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Biomedical subjects

B G Wolff

Publications and source records attributed to B G Wolff.

At least 19 recordsLinked to original sources
PubMed2002

Management of patients with colorectal cancer and concomitant abdominal aortic aneurysm.

PURPOSE: The aim of this study was to determine the optimal management of patients with colorectal cancer and abdominal aortic aneurysm in the elective situation. METHODS: All patients with a history of colorectal cancer and abdominal aortic aneurysm between 1986 and July 2000 were identified, and charts of those with concomitant disease were reviewed. RESULTS: A total of 435 patients with available charts were reviewed. Eighty-three patients with concomitant abdominal aortic aneurysm and colorectal cancer were identified. In 64 patients the colorectal cancer was treated first, and 44 of these patients had an abdominal aortic aneurysm less than 5 cm in diameter (average = 3.8 cm). No abdominal aortic aneurysm ruptured in the postoperative period. Median delay to colorectal cancer surgery from diagnosis was four days. Twenty patients with abdominal aortic aneurysm of 5 cm or greater (average = 5.4 cm) were treated for colorectal cancer first. In two of these patients (with abdominal aortic aneurysms sized 5 and 6.4 cm), the abdominal aortic aneurysm ruptured in the early postoperative period. Median delay to colorectal cancer resection was eight days. Twelve patients had both abdominal aortic aneurysm and colorectal cancer treated at the same time. The average size of the abdominal aortic aneurysm was 6.4 cm. Median delay from colorectal cancer diagnosis to resection was 15 days. No documented cases of graft infection occurred in this group; median follow-up was 3.2 years. Seven patients underwent abdominal aortic aneurysm repair before resection of colorectal cancer; in two patients, colorectal cancer was found at the time of resection. The average size of abdominal aortic aneurysm was 6 cm and median delay to treatment of colorectal cancer was 122 days, a statistically significant longer delay than in the other two groups (P < 0.0001). CONCLUSION: In patients with colorectal cancer and abdominal aortic aneurysm of 5 cm or more, treatment of colorectal cancer first may result in life-threatening rupture, whereas treatment of abdominal aortic aneurysm first may significantly delay treatment of colorectal cancer. Concomitant treatment seems to be a safe alternative. If anatomically suitable, the abdominal aortic aneurysm may be considered for endovascular repair followed by a staged colon resection. The presence of an abdominal aortic aneurysm less than 5 cm does not affect colorectal cancer treatment.

Aged↗
PubMed2001

Intraoperative irradiation for locally recurrent colorectal cancer in previously irradiated patients.

PURPOSE: Information in the literature regarding salvage treatment for patients with locally recurrent colorectal cancer who have previously been treated with high or moderate dose external beam irradiation (EBRT) is scarce. A retrospective review was therefore performed in our institution to determine disease control, survival, and tolerance in patients treated aggressively with surgical resection and intraoperative electron irradiation (IOERT) +/- additional EBRT and chemotherapy. METHODS AND MATERIALS: From 1981 through 1994, 51 previously irradiated patients with recurrent locally advanced colorectal cancer without evidence of distant metastatic disease were treated at Mayo Clinic Rochester with surgical resection and IOERT +/- additional EBRT. An attempt was made to achieve a gross total resection before IOERT if it could be safely accomplished. The median IOERT dose was 20 Gy (range, 10--30 Gy). Thirty-seven patients received additional EBRT either pre- or postoperatively with doses ranging from 5 to 50.4 Gy (median 25.2 Gy). Twenty patients received 5-fluorouracil +/- leucovorin during EBRT. Three patients received additional cycles of 5-fluorouracil +/- leucovorin as maintenance chemotherapy. RESULTS: Thirty males and 21 females with a median age of 55 years (range 31--73 years) were treated. Thirty-four patients have died; the median follow-up in surviving patients is 21 months. The median, 2-yr, and 5-yr actuarial overall survivals are 23 months, 48% and 12%, respectively. The 2-yr actuarial central control (within IOERT field) is 72%. Local control at 2 years has been maintained in 60% of patients. There is a trend toward improved local control in patients who received > or =30 Gy EBRT in addition to IOERT as compared to those who received no EBRT or <30 Gy with 2-yr local control rates of 81% vs. 54%. Distant metastatic disease has developed in 25 patients, and the actuarial rate of distant progression at 2 and 4 years is 56% and 76%, respectively. Peripheral neuropathy was the main IOERT-related toxicity; 16 (32%) patients developed neuropathies (7 mild, 5 moderate, 4 severe). Ureteral narrowing or obstruction occurred in seven patients. All but one patient with neuropathy or ureter fibrosis received IOERT doses > or =20 Gy. CONCLUSION: Long-term local control can be obtained in a substantial proportion of patients with aggressive combined modality therapy, but long-term survival is poor due to the high rate of distant metastasis. Re-irradiation with EBRT in addition to IOERT appears to improve local control. Strategies to improve survival in these poor-risk patients may include the more routine use of conventional systemic chemotherapy or the addition of novel systemic therapies.

Adult↗
PubMed2001

Atypical diverticular disease: surgical results.

PURPOSE: Patients with diverticular disease may present with chronic symptoms but never develop diverticulitis. The purpose of this research was to review the outcome of surgical intervention in this subgroup of patients with atypical "smoldering" diverticular disease. METHODS: Records of 930 patients who underwent sigmoid resection for diverticular disease during a ten-year period at the Mayo Clinic in Rochester, Minnesota, were reviewed. Forty-seven patients (5 percent) fit our inclusion criteria for smoldering diverticular disease and underwent sigmoid colectomy with primary anastomosis. A minimum of 12 months of follow-up was completed in 68 percent of these patients. RESULTS: Evidence of acute or chronic inflammatory changes was present in 76 percent of resected specimens. Complete resolution of symptoms occurred in 76.5 percent, with 88 percent being pain free. CONCLUSIONS: We conclude that the diagnosis and presentation of atypical smoldering diverticular disease is an uncommon and poorly defined entity. However, sigmoid resection in this subgroup of patients is safe and is associated with resolution of symptoms in the majority of cases.

Aged↗
PubMed2001

Wide-lumen stapled anastomosis vs. conventional end-to-end anastomosis in the treatment of Crohn's disease.

PURPOSE: Preanastomotic recurrence and stricturing after surgery for ileocolic Crohn's disease is a frequent, unexplained phenomena that may lead to prompt reoperation. The aim of this study was to determine whether a wide-lumen stapled anastomosis (side-to-side, functional end-to-end) provides better outcome than a conventional sutured end-to-end anastomosis METHOD: A case-control comparative analysis of patients with Crohn's disease from two inflammatory bowel disease centers treated with wide-lumen stapled anastomosis and a matched (age and gender) group treated with conventional sutured end-to-end anastomosis was performed. RESULTS: A total of 138 patients with Crohn's disease were treated, 69 with wide-lumen stapled anastomosis and 69 with conventional sutured end-to-end anastomosis. Preoperative therapy, number of previous resections, indication for operation, and length of bowel resected were similar in both groups. Fewer complications occurred after wide-lumen stapled anastomosis (P = 0.048). A total of 55 patients developed recurrent Crohn's disease symptoms, 39 (57 percent) in the conventional sutured end-to-end anastomosis and 16 (24 percent) in the wide-lumen stapled anastomosis group. Median follow-up was 70 and 46 months, respectively. After conventional sutured end-to-end anastomosis 18 reoperations were required, 15 for anastomotic stricture and 3 for fistulization. After wide-lumen stapled anastomosis three reoperations were necessary, two for stricture and one for fistulization. The cumulative reoperation rate for anastomotic recurrence was significantly lower (P = 0.017; log-rank test) for the wide-lumen stapled anastomosis group. CONCLUSION: Wide-lumen stapled anastomosis is as safe as conventional sutured end-to-end anastomosis and results in a lower incidence of symptomatic recurrent Crohn's disease and need for reoperation. Further prospective study of the wide-lumen stapled anastomosis technique is necessary to define the precise role of this operation in patients with Crohn's disease.

Adolescent↗
PubMed2001

A comparison of endoscopic ultrasound, magnetic resonance imaging, and exam under anesthesia for evaluation of Crohn's perianal fistulas.

BACKGROUND & AIMS: To determine accuracy of endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) for evaluation of Crohn's disease perianal fistulas. METHODS: Thirty-four patients with suspected Crohn's disease perianal fistulas were prospectively enrolled in a blinded study comparing EUS, MRI, and examination under anesthesia (EUA). Fistulas were classified according to Parks' criteria, and a consensus gold standard was determined for each patient. Acceptable accuracy was defined as agreement with the consensus gold standard for > or =85% of patients. RESULTS: Three patients did not undergo MRI; 1 did not undergo EUS or EUA; and consensus could not be reached for 1. Thirty-two patients had 39 fistulas (20 trans-sphincteric, 5 extra-sphincteric, 6 recto-vaginal, 8 others) and 13 abscesses. The accuracy of all 3 modalities was > or =85%: EUS 29 of 32 (91%, confidence interval [CI] 75%-98%), MRI 26 of 30 (87%, CI 69%-96%), and EUA 29 of 32 (91%, CI 75%-98%). Accuracy was 100% when any 2 tests were combined. CONCLUSIONS: EUS, MRI, and EUA are accurate tests for determining fistula anatomy in patients with perianal Crohn's disease. The optimal approach may be combining any 2 of the 3 methods.

Adolescent↗
PubMed2000

Familial adenomatous polyposis: results after ileal pouch-anal anastomosis in teenagers.

PURPOSE: Virtually all untreated patients with familial adenomatous polyposis develop colorectal carcinoma. Thus, prophylactic colectomy is indicated. Detractors of ileal pouch-anal anastomosis prefer ileorectal anastomosis for teenagers because of the potential negative impact of ileal pouch-anal anastomosis on quality of life. The aim of this study was to assess the effects on quality of life of ileal pouch-anal anastomosis in teenagers with familial adenomatous polyposis. METHODS: Between 1981 and 1998, 48 teenagers underwent ileal pouch-anal anastomosis for familial adenomatous polyposis. One patient had proctectomy and ileal pouch-anal anastomosis after previous ileorectal anastomosis. A temporary diverting loop ileostomy was established in 42 patients (87.5 percent). One patient had colonic carcinoma diagnosed preoperatively. Two other patients were found to have unsuspected rectal cancer at surgery. Mean follow-up (+/- standard deviation) in 43 patients was 80.5 +/- 42 months. RESULTS: There was no immediate postoperative mortality. Postoperative complications included pelvic sepsis (3 patients; 1 requiring reoperation) and bleeding (1 patient; no surgery required). One patient died of metastatic colonic carcinoma. Ten patients required reoperation, seven had bowel obstruction, one had portal hypertension, and two required an ileostomy. The mean (+/- standard deviation) daytime and nighttime stool frequency was 4 +/- 1.5 and 1 +/- 1, respectively. One patient reported daytime and nighttime incontinence, and two patients reported nighttime incontinence only. No patient experienced impotence or retrograde ejaculation. Social, sexual, sport, housework, recreation, family, travel, and work activities were improved or unchanged in 82.5, 87, 80, 90, 80, 92.5, 77.5, and 89 percent of patients, respectively. Three male patients fathered children, and three female patients had a total of six children after normal pregnancies and deliveries. CONCLUSION: The impact of ileal pouch-anal anastomosis on quality of life was favorable in the majority of teenagers. The risk of rectal cancer should be the major consideration before proposing an operation to teenagers with familial adenomatous polyposis.

Adenomatous Polyposis Coli↗
PubMed2000

Does technique of anastomosis play any role in developing late perianal abscess or fistula?

PURPOSE: This study examines the risk factors for developing perianal abscess or fistula formation after ileal pouch-anal anastomosis procedure for chronic ulcerative colitis or familial adenomatous polyposis. METHODS: A total of 1,457 patients with J-pouch, 1,304 (89.5 percent) with chronic ulcerative colitis and 153 (10.5 percent) with familial adenomatous polyposis who had a two-stage procedure without any evidence of previous perianal disease were included in the study. The effect of pouch-to-anal anastomosis type on perianal abscess or fistula formation was evaluated. RESULTS: A total of 108 patients (7.4 percent) had a perianal abscess or fistula after the ileal pouch-anal anastomosis procedure after at least one year of follow-up. No statistically significant difference was identified in fistula formation regarding the age and gender of the patients (P > 0.05), nor did the risk of fistula formation differ significantly between the patients with handsewn vs. stapled anastomoses (P > 0.05). However, patients with a diagnosis of chronic ulcerative colitis, compared with patients with familial adenomatous polyposis, had a statistically higher risk of developing abscess or fistula (P = 0.012). CONCLUSION: The most important risk factor in developing perianal sepsis in long-term patients with ileal pouch-anal anastomosis is the initial disease type. After excluding patients without Crohn's disease, the risk of developing an abscess or fistula was found to be significantly greater in patients with chronic ulcerative colitis compared with patients with familial adenomatous polyposis, and this risk is independent of anastomotic technique.

Abscess↗
PubMed2000

Functional outcomes after ileal pouch-anal anastomosis for chronic ulcerative colitis.

OBJECTIVE: To assess long-term outcomes after ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (CUC) with specific emphasis on patient sex, childbirth, and age. SUMMARY BACKGROUND DATA: Childbirth and the process of aging affect pelvic floor and anal sphincter function independently. Early function after IPAA is good for most patients. Nonetheless, there are concerns about the impact of the aging process as well as pregnancy on long-term functional outcomes after IPAA. METHODS: Functional outcomes using a standardized questionnaire were prospectively assessed for each patient on an annual basis. RESULTS: Of the 1,454 patients who underwent IPAA for CUC between 1981 and 1994, 1,386 were part of this study. Median age was 32 years. Median length of follow-up was 8 years. Pelvic sepsis was the primary cause of pouch failure irrespective of sex or age. Functional outcomes were comparable between men and women. Eighty-five women who became pregnant after IPAA had pouch function, which was comparable with women who did not have a child. Daytime and nocturnal incontinence affected older patients more frequently than younger ones. Incontinence became more common the longer the follow-up in older patients, but this was not found in younger patients. Poor anal function led to pouch excision in only 3 of 204 older patients. CONCLUSIONS: Incontinence rates were significantly higher in older patients after IPAA for CUC compared with younger patients. However, this did not contribute to a greater risk of pouch failure in these older patients. Patient sex and uncomplicated childbirth did not affect long-term functional outcomes.

Adult↗
PubMed2000

Surgical management of diverticulitis.

Diverticular disease, and particularly diverticulitis, has an increasing incidence in Westernized countries because of low-fiber diet. Diverticular disease may be classified as asymptomatic, atypical, acute or uncomplicated, and complicated. Conservative or medical management is usually indicated for acute or uncomplicated diverticulitis, with elective surgical resection generally being recommended after two documented episodes. Complicated diverticulitis, because of the high rate of recurrent problems, is generally managed promptly with sigmoid resection. Sigmoid resection for diverticulitis, under appropriate circumstances, has one of the highest success rates of any of the common gastrointestinal procedures.

Colon, Sigmoid↗
PubMed2000

Operative techniques for radical surgery for rectal carcinoma: can surgeons improve outcomes?

Local recurrence rates following resection of rectal cancer with curative intent are extremely variable. An appropriate anatomic dissection of the rectum is essential to accomplish a complete removal of the tumor and has been described since the 1940s. In the last two decades, increased emphasis has been placed on the concept of total mesorectal excision as the fundamental technical step to minimize local recurrence rates. It is currently accepted, however, that complete removal of the mesorectum is not necessary for all rectal cancer cases. On the other hand, measurement of the free radial margins should be routinely performed to evaluate the local aggressiveness of the disease and assess the potential for a curative resection.

Adenocarcinoma↗
PubMed1998

Ileal pouch-anal anastomosis in patients with colorectal cancer: long-term functional and oncologic outcomes.

UNLABELLED: When colorectal cancer complicates chronic ulcerative colitis or familial adenomatous polyposis, the role of ileal pouch-anal anastomosis is uncertain because of concerns that the procedure may compromise oncologic therapy and that oncologic therapy may compromise ileal pouch-anal anastomosis function. AIM: This study was undertaken to investigate the impact both of ileal pouch-anal anastomosis on cancer outcomes and of cancer treatments on ileal pouch-anal anastomosis function. PATIENTS AND METHODS: Of 1,616 patients undergoing ileal pouch-anal anastomosis for chronic ulcerative colitis or familial adenomatous polyposis (1981-1994), 77 patients were identified with adenocarcinoma of the colon (56), rectum (17), or both (4). Data were obtained from an ileal pouch-anal anastomosis registry, case notes, and postal and telephone surveys. RESULTS: Mean age of the 77 index patients was 37 (range, 13-60) years. Stage distribution was as follows: Stage 0, 9; Stage I, 31; Stage II, 15; Stage III, 22 patients. Twelve patients died with systemic disease (6 with a local component) after a mean follow-up of 6 (range, 2-15) years. Twenty-two patients received adjuvant therapy (chemotherapy, 16; radiotherapy, 2; both, 4 patients). Chemotherapy complications requiring dose reduction or interruption occurred in three (15 percent) patients. One patient developed radiation enteritis (17 percent). Pouch failure occurred in 16 percent of cancer patients, compared with 7 percent for the overall registry. There were no differences between cancer and non-cancer groups in operative complications, median stool frequency, incontinence, pad usage, or pouchitis. CONCLUSIONS: Although pouch failure is more common, ileal pouch-anal anastomosis can be performed in the setting of colorectal cancer without significant impact on oncologic outcome or long-term ileal pouch-anal anastomosis function.

Adenocarcinoma↗
PubMed1998

Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium Tc 99m 88BV59H21-2V67-66 (HumaSPECT-Tc), a totally human monoclonal antibody. Patient management benefit from a phase III multicenter study.

PURPOSE: The study contained herein was undertaken to evaluate the accuracy of radiolabeled human monoclonal antibody, 88BV59H21-2V67-66 (88BV59 or HumaSPECT-Tc), in predicting disease resectability in presurgical subjects with recurrent, metastatic, or occult colorectal carcinoma. METHODS: A total of 219 patients with disease visualized on computed tomographic scan (recurrent or metastatic disease) or with negative or equivocal computed tomographic scan and rising carcinoembryonic antigen serum levels (occult group) received technetium Tc99m-labeled 88BV59 intravenously. Planar and single photon emission computed tomograhic images were obtained 14 to 20 hours postinfusion, before surgery. The ability of computed tomographic and HumaSPECT-Tc imaging to define the extent of disease and to predict resectability was evaluated based on surgical and histopathologic results. RESULTS: In patients with recurrent or metastatic disease (170 evaluable patients), the accuracy of predicting nonresectability of disease was significantly greater (P < 0.001) for HumaSPECT-Tc than for computed tomography (60 vs 29 percent). Computed tomography understaged 41 percent of patients believed to have resectable disease compared with 27 percent for HumaSPECT-Tc (P < 0.001). In occult disease patients (29 computed tomographic and 28 HumaSPECT-Tc evaluable patients), the overall accuracy of predicting resectability/nonresectability was 6 percent for HumaSPECT-Tc compared with 24 percent from computed tomography. Administration of HumaSPECT-Tc had no effect on monoclonal antibody-based in vitro diagnostic assays. Only a single patient demonstrated an anti-antibody response (90 ng/ml) at nine weeks postinfusion. CONCLUSION: HumaSPECT-Tc was more accurate than computed tomography in determining disease resectability in patients with metastatic, recurrent, or occult cancer. The addition of HumaSPECT-Tc imaging can play a significant role in patient management decisions.

Adult↗
PubMed1998

Prophylactic oophorectomy in colorectal carcinoma: preliminary results of a randomized, prospective trial.

UNLABELLED: Controversy exists regarding the role of prophylactic oophorectomy during resection for primary colorectal cancer. PURPOSE: A prospective, randomized trial was initiated to evaluate the influence of oophorectomy on recurrence and survival in patients with Dukes Stages B and C colorectal cancer. METHOD: Between November 1986 and March 1997, 155 patients were randomized to oophorectomy or no oophorectomy at laparotomy for resection of colorectal cancer. RESULTS: No incidence of gross or microscopic metastatic disease to the ovary was found among 77 patients randomized to oophorectomy, in contrast to previous reports. Preliminary crude survival curves suggested a survival benefit for oophorectomy between two and three years from surgery, but Kaplan-Meier survival analysis indicated that this was not statistically significant and the benefit does not appear to persist at five years. Kaplan-Meier curves of recurrence-free survival, however, suggest a more substantial separation of the curves, with 80 percent vs. 65 percent five-year disease-free survival for oophorectomy vs. nonoophorectomy, but further patient accrual is necessary to provide sufficient statistical power. CONCLUSIONS: Occult colorectal carcinoma metastatic to the ovaries has not been documented in this series of putative Dukes Stages B and C tumors. The possibility of a recurrence-free survival advantage emphasizes the need to continue this preliminary work.

Aged↗
PubMed1998

Factors determining recurrence following surgery for Crohn's disease.

Many factors have been examined in an attempt to define groups at higher risk for recurrence or recrudescence of Crohn's disease. Among these factors are age and onset of disease, gender, site of disease, number of resections, symptomatic status at the time of surgery, length of small bowel resection, fistulizing versus obstructive forms of disease, proximal margin length, microscopic margin histology, strictureplasty, and number of sites of disease, as well as the presence of colonic only disease, the presence of granulomas, blood transfusions, family history, and prophylactic treatment. To date, only proctocolectomy with Brooke ileostomy versus other procedures for colonic only disease, and prophylactic treatment have been shown with some degree of confidence to lead to a lower recurrence rate after surgery for Crohn's disease.

Adult↗
PubMed1998

Surgical treatment of adenocarcinoma of the rectum.

OBJECTIVE: The authors' aim was to determine survival and recurrence rates in patients undergoing resection of rectal cancer achieved by abdominoperineal resection (APR), coloanal anastomosis (CAA), and anterior resection (AR) without adjuvant therapy. SUMMARY BACKGROUND DATA: The surgery of rectal cancer is controversial; so, too, is its adjuvant management. Questions such as preoperative versus postoperative radiation versus no radiation are key. An approach in which the entire mesorectum is excised has been proposed as yielding low recurrence rates. METHODS: Of 1423 patients with resected rectal cancers, 491 patients were excluded, leaving 932 with a primary adenocarcinoma of the rectum treated at Mayo. Eighty-six percent were resected for cure. Surgery plus adjuvant treatment was performed in 418, surgery alone in 514. These 514 patients are the subject of this review. Among the 514 patients who underwent surgery alone, APR was performed in 169, CAA in 19, AR in 272, and other procedures in 54. Eighty-seven percent of patients were operated on with curative intent. The mean follow-up was 5.6 years; follow-up was complete in 92%. APR and CAA were performed excising the envelope of rectal mesentery posteriorly and the supporting tissues laterally from the sacral promontory to the pelvic floor. AR was performed using an appropriately wide rectal mesentery resection technique if the tumor was high; if the tumor was in the middle or low rectum, all mesentery was resected. The mean distal margin achieved by AR was 3 +/- 2 cm. RESULTS: Mortality was 2% (12 of 514). Anastomotic leaks after AR occurred in 5% (16 of 291) and overall transient urinary retention in 15%. Eleven percent of patients had a wound infection (abdominal and perineal wound, 30-day, purulence, or cellulitis). The local recurrence and 5-year disease-free survival rates were 7% and 78%, respectively, after AR; 6% and 83%, respectively, after CAA; and 4% and 80%, respectively, after APR. Patients with stage III disease, had a 60% disease-free survival rate. CONCLUSIONS: Complete resection of the envelope of supporting tissues about the rectum during APR, CAA, and AR when tumors were low in the rectum is associated with low mortality, low morbidity, low local recurrence, and good 5-year survival rates. Appropriate "tumor-specific" mesorectal excision during AR when the tumor is high in the rectum is likewise consistent with a low rate of local recurrence and good long-term survival. However, the overall failure rate of 40% in stage III disease (which is independent of surgical technique) means that surgical approaches alone are not sufficient to achieve better long-term survival rates.

Adenocarcinoma↗
PubMed1998

Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium 99m-labeled totally human monoclonal antibody 88BV59: results of pivotal, phase III multicenter studies.

PURPOSE: To assess the performance and potential clinical impact of a totally human monoclonal antibody, 88BV59 (HumaSPECT) (INTRACEL, Corp, Rockville, MD), in 202 assessable presurgical patients with recurrent, metastatic, or occult colorectal cancer. METHODS: 88BV59, labeled with technetium Tc 99m (99mTc) (HumaSPECT-Tc), was injected intravenously, and planar and single photon emission tomography (SPECT) images were obtained 14 to 20 hours postinjection. Surgical and pathologic verification of tumor were used as the standard against which the performance of HumaSPECT-Tc imaging and computed tomography (CT) analysis were evaluated. RESULTS: All patients entered onto the recurrent disease study had at least one tumor site defined on CT. The sensitivity of HumaSPECT-Tc in those CT-positive patients was 87%. The specificity of HumaSPECT-Tc was 57% compared with 17% for CT and the difference was statistically significant (P < .001). The diagnostic information provided by HumaSPECT-Tc significantly (P < .001) improved the accuracy of the identification of resectable and nonresectable disease over that of CT (80% v 62%). HumaSPECT-Tc scans resulted in a significant (P < .001) reduction versus CT in terms of the proportion of patients understaged (27% v 41%) and overstaged (4% v 26%). In patients with occult disease (increasing carcinoembryonic antigen [CEA] titer, negative diagnostic work-up, negative CT), HumaSPECT-Tc correctly identified disease in 15 of 22 (68%) patients. HumaSPECT-Tc images provided additional clinical data that would have affected patient management decisions in 40 of 202 (19.8%) patients. In 365 patients who received 88BV59, only a single detectable human anti-human antibody (HAHA) response (90 ng/mL) at 9 weeks postinfusion was observed. CONCLUSION: HumaSPECT-Tc can provide important and accurate information about the presence and location of disease in patients with a high clinical suspicion of metastatic or recurrent colorectal cancer and either positive (known disease) or negative (occult disease) CT scans.

Adult↗