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Background Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown. Methods In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS). Results From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51–1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51–0.96). Conclusions Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.

Background and Objectives The increasing use of peripherally inserted central venous catheters (PICCs) for chemotherapy has led to the observation of an elevated risk of complications and failures. This study investigates PICC failures in cancer patients. Methods A prospective study was conducted at a single cancer institution on 291 PICC placement for chemotherapy. The primary study outcome was PICC failure. Results Median follow-up was 119 days. PICC complications occurred in 72 patients (24.7%) and failures with removal in 44 (15.1%). Reasons for failures were upper extremity deep venous thrombosis (UEDVT) 12 (4.1%), central line associate bloodstream infection (CLABSI) 5 (1.7%) with an infection rate of 0.95 per 1,000 catheter days, exit site infection 9 (3.1%) with a rate of 1.46 per 1,000 catheter days, catheter dislodgment 11 (3.8%), and occlusion 7 (2.4%). Statistically significant risk factors were previous DVT (HR 2.95, 95%CI 1.33–6.53), reason for PICC implant (HR 3.65, 95%CI 1.12–10.34) and 5-fluorouracil, oxaliplatin and bevacizumab based chemotherapy (HR 3.11, 95%CI 1.17–8.26). Conclusions PICC is a safe venous device for chemotherapy delivery. Nevertheless, a 15% rate of failure has to be taken in account when planning PICC insertion for chemotherapy purposes. J. Surg. Oncol. 2016;113:708–714. © 2016 Wiley Periodicals, Inc.

A short peripheral intravenous catheter or cannula (PIVC) is frequently used to deliver chemotherapy in oncology practice. Although safe and easy to insert, PIVCs do fail, leading to personal discomfort for patients and adding substantially to treatment costs. As the procedure of peripheral catheterization is invasive, there is a need for greater consistency in the choice, insertion and management of short PIVCs, particularly in the oncology setting where there is a growing trend for patients to receive many different courses of IV treatment over a number of years, sometimes with only short remissions. This article reviews best practice with respect to PIVCs in cancer patients and considers the necessity for bundling these actions. Two care bundles, addressing both insertion and ongoing care and maintenance, are proposed. These have the potential to improve outcomes with the use of short PIVCs for vascular access in oncology practice.

Background and Objectives Over the last decade, lymphatic mapping and sentinel lymph node (sN) biopsy have greatly increased the possibility of identifying nodal metastasis in clinically node-negative patients with melanoma and breast cancer, thus improving the accuracy of pathologic staging. Recently, sN biopsy has been applied also in colorectal cancer. This prospective study aimed to assess its feasibility and accuracy in predicting regional lymph nodes metastases in colorectal cancer patients as well as the impact on treatment decision-making. Materials and Methods Lymphatic mapping was accomplished by means of blue dye, which was intraoperatively injected into the subserosa overlying the tumor site in 26 patients undergoing colorectal cancer surgery. Following bowel resection, the operative specimen was inspected to identify each blue-stained node, the sN, which was sent separately to the pathologist. One half of each sN was examined by multiple 200 μm sections, while the second half was examined by standard bi-valving technique with hematoxylin-eosin (HE all the other regional non-sentinel nodes were routinely examined by standard bi-valving technique and H&E staining. Results At least one sN was detected in 24 of 26 patients (92.3%); two patients with rectal cancer had no sN identified. Overall, 70 sN were retrieved into the operative specimens, with a mean of 2.9 sNs/patient, and 19 sNs were tumor-positive. An agreement between sN and regional lymph-node status was observed in 20 of 24 patients (83.4%). The sN was histologically negative in two of nine patients with positive regional nodes (sensitivity = 77.8%; false-negative rate of 22.2%); in two of seven patients with tumor-positive sN (28.6%), the sN was the exclusive site of regional nodal metastasis. The negative predictive value was 88.2% (15 of 17 patients), and the overall accuracy was 91.7% (22 of 24 patients). As regards the contribution to the detection of nodal metastasis according to the pathologic technique, standard H&E bi-valving technique detected 16 of 19 tumor-positive sNs (84.2%) while, by means of serial sectioning, metastases were detected in the remaining 3 of 19 sNs (15.8%). Conclusions The sN biopsy proved feasible, with a rather short learning curve. The focused analysis of the sN by means of serial sectioning improved the detection rate of nodal metastasis compared to standard bi-valving examination, so that a more accurate nodal staging should be expected; finally, an elective localization of metastasis within the sN was observed in almost one third of regional node-positive patients. J. Surg. Oncol. 2004;85:166–170. © 2004 Wiley-Liss, Inc.

