Purpose Fecal incontinence is a frequently observed symptom after lower rectal surgery with sphincter manipulation. The aim of this study was to evaluate a proposed modification to the fecal ...incontinence quality of life (FIQL) scale for the assessment of the quality of life among patients with very low rectal cancer who have undergone intersphincteric resection. Methods A single 14-item composite scale was prepared that was derived from items in the “Lifestyle” and “Coping” subscales of the original FIQL. The scale was tested with a convenience sample of 152 postoperative patients. In addition to classic psychometric evaluation, newer statistical techniques, such as a multiple correspondence analysis and partial credit model, were performed to evaluate the item response patterns. Results The proposed scale exhibited an item-rest correlation of 0.66-0.84 and a Cronbach's alpha of 0.96, and was correlated with concurrently measured Social Functioning subscale of the Medical Outcomes Study Short Form 36 (−0.70), physical role limitation (−0.61), and Wexner continence grading scale (−0.61). Multiple correspondence analysis supported a uni-dimensional construct, and the partial credit model showed a varying yet overlapping range of item response thresholds across items. Several items, such as “Locating bathroom whenever going out”, reflected more a serious condition than items such as “Avoiding eating-out.” Weighted item scores based on estimated thresholds provided results comparable with those based on non-weighted scores. Conclusions The proposed modification to the FIQL scale exhibited high internal consistency and satisfactory concurrent and convergence validity. The modified scale is practical to administer and is sensitive to a range of functional problems associated with fecal incontinence among patients who have undergone intersphincteric resection.
Antineoplastons are naturally occurring peptides and amino acid derivatives found in human blood and urine. Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly ...inhibit normal cell growth. Antineoplastons contain 3-phenylacetylamino-2, 6-piperidinedione (A10), phenylacetylglutamine plus phenylacetylisoglutamine (A10-I), and phenylacetylglutamine plus phenylacetate (AS2-1). This open label, non- blinded randomized phase II study compared the efficacy of hepatic arterial infusion (HAI) with 5-fluorouracil,with or without antineoplastons as a postoperative therapy for colorectal metastasis to the liver.
Sixty-five patients with histologically confirmed metastatic colon adenocarcinoma in liver, who had undergone hepatectomy, and/or thermal ablation for liver metastases were enrolled between 1998- 2004 in Kurume University Hospital. Patients were randomly assigned to receive systemic antineoplastons (A10-I infusion followed by per-oral AS2-1) plus HAI (AN arm) or HAI alone (control arm) based on the number of metastases and presence/ absence of extra-hepatic metastasis at the time of surgery. Primary endpoint was cancer-specific survival (CSS); secondary endpoints were relapse-free survival (RFS), status and extent of recurrence, salvage surgery (rate) and toxicity.
Overall survival was not statistically improved (p=0.105) in the AN arm (n=32). RFS was not significant (p=0.343). Nevertheless, the CSS rate was significantly higher in the AN arm versus the control arm (n=33) with a median survival time 67 months (95%CI 43-not calculated) versus 39 months (95%CI 28-47) (p=0.037) and 5 year CSS rate 60% versus 32% respectively. Cancer recurred more often in a single organ than in multiple organs in the AN arm versus the control arm. The limited extent of recurrent tumours in the AN arm meant more patients remained eligible for salvage surgery. Major adverse effects of antineoplastons were fullness of the stomach and phlebitis. No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.
Antineoplastons (A10 Injection and AS2-1) might be useful as adjunctive therapy in addition to HAI after hepatectomy in colorectal metastases to the liver.
ClinicalTrials.gov UMIN000012099.
To clarify the prognostic impact of tumor nodules without residual lymph node (LN) structure (ND) in colorectal cancer and to determine optimal categorization of ND in tumor staging.
A multicenter, ...retrospective pathologic review was performed for 1716 patients with stages I to III curatively resected colorectal cancer treated at 11 institutions between 1994 and 1998. An additional 2242 patients from nine institutions were enrolled between 1999 and 2003 as a second cohort to validate the results.
LN metastasis (LNM) and ND were observed in 33.7% and 16.0% (smooth-contour nodule S-ND, 8.2%; irregular-contour nodule I-ND, 10.7%) of patients in the first cohort. S-ND and I-ND were similarly distributed in the regional area. There was no considerable difference in the impact on survival between S-ND (hazard ratio HR, 2.7; 95% CI, 1.9 to 3.8) and I-ND (HR, 4.3; 95% CI, 3.3 to 5.8) or between LNM (HR, 4.5; 95% CI, 3.4 to 6.0) and ND (HR, 4.0; 95% CI, 3.1 to 5.3). LNM and ND were similarly associated with the mode of recurrence. Tumor nodules ≥ 5 mm growing with venous/perineural invasion (ND v/pni+), judged with 0.61 κ value among 11 observers, had an independent prognostic value for 5-year survival of 42%; similar results were observed in the second cohort.
These results do not support the TNM system in which S-ND is treated differently from I-ND in tumor staging; LNM and ND should be considered together in the same category. The presence of ND (v/pni+) has a considerable adverse prognostic effect.
