Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: a phase II study

This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II–IIIA breast cancer were treated with gemcitabine 1000 mg m−2 over 30 min on days 1 and 4, epirubicin 90 mg m−2 as an intravenous bolus on day 1, and taxol 175 mg m−2 as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8–97.8), with 26.8% complete responses (95% CI 13.3–40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8–25.4); 15 patients (36.6%; 95% CI 21.9–51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles (granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (⩾20% in 71.4% of the patients) and at definitive surgery (28.6%, P<0.05) was observed. The gemcitabine, epirubicin, taxol regimen is active and well tolerated as PCT for operable breast cancer. This combination allows the administration of full doses of active agents with a low incidence of febrile neutropenia

Older People’s Needs and Opportunities for Assistive Technologies

Older adults experience a disconnect between their needs and adoption of technologies that have potential to assist and to support more independent living. This paper reviewed research that links people’s needs with opportunities for assistive technologies. It searched 13 databases identifying 923 papers with 34 papers finally included for detailed analysis. The research papers identified needs in the fields of health, leisure, living, safety, communication, family relationship and social involvement. Amongst these, support for activities of daily living category was of most interest. In specific sub-categories, the next most reported need was assistive technology to support walking and mobility followed by smart cooking/kitchen technology and assistive technology for social contacts with family member/other people. The research aimed to inform a program of research into improving the adoption of technologies where they can ameliorate identified needs of older people

Metronomic oral vinorelbine as first-line treatment in elderly (>65 year) patients with advanced NSCLC

Introduction: Non-small cell lung cancer (NSCLC) is one of the most frequent malignancies, and the majority of diagnosis are made at an advanced stage (IIIB/IV), with unsatisfactory results. Vinorelbine is a microtubule-targeting agent, with a favorable safety profile, and is currently available also as oral chemotherapeutic agent. Metronomic chemotherapy (MCT) is an attractive strategy for treating cancer, which has been shown to reduce toxicities and to extend duration of treatment, resulting in lower resistances and prolonged survival rates. The aim of our study was to evaluate the role of oral metronomic vinorelbine (mVNR) as first-line treatment in population of elderly unfit-platin patients with advanced NSCLC. Materials and Methods: Twenty patients (13 men and 7 women, median age 78 years, range 66-88) with advanced NSCLC (3 patients stage IIIb, 17 patients stage IV) and a median of 4 major co-morbidities, non-oncogenic addicted and unfit for platin, were treated with oral mVNR as first-line treatment, at a dose of 40 mg (Group 1, 9 patients) or 50 mg (Group 2, 11 patients) as MCT on days Monday, Wednesday and Friday. The ECOG performance status was 1 (PS1) in 11 patients and 2 or 3 (PS2-3) in 9. Results: The median overall survival (OS) was 7.80 months (PS1: 11.27 months; PS2-3: 4.3 months) and time-to-progression (TTP) was 3.07 months (PS1: 3.0 months; PS2-3: 3.5 months). The median OS in Group 1 was 4.5 months and 9.4 months in Group 2. Best response showed stable disease in 5 cases, partial response in 4, progression disease in 7. Low toxicity was reported because grade 1-2 asthenia was the most frequently reported symptom. Conclusions: Metronomic chemotherapy is a new approach that combines good tolerability and acceptable activity. Our preliminary data suggest that oral mVNR in advanced NSCLC may be an effective first-line treatment, even in elderly and unfit patients with major co-morbidities

Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer

Background: Neoadjuvant anthracycline- and taxane-based chemotherapy is frequently administered in breast cancer. Pathological complete response (pCR) rates vary according to clinical disease stage and biology of breast cancer. The critical role of angiogenesis in the progression of breast cancer, together with significantly improved efficacy when bevacizumab is combined with chemotherapy in the metastatic setting, provides a strong rationale for evaluating the integration of bevacizumab into neoadjuvant chemotherapy regimens. Methods: A single-arm, multicentre, phase II, open-label study evaluated four 3-weekly cycles of FEC (5-fluorouracil 600 mg/m(2), epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)) followed by 12 cycles of weekly paclitaxel (80 mg/m(2)) in combination with bevacizumab 10 mg/kg every 2 weeks as neoadjuvant therapy for HER2-negative stage III locally advanced or inflammatory breast carcinoma. The primary endpoint was pCR rate. Results: Planned treatment was completed in 49 of the 56 enrolled patients. In the intent-to-treat population, the pCR rate was 21% and the clinical response rate was 59%. Breast-conserving surgery was achieved in 34% of patients. In the subgroup of 15 patients with triple-negative disease, the pCR rate was 47%. Grade 3 adverse events in >= 5% of patients were neutropenia, leucopenia, asthenia, and rash. One case each of hypertensive retinopathy and post-operative wound complication, both after treatment completion, were considered probably related to bevacizumab. There were no treatment-related deaths and no cardiac function abnormalities. Conclusions: This study indicates that FEC followed by weekly paclitaxel with bevacizumab is an active neoadjuvant regimen for locally advanced breast cancer, with no major safety concerns. Clinical trial registration: NCT00559845. (C) 2013 Elsevier Ltd. All rights reserved

Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: a phase II study

This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II-IIIA breast cancer were treated with gemcitabine 1000 mg m(-2) over 30 min on days 1 and 4, epirubicin 90 mg m(-2) as an intravenous bolus on day 1, and taxol 175 mg m(-2) as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8 - 97.8), with 26.8% complete responses ( 95% CI 13.3 - 40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8 - 25.4); 15 patients (36.6%; 95% CI 21.9 - 51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles ( granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (>= 20% in 71.4% of the patients) and at definitive surgery (28.6%, P<0.05) was observed. The gemcitabine, epirubicin, taxol regimen is active and well tolerated as PCT for operable breast cancer. This combination allows the administration of full doses of active agents with a low incidence of febrile neutropenia