Sentinel lymph node (sN) biopsy has gained special attention among surgical and medical oncologists as it represents an accepted technique for detecting occult nodal disease in regional lymph nodes of patients with melanoma and breast cancer. The histopathologic examination of the sN may well predict regional lymph node status in order to define the most suitable loco-regional and systemic treatment. Recently, this technique has also been applied to other solid tumor types such as gynecologic and urologic malignancies, squamous head and neck cancer, thyroid cancer, non-small-cell lung cancer, Merkel cell carcinoma, and gastric cancer. The aim of this literature review is to define the rationale of sN biopsy in these tumor sites, the most effective procedure for sN detection, and the accuracy of the sN in predicting regional nodal status, as well as the surgical perspectives of sN biopsy application.

The status of axillary nodes is the most important prognostic factor in breast cancer to select patient subgroups for adjuvant chemotherapy; the current standard of care for surgical management of invasive breast cancer is complete removal of the tumor by either mastectomy or lumpectomy followed by axillary lymph node dissection (ALND). The recent introduction of intraoperative lymphatic mapping and sentinel lymph node biopsy (SLND) represents a major new opportunity for appropriate and less invasive surgical management of many tumors. There is an almost uniformly enthusiasm concerning the potential of this technique in breast carcinoma management, shown by published data. A peculiar attention to the so-called “sentinel node debate” in breast cancer surgery is a constant in the last years issues of the major medical journals. Even patients have become more aware about medical enthusiasm and their request of concise information on the topic and the possibilities of this approach is an increasing reality in medical practice. The aim of this paper is to review recent literature to offer an overview about the main controversial methodological aspects and a wide analysis of reported results. The most significative international literature papers from Medline were retrieved from 1993 to September 1999, and 4782 procedures were analysed. This extensive review of the literature has confirmed accuracy, feasibility and reliability of the SN detecting technique in axillary mapping. Provided a good proficiency in SN localisation and pathological evaluation, human resources and efforts should be mainly focused on its clinical validation as an alternative to ALND instead of on further phase I–-II clinical studies.

Radioimmunoguided surgery (RIGS) with radiolabeled monoclonal antibodies (MoAbs) has been reported as useful in second-look colorectal cancer procedures to improve surgical decision-making by helping avoid needless extensive surgery and expanding curative resection to sites of recurrence that have been missed previously. Sixteen asymptomatic patients with an history of colorectal cancer surgery underwent second-look surgery using the RIGS system, solely on the basis of rising serum levels of carcinoembryonic antigen (CEA). All patients were injected preoperatively with the anti-tumor-associated glycoprotein (TAG) 125I-labeled MoAb B72.3. Both traditional and RIGS exploration were used to determine the extension of a possible recurrence and its resectability for cure. Recurrent disease was observed in 14 of the 16 patients as the result of this combined exploration. Exploration alone showed the presence of recurrent disease in 9 of 16 patients (56.2%). Thus, RIGS found overlooked tumor in five patients (31.2%). All the additional RIGS-detected tumor sites were locoregional recurrences resectable for cure; conversely, no diagnostic improvements were shown in patients with liver metastases. Resection for cure was obtained by this approach in 9 of 16 patients (56.2%). Two patients without disease at the exploratory laparotomy recurred within 2 months at sites away from the abdomen. RIGS improved the results of colorectal cancer CEA-guided second-look procedures in asymptomatic patients by recruiting one-third of patients to curative resections.

Sixty-four patients with recurrent or metastatic colorectal cancer underwent radioimmunoguided surgery (RIGS). Thirty patients (Group A) were preoperatively injected with radiolabeled monoclonal antibody (MAb) B72.3, a whole IgG1 that reacts with tumor-associated glycoprotein (TAG-72) antigen. Thirty-four patients (Group B) were given monoclonal antibody FO23C5, an F(ab')2 which reacts with the carcinoembryonic antigen (CEA). The use of F(ab')2 antibodies ensured a lower time interval from the preoperative injection of the radiolabeled MAb to surgery. This interval was 22.7 days for Group A patients and 10.9 days for Group B patients. The correct RIGS identification of tumor sites occurred in 80.4% of Group A patients and in 92.6% of Group B patients. Additional information capable of modifying surgical strategy was obtained in 23.3% of Group A patients and in 8.8% of Group B patients. This difference was due to the different patterns of biodistribution and pharmacokinetics of the two MAbs. Although FO23C5 yields an improved diagnostic resolution for macroscopic tumor sites, we believe that B72.3 or other whole IgG1 should be the first choice for RIGS in recurrent or metastatic colorectal cancer patients.

