It's never too late - balance and endurance training improves functional performance, quality of life, and alleviates neuropathic symptoms in cancer survivors suffering from chemotherapy-induced peripheral neuropathy: results of a randomized controlled trial.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) can affect functional performance and quality of life considerably. Since balance training has proven to enhance physical function, it might be a promising strategy to manage CIPN-induced functional impairments. METHODS: Fifty cancer survivors with persisting CIPN after finishing their treatment were randomly allocated to an intervention (IG) or active control group (CG). The IG did endurance plus balance training, the CG only endurance training (twice weekly over 12 weeks). Pre- and post-assessments included functional performance, cardiorespiratory fitness, vibration sense, and self-reported CIPN symptoms (EORTC QLQ-CIPN20). RESULTS: Intention-to-treat analyses (n = 41) did not reveal a significant group difference (CG minus IG) for sway path in semi-tandem stance after intervention (primary endpoint), adjusted for baseline. However, our per-protocol analysis of 37 patients with training compliance ≥70% revealed: the IG reduced their sway path during semi-tandem stance (- 76 mm, 95% CI -141 - -17; CG: -6 mm, 95% CI -52 - 50), improved the duration standing on one leg on instable surface (11 s, 95% CI 8-17; CG: 0 s, 95%CI 0-5) and reported decreased motor symptoms (-8points, 95% CI -18 - 0; CG: -2points 95% CI -6 - 2). Both groups reported reduced overall- (IG: -10points, 95% CI -17 - -4; CG: -6points, 95% CI -11 - -1) and sensory symptoms (IG: -7points, 95% CI -15 - 0; CG: -7points, 95% CI -15 - 0), while only the CG exhibited objectively better vibration sense (knuckle: 0.8points, 95% CI 0.3-1.3; IG: 0.0points, 95% CI -1.1 - 0.9; patella: 1.0points, 95% CI 0.4-1.6: IG: -0.8points, 95% CI -0.2 - 0.0). Furthermore, maximum power output during cardiopulmonary exercise test increased in both groups (IG and CG: 0.1 W/kg, 95% CI 0.0-0.2), but only the CG improved their jump height (2 cm, 95% CI 0.5-3.5; IG: 1 cm, 95% CI -0.4 - 3.2). CONCLUSION: We suppose that endurance training induced a reduction in sensory symptoms in both groups, while balance training additionally improved patients' functional status. This additional functional effect might reflect the IG's superiority in the CIPN20 motor score. Both exercises provide a clear and relevant benefit for patients with CIPN. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) number: DRKS00005419 , prospectively registered on November 19, 2013.

Data Logging Evidence of Cochlear Implant Use in Single-Sided and Bilateral Deafness.

PURPOSE: This study analyses data logs in order to investigate the usage pattern of cochlear implant (CI) recipients with single-sided deafness (SSD-CI) and bilaterally deaf, uni- or bilaterally implanted CI recipients (Uni-CI and Bil-CI). Data logging is available from SCAN, an automated auditory scene classifier which categorizes auditory input into 6 listening environments. METHODS: CI usage data were retrospectively available from data logs of 206 CI recipients using the Nucleus 6 system obtained between January 2013 and June 2015. For all recipients, we analysed time on air and time spent in the listening environments. For statistical analysis, we matched the CI recipients according to age and duration of CI experience and classified them into 4 age groups. RESULTS: SSD-CI showed a similar time on air compared to Uni- and Bil-CI. Usage behaviour of SSD-CI was comparable to Uni- and Bil-CI regarding exposure to music, speech in quiet and speech in noise. With increasing age, exposure to quiet increased and exposure to music decreased across all CI recipient groups in relation to time on air. CONCLUSION: In total, the CI usage pattern of SSD-CI is comparable for the majority of listening environments and age groups to that of Uni- and Bil-CI. The results of our study show that SSD-CI benefit equally from CI implantation.

High Rates of Thromboembolic Events in Patients with Germ Cell Cancer Undergoing Cisplatin-Based Polychemotherapy.

