Impact of guideline changes on adoption of hypofractionation and breast cancer patient characteristics in the randomized controlled HYPOSIB trial.

PURPOSE: Hypofractionated radiotherapy is the standard of care for adjuvant whole breast radiotherapy (RT). However, adoption has been slow. The indication for regional nodal irradiation has been expanded to include patients with 0-3 involved lymph nodes. We investigated the impact of the publication of the updated German S3 guidelines in 2017 on adoption of hypofractionation and enrollment of patients with lymph node involvement within a randomized controlled phase III trial. METHODS: In the experimental arm of the HYPOSIB trial (NCT02474641), hypofractionated RT with simultaneous integrated boost (SIB) was used. In the standard arm, RT could be given as hypofractionated RT with sequential boost (HFseq), normofractionated RT with sequential boost (NFseq), or normofractionated RT with SIB (NFSIB). The cutoff date for the updated German S3 guidelines was December 17, 2017. Temporal trends were analyzed by generalized linear regression models. Multiple logistic regression models were used to investigate the influence of time (prior to/after guideline) and setting (university hospital/other institutions) on the fractionation patterns. RESULTS: Enrollment of patients with involved lymph nodes was low throughout the trial. Adoption of HFseq increased over time and when using the guideline publication date as cutoff. Results of the multiple logistic regressions showed an interaction between time and setting. Furthermore, the use of HFseq was significantly more common in university hospitals. CONCLUSION: The use of HFseq in the standard arm increased over the course of the HYPOSIB trial and after publication of the S3 guideline update. This was primarily driven by patients treated in university hospitals. Enrolment of patients with lymph node involvement was low throughout the trial.

Secondary malignancy risk for patients with localized prostate cancer after intensity-modulated radiotherapy with and without flattening filter.

Men treated for localized prostate cancer by radiotherapy have often a remaining life span of 10 yr or more. Therefore, the risk for secondary malignancies should be taken into account. Plans for ten patients were evaluated which had been performed on an Oncentra® treatment planning system for a treatment with an Elekta Synergy™ linac with Agility™ head. The investigated techniques involved IMRT and VMTA with and without flattening filter. Different dose response models were applied for secondary carcinoma and sarcoma risk in the treated region and also in the periphery. As organs at risk we regarded for carcinoma risk urinary bladder, rectum, colon, esophagus, thyroid, and for sarcoma risk bone and soft tissue. The excess absolute risk (EAR) was found very similar in the treated region for both techniques (IMRT and VMAT) and also for both with and without flattening filter. The secondary sarcoma risk resulted about one magnitude smaller than the secondary carcinoma risk. The EAR to the peripheral organs was statistically significant reduced by application of the flattening filter free mode concerning the flattening filter as main source of scattered dose. Application of flattening filter free mode can thus support to reduce second malignancy risk for patients with localized prostate cancer.

Re-irradiation for humeral epicondylitis : Retrospective analysis of 99 elbows.

BACKGROUND: Humeral epicondylitis is a common elbow disease. The prevalence is about 1.7%. One of the most effective treatment options is radiotherapy. Some authors mention that they apply a second or third course of radiation for recurrent pain or partial or no response to the initial course. As the results of a re-irradiation have not been systematically analyzed, the aim of this study was to document the results of repeated radiation treatment and to identify those patients who will benefit. MATERIAL AND METHODS: The analysis was performed on patients from three German radiotherapy institutions and included 99 re-irradiated elbows. Pain was documented with the numeric rating scale (NRS). Evaluation of the NRS was done before and directly after each radiation therapy as well as for the follow-up of 24 months. The median age of the patients was 51 years with 48.8% male and 51.2% female patients. Repeated radiation was indicated because the initial radiotherapy resulted in 39.7% of no response, in 41.0% of partial response and in 19.3% of recurrent pain. RESULTS: A significant response to re-irradiation was found. For the whole sample the median pain score was 6 before re-irradiation, 3 after 6 weeks, 2 after 12 months and 1 after 24 months. The percentage of patients being free of pain or with very little pain was 50.9% 24 months after re-irradiation. All subgroups, notably those with no response, partial response and recurrent pain had a significant reduction of pain. CONCLUSION: Re-irradiation of humeral epicondylitis is an effective and safe treatment. All subgroups showed a good response to re-irradiation for at least 24 months.

