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Objective: To investigate the association between serum immunoglobulin G (IgG) concentrations and the incidence of infections in patients with chronic lymphocytic leukemia (CLL) and secondary immunodeficiency receiving treatment with Privigen., Materials and Methods: Data was analyzed from a non-interventional study conducted in 31 centers in Germany and 1 in Austria. Adult CLL patients with hypogammaglobulinemia and recurrent infections were allowed to enter the study upon signing informed consent, if a prior decision for treatment with Privigen had been made. All infections requiring an antimicrobial treatment were subject to analysis. Patients were stratified according to their mean post-baseline serum IgG trough levels in a group with lower IgG trough levels (≤ 5.0 g/L), and a group with higher IgG trough levels (> 5.0 g/L)., Results: Overall, 89 patients and 840 treatment cycles were analyzed. Up to 11 treatment cycles (average duration 29 days) were documented in each patient. In the group with higher IgG trough levels (> 5.0 g/L, N = 72), significantly fewer infections were observed than in the group with lower IgG trough levels (≤ 5.0 g/L, N = 17), including fewer severe and serious infections. The Privigen dosage was a major determinant of the post-baseline serum IgG levels. Overall tolerability of Privigen was assessed as very good or good in 91% of patients., Conclusion: This analysis confirms the association of serum IgG trough levels with the incidence of infections and highlights the importance of careful monitoring of IgG levels during treatment of secondary immunodeficiencies in CLL patients.

Clinical trials in chronic myeloid leukemia (CML) are usually carried out in specialized centers whereas primary care for patients (pts) with CML is mainly provided by local oncology practices. The aim of this study was to assess treatment practices in pts with CML in the setting of private oncology practices in Germany. We collected data of 819 pts with a confirmed diagnosis (dx) of CML in 2013 or later from 43 practices. At dx, 84.2% (n=690) and 9.4% (n=77) of pts were in chronic or accelerated phase, 0.7% (n=6) had a blast crisis. Molecular monitoring was provided by EUTOS certified laboratories in 87.7% of pts. Typical BCR::ABL1 transcripts were detected in 86.6% (n=709). Molecular response was assessed after 2.8, 6.0, 9.4 and 12.9 m (mean) after start of treatment. Of the pts with available data, 11.1% did not achieve early molecular response and at 18 m, 83.7% had at least a major molecular response. 288 (35.2%) of pts switched to 2 nd line (2L) treatment after a mean of 21.0 months. Reasons for 2L treatment were side effects in 43.4% and suboptimal response or failure in 31.4% of pts. 106 pts went on to third line (3L) treatment. 36.8 % of pts switched to and 92.8 % of pts still on 3L treatment achieved BCR::ABL1 IS ≤1% at 12 m. In conclusion, in Germany pts with CML are routinely monitored by qPCR and good responses are achieved in the majority. Treatment changes are mainly due to adverse events rather than suboptimal responses., (© 2024. The Author(s).)

Objective: Many preference-sensitive decisions have to be made in breast cancer care and little is known about the decision-making processes between breast cancer patients and the different health care professionals engaged in their treatment., Methods: All female breast cancer patients who underwent surgery in four German breast centers between 07/2016 and 12/2018 were invited to fill in a survey. The decision-making process was evaluated using the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and a German measure to assess satisfaction with care (ZAPA). The higher the total score (0-100), the higher the experienced degree of participation and satisfaction, respectively. Participants were asked to separately rate consultations with their inpatient hospital doctors, outpatient gynecologists, outpatient oncologists and primary care providers. An overall mean score for the degree of participation and the satisfaction with care was calculated for each patient across all consultations assessed. Differences between the 4 treating physician groups were analyzed as well., Results: Of 1068 approached patients, 563 with a mean age of 62 and a standard deviation (SD) of 12.2 years filled in the survey (response rate: 53%). The overall SDM-Q-9 score was 73.8 (SD: 20.8). Older patients stated a higher level of participation than younger, different physician groups were rated quite similarly. Overall satisfaction with care was 87.4 (SD: 15.5)., Conclusions: Overall, patients reported to have experienced a high level of shared decision-making (SDM) and were quite satisfied with their treatment. However, we do not know whether non-responders might have had different experiences., (© 2022 John Wiley & Sons Ltd.)

Purpose: Immunomodulatory drugs (IMIDS) have changed the treatment and outcome of patients suffering from multiple myeloma. However, with the oral administration adherence becomes an issue. Since there is no "gold standard" in measuring adherence, we assessed the adherence of myeloma patients with the help of different data sources., Methods: All patients who have been receiving IMIDS for at least 3 months were eligible. Computer assisted personal interviews of patients and, if possible, their caregivers were carried out. Attending oncologists evaluated the patient's adherence with the help of a standardized questionnaire. In addition, a retrospective analysis of prescription data was conducted. All data were analyzed statistically using SPSS., Results: One hundred myeloma patients, 35% female, 65% male, with a median age of 70 years (37-86) were interviewed. Prescription data could be evaluated in terms of adherence in 78 patients (78%), 56 caregivers could be questioned (56%). Ninety-seven percent of patients rated themselves as adherent in taking IMIDS. Data from treating oncologists, caregivers and prescriptions supported this result. IMID therapies were rated as very effective and significant, toxicities were acceptable and dosing regimens simple/uncomplicated., Conclusions: Myeloma patients seem to be highly adherent to IMID treatments.

