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R Fietkau

Publications and source records attributed to R Fietkau.

At least 19 recordsLinked to original sources

ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology.

Enteral nutrition (EN) by means of oral nutritional supplements (ONS) and tube feeding (TF) offers the possibility of increasing or ensuring nutrient intake in cases where normal food intake is inadequate. These guidelines are intended to give evidence-based recommendations for the use of ONS and TF in cancer patients. They were developed by an interdisciplinary expert group in accordance with officially accepted standards, are based on all relevant publications since 1985 and were discussed and accepted in a consensus conference. Undernutrition and cachexia occur frequently in cancer patients and are indicators of poor prognosis. EN should be started if undernutrition already exists or if food intake is markedly reduced for more than 7-10 days. Standard formulae are recommended for EN. Nutritional needs generally are comparable to non-cancer subjects. In cachectic patients metabolic modulators such as progestins, steroids and possibly eicosapentaenoic acid may help to improve nutritional status. EN is indicated preoperatively for 5-7 days in cancer patients undergoing major abdominal surgery. During radiotherapy of head/neck and gastrointestinal regions dietary counselling and ONS prevent weight loss and interruption of radiotherapy. Routine EN is not indicated during (high-dose) chemotherapy.

Cachexia↗

Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study.

The aim of this study was to investigate the efficacy and safety of chemoradiation using capecitabine and irinotecan as neoadjuvant therapy for patients with rectal cancer. Conventional radiation was given at daily fractions of 1.8 Gy on 5 days a week for a total dose of 55.8 (50.4 + 5.4) Gy. Concurrently, irinotecan 40 mg m(-2) once weekly and capecitabine continuously at dose levels of 500, 650, 750 and 825 mg m(-2) twice daily were administered. Surgery was performed 4-6 weeks following completion of chemoradiation. A total of 28 patients (3 UICC II, 25 UICC III) were enrolled and all received treatment. Dose-limiting toxicity was diarrhoea grade IV and hand-foot syndrome at the 825 mg m(-2) dose level. The maximum tolerated dose of capecitabine was 750 mg m(-2). Diarrhoea was the most common toxicity: grade III in nine patients. Two patients died, one due to pneumonia and one due to sudden cardiac death. A complete response and only microfocal residual tumour disease was achieved in four and three patients (27%). In all, 25 of 28 patients undergoing surgery, 24 (96%) had R0 resection. Preoperative chemoradiation based on continuous daily capecitabine and weekly irinotecan appears to tolerated and effective in patients with rectal cancer.

Aged↗

Concurrent chemoradiotherapy and adjuvant chemotherapy with Topotecan for patients with glioblastoma multiforme.

PURPOSE: The prognosis for patients with glioblastoma multiforme remains poor. Phase II studies, meta-analyses and a phase III study show that concurrent chemoradiotherapy has an advantage over irradiation alone. In this study the effectiveness of concurrent chemoradiotherapy with Topotecan and an adjuvant chemotherapy with Topotecan was investigated. PATIENTS AND METHOD: Forty-two patients with predominantly unfavourable prognosis factors were included in the study and treated as follows: hyperfractionated accelerated radiotherapy (2x1.75Gy to 45.5 + 12.25 Gy (RP)) with a concurrent, continuous infusion of Topotecan (0.5 mg/m(2)/d, days 1-21). On day 28 the adjuvant chemotherapy (three courses) was begun according to the same scheme. RESULT: Haematological toxicities were 13/42 (30%) grade III leucopenia, 2/42 (4%) grade IV, as well as 5/42 (10%) grade III thrombopenias and 1/42 (2%) grade IV. 30/42 (71%) patients showed improvement or stabilisation of an existing neurological symptomatic complex. The median time to progression was 7.2 (+/- 0.8) months, the median total survival was 10 (+/- 1.2) months, the 2 year survival rate 4.7 (+/- 0.3)%. Prognostic factors were age, surgical radicality, performance status and the tumour volume before therapy. SUMMARY: Concurrent chemoradiotherapy and an adjuvant chemotherapy with Topotecan is feasible at acceptable toxicity levels also for patients with a moderate performance status. The patients benefit from the improvement of the clinical symptomatic complex and, even with unfavourable prognosis factors, have a higher median survival in comparison to data published on similar groups of patients given only radiotherapy.

