Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE), endorsed by the European Society for Radiotherapy and Oncology (ESTRO), the European Society of Digestive Endoscopy (ESDO), and the European Society for Clinical Nutrition and Metabolism (ESPEN). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations for malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliative treatment of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass (strong recommendation, high quality evidence). 2 For patients with longer life expectancy, ESGE recommends brachytherapy as a valid alternative or in addition to stenting in esophageal cancer patients with malignant dysphagia. Brachytherapy may provide a survival advantage and possibly a better quality of life compared to SEMS placement alone. (Strong recommendation, high quality evidence.) 3 ESGE recommends esophageal SEMS placement as the preferred treatment for sealing malignant tracheoesophageal or bronchoesophageal fistula (strong recommendation, low quality evidence). 4 ESGE does not recommend the use of concurrent external radiotherapy and esophageal stent treatment. SEMS placement is also not recommended as a bridge to surgery or prior to preoperative chemoradiotherapy. It is associated with a high incidence of adverse events and alternative satisfactory options such as placement of a feeding tube are available. (Strong recommendation, low quality evidence.) Main recommendations for benign disease 1 ESGE recommends against the use of self-expandable stents (SEMSs) as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and costs (strong recommendation, low quality evidence). 2 ESGE suggests consideration of temporary placement of SEMSs as therapy for refractory benign esophageal strictures (weak recommendation, moderate evidence). Stents should usually be removed at a maximum of 3 months (strong recommendation, weak quality evidence). 3 ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures, because of their lack of embedment and ease of removability (weak recommendation, low quality evidence). 4 For the removal of partially covered esophageal SEMSs that are embedded, ESGE recommends the stent-in-stent technique (strong recommendation, low quality evidence). 5 ESGE recommends that temporary stent placement can be considered for treating esophageal leaks, fistulas, and perforations. The optimal stenting duration remains unclear and should be individualized. (Strong recommendation, low quality evidence.) 6 ESGE recommends placement of a SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive esophageal variceal bleeding (strong recommendation, moderate quality evidence).

Optimization and it's influence on value of doses in HDR and PDR brachytherapy.

The aim of this work is to examine the influence of the dose optimization procedure on the value of radiation doses in organs of risk and to compare value of doses measured in healthy tissues according to chosen different PDR brachytherapy (PDRBT) and HDR brachytherapy (HDRBT) fractionation schedule. Fifty one patients treated with PDRBT were qualified for calculations. This group included patients with head and neck cancer, brain tumor, breast cancer, sarcoma, penile cancer and rectal cancer. The doses were calculated in chosen critical points in surrounded healthy tissues. For all treatment plans the doses were compared with the use of the BED (Biologically Equivalent Dose) formula and PDR along with HDR values were calculated. Differences among total doses in PDRBT and different schemas of HDRBT in critical points before and after dose point and volume optimization, were analyzed. The same dependences were examined also for BEDs. One ascertained that in biologic equivalent (to PDR) HDRBT the increase of fraction dose from 4 Gy to 10 Gy caused the necessity of decrease of total dose in treatment area (p<0,001). The use of HDR instead of PDR essentially lowered physical and biological doses in examined organs of risk. In many examined critical points in organs of risk where biological equivalence dose in the treatment area was the same, one ascertained the decrease of total physical HDR dose according to the growth of the fraction dose. Similar dependences appeared also for biologically equivalent doses. The optimization process in PDRBT improved the dose homogeneity in the treatment area, but simultaneously induced unprofitable (essential statistically) increase of dose in some healthy organs of risk, what makes an increase risk for radiation-induced complications. The use of biologically equivalent HDRBT instead of PDRBT makes for the decrease of physical doses in the treatment area and the decrease of physical and biologically equivalent doses in healthy organs of risk.

The use of high dose rate endobronchial brachytherapy to palliate symptomatic recurrence of previously irriadiated lung cancer.

