Community-based Oncology Group Practice Research Articles

Outpatient Management of Patients with Immune Thrombocytopenia (ITP) by Hematologists 1995-2014

Background: The aim of this study was to evaluate the treatment reality for outpatients with immune thrombocytopenia (ITP) managed by hematologists in routine care. Patients and Methods: All patients with ITP diagnosed between 06/1995 and 12/2014 in a community-based oncology group practice in Germany were retrospectively analyzed. Results: 422 patients with a median age of 55 years (range 7-91 years) were evaluated. 57% were female and 43% male. Only 198 (47%) patients needed therapy. First-line therapy (n = 198) consisted of steroids in 81%, intravenous immunoglobulins (IVIG) in 12%, and IVIG plus steroids in 6%. Patients received a median of 2 (range 1-10) lines of therapy. The most frequently used treatment modalities were steroids in 93%, IVIG in 55%, splenectomy in 21%, and other immunosuppressive agents (OISA) in 23% of patients. Rituximab and thrombopoietin receptor agonists (TRAs) were used in 10% and 6% only. 9 (2%) patients needed hospitalization due to bleeding complications. 72% of patients achieved a durable remission after their last line of therapy. 1 (0.2%) patient died due to bleeding complications. Conclusion: The treatment modalities most frequently used are steroids, immunoglobulins, splenectomy, and OISA. Rituximab and TRAs are only used infrequently. 72% of ITP patients achieve durable remissions. The rate of hospital admissions due to bleeding complications and the ITP-related mortality are low. The majority of ITP patients can be safely managed by hematologists on an outpatient basis.

Treatment Reality of Patients with Immune Thrombocytopenia (ITP) in Routine Care

Introduction: New treatment options like thrombopoietin receptor agonists (TRAs) and rituximab have been introduced into the clinic which have found their way into national and international treatment guidelines. The aim of this study was to answer the following questions concerning diagnosis and treatment of patients with ITP in routine care: 1.How are patients diagnosed and treated?2.Which sequences of therapy are applied?3.How many patients die due to bleeding complications?Methods: All patients with ITP diagnosed between 06/1995-06/2014 in a community-based oncology group practice in Germany were analyzed retrospectively.Results: 402 patients with a median age of 55 (7-90) were evaluated. 57% were female and 43% male. 357 (89%) were classified as primary ITP and 311 (77%) as having chronic ITP. In 234 patients (58%) a bone marrow biopsy was part of the diagnostic work up. Only 191 patients (48%) needed therapy. First line therapy (n=191) were steroids in 81%, intravenous immunoglobulins (ivIgG) in 12% and ivIgG plus steroids in 6%. Second line therapy (n=102) were ivIgG in 49%, steroids in 23%, ivIgG plus steroids in 17%, other immunosuppressive agents in 11% and splenectomy in 5%. Third line therapy (n=63) was splenectomy in 22%, other immunosuppressive agents in 27%, steroids in 19%, ivIgG in 16%, 11% combination therapy, rituximab in 10% and TRAs in 5%. Fourth line therapy (n=38) consisted of steroids in 26%, splenectomy in 26%, immunosuppressive agents in 34%, ivIgG in 13%, rituximab in 11% and TRAs in 3%. Patients received a median of 2 lines (1-10) of therapy. Treatment modalities most frequently used were steroids in 93%, immunoglobulins in 56%, splenectomy in 21% and other immunosuppressive agents in 21% of patients. Rituximab and TRAs were used in 10% and 5% only. 75% of patients received a durable remission (complete or partial) after their last therapy. 10% showed no response, in 15% remission couldn’t be evaluated due to external treatments. 146 patients (76%) are off treatment. 1 patient (0.2%) died due to bleeding complications.Conclusions: Bone marrow biopsy is used as a diagnostic procedure in 58% of patients. Treatment modalities most frequently used are steroids, immunoglobulins, splenectomy and other immunosuppressive agents. Rituximab and TRAs are used infrequently. A high percentage of ITP-patients achieve durable remissions and ITP-related mortality is low. DisclosuresNo relevant conflicts of interest to declare.