Radiotherapy for osteoarthritis of the ankle and tarsal joints-analysis of 66 joints.

PURPOSE: Osteoarthritis of the ankle and tarsal joints is less common than osteoarthritis of the knee or hip, but the associated disability is at least as severe as that of the other major joints of the lower limb. The results for total arthroplasty are still not satisfactory. For this reason, arthrodesis is still the gold standard of non-joint-conserving surgery. For the reason of functionality, joint-conserving therapies play a major role in treatment of ankle and tarsal osteoarthritis. Low-dose radiotherapy has a long history of treatment of osteoarthritis. The aim of this survey was to examine the results of low-dose radiotherapy for osteoarthritis of the ankle and tarsal joints. MATERIALS AND METHODS: The analysis was performed on patients of three German radiotherapy institutions and included 66 irradiated joints. Pain was documented with the numeric rating scale (NRS). Evaluation of the NRS was done before and directly after each radiation therapy course as well as for the follow-up of 24 months. The median age of the patients was 68 years, with 24.5% male and 75.5% female patients. The upper ankle was treated in 37.9%, the lower ankle in 27.3% and the tarsal joints in 34.8%. RESULTS: We could find a significant response to radiotherapy. For the whole sample, the median pain was 7 on the NRS before radiotherapy, 5 after 6 and 12 weeks, and 4 after 12 months. The percentage of patients with 0 or 1 on the NRS was 19.6% 12 months after radiotherapy. An improvement of joint mobility could be detected in 56.7% of the cases. All investigated subgroups had a significant reduction in pain. CONCLUSION: Radiotherapy of ankle and tarsal osteoarthritis is an effective treatment without showing side effects. All analysed subgroups show a good response to radiotherapy for at least 24 months.

Re-irradiation for osteoarthritis-retrospective analysis of 217 joints.

PURPOSE: Osteoarthritis is a common disease with a prevalence of approximately 8.9% among the average population. One treatment option is low-dose radiotherapy. Some authors mention that they apply a second or third course of radiation for recurrent pain or partial or no response to the initial course. As the results of re-irradiation have not been analysed systematically, the aim of this study was to document the results of repeated radiation treatment and to identify those patients who will benefit. METHODS AND MATERIALS: The analysis was performed on patients of three German radiotherapy institutions and included 217 re-irradiated joints. Pain was documented with the numeric rating scale (NRS). Evaluation of the NRS was done before and directly after each radiation therapy as well as at the follow-up of 24 months. The median age of the patients was 67 years, with 40% male and 60% female patients. Re-irradiation was indicated because the initial radiotherapy resulted in no response in 21.2%, in partial response in 41.5%, and in recurrent pain in 37.3%. RESULTS: We found a significant response to re-irradiation. For the whole sample, the median pain was 6 before re-irradiation, 4 after 6 weeks, and 3 after 12 weeks, 6 months, 12 months, and 24 months. The percentage of patients being free of pain or with very little pain was approximately 25% 12 months after re-irradiation. All subgroups, notably those with no response to the first course versus partial response to the first course versus recurrent pain, had significant reduction of pain. CONCLUSION: Re-irradiation of osteoarthritis is an effective and safe treatment. All subgroups showed a good response to re-irradiation for at least 24 months.

[Quality of life and Potential Incriminating Factors Among Palliative Care Givers: A German Survey of the KOMPACT Working Group]. / Belastungen im Berufsalltag von Palliativpflegekräften ­ eine Befragung in Kooperation mit dem KompetenzZentrum Palliative Care Baden-Württemberg (KOMPACT).