Endobronchial obstruction associated with lung cancer represents a common and potentially life threatening complication of newly diagnosed or recurrent disease. The vast majority of patients with obstructive lesions are not curable so it is desirable to palliate these patients as quickly as possible without compromising quality of life. High dose rate brachytherapy (HDR-BT) represents a therapeutic option with several advantages over external beam radiotherapy (EBRT), particularly in previous irradiated patients. The primary objective of this retrospective analysis was to assess palliation efficacy and complication rate of repeated brachytherapy treatment in previously irradiated patients. Between July 2000 and December 2005, 270 patients with endobronchial recurrence after prior given HDR-BT and / or another treatment modality were again treated with HDR-BT. It makes 270 of 1036 patients (26 %) treated on lung cancer with HDR-BT at all in this period. Brachytherapy was delivered with a dose per fraction 8 or 10 Gy specified from the center of the source at 0,5 or 1,0 cm. The symptomatic response rate were as follows: dyspnea had a 76 % response rate, cough 77 % response rate, hemoptysis 92 % response rate, and post-obstructive pneumonia 82 % response rate, respectively. Among 270 of the patients 218 had follow up endoscopic examination (1 â 3 months after brachytherapy completion). Total response rate in this group was 80 %. Of 200 patients whose chest x-ray showed evidence of collapse or atelectasis caused by endobronchial recurrence obstruction, 146 (73 %) had evidence of re-aeration. The median duration of palliation, marked by symptoms or a chest x-ray that worsened was five months, the range varying from 2 to 14 months. We have noticed superficial mucosal necrosis in 166 of patients (61,5 %) and broncho-esophageal fistula in 6 of patients (2,2 %). Repeated HDR-BT effectively relieves the symptoms of endobronchial obstruction due to recurrent lung cancer and can be given safely as an outpatient procedure. Future studies should aim to determine the maximum tolerated dose and appropriate patient selection.

Advanced tracheal carcinoma--a therapeutic significance of HDR brachytherapy in palliative treatment.

The purpose of this study was to determine the benefit of high dose rate endotracheal brachytherapy as an exclusive palliative treatment of obstructive tracheal cancer. Thirty-five patients with advanced tracheal carcinoma were treated between May 1999 and March 2001 in Greatpoland Cancer Center. They were qualified for brachytherapy due to life-threatening situations. Fourteen patients were irradiated using three fractions 7.5 Gy each one every week, six patients received three fractions 10 Gy each one every week and fifteen patients received one fraction of 10 Gy. Survival time was compared with chosen clinical factors (age, sex, Karnofsky status, tumor location, lymph nodes involvement and percent of obturation) and prescribed dose. The median survival (Kaplan-Meier) for all patients was 6.6 months. Patients with an endoscopically controlled complete remission 4 weeks after the treatment had a significantly better survival in comparison to patients with a partial remission or no change of tumor size (p=0.0003). Univariate analysis revealed significant difference between patients with Karnofsky score equal with 60 or lower (28/35, 80%) and higher than 60 (7/35, 20.0%) (p=0.005). Difference between the grade of tumor obturation (more than 60% of tracheal lumen (27/35, 77.1%), 60% or lower (8/35, 22.9%) was found in univariate analysis (p=0.04). In multivariate analysis statistically important prognostic factor for survival was Karnofsky score (p=0.04). Statistical analysis revealed no differences in survival according to sex and age (p=0.43 for age, p=0.19 for sex), tumor localization (p=0.13), lymph node involvement (p=0.48) or fractionation scheme (p=0.62). Exclusive HDR brachytherapy of advanced tracheal carcinoma was a safe palliative method of treatment and caused in many patients prolonged survival and improved quality of life. Most important prognostic factor for survival, confirmed in both univariate and multivariate analysis, was Karnofsky score.

Bilateral breast cancer.