Twenty-one patients with histologically proven locally advanced breast cancer (LABC) were treated with a combined modality approach based on primary chemotherapy and radical modified mastectomy followed by adjuvant chemotherapy. Surgery was performed by using radioimmunoguided surgery (RIGS) technique with the preoperative injection of Iodine-125 labeled monoclonal antibodies (MoAbs) B72.3 anti-TAG (11 patients, Group A) and FO23C5 anti-carcinoembryonic antigen (CEA; 10 patients, Group B). The role of RIGS was defined at surgery by using an intraoperative hand-held gamma-detecting probe (GDP) to locate the primary tumor, possible clinically occult multicentric foci and ipsilateral lymph node metastases. In Group A, RIGS correctly defined the primary tumor in seven out of 11 patients (63.3%) and was able to find multicentric tumors in two out of four patients (50%). Positive lymph nodes were identified by RIGS in three out of eight patients (37.5%). In Group B, patients RIGS correctly located the primary in 4/10 cases (40%); in two RIGS-positive cases, the tumor was clinically not evident after primary chemotherapy (yT0). RIGS correctly identified multicentric foci of tumor in one out of two cases (50%). Correct lymph nodal RIGS assessment was observed in three out of nine patients (33.3%). No RIGS false-positive findings occurred in the 21 patients included in the study. RIGS appears to be a reliable technique for the intraoperative diagnosis and staging of breast cancer with a potential role especially when conservative surgery is planned after primary chemotherapy in LABC.

Subclavian percutaneous access with reservoir placement has been shown to be difficult or contraindicated in some patients. Of 465 cancer patients who required a port placement between January 1992 to January 1995, 41 (8.8%) had alternative percutaneous femoral access with a totally implantable port reservoir located in the abdomen because of the inaccessibility to subclavian or jugular veins and/or the presence of massive cutaneous metastases or severe radiodermitis in the upper part of the torso. Overall implant days was 9880, with an average of 241 days (range: 65–445). Ports were alternatively used for chemotherapy and nutritional purposes in 11 of 41 patients. Late morbidity causing the removal of the implanted ports was observed in two of 41 (4.9%) and in 25 of 424 (5.9%) patients in the femoral and subclavian series, respectively ( P =0.86). The femoral percutaneous access for totally implantable port devices appears to be a safe alternative for cancer patients when subclavian and/or jugular vein catheterization and reservoir in the upper part of the torso is contraindicated.

Background Heparin solution is routinely used to maintain the patency of infusion devices. Literature supports the alternative use of normal saline solution for flushing and locking intravenous infusion devices especially for pediatric patients. There is uncertainty regarding safety and efficacy of this policy for intermittent locking of implanted ports. Objective This study evaluates efficacy and safety of normal saline solution for intermittent locking procedures of implanted ports. Methods This is a retrospective observational cohort study of 610 implanted ports receiving 2 different locking solutions conducted at the National Institute for Cancer Research, IST Genova, Italy, from January 2007 to August 2009. Group A (n = 297) received heparinized solution (10 mL/500 U heparin), whereas group B (n = 313), 10 mL normal saline. Primary endpoint was irreversible port occlusion. Minimum follow-up was 12 months. The role of age, type of tumor, disease stage, access site, access body side, catheter tip position, and concomitant use of parenteral nutrition and chemotherapy was evaluated in secondary aim. Results : Results fail to show statistically significant differences in implanted ports survival free from failure for occlusive events between the use of heparinized solution and that of normal saline for the maintenance of port patency, both in univariate (P = .9) and in multivariate analyses (P = .7). Conclusion Normal saline solution seems to be as effective as heparinized solution for keeping patent implanted ports in adult cancer patients. Implications for practice Switching from heparinized solution to normal saline for catheter intermittent lock of ports seems a safe procedure.

