Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients.

Background: The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) can induce high complete remission rates with acceptable toxicity in elderly patients with acute myeloid leukemia (AML). We present the final results of a randomized-controlled trial comparing IMA with the standard 7 + 3 induction regimen consisting of continuous infusion cytarabine plus daunorubicin (DA). Patients and methods: Patients with newly diagnosed AML >60 years were randomized to receive either intermediate-dose cytarabine (1000 mg/m2 twice daily on days 1, 3, 5, 7) plus mitoxantrone (10 mg/m2 days 1-3) (IMA) or standard induction therapy with cytarabine (100 mg/m2 continuously days 1-7) plus daunorubicin (45 mg/m2 days 3-5) (DA). Patients in complete remission after DA received intermediate-dose cytarabine plus amsacrine as consolidation treatment, whereas patients after IMA were consolidated with standard-dose cytarabine plus mitoxantrone. Results: Between February 2005 and October 2009, 485 patients were randomized; 241 for treatment arm DA and 244 for IMA; 76% of patients were >65 years. The complete response rate after DA was 39% [95% confidence interval (95% CI): 33-45] versus 55% (95% CI: 49-61) after IMA (odds ratio 1.89, P = 0.001). The 6-week early-death rate was 14% in both arms. Relapse-free survival curves were superimposable in the first year, but separated afterwards, resulting in 3-year relapse-free survival rates of 29% versus 14% in the DA versus IMA arms, respectively (P = 0.042). The median overall survival was 10 months in both arms (P = 0.513). Conclusion: The dose escalation of cytarabine in induction therapy lead to improved remission rates in the elderly AML patients. This did not translate into a survival advantage, most likely due to differences in consolidation treatment. Thus, effective consolidation strategies need to be further explored. In combination with an effective consolidation strategy, the use of intermediate-dose cytarabine in induction may improve curative treatment for elderly AML patients.

Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO){dagger}.

BACKGROUND: This prospective multicentre phase II trial assessed the feasibility and efficacy of perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in patients with gastro-oesophageal adenocarcinoma. METHODS: Patients with curatively resectable adenocarcinoma of the stomach, the gastro-oesophageal junction or the lower third of the oesophagus were enrolled. Patients received docetaxel 75 mg/m(2) plus cisplatin 60 mg/m(2) (day 1), followed by oral capecitabine 1875 mg/m(2) divided into two doses (days 1-14) every 3 weeks. There were three cycles preoperatively and three cycles postoperatively. The primary end point was the R0 resection rate. RESULTS: Fifty-one patients were recruited and assessed for feasibility and efficacy. 94.1% of patients received all three planned cycles preoperatively, and 52.9% received three cycles postoperatively. The R0 resection rate was 90.2%. 13.7% of patients showed complete pathological remission (pCR). Toxicity was acceptably tolerable. Without prophylactic granulocyte colony-stimulating factor administration, neutropenic fever developed in 21.5% of patients preoperatively (grade 3 or 4) and in 11.1% of patients postoperatively. CONCLUSIONS: DCX is a safe and feasible perioperative regimen in the treatment of gastro-oesophageal adenocarcinoma with a high percentage of cycles delivered pre- and postoperatively, compared with standard practice. The high efficacy in terms of R0 resection rate and pCR is very promising.

[The role of next of kin in medical decision-making--empirical findings from haemato-oncological diseases]. / Die Rolle der Angehörigen bei medizinischen Entscheidungen--Empirische Befunde zu hämatoonkologischen Erkrankungen.

AIM OF THE STUDY: Models of shared decision making in the patient-doctor relationship are attracting increasing attention. A recent study focuses on the so far inadequate attention paid to the role of next of kin. It was examined in which decision areas next of kin of haematological cancer patients were included, further what support next of kin could provided and finally which factors encouraged the participation of next of kin in that process. METHODS: From 2006-2008 empirical data were collected from hemato-oncological patients undergoing treatment as well as from their families. The participating family members of patients were mailed questionnaires based on the patient sample (designation of a family member by the patient: 118/177 or 66.7%) on average half of a year following the patient's (in- or outpatient) treatment. The response rate of the participants was 67.8% (80/118). Of the respondents, 65% were spouses or partners of the patients, the average age was 53.9 years, and 66.3% were female. RESULTS: Family members think it makes sense for them to take an active part in medical decisions affecting their loved ones and a majority of them reported having participated in decision-making processes concerning a variety of issues. Being involved in their loved one's discussions with their doctors has a significant influence on this. Family members' level of education was the only clear predictor for participation in discussions with doctors that could be isolated. CONCLUSION: It is clear that family members, especially spouses and partners, consider it meaningful to participate in medical decisions affecting their loved ones, and that they want to be able to do this in the clinical context. One limitation that must be mentioned is that due to the small size of the sample and an approach that focused on initial exploration, the results should be interpreted as a point of orientation. Further studies should look in more detail at how inner family structures play a role in patient-doctor shared decision-making, as well as the concrete conditions and implications that play a role in family members' participation in this process, i.e., adherence to "doctor's orders" and possible decision-making conflicts on the part of the patient.