A matched pair analysis of intra- and postoperative catumaxomab in patients with ovarian cancer from a multicenter, single-arm phase II trial versus a consecutive single-center collective of ovarian cancer patients without immunotherapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5080-5080 ◽  
Author(s):  
Klaus Pietzner ◽  
Radoslav Chekerov ◽  
Alexander Reinthaller ◽  
Daniel Reimer ◽  
Toralf Reimer ◽  
...  

5080 Background: Advanced ovarian cancer is still connected to high mortality rates due to intraperitoneal tumor cells that survive radical cytoreductive surgery as well as adjuvant chemotherapy. These persistent tumor cells need to be targeted in order to improve survival. Catumaxomab has demonstrated the ability to kill EpCAM-positive intraperitoneal tumor cells of ovarian cancer patients in studies aiming to controll malignant ascites in the recurrent setting. This analysis was conducted to investigate the efficacy of intraperitoneal catumaxomab at the timepoint of primary cytoreductive surgery and postoperative period, prior to standard adjuvant chemotherapy. Methods: Ovarian cancer patients undergoing radical surgery received one intraoperative (10 μg) followed by four subsequent intraperitoneal (i.p.) dosages (10, 20, 50 and 150 μg) of catumaxomab on days 7, 10, 13, and 16, respectively. Because of the single arm design of the study, the patients treated with catumaxomab were compared in a matched pair analysis to consecutive patients with primary ovarian cancer who received standard treatment without catumaxomab in a large center, in order to compare survival. The two main prognostic factors of stage and level of tumorreduction were chosen as matching criteria. Results: Of 58 patients screened, 41 were treated with catumaxomab and available for survival evaluation. Median age was 57 years in the catumaxomab group and 59 years in the matched-pair control group. The most comon histology was the serous subtype with 70.7 % in the catumaxomab and 80.5 % of the patients in the control group. The median for overall survival was reached for the historical consecutive matched-pair control collective, but is not yet reached for the catumaxomab group. However, 3-year survival data were available for both groups and showed survival of 85.4% (35) in the catumaxomab group and 63.4% (26) in the matched-pair control group (p-value: 0.041; HR 2.073) Conclusions: There seems to be a trend to beneficial 3-year survival in the catumaxomab group, suggesting that a phase III trial is warranted.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 2544-2544 ◽  
Author(s):  
M. A. Stroehlein ◽  
K. U. Gruetzner ◽  
A. Tarabichi ◽  
K. W. Jauch ◽  
K. Bartelheim ◽  
...  

2544 Background: Peritoneal carcinomatosis (PC) due to GI-tract cancer is an advanced tumor stage with poor survival. At present, no standard therapy has been recommended, as chemotherapy and surgery showed only limited efficacy in affected patients. When applied intraperitoneally (i.p.), the trifunctional antibody catumaxomab could be shown to destroy intraperitoneal tumor cells in patients with malignant ascites due to ovarian cancer. While binding simultaneously to EpCAM (on tumor cells), CD3 (T cells) and, via the Fc region, to Fc gamma receptor 1 and 3 on accessory cells, it induces a complex immunoreaction against epithelial tumor cells. The aim of this study was to investigate clinical efficacy of i.p. catumaxomab therapy in patients with PC compared to a matched control group. Methods: Between 2003 and 2005, 22 patients with PC due to cancer of colon (n=10), stomach (8), pancreas (3) and CUP (1) received treatment with catumaxomab within a phase I study. Treatment consisted of 3 to 4 i.p. applications (10–200 μg) of escalating catumaxomab doses. The survival was compared with patients receiving conventional therapies in a matched-pair analysis regarding sex, age, tumor surgery, chemotherapy, and extent of PC. Patients with existing ileus and clinically significant ascites were not included. Results: Follow up of patients receiving catumaxomab showed a median survival of 12.2 months (range 2–34) after first diagnosis of peritoneal carcinomatosis vs. 9.7 months (range 1–40) in patients with conventional treatment (p=0.005; log-rank). These data will be updated at presentation. Conclusion: Intraperitoneal treatment with the trifunctional antibody catumaxomab may be an attractive option for treatment of patients with peritoneal carcinomatosis due to GI-tract cancer. The convincing results have to be further investigated in clinical phase II/III trials. [Table: see text]


Author(s):  
Alexander Rühle ◽  
Sofie Rothhaar ◽  
Erik Haehl ◽  
Tobias Kalckreuth ◽  
Tanja Sprave ◽  
...  