AIM OF THE STUDY: Due to the aging population in Germany, the need for palliative care institutions will increase. Considering the lack of resources, work stress of palliative care nurses could increase significantly. It was the aim of this study to identify risk factors for job overload and work stress of palliative care nurses in the inpatient and outpatient setting. METHODS: In cooperation with the KOMPACT Working Group, we conducted an anonymous survey of palliative care givers in Baden-Württemberg, Germany. We used a paper questionnaire to inquire about job stress and workload, self-assessment of health condition and aspects about mental and emotional well-being. 167 palliative care nurses from 34 different institutions participated in the survey. RESULTS: The results showed a significant difference between inpatient and outpatient palliative care workers regarding the type and intensity of work stress. The overall stress level was significantly higher for the nurses in inpatient palliative care units (p<0.001). A high weekly working time combined with missing work experience in the field of palliative care led to a poorer compatibility of job and family. Higher stress levels resulted in a lower satisfaction with the work. Dissatisfaction with the working conditions was associated with a worse health status defined by self-assessment. Mental and emotional condition of palliative care nurses was significantly worse in comparison with the norm sample, many nurses showed "strikingly" or even "seriously" high values. The survey also showed that the structural conditions in inpatient palliative care units were not optimal. CONCLUSION: Compared to outpatient palliative care services, working conditions seem to be worse in inpatient palliative care setting, which could result in higher stress for the nurses. Interventions to reduce work-related stress appear not to be well implemented in the daily work of palliative care nurses. Standards for care as well as advanced training programs for palliative care nurses should be reevaluated.

Quality of life and oncological outcome in endometrial cancer patients after vaginal brachytherapy: comparison of two dosing schemes.

PURPOSE: Vaginal brachytherapy reduces the risk of local recurrence and was shown to be equieffective in preventing vaginal vault recurrence, but less toxic compared to external-beam radiotherapy in a subset of high intermediate-risk endometrial cancer patients and is administered as single adjuvant treatment in those patients. Different radiotherapeutic approaches with various dosing schemes exist toward brachytherapy. The aim of this study was to compare the outcome and long-term quality of life after brachytherapy with two different high-dose-rate dosing schemes. METHODS: Retrospective analysis was conducted of the recurrence and survival rates of 104 patients with endometrial cancer FIGO stage I-II that underwent adjuvant brachytherapy with three times 5 Gy or four times 5 Gy to the upper two-thirds of the vaginal vault in two different institutions between January 2010 and December 2013. Quality of life was assessed by EORTC QLQ-30 questionnaire and EN 24 module. RESULTS: The vaginal vault recurrence rates were 4.9% and 5.0% for patients treated with 3 × 5 Gy and 4 × 5 Gy, respectively (p = 0.98). We did not observe a difference in pelvic recurrence (p = 0.96), overall survival (p = 0.33) or quality of life between the different radiotherapy regimens. Metastatic recurrence and the use of chemotherapy contribute to impairment on quality of life. Younger patients (< 70 years) reported worse emotional functioning (p = 0.02) and higher symptom scales of diarrhea (p = 0.01) and financial problems (p = 0.03). Sexual activity was lower in patients younger than 70 years (p = 0.05). CONCLUSIONS: Further prospective studies are needed to evaluate the effect of dosing schemes on recurrence rates and quality of life. Younger patients (< 70 years) seem to experience greater reduction in quality of life due to endometrial cancer diagnosis.

Sentinel Lymph Node Biopsy in Breast Cancer Patients by Means of Indocyanine Green Using the Karl Storz VITOM® Fluorescence Camera.

Currently, the use of radioisotope and blue dye for sentinel lymph node biopsy (SLNB) for axillary staging in breast cancer is common. Recently, indocyanine green (ICG) has been proposed as an alternative sentinel lymph node (SLN) tracking agent. We evaluated the clinical value of ICG as an additional tracer in combination with Technetium99m and as an alternative to Technetium99m for the identification of SLN in 104 breast cancer patients. 21 patients had at least 1 histologically tumor-positive SLN. All 21 patients were detected by ICG; in one of these 21 sentinel-positive patients, Technetium99m was unable to identify lymph node involvement. Our results show that ICG is as effective as the radioisotope for SLNB. In addition, as a near-infrared dye, it has the advantages of real-time visualization, lower cost, and wider availability, since no radioactive material needs to be handled. This trial is registered with German Clinical Trial Register Main ID: DRKS00013606.

Volumetric-modulated arc therapy and intensity-modulated radiation therapy treatment planning for prostate cancer with flattened beam and flattening filter free linear accelerators.