BACKGROUND: We examined whether or not extended prophylaxis with low molecular weight heparin (LMWH) would significantly reduce thromboembolic event (TEE) rates in germ cell cancer patients undergoing cisplatin-based chemotherapy. PATIENTS AND METHODS: LMWH prophylaxis was given from the first day of chemotherapy until 21 days after completing the last chemotherapy cycle to 45 out of 93 (48.4%) patients (extended), and to 48 out of 93 (51.6%) patients during their hospitalization only (limited) between January 2008 and December 2013. Patients were analyzed retrospectively for TEEs such as deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI) or peripheral arterial thrombosis. RESULTS: A total of 22/93 (23.7%) patients experienced 30 TEE during chemotherapy: 12 out of 30 (40%) deep vein thrombosis, 4 out of 30 (13.3%) MI, 10 out of 30 (33.3%) PE and 4 out of 30 peripheral arterial thrombosis (13.3%). TEE rates in both groups did not differ significantly (extended: 26.7 vs. limited: 20.8%). CONCLUSIONS: The introduction of extended LMWH prophylaxis did not significantly reduce TEE rates in our patient cohort.

Trained clinical nurse specialists proficiently obtain bone marrow aspirates and trephine biopsies in a nearly painless procedure--a prospective evaluation study.

Patients often experience bone marrow examinations (BMEs) as frightening and painful. Varying operators and uncertainty about who will perform the BME worsen their anxiety. In our study, clinical nurse specialists (CNSs) were trained to perform BMEs to ensure continuity and to test the feasibility, patient satisfaction, and biopsy quality. This exploratory evaluation assessed 574 BMEs at our tertiary center between January 2012 and February 2013, 398 BMEs performed by CNS and 176 by physicians. Our aims were to determine whether BMEs by CNS yield results similar to those of physicians, analyzing (1) patient satisfaction with the BME (a) consent and (b) performance, (2) induced pain, and (3) quality of aspirates and length of trephine biopsies. When performed by CNS, 100 % of the patients were satisfied with the consent procedure and 99 % with the BME performance (physicians 99 and 91 %, respectively). The median pain score was low when both CNS and physicians performed the BME, with no or only mild pain in 92 and 76 % of patients, respectively. Bone marrow (BM) aspirates by CNS and physicians were assessed as technically evaluable in ~70 %; moreover, the median length of trephine biopsies was similar when performed by CNS or physicians with 12 and 13 mm, respectively. In conclusion, BMEs conducted by motivated CNS and within a structured training program are feasible and yield equal outcomes compared to physicians. The use of adequate pain management during BMEs by trained and experienced operators results in an extremely rare use of sedatives, low pain scores, and high patient satisfaction.

Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy.

BACKGROUND: Lymphoma patients undergoing therapy must cope with the side-effects of the disease itself, therapy and associated immobility. Peripheral neuropathy (PNP), loss of balance control and weakness not only diminishes patients' quality of life (QOL), it can also affect planning and the dosage of therapy. Exercise may enable patients to reverse these declines, improving their performance level and QOL. PATIENTS AND METHODS: We carried out a randomized, controlled trial, assigning 61 lymphoma patients either to a control group (CG; N=31) or to a 36-week intervention (IG; N=30), consisting of sensorimotor-, endurance- and strength training twice a week. Primary end point was QOL; secondary end points included movement coordination, endurance, strength and therapy-induced side-effects. RESULTS: Intergroup comparison revealed improved QOL- (ΔT1-T0; P=0.03) and PNP-related deep sensitivity in the IG: 87.5% were able to reduce the symptom, compared with 0% in the CG (P<0.001). Significant differences in the change of balance control could be found between the groups, with the IG improving while the CG steadily declined (monopedal static ΔT3-T0; P=0.03; dynamic ΔT3-T0; P=0.007; perturbed mono-ΔT3-T0; P=0.009 and bipedal ΔT3-T0; P=0.006), failed attempts (monopedal static ΔT3-T0; P=0.02, dynamic ΔT3-T0; P<0.001and perturbed ΔT3-T0; P=0.006) and improved time to regain balance (ΔT3-T0; P=0.04). Moreover, the change in the aerobic performance level (ΔT3-T0; P=0.05) and additional amount of exercise carried out per week [metabolic equivalent (MET); P=0.02] differed significantly across groups. CONCLUSIONS: Exercise, especially sensorimotor training, is a feasible and promising method to support cancer patients during therapy. It improves patients QOL, reduces restrictions from side-effects such as PNP and improves patients' balance control, physical performance level and mobility. GERMAN CLINICAL TRIALS REGISTER NUMBER: DRKS00003894.