Background: Brain metastases (BMs) have a major impact on life expectancy and quality of life for many breast cancer patients. Knowledge about treatment patterns and outcomes is limited., Methods: We analysed clinical data of 1712 patients diagnosed with BMs from breast cancer between January 2000 and December 2016 at 80 institutions., Results: Median age at diagnosis of BMs was 56 years (22-90 years). About 47.8% (n = 732) of patients had HER2-positive, 21.4% (n = 328) had triple-negative and 30.8% (n = 471) had hormone receptor (HR)-positive, HER2-negative (luminal-like) primary tumours. The proportion of patients with HER2-positive BMs decreased comparing the years 2000-2009 with 2010-2015 (51%-44%), whereas the percentage of patients with luminal-like tumours increased (28%-34%; p = 0.0331). Patients with BMs in the posterior fossa were more often HER2 positive (n = 169/314, 53.8%) than those diagnosed with triple-negative (n = 65/314, 20.7%) or luminal-like primary breast cancer (n = 80/314, 25.5%), (p < 0.0001). Median overall survival (OS) time after development of BMs for the overall cohort was 7.4 months (95% confidence interval [CI]: 6.7-8.0 months). One-year survival rate was 37.7% (95% CI: 35.2-40.1). Patients with HER2-positive tumours had the longest median OS of 11.6 months (95% CI: 10.0-13.4) compared with 5.9 months (95% CI: 5.0-7.2) for patients with luminal-like and 4.6 months (95% CI: 3.9-5.4) for patients with triple-negative tumours. Patients with HER2-positive tumours who received anti-HER2 treatment had longer median OS than those without (17.1 months versus 7.2 months, p < 0.0001)., Conclusions: Prognosis of patients after developing BMs varies significantly according to the subtype. The outcome in this cohort is similarly poor in triple-negative and HR-positive/HER2-negative patients. Our results underline the high medical need for improvement of treatment and prevention strategies for BMs in breast cancer patients., (Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Many women have symptoms of various kinds after being treated for breast cancer. It is unclear how frequently these different side effects of treatment arise., Method: All women who underwent surgery for breast cancer and subsequently received adjuvant systemic treatment in a single certified breast-cancer center from 2006 to 2010 were asked to fill out a standardized questionnaire. Medical data were retrieved from their charts and statistically analyzed together with the questionnaire responses. The questionnaire was also given to an age-adjusted control group., Results: 734 questionnaires were filled out and returned (response rate, 70%). The mean interval from the diagnosis of breast cancer to the time of response to the questionnaire was 38 months. The median age at time of response to the questionnaire was 65 years (range, 30 to 91 years). The distribution of UICC stages at the time of initial diagnosis was as follows: I 46%, II 42%, III 12%. 78% of the patients underwent breat conserving surgery, 85% had radio - therapy, 85% had antihormonal treatment, and 49% had chemotherapy. 91% were satisfied or very satisfied with the outcome of surgery. 34% reported operation site pain; 35% reported limitations of shoulder or arm function. Younger patients suffered from emotional sequelae more than older ones did. 25% reported a change in their relationship with their spouse. Before being diagnosed with breast cancer, 9% had consulted a psychiatrist or psychotherapist; after the diagnosis, 19% did. 14% had taken psychoactive medication before the diagnosis, and 26% did afterward., Conclusion: Treatment for breast cancer has negative physical, emotional, and social effects on many patients. They suffer these effects to varying degrees depending on age, type of surgery, and systemic treatment.

Background: Systematic evaluation of psychosocial distress in oncology outpatients is an important issue. We assessed feasibility and benefit of standardized routine screening using the Distress Thermometer (DT) and Problem List (PL) in all patients of our community-based hematooncology group practice., Patients and Methods: One thousand four hundred forty-six patients were screened between July 2008 and September 2008. Five hundred randomly selected patients were sent a feedback form., Results: The average distress level was 4.7, with 37% indicating a distress level >5. Patients with nonmalignant diseases (81% autoimmune diseases or hereditary hemochromatosis) showed the highest distress level of 5.2. Most distressed were patients who just learned about relapse or metastases (6.4), patients receiving best supportive care (5.4) and patients receiving adjuvant antihormonal therapy (5.4). Ninety-seven percent of patients appreciated to speak to their doctor about their distress. Fifty-six percent felt better than usual after this consultation., Conclusion: DT and PL are feasible instruments to measure distress in hematooncology outpatients receiving routine care. DT and PL are able to improve doctor-patient communication and thus should be implemented in routine patient care. The study shows that distress is distributed differently between individuals, disease groups and treatment phases., (© The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.)