This study on patients with localized prostate cancer was set up to investigate valuable differences using flattened beam (FB) and flattening filter free (FFF) mode in the application of intensity-modulated radiotherapy (IMRT) and volumetric-modulated arc therapy (VMAT). For ten patients, four different plans were calculated with Oncentra planning system of Elekta, using Synergy machines: IMRT and VMAT, with and without flattening filter. Homogeneity and conformity indexes, dose to the organs at risk, and measurements of peripheral dose and dosimetric plan verification including record of the delivery times were analyzed and statistically evaluated. The indexes for homogeneity and conformity (CTV and PTV) are either advantageous or not significantly different for FFF compared to FB with one minor exception. Regarding the doses to the organs at risk and the measured peripheral dose, equivalent or lower doses were delivered for FFF than with FB. Furthermore, the delivery times were significantly shorter for FFF. VMAT compared to IMRT reveals benefits or at least equivalent values. VMAT-FFF combines the most advantageous plan quality parameters with the shortest delivery times and reduced peripheral dose and is therefore recommended for the given equipment and cancer localization.

Workload and quality of life of medical doctors in the field of oncology in Germany--a survey of the working group quality of life of the AIO for the study group of internal oncology.

BACKGROUND: An increasing number of surveys have investigated professional stress and satisfaction among oncologists. Coevally, structural development has changed the oncological working environment. This survey investigated the quality of life and job stress among German oncological physicians. METHODS: A 48-item questionnaire, which included the 'Stress questionnaire of physicians and nurses' (FBAS), was developed by the 'Quality of life' working group of the Internal oncology study group (AIO), and distributed anonymously at the annual meeting of the AIO working group in 2010. Descriptive statistics as well as univariate and multivariate analysis were performed. RESULTS: 261 oncologists, mostly male (64%), older than 40 years (38%), and medical specialists (78%), took part in the survey. 'Structural conditions' were identified as causing the highest mean stress levels, followed by 'professional and private life'. Female participants showed a significantly lower global quality of life than male participants (p = 0.020). 'Structural conditions' induced more stress among younger oncologists < 50 years old (p < 0.001). Qualification status was influenced by gender (p < 0.001); the multivariate analysis described the dependence of gender (p = 0.0045), working situation (p = 0.0317) and global stress (p = 0.0008). CONCLUSION: Structural conditions, age younger than 50 years and female gender were identified as stress risk factors among the AIO members, and showed that job stress is present in German oncology. Further research is warranted to develop evidence-based intervention strategies. © 2015 S. Karger GmbH, Freiburg.

A comparative study of a modified filtering trabeculotomy and conventional trabeculectomy.

PURPOSE: The objective of the study reported here was to evaluate the outcome of a modified filtering trabeculotomy (FTO) without iridectomy in open-angle glaucoma compared with that of conventional trabeculectomy (trab). PATIENTS AND METHODS: Thirty eyes of 30 patients who underwent modified FTO were prospectively followed for 1 year and were compared with 87 conventional trab patients (87 eyes), matched for age and preoperative intraocular pressure (IOP). The FTO procedure consisted of a deep sclerectomy and trabeculotomy preserving the trabeculo-Descemet membrane, without iridectomy. Main outcome measures were complete success (IOP <18 mmHg and >/=30% IOP reduction, without medication), IOP, visual acuity, medication, complications, and subsequent surgeries. RESULTS: In the conventional trab group, the median preoperative IOP was 23.0 mmHg (interquartile range 20.0-27.0) with 3.0 (2.0-3.0) medications, compared with 23.0 mmHg (20.0-27.0) and 3.0 (2.8-4.0) in the modified FTO group. Median postoperative IOP at 12 months was 12.0 mmHg (10.0-13.0) in the conventional trab and 11.0 mmHg (8.0-14.0) in the modified FTO group (P=0.3). The complete success rate at 1 year was 83.1% and 79.3% in the conventional trab group and modified FTO group, respectively (P=0.8). The complications hypotony (20.7%, 24.1%), choroidal detachment (2.3%, 10.3%), and bleb scarring (17.2%, 13.8%), were present in the conventional trab group and modified FTO group, respectively. CONCLUSION: The outcomes of reduced IOP and medications in the FTO group were not different to those in the conventional trab group over 1 year, but some complications were more often seen with the modified FTO technique. The new filtration trabeculotomy, however, has the advantage of avoiding iridectomy, thus reducing the risk of cataract formation, and may result in the development of more favorable blebs by controlling the flow over two resistance levels.