Metastatic breast cancer: prolongation of survival in routine care is restricted to hormone-receptor- and Her2-positive tumors.

18,000 women die due to metastatic breast cancer in Germany per year. Median survival is 20–28 months after diagnosis. The question we wanted to answer was whether survival has improved in routine care? For this purpose we conducted a retrospective analysis of all patients with metastatic breast cancer who were treated between 06/1995-06/2013 in a community-based oncology group practice in Germany. 716 patients were analyzed with a median age of 61 (31–93). Localizations of metastases were distributed as follows: 47% visceral, 36% bone, 9% lymphatic, 4% CNS, 4% others. 79% were hormone-receptor-positive, 20% Her2-positive, 9% triple-negative. Median overall survival was 34 months (95% Confidence Interval: 31–37), median disease-specific survival 36.8 months and disease-specific survival after 5 years 34%. Survival was significantly correlated with localizations of metastases, number of metastasized organs, disease free survival since initial diagnosis, hormone-receptor status and age. Patients with hormone-receptor-positive tumors had a median overall survival of 37 months, Her2-positive patients of 34 months and triple-negative patients of 13 months. 86% of hormone-receptor-positive patients received antihormonal therapy. 81% of Her2-positive patients received anti-Her2 therapy. In summary, longer survival is strongly restricted to hormone receptor- and Her2-positive tumors most likely due to targeted therapies directed against the estrogen-receptor and Her2.

Psychosocial Distress in Caregivers of Patients with a Metastatic Solid Tumor in Routine Care: A Survey in a Community Based Oncology Group Practice in Germany

Introduction: Psychosocial distress in caregivers of cancer patients is highly prevalent, particularly in advanced stages. Little data is available concerning extent and main issues of caregivers’ distress from patients who receive their treatment in an oncology group practice. Methods: Standardized cross-sectional survey was administered to caregivers and patients with a metastatic solid tumor who were treated in a community based oncology group practice. Patients provided information concerning their caregivers and level of distress. Caregivers assessed level and main issues of distress. The extent of distress was evaluated using the Distress Thermometer (DT), main issues of distress were evaluated by the Hospital Anxiety and Depression Scale (HADS-D). Results: 200 patients (35% male) with a median age of 68 (38 – 93) were interviewed. DT mean score was 4.7, with 35% scoring above cut-off (> 5). 90% named one or more caregiver, 1.3 were named in mean (0 – 4). 137 caregivers (42% male) with a median age of 61.5 (25 – 86) were interviewed. DT mean score was 5.4, with 48% scoring above cut-off (> 5). According to HADS-D 20% were anxious (cut-off >= 11) and 15% depressed (cut-off >= 9) in a clinical sense. With regard to the distress level of caregivers and patients, gender was not found to be a confounding variable although female patients showed higher distress levels than male patients. Conclusion: Caregivers are screened as highly distressed, sometimes even more than the patients themselves. A significant proportion seems to be anxious and depressed and therefore should be offered help.

P-157 Routine care reality of patients with myelodysplastic syndromes who received diagnosis and treatment in a community-based oncology group practice in Germany

P-157 Routine care reality of patients with myelodysplastic syndromes who received diagnosis and treatment in a community-based oncology group practice in Germany

Improved Survival of HER2-Positive Metastatic Breast Cancer in Routine Care

Purpose: Targeted therapy directed against HER2 has improved the outcome of patients with HER2-positive metastatic breast cancer in prospective clinical trials. No data are available how anti-HER2-therapy has influenced survival of unselected patients with HER2-positive metastatic breast cancer who receive treatment in routine care. Methods: Data of 118 subsequent patients with HER2-positive metastatic breast cancer who were treated in a community-based oncology group practice between 1995 and 2010 were analyzed retrospectively. Results: Median age at initial diagnosis of metastasis was 58 years (33-92). Twenty-two percent were metastasized at diagnosis of breast cancer, seventy-eight percent developed metastases in the course of the disease. Distribution of metastatic sites at initial diagnosis of metastasis was: 23% bone, 58% visceral, 5% CNS, 10% lymph nodes, 4% other. Hormone receptor was positive in 68% and negative in 31%. Palliative treatment consisted of antihormonal therapy in 56%, chemotherapy in 90% and radiotherapy in 50%. Seventy-five percent received anti-HER2-therapy consisting of trastuzumab in 80% and lapatinib in 1%, 19% received trastuzumab + lapatinib sequentially. Twenty-five percent received no anti-HER2-therapy. Median overall survival since initial diagnosis of metastasis was 34 months (0-277+). Conclusion: It could be shown that, compared to historical controls, targeted therapy against HER2 prolongs overall survival of patients with HER2-positive metastatic breast cancer who receive treatment in routine care.