Abstract Purpose This study analyzed survival and toxicity after (chemo)radiotherapy for primary salivary gland cancer patients aged ≥ 65 years and compared these results with younger patients using a matched-pair analysis. Methods Twenty-nine elderly patients with primary salivary gland carcinomas treated with (chemo)radiotherapy from 2008 to 2020 at University of Freiburg Medical Center were analyzed for oncological outcomes and therapy-associated toxicities. Local/locoregional control (LRC), progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan–Meier method, and the influence of clinical parameters on patient outcomes was assessed. A matched-pair analysis was performed after matching with patients < 65 years. Results Nine patients (31.0%) received definitive (chemo)radiotherapy, and 20 patients (69.0%) were treated in the adjuvant setting. 2-year LRC, PFS and OS ranged at 82.4%, 53.7% and 71.8%, respectively. Smoking (HR 3.980, p = 0.020), reduced performance status (HR 3.735, p = 0.016) and higher comorbidity burden (HR 4.601, p = 0.005) correlated with inferior OS. Using a matched-pair analysis with younger patients, elderly patients exhibited a trend towards reduced OS (HR 3.015, p = 0.065), but not PFS (HR 1.474, p = 0.371) or LRC (HR 1.324, p = 0.633). Acute and chronic grade 3 toxicities occurred in 31.0% and 12.5% of elderly patients, respectively, and the matched-pair analysis revealed no significant differences between age groups regarding treatment-related toxicities. Conclusion Treatment-related toxicities as well as LRC and PFS were comparable for salivary gland cancer patients undergoing radiotherapy. Therefore, concerns for more pronounced toxicities or reduced local/locoregional response rates should not guide treatment decisions in affected elderly patients.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2283-2283
Author(s):  
Nadira Durakovic ◽  
Ana Boban ◽  
Mirando Mrsic ◽  
Dubravka Sertic ◽  
Ranka Serventi Seiwerth ◽  
...  

Abstract Infections due to multidrug-resistant (MDR) Gram-negative bacteria have been increasing and they are an important cause of nosocomial morbidity and mortality, especially in immunocompromised patients. In order to determine efficacy and safety of colistin (colistimethate sodium) use in the treatment of MDR Pseudomonas aeruginosa sensitive to colistin, a comparison of renal function, other toxicities, and outcome of therapy was done between a group of patients treated with colistin and patients treated with other antipseudomonas drugs as control group. A group of 26 patients that was hospitalized in our institution between February 2002 and December 2006 and treated with intravenous colistin for an infection caused by MDR P.aeruginosa was compared in a matched-pair analysis to a group of 26 patients treated with other antipseudomonas drugs. Patients were 52% male and 48% female; mean age was 37 years (range 17–63). All of the patients were treated for haematological malignancy, most received intensive chemotherapy regimens (44%), 19% received allogeneic and 31% autologous transplants. Groups of patients did not differ in age, sex, disease, or kind of treatment received. All of the patients in both groups had clinical signs of sepsis; in 69% of patients from colistin group and 84% from control group P.aeruginosa was isolated from blood, and in 27% and 12% it was isolated from skin lesions that had clinical presentation of echtyma gangrenosum, respectively. Patients treated with colistin received 3 MU of colistin every 8 hours for a mean (± SD) duration of 12.5 (± 5.4) days. Due to nature of their disease, and severity of infections, all of the patients received more than two other possibly nephrotoxic drugs; in colistin group 4 other concomitant drugs, on control group 3; most frequently vancomycin, cefepime, amikacine, garamycine and amphotericine B deoxycholate was used. Of 26 patients receiving colistin, 76.9% of patients had the drug discontinued after successful clearance of infection, while in control group 65.4% of patients had the drug discontinued due to same reason. Only one patient had displayed neurological toxicity (Jacksons attack with secondary generalisation), but the drug was not discontinued, dose was modified, patient had no further attacks. There was no statistically significant difference in the level of serum creatinine, creatinine clearance (calculated), or potassium levels between prior to therapy and after treatment discontinuation between groups. One patient treated with colistin developed renal failure and was subjected to continuous venovenous hemodiafiltration; of note is that at the time colistin introduction patient already had impaired renal function. In one patient drug was discontinued due to suspected allergic reaction. No other adverse events of colistin therapy were noted. Colistin is an effective antimicrobial drug for the treatment of severe infections caused by MDR P.aeruginosa in haematological patients. The safety profile observed is acceptable in these severe life-threatening infections, in matched-pair analysis it did not display greater toxicity than other antipseudomonas drugs. Further studies are needed to better address the treatment of MDR P. aeruginosa, naimely the optimal dose and schedule, also route of administration of colistin, as well as drug-to-drug interactions.


2017 ◽  
Vol 143 (7) ◽  
pp. 1347-1355 ◽  
Author(s):  
Nora Schweitzer ◽  
Tim Weber ◽  
Martha M. Kirstein ◽  
Mareike Fischer ◽  
Anna-Maria Kratzel ◽  
...  

Brachytherapy ◽  
2016 ◽  
Vol 15 ◽  
pp. S76-S77
Author(s):  
Piotr Wojcieszek ◽  
Marta Szlag ◽  
Agnieszka Cholewka ◽  
Marek Fijałkowski ◽  
Brygida Białas ◽  
...  

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