Searching standard parameters for volumetric modulated arc therapy (VMAT) of prostate cancer.

BACKGROUND: Since December 2009 a new VMAT planning system tool is available in Oncentra MasterPlan v3.3 (Nucletron B.V.). The purpose of this study was to work out standard parameters for the optimization of prostate cancer. METHODS: For ten patients with localized prostate cancer plans for simultaneous integrated boost were optimized, varying systematically the number of arcs, collimator angle, the maximum delivery time, and the gantry spacing. Homogeneity in clinical target volume, minimum dose in planning target volume, median dose in the organs at risk, maximum dose in the posterior part of the rectum, and number of monitor units were evaluated using student's test for statistical analysis. Measurements were performed with a 2D-array, taking the delivery time, and compared to the calculation by the gamma method. RESULTS: Plans with collimator 45° were superior to plans with collimator 0°. Single arc resulted in higher minimum dose in the planning target volume, but also higher dose values to the organs at risk, requiring less monitor units per fraction dose than dual arc. Single arc needs a higher value (per arc) for the maximum delivery time parameter than dual arc, but as only one arc is needed, the measured delivery time was shorter and stayed below 2.5 min versus 3 to 5 min. Balancing plan quality, dosimetric results and calculation time, a gantry spacing of 4° led to optimal results. CONCLUSION: A set of parameters has been found which can be used as standard for volumetric modulated arc therapy planning of prostate cancer.

Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases.

BACKGROUND: Recently published results of quality of life (QoL) studies indicated different outcomes of palliative radiotherapy for brain metastases. This prospective multi-center QoL study of patients with brain metastases was designed to investigate which QoL domains improve or worsen after palliative radiotherapy and which might provide prognostic information. METHODS: From 01/2007-01/2009, n=151 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. Most patients (82 %) received whole-brain radiotherapy. QoL was measured with the EORTC-QLQ-C15-PAL and brain module BN20 before the start of radiotherapy and after 3 months. RESULTS: At 3 months, 88/142 (62 %) survived. Nine patients were not able to be followed up. 62 patients (70.5 % of 3-month survivors) completed the second set of questionnaires. Three months after the start of radiotherapy QoL deteriorated significantly in the areas of global QoL, physical function, fatigue, nausea, pain, appetite loss, hair loss, drowsiness, motor dysfunction, communication deficit and weakness of legs. Although the use of corticosteroid at 3 months could be reduced compared to pre-treatment (63 % vs. 37 %), the score for headaches remained stable. Initial QoL at the start of treatment was better in those alive than in those deceased at 3 months, significantly for physical function, motor dysfunction and the symptom scales fatigue, pain, appetite loss and weakness of legs. In a multivariate model, lower Karnofsky performance score, higher age and higher pain ratings before radiotherapy were prognostic of 3-month survival. CONCLUSIONS: Moderate deterioration in several QoL domains was predominantly observed three months after start of palliative radiotherapy for brain metastases. Future studies will need to address the individual subjective benefit or burden from such treatment. Baseline QoL scores before palliative radiotherapy for brain metastases may contain prognostic information.

Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial.

