Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba.

PURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the effectiveness/safety of neoadjuvant therapy with subcutaneous (SC) trastuzumab- pertuzumab chemotherapy (real world) to extend the evidence, which comes mainly from clinical trials (selected population; intravenous [IV] trastuzumab). MATERIALS AND METHODS: A prospective, longitudinal, observational study in a Cuban hospital. POPULATION: women aged ≥18 years with histologically confirmed HER2+ early-stage BC (2017-2021) eligible for neoadjuvant treatment (IV pertuzumab, SC trastuzumab, taxane-based chemotherapy). The aim was to determine the pathological complete response (pCR) rate to this scheme, its safety, and the impact of patient's characteristics on the outcomes. RESULTS: Eighty-seven women were included: n=29 (DPT [docetaxel-IV pertuzumab- SC trastuzumab 600 mg; 4 cycles]); n=58 (ddAC-DPT [dose-dense anthracycline-based scheme+DPT]; 8 cycles). The median age was 57 years (range 30-83), ECOG 0: 97%. Time from diagnosis to treatment (median) was 28 days. The overall pCR rate was 62.1% (55.2%, DPT; 66.5%, ddAC-DPT; p =0.351); HR+, 47.7% vs. HR-, 76.7% (p=0.006). There were no statistically significant differences based on nodal status, stage, or Ki-67 levels. Overall, 94.2% of patients experienced ≥1 adverse event related to treatment, all of them grade 1-3 and more common with ddAC-DPT. The main cause of treatment delays (n=19; ddAC-DPT, 16; DPT, 3) was treatment-related toxicities. CONCLUSION: Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile.

COVID-19 and Cancer in Cuba.

The COVID-19 pandemic has called attention to the contribution of comorbidities, including cancer and brought additional challenges to previously existing programs for cancer treatment and control. The COVID-19 pandemic in Cuba was addressed through an integrated all-society action plan that to date has been largely successful with a low incidence of COVID-19 and mortality rates several-fold lower than worldwide averages. Despite downsizing many other health components all oncology services were maintained. Between March 11, when the first case was detected, until July 23, Cuba reported 2,449 cases of COVID-19 that included 28 (1.14%) with a diagnosis of cancer. Distribution among cancer diagnoses did not deviate from that expected according to cancer epidemiology in Cuba. However, although the probability of getting infected with the coronavirus for a cancer patient (0.012%), was not higher than that of the general population (0.020%), 9 of the 28 (32.1%) died, a lethality higher than that of COVID-19 patients without cancer (3.5%) a difference that is statistically significant (P< .001). We argue that going forward scientific research on the relationship of aging, inflammation and cancer, including identification of biomarkers and the development of novel therapeutic interventions, should become one of the priorities in the post-COVID agenda of both oncologists and infectious disease scientists.

Impacto de factores pronósticos y predictivos del cáncer de mama en laUnidad Oncológica Provincial, de Matanzas / Prognostic and predictive factors of the breast cancer impact at the Matanzas Provincial Oncology Unit

Se realizó un estudio descriptivo de prevalencia o corte transversal, para valorar factores pronósticos y predictivos del cáncer de mama a partir de recidivas en 496 mujeres tratadas en la Unidad Oncológica Provincial de Matanzas, remitidas por hospitales provinciales y territoriales, desde enero de 2004 hasta diciembre de 2008. Se recogieron los datos mediante encuestas aplicadas a historias clínicas e informes de biopsias, procesadas por Sistema Epi Info versión 6.04. Hubo mayor incidencia de cáncer de mama en mujeres postmenopáusicas y mayor agresividad en premenopáusicas. Casi la mitad de las pacientes se diagnosticaron en etapa precoz y existió alto índice de recidivas, sobre todo en etapas avanzadas. El carcinoma lobulillar invasivo se destacó con más recidivas, mientras el tubular poseyó mejor pronóstico. Por su parte, el carcinoma ductal in situ y el lobular in situ presentaron más recurrencias que lo esperado. La cirugía conservadora exhibió mayor número de recidivas a distancia que la mastectomía radical modificada, mientras ésta mostró recidivas locales (2,1 por ciento) y las primeras, ninguna. La conservadora se relacionó con alto porcentaje de persistencia de la enfermedad, en la cual influyeron los bordes de sección comprometidos. El estatus ganglionar, tamaño tumoral y grado histológico se destacaron como los principales factores pronósticos anátomo-patológicos, no así los receptores hormonales. Existió buena respuesta al tamoxifeno y a ciclos de ciclofosfamida, metrotexate y 5 flouracilo. Se concluye demostrando la influencia de los factores pronósticos y predictivos modificables y no modificables sobre el alto índice de recidivas, y recomendando medidas para mejorar dichos indicadores...(AU)