Identifying Caregivers and Their Meaning for Patients with Metastatic Solid Tumours in Routine Care: A Survey at a Community-Based Oncology Group Practice in Germany

Purpose: To determine the importance of different contact persons for patients with metastatic solid tumours treated in a community-based oncology group practice. Methods: Psychosocial distress was measured between 04-07/2009 using the distress thermometer and problem list. All patients were asked 3 questions: To whom do you talk, when you are distressed? Which persons are helpful to reduce your distress? How did helpful persons help you? Results: 202 patients with a median age of 68 years (37-85) completed the interview. Most important contact persons named by patients were: oncologist (84%), partner (71%), children (64%), friends (53%) and general practitioner (52%). The most helpful persons were oncologist (97%), friends (94%), partner (92%), children (92%) and general practitioner (91%) and the most important qualities of help were listening, patience and mindfulness. The most important qualities of help from the oncologist were: therapy, listening and information/advice. Conclusion: Patients with metastatic solid tumours use a helping network of contact persons when they are distressed. The oncologist, partner, children, friends and general practitioner are key persons. Training of oncologists in distress management is of utmost importance. Furthermore the patient's network should be strengthened by improving the information flow and by continuous support for the main caregivers.

P5-17-01: Evaluation of Psychosocial Distress in Main Care-Givers of Patients with Metastatic Breast Cancer Who Receive Treatment in a Community Based Oncology Group Practice.

Abstract Introduction: It is well-known that people who care for patients with a metastatic carcinoma are exposed to an above-average level of psychosocial distress. No data are available concerning the distress of main care-givers of female patients with metastatic breast cancer, who are treated in a community based oncology group practice. Methods: Standardized cross-sectional survey of main care-givers and patients with metastatic breast cancer who were treated in a community based oncology group practice in Germany between 04/2010-03/2011. Psychosocial distress of the patients and their main care-givers were evaluated using the German versions of the Distress Thermometer (DT) and the Problem List (PL). In addition anxiety and depression of the main care-givers were assessed using the Hospital Anxiety and Depression Scale (HADS-D). Results: 83 female patients with a median age of 65 (41-93) were interviewed. 6% did not have a main care-giver, 7% indicated that they needed no support, 48% reported one main care-giver and 39% several. Partners (60%), children (47%), siblings (11%) and friends (10%) were the most important care-givers. 47% of patients preferred visiting the practice in companion with their care-givers. The patients’ median score on the DT was 5 (0-10), with 34% scoring above cut-off (> 5) for psychosocial distress. 52 main care-givers (61% male, 39% female) with a median age of 57.5 (41-86) were interviewed. The relationships to the patients were as follows: partners 62%, children 27%, mothers, siblings and friends each with 4%. The main care-givers themselves were supported by partners (54%), children (21%) friends (17%) and siblings (8%), 23% did not receive any support. The median score on the DT was 5 (0-10), with 44% scoring above cut-off (> 5) for psychosocial distress. According to the HADS-D 37% (cut-off ≥ 8) of the care-givers reported anxiety, with a mean score of 6.6 (0-14). 15% could be regarded as depressed (cut-off ≥ 8), with a mean score of 4.1 (0-15). Conclusions: The main care-givers are distressed even more than the patients themselves. 37% of care-givers reported anxiety; depression can be observed too, but less frequently in 15%. Both issues should be addressed by healthcare professionals. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-17-01.

