Metronomic chemotherapy for scheduling oral cancer surgery during the COVID-19 pandemic.

Worldwide, hospitals are facing problems in managing cancer patients during the ongoing COVID-19 pandemic. Given the immense cancer burden of oral cancer in India, scheduling surgeries are becoming increasingly difficult. Upfront surgeries are recommended for curative treatment of oral cancers and postponing them raises the fear of progression. Metronomic chemotherapy can be considered during the waiting period given its potential oncological benefits and ease of administration without much toxicity.

[A Case of Unclassified Sex Cord-Stromal Tumor Containing hCG-Positive Cells].

We present a case of unclassified sex cord-stromal testicular tumor with lung metastasis. A 48-year-old man consulted our hospital for left testicular enlargement that began 3 years ago. Computed tomography revealed a heterogeneously enhanced left testicular tumor 11 cm in diameter and a 5 mm metastatic lung tumor. The human chorionic gonadotropin (hCG) level was elevated (141.6 mU/ml), whereas the levels of α-fetoprotein (AFP) and LDH were normal. The external genitalia were normal and gynecomastia was not observed. Left high orchiectomy followed by 3 cycles of BEP chemotherapy (bleomycin, etoposide, and cisplatin) every 4 weeks was performed. The pathology of the excised specimen was unclassified sex cordstromal testicular tumor containing hCG-positive cells. On immunohistochemistry, the tumor cells were partly positive for AE1/AE3, hCG, and calretinin. Vimentin was diffusely positive, but OCT3/4, SALL4, GATA3, and CK7 were negative. After BEP treatment, the metastatic lung lesion disappeared. Unclassified sex cord-stromal testicular tumor is a rare disease and its treatment has not been established. Thus, further accumulation of cases is needed.

Chemotherapy and Supportive Care Agents as Essential Medicines for Children With Cancer.

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. This impressive statistic is largely the result of integrating research with clinical care. At the core of this endeavor are multiagent combination chemotherapy and supportive care agents (CASCA). Most CASCAs belong to the class of sterile injectable drugs, which make up the backbone of many proven and life-saving pediatric oncology regimens. There are few if any alternative agents available to treat most life-threatening childhood cancers. In the United States, shortages of CASCAs are now commonplace. The consequences of drug shortages are far reaching. Beyond the economic costs, these shortages directly affect patients' lives, and this is especially true for children with cancer. Drug shortages in general and shortages of CASCAs specifically result in increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths. One way to mitigate drug shortages is to adopt an essential medicines list and ensure that these medications remain in adequate supply at all times. We argue for creation of a CASCA-specific essential medicines list for childhood cancer and provide ethical and policy-based reasoning for this approach. We recognize that such a call has implications beyond pediatric cancer, in that children with other serious disease should have an equal claim to access to guaranteed evidence-based medicines. We provide these arguments as an example of what should be claimed for medical indications that are deemed essential to preserve life and function.

Can carboplatin or etoposide replace actinomycin-d for second-line treatment of methotrexate resistant low-risk gestational trophoblastic neoplasia?

OBJECTIVE: To evaluate the impact of periodic shortage of actinomycin-d (Act-d) in the treatment of Brazilian patients with low-risk gestational trophoblastic neoplasia (GTN) after methotrexate and folinic acid rescue (MTX/FA) resistance, treated alternately with carboplatin or etoposide as a second-line regimen. METHODS: Retrospective cohort that included patients with failure of first-line MTX/FA regimen for low-risk GTN treated at Rio de Janeiro Federal University, Universidade Federal de São Paulo and Irmandade da Santa Casa de Misericórdia de Porto Alegre, from January/2010- December/2017. RESULTS: From 356 patients with low-risk GTN treated with MTX/FA, 75 (21.1%) developed resistance, of which 40 (53.3%) received Act-d, 23 (30.7%) carboplatin and 7 (9.3%) etoposide. Although patients treated with single-agent chemotherapy as a second-line regimen had comparable clinical and primary treatment characteristics, those treated with Act-d (80%, p = 0.033) or etoposide (71.4%, p = 0.025) had higher remission rates when compared with carboplatin (47.8%). Only 29% of patients treated with carboplatin received the chemotherapy cycles without delay compared to Act-d (98%, p < 0.001) or etoposide (85%, p = 0.009). Patients treated with carboplatin had significantly more hematological toxicity, notably anemia (30.4%, p = 0.008), lymphopenia (47.7%, p < 0.001) and thrombocytopenia (43.4%, p < 0.001), as well as a higher occurrence of febrile neutropenia (14.4%, p = 0.044) and vomiting (60%, p < 0.001) than those receiving Act-d (5%, none, 2.5%, none, 10%, respectively). CONCLUSION: Carboplatin did not have a satisfactory clinical response rate, likely due to severe hematological toxicity, which postponed chemotherapy. Our results reinforce the preference for Act-d as a second-line agent in patients with low-risk GTN after MTX/FA resistance.