The aim of this study was to evaluate the clinical and pathological features of breast cancer patients with bilateral breast cancer and to assess the impact of the second breast cancer on their prognosis. Thirty six breast cancer patients with bilateral (metasynchronous) cancer were treated in Greatpoland Cancer Center from 1983 to 1995. It constituted 4.1% of all breast cancer patients treated in those years. 5-year survival rates were compared with clinical data (age, clinical stage, histological diagnosis), methods of treatment and length of interval between occurring of both tumors. Five year survival of patients treated for second breast cancer was 55.6% (20/36), disease-free survived--15/36 (41.7%). 5-year survival rate was greater in group of patients with clinical stage T1 or T2 (69.6%, 16/23) than in group with T3 or T4 (30.8%, 4/13) (p=0.009). In group of 20 patients without nodal involvement (N0) 5 years survived 75.0% of patients (15/20), in group with N1--11.1% (1/9) (p=0.01). Length of interval between both breast tumors influenced 5-year survival rate. In group of patients with interval longer than 5 years, 5-year survival rate was 73.9% (17/23), in group of patients with interval shorter than 2 years--0% (0/6) (p=0.002). No correlations were observed between survival rate and age, histological diagnosis, methods of treatment.

Locoregional recurrence of breast cancer: a retrospective comparison of treatment methods.

The study was made to evaluate the clinical and pathological features of breast cancer patients with locally recurrent breast cancer and to assess the impact of the treatment method on their prognosis. Fifty-four patients with local recurrence after breast cancer were treated in Greatpoland Cancer Center between 1983 and 1995. It constituted 6.2% (54/878) of all patients with breast cancer treated in this period. Median length of interval between primary lesion and recurrence was 26.6 months, in 12/54 cases (22.2%) was longer then 5 years. Patients in time of recognizing primary breast cancer had tumor in clinical stage T2 (n=25) and T3 or T4 (n=29), in stage N0 (n=16) and N1 (n=36). Patients with recurrent breast cancer were treated using different methods. In 26 cases recurrent tumor was excited and then, in 15 cases irradiated, in 11 cases irradiated and additionally treated by chemotherapy or by hormonotherapy. In 28 cases patients were disqualified for excision due to local advance of disease. They were all irradiated and then treated by chemotherapy (n=17) or hormonotherapy (n=11). 5-year survival rates were compared with the chosen clinical factors (age, clinical stage, histopathology), length of interval between primary tumor and recurrence and with different methods of treatment including excision or not. 5-year overall survival rate was 33.3%. In locally advanced tumors (stage T3) the effect was worse then in stage T2 tumors. Five-year survival rates after recurrence were 20.8% and 52.0%, respectively (p=0.001). No statistically important correlations between lymph node involvement, age, histology and survival rate were found. Differences between 5-year survival rate were observed according to length of interval between recognizing the primary lesion and recurrence. Patients with interval shorter then 24 months had survival rate 14.3%, between 24 and 60 months - survival rate 64.3% and with interval longer then 60 months - 41.7%. Statistically important differences were noted between first and second group (p=0.01) and first and third group (p=0.03). Patients treated with local excision followed by radiotherapy and/or systemic therapy had greater 5-year survival rate (53.9%) then patients disqualified for incision (14.3%) (p=0.0001).

Significance of DNA ploidy measurements in Spitz nevi.

In 28 Spitz nevi DNA content was determined by video-imaging cytometry. The nevi were selected for this study because of difficulties in differentiation from melanoma and heterogeneity of this type of nevus. Morphological features of Spitz nevi and differences helpful for differentiation between Spitz nevi and malignant melanoma were identified. DNA ploidy was measured in paraffin embedded and fresh tissue material from each patient and the results were comparable. The sample preparation process and video-imaging method are presented in this study. Twenty two (78.6%) lesions contained diploid cell populations, 5 (17.9%) aneuploid and 1 (3.6%) tetraploid cell population. A significant correlation was observed between DNA ploidy measured in fresh tissue and retrospective material. The results indicate the presence of abnormal DNA content in some of the lesions. This observation does not indicate that DNA ploidy cytometry is useful for the differentiation of Spitz nevi from malignant melanoma.

[Malignant vulvar melanoma]. / Czerniak zlosliwy sromu.

Vulvar malignant melanoma is a rare neoplasm with mostly poor prognosis. As compared with malignant melanoma of the skin vulvar melanoma infiltrates early deep into tissues and into abundant lymph and blood vascularisation. Epidemiology, clinical and histopathological data of primary vulvar melanoma are presented. Currently used methods of treatment are analysed. According to many authors the radical vulvar excision with bilateral lymphangiectomy in all stages of melanoma is a treatment of choice. Due to small population of patients with vulvar melanoma the randomized trials comparing different methods of treatment are not existing. Vulvar melanoma remains controversial medical problem with poor prognosis.

[A case of metastatic malignant melanoma of the vagina with a background of primary vaginal melanoma--clinical case]. / Przypadek przerzutowego czerniaka zlosliwego pochwy na tle czerniaka pierwotnego pochwy--przypadek kliniczny.

Primary vaginal malignant melanoma is an uncommon disease with poor prognosis. As compared with malignant melanoma of the skin, vaginal melanoma infiltrates early deep into tissues and in the abundant lymph and blood vascularisation. Epidemiology, clinical and histopathological data and treatment methods of primary and metastatic vaginal melanoma are discussed. A case of 53 years old women with malignant melanoma of the skin with metastasis to vagina treated in Wielkopolska Center of Oncology is presented. According to the literature aggressive surgical therapy can improve greatly the outlook for patients with vaginal melanoma.

Examination of DNA-ploidy in melanocytic nevi cells using video-imaging cytometry.

DNA content in 61 different types of melanocytic nevi was determined by video-imaging cytometry. The nevi were selected for this study because of melanoma risk associated with each nevus, which is 20-50% according to different authors. DNA ploidy was detected in paraffin embedded and fresh tissue material of each patient and the results were comparable. The sample preparation process and video-imaging method were presented in this study, 47 (77.0%) lesions exhibited diploid cell populations, 13 (21.3%) aneuploid and 1 (1.7%) tetraploid cell population. A significant correlation was observed between DNA ploidy measured in fresh tissue and retrospective material. The results indicate the presence of abnormal DNA content in some of the lesions.

DNA ploidy in malignant melanoma, skin cancer and pigmented nevi.

The determination of DNA content in human cancers is the subject of increasing interest, particularly in view of its potential clinical applications. There are relatively few studies which describe DNA content of skin neoplasms and pigmented nevi. These studies have shown conflicting results. In the present investigation the authors measured DNA ploidy using flow and video-imaging cytometry in 51 malignant melanomas, 20 skin cancers and 48 pigmented nevi. For DNA measurement paraffin embedded tissues and fresh cell smears were used. Clinical and histological data of malignant melanomas were recorded and correlated with DNA ploidy. DNA histograms were examined for DNA aneuploidy by DNA Index. DNA ploidy in primary lesions of melanomas and their metastases were compared. The aneuploidy rate, found in our observation, was significantly higher in whole malignant melanoma group, in clinical Stage II and III, in tumors with thickness greater then 1.5 mm, tumors with Clark level III, IV and V. Another clinical and histological factors did not show significant correlation with ploidy. Aneuploidy was found in 8 of 20 (45.0%) skin cancers. In the whole population of pigmented nevi aneuploid DNA content was identified in 10 nevi (20.1%). The results of this study suggest that aneuploidy seems to be connected with advanced stage of malignant melanoma but it does not replace other prognostic factors. Both cytometric methods can be used for routine DNA ploidy analysis. Ploidy studies are not useful for predicting metastatic potential of primary melanoma. Results obtained from fresh cell smears and paraffin embedded tissues were identical.