Evaluation of psychosocial distress in patients treated in a community-based oncology group practice in Germany

BackgroundSystematic 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 methodsOne thousand four hundred forty-six patients were screened between July 2008 and September 2008. Five hundred randomly selected patients were sent a feedback form. ResultsThe 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. ConclusionDT 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.

Identifying caregivers and their meaning for patients with metastatic solid tumors: A prospective study at a community-based oncology group practice in Germany.

e19637 Background: Relief of psycho-social distress is an important aspect in the treatment of patients with metastatic cancer. Therefore it is important to find out which persons are called on most frequently to find help in dealing with this situation. We also evaluated to what extend the patients considered these persons as actually helpful. Methods: 202 patients with metastatic solid tumors visiting the practice between April and July 2009 were screened for psycho-social distress using the Distress Thermometer (DT) and Problem List (PL). Thereafter a standardized personal interview was held where patients were asked to name their important contact persons. For each contact person the patient was asked to indicate if this contact was helpful or not and if yes, in which way it was helpful. Results: The 202 observed patients showed a mean distress level of 4.4 with 29% of patients indicating a distress score > 5.0. 92% named physical problems as a source of distress while emotional, practical, familial, or spiritual problems were causing distress in 63%, 14%, 12% and 4% respectively. 84% of patients named their oncologist as an important person to help them with their distress. Partner, children, friends and general practitioner were important persons for 71%, 64%, 53% and 52% respectively. 97% of patients seeking help from their oncologist described this as helpful. 24 patients (12%) had contacted a psychologist. This was helpful for 17 (71%) of these patients. There is a correlation between distress level and number of different persons contacted. (r=.305; p<0.001). The most helpful aspect for all contact persons was “Listening” except for oncologists (“Therapy”) and Cancer Counselling Service (“Information/Advice”). Conclusions: Psycho-social distress in patients with metastatic solid tumors is mostly caused by physical and by emotional problems. Most patients treated in an oncology practice reported a network of care-giving persons as helpful in the coping process. Thus it is of utmost importance to identify patients without care care giving persons and to improve support for main care givers. No significant financial relationships to disclose.

Evaluation of Important Contact Persons and Their Helpfulness in Coping with Metastatic Breast Cancer Induced Psycho-Social Distress. A Prospective Study at a Community-Based Oncology Group Practice in Germany.

Abstract Introduction: Since psycho-social distress is a prevalent condition in metastatic breast cancer patients, it is important to find out which contact persons are called on most frequently to find help in dealing with this situation. In addition to the significance of these contact persons we wanted to find out to what extend they were actually helpful for the patients when contacted.Methods: 57 patients with metastatic breast cancer visiting the practice in April and May 2009 were administered the Distress Thermometer (DT) and Problem List (PL). Thereafter a standardized personal interview was held concerning their important contact persons where patients were asked to name their important contact persons freely. After this additionally a list of possible contact persons was read to the patients to complete the set of persons the patient has contacted. For each contact person the patient was asked to indicate if this contact was helpful or not.Results: The mean distress level observed in this population of 57 metastatic breast cancer patients was 4.9. 36% showed a distress level &amp;gt; 5. Physical problems as a source of distress were stated by 93%, emotional, familial, practical or spiritual problems were causing distress in 72%, 26%, 21% and 4% respectively. 88% of patients named their oncologist as an important person to help them with their distress. Children, partner, friends and general practitioner were important persons for 70%, 65%, 60% and 54% respectively. Regarding only the free answers the order of the most important persons was partner (60%), children (54%), friends (42%), other family members (35%), oncologist (28%), general practitioner (14%). All patients (100%) who sought help from their oncologist described this as helpful. Children, partner, friends and general practitioner were helpful in 90%, 86%, 94% and 94% of cases. 10 patients (18%) had contacted a psychiatrist. This was helpful for 8 (80%) of these patients.There is a positive and statistically significant correlation between distress level and number of persons contacted. (r=.283; p=0.033).Conclusions: Psycho-social distress in patients with metastatic breast cancer is mostly caused by physical and emotional problems. Patients treated in an oncology practice reported a network of care-giving persons as helpful in the coping process. Persons described as being most helpful were oncologists, partner, children, friends an general practitioner. Patients with higher distress levels tend to contact more different persons in trying to find help. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1072.

