SummaryTo evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel, cisplatin and 24 h continuous infusion of 5-FU/folinic acid in patients (pts) with unresectable, locally advanced or metastatic gastric adenocarcinoma. Forty-five chemotherapy-naive pts (28 male and 17 female) with a median age of 60 years (range 35-74) were enrolled. 5-FU 2 g/m 2 was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m 2 as a 2 h infusion. Paclitaxel 175 mg/m 2 was administered as a 3 h-infusion on days 1 and 22 and cisplatin 50 mg/m 2 as 1 h infusion on days 8 and 29. Six weeks of therapy (days 1, 8, 15, 22, 29, 36) followed by 2 weeks rest were considered one cycle. A median of 3 cycles (range 1-4) were administered to 45 pts assessable for response, survival and toxicity. Five pts (11%) obtained a CR and 18 pts (40%) a PR (ORR 51%; 95% Cl: 35.8-66.3%). Responses were achieved in the liver, lymph nodes, lungs and at the site of the primary tumour. Nine pts (20%) had stable disease. Thirteen pts (29%) were considered to have failed treatment, 8 pts (18%) due to progressive disease and 5 pts (11%) who did not receive one complete cycle of therapy due to acute non-haematologic toxicity. The median progression-free and overall survival times were 9 months (range 1-36+) and 14 months (range 2-36+), respectively. Neutropenia WHO III°/IV°occurred in 7 pts (15%) with only 1 pt having grade IV. Additional non-haematologic WHO III°/IV°toxicities included nausea/vomiting in 5 (11%), alopecia in 22 (49%), and diarrhoea in 1 patient each (2%). Dose reductions or treatment delays were necessary in 8 pts (17%), mainly due to neutropenia. All pts were treated on an outpatient basis. The combination of paclitaxel, cisplatin and continuously infused 5-FU/folinic acid appears to be a highly active regimen for the treatment of pts with advanced gastric cancer. While the overall acceptable toxicity allows its use in the palliative setting, it may also be an attractive option to be tested for neoadjuvant or adjuvant treatment.

The aim of this study was to evaluate the toxicity and efficacy of combination chemotherapy with weekly 24-h continuous infusion of 5-fluorouracil (5-FU)/folinic acid, weekly paclitaxel and 3-weekly cisplatin in patients with unresectable, locally advanced or metastatic gastric adenocarcinoma. Between November 1999 and November 2001, 29 chemotherapy-naive patients (13 male and 16 female) with a median age of 56 years (range 22-72) were consecutively enrolled at three centers. 5-FU 2 g/m2 was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m2 as a 2-h infusion. Paclitaxel 80 mg/m2 was administered as a 1-h infusion weekly and cisplatin 50 mg/m2 as 1-h infusion on days 8 and 29. Six weeks of therapy (days 1, 8, 15, 22, 29 and 36) followed by 1 week of rest was considered one cycle. A median of 3 cycles (range 1-5) was administered to 29 patients with a total of 73 cycles applied. All patients were assessable for toxicity and survival, 28 patients were assessable for response (one patient received less than one complete cycle and could not be evaluated for response). Four patients (14%) obtained a complete response and 10 patients (34%) a partial response (overall response rate 48%, 95% CI 29-68%). Seven patients (24%) had stable disease. Seven patients (24%) had progressive disease during or within 4 weeks after treatment. The median progression-free and overall survival times were 8 months (range 1-23) and 11 months (range 1-23), respectively. Overall toxicity was acceptable. Hematological toxicity was favorable with only one patient (3%) experiencing WHO grade 3/4 leukocytopenia and one patient (3%) WHO grade 3/4 anemia. Non-hematologic WHO grade 3/4 toxicities included alopecia in 19 (66%), nausea/vomiting in six (21%), diarrhea in six (21%), neurotoxicity grade 3 in three (10%) and infection in three (10%) patients. A total of 42 applications (10%) (range 0-5) had to be postponed and dose reductions of at least one drug was necessary in 37% of applications. In three patients (10%) treatment was stopped because of toxicity. All patients were treated on an outpatient basis. Thus, the combination of weekly paclitaxel, cisplatin and continuously infused 5-FU/folinic acid appears to be a highly active regimen for the treatment of patients with advanced gastric cancer. Compared with our previous experience with the same combination of drugs but using paclitaxel at 175 mg/m2 given every 3 weeks, the protocol with weekly application of paclitaxel 80 mg/m2 shows a reduced incidence of hematologic toxicity, particularly leukopenia. Other organ toxicities apart from a slightly higher incidence of peripheral neuropathy were comparable between the two treatment protocols. Efficacy with a response rate of 50% was well preserved by this weekly regimen.