Multicentre phase II trial of trastuzumab and capecitabine in patients with HER2 overexpressing metastatic pancreatic cancer.

BACKGROUND: New therapeutic options for metastatic pancreatic cancer are urgently needed. In pancreatic cancer, overexpression of the epidermal growth factor receptor 2 (HER2) has been reported in up to 45%. This multicentre phase II study investigated the efficacy and toxicity of the HER2 antibody trastuzumab combined with capecitabine in the patients with pancreatic cancer and HER2 overexpression. METHODS: Primary endpoint was progression-free survival (PFS) after 12 weeks. A total of 212 patients were screened for HER2 expression. RESULTS: Immunohistochemical (IHC) HER2 expression was: 83 (40%) grade 0, 71 (34%) grade 1, 31 (15%) grade 2, 22 (11%) grade 3. A total of 17 patients with IHC +3 HER2 expression or gene amplification could be assessed for the treatment response. Grade 3/4 treatment toxicities were: each 7% leucopenia, diarrhoea, nausea and hand-foot syndrome. Progression-free survival after 12 weeks was 23.5%, median overall survival (OS) 6.9 months. CONCLUSION: This study demonstrates +3 HER2 expression or gene amplification in 11% of patients. Contrary to breast and gastric cancer, only 7 out of 11 (64%) patients with IHC +3 HER2 expression showed gene amplification. Although the therapy was well tolerated, PFS and OS did not perform favourably compared with standard chemotherapy. Together, we do not recommend further evaluation of anti-HER2 treatment in patients with metastatic pancreatic cancer.

Immunochemotherapy with rituximab, methotrexate, procarbazine, and lomustine for primary CNS lymphoma (PCNSL) in the elderly.

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non-Hodgkin lymphoma confined to the central nervous system. In this article, we report the results of a pilot trial adding rituximab to the established regimen consisting of methotrexate, procarbazine, and lomustine (R-MCP). DESIGN AND METHODS: PCNSL patients ≥65 years without Karnofsky performance score (KPS) limit were included. R-MCP regimen consisted of rituximab (375 mg/m(2) i.v. on days -6, 1, 15, and 29), methotrexate (3 g/m(2) i.v., days 2, 16, and 30) followed by folinic rescue, procarbazine (60 mg/m(2) orally, days 2-11), and lomustine (110 mg/m(2) orally, day 2). A maximum of three 43-day cycles were applied. Primary end point was response to treatment obtained by magnetic resonance imaging. Secondary end points were overall survival (OS) and progression-free survival (PFS). RESULTS: Twenty-eight patients were included (median age 75, median KPS 60%). Best documented response: complete remission in 18 of 28 (64%), partial remission in 5 of 28 (18%), stable disease in 1 of 28 (4%), and progressive disease in 2 of 28 (7%) patients. Response was not assessed in two patients. Two treatment-associated deaths were observed. After a median follow-up of 36 months, the 3-year PFS and OS was 31%. CONCLUSION: R-MCP regimen is well tolerated and active in elderly patients with newly diagnosed PCNSL.

Criteria for the differential indication of asthma education versus asthma instruction for families of preschoolers: results from the randomized DIAT2 study (Differential Indication of Asthma Trainings in Toddlers).

