Implementation and evaluation of a remote geriatric assessment and intervention program in Brazil.

BACKGROUND: This study sought to determine the feasibility and acceptability of a remote geriatric assessment (GA) and implementation (GAIN) program in Brazil. The authors also explored the effect of this program on health-related quality of life (HR-QOL) outcomes 3 months after initiating treatment. METHODS: This is a longitudinal study enrolling older adults (65+ years), diagnosed with any type of solid tumor, scheduled to initiate chemotherapy in a networked Brazilian cancer center. The GA was performed through telehealth. We assessed the feasibility of the remote GA, acceptability to patients, and changes in patient-centered outcomes (HR-QOL, mood, function) from baseline to month 3. Linear mixed model analysis was done, adjusting for age, gender, race, income, and disease stage. RESULTS: Fifty-six patients completed all intended assessments. Notably, the threshold of feasibility was 70% and there was 92% complete adherence. Average age was 76 years old (SD = 7.2). Most patients were female (57%), married (59%), and had a college degree (46%). The most common diagnoses were gastrointestinal (39%) and gynecological cancers (18%); most were diagnosed at an advance disease stage (77%). A total of 32 patients were referred to a remote appointment and 86% followed this recommendation(s). Significant improvement in Functional Assessment of Cancer Therapy - General FACT-G (mean difference, 6.04; p < .001), Geriatric Depression Scale (mean difference, -0.86; p = .008), and instrumental activities of daily living ratio (mean difference, 0.17; p < .001) were found. CONCLUSION: Remote GAIN is feasible and acceptable to older adults with cancer receiving treatment in Brazil. The authors also found significant improvement in HR-QOL outcomes over time. Notably, this GAIN program could guide early detection of chemotherapy toxicity and improving patient-reported outcomes in low-resource environments.

Liposomal paclitaxel induces apoptosis, cell death, inhibition of migration capacity and antitumoral activity in ovarian cancer.

The main goal of this study is to evaluate the efficacy of the paclitaxel (PTX) drug formulated with a liposomal nanosystem (L-PTX) in a peritoneal carcinomatosis derived from ovarian cancer. In vitro cell viability studies with the human ovarian cancer line A2780 showed a 50% decrease in the inhibitory concentration for L-PTX compared to free PTX. A2780 cells treated with the L-PTX formulation demonstrated a reduced capacity to form colonies in comparison to those treated with PTX. Cell death following L-PTX administration hinted at apoptosis, with most cells undergoing initial apoptosis. A2780 cells exhibited an inhibitory migration profile when analyzed by Wound Healing and real-time cell analysis (xCELLigence) methods after L-PTX administration. This inhibition was related to decreased expression of the zinc finger E-box-binding homeobox 1 (ZEB1) and transforming growth factor 2 (TGF-ß2) genes. In vivoL-PTX administration strongly inhibited tumor cell proliferation in ovarian peritoneal carcinomatosis derived from ovarian cancer, indicating higher antitumor activity than PTX. L-PTX formulation did not show toxicity in the mice model. This study demonstrated that liposomal paclitaxel formulations are less toxic to normal tissues than free paclitaxel and are more effective in inhibiting tumor cell proliferation/migration and inducing ZEB1/TGF-ß2 gene expression.

A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial.

PURPOSE: Chemoradiotherapy is the standard treatment for patients with inoperable locally advanced oesophageal cancer. We sought to assess the safety and efficacy of chemoradiation combined with nimotuzumab, a humanised antibody directed against epidermal growth factor receptor (EGFR). PATIENTS AND METHODS: Untreated patients with inoperable locally advanced oesophageal cancer and no distant metastases were randomised to chemoradiotherapy (cisplatin and fluorouracil combined with external beam radiation) alone or in combination with nimotuzumab. The primary end-point was the endoscopic complete response (eCR) rate, and secondary end-points comprised quality of life (QoL) and safety. The combined eCR and pathologic complete response (cEPCR) and overall survival (OS) were also evaluated. RESULTS: We enrolled 107 patients with a mean age of 59 years, and 93% had squamous cell carcinoma. Toxicity was manageable in both arms with no important differences in adverse events (AEs). We performed post-treatment endoscopies in 67 patients, including 60 who had a biopsy. In the intent-to-treat population, the eCR rates with and without nimotuzumab were 47.2% and 33.3% (P = 0.17), respectively, and the cEPCR rates were 62.3% and 37.0% (P = 0.02), respectively. With a median follow-up of 14.7 months, the hazard ratio (HR) for OS was 0.68 (95% confidence interval (CI): 0.44-1.07; P = 0.09) with a median OS of 15.9 months for the nimotuzumab arm and 11.5 months for the control arm. Regarding QoL, a significant difference was observed for the physical subscale score (P = 0.03) with lower values for the control arm. CONCLUSION: Combined chemoradiotherapy plus nimotuzumab is safe for patients with locally advanced oesophageal cancer, it appears to increase the cEPCR rate, and without compromising QoL. CLINICAL TRIALS: Identification number: EF024-201; Trial registry: NCT01249352.

