Phase Ib Study of PEGylated Recombinant Human Hyaluronidase and Gemcitabine in Patients with Advanced Pancreatic Cancer.

Purpose: This phase Ib study evaluated the safety and tolerability of PEGylated human recombinant hyaluronidase (PEGPH20) in combination with gemcitabine (Gem), and established a phase II dose for patients with untreated stage IV metastatic pancreatic ductal adenocarcinoma (PDA). Objective response rate and treatment efficacy using biomarker and imaging measurements were also evaluated.

Experimental Design: Patients received escalating intravenous doses of PEGPH20 in combination with Gem using a standard 3+3 dose-escalation design.

[Combined treatment of patients with locally advanced rectal cancer].

The objective of this study was to improve the immediate and long-term results of combined treatment of patients with locally advanced rectal cancer. The study included 128 patients with morphologically confirmed diagnosis and clinical stage cT3/T4 and N-/N+, treated from 1998 to 2009. The comparison group had 64 patients, combined treatment included prolonged preoperative radiotherapy 4 Gy and 40 Gy, surgery was performed after 4 weeks.

[Pathomorphism of rectal cancer during neoadjuvant chemoradiotherapy].

The pathomorphism of rectal cancer (RC) was studied in 99 patients who received neoadjuvant chemoradiotherapy using two drugs (5-fluorouracil and xeloda). A morphological study indicated the qualitatively similar manifestations of pathomorphism (tumor necrosis, inflammation, and sclerosis) which were more pronounced in the use of xeloda. Three degrees of the pathomorphism of RC have been identified: the tumor was unchanged, changed, and undetectable.

[The distal resection margin in rectal cancer surgery].

Spread of the tumor in the distal direction is an important factor that must be considered when performing organ-serving surgery for rectal cancer. Particular relevance it has acquired in recent years due to the general tendency to expand the indications for the preservation of natural reflex-apparatus in patients with medium- and lower-ampullar part of the rectum.

[The influence of lymphadenectomy on the results of the gastric cancer treatment].

Results of randomized studies and meta-analyses of the long-term results of surgical treatment of the gastric cancer with lymphadenectomy were compared. The D2 lymphadenectomy permits low indices of postoperative morbidity and mortality. The further lymphadenectomy volume increase does not lead to the significant improvement of the long term treatment results.

[D2 lymphadenectomy for surgical and combined treatment of the gastric cancer].

Immediate results of 100 D2 lymphadenectomies, performed for gastric cancer, were analyzed. The combined treatment included preoperative radiotherapy (n=39), combinations of pre- and postoperative radiotherapy (n=18) and adjuvant chemotherapy (n=18). The majority of patients had tumors of the lower third of the stomach, histologically low- and non-differentiated adenocarcinomas.

[Clinico-morphological parallels among stomach cancer patients].

The paper reports the demographic and clinical data on more than 1,100 stomach cancer patients who underwent radical surgery in 1970-2007. Significant changes in structure and histological pattern of that pathology and primarily the growing fraction of signet ring and undifferentiated cell cancer (30%) are evident. It was matched by similarly important changes in the demographic and clinical data on patients with different morphological patterns and extent of tumor cell differentiation.

[Effect of morphologic features on recurrence and metastasis in stomach cancer].

Data on examination of 192 patients radically operated for stomach cancer at the Center's Clinic were analyzed vis-a-vis postoperative recurrences. Marked dependence of metastatic spread features and pathway on histological pattern of tumor was established. This can be used in working out therapeutic strategies.

[Comparative analysis of long-term results of combined and surgical treatment at the patients with signet ring cell carcinoma of stomach].

Overall 194 patients with signet ring cell carcinoma of stomach were treated, 124 (64%) of them underwent combined treatment (preoperative radiotherapy with subsequent operation), 70 (36%) - only surgical treatment. There were no differences in survival rate between two groups at early (pT1) cancer. The combined method has advantages over isolated surgical at T2 tumors (both with and without regional lymphatic metastases) and at T3 tumors without regional lymphatic metastases (p=0.

[Treatment for primary multiple malignant tumors, a gastric one included].