Adult↗

Intensified concurrent chemoradiotherapy with 5-fluorouracil and irinotecan as neoadjuvant treatment in patients with locally advanced rectal cancer.

This study aimed to evaluate the feasibility and efficacy of neoadjuvant chemoradiotherapy intensified with irinotecan in patients with locally advanced rectal cancer. Eligible patients had nonmetastatic disease at a locally advanced stage that made R0 resection and sphincter preservation uncertain. They received preoperative radiation over 6 weeks to 45 Gy and boost of 5.4 Gy and concurrent continuous infusion 5-fluorouracil 250 mg m(-2) day(-1) and weekly irinotecan 40 mg m(-2). In all, 37 patients entered the study. T stage at baseline as determined by ultrasound was T2/T3/T4 in 2/19/16 patients; 31 patients had lymph node involvement. The predominant toxicity was diarrhoea (grade 3/4 in 10/2 patients). Haematologic toxicity and surgical complications were moderate. Among 36 patients undergoing surgery, 32 (89%) had R0 resection and 23 (64%) sphincter preservation. Pathologic complete response (pCR) was achieved in eight (22%) of 36 patients, and 10 patients (28%) had only microscopic residual disease. At 4 years, overall survival was 66%, disease-free survival 73%, local relapse rate 7%, and distant failure rate 24%. Extent of resection and postoperative nodal status were significant predictors of overall and disease-free survival. Intensified neoadjuvant chemoradiotherapy with irinotecan can be safely administered and results in a high pCR rate.

Adenocarcinoma↗

Definitive and neoadjuvant radiochemotherapy of squamous cell carcinoma of the oesophagus.

In cases of advanced carcinoma of the oesophagus with no metastatic spread, a concurrent radiochemotherapy can improve the patient's prognosis in comparison to radiotherapy alone. This approach increases the treatment-related toxicity, in particular haematological side effects. Therefore therapy must be adapted to the general condition of the patient, demanding an intensive supportive treatment and monitoring of the patient. At present the optimal radiation dose and the role of brachytherapy for the reduction of the still high rate of local recurrences has not been determined. The value of neoadjuvant radiochemotherapy for operable or inoperable tumours is unclear. Meta-analyses did show an improvement of the prognosis, however most of the randomised studies found improvement only for the recurrence rate but not for survival. The reasons for this are numerous; however, the high postoperative lethality after radiochemotherapy in some studies is conspicuous. Conversely, the initial results of randomised studies show that operative measures could possibly be forgone if a complete remission is achieved by concurrent radiochemotherapy. Nevertheless, this approach must also be regarded critically, as the local recurrence rate after radiochemotherapy alone is high and long-term results are not available.

Antineoplastic Agents↗

Adjuvant vs. neoadjuvant radiochemotherapy for locally advanced rectal cancer: the German trial CAO/ARO/AIO-94.