Background
The histogenesis of the pattern of cancer spread along Auerbach’s plexus (myenteric spread: MS) remains unclear and its prognostic value in colorectal cancer (CRC) has not been thoroughly ...investigated.
Methods
Pathology slides of 2845 pT2/pT3/pT4 CRCs stained with hematoxylin–eosin (H&E) were reviewed at 10 institutions. MS was classified into 2 groups depending on whether it was accompanied by the finding of perineural invasion (PN) within the lesion. In addition, immunohistochemical staining (D2-40, S100, CD56, synaptophysin) was performed for serially sectioned specimens from 50 CRCs diagnosed as having PN-negative MS.
Results
MS was observed in 504 patients (17.7 %); 360 patients were classified as having PN-positive MS and 144 as having PN-negative MS. The 5-year disease-free survival rate of patients with MS was lower than that of patients without MS (63.3 vs 82.7 %,
P
< 0.0001); however, there was no significant difference in survival outcome according to the presence or absence of intralesion PN in MS. Multivariate analysis showed that the prognostic impact of MS was independent of conventional prognosticators including T and N stages, vascular invasion and extramural PN. In all the tumors having PN-negative MS, remnants of neural tissue were identified within or around cancer nests located at the leading edge of MS.
Conclusions
MS is an important prognostic factor for CRC. This feature is the result of cancer development with replacement of Auerbach’s plexus and can be classified as intramural PN. The clinical significance of “Pn1” in the UICC/AJCC TNM classification could be enhanced by individual assessment both intramurally and extramurally.
Background
The goal of this multicenter study was to clarify the determinants of local excision for patients with T1–T2 lower rectal cancer.
Methods
Data from 567 consecutive patients who underwent ...radical resection for T1–T2 lower rectal cancer at 12 institutions between 1991 and 1998 were reviewed. Rates of lymph node metastasis were investigated using a tree analysis, which was hierarchized using independent risk factors for nodal involvement.
Results
The independent risk factors for lymph node metastasis were female gender, depth of tumor invasion, histology other than well-differentiated adenocarcinoma, and lymphatic invasion. According to the first three parameters that can be obtained preoperatively, only 0.99% of the patients without risk factors had lymph node metastasis. On the other hand, even if the lower rectal cancer was at stage T1, women with histological types other than well-differentiated adenocarcinoma had an approximately 30% probability of having lymph node metastasis. Lymphatic invasion was most useful to predict nodal involvement among patients with T2 lower rectal cancer. The rates of lymph node metastasis in T2 patients with and without lymphatic invasion were 32.9% and 9.1%, respectively.
Conclusions
Gender is one of the most important predictors for lymph node metastasis in patients with early distal rectal cancer. Three parameters, including depth of tumor invasion, histology, and gender, are useful determinants for local excision. Additional studies are required to establish the minimum optimal treatment for T2 lower rectal cancer.
The clinical situation of familial adenomatous polyposis (FAP) in Japan has changed in the period since the last analysis of data of the Japanese Polyposis Center. To reevaluate our data and ...elucidate the changes we analyzed the records of the 1390 FAP patients in 900 families registered with the Polyposis Committee of the Japanese Society for Cancer of the Colon and Rectum. In the 13-year period 1990-2003, clinical differences between men and women with FAP diminished. The postoperative prognosis was substantially better in patients without advanced colorectal cancer (stage > or = T2) than in those with early cancer or no cancer. Mean age at death improved from 42.5 years in the period before 1990 to 46.0 years, and it was a result of a decreased proportion of deaths from colorectal cancer. The distribution of colorectal cancer in FAP patients was similar to that in the general population. Desmoid tumors accounted for about 10% of deaths in the recent 13 years (1990-2003). The cumulative risk of rectal cancer in the preserved rectum was 12% at 10 years and 23% at 15 years. The registry system in Japan revealed a new clinical situation in FAP patients, and the findings of this study will be useful to improve the prognosis of patients with FAP.
This study was conducted to evaluate the validity of thermography in breast examination.
We performed contact thermography and measured the direct temperature by inserting a needle-type thermometer ...into the tissue. The core temperature of the tumor (dTt) and the temperature of the tissue surrounding the tumor (dTs) were compared with normal tissue. The microvessel density (MVD) and the MIB-1 labeling index (MIB-1 LI) of the tumor were examined immunohistochemically. The subjects were 48 women with primary invasive ductal carcinoma. The area of the tumor was diagnosed pathologically, and the hot area was measured using thermography.
The dTt was significantly higher than the dTs. Both the dTt and dTs were significantly higher when the thermographical hot area was positive, or when more than four lymph node metastases were found. The dTs was correlated with MVD. A correlation between MVD and tumor temperature measured directly was also confirmed. A higher dTs was related to the dissociated wide area of the thermogram.
These findings suggested a relationship between dTs and the high-risk group of breast cancer. We also found that abnormalities in temperature were reflected in thermography and that a higher dTs was related to the dissociated wide area of the thermogram.
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