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National Cancer Institute®
Ultima Vez Modificado: 21 de noviembre del 2001
UI - 20138879
AU - Sasaki K; Nozaki M; Kikutchi Y; Yamaki T; Soejima K
TI - Reconstruction of perianal skin defect using a V-Y advancement of bilateral gluteus maximus musculocutaneous flaps: reconstruction considering anal cleft and anal function.
SO - Br J Plast Surg 1999