BACKGROUND: Asthma management of preschoolers is more improved by a family oriented psycho-educational program provided by a multi-professional team than by a short instruction alone. For some families however an instruction could be sufficient. Criteria to assign education or instruction to asthmatic schoolchildren (DIA) have been evaluated . This paper describes the use of those criteria in the Preschoolers' and parents' asthma education trial (P (2)AET) . PATIENTS: DIA at study entry were available of 233 children (aged 2-5 [mean 3.9] years) participating in the randomised controlled P (2)AET (education, instruction, waiting group). Children had been included after having at least 3 obstructive episodes in their life plus chronic or recurrent wheeze in the 6 months before the start of the study. 74 % were on inhaled corticosteroids. METHODS: Logistic regression procedures were used to assess the predictive value of DIA and possible confounders on the success of the interventions (education and instruction). RESULTS: Regarding the outcome "better in asthma management test" education is superior to instruction (OR 5.2; CI 1.7-16). DIA "quarrel about inhalation" indicates an even greater advantage of education (OR 19; CI 2-176). An equal high advantage was found, when there was NO "need for peer support" (OR 11; CI 2-64). CONCLUSION: Families with asthmatic preschoolers displaying dysfunctional interaction, which can only be corrected in an educational process, should be provided with the psycho-educational program promptly.

[Unilateral deafness and cochlear implantation: audiological diagnostic evaluation and outcomes]. / Einseitige Taubheit und Cochlear-implant-Versorgung: Audiologische Diagnostik und Ergebnisse.

Cochlear implantation (CI) is a new form of treatment in the rehabilitation of single-sided deafness. The patient requires thorough initial examination and a full explanation of alternative treatment options prior to determining the indication for CI treatment. To date, we have treated 28 patients with CI, of whom data are available for 11 after 12 months. We examined speech comprehension in background noise and localisation ability 12 months after CI implantation compared to conventional CROS (contralateral routing of signal) hearing aids, BAHA (bone-anchored hearing aid) and hearing in untreated patients. In addition, we determined the subjective handicap (HHIE, hearing handicap inventory for the elderly) and the subjective success (IOI-HA, international outcome inventory for hearing aids; SSQ, spatial and qualities of hearing scale) of each treatment option. After 12 months' experience, the results show a significantly better localisation ability and an improvement in speech comprehension in background noise with CI than with the other treatment options. Subjective results also show a clear benefit with CI. Careful patient selection is a decisive factor for successful treatment of this patient group. Under these conditions, CI is a treatment option with which significant improvement in speech comprehension and localization ability in single-sided deafness is possible.

Prognostic factors for survival after allogeneic transplantation in acute lymphoblastic leukemia.

Allogeneic stem cell transplantation (allo-SCT) offers a curative option in adult patients with acute lymphoblastic leukemia (ALL). Prognostic factors for survival after allo-SCT have not been sufficiently defined: pheno-/genotype, patients´ age, conditioning regimens and remission at allo-SCT are under discussion. We analyzed the outcome of 180 consecutive adult ALL-patients undergoing allo-SCT at our center between 1995 and 2018 to identify specific prognostic factors. In our cohort 19% were older than 55 years, 28% had Philadelphia-positive B-ALL, 24% T-ALL. 54% were transplanted in first complete remission (CR1), 13% in CR2 after salvage therapy, 31% reached no remission (8% within first-line, 23% within salvage therapy). In 66% conditioning contained total body irradiation (TBI). With a median follow-up of 10 years, we observed an overall survival of 33% at 10 years, and a progression free survival of 31%. The cumulative incidence of relapse was 41% at 10 years, the cumulative incidence of non-relapse mortality 28%. Acute graft-versus-host disease (GvHD) II°-IV° occurred in 31%, moderate/severe chronic GvHD in 27%. Survival was better in patients reaching CR before allo-SCT and in those receiving TBI. No difference between patients younger/older than 55 years and between different phenotypes was observed. Survival after allo-SCT improved considerably over the last decades.

Preschoolers' and parents' asthma education trial (P2AET)--a randomized controlled study.

