualified health professionals. Further research is required to understand which programmatic design features are critical to effectiveness.     

Comparing Barriers and Facilitators to Adolescent and Young Adult Clinical Trial Enrollment Across High- and Low-Enrolling Community-Based Clinics

BackgroundAdolescent and young adult (AYA) patients with cancer are underrepresented on cancer clinical trials (CCTs), and most AYAs are treated in the community setting. Past research has focused on individual academic institutions, but factors impacting enrollment vary across institutions. Therefore, we examined the patterns of barriers and facilitators between high- and low-AYA enrolling community-based clinics to identify targets for intervention.Materials and MethodsWe conducted 34 semi-structured interviews with stakeholders employed used at National Cancer Institute Community Oncology Research Program (NCORP) affiliate sites (“clinics”). Stakeholders (eg, clinical research associates, patient advocates) were recruited from high- and low-AYA enrolling clinics. We conducted a content analysis and calculated the percentage of stakeholders from each clinic type that reported the barrier or facilitator. A 10% gap between high- and low-enrollers was considered the threshold for differences.ResultsBoth high- and low-enrollers highlighted insufficient resources as a barrier and the presence of a patient eligibility screening process as a facilitator to AYA enrollment. High-enrolling clinics reported physician gatekeeping as a barrier and the improvement of departmental collaboration as a facilitator. Low-enrollers reported AYAs’ uncertainty regarding the CCT process as a barrier and the need for increased physician endorsement of CCTs as a facilitator.ConclusionsHigh-enrolling clinics reported more barriers downstream in the enrollment process, such as physician gatekeeping. In contrast, low-enrolling clinics struggled with the earlier steps in the CCT enrollment process, such as identifying eligible trials. These findings highlight the need for multi-level, tailored interventions rather than a “one-size-fits-all” approach to improve AYA enrollment in the community setting.     

Circulating Biomarkers for Therapeutic Monitoring of Anti-cancer Agents

Circulating biomarkers have emerged as valuable surrogates for evaluating disease states in solid malignancies. Their relative ease of access and rapid turnover has bolstered clinical applications in monitoring treatment efficacy and cancer progression. In this review, the roles of various circulating biomarkers in monitoring treatment response are described. Non-specific markers of disease burden, tumor markers (eg CA 125, CEA, PSA, etc.), circulating tumor cells, nucleic acids, exosomes, and metabolomic arrays are highlighted. Specifically, the discovery of each of these markers is reviewed, with examples illustrating their use in influencing treatment decisions, and barriers to their application noted where these exist. Finally, opportunities for future work using these circulating biomarkers are discussed.     

Real world versus ivory tower: the challenge for academic surgery

Academic surgeons increasingly must balance scientific pursuits with the demands of maintaining a clinical practice. This article describes the core values of the Association for Academic Surgery and how these values can guide the survival of the society and of academic surgery given the changing healthcare landscape. These values include: promotion, diversity and inclusivity, scientific excellence, innovation, collaboration, and mentorship. By redefining academic surgery, enabling the collective mind, and harnessing technology, the society and academic surgery can be resilient in the face of current and future adversity.