AIM: The standard treatment for patients with clinically resectable rectal cancer is surgery. Postoperative radiochemotherapy (RCT) is recommended for advanced disease (pT3/4 or pN+). In recent years, encouraging results of pre-operative radiotherapy have been reported. This prospective randomized phase-III-trial (CAO/ARO/AIO-94) compares the efficacy of neoadjuvant RCT to standard postoperative RCT. We report on the design of the study and first results with regard to toxicity of RCT and postoperative morbidity. PATIENTS AND METHODS: Patients with locally advanced operable rectal cancer (uT3/4 or uN+, Mason CS III/IV) were randomly assigned to pre or postoperative RCT: A total dose of 50.4 Gy (single dose 1.8 Gy) was applied to the tumour and the pelvic lymph nodes. 5-FU (1000 mg/m2/d) was administered concomitantly in the 1th and 5th week of radiation as 120 h-continuous infusion. Four additional cycles of 5-FU-chemotherapy (500 mg/m2/d, i.v.-bolus) were applied. RCT was identical in both arms except for a small-volume boost of 5.4 Gy postoperatively. The time interval between RCT and surgery was 4-6 weeks in both arms. Techniques of surgery were standardized and included total mesorectal excision. Primary endpoints of the study are 5-year survival and local and distant control. Secondary endpoints include the rate of curative (R0) resection and sphincter saving procedures, toxicity of RCT, surgical complications and quality of life. RESULTS: As of July 2002, 805 patients were randomized from 26 participating institutions. Acute toxicity (WHO) of RCT was low, with less than 15% of patients experiencing grade 3 or higher toxicity: The principal toxicity was diarrhea, with 12% in the postoperative RCT-arm and 11% in the pre-operative RCT-arm having grade 3-, and 1% in either arm having grade 4-diarrhea. Erythema, nausea and leukopenia were the next common toxicities, with less than 3% of patients in either arm suffering grade 3 or greater leukopenia or nausea. Postoperative complication rates were similar in both arms, with 12% (postop. RCT) and 12% (pre-op. RCT) of patients, respectively, suffering from anastomotic leakage, 3% (postop. RCT) and 3% (pre-op. RCT) from postoperative bleeding, and 6% (postop. RCT) and 4% (pre-op. RCT) from delayed wound healing. CONCLUSION: The patient accrual to the trial is satisfactory. Neoadjuvant RCT is well tolerated and bears no higher risk for postoperative morbidity.

Adult↗

Phase I/II clinical trial of concurrent radiochemotherapy in combination with topotecan for the treatment of brain metastases.

The prognosis of patients with brain metastases is very poor. In this phase I/II study we tested the feasibility, dosage, toxicity and tumour efficacy of a concurrent radiochemotherapy regimen including topotecan. Twenty patients were recruited between July 1998 and February 2000 (9 women, 11 men) and treated with a whole-brain irradiation of 40 Gy (some patients were also given a boost) in combination with topotecan given as a 21-day continuous infusion in a dosage of 0.4 to 0.6 mg/m2/day. The median survival was five months (95% Confidence Interval (CI): 2-8 months). In 13 of 20 patients, it was possible to evaluate the remission with computed tomography (CT) scans or magnetic resonance scans. We detected four complete responders (CRs), two partial responders (PRs), and one progressive disease (PD). 6 patients had stable disease (SD). An intracerebral recurrence was experienced in 3 patients, 3 patients experienced spinal lesions. Systemic progression of cancer outside the central nervous system (CNS) was dominant in 9 of 20 patients. A reversible, non-cumulative haematological toxicity mainly occurring from a dose of 0.5 mg/m2/day and above was dose-limiting for this type of therapy. Combined concurrent radiochemotherapy with topotecan is feasible in spite of various pretreatments. Myelosuppression was the dominant toxicity, which was reversible and manageable. We recommend a dose of 0.4 mg/m2/day of topotecan as a 21-day continuous infusion therapy in combination with radiotherapy.

Adult↗

Adjuvant versus neoadjuvant radiochemotherapy for locally advanced rectal cancer. A progress report of a phase-III randomized trial (protocol CAO/ARO/AIO-94).