We aimed to evaluate a family-oriented psycho-educational asthma training program for the age group of 2-5 years, involving both parents and children. Children were included after having at least 3 obstructive episodes in their life plus chronic or recurrent wheeze in the 6 months before the start of the study. In the multicenter randomized trial we had (1) a waiting group (WG), (2) an instruction group (IG) trained in a structured way according to the national asthma guideline, and (3) an education group (EG), having a standardized multiprofessional psycho-educational program, according to the national licensed asthma education for the age group of 6-18 years. All were assessed after 6 months. A subgroup analysis was performed on those being on regular inhaled corticosteroids at study entry (74.3%). A total of 338 children were randomized, and 288 (85%) completed the study. In the asthma emergency management, test scores increased most in EG, less in IG, and not in WG. For emergency visits the risk ratio for EG was 0.68 compared to IG: Patients regularly inhaling corticosteroids (74.3%) had an increased risk for emergency visits when having only an instruction (OR 3.99 [1.89-8.40]) or had been waiting (OR 2.5 [1.16-5.37]) when compared to those having an asthma education. We conclude that in the German health system, the family oriented psycho-educational program provided in a standardized manner by a multiprofessional team is effective also in the age group of 2-5 years. It should be made accessible to each asthmatic child.

High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study.

BACKGROUND: To improve survival of elderly patients with primary central nervous system lymphoma (PCNSL), we conducted a phase II study with high-dose methotrexate (MTX) combined with procarbazine and CCNU. To reduce neurotoxicity, whole-brain irradiation was reserved for patients not responding to chemotherapy. PATIENTS AND METHODS: High-dose MTX was applied on days 1, 15, and 30, procarbazine on days 1-10, and CCNU on day 1. Study treatment comprised up to three 45-day cycles. There was no lower limit of Karnofsky performance status (KPS). RESULTS: Thirty patients with PCNSL (n = 29) or primary ocular lymphoma (n = 1) were included (median age 70 years, range 57-79 years). The median initial KPS was 60% (range 30%-90%). Best documented response in 27 assessable patients were 12 of 27 (44.4%) complete remissions, 7 of 27 (25.9%) partial remissions, and 8 of 27 (29.6%) disease progressions. Two patients died of probable treatment-related causes. With a median follow-up of 78 months (range 34-105), the 5-year overall survival is 33%. Eight of 30 patients (26.7%) are currently alive and well, six without signs of leukoencephalopathy. CONCLUSION: The combination of high-dose MTX with procarbazine and CCNU is feasible and effective and results in a low rate of leukoencephalopathy. Comorbidity and toxicity remain of concern when treating PCNSL in elderly patients.

Thalidomide in consecutive multiple myeloma patients: single-center analysis on practical aspects, efficacy, side effects and prognostic factors with lower thalidomide doses.

PURPOSE: In this single-center analysis, we assessed whether lower thalidomide doses are feasible and result in favourable treatment response in multiple myeloma (MM) patients. RESULTS: Between May 2001 and October 2006, 38 consecutive MM patients received thalidomide. Their median age was 62.4 yr, all had stage II/III MM and 31.6% had deletion 13q14 (del13q14). Prior to thalidomide, patients had received a median of two treatment lines. The median thalidomide dose was 100 mg/d (range 50-800) and the median treatment duration was 34 wk. The median cumulative thalidomide dose was 24 g. Sixteen patients received thalidomide as a single agent and 22 in combination (+dexamethasone n = 18; others n = 4). The median time-to-treatment failure (TTF) after thalidomide initiation was 30.4 wk. Analysis of prognostic factors showed a significantly prolonged TTF without del13q14 (38.1 vs. 8.9 wk with del13q14; P = 0.006). Our analysis of TTF between thalidomide given alone vs. in combinations showed a better TTF for the combination (23.6 vs. 30.6 wk), albeit not reaching significance (P = 0.20). Other parameters, such as age, stage, and prior SCT showed no difference in TTF. Peripheral polyneuropathy (PNP) frequencies were increased with longer (>28 wk) and increased cumulative thalidomide doses (>40 g), which emphasizes (a) the need to carefully escalate thalidomide from 50 to 200 mg/d, thereby reducing side effects and increasing patient compliance, and (b) that PNP occurs more frequently with longer and higher thalidomide doses. CONCLUSION: The strategy to lower thalidomide doses seems a feasible and attractive approach in MM patients, this being currently tested in prospective randomized trials.