Cases of primary multiple malignant tumors, with one localized in the stomach, have been studied. In cases of radical surgery, second tumors were detected in 6.2% while in patients with early gastric cancer--twice as many (12.

[Regularities of relapse and metastasis of signet ring cell carcinoma of the stomach following combined and surgical treatment].

Characteristics of recurrence and metastatic development of signet ring cell carcinoma of the stomach were studied in 59 cases after combined and surgical treatment. Peritoneal dissemination appeared to be the most frequent pattern of tumor progression. It accounted for 55% of all relapses and occurred in 27% of patients even without extension through serous membrane (pT2).

[Comparative analysis of long-term results of combined and surgical treatment in gastric cancer].

The end-results of combined and surgical treatment of gastric cancer are compared. Survival rates were sufficiently high in both procedures in cases without extension through the serosa (T1-2) or regional metastases with adenocarcinoma cells were well differentiated (NO). However, combined treatment proved more effective in cases of the opposite situations (p=0.

[Comparative assessment of immediate results of combined and surgical treatment of gastric cancer].

The 30-year experience with combined and surgical treatment of gastric cancer gained at the Center is discussed. The results of surgery were improved due to use of intensive preoperative radiotherapy, metronidazole and dynamic fractionated treatment. There was no correlation between intensive preoperative radiotherapy and postoperative complication incidence or lethality, irrespective of extent of surgery or lymph node dissection.

[Recurrences after surgical treatment of early (pT1) cancer of the stomach: laws of development, extended lymphadenectomy in prophylaxis of recurrences].

Long-term results of treatment of 175 patients with early cancer of the stomach are analyzed. Recurrences of the disease (local, regional recurrences and distant metastases) were diagnosed in 14 (8.2% of all operated) patients.

[Long-term results of pre- and intraoperative radiotherapy in the combined treatment for stomach cancer].

The paper discusses the end results of combined treatment of stomach cancer (radical surgery plus pre- and intraoperative radiotherapy). A randomized evaluation showed that it might be used for loco-regional monitoring. Five-year rates and median of survival rose significantly, as compared with surgery alone, in tumor extension through the stomach wall (T3-4), metastatic dissemination to lymph nodes (N1-2), combinations of such pathologies as well as in cases of low-differentiated, undifferentiated and signet- cell cancer.

[Early cancer of the stomach: pattern of lymphatic metastasizing and its influence on surgical approach].

Results of surgical treatment of 156 patients were analyzed. There were no metastases to the lymph nodes in patients with invasion of mucous membrane only. In patients with invasion of the tumor into a submucous layer regional metastases were revealed in 18 (19%) cases.

Clinicopathological features and outcome of surgical treatment of 149 patients with early (pT1) gastric cancer.

Background: Controversy exists concerning the definition of, treatment approach to, prognostic factors of and survival data on early gastric cancer.

Patients And Methods: 149 patients who underwent curative gastrectomy for carcinoma between 1972 and 2002 and were classified as having early gastric cancer (T1Nany) were included into a retrospective study. Patients were followed for a median of 5.

[Pre- and intraoperative radiotherapy for locally advanced gastric cancer in conjunction with extended lymph node dissection: results of phase II clinical study].

The paper discusses our findings on a phase II clinical study of an original procedure for therapy of locally advanced gastric cancer including pre- and intraoperative radiotherapy (IORT) and extended lymph node dissection. Out of 24 patients, none had intraoperative complications while postoperative ones developed in 16%; lethality rate was 4%. As far as immediate results are concerned, intensive pre- and intraoperative radiotherapy proved fully compatible with any surgical procedure including extended and extended-combined ones.

[Surgical treatment of advanced cancer of the stomach].

Experience in surgical treatment of gastric cancer with distant metastases was analyzed. Distant metastases were located most often in the peritoneum (19 patients), distant lymph nodes (16), liver (10) and ovaries (5). Surgery was performed as gastrectomy (27 patients), subtotal resection of the stomach (25) and extirpation of the gastric stump (4); metastatic tumors were removed in half of the patients.