Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multiinstitutional Study.

Background: Breast cancer cryoablation clinical trials have strict inclusion criteria that exclude patients with potentially treatable disease. Objective: This study's purpose was to evaluate the safety and outcomes of breast cancer cryoablation without surgical excision in patients ineligible for prospective cryoablation clinical trials due to unfavorable patient or tumor characteristics. Methods: This retrospective study included women who underwent cryoablation of biopsy-proven unifocal primary breast cancer with locally curative intent, without surgical excision, despite being ineligible for (and thus excluded from) cryoablation clinical trials, across seven institutions between January 1, 2000 and August 26, 2021. Adverse events (AEs) were recorded. Cryoablation procedures were classified as technically successful if they were not prematurely terminated and achieved intended treatment parameters and the first imaging follow-up showed no evidence of residual disease. Results of follow-up biopsies were recorded. Ipsilateral breast tumor recurrences (IBTR) diagnosed during follow-up were identified and classified as true recurrence or new primary disease. A competing-risk model was used to estimate the cumulative incidence of IBTR accounting for death before IBTR. Results: The final study sample included 112 patients (median age, 71 years). A total of 7/112 (6.3%) patients had a minor AE; no moderate or major AE occurred. A total of 110/112 (98.2%) cryoablation procedures were technically successful. During median follow-up of 2.0 years, 22/110 (20.0%) patients underwent biopsy for suspicious imaging findings in the ipsilateral breast, yielding benign concordant findings in 9/22 (40.9%) and IBTR in 12/22 (54.5%). Overall, 12/110 (10.9%) patients experienced IBTR, including 7 with true recurrence and 5 with new primary disease; 3/12 (25.0%) patients with IBTR had received earlier adjuvant or neoadjuvant therapy. When accounting for death as a competing risk, the cumulative incidence of IBTR was 5.3%, 12.2%, and 18.2% at 1, 2, and 3 years, respectively. Conclusion: In select individuals with unfavorable patient or tumor characteristics, breast cancer cryoablation provides a safe alternative to surgery with good outcomes. These findings may be particularly relevant in patients who are also poor surgical candidates. Clinical Impact: Breast cancer cryoablation can be safely applied in a larger patient population than defined by clinical trial inclusion criteria.

"A labor of love": Integrating mental health and HIV care: Lessons from a multicountry mental health learning network.

Mental health conditions among people living with HIV (PLWH) are important to address as they adversely affect quality of life, impede adherence to HIV treatment and increase mortality. Planning for integrating mental health care in resource-limited HIV care settings requires substantial effort. Learning networks are a useful way to exchange knowledge between countries about best and current practices in planning mental health care for PLWH. This paper describes the launch of a mental health learning network within a global health implementing center and the lessons learned across participating members from six countries: the United States, Jamaica, Trinidad and Tobago, Zimbabwe, Malawi and India. Lessons learned from the learning network sessions spanned four broad domains: (i) the need for routine and integrated mental health data collection, (ii) developing standardized protocols to implement mental health care, (iii) adequate training and supervision of health care staff and (iv) prioritization of mental health care integration by program funders. We find that time and resource constraints can be barriers to shared leadership and sustainability of learning networks. Prioritizing learning networks as an important component of integrated HIV and mental health care programs is one of the potential strategies to ensure long-term continuity.

Global Mental Health: Where We Are and Where We Are Going.

PURPOSE OF REVIEW: To summarize recent findings in global mental health along several domains including socioeconomic determinants, inequities, funding, and inclusion in global mental health research and practice. RECENT FINDINGS: Mental illness continues to disproportionately impact vulnerable populations and treatment coverage continues to be low globally. Advances in integrating mental health care and adopting task-shifting are accompanied by implementation challenges. The mental health impact of recent global events such as the COVID-19 pandemic, geo-political events, and environmental change is likely to persist and require coordinated care approaches for those in need of psychosocial support. Inequities also exist in funding for global mental health and there has been gradual progress in terms of building local capacity for mental health care programs and research. Lastly, there is an increasing effort to include people with lived experiences of mental health in research and policy shaping efforts. The field of global mental health will likely continue to be informed by evidence and perspectives originating increasingly from low- and middle-income countries along with ongoing global events and centering of relevant stakeholders.

Discrimination of breast cancer by anti-malignin antibody serum test in women undergoing biopsy.

PURPOSE: The anti-malignin antibody serum (AMAS) test (Oncolab, Boston, MA) has been reported as 97% sensitive and 95% specific for malignancies. To objectively assess accuracy of this test for discrimination of breast cancer, we studied a series of women undergoing core breast biopsy. SUBJECTS AND METHODS: Seventy-one core-needle breast biopsies were classified as malignant, suspicious, or benign by two independent pathologists blinded to AMAS results. Corresponding sera were read as AMAS positive, negative, or borderline by criteria used by Oncolab and also using criteria derived from receiver-operator curves based on values for slow (S-tag), fast (F-tag), and their difference (Net-tag) antibody reported by Oncolab. We calculated sensitivity and specificity and analyzed distributions by Fisher's exact test. RESULTS: Biopsies were read as 42 (59%) benign, 12 (17%) suspicious, and 17 (24%) malignant. By Oncolab criteria, sensitivity (59%) and specificity (62%) were maximized by pooling suspicious with malignant and AMAS borderline with positive (P = 0.098). Receiver-operator curves showed best sensitivity (62%) and specificity (69%) for the criterion AMAS positive if Net-Tag > 135 microg/mL or S-Tag > 220 microg/mL (P = 0.015). CONCLUSIONS: The AMAS test discriminates suspicious and malignant from benign lesions, but sensitivity is insufficient to identify patients to be spared biopsy and false-positive rates are too high for population screening.

Postoperative ultrasound-guided percutaneous placement of a new breast brachytherapy balloon catheter.

BACKGROUND: The optimal technique and timing for the implantation of a recently developed breast brachytherapy balloon catheter (MammoSite; Proxima Therapeutics, Alpharetta, Georgia) have not been well defined. We hypothesized that placing this postoperatively, utilizing percutaneous ultrasound-guided placement, would be preferable. METHODS: Patients who met eligibility requirements for breast brachytherapy were implanted with the MammoSite device utilizing percutaneous ultrasound-guided technique. Additionally, to study optimal timing, a historical cohort of patients operated upon for breast cancer by two of the authors were analyzed to compare the intraoperative and postoperative candidacy for MammoSite placement. RESULTS: Twenty-one of 23 patients successfully completed brachytherapy after implantation, with only 2 (9%) requiring catheter removal secondary to unfavorable balloon positioning. There were no serious complications. Of 343 historical patients with breast cancer, 137 were intraoperative candidates for brachytherapy, but final postoperative histology disqualified 40 (29%). CONCLUSIONS: Implantation of the MammoSite brachytherapy device is optimally performed postoperatively, after the final pathology is defined, utilizing ultrasound-guided percutaneous technique.