The role of elective lymph node dissection (ELND) for treatment of cutaneous melanoma is still debated. Initially, lymphatic mapping technique was performed by an intradermic injection of vital blue dye; subsequently, it was improved by the use of radioguided surgery (RGS). Preliminary experience with this technique proved effective for detection of clinical occult lymph node metastasis; it may also enable the surgeon to perform a selective lymph node dissection (SLND) to concentrate on pathologic node-positive patients for the same potential benefits that have been provided by ELND. We performed sentinel node biopsy on 48 patients with stage pT3N0M0 melanoma. Vital blue dye mapping only was carried out on 39 patients; the remaining nine patients had a combined lymphatic mapping with both blue dye and RGS. The sentinel lymph node (SLN) was identified in 46 of 48 patients (95.8%). Ten patients (20.8%) were found to have metastatic melanoma cells in their SLN(s); all these patients underwent SLND of the affected basin. Our findings confirm that the intraoperative lymphatic mapping of the SLN using both blue dye and radiodetection is an appropriate and simple technique for selecting patients who are more likely to benefit from lymph node dissection.

Uniform and accurate staging of gastric cancer is essential to predict prognosis and assess the effectiveness of treatment strategies. An appropriate amount of surgical resection of the primary tumor and lymph node dissection appears to be fundamental for such staging. In seven out of 10 patients who were candidates for curative surgery, we assessed the usefulness of radioimmunoguided surgery (RIGS) using B72.2 monoclonal antibody (MoAb) labeled to Iodine-125 (I125) for the intraoperative staging of the tumor and the first (N1) and second echelon (N2) lymph nodes. We obtained a correct RIGS identification of primary lesions in four out of seven patients (57.1%), while lymph node staging assessment showed positive results in two out of four patients with lymph node metastases. RIGS correctly identified 26/ 40 (65%) metastatic nodes of these last two patients. RIGS intraoperative staging of gastric cancer--which may be essential for the assessment of the extension of the primary resection and to modulate lymph node dissection--was unsatisfactory. We believe that other technical approaches and more specific MoAbs should be evaluated for RIGS purposes in gastric cancer surgery.

Purpose The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE. Patients and Methods In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications. Results Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period. Conclusion In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.

Summary Background The majority of high-dose chemotherapy (HDC)-related complications results from bone marrow aplasia, but the graft infusion per se may cause adverse reactions due to the injection of both dimethyl sulfoxide (DMSO) and cell lysis products We evaluated the feasibility of a two-step chemotherapy regimen with peripheral blood progenitor cell (PBPC) support in association with a novel procedure to remove DMSO and products of cell lysis from the cryopreserved cells Patients and methods Stage III and IV breast cancer patients received induction chemotherapy with three cycles of CEF (cyclophosphamide 600 mg/m2, epirubicin 100 mg/m2, 5-fluorouracil 600 mg/m2) followed by three cycles of HDC consisting of escalating doses of cyclophosphamide (dose range 1200–3000 mg/m2) and carboplatin (dose range 600–1000 mg/m2), supported by DMSO-free PBPC reinfusion. DMSO was removed by a washing/enzymatic digestion procedure Results Twenty patients received induction chemotherapy and eighteen completed the entire chemotherapy program, a total of fifty-four cycles of HDC were administered Dose limiting toxicity of HDC was long-lasting grade 4 neutropenia associated with documented infection The maximum tolerated dose (MTD) was cyclophosphamide 3000 mg/ m2 and carboplatin 600 mg/m2 No side effects related to PBPC reinfusion were observed Conclusions The proposed two-step chemotherapy regimen, associated with a novel washing/enzymatic digestion procedure, is feasible in advanced breast cancer patients in the absence of complications related to the specific toxicity of PBPC reinfusion

Objectives Two-hundred eighteen patients with TNM stage II-III resectable rectal cancer, enrolled into a randomized clinical trial, were assessed for efficacy and toxicity of adjuvant postoperative radiation therapy (RT) vs. those of combined RT and chemotherapy (CT), with 5-fluorouracil (5-FU) plus levamisole. End points were overall survival, disease-free survival, the rate of loco-regional recurrence, and treatment-related toxicity. Methods Patients in arm I underwent RT (50 Gy) in daily fractions of 2 Gy, 5 days/week for 5 weeks. Patients in arm II began with 5-FU (450 mg/m2/day intravenous bolus, days 1–5) plus levamisole (150 mg/day orally, days 1–3); postoperative RT was delivered during week 2 at the same dosage and schedule as in arm I. The other five cycles of CT (5-FU every 28 days and levamisole every 15 days for the length of 5-FU administration) continued after the end of RT if clinical and hemato-biochemical parameters were normal. Results RT was completed or modified in 170 (90%) of 189 evaluable patients undergoing RT (both treatment groups). Only 44 (59%) of 75 evaluable patients of arm II completed or had an adjustment of the CT schedule; the remaining 31 patients (41%) had to stop or never started the CT regimen. Patients undergoing combined RT and CT had more severe toxicity (enteritis, P = 0.03). There was one CT-related death (gastrointestinal bleeding) in this subset. No significant difference was observed in outcome of patients in the two study groups, nor for pattern of recurrence (heterogeneity χ2 = 4.82; d.f. = 2; P = 0.08). Conclusions These preliminary findings suggest a similar efficacy, coupled with less morbidity, of postoperative RT alone compared with a combined regimen of postoperative RT and CT in patients undergoing radical surgery for stage II-III rectal cancer. J. Surg. Oncol. 2000;75:80–88. © 2000 Wiley-Liss, Inc.