The use of imperfect diagnostic tests had an impact on prevalence estimation.

OBJECTIVE: Problems arising with the estimation of sensitivity and specificity when two imperfect diagnostic tests are applied are widely discussed. Effects on the estimation of prevalence may be of importance as well. Different methods of dealing with two or more imperfect tests and unknown reference standard are contrasted with regard to their implications on prevalence estimation: discrepant analysis, composite reference standards, and latent class models. STUDY DESIGN AND SETTING: Prospective epidemiological multicenter study to determine the prevalence of respiratory syncytial virus in children with lower respiratory tract infections. A subsample of 1,003 patients from a hospital population and from a practice population is considered. Virus isolation, polymerase chain reaction, and rapid antigen test had been applied. RESULTS: Prevalence estimates obtained under various assumptions ranged from 0.263 to 0.386 in the hospital population and from 0.214 to 0.277 in the practice population. CONCLUSION: Estimation procedures involving a resolver test applied to some but not all cells are at risk of introducing a serious bias in prevalence estimation as well as in the estimation of test accuracy parameters. Estimation via latent class modeling may be more useful, but care should be taken regarding the underlying assumptions.

High-dose chemotherapy and autologous peripheral blood stem cell transplantation in adult patients with high-risk or advanced Ewing and soft tissue sarcoma.

PURPOSE: Despite the availability of combined-modality treatment for Ewing sarcoma (ES) and soft tissue sarcomas (STS), results from independent groups still indicate a poor prognosis for high-risk and metastasized patients. The benefit of high-dose chemotherapy (HDCT) with autologous peripheral blood stem cell transplantation (ASCT) as compared to standard treatment is not defined. METHODS: Here, we report of HDCT in 35 consecutive adult patients with poor-risk ES or rhabdomyosarcoma (n = 11) and STS (n = 24) undergoing ASCT between July 1992 and March 2003. At a median follow-up of 100.6 months after ASCT, 11 patients are alive, with nine in sustained complete remission (CR) and each one in partial remission (PR) and stable disease. Median overall survival (OS) from ASCT was 17.1 months. Response to pretreatment, Karnofsky index > 80%, R (0) resection and first-line ASCT were associated with long-term OS (p < 0.05). CONCLUSION: These data indicate that (1) patients achieving a CR or PR following induction, with preserved performance status and R (0) resection may benefit from ASCT and (2) that this can be an useful therapeutic modality in a subset of patients, in some achieving remarkable responses.

High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group.

To investigate safety and efficacy of high-dose chemotherapy followed by autologous stem cell transplantation (HCT-ASCT) in relapsed/refractory (r/r) primary central nervous system lymphoma (PCNSL), we conducted a single-arm multicentre study for immunocompetent patients (<66 years) with PCNSL failing high-dose methotrexate)-based chemotherapy. Induction consisted of two courses of rituximab (375 mg/m2), high-dose cytarabine (2 × 3 g/m2) and thiotepa (40 mg/m2) with collection of stem cells in between. Conditioning for HCT-ASCT consisted of rituximab 375 mg/m2, carmustine 400 mg/m2 and thiotepa (4 × 5 mg/kg). Patients commenced HCT-ASCT irrespective of response after induction. Patients not achieving complete remission (CR) after HCT-ASCT received whole-brain radiotherapy. Primary end point was CR after HCT-ASCT. We enrolled 39 patients; median age and Karnofsky performance score are 57 years and 90%, respectively. About 28 patients had relapsed and 8 refractory disease. About 22 patients responded to induction and 32 patients commenced HCT-ASCT. About 22 patients (56.4%) achieved CR after HCT-ASCT. Respective 2-year progression-free survival (PFS) and overall survival (OS) rates were 46.0% (median PFS 12.4 months) and 56.4%; median OS not reached. We recorded four treatment-related deaths. Thiotepa-based HCT-ASCT is an effective treatment option in eligible patients with r/r PCNSL. Comparative studies are needed to further scrutinise the role of HCT-ASCT in the salvage setting.

