Objective To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. Methods A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Results Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Conclusions Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies. A large magnitude of effect in PFS improvement should establish benefit, and further communication with regulatory authorities to clarify acceptable endpoints should be undertaken.

The three major hereditary cancer syndromes in Latinos (Hereditary Breast and Ovarian Cancer, Familial Adenomatous Polyposis and Lynch Syndrome) have been shown to exhibit geographic disparities by country of origin suggesting admixture-based disparities. A solid infrastructure of clinical genetics geared towards diagnosis and prevention could aid in reducing the mortality of these cancer syndromes in Latinos. Currently, clinical cancer genetic services in Latin America are scarce. Moreover, limited studies have investigated the mutational spectrum of these cancer syndromes in Latinos resulting in gaps in personalized medicine affecting diagnosis, treatment and prevention. The following commentary discusses available genotype and clinical information on hereditary cancer in Latinos and highlights the limited access for cancer genetic services in Latin America including barriers to genetic testing and alternatives for providing better access to genetic services. In this review, we discuss the status of clinical genetic cancer services for both US Latinos and those Latinos living in Latin America.

Hereditary cancer predisposition syndromes comprise approximately 10% of diagnosed cancers; however, familial forms are believed to account for up to 30% of some cancers. In Hispanics, the most commonly diagnosed hereditary cancers include colorectal cancer syndromes such as, Lynch Syndrome, Familial Adenomatous Polyposis, and hereditary breast and ovarian cancer syndromes. Although the incidence of hereditary cancers is low, patients diagnosed with hereditary cancer syndromes are at high-risk for developing secondary cancers. Furthermore, the productivity loss that occurs after cancer diagnosis in these high-risk patients has a negative socio-economic impact. This review summarizes the genetic basis, phenotype characteristics, and the National Comprehensive Cancer Network’s screening, testing, and surveillance guidelines for the leading hereditary cancer syndromes. The aim of this review is to promote a better understanding of cancer genetics and genetic testing in Hispanic patients.

Objective: Cancer patients have increased risk of poor outcomes after disasters. On September 2017 Hurricanes Irma and María affected Puerto Rico (PR) and US Virgin Islands, causing the population to experience major disruptions in essential services and environmental health issues. Using qualitative methods, this ongoing study documents the stressors, responses, and experiences of patients, and providers/organizations involved in the receipt and delivery of gynecologic oncology care in PR, respectively. Methods: We conducted two focus groups (November-December 2018) among women ≥21 years with gynecologic cancer (n=12) and eight key-informant interviews among providers/stakeholders who offer services to these population in PR. Patients’ interviews addressed psychosocial and environmental stressors and multi-level responses experienced by the women in the aftermath of the hurricanes, and concerns regarding their condition. Key-informants’ interviews addressed problems encountered in their clinics/organizations in the aftermath of the hurricanes, perceived stressors and risks of patients, and recommendations for future preparedness efforts. Sessions were audio-recorded and transcribed to identify emergent themes. Results: The focus groups evidence that all patients faced lasting difficulties having a healthy diet and with communication, electricity and water services. Women under the Government Health Plan (GHP) faced longer time without essential services and were less prepared for the hurricanes than those with private health insurance. None received disaster preparedness information from their clinics/physicians and all expressed feeling environmental stressors such as heat, mosquitoes, humidity, noise and air pollution produced by household electric generators. All patients experienced delay in cancer treatment, but women in the GHP had longer delays, as most public hospitals were saturated or inoperable. Key-informants expressed that clinics/organizations did not have an emergency plan in place, services were saturated because the collapse of many facilities, and that some patients decided to interrupt their treatments, and others experienced recurrence. The biggest obstacle was lack of effective communication between the government and the health services, calling for interdependence of systems, but with better communication. Conclusion: Study results are guiding the topics that will be assessed in the subsequent quantitative phase of this NCI sponsored project, and the development of a disaster management plan for cancer patients in PR. Results show that all components of disaster management (planning, preparedness, response and recovery) failed. Disparities in preparedness and healthcare interruption in patients in the GHP could affect patient outcomes. NCI Grant #R21CA239457. Citation Format: Ana P. Ortiz, Mirza Rivera, Sandra I. Garcia-Camacho, William Calo, Guillermo Tortolero-Luna, Sharee Umpierre, Istoni Daluz-Santana, Pablo Mendez. Impact of hurricane-related stressors and responses on oncology care and outcomes of women with gynecologic cancer in Puerto Rico [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-157.

Lynch syndrome (LS) is an autosomal dominant disorder caused by DNA mismatch repair (MMR) system deficiencies. Women affected by LS present a 40 to 60% lifetime risk of endometrial cancer (EC). Objective This case-case study aims to determine the frequency of the hMLH1, hMSH2, and hMSH6 MMR proteins and the factors (age, family history of cancer [FHC] related to LS, and body mass index [BMI]) associated to their absence in EC patients attending the University District Hospital of San Juan, Puerto Rico. Method/Materials Twenty cases were preliminary evaluated for the MMR protein expression by immunohistochemistry testing and classified as positive-cases (presence of protein) or negative-cases (absence of protein). The statistical analysis was based on the logistic regression model using the Maximum Likelihood estimation (MLE). The Bayesian approach was used to determine the posterior probability {posterior Pr[OR>1]}. Results Results showed absence for at least one MMR protein in 25% of the cases; 15% for hMLH1 and 10% for hMSH2. None of the cases showed an absence for hMSH6. The MLE demonstrated that women diagnosed with EC before the age of 50 (OR: 12.4; 95%CI = 0.5–322.7), having FHC related to LS (OR: 17.7; 95%CI = 0.6–534.6), and having lower BMI (OR: 2.38; 95%CI = 0.39–14.28) present higher odds than their counterparts of lacking an MMR protein, once adjusting for potential predictors (p > .05). The posterior probability that an excess risk of lacking an MMR protein occurs was ≥ 95% for each predictor. Conclusion Our study in this Hispanic population supports previous studies in that younger age, FHC, and lower BMI are associated with increased odds of having an absence of MMR protein expression. Further studies with larger sample sizes should be performed.