We carried out a descriptive study of prevalence or cross sectional study to assess predictive and prognostic factors of the breast cancer from recidivism in 406 women treated at the Matanzas Provincial Oncology Unit, and remitted from provincial and territorial hospitals, since January 2004 to December 2008. Data were collected from clinical records and biopsy informs, processed with the Epi Info System, Version 6.04. There was a higher incidence of the breast cancer in post-menopausal women and a higher aggressiveness in pre-menopausal women. Almost half of the patients were diagnosed in the precocious stage and there was a high index of recidivism, mainly in advanced stages. The invasive lobular carcinoma presented more recidivists, while the tubular one had a better prognosis; the ductal carcinoma in situ and the lobular carcinoma in situ had more recurrences than they were expected. The conservative surgery showed a higher number of recidivists in distance than the modified radical mastectomy, while the last one showed local recidivism (2,1 por ciento) and the first, no one; the conservative one was related with a high percent of disease persistence, in which the compromised section edges. The ganglion status, tumour size and histological level were pointed out as the main anatomic-pathological prognosis facts, but not the hormonal receptors. There it was a good answer to tamoxifen and to CMF (cyclophosphamide, metothrexate and 5 flouracil) cycles. In conclusion, we demonstrated the influence of the modifiable and non-modifiable prognostic and predictive facts on the high index of recidivism and recommend taking measures to improve those indicators...(AU)

Impacto de factores pronósticos y predictivos del cáncer de mama en laUnidad Oncológica Provincial, de Matanzas / Prognostic and predictive factors of the breast cancer impact at the Matanzas Provincial Oncology Unit

Se realizó un estudio descriptivo de prevalencia o corte transversal, para valorar factores pronósticos y predictivos del cáncer de mama a partir de recidivas en 496 mujeres tratadas en la Unidad Oncológica Provincial de Matanzas, remitidas por hospitales provinciales y territoriales, desde enero de 2004 hasta diciembre de 2008. Se recogieron los datos mediante encuestas aplicadas a historias clínicas e informes de biopsias, procesadas por Sistema Epi Info versión 6.04. Hubo mayor incidencia de cáncer de mama en mujeres postmenopáusicas y mayor agresividad en premenopáusicas. Casi la mitad de las pacientes se diagnosticaron en etapa precoz y existió alto índice de recidivas, sobre todo en etapas avanzadas. El carcinoma lobulillar invasivo se destacó con más recidivas, mientras el tubular poseyó mejor pronóstico. Por su parte, el carcinoma ductal in situ y el lobular in situ presentaron más recurrencias que lo esperado. La cirugía conservadora exhibió mayor número de recidivas a distancia que la mastectomía radical modificada, mientras ésta mostró recidivas locales (2,1 por ciento) y las primeras, ninguna. La conservadora se relacionó con alto porcentaje de persistencia de la enfermedad, en la cual influyeron los bordes de sección comprometidos. El estatus ganglionar, tamaño tumoral y grado histológico se destacaron como los principales factores pronósticos anátomo-patológicos, no así los receptores hormonales. Existió buena respuesta al tamoxifeno y a ciclos de ciclofosfamida, metrotexate y 5 flouracilo. Se concluye demostrando la influencia de los factores pronósticos y predictivos modificables y no modificables sobre el alto índice de recidivas, y recomendando medidas para mejorar dichos indicadores...

We carried out a descriptive study of prevalence or cross sectional study to assess predictive and prognostic factors of the breast cancer from recidivism in 406 women treated at the Matanzas Provincial Oncology Unit, and remitted from provincial and territorial hospitals, since January 2004 to December 2008. Data were collected from clinical records and biopsy informs, processed with the Epi Info System, Version 6.04. There was a higher incidence of the breast cancer in post-menopausal women and a higher aggressiveness in pre-menopausal women. Almost half of the patients were diagnosed in the precocious stage and there was a high index of recidivism, mainly in advanced stages. The invasive lobular carcinoma presented more recidivists, while the tubular one had a better prognosis; the ductal carcinoma in situ and the lobular carcinoma in situ had more recurrences than they were expected. The conservative surgery showed a higher number of recidivists in distance than the modified radical mastectomy, while the last one showed local recidivism (2,1 por ciento) and the first, no one; the conservative one was related with a high percent of disease persistence, in which the compromised section edges. The ganglion status, tumour size and histological level were pointed out as the main anatomic-pathological prognosis facts, but not the hormonal receptors. There it was a good answer to tamoxifen and to CMF (cyclophosphamide, metothrexate and 5 flouracil) cycles. In conclusion, we demonstrated the influence of the modifiable and non-modifiable prognostic and predictive facts on the high index of recidivism and recommend taking measures to improve those indicators...

Prevalence of BRCA1 and BRCA2 mutations in breast cancer patients from Cuba.

The contribution of BRCA1 and BRCA2 to breast cancer incidence in Cuba has not yet been explored. In order to estimate the proportion of breast cancers due to BRCA1 and BRCA2 mutations in Cuba, and to identify possible Cuban founder mutations, we conducted a study of unselected breast cancer patients from Havana, Cuba. We enrolled 336 women with breast cancer from a large public hospital in the city. A family history of cancer was obtained from each patient and a blood sample was processed for DNA analysis. Mutations in BRCA1 and BRCA2 were sought using a combination of techniques, but all mutations were confirmed by direct sequencing. We were able to successfully complete testing on samples from 307 women. Among these, eight mutations were identified (seven in BRCA2 and one in BRCA1) representing 2.6% of the total, including 10% of familial cases and 10% of cases under age forty. One BRCA2 mutation (c.3394C > T) was found in two women, but no clear example of a founder mutation was identified. In summary, BRCA1 and BRCA2 mutations are not uncommon in Cuban women with breast cancer, but the absence of founder mutations precludes the development of a rapid and inexpensive clinical screening test.