Anemia diagnosis and therapy in malignant diseases: implementation of guidelines-a representative study.

PURPOSE: Anemia in cancer should be diagnosed and treated according to guideline recommendations. The implementation of ESMO and German guidelines and their effect on anemia correction was analyzed. METHODS: This retrospective epidemiological study, representative for Germany, analyzed data on anemia management of cancer patients with anemia ≥ grade 2. The Guideline Adherence Score (GLAD) for diagnosis (GLAD-D) and therapy (GLAD-T) was defined as follows: 2 points for complete, 1 point for partial, 0 point for no adherence. RESULTS: Data were analyzed for 1046 patients. Hb levels at diagnosis of anemia were 8-10 g/dL in 899 (85.9%) patients, 7-8 g/dL in 92 (8.7%), and < 7 g/dL (5.0%) in 52. Transferrin saturation was determined in 19% of patients. Four hundred fifty-six patients received RBC (43.6%), 198 (18.9%) iron replacement, 106 (10.1%) ESA, and 60 (5.7%) vitamin B12 replacement. 60.6% of patients receiving iron replacement were treated intravenously and 39.4% were treated orally. Two hundred eighty-eight (36.6%) of 785 patients receiving transfusions had no guideline-directed indication. GLAD-D was 2 in 310 patients (29.6%), 1 in 168 (16.1%), and 0 in 568 (54.3%). GLAD-T was 2 in 270 patients (25.8%), 1 in 320 patients (30.6%), and 0 in 456 patients (43.6%). Higher GLAD-D significantly correlated with higher GLAD-T (τB = 0.176, p < 0.001). GLAD-T 2 was significantly associated with greater Hb increase than GLAD-T 0/1 (p < 0.001) at 28 days (10.2 vs. 9.7 g/dL) and at 2 months (10.4 vs. 9.9 g/dL). CONCLUSIONS: Anemia assessment is inadequate, transfusion rates too high, and iron and ESA therapy too infrequent. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05190263, date: 2022-01-13.

Quality of therapy in early ovarian cancer: results of the quality assurance program of the AGO Study Group.

OBJECTIVE: The quality assurance program for ovarian cancer (QS-OVAR) evaluates the implementation of treatment standards and impact on survival for International Federation of Gynecology and Obstetrics (FIGO) stage I ovarian cancer. METHODS: Patients with a first diagnosis of ovarian cancer, diagnosed in the third quarter of 2004, 2008, 2012, and 2016, were documented. Surgical quality was categorized as optimal (maximum one surgical item missing) versus suboptimal (≥2 surgical items missing). Chemotherapy was defined as optimal according to national guidelines. Treatment quality was classified into four categories: surgery and chemotherapy were optimal, optimal surgery and suboptimal chemotherapy, suboptimal surgery and optimal chemotherapy, and surgery and chemotherapy were suboptimal. RESULTS: In total, 19.9% (n=700) of ovarian cancer patients were diagnosed with FIGO stage I. Median age was 60 years (range 18-96), 47.1% had FIGO stage IA and 47.9% had stage IC, with 37.1% high grade serous histology. Optimal surgical quality increased over time from 19.9% to 54.1%. The optimal surgery population increased from 42.2% to 70.9%. Disease free survival improved significantly in the optimal surgery population (84% after 48 months vs 71% in the suboptimal surgery population). Overall survival increased with 91% after 48 months in the optimal surgery population versus 76% in the suboptimal surgery population. In total, 20.7% of patients were undertreated concerning systemic treatment and 1% overtreated. Optimal chemotherapy standard was administered increasingly over time (71.4-80.8%). Disease free survival and overall survival were prolonged with adjuvant chemotherapy. The optimal surgery/chemotherapy subgroup increased from 37.9% to 54.1% with significantly longer disease free survival and overall survival (overall survival at 48 months: optimal surgery and chemotherapy 93%; suboptimal surgery and chemotherapy 68%). CONCLUSION: Although QS-OVAR data showed that the quality of therapy has improved over the years, not all surgical standards were met in nearly 50% of patients. The steady increase in the optimal surgery and chemotherapy collective is an important tool for improvement of prognosis of ovarian cancer patients.

Immunoglobulin substitution in patients with secondary antibody deficiency in chronic lymphocytic leukemia and multiple myeloma: a representative analysis of guideline adherence and infections.

INTRODUCTION: In secondary immunodeficiency, immunoglobulin replacement therapy (IgRT) is recommended by guidelines (GL) for patients with IgG level < 4 g/l and more than 3 infections or a severe infection. IgRT may be appropriate if IgG level < 4 g/l and/or 1-3 less severe infections (≤ grade 2). METHODS: This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analyzed. RESULTS: Data from 1086 patients (CLL 490, MM 596) were collected from 86 centers. Of all patients, 34.8% developed IgG deficiency during therapy (CLL 35.5%; MM 34.2%). IgRT was given in 23.5% of CLL and 14.4% of MM patients. GLAD in hypogammaglobulinemia and indication to IgRT was 23.3% of 86 CLL and 22.1% of 77 MM patients. Without GLAD, the hazard ratio (HR) for any infection was 4.49 (95% CI 3.72-5.42; p < 0.001) and for severe infections (grade ≥ 3) 10.64 (95% CI 7.54-15.00; p < 0.001). Significant independent risk factors for infections were a higher Charlson Comorbidity Index, IgG deficiency, and 3rd + line treatment, as well as therapy with BTK inhibitors or chemotherapy in CLL. Multivariable analysis showed a significantly lower risk of severe infections after start of IgRT with a HR of 0.47 (95% CI 0.28-0.77; p = 0.003). CONCLUSIONS: Guideline adherence correlated with fewer and less severe infections but was low in patients with indication to IgRT. Risk factors for infection can be identified. Risk of severe infections was significantly lower in patients with IgRT.

