Health status and infections in patients with symptomatic primary and secondary immunoglobulin G (IgG) deficiencies receiving intravenous IgG replacement.

BACKGROUND: The effects of intravenous immunoglobulin G replacement on perceived health and infection susceptibility of patients suffering from immunoglobulin G (IgG) deficiencies should be evaluated in a prospective analysis. METHODS: Patients with symptomatic primary or secondary IgG deficiencies were interviewed prior to the first IgG infusion (t0) and over the course of their treatment (t1 - t6). The respondents rated their current health using a 100 point scale (EQ-5D-5L), ranging from 0 ('worst imaginable health') to 100 ('best imaginable health'). The patients also provided information on the frequency of infections and of infections requiring antibiotics in the past 8 weeks. A healthy control group (CG) without oncologic diseases answered the questions once. RESULTS: One hundred six patients with a median age of 65 years (21-85 years) were investigated. The median serum IgG concentration changed from 500 mg/dl (t0) to 772 mg/dl (t6). The mean number of infections and of infections requiring antibiotics decreased during IgG replacement significantly. Current health according to EQ-5D-5L improved from 57 (t0) to 68 (t6), compared to 73 in the CG. CONCLUSION: During the course of IgG replacement patients reported fewer and less severe infections. Their health assessment improved but still was inferior to the healthy CG.

High adherence of patients with multiple myeloma who receive treatment with immunomodulatory drugs (IMIDS) in hematology/oncology group practices in Germany.

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.

Metastatic Breast Cancer: Prolonging Life in Routine Oncology Care.

Overall survival (OS) of patients with metastatic breast cancer (MBC) has improved within controlled clinical trials. Whether these advances translate into improved OS in routine care is controversial. We therefore analyzed retrospectively unselected female patients from five oncology group practices and one university outpatient clinic, whose initial diagnosis of MBC was between 1995 and 2022. A total of 1610 patients with a median age of 63 years (23-100) were evaluated. In all, 82.9% had hormone-receptor-positive disease, and 23.8% were HER2-positive. Evaluation in time cohorts by initial MBC diagnosis date showed a continuous prolongation of median OS from 31.6 months (0.5-237.3+) (1995-2000) to 48.4 months (0.4-61.1+) (2018-2022) (p = 0.003). Univariable analyses showed a significant dependence on the time cohort of diagnosis, metastatic status at initial diagnosis, age at metastasis, hormone and HER2 status, general condition, metastasis localization, and the number of affected organs. A multivariable analysis revealed a significant dependence of survival probability on receptor status, general condition, and number of metastatic sites, as well as the time between initial breast cancer diagnosis and the diagnosis date of MBC in months. In sum, OS of patients with MBC has improved continuously and significantly in routine care over the last 27 years.

Successful Evidence-Based Treatment of Patients with Advanced Pancreatic Cancer in Community-Based Oncology Group Practices.

BACKGROUND: Randomized clinical trials do not reflect the day-to-day reality of patient care; hence, the treatment of patients with advanced pancreatic cancer in oncology group practices was evaluated. PATIENTS AND METHODS: All consecutive patients with advanced pancreatic cancer who were treated between 01/2012 and 12/2015 in 4 oncology group practices were analyzed retrospectively using SPSS software. RESULTS: 324 patients with a median age of 70 years (range 32-94 years) were analyzed. The majority were male (56%) and had distant metastases (74%). Chemotherapy was the major modality of treatment (86%) with a median overall survival (OS) of 33.3 weeks (range 1.7-245.4 weeks). Chemotherapy significantly (p < 0.001) improved OS in comparison to best supportive care only (37.6 vs. 13.9 weeks). Patients with locally advanced disease had a better prognosis compared to patients with metastases (median OS 49.6 vs. 30.4 weeks; p < 0.001). An age-adjusted Charlson comorbidity score of ≥ 9 was found to influence the OS significantly (p = 0.004). CONCLUSION: Chemotherapy remains the main modality of treatment for patients with advanced pancreatic cancer with an OS comparable to prospective randomized trials. The OS of this patient cohort has remained the same over the last 20 years despite advances in treatment modalities.

Dermatux: phase IV trial of Cetuximab plus FOLFIRI in first-line metastatic colorectal cancer receiving a pre-defined skin care.

PURPOSE: Cetuximab-induced skin rash Gd3+ occurs in ≥16% patients (pts) (Heinemann et al., Lancet Oncol 15(10):1065-1075, 2014; Van Cutsem et al. J Clin Oncol 27(19):3117-25; 2009b). Survival, response, and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline. METHODS: This is a national, multicenter, phase 4, first-line mCRC (K-RAS wt) trial. Pts received irinotecan 180 mg/m² (d1), FA 400 mg/m² (d1), 5-FU 400 mg/m² (d1), 5-FU 2400 mg/m² (d1-2), and cetuximab [400 mg/m² (d1), and then 250 mg/m² qw], prophylactic 0.1% vitamin K1 ointment qd, and oral doxycycline 100 mg bid. PRIMARY OBJECTIVE: 1-year PFS rate; secondary objectives: skin side-effects (grade, onset), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) time, and overall survival (OS) time and safety. RESULTS: Twenty centers recruited 55 patients. Recruitment started Q1 2011 and ended Q3 2013 due to slow accrual. Characteristics were in line with CRYSTAL trial except for age and colonic location. 1-year PFS rate was 25.9%, mOS 21.8 months (m), and mPFS 8.5 m. ORR was 63.0%, DCR 77.8%. Rash Gd2+ occurred in 42.6% [median onset was 4.0 weeks (w)]; paronychia Gd2+ occurred in 22.2% (median onset 15.4w.); skin fissures Gd2+ occurred in 31.5% (median onset 19.9 weeks) 7% pts abandoned cetuximab treatment due to toxicity. CONCLUSION: Our data reveal encouraging improvements in skin reactions and their time to occurrence due to a pre-defined skin care.

Standard of care of patients with Chronic Myeloid Leukemia (CML) treated in community based oncology group practices between 2001-2015 in Rhineland- Palatinate (Germany)

Background: The aim of this study was to assess retrospectively treatment and outcome of CML-patients in community based oncology practices in Germany and whether European LeukemiaNET (ELN) recommendations were followed. Method: All Ph+, BCR-ABL1+ CML-patients who were treated between 11/2001 and 12/2015 in nine oncology group practices were analyzed retrospectively. Results: Two hundred sixty patients with a median age of 60 (18­90) were analyzed. 254 (98%) were in chronic phase, 5 (2%) in accelerated and 1 (0.4%) in blast crisis. 248 patients (95%) received some form of TKI-therapy. 1st line TKI was imatinib in 197 patients (79%), 51 (21%) received a second generation TKI. 75% of TKI-therapies were monitored by PCR. Overall survival after 10 years according to Charlson comorbidity index (CCI) was: CCI 2: 100%; CCI 3­4: 83%; CCI 5­6: 52%; CCI ≥7: 39%. More patients died from comorbidities (8%) than from CML (5%). Whether patients died was strongly correlated to CCI at diagnosis: CCI 2: 3% of patients died, CCI 3­4: 16% of patients died, CCI 5­6: 38% of patients died, CCI ≥ 7: 42% of patients died. Conclusion: CML-patients treated in oncology group practices receive standard of care as recommended by ELN. Overall survival in routine care is comparable to international studies. Molecular monitoring should be improved (AU)