Results From a Large,Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region

Background

Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.

Non-Hodgkin's lymphomas in 137 patients aged 70 years or older: a retrospective European Organization for Research and Treatment of Cancer Lymphoma Group Study

The results of a European Organization for Research and Treatment of Cancer (EORTC) retrospective study on non-Hodgkin's lymphoma (NHL) in elderly patients (greater than or equal to 70 years of age) seen in Europe in 1984 are reported. A precodified form was sent to 55 European institutes in order to evaluate the incidence of NHL in the elderly with regard to natural history, treatment-related toxicity, response, and survival. Thirteen institutes participated in the study. One hundred thirty-seven cases of NHL were observed in the elderly during 1984, making up 28% of the total number of NHL seen in those institutes. The median age was 77 years; 21% of the patients had favorable (low-grade) and 73% unfavorable (intermediate- and high-grade) histology, according to the Working Formulation. Stage at presentation was localized (I and II) in 60% and advanced in 37% of the patients. Most of the physicians used standard therapy regimens at reduced doses, from the beginning of the treatment. Sixty patients (44%) underwent a "conservative" treatment (one or two antineoplastic drugs or local field radiotherapy) and 77 (56%) an "aggressive" treatment (polychemotherapy regimens or extended field radiotherapy). Response was similar between the two treatment groups, but severe and lethal toxicity was significantly higher among patients treated with aggressive therapy. Prospective randomized studies are clearly needed to define the optimal treatment in elderly patients with advanced unfavorable NHL.     

Monocytoid B-cell lymphoma with bone marrow and peripheral blood involvement at presentation

A case of malignant lymphoma showing in a lymph node the characteristic morphologic features of the so-called monocytoid B-cell lymphoma (MBCL) is described. This case differs from the reported cases in the literature because atypical cells were observed in the bone marrow biopsy and marrow and peripheral blood smears that were obtained from the patient, a 61-year-old man, during the staging procedures. Lymphocyte surface marker studies on peripheral blood by flow cytometry and DNA analysis revealed a monoclonal population of lambda-positive lymphocytes. The immunophenotype of MBCL cells was studied both in paraffin-embedded lymph node sections by immunoperoxidase method and in peripheral blood by flow cytometric analysis; the cells expressed the SIg with lambda light chain restriction and the HLA-DR antigen; they also had positive results for B-cell-associated antigens, including LN1, LN2, CD 20, CD 22, CD 19, CD 9 but not CD 21, CD 24, and CD 10, T-cell-associated antigens and monocytic markers. In addition, they had negative results for CD 25, CD 38, PCA-1. This report emphasizes that in MBCL, peripheral and marrow involvement may occur at presentation analogous to other low-grade B-cell lymphomas. The immunophenotypic characteristics of MBCL cells, though not pathognomonic, are considered to be helpful in differentiating them from circulating cells of other B-cell lymphomas.     

Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer).

BACKGROUND: First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined. PATIENTS AND METHODS: Women with stage III or IV breast cancer aged > or =70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80 mg/m(2) was administered weekly for 3 weeks every 28 days. RESULTS: Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5-18.7) and median survival was 35.8 months (95% CI 19-not defined). CONCLUSIONS: Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.     

Impact of Aspirin on clinical outcome in advanced HCC patients receiving sorafenib and regorafenib

Background and aimThe aim of our retrospective study is to evaluate the prognostic significance of aspirin in patients with advanced HCC treated with sorafenib.Methods304 patients with HCC,consecutively treated with sorafenib from May 2007 to September 2018, were included in the clinical study. Of Them 93 patients token aspirin. Progression-free survival (PFS)and overall survival (OS)were estimated with the Kaplan–Meier method and compared with the log-rank test.ResultsThe concomitant use of sorafenib and aspirin was associated with a median OS of 18.3 months compared to 8.8 months of patients who did not receive aspirin (HR 0.57; P < 0.0001). The concomitant use of sorafenib and aspirin was associated with a median PFS of 7.3 months compared to 3.0 months of patients who did not receive aspirin (HR 0.61; P = 0.0003). In the multivariate analysis, the use of aspirin maintained an independent prognostic value for OS(HR 0.61; P = 0.0013). In second line the concomitant use of regorafenib and aspirin was associated with a median OS of 16.9 months compared to 8.0 months of patients who did not receive aspirin (HR 0.30; P = 0.02).ConclusionGlobally, our data seem to suggest that aspirin use may improve the clinical outcome of patients with advanced hepatocellular carcinoma receiving sorafenib and regorafenib.     

Comprehensive geriatric assessment adds information to Eastern Cooperative Oncology Group performance status in elderly cancer patients: an Italian Group for Geriatric Oncology Study.