One hundred thirty-six patients with colorectal and breast cancer were enrolled in a retrospective study using radioimmunoguided surgery (RIGS) with Iodine-125 (I125) radiolabeled B72.3 (Group A, 73 patients) and F023C5 (Group B, 63 patients) monoclonal antibodies (MAbs). The correlation between intraoperative tumor-to-normal tissue (T/NT) gamma-detecting probe (GDP) counts ratio and the expression of tumor-associated glycoprotein (TAG)-72 (GroupA patients) and carcinoembryonic antigen (CEA; Group B patients) tumor-associated antigens (TAA) expression of 209 resected or biopsy tumor specimens was assessed. Ex vivo radioimmunolocalization index (R.I.) was carried out on the same specimens as a control of intraoperative GDP ratio values. RIGS positive definition of tumor occurred in 80/113 (70.8%) tumor sites of Group A patients and in 84/96 (87.5%) tumor sites of Group B patients. Mean percent B72.3 TAA expression of 113 tumor sites of Group A patients was 62.74 +/- 28.79% vs. 73.00 +/- 26.28% of 96 tumor sites of Group B patients (P < 0.05). The higher incidence of positive RIGS results was observed in tumor sites with the higher expression of the relative TAA. A statistically significant correlation between RIGS ratios and B72.3 and CEA expression was observed in the 113 tumor sites of Group A (P < 0.05) and in the 96 tumor sites of Group B (P < 0.01), respectively. The role of a preoperative evaluation of TAA expression in patients undergoing RIGS is discussed. Its assessment, whenever possible, may help to select those patients who will benefit more from this immunodiagnostic technique.

Stage I-II colorectal cancer (pT2-3, pN0 UICC-TNM Classification) has aproximately a 30% 5-year recurrence rate 1-2. Despite many factors that have been related to prognosis, lymph-node involvement is still considered to be the most important one based on clinical factors and survival estimates 3-6. Although recent reports have shown the possibility to detect the presence of micrometastases in previously H&E staged pN0 lymph-nodes by means of immunohistochemistry using monoclonal antibodies against cytokeratins, there is no agreement on the clinical impact of these observations 7-14. To assess the clinical significance of lymph node micrometastases revealed by immunohistochemical staining with monoclonal antibodies against cytokeratin in large bowel cancer, we reviewed retrospectively all the pericolic lymph nodes of 90 patients with Stage II colorectal cancer (pT2pT3 pN0) observed from 1980 to 1990. PATIENTS AND METHODS

BACKGROUND Angiosarcoma (AS) accounts for 1 to 2% of all soft tissue sarcoma. Both primary and secondary AS may occur, the latter being reported in the upper extremity with lymphedema after extended radical mastectomy for breast cancer (postmastectomy AS) or following radiotherapy of the breast, the thoracic wall, or other sites (radiation-associated AS). The authors report two cases of cutaneous radiation-associated AS and review literature regarding treatment planning and follow-up data to define the most appropriate therapy for cutaneous and noncutaneous radiation-associated AS. METHODS The clinical records of two patients with radiation-associated AS were analyzed and previously reported cases were reviewed. RESULTS Case 1: a female age 67 years developed cutaneous AS in the residual breast 27 months after breast-conserving therapy and conventional external beam radiotherapy (EBR). She underwent chemotherapy followed by simple mastectomy and chemotherapy with the same regimen but developed early recurrence that was treated with hyperthermia and EBR, wide excision, and second-line chemotherapy. She died 30 months after primary diagnosis of AS with multiple metastases. Case 2: a male age 59 years developed cutaneous AS in the left groin, 10 years after conservative surgery and EBR for a penile carcinoma. Early recurrence following wide excision was treated with chemotherapy, re-excision, and immunochemotherapy but the patient died 24 months after the primary diagnosis of cutaneous AS with local progression and distant metastases. CONCLUSIONS The prognosis of radiation-associated AS is dismal, due mostly to its poor differentiation and frequent diagnostic delay. Simple mastectomy is advised for patients with cutaneous AS after breast-conserving surgery with wide tumor-free margins. If primary surgery fails, survival is seriously compromised because adjuvant or palliative treatments are not effective. Cancer 1996;77:2496-502.