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer.

Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2+ metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2+ MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease. In 2006, both agencies approved trastuzumab as adjuvant therapy for patients with HER2+ early breast cancer (EBC). Observational studies on real-world treatment patterns for HER2+ EBC between 2005 and 2015 suggest that 19.1% to 59.5% of patients across regions of North America, Europe, Australia, New Zealand, and China did not receive (neo)adjuvant trastuzumab. Data suggest that some patient subgroups, including older patients, those with HER2+/hormone receptor-positive disease, and women with small and/or node-negative HER2+ tumors, were less likely to receive anti-HER2 therapy. Barriers to accessing trastuzumab are multifactorial and include issues related to drug funding and high treatment costs for patients that have been reported worldwide. Herein, we review available literature on the use of, and barriers to, treatment with trastuzumab in patients with HER2+ breast cancer. We also discuss how the availability of safe and effective biosimilars might increase access to trastuzumab and allow greater use of anti-HER2 therapy, potentially improving patient outcomes.

Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.

BACKGROUND: With the growing use of oral anticancer medications, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer. OBJECTIVE: To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. METHODS: This study used data from 2 administrative health care claims databases--Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: Symphony Health Solutions' ProMetis Lx (June 2009 to March 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups. RESULTS: 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 AA claim were selected from Dataset 1 and Dataset 2, respectively. The mean (median) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n = 492) in Study Population 1 and 93% (100%; n = 2,449) in Study Population 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n = 488) mg and 10.6 (10.0; n = 2,425) mg in Dataset 1 and 2, respectively. Similar adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without. CONCLUSIONS: Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These findings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice.

Does aid reach the poor? Experiences of a childhood leukaemia outreach-programme.

Previously, we found that the access to donated chemotherapy for childhood leukaemia patients in Indonesia was limited: only 16% of eligible families received donations. After the introduction of a structured parental education programme, we examined the access of parents of children with leukaemia to donated chemotherapy in an Indonesian academic hospital. The programme consisted of a video-presentation in hospital, information-booklet, audiocassette, DVD, procedures for informed-consent, statement of understanding for donated chemotherapy and a complaints-mechanism. Of 72 new patients, 51 parents (71%) were interviewed by independent psychologists using questionnaires. Parents of 21 patients (29%) did not participate because their children dropped-out (n=10) or died (n=11) before an interview took place. Four patients had health insurance and did not need donated chemotherapy. Access to donated chemotherapy was improved: 46/47 patients (98%) received donations. Structured parental education improved the access to donated chemotherapy. Outreach-programmes may benefit from this approach. This may enable more patients from poor socio-economic backgrounds in the developing countries to receive aid and achieve cure.

The effect of accessibility to drugs on outcome of therapy in patients with malignant lymphoma.