High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study).

To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2 days 2, 16, 30), procarbazine (60 mg/m2 days 2-11) and lomustine (110 mg/m2, day 2)-R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3%; R-MP 34.9%; R-MPL 38.8%) and overall survival (All 47.0%; R-MP 47.7%; R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.

Evaluation of immunomodulatory treatment based on conventional and lineage-specific chimerism analysis in patients with myeloid malignancies after myeloablative allogeneic hematopoietic cell transplantation.

Both conventional chimerism analysis (CCA) and lineage-specific chimerism analysis (LCA) have potential pitfalls as diagnostic means for the detection of minimal residual disease after allogeneic hematopoietic cell transplantation (aHCT). Therefore, the present study examines the results of both methods in order to determine how predictive consecutive evaluations were, with respect to the risk that the patient would relapse during post-transplant follow-up and with respect to responsiveness to immunomodulatory treatment. A total of 168 individuals with acute myeloid leukemia (AML) (n = 137) and myelo dysplastic syndrome (n = 31) were investigated with CCA and LCA at mean intervals of 24 days (range: 11-116). The median follow-up after myeloablative aHCT was 22 months (range: 4-49). Of 168 patients, 65 experienced a clinical relapse after aHCT. CCA and LCA were comparatively sensitive and specific for relapse at the intervals of chimerism testing employed in this study. Of 32 patients, 10 who were offered donor lymphocyte infusions (DLI) treatment for increasing (n = 29) or stable (n = 3) mixed chimerism (MC) achieved at least transitory CC. The observation that all patients with increasing MC relapsed despite DLI treatment (54%) or withdrawal of immune suppression (24%) indicates that novel strategies to deal with rapidly evolving relapse in AML patients, such as shortening of chimerism monitoring intervals, need to be evaluated.

Independence and health related quality of life in 200 onco-geriatric surgical patients within 6 months of follow-up: Who is at risk to lose?

AIMS: Comprehensive Geriatric Assessment (CGA) provides information on aspects of older patients to predict risks and benefits of interventions. METHODS: To evaluate the application of CGA (including quality of life (QOL)) for the risk prediction of postoperative dependence and QOL in elderly patients with malignant tumours, a prospective observational study including 200 patients >70 years was performed. The primary outcome was postoperative activities of daily living (ADL < 95), secondary outcome was QOL at 6 months. Multivariate regression was performed to assess the impact of associated factors (socio-demographic, clinical, functional, cognitive variables, resilience, and EORTC-QLQ-C30 QOL). RESULTS: Median age of patients was 75 (70-88) years with 69% males. The majority of operations was for colon carcinoma; morbidity was 24.8%, mortality 1.5%. Impairment in ADL (<95) affected 6.7% (13/195) pre-, and 9.7% (12/124) post-operatively. Analyzing factors predicting loss of ADL, the following reached significance: BMI (OR: 1.7; p = 0.019), ADL (OR: 0.67; p = 0.0317), and of the QLQ-C30: diarrhea (OR: 1.04; p = 0.013), emotional functioning (OR: 0.91; p = 0.0242), physical functioning (OR: 0.92; p = 0.027). QOL paralleled ADL (pre-op: 65.4 to 67 postoperatively, respectively); predictive were: Karnofsky Index (Parameter Estimate (PE): 0.55; p = 0.0003) and (QLQ-C30) emotional functioning (PE: 0.14; p = 0.0208). CONCLUSIONS: Those considered for oncologic surgery can be assured that few lose independence. CGA/QOL highlight signs of vulnerability and options for pre-habilitation. Registries including a minimal CGA data set will make pre-selections reproducible and objectify risk/benefit estimations - relevant for those withheld from potentially curative surgery.