It was our goal to compare the Proseal-laryngeal mask airway (PLMA) with the classical laryngeal mask airway (LMA) in a german multicenter trial. Handling of the instruments and application criteria were to be tested. 7 anaesthesia departments were able to take part in this study. 280 patients could be investigated after approval of the ethics committee of the medical faculty of the university of Goettingen. 145 patients received the PLMA and 135 the LMA. The surgical interventions were small to moderate procedures with a duration of at least 20 minutes in the sections general surgery, trauma/orthopedic surgery, urology, vascular surgery, gynecology, ENT-surgery and ophthalmology. There was equivalence of the two instruments PLMA and LMA concerning duration and ease of insertion, endoscopic position check, observations on emergence, potential for injury and some postoperative complaints. This equivalence could be confirmed statistically. Laryngospasm was observed in three, Bronchospasm in two patients with the PLMA, in no one with the LMA. In one case of laryngospasm and another of bronchospasm a mechanism of supraglottic laryngeal stenosis has been involved which may occur in rare instances with the PLMA. This mechanism is due to the double cuff of the PLMA with the instruments proximity to the laryngeal inlet. The seal pressure in both groups differs significantly (p = 0.001). The mean value for the seal pressure was 29,3 +/- 0,21 mbar for the PLMA and 20,9 +/- 0,21 mbar for the LMA. In the PLMA the gastric tube could be positioned with the first attempt in 118 patients, with the second attempt in 17 cases. In 10 patients the gastric tube could not be placed. Contrary to the LMA the tip of the PLMA cuff may be bent in some cases with loss of airway safety and positioning of the gastric tube. The symptoms sore throat and painful swallowing on the first postoperative day were more frequent with LMA application. These differences could be confirmed statistically (sore throat p = 0.01, painful swallowing p = 0.04). They may be explained by the more rigid LMA compared to the PLMA and by the fact that the LMA in this study was older than the PLMA, loosing plasticizer. The drainage tube within the PLMA offers safety from aspiration in patients with no primary aspiration risk, additional reassurance for a correct position and a better stability of the airway. Our data may support a wider indication range for the PLMA compared with the LMA. The PLMA may be applied in laparoscopies and lower abdominal surgical interventions. Careful clinical observation will show, if the minimal invasiveness of the PLMA offers an advantage for these patients. The PLMA should not be applied in patients with increased aspiration risk.

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Schäden und Gefahren durch Einsatz der Kehlkopfmaskenen Beißblocker oder dem Schlauch der Kehlkopfmaske führt zur endgültigen Dislokation von vorher durch Parodontose oder vorherige Verletzung gelockerten Frontzähnen. Das Risiko kann gemindert werden durch den Einsatz eines passenden Beißblockers. Obwohl Zahnschäden nicht als typisches Risiko bei Kehlkopfmaskeneinsatz gelten, ist also die Beachtung des Zahnstatus auch hier geboten. Halsschmerzen Halsschmerzen nach Einsatz der Kehlkopfmaske sind nicht selten, sie werden in der Häufigkeit mit ca. 10% angegeben (zwischen 0 und 70% [2]). Die Häufigkeit hängt vom Cuff-Druck ab [10]. Wenn man beachtet, daß auch bei Maskennarkosen postoperativ eine Häufigkeit von 18% gefunden wurde, während in derselben Studie die tracheale Intubation mit einer Halsschmerzfrequenz von 45-65% belastet war [22], dann scheint hier kein schwerwiegendes Problem zu liegen. Eine Beschränkung in Cuff-Druck und eine wiederholte intraoperative Druckkontrolle bei längeren Narkosen läßt sich aus den bekannten Befunden ableiten. Ob die Vermeidung von Lidocaingel als Gleitmittel einen Beitrag zur Senkung der Häufigkeit dieser Komplikation liefern kann, wie das für die tracheale Intubation gezeigt wurde [25], darf vermutet werden.