The impact of new treatment options for advanced colorectal cancer on routine care: results of a retrospective analysis of 206 consecutive patients treated in a community-based oncology group practice in Germany

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.

3009 Evaluation of psycho-social distress in patients treated in a community based oncology group practice in Germany

3009 Evaluation of psycho-social distress in patients treated in a community based oncology group practice in Germany

Evaluation of psycho-social distress in patients treated in a community-based oncology group practice in Germany

e20577 Background: Systematic evaluation of psycho-social distress in oncology outpatients is an important issue. Therefore we assessed feasibility and benefit of standardized routine screening using the Distress Thermometer (DT) and the Problem List (PL) in daily practice. Methods: All patients attending the practice between July and September 2008 were administered the DT and the PL. Patients were classified into the disease groups solid tumors, hematological neoplasms, benign hematological diseases and other non-malignant diseases. The individual treatment phase was evaluated additionally. Participants in a mammography screening programme were assessed as a control group. 500 randomly selected patients were sent a feedback-form to describe how they experienced the DT's influence on the doctor-patient-communication. Results: The 1,446 patients reported an average distress level of 4.7 with 37% indicating a distress level &gt; 5. Patients with other non-malignant diseases (81% autoimmune diseases or hereditary hemochromatosis) showed the highest average distress level of 5.2. Regarding the treatment phases, the most distressed patients were patients who just learned about their diagnosis of relapsed or metastatic disease (6.4), patients receiving Best Supportive Care (5.4) and patients receiving adjuvant anti-hormonal therapy (5.4). The most frequently indicated problems causing distress were exhaustion/fatigue (49%), pain (44%), impaired mobility (41%) and sleep disorders (39%) respectively. Breast cancer patients stated a distress level of 5.2. The average distress level in 474 mammography screening participants was 3.3. 37% of 190 patients who returned the feedback-form indicated that the DT and PL were useful tools to speak to their doctor about their distress more precisely. 38% felt better than usual after this conversation. Conclusions: The study shows that cancer patients do not necessarily show higher distress than patients with severe non-malignant diseases. The problems patients most frequently indicate as distressing are somatic disorders. DT and PL are applicable for routine screening in an outpatient setting. Physicians as well as patients stated that the use of the DT improved the quality of their communication. No significant financial relationships to disclose.

Improved Survival of Patients with Metastatic Breast Cancer in Routine Care: Results of a Retrospective Study in a Community-Based Oncology Group Practice 1995–2005

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.

Treatment of Advanced Non Small Cell Lung Cancer in Routine Care: A Retrospective Analysis of 212 Consecutive Patients Treated in a Community Based Oncology Group Practice

Treatment outcome data generated in prospective trials are intrinsically biased due to necessary selection criteria. Therefore the results obtained may not reflect the actual impact of current treatment options for an unselected general population. We analysed the treatment modalities and the outcome in 212 consecutive patients with non small cell lung cancer stages IIIB and IV who were seen in a community based oncology group practice between 6/1995 and 6/2006. 93 presented with stage IIIB and 119 with stage IV. Chemotherapy was given to 194/212 patients (92%), 114 patients (54%) received palliative radiation at one point during treatment. Treatment consisted of chemotherapy only in 86 patients (40%) and radiation only in 6 patients. 12 patients received best supportive care only. Patients with stage IIIB have survival rates at 12, 24 and 36 months of 64%, 27% and 21% respectively and for patients with stage IV the survival rates at 12, 24 and 36 months are 40%, 19% and 11% respectively. The median survival for stages IIIB and IV is 16 and 11 months respectively. In a multivariate analysis incorporating the factors stage (IIIB vs. IV), age (<70 vs. >/=70 years) and performance status (WHO 0/1 vs. 2/3) only stage and performance status were independent factors for survival. These retrospective data concerning analysis of survival, response rates and toxicity in a community setting confirm published results of phase II-III studies and indicate that results generated in prospective trials can be transferred into routine care.