BACKGROUND: Fluorouracil-based chemoradiotherapy is regarded as a standard perioperative treatment in locally advanced rectal cancer. We investigated the efficacy and safety of substituting fluorouracil with the oral prodrug capecitabine. METHODS: This randomised, open-label, multicentre, non-inferiority, phase 3 trial began in March, 2002, as an adjuvant trial comparing capecitabine-based chemoradiotherapy with fluorouracil-based chemoradiotherapy, in patients aged 18 years or older with pathological stage II-III locally advanced rectal cancer from 35 German institutions. Patients in the capecitabine group were scheduled to receive two cycles of capecitabine (2500 mg/m(2) days 1-14, repeated day 22), followed by chemoradiotherapy (50·4 Gy plus capecitabine 1650 mg/m(2) days 1-38), then three cycles of capecitabine. Patients in the fluorouracil group received two cycles of bolus fluorouracil (500 mg/m(2) days 1-5, repeated day 29), followed by chemoradiotherapy (50·4 Gy plus infusional fluorouracil 225 mg/m(2) daily), then two cycles of bolus fluorouracil. The protocol was amended in March, 2005, to allow a neoadjuvant cohort in which patients in the capecitabine group received chemoradiotherapy (50·4 Gy plus capecitabine 1650 mg/m(2) daily) followed by radical surgery and five cycles of capecitabine (2500 mg/m(2) per day for 14 days) and patients in the fluorouracil group received chemoradiotherapy (50·4 Gy plus infusional fluorouracil 1000 mg/m(2) days 1-5 and 29-33) followed by radical surgery and four cycles of bolus fluorouracil (500 mg/m(2) for 5 days). Patients were randomly assigned to treatment group in a 1:1 ratio using permuted blocks, with stratification by centre and tumour stage. The primary endpoint was overall survival; analyses were done based on all patients with post-randomisation data. Non-inferiority of capecitabine in terms of 5-year overall survival was tested with a 12·5% margin. This trial is registered with ClinicalTrials.gov, number NCT01500993. FINDINGS: Between March, 2002, and December, 2007, 401 patients were randomly allocated; 392 patients were evaluable (197 in the capecitabine group, 195 in the fluorouracil group), with a median follow-up of 52 months (IQR 41-72). 5-year overall survival in the capecitabine group was non-inferior to that in the fluorouracil group (76% [95% CI 67-82] vs 67% [58-74]; p=0·0004; post-hoc test for superiority p=0·05). 3-year disease-free survival was 75% (95% CI 68-81) in the capecitabine group and 67% (59-73) in the fluorouracil group (p=0·07). Similar numbers of patients had local recurrences in each group (12 [6%] in the capecitabine group vs 14 [7%] in the fluorouracil group, p=0·67), but fewer patients developed distant metastases in the capecitabine group (37 [19%] vs 54 [28%]; p=0·04). Diarrhoea was the most common adverse event in both groups (any grade: 104 [53%] patients in the capecitabine group vs 85 [44%] in the fluorouracil group; grade 3-4: 17 [9%] vs four [2%]). Patients in the capecitabine group had more hand-foot skin reactions (62 [31%] any grade, four [2%] grade 3-4 vs three [2%] any grade, no grade 3-4), fatigue (55 [28%] any grade, no grade 3-4 vs 29 [15%], two [1%] grade 3-4), and proctitis (31 [16%] any grade, one [<1%] grade 3-4 vs ten [5%], one [<1%] grade 3-4) than did those in the fluorouracil group, whereas leucopenia was more frequent with fluorouracil than with capecitabine (68 [35%] any grade, 16 [8%] grade 3-4 vs 50 [25%] any grade, three [2%] grade 3-4). INTERPRETATION: Capecitabine could replace fluorouracil in adjuvant or neoadjuvant chemoradiotherapy regimens for patients with locally advanced rectal cancer. FUNDING: Roche Pharma AG (Grenzach-Wyhlen, Germany).

Dysphagia. Impact on quality of life after radio(chemo)therapy of head and neck cancer.

BACKGROUND: In the past, xerostomia was considered one of the most important determining factors of quality of life (QoL) after radiotherapy (RT) of the head and neck region. In addition, more recent studies have shown that RT-induced dysphagia has an essential influence on the QoL. PATIENTS AND METHODS: Between September 2005 and August 2007, 35 patients with locally advanced squamous cell carcinoma of the head and neck region were included in the prospective study. Patients were treated by IMAT (intensity-modulated arc therapy) or IMRT (intensity-modulated radiotherapy) planned on 3D imaging. A total of 28 patients (80%) received concomitant chemotherapy. The evaluation of QoL (EORTC QLQ-C30, H&N C-35) and toxicities (CTC 2.0) were assessed at the beginning of, during, and after RT as well as up to 12 months after the end of therapy. RESULTS: At the end of therapy, 86% of the patients experienced difficulties in swallowing (62% CTC II-III°). Twelve months after the end of treatment, 15% still suffered from dysphagia CTC II-III°. Concomitant chemotherapy exacerbated the incidence and gravity of dysphagia, resulting in increasing dietary problems. QoL (EORTC) was significantly affected by dysphagia. In particular, the global state of health and QoL were influenced at the end of treatment (p=0.033) and at a later stage (p=0.050). CONCLUSION: The findings of this study suggest that more emphasis should be placed on structured clinical diagnostics, therapy, and rehabilitation of deglutition problems. This means in particular to not only spare the parotids while planning the irradiation, but also to take into consideration the important structures for deglutition, like the retropharyngeal muscles.