Development and implementation of a comprehensive psychosocial screening program in a Brazilian cancer center.

OBJECTIVE: International guidelines recommend routine screening for distress as part of care practices. Accordingly, a Brazilian cancer center developed and implemented a distress screening program (DS) in 2007, which was enhanced in 2009 through the inclusion of a psychosocial care meeting group (DS + PCM) regarding patients' psychosocial needs. The current paper will provide an overview of the development and pilot implementation of this program and initial analyses to assess patient outcomes and report initial results to extend international research on this key aspect of cancer care. METHOD: Patients were assessed for distress, anxiety and depression, and in the DS+PCM phase for quality of life at the first day of chemotherapy infusion, at midpoint, and at treatment end. We compared data from program phases (DS vs DS + PCM), with a sequential cohort design and mixed effects modeling. RESULTS: Clinical and demographic characteristics were similar between groups. Patients receiving DS + PCM showed significantly lower distress and depression/anxiety upon chemotherapy initiation (Ps < .001). While both groups reported significantly lowered distress and total depression/anxiety scores across time (Ps < .003), patients receiving DS + PCM maintained the lowest distress and total anxiety/depression at all assessments. Patients from DS + PCM group also reported improvements in quality of life over time. CONCLUSIONS: The current study provides preliminary evidence that a multidisciplinary structured screening program utilizing validated measures and team meetings is associated with reduced impairment in patients' psychological well being. This program provided more opportunities for collaboration among providers with increased multidisciplinary meetings, enabled patients to more easily report problems, and ensured rapid access to relevant resources.

Combined paclitaxel, cisplatin and fluorouracil therapy enhances ionizing radiation effects, inhibits migration and induces G0/G1 cell cycle arrest and apoptosis in oral carcinoma cell lines.

Although taxels (in particular paclitaxel), cisplatin and fluorouracil (TPF) chemotherapy has been approved for use in the treatment of head and neck squamous cell carcinoma (HNSCC), little is known with regard to the cellular mechanisms of this novel drug association. In order to investigate the reaction of cells to this novel treatment, the present study aimed to examine the cytotoxic effect of TPF in HNSCC cell lines in combination with irradiation, to analyze its effect on cell cycle progression and cell death, and to evaluate its ability to alter cell migration. An MTT assay was used to determine cell viability following TPF and cisplatin treatments in two human HNSCC cell lines (FaDu and SCC-9) and one keratinocyte cell line (HaCaT). The concurrent use of TPF or cisplatin and irradiation was also analyzed. Flow cytometric analysis was utilized to determine the cell cycle distribution and to verify the induction of apoptosis. The capacity of the drugs to alter oral cancer cell migration was also evaluated using a Transwell migration assay. The results indicated that TPF and cisplatin were cytotoxic to all cell lines, and enhanced the effects of ionizing radiation. FaDu cells were significantly more sensitive to the two treatments, and TPF was more cytotoxic than cisplatin for all cells. Flow cytometric analysis revealed that TPF increased the number of cells in G0/G1 phase in the SCC-9 cell line, and indicated apoptotic cell death. The results of the Transwell assay demonstrated that TPF inhibited migration in oral carcinoma cell lines. The results of the present study indicated that TPF functions in oral carcinoma cell lines through the enhancement of ionizing radiation effects, inducing cell cycle arrest at G0/G1 and apoptosis, in addition to inhibiting migration.