AIM: The standard treatment for patients with clinically resectable rectal cancer is surgery. Postoperative radiochemotherapy is recommended for patients with advanced disease (pT3/4 or pN+). In recent years, encouraging results of preoperative radiotherapy have been reported. This prospective randomized phase-III trial (CAO/ARO/AIO-94) compares the efficacy of neoadjuvant radiochemotherapy to standard postoperative radiochemotherapy. We report on the design of the study and first results with regard to toxicity of radiochemotherapy and postoperative morbidity. PATIENTS AND METHODS: Patients with locally advanced operable rectal cancer (uT3/4 or uN+, Mason CS III/IV) were randomly assigned to pre- or postoperative radiochemotherapy: A total dose of 50.4 Gy (single dose 1.8 Gy) was applied to the tumor and the pelvic lymph nodes. 5-FU (1,000 mg/m2/d) was administered concomitantly in the first and fifth week of radiation as 120-h continuous infusion. Four additional cycles of 5-FU chemotherapy (500 mg/m2/d, i.v. bolus) were applied. Radiochemotherapy was identical in both arms except for a small-volume boost of 5.4 Gy in the postoperative setting. Time interval between radiochemotherapy and surgery was 4-6 weeks in both arms. Techniques of surgery were standardized and included total mesorectal excision. In addition, stratification according to surgeons involved has been provided for. Primary endpoints of the study are 5-year overall-survival, local and distant control, secondary endpoints include rate of curative (R0) resections and sphincter saving procedures, toxicity of radiochemotherapy, surgical complications and quality of life. RESULTS: As of 15th November 2000, 628 patients were randomized from 26 participating institutions: 310 patients were randomized to postoperative radiochemotherapy, 318 patients to preoperative radiochemotherapy. Acute toxicity (WHO) of radiochemotherapy was low, with less than 15% of patients experiencing Grade 3 or higher toxicity: The principal toxicity was diarrhea, with 12% in the postoperative radiochemotherapy arm and 10% in the preoperative radiochemotherapy arm having Grade-3, and 1% in either arm having Grade-4 diarrhea. Erythema, nausea and leukopenia were the next common toxicities, with less than 3% of patients in either arm suffering Grade 3 or greater leukopenia or nausea. Postoperative complication rates were similar in both arms, with 12% (postoperative radiochemotherapy) and 13% (preoperative radiochemotherapy) of patients, respectively, suffering from anastomotic leakage, 4% (postoperative radiochemotherapy) and 3% (preoperative radiochemotherapy) from postoperative bleeding, and 6% (postoperative radiochemotherapy) and 5% (preoperative radiochemotherapy) from delayed wound healing. CONCLUSION: The patient accrual of our trial is satisfactory, neoadjuvant radiochemotherapy is well tolerated and bears no higher risk for postoperative morbidity.

Adult↗

[3 years experience with low dosage fractionated percutaneous teletherapy in subfoveal neovascularization. Clinical results].

AIM: The effect of low dose fractionated percutaneous teletherapy to visual acuity and the changes in subfoveolar neovascular membranes in age-related macular degeneration were investigated. PATIENTS AND METHOD: 126 eyes of 118 patients (age 55-89 years; mean 74 ys.) were treated. Best distal and near visual acuity was assessed prior to (= initial visual acuity [IVA]) and 3, 6, 12, 18, 24, 30 and 36 months after teletherapy. Fluorescein angiography was performed prior to and 6, 12, 24 and 36 months after radiation therapy. For analysis patients were divided into different groups by IVA and membrane size. Maximal duration of observation was 36 months. Teletherapy was done by a 9-MeV photon linear accelerator through a lateral port in half-beam technique with a single dose of 2 Gy up to a total dose of 20 Gy within 12 days. RESULTS: No severe negative side effects have been observed. Eight patients reported of epiphora and four patients complained of transient sicca syndrome. Visual acuity decreased more than one line in the group IVA 0.05-0.2. The group IVA 0.3-0.5 remained unchanged for 1 year. We found a tendency for increased visual acuity in group IVA > or = 0.6 for 18 months. After that time both groups showed decreased visual acuity, but all these patients reported of reduced metamorphopsia and increased color and contrast perception. CONCLUSIONS: There is an influence of low dose fractionated percutaneous teletherapy on visual acuity, subfoveal neovascular membranes and metamorphopsia. IVA and duration of anamnesis play an important role. There seems to be no persistent effect; possibly increased dosage will bring a benefit.

Aged↗

Concomitant radiochemotherapy of advanced non-small-cell lung cancer.