Cancer patients and the Internet: a survey of the 'Quality of Life' Working Groups of the Arbeitsgemeinschaft für Internistische Onkologie and the Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie.

BACKGROUND: Patient-reported outcomes, such as quality of life (QoL) assessment, are becoming more important as endpoint in clinical trials and for decision making regarding new anticancer product approvals. Nevertheless, numerous obstacles exist regarding the implementation of QoL assessment in the daily practice of medical oncologists. Regular, computerized or internet home-based QoL assessments could be a step forward. METHODS: Using a 15-item paper questionnaire, we conducted a survey among 1580 cancer patients regarding their willingness to use internet QoL assessment, and collected personal data and information about current disease and performance status. RESULTS: Younger patients (i.e. ≤65 years) significantly more often had internet access (78% versus 36%; χ(2) test, p < 0.001). Moreover, the availability of internet access correlated with higher education levels. 55% of all polled patients are willing to use an internet-based QoL assessment tool, regardless of the type of internet access, whereas almost two-thirds (n = 600; 65%) of patients with their own internet access would be willing to use it for providing statements about QoL. Of these, especially younger patients in good health status with higher education degrees indicated their willingness to use such tools. CONCLUSION: These data may serve as a basis for identifying patient groups willing to participate in pilot projects to evaluate the implementation of internet-based regular assessment of QoL in cancer.

Clostridium difficile-associated diarrhea in radiooncology: an underestimated problem for the feasibility of the radiooncological treatment?

BACKGROUND AND PURPOSE: Over the last years an increasing incidence of Clostridium difficile-associated diarrhea (CDAD) has been reported. Especially haematology-oncology patients are at risk of developing CDAD.The aim of this analysis is to determine the incidence of CDAD in radiooncological patients and to find out what relevance CDAD has for the feasibility of the radiooncological treatment, as well as to detect and describe risk factors. PATIENTS AND METHODS: In a retrospective analysis from 2006 to 2010 34 hospitalized radiooncological patients could be identified having CDAD. The risk factors of these patients were registered, the incidence was calculated and the influence on the feasibility of the radiooncological therapy was evaluated. Induced arrangements for prophylaxis of CDAD were identified and have been correlated with the incidence. RESULTS: The incidence of CDAD in our collective is 1,6%. Most of the patients suffering from a CDAD were treated for carcinoma in the head and neck area. Common risk factors were antibiotics, proton pump inhibitors, cytostatic agents and tube feeding.Beside a high rate of electrolyte imbalance and hypoproteinemia a decrease of general condition was frequent. 12/34 patients had a prolonged hospitalization, in 14/34 patients radiotherapy had to be interrupted due to CDAD. In 21 of 34 patients a concomitant chemotherapy was planned. 4/21 patients could receive all of the planned cycles and only 2/21 patients could receive all of the planned cycles in time.4/34 patients died due to CDAD. In 4/34 patients an initially curative treatment concept has to be changed to a palliative concept.With intensified arrangements for prophylaxis the incidence of CDAD decreased from 4,0% in 2007 to 0,4% in 2010. CONCLUSION: The effect of CDAD on the feasibility of the radiotherapy and a concomitant chemotherapy is remarkable. The morbidity of patients is severe with a high lethality.Reducing of risk factors, an intense screening and the use of probiotics as prophylaxis can reduce the incidence of CDAD.

Preoperative radiotherapy of advanced rectal cancer with capecitabine and oxaliplatin with or without cetuximab: A pooled analysis of three prospective phase I-II trials.