PURPOSE: To appraise the performance of Comprehensive Geriatric Assessment (CGA) in elderly cancer patients (> or = 65 years) and to evaluate whether it could add further information with respect to the Eastern Cooperative Oncology Group performance status (PS). PATIENTS AND METHODS: We studied 363 elderly cancer patients (195 males, 168 females; median age, 72 years) with solid (n = 271) or hematologic (n = 92) tumors. In addition to PS, their physical function was assessed by means of the activity of daily living (ADL) and instrumental activities of daily living (IADL) scales. Comorbidities were categorized according to Satariano's index. The association between PS, comorbidity, and the items of the CGA was assessed by means of logistic regression analysis. RESULTS: These 363 elderly cancer patients had a good functional and mental status: 74% had a good PS (ie, lower than 2), 86% were ADL-independent, and 52% were IADL-independent. Forty-one percent of patients had one or more comorbid conditions. Of the patients with a good PS, 13.0% had two or more comorbidities; 9.3% and 37.7% had ADL or IADL limitations, respectively. By multivariate analysis, elderly cancer patients who were ADL-dependent or IADL-dependent had a nearly two-fold higher probability of having an elevated Satariano's index than independent patients. A strong association emerged between PS and CGA, with a nearly five-fold increased probability of having a poor PS (ie, > or = 2) recorded in patients dependent for ADL or IADL. CONCLUSION: The CGA adds substantial information on the functional assessment of elderly cancer patients, including patients with a good PS. The role of PS as unique marker of functional status needs to be reappraised among elderly cancer patients.     

Inclusive nursing care for individuals suffering from Down's syndrome under Paterson and Zderad's view

This is a thought-provoking study approaching inclusive nursing care rendered to individuals suffering from Down's syndrome in light of some assumptions made in Paterson and Zderad's theory. Its aim is to uncover Paterson and Zderad's humanistic theory, by emphasizing some of its assumptions as applied to individuals suffering from Down's syndrome, and by outlining the participation of nurses in inclusive care of such cases, through a conscious practice related to the humanistic theory. By providing individuals suffering from Down's syndrome with health care based on the humanistic theory referential, it is possible to reckon each human being as a unique existent being, therefore understanding his/her meaning.     

The combination of gemcitabine and vinorelbine is an active regimen as second-line therapy in patients with metastatic breast cancer pretreated with taxanes and/or anthracyclines: a phase I-II study

Purpose. To evaluate the activity and toxicity of gemcitabine and vinorelbine (GemVin), in patients with advanced breast cancer, previously treated with anthracyclines alone or with taxanes. Patients and methods. Nine patients were entered into the phase I and 50 patients were entered into the phase II study. Gemcitabine was administered beginning with the dose of 800 mg/m² and vinorelbine was given at the fixed dose of 25 mg/m², both on days 1 and 8, every 21 days. Escalated dose levels of gemcitabine were planned by increments of 200 mg/m² per level. The median age of the 50 assessable patients for the phase II study was 56.5 years (range 30–70) and median performance status (PS, ECOG score), 1 (range 0–2). The dominant sites of metastases were viscera in 40, bone in five and soft tissue in five patients. First-line chemotherapy for metastatic disease with taxanes and anthracyclines or with anthracyclines alone was administered in 36 and 14 patients, respectively. Results. The optimal schedule for the combination was gemcitabine 800 mg/m² and vinorelbine 25 mg/m². The maximum tolerated dose of gemcitabine was 1000 mg/m², with grade 4 neutropenia occurring in two cases at this dose level. Overall, 267 cycles were given to the 50 patients enrolled into the phase II (mean 5.3; range 3–9). The schedule was well tolerated: three patients experienced grade 4 neutropenia and another four patients experienced grade 3 anemia. Non-hematological toxicities were moderate. A major objective response was observed in 42% of patients (95% confidence interval (CI), 28–57%), with complete remission in four (8%) and partial response in 17 (34%) patients. The median time to progression was 6 months. Activity as well as toxicity were similar in the subgroups of the patients pretreated either with combinations of taxanes and anthracyclines or anthracyclines alone. Conclusions. The optimal GemVin schedule is an effective and well tolerated second-line therapy in patients with metastatic breast cancer pre-treated with anthracycline – based schedules or with combinations of anthracyclines and taxanes.     

Combination Chemotherapy Specifically Devised for Elderly Patients with Unfavorable Non-Hodgkin's Lymphoma

The results of a prospective trial with a specifically devised chemotherapy regimen in elderly patients with unfavorable non-Hodgkin's lymphoma (NHL) are reported. Between April 1983 and April 1986, 37 consecutive patients 70 years old or more (median age 80) received etoposide and prednimustine (E%P) 100 mg/m² p.o. for 5 days every 21 days. Thirteen patients were previously treated. Objective response rate in the 35 evaluable patients is 66% with 46% complete response. The objective response rate in the 22 previously untreated patients is nearly 70% with 50% complete response. Median survival is 14 months. The overall toxicity was reasonably acceptable. There were 5% (2 patients) treatment-related deaths, but in an unselected elderly population. We experienced the usefulness of a properly oriented clinical approach to elderly patients with NHL. We suggest that a combination regimen E%P, suitable for oral administration, may be safely employed in elderly patients with unfavorable NHL.