This phase II trial evaluated efficacy and tolerability of R-CHOP for up to 8 courses in Richter transformation (RT) and up to 6 courses in CLL plus autoimmune cytopenia (AIC) or high-risk (HR) features. HR was defined as fludarabine-refractoriness or early relapse (<36 months) after fludarabine-based treatment; 26 patients were included as HR, 19 patients had AIC, and 15 patients had RT. In the HR cohort, overall response rate was 54%, progression-free and overall survival were 9 and 21 months. In AIC patients overall response rate was 74%, progression-free and overall-survival were 10 and 41 months, respectively, and median increase in hemoglobin was 3.4 g/L. RT patients responded in 67%, progression-free was 10 and overall survival 21 months. The most common adverse events were hematologic toxicities in 92%. Severe infections occurred in 28%. Treatment was discontinued early in 45% of all patients mainly as a result of toxicity. This trial shows that R-CHOP has no role in treating complicated CLL. R-CHOP is associated with significant toxicities and fairly low efficacy compared with almost every other CLL-regimen. In RT, it might still be used as an induction therapy before allogeneic stem cell transplantation.

PurposeAlthough treatment for early breast cancer improved prognosis greatly, it can have significant long-term consequences, which must be considered during treatment decision.Methods453 patients with neoadjuvant or adjuvant treatment intention were recruited into the MaTox project within the prospective, multicentre, population-based German TMK cohort study (Tumour Registry Breast Cancer) between 2008 and 2009. Patient-reported outcomes (PROs) on 26 treatment-related symptoms were assessed via a specifically designed questionnaire at 4 weeks, 6 months, 18 months and 3 years after start of systemic treatment.ResultsThe results show that alterations in smell, taste and appetite were clearly improved 3 years after treatment. In contrast, post-surgical symptoms, restrictions in memory/attention, musculoskeletal system and polyneuropathy worsened substantially over time and were persistent after 3 years: 78% of the patients recorded impairment in memory, 73% muscle pain, 67% pain at the operated site and 57% paraesthesia in fingers or toes. A logistic regression model showed that risk factors for developing persistent paraesthesia symptoms were age, early paraesthesia symptoms and taxane-based therapy.ConclusionsOur data show that most patients with breast cancer have persistent impairments negatively influencing their daily life even 3 years after treatment. Furthermore, we highlight areas requiring special attention in follow-up care.Electronic supplementary materialThe online version of this article (doi:10.1007/s10549-017-4365-7) contains supplementary material, which is available to authorized users.

Background:An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory.Methods:Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m−2 plus vinorelbin 25 mg m−2 on days 1+8 (GemVin), or plus cisplatin 30 mg m−2 on days 1+8 (GemCis), or plus capecitabine 650 mg m−2 b.i.d. orally days 1–14 (GemCap), q3w. The primary end point was response rate.Results:A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ⩾grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand–foot syndrome in 2.0% of the GemCap patients (per patient analysis).Conclusions:This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.

A median number of two (range 1-7) BPV treatment cycles were given to the patients. The majority of the patients (n = 54; 69 %) responded after at least one cycle of chemotherapy with 3 CR, 10 nCR, 10 VGPR and 31 PR. Median PFS and OS for patients without severe hematological toxicities due to previous treatments (n = 45) were 11 and 50 months, respectively. Outcome for these patients was significantly better than that for patients with severe hematological toxicities (grade 3 or 4, n = 33) with a PFS, and OS of 3 months (p < 0.05) and 5 months (p < 0.001), respectively. The regimen was well tolerated with few significant side effects in patients without severe hematological toxicities due to previous treatments. These results indicate that the combination of bortezomib, bendamustine and prednisone is well tolerated in patients with relapsed or refractory MM.

Clinical research has resulted in an improvement of treatment options for patients with immune thrombocytopenia (ITP) over the last years. However, only few data exist on the real-life management of patients with ITP. To expand the knowledge, a multicenter, national survey was undertaken in 26 hematology practices distributed all over Germany. All patients with a diagnosis of ITP were documented using questionnaires, irrespective of the diagnosis date over a period of 2 years. Overall, data of 1023 patients were evaluated with 56% of patients being older than 60 years. Seventy-nine percent of the patients had chronic (> 12 months), 16% persistent (> 3–12 months), and 5% newly diagnosed (0–3 months) ITP. In 61% of cases, the disease lasted 3 or more years before survey documentation started. Main strategies applied as first-line therapy consisted of steroids in 45% and a “watch and wait” approach in 41% of patients. During second- and third-line strategies, treatment with steroids decreased (36% and 28%, respectively), while treatment modalities such as TPO-RAs increased (19% and 26%, respectively). As expected, patients with a low platelet count and thus a higher risk for bleeding and mortality received treatment (esp. steroids) more frequently during first line than those with a higher platelet count. Up to a third of patients were treated with steroids for more than a year. Overall, our study provides a cross-section overview about the current therapeutic treatment landscape in German ITP patients. The results will help to improve therapeutic management of ITP patients.