PURPOSE: A pooled analysis of three prospective trials of preoperative radiochemotherapy (RCT) for rectal cancer by using oxaliplatin and capecitabine with or without cetuximab was performed to evaluate the impact of additional cetuximab on pathologic complete response (pCR) rates and tumor regression (TRG) grades. METHODS AND MATERIALS: Of 202 patients, 172 patients met the inclusion criteria (primary tumor stage II/III, M0). All patients received concurrent RCT, and 46 patients received additional cetuximab therapy. A correlation of pretreatment clinicopathologic factors and cetuximab treatment with early pCR rates (TRG > 50%) was performed with univariate and multivariate analyses. Toxicity data were recorded for all patients. RESULTS: Of 172 patients, 24 (14%) patients achieved a pCR, and 84 of 172 (71%) patients showed a TRG of >50% in the surgical specimen assessment after preoperative treatment. Age, gender, and T/N stages, as well as localization of the tumor, were not associated with pCR or good TRG. The pCR rate was 16% after preoperative RCT alone and 9% with concurrent cetuximab therapy (p = 0.32). A significantly reduced TRG of >50% was found after RCT with cetuximab compared to RCT alone (p = 0.0035). This was validated by a multivariate analysis with all available clinical factors (p = 0.0037). Acute toxicity and surgical complications were not increased with additional cetuximab. CONCLUSIONS: Triple therapy with RCT and cetuximab seems to be feasible, with no unexpected toxicity. Early response assessment (TRG), however, suggests subadditive interaction. A longer follow-up (and finally randomized trials) is needed to draw any firm conclusions with respect to local and distant failure rates.

Fistula-associated anal adenocarcinoma in Crohn's disease.

BACKGROUND: Adenocarcinoma arising from perianal fistulae in patients with Crohn's disease (CD) is rare. The literature consists mainly of case reports and small series making characterization of this clinical entity difficult. We present 6 patients with CD and fistula-associated anal adenocarcinoma (FAAA) and a systematic review of published series. METHODS: Retrospective charts were reviewed of 6 consecutive patients with FAAA in CD treated from 1992 through 2007. All available variables of our patients and of all available published cases were included for statistical analysis. RESULTS: All patients treated at our institution had severe perianal CD at presentation. The average age at time of diagnosis was 45.5 years. All patients underwent abdominoperineal resection (APR) and 4 received chemoradiation. Four patients died with metastatic disease, 1 is alive with pelvic recurrence at 55 months, and 1 is alive without evidence of disease at 19 months follow-up. A total of 23 publications including 65 patients (37 female, mean age 53 years) with FAAA were reviewed in our systematic review. The average fistula duration was 14 years. Mean delay of cancer diagnosis was 11 months. APR was performed in 56 patients with an overall 3-year survival rate of 54%. Thirteen of 15 patients with node-positive tumors died with recurrent disease following surgery. CONCLUSIONS: Adenocarcinoma arising from long-standing perianal CD fistulae is being increasingly reported. The outcome is poor following operative treatment, especially if perirectal lymph nodes are involved. Periodical cancer surveillance should be performed in all patients with long-standing perianal CD fistulae.

IMRT of prostate cancer: a comparison of fluence optimization with sequential segmentation and direct step-and-shoot optimization.

BACKGROUND AND PURPOSE: Intensity-modulated radiation therapy (IMRT) has shown its superiority to three-dimensional conformal radiotherapy in the treatment of prostate cancer. Different optimization algorithms are available: algorithms which first optimize the fluence followed by a sequencing (IM), and algorithms which involve the machine parameters directly in the optimization process (DSS). The aim of this treatment-planning study is to compare both of them regarding dose distribution and treatment time. PATIENTS AND METHODS: Ten consecutive patients with localized prostate cancer were enrolled for the planning study. The planning target volume and the rectum volume, urinary bladder and femoral heads as organs at risk were delineated. Average doses, the target dose homogeneity H, D(5), D(95), monitor units per fraction, and the number of segments were evaluated. RESULTS: While there is only a small difference in the mean doses at rectum and bladder, there is a significant advantage for the target dose homogeneity in the DSS-optimized plans compared to the IM-optimized ones. Differences in the monitor units (nearly 10% less for DSS) and the number of segments are also statistically significant and reduce the treatment time. CONCLUSION: Particularly with regard to the tumor control probability, the better homogeneity of the DSS-optimized plans is more profitable. The shorter treatment time is an improvement regarding intrafractional organ motion. The DSS optimizer results in a higher target dose homogeneity and, simultaneously, in a lower number of monitor units. Therefore, it should be preferred for IMRT of prostate cancer.