Due to necessary selection criteria, the results obtained in clinical trials may not reflect the actual impact of current treatment options for unselected general populations. We analysed the treatment modalities and the outcome in 206 consecutive patients with advanced colorectal cancer who started treatment between 1/1999 and 11/2004. The median age of this cohort was 66 years (range 30-87) and 39 patients (19%) were ≥ 75 years old. First-line treatment consisted of low-dose bolus 5-fluorouracil and folinic acid regimens in 68 patients (33%), weekly 24-h 5-fluorouracil infusion and folinic acid in 36 patients (17%), weekly 24-h 5-fluorouracil infusion plus oxaliplatin or irinotecan in 60 patients (29%), capecitabine regimens in 22 patients (11%), monotherapy with oxaliplatin or irinotecan in six patients (3%) and other regimens in 14 patients (7%). A total of 166 patients (81%) received a second-line treatment and third-line chemotherapy was given to 122/206 patients (59%). With a minimum follow-up of 18 months, the median survival of the cohort is 21 months (range 1-85) and 17 months (range 3-57) for patients ≥ 75 years. We conclude that the increased survival seen in prospective studies can be transferred to routine care for unselected patients with advanced colorectal cancer., (© 2009 The Authors. European Journal of Cancer Care © 2009 Blackwell Publishing Ltd.)

Background: Little is known about the treatment reality in metastatic breast cancer (MBC) outside clinical trials. We undertook this analysis to evaluate the actual treatment reality for unselected patients with MBC in routine care., Patients and Methods: All patients with MBC, who were treated in our community-based group practice between 1995 and 2005, were analyzed retrospectively concerning prognostic factors, treatment, and survival., Results: 403 consecutive patients were evaluated with a median age of 60 years (range 32-93). Aromatase inhibitor therapy was used in 87% of all patients. 83% received chemotherapy with the median number of lines being 3 (1-15). An anthracycline was given to 49%, a taxane was used in 55%, vinorelbine in 42%, capecitabine in 36%, gemcitabine in 28%, and a platinum compound in 9%. 94% of patients with bone metastasis received a bisphosphonate, and 63% of HER-2/neu-positive patients were treated with trastuzumab. Median survival since the start of palliative therapy was 30 months. Statistical analysis revealed as major prognostic factors hormone receptor status and prevalence of only bone metastasis., Conclusions: Treatment reality of MBC in routine care reveals a prolonged median survival of 30 months which is probably due to the sequential use of the most effective treatment modalities., (Copyright 2009 S. Karger AG, Basel.)

Background: With regard to incidence, ovarian cancer has the highest mortality of all gynecologic cancers., Patients and Methods: The treatment of 139 consecutive patients with epithelial ovarian cancer who were treated in an oncology group practice in Koblenz, Germany between 1995 and 2003 was evaluated retrospectively., Results: The median age of the patients was 61 years (18-84). FIGO stages were distributed as follows: stage I 15.8%, stage II 12.9%, stage III 53.2%, stage IV 16.5%. 49 patients (35.5%) received surgical treatment at a university hospital or a teaching hospital. 89 patients (64.5%) were operated on in a local or district hospital. A macroscopically complete resection was achieved in only 15 patients (10.8%). The residual tumor was <1 cm in 50 patients (36%), >1 cm in 24 patients (17.3%), and >2 cm in 49 patients (35.5%). 93.3% of the patients received postoperative, platinum-based chemotherapy. Median survival since first diagnosis was 42 months (1-346(+)). The 5-year survival rate of the whole cohort was only 28%., Conclusions: Overall survival in epithelial ovarian cancer was significantly inferior in this patient cohort compared to the results of the FIGO report from 2003. One possible cause may be the suboptimal surgical treatment, with 52.8% of the patients having a postoperative residual tumor larger than 1 cm.

Background: Whenever possible, treatment of breast cancer should be performed in an outpatient setting, but only few data about patients being treated exclusively on an outpatient basis are available., Patients and Methods: A retrospective analysis was performed in 90 unselected patients who were treated consecutively in our oncology group practice between 6/95 and 8/99., Results: Median age at detection of metastases was 55 years (30-90) and performance status ranged from 0 to 2. 83 patients (92.2%) received chemotherapy, 7 (7.8%) received endocrine therapy only. CMF was used in 27.7%, anthracyclines in 71.1% and taxanes in 43.3%. 855 chemotherapy cycles were performed and the observed toxicity was mild. Reversible grade 3 and 4 hematotoxicity was seen after 27 cycles (3.2%). Neurotoxicity or mucositis grade 3 and 4 were seen in 6 patients (6.6%). Therapy-associated hospitalization occurred in 1 patient thrice due to febrile neutropenia. Complete remissions were seen in 5 patients (5.6%) during first-line therapy. Median survival of the whole cohort until the end of the follow-up period (2/03) was 28 months (2-259). Overall survival after 1, 2, 3 and 5 years was 83, 56, 33 and 18% respectively. 50% could die at home., Conclusions: Treatment of metastatic breast cancer can be performed with minimal toxicity and a high patient acceptance in the outpatient setting. Overall survival and median survival are comparable to historical results achieved in specialized academic hospitals. Hospitalization could be avoided in the majority of patients and half of them could die at home.