OBJECTIVE: To determine the compliance rate, reasons for default and factors affecting compliance. PATIENTS AND METHODS: A prospective study of patients with malignant lymphoma (ML) at the University of Benin Teaching Hospital, Benin City, Nigeria. A total of 190 patients on chemotherapy for ML were followed up for between 6 and 18 months during study period (1995-2003). The reasons for default were recorded. Compliant and noncompliant patients were compared in terms of survival and sociodemographic data. STATISTICAL ANALYSIS: Instat Package system for frequency counts, chi-squares and cross tabulations using Yates correction when necessary and the Fisher's exact test. RESULTS: Noncompliance rate was 63.2%. Major reasons for defaulting were high cost of drugs in 40 cases (33.3%), scarcity of drugs in 29 cases (24.2%) and side effects in 24 cases (20.6%). Compliance was significantly associated with higher levels of education, socioeconomic status, geographical abode (P<0.001) and gender (P= 0.031). Survival was found to be significantly associated with compliance in non-Hodgkin's lymphoma (NHL) (P>0.001) while the relative risk (RR) was below unity in ML. CONCLUSION: The level of compliance with medical therapy is still very poor. Health education and the provision of affordable, accessible and appropriate medical therapy are required. A multidisciplinary approach to improve compliance of patients with medical therapy is advocated.

Calidad del registro de quimioterapia en los servicios de farmacia hospitalaria de Andalucía / Chemotherapy registry quality in Andalusian hospital pharmacy departments

Objetivo: Analizar la calidad de los registros de las unidadescentralizadas de citostáticos de los hospitales de Andalucía y la disponibilidadde datos para analizar la utilización de estos fármacos.Método: Se elaboró un cuestionario ad hoc, usando variablesrelativas a la cobertura de información sobre pacientes y tratamientos,grado de informatización y organización. Los cuestionarios secumplimentaron en septiembre de 2005 mediante encuesta al responsablede los tratamientos quimioterápicos de los 19 servicios defarmacia de los hospitales que tratan pacientes oncológicos enAndalucía.Resultados: La tasa de respuesta fue del 100%, aunque un serviciono contaba con unidad centralizada de citostáticos. La coberturade preparación centralizada fue del 89% para hospital de día, el84% para pacientes ingresados, el 79% para pacientes hematológicosy el 69% para pacientes pediátricos. El registro está informatizadosólo en 13 hospitales (68%), con una gran variabilidad en losprogramas usados. La dispensación de temozolamida y de capecitabinacuenta con registro propio en el 68 y 42% de los casos. El nombredel paciente y el nombre y la dosis del citostático son los únicosdatos que se registran en todos, mientras que el nombre del protocolosólo se registra en el 47%, el diagnóstico, estadiaje y clasificaciónTNM en el 58, 31 y 16% respectivamente.Conclusiones: Existe una gran variabilidad en los sistemas deinformación para la gestión de uso de citostáticos, y carenciasimportantes en la disponibilidad de datos del paciente para realizarestudios de utilización y adecuación de la prescripción

Objective: To analyze registry quality in centralized cytostatictherapy units in Andalusian hospitals, and the availability of datato analyze the use of these drugs.Method: An ad hoc questionnaire was designed using variablesrelated to information coverage on patients and their treatments,data processing extent, and organization. Questionnaireswere completed in September 2005 by surveying people responsiblefor chemotherapy in all 19 pharmacy departments inAndalusian hospitals that treat oncologic patients.Results: Response rate was 100%, but one department hadno centralized cytostatic therapy unit. Centralized preparationcoverage was 89% for the day hospital, 84% for inpatients, 79%for hematologic patients, and 69% for pediatric patients. Registriesare computerized in only 13 hospitals (68%) with a varietyof software programs. Temozolamide and capecitabine dispensationhas a separate registry in 68% and 42% of cases, respectively.Patient name, and cytostatic name and dosage are the onlydata recorded in all instances, while protocol name is only recordedin 47%, and diagnosis, staging, and TNM categorization in58%, 31%, and 16% of cases, respectively.Conclusions: There is great variability regarding informationsystems for cytostatic use management, and a relevant shortage ofpatient data available for prescription use and adaptation studies

Problemática asistencial del tratamiento combinado en los pacientes con tumores de cabeza y cuello localmente avanzados (réplica) / Health-care issues of combination treatment in patients with locally advanced head and neck tumors (reply)

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