Drug Shortages in Oncology: ASCO Clinical Guidance for Alternative Treatments.

PURPOSE: To increase awareness, outline strategies, and offer clinical guidance on navigating the complexities of treatment planning amid antineoplastic drug shortages. METHODS: A multidisciplinary panel of oncologists, ethicists, and patient advocates was assembled to provide rapid clinical guidance to help providers navigate appropriate patient care in cases where rationing or alternative therapies must be considered. The groups of content experts developed general principles for resource allocation during shortages and clinical guidance on alternative therapies for specific disease sites. The recommendations are supported by evidence when available. RESULTS: A total of 44 volunteers with content expertise formed the Advisory Group that developed general guidance on the prioritization of antineoplastic agents in limited supply. Disease site-specific clinical guidance was then produced by subgroups on the basis of members' specialties and expertise. The majority of alternative treatment options were developed in consideration of cisplatin and carboplatin shortages. All guidance is posted on ASCO's website. RECOMMENDATIONS: The prioritization of antineoplastic agents in limited supply should be based on specific goals of the therapy where evidence-based medicine has shown survival outcome and life-extending benefit in both early and advanced stages. Recommendations for specific disease sites are presented. While management options vary according to the disease site, alternatives are presented. For settings in which there are no alternatives with comparable efficacy and safety, it is recommended that patients are referred to an area where the necessary drug is available or can be obtained.Additional information is available at asco.org/drug-shortages.

Minimally invasive hysterectomy surgery rates for endometrial cancer performed at National Comprehensive Cancer Network (NCCN) Centers.

OBJECTIVES: Minimally invasive surgery (MIS) is a quality measure for endometrial cancer (EC) established by the Society of Gynecologic Oncology and the American College of Surgeons. Our study objective was to assess the proportion of EC cases performed by MIS at National Comprehensive Cancer Network (NCCN) centers and evaluate perioperative outcomes. METHODS: A retrospective cohort study of women who underwent surgical treatment for EC from 2013 to 2014 was conducted at four NCCN centers. Multivariable mixed logistic regression models analyzed factors associated with failure to perform MIS and perioperative complications. RESULTS: In total 1621 patients were evaluated; 86.5% underwent MIS (robotic-assisted 72.5%, laparoscopic 20.9%, vaginal 6.6%). On multivariable analysis, factors associated with failure to undergo MIS were uterine size >12cm (Odds Ratio [OR]: 0.17, 95% CI 0.03-0.9), stage III (OR: 0.16, 95% CI 0.05-0.49) and IV disease (OR: 0.07, 95% CI 0.02-0.22). For stage I/II disease, complications occurred in 5.1% of MIS and 21.7% of laparotomy cases (p<0.01). Laparotomy was associated with increases in any complication (OR: 6.0, 95% CI 3.3-10.8), gastrointestinal (OR: 7.2, 95% CI 2.6-19.5), wound (OR: 3.7, 95% CI 1.5-9.2), respiratory (OR 37.5, 95% CI 3.9-358.0), VTE (OR 10.5, 95% CI 1.3-82.8) and 30-day readmission (OR: 2.6, 95% CI 1.4-4.9) compared to MIS. CONCLUSIONS: At NCCN-designated centers, the MIS hysterectomy rate in EC is higher than the published national average, with low perioperative complications. Previously identified disparities of age, race, and BMI were not observed. A proposed MIS hysterectomy benchmark of >80% in EC care is feasible when performed at high volume centers.

Gynecologic cancer in HIV-infected women: treatment and outcomes in a multi-institutional cohort.

OBJECTIVE: To evaluate gynecologic cancer treatments in HIV-infected women for adherence to National Comprehensive Cancer Network (NCCN) guidelines and to describe survival by adherence to guidelines. DESIGN: Beyond cervical cancer, there are little data on treatment and outcomes for these women. This is a retrospective cohort study of HIV-infected women with gynecologic cancers. METHODS: HIV-infected women with gynecologic cancers from 2000 to 2015 were identified at two urban, comprehensive cancer centers. Chart reviews extracted demographic, HIV, and cancer-related variables. Cancer treatment was evaluated for adherence to NCCN guidelines. Overall survival was compared between those who received NCCN adherent and nonadherent cancer care. RESULTS: Fifty-seven women were identified; 15 vulvar (26%), 26 cervical (46%), nine ovarian (16%), and seven endometrial (12%) cancers. Median time from HIV to cancer diagnosis was 8.5 years, and 88% of women were black. Thirty patients (53%) had stage I, and 27 (47%) had stage II-IV disease. Overall, 28 women (49%) received NCCN-adherent care; 22 of 30 stage I (73%) and six of 27 stage II-IV patients (22%). Among 29 women not receiving NCCN-adherent care, 69% were due to patient-related factors or toxicity. Among women with II-IV cancers, 48-month survival was higher in women who received NCCN-adherent care than those who did not (60 versus 28%). CONCLUSION: Most HIV-infected women with advanced gynecologic cancers did not receive NCCN-adherent care and had worse survival compared to those who did. Focus on treatment-related toxicities and patient-related barriers to cancer care are necessary in this population.

Distress Screening: Evaluating a Protocol for Gynecologic Cancer Survivors
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BACKGROUND: A gynecologic cancer diagnosis and subsequent treatment may cause significant morbidity, leading to increased distress levels and poorer quality of life (QOL) for survivors. Clinicians have explored opportunities to integrate comprehensive distress management protocols into clinical settings using existing supportive care resources.
. OBJECTIVES: The aims were to improve multidisciplinary management of distress using a clinical pathway for gynecologic cancer survivors and to improve patient satisfaction with distress management.
. METHODS: This study is phase II of a quality improvement initiative to assess distress using the National Comprehensive Cancer Network Distress Thermometer and Patient Related Outcome Measures Information Systems QOL tool and to evaluate the use of a clinical pathway to identify and link gynecologic cancer survivors to multidisciplinary supportive care resources. The data were compared to results from phase I of this study with data triangulation that included medical record audits.
. FINDINGS: Thirty-five percent of survivors reported distress scores of 5 or greater. The use of a clinical pathway model for universal distress screening increased referrals to multidisciplinary service teams from 19 to 34, with a 32% increase in social work referrals. Patients appreciated the comprehensive approach the healthcare team used to treat cancer and help improve QOL.