Guideline adherence in bone-targeted treatment of cancer patients with bone metastases in Germany.

PURPOSE: To assess adherence to the current European Society for Medical Oncology (ESMO) clinical practice guideline on bone health in cancer patients and the German guidelines for lung, breast, and prostate cancer among German oncologists in hospitals and office-based physicians and to identify predictors of guideline compliance to assess the needs for dedicated training. METHODS: This was a retrospective sample analysis representing hospitals and office-based physicians in Germany in 2016. Records from lung, breast, and prostate cancer patients who had received a diagnosis of bone metastasis between April 1, 2015, and March 31, 2016, were included. Oncologists at participating centers answered a self-assessment survey on aspects related to their professional life, including guideline adherence and years of clinical experience in medical oncology. Guideline adherence rates were assessed from patient records. Treatment variables and survey data were used to identify predictors of guideline compliance in a Classification and Regression Tree (CART) analysis. RESULTS: Disregarding recommendations for supplementation of calcium and vitamin D, guideline adherence among physicians treating lung, breast, or prostate cancer patients was 62%, 92%, and 83%, respectively. Compliance was 15%, 42%, and 40% if recommendations for dietary supplements were taken into account. Identified predictors of guideline compliance included treatment setting, medical specialty, years of professional experience, and frequency of quality circle attendance. CONCLUSIONS: Compliance with the ESMO and the German guidelines in cancer patients varies between medical specialties. In particular, patients with lung cancer and bone metastases often do not receive the recommended osteoprotective treatment and required supplementation. Discrepancies between guideline recommendations and common practice should be addressed with dedicated training.

G-CSF guideline adherence in Germany, an update with a retrospective and representative sample survey.

BACKGROUND: Current guidelines (GL) recommend neutropenia prophylaxis with G-CSF after chemotherapy (CTX) for patients with high (≥ 20%), or, if additional risk factors are present, intermediate (≥ 10-20%) risk of febrile neutropenia. The first sample survey in 2012 (NP1) showed lack of GL adherence. The aim of this second sample survey was to evaluate if GL adherence and implementation have improved. METHODS: The sample size represented 1.0% of the incidences of lung and 1.1% of breast cancer in Germany in 2010. Data of patients with a febrile neutropenia (FN) risk ≥ 10% who had received at least 2 cycles of chemotherapy between October 2014 and September 2015 was surveyed retrospectively. RESULTS: Data from 573 lung cancer (LC) and 801 breast cancer (BC) patients was collected from 109 hospitals and 83 oncology practices with 222 physicians participating. Compared with the NP1 survey, GL adherence increased in LC and FN high-risk (HR) chemotherapy from 15.4 to 47.8% (p < 0.001), and in FN intermediate-risk (IR) chemotherapy from 38.8 to 44.3% (p = 0.003). In BC and FN-HR chemotherapy, GL adherence was unchanged: 85.6% vs. 85.1% (p = 0.73) but increased in FN-IR from 49.3 to 57.8% (p < 0.001). In all IR CTX cycles, there are also no significant differences in GL adherence between the first (51.3%) and subsequent cycles (51.1%; p = 0.948). In LC patients treated in certified or comprehensive cancer centers, the GL adherence in FN-HR chemotherapy was 53.0% vs. 44.9% in other centers (p = 0.295); in FN-IR chemotherapy, it was 45.1% vs. 43.8% (p = 0.750). In BC with FN-HR chemotherapy, GL adherence in certified or comprehensive centers was 85.4% vs. 84.7% in other institutions (p = 0.869); in FN-IR chemotherapy, it was 60.2% vs. 55.0% (p = 0.139). GL adherence in FN-HR chemotherapy and in FN-IR chemotherapy differed between pulmonologists and hematologist-oncologists (FN-HR: 25.0% vs. 43.6%, p < 0.001; 38.1% vs. 48.6%, p < 0.001). Comparing gynecologists with hematologist-oncologists, GL adherence in FN-HR chemotherapy was 86.2% vs. 82.5%. In FN-IR chemotherapy, GL adherence by gynecologists and hematologist-oncologists was 58.6% and 55.6%, respectively (p = 0.288; p = 0.424). Classification and regression tree analysis split pulmonologists and other specialists, with the latter adhering more to GL (p < 0.001). Hematologist-oncologists and gynecologists with more than 2 years of professional training in medical cancer therapy adhered more closely to GL than others (68.7% vs. 46.2%, p < 0.001). Pulmonologists attending ≥ 2 national congresses annually adhered more to guidelines than other pulmonologists (44.8% vs. 24.3%, p < 0.001). CONCLUSIONS: Adherence to G-CSF GL in Germany has increased but is still insufficient. Certified and comprehensive cancer centers show a higher rate of GL implementation. In GL adherence, there is still a disparity between cancer types and between oncology treatment specialists.