CHO(E)P-14 followed by alemtuzumab consolidation in untreated peripheral T cell lymphomas: final analysis of a prospective phase II trial.

The rate of long-term remissions after treatment of peripheral T cell lymphomas (PTCL) with standard CHOP-like protocols is unsatisfactory. A prospective multicenter phase II trial was initiated in untreated patients with PTCL of all International Prognostic Index-risk groups, evaluating alemtuzumab consolidation in patients with complete or good partial remission after CHO(E)P-14 induction. Twenty-nine (70.7 %) of the 41 enrolled patients received alemtuzumab consolidation (133 mg in total). The main grades 3-4 toxicities during alemtuzumab therapy were infections and neutropenia with one potentially treatment-related death. Complete responses were seen in 58.5 %, partial responses in 2.4 % and 29.3 % had progressive disease. After a median observation time of 46 months, 19 patients have died, 16 of them due to lymphoma and/or salvage therapy complications. Event-free and overall survival at 3 years in the whole intent to treat population are 32.3 and 62.5 %, respectively, and 42.4 and 75.1 % in the patients who received alemtuzumab. In conclusion, application of a short course of alemtuzumab after CHO(E)P-14 induction is feasible although complicated by severe infections. A current phase III trial, applying alemtuzumab as part of the initial chemotherapy protocol to avoid early progression, will further clarify its significance for the therapeutic outcome.

Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial.

Platinum/taxane combinations are widely used in patients with carcinoma of unknown primary (CUP), yielding response rates of 30% and median overall survival of 9-11 months in selected patients. Yet these combinations have not been subject to a randomised trial to overcome selection bias, a major problem in CUP. We randomised 92 patients to either paclitaxel/carboplatin (arm A) or the non-platinum non-taxane regimen gemcitabine/vinorelbine (arm B). The primary endpoint was rate of practicability as defined: application of >or=2 cycles of therapy (1) with a maximal delay of 1 week (2) and survival of >or=8 months (3). Practicability was shown in 52.4% (95% CI 36-68%) in arm A and in 42.2% (95% CI 28-58%) in arm B, respectively. The median overall survival, 1-year survival -rate and response rate of patients treated in arm A was 11.0 months, 38, and 23.8%, arm B 7.0 months, 29, and 20%. In conclusion, the paclitaxel/carboplatin regimen showed clinically meaningful activity in this randomised trial (Clinical trial registration number 219, 'Deutsches KrebsStudienRegister', German Cancer Society.)

[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.