Concurrent radiochemotherapy (RCT) is a promising new therapy option in advanced non-small cell lung cancer (NSCLC). In randomized trials concomitant RCT has been shown to be superior compared to radiotherapy alone and to sequential radiochemotherapy. In most treatment schedules platinum salts alone or in combination with etoposide, mitomycin C or vinca-alkaloids have been used. Up to now altered fractionation schemas-particularly hyperfractionated radiotherapy-have not been demonstrated to be superior to conventional fractionation (2 Gy daily up to 56-60 Gy), when employed concurrently to chemotherapy. Nevertheless open questions remain: (1) What is the best chemotherapy administered simultaneously to radiotherapy? (2) Might newer drugs (e.g. taxanes, inhibitors of topoisomerase I and II, gemcitabine) be more effective and reveal fewer side effects compared to platinum salts? (3) Is there a role for adjuvant chemotherapy following RCT? (4) What is the most effective radiotherapy schedule in concepts with RCT? (5) What radiation dose is necessary to optimize local control in RCT?

Carcinoma, Non-Small-Cell Lung↗

Effectiveness of Trastuzumab (Herceptin) in a patient with locally recurrent breast cancer after cardiac failure caused by severe cytotoxic pretreatment.

In HER2-positive breast cancer patients, the humanized anti-HER-2 monoclonal antibody trastuzumab (Herceptin) may improve overall survival. No reports exist regarding the application of trastuzumab in patients with cytotoxically induced cardiac failure and decreased left ventricular ejection fraction or about locally recurrent and advanced disease. In this case report, trastuzumab resulted in a complete and long-lasting response of recurrent and locally advanced breast cancer and was well tolerated in a severely cytotoxically pretreated patient with cardiac failure. We encourage other oncologists to offer trastuzumab also to severely cytotoxically pretreated patients with conditions after cardiac insufficiency or with locally advanced breast cancer.

Antibodies, Monoclonal↗

Extensive surgery after high-dose preoperative chemoradiotherapy for locally advanced recurrent rectal cancer.

PURPOSE: This was a pilot study of high-dose preoperative concurrent radiation and chemotherapy before extensive surgery in patients with locally advanced recurrent rectal cancer. Here we report on curative resectability, acute toxicities during chemoradiotherapy, surgical complications, local control, and three-year survival rates achieved with this aggressive multimodal regimen. METHODS: Between 1994 and 1997, 35 previously nonirradiated patients with pelvic recurrence of rectal cancer were entered in the study. All patients presented with tumor contiguous or adherent to adjacent pelvic organs and were not deemed amenable to primary curative surgery. A total radiation dose of 50.4 Gy with a small-volume boost of 5.4 to 9 Gy was delivered in conventional fractionation (single dose, 1.8 Gy). 5-Fluorouracil was scheduled as a continuous infusion of 1,000 mg/m2/day on Days 1 to 5 and 29 to 33. Six weeks after completion of chemoradiotherapy, patients were reassessed for resectability, and radical surgery was attempted whenever feasible. RESULTS: After preoperative chemoradiotherapy 28 of 35 patients (80 percent) underwent resection with curative intent. In 16 of 35 patients (57 percent) extended resection of adjacent organs was performed. Resections with negative margins were achieved in 17 patients (61 percent); 9 patients had microscopic, and 2 patients had gross residual disease. There was no postoperative mortality. Fourteen patients (44 percent) experienced postoperative complications. Toxicity from chemoradiotherapy occurred mainly as diarrhea (National Cancer Institute Common Toxicity Criteria Grade 3; 23 percent), dermatitis (Grade 3; 11 percent), and leucopenia (Grade 3; 11 percent). One patient died of tumortoxic multiple organ failure during chemoradiotherapy. With a median follow-up of 27 months, local re-recurrence after curative resection was observed in only three patients (18 percent); six patients developed distant metastases. Three-year actuarial survival rate was significantly improved after complete resection (82 percent) as compared with noncurative surgery (38 percent; P = 0.03). CONCLUSION: A combination of high-dose preoperative chemoradiotherapy followed by extended surgery can achieve clear resection margins in more than 60 percent of patients with recurrent rectal tumor not amenable to primary surgery. An encouraging trend evolved for this multimodal treatment to improve long-term local control and survival rate.

Adult↗