PURPOSE To assess the role of radioimmunoguided surgery (RIGS) using a handheld intraoperative gamma-detecting probe (GDP) to identify neoplastic disease after primary chemotherapy in locally advanced breast cancer (LABC) patients injected with iodine 125-labeled monoclonal antibodies (MAbs). PATIENTS AND METHODS Twenty-one patients with histologically documented LABC were treated with a combined modality approach. After three courses of primary chemotherapy and before modified radical mastectomy, the 125I-radiolabeled MAbs B72.3 (anti-TAG72) and FO23C5 (anti-carcinoembryonic antigen [CEA]) were administered to 11 patients (group A) and 10 patients (group B), respectively. At surgery, a GDP was used to locate the primary tumor and to assess possible tumor multicentricity and the presence of ipsilateral axillary metastases. Routine pathologic examination was performed in neoplastic and normal tissue specimens of all 21 patients. In addition, immunohistochemical assay for TAG72 and CEA expression was performed. RESULTS In group A patients, RIGS identified primary tumor in seven of 11 patients (63.3%) and unpalpable multicentric tumor lesions were located in two of four (50%). Positive axillary lymph nodes were histologically documented in eight of 11 patients (72.7%) and RIGS identified three of eight (37.5%). In group B, RIGS located the primary tumor lesion in four of 10 patients (40%); in two cases, the tumor was not clinically evident. Multicentricity was observed in one of two patients and lymph node involvement in three of nine (33.3%). No false-positive results were observed in either group A or B. CONCLUSION RIGS appears to be a safe and reliable technique. However, the MAbs used in this study are not sufficiently specific. RIGS represents a technique for which the full potential for intraoperative assessment of breast cancer lesions can be reached when more specific antibodies become readily available.

We have recently demonstrated that continuous-infusion (CI) 5-fluorouracil (FU) eradicates human colon carcinoma cells made resistant to bolus FU in vitro. In addition, in the same experimental system, the mechanisms of resistance to pulse and CI FU were found to be different. These observations led us to test the clinical activity of a standard regimen of CI FU (300 mg/m2 per day) in a cohort of 15 patients with advanced measurable colorectal cancer who were in progression after having failed to respond to bolus treatment with FU alone (3 patients) or FU combined with high-dose 6-S-leucovorin (LV) (12 patients). The median age of the patients was 68 years, and their median Eastern Cooperative Oncology Group performance status (ECOG PS) was 1. No myelotoxicity was observed. Mild diarrhea, mucositis, and vomiting occurred in 32%, 26%, and 19% of the patients, respectively, with no WHO grade 3 or 4 episodes being noted. In all, 6 of 15 patients complained of hand-foot syndrome, which was severe in 2 instances, lasting approximately 1 week. Overall, 1 partial response and 6 instances of disease stabilization, including 3 minor responses, were obtained both in patients who had been pretreated with pulse FU alone and in patients who had failed first-line treatment with FU + LV. Finally, 8 patients failed CI FU. In conclusion, these results, obtained in patients who were clearly progressing after having failed first-line treatment, support our experimental finding that resistance to bolus FU may be overcome by CI FU and extend this possibility to patients who are resistant to bolus treatment with FU + LV.

8021 Background: Efficacy of prophylaxis with fixed dose of warfarin or low molecular weight heparin (LMWH) for upper limb deep vein thrombosis (UL-DVT) related to central vein catheter (CVC) has b...

Estrogen (ER) and progesterone (PgR) receptors were evaluated in the tumor tissue (T) and in the mammary gland far from malignancy (D) in 36 breast cancers. Results were correlated with the pathological grading of the tumor and the axillary nodal status. It is suggested that a lower cancer malignancy with negative nodes and lower values of pathological grading (G1-G2) may be associated with a high level of ER in the mammary parenchyma far from the tumor (D).

The histories of 90 consecutive patients who underwent curative surgery for rectal cancer from January 1975 to December 1981 were reviewed. Twenty of 90 patients (22.2%) recurred locally. The site of the primary lesion and tumor differentiation are the most important factors influencing local recurrence. Median survival from recurrence was 3 months and no patient was alive after 15 months. No significant difference in survival was observed in patients surgically treated for recurrence compared to untreated patients.