Background and purpose: Patients with severely impaired pulmonary function have an increased operative risk for major lung resection. The clinical benefits of pre-and perioperative, non-invasive pressure support ventilation (NIPSV) have up to now not been extensively evaluated. Patients with severely reduced pulmonary function were investigated in this prospective and randomised single centre clinical trial. Methods: Standard pulmonary evaluation was performed in all patients before major lung resection. To predict postoperative pulmonary function, a lung perfusion-ventilation scan was carried out. All patients enrolled in the study were instructed preoperatively on how to use a NIPSV respirator. After lung resection patients were randomised either for continuation of NIPSV or for standard treatment. Results: Of the 52 patients assessed, 21 patients met the inclusion criteria for the study protocol. Predicted mean postoperative FEV 1 was 1.10 L (range 0.92 -1.27 L). Lobectomy was performed in 14 patients, pneumonectomy in 6 patients and a segmentectomy in 1 patient. No inhospital deaths occurred. Pulmonary complications (reintubation, pneumonia) were more frequent in the NIPSV group than in the control group (3 patients versus 1 patient), without statistical significance (p = 0.31). Conclusions: We observed no mortality and a low morbidity in this high risk group. Postoperative continuation of NIPSV had no beneficial effect on the clinical outcome. Preoperative conditioning with NIPSV, however, seems to be a suitable tool for patients with severely impaired pulmonary function. This study may serve therefore as basis for further investigations for the potential clinical benefits of prophylactic NIPSV in major lung surgery.
Background: Cisplatin-based chemotherapy in combination with thoracic radiotherapy is frequently used as a standard treatment for patients with unresectable NSCLC stage IIIA/ IIIB disease. Within three years up to 70% of these patients develop a disease recurrence and a subgroup relapses within the radiation fi eld. Th erapy is challenging for this patient group, since a high degree of tumour hypoxia often makes these tumours resistant to chemotherapy, even if small portions of normoxic regions, in particular in the outer regions of the tumour, might still exist. As Mitomycin is known to be effective under hypoxic conditions, a combination of Mitomycin with Vinorelbine or Cisplatin was used to treat relapses that occur in the radiation fi eld. Simultaneously, erythropoietin was applied to decrease tumour hypoxia.Methods: Fifteen patients pretreated with defi nitive radio-or radio-chemotherapy who developed a symptomatic relapse within the radiation fi eld were enrolled in the study: 5 patients with stage IIIB and 10 with stage IV. Patients received Mitomycin 8 mg/m 2 on day 1 with either Vinorelbine 25 mg/ m 2 (in case of Cisplatin pretreatment) on days 1 and 8 or Cisplatin 40 mg/m 2 on days 1 and 8 of a 21-day cycle to a maximum of 4 cycles. 40,000 IE Erythropoietin was administered s.c. every 7 days to maintain Hb levels between 12 and 13.0 g/ dl. Response (WHO criteria), time to progression, survival, toxicities and Hb values were evaluated.Results: A median of 2 cycles was administered (1-4). Fourteen patients were assessable for clinical response, one died before fi rst tumour response evaluation. One patient achieved a partial response, stable disease was observed in 6 patients. Median time to progression was 2.3 months (95% CI, 1.20-5.60 months) and median survival was 4.6 months (95% CI, 3.42-6.54 months). Main Grade 3/4 toxicities included leucocytopenia (4/15) and neutropenia (4/15). One patient died of a pulmonary fi brosis probably due to Mitomycin medication. Median Hb levels were maintained above 11 g/dl.Conclusion: Th is is the fi rst trial investigating a standardised treatment of pretreated patients with a relapse within the radiation fi eld. Th e therapeutic concept including Mitomycin for the treatment of recurrent disease in the radiation fi eld off ers an active regimen with modest toxicity. Stable disease was observed in 43%, partial response in 7% of the patients and reaches a similar rate as known from chemotherapy results of pretreated patients. Median survival was poor, but may be due to the limited prognosis of this selected patient cohort. Th ere was a trend to better results in patients with performance status 0 or 1 and response to previous radiochemotherapy. Further studies for patients with radiation fi eld relapses are warranted.
10600 Background: MAINTRAC as developed by our coworkers from Jena finds more CETC. They found CETC in 90% of high risk patients. Circulating cells in epithelial mesenchymal transition (EMT+) should be detectable in early disease. Methods: 2 colours (7AAD, EP-FITC) detected living and dead cells. Cells in EMT (EP-FITC, Vim-PE) were analysed in paralell. Complex marker expression urged us to introduce a three colour technique. 1. EPCAM-FITC, Vimentin-PE and DAPI , marking living or dead cells in EMT. 2. EP-FITC, Vim-PE and CD44 PB for stemness. ACA9 (hypoxia) and PARP-1 expression (genotox) were used too. Results: In the 2 colour phase we examined CEC in 110 patients with early disease and 44 patients with metastasis. Cells were detectable in both disease situations in 50 and 60% of patients, in a control population only in few patients low numbers were found. In non cancer situations e.g liver disease high numbers of EMT+cells were found.The results of 3 colour analysis are shown in the table. No clear differences between the classical risk groups are found, other subgroups are too small yet to be considered. Conclusions: Our findings show that in both disease situations cells merging EMT, stemcells ( EP+,Vim+.CD44+) and other markers are detectable. This cell type however is found also in non cancer conditions.We hypothesize that hypoxia is the common driver. Metastasis gives different patterns. Highly aggressive cancers show often none or few cells. In less agressive disease high cell numbers are found. We need to characterize the "benign" EMT phenomenon, as it could mingle with "real" CTC. Definitely liver is the source of these benign cells. Multi colour analysis will reveal the differences. Nevertheless monitoring of this special cell type could give new insights in the metastatic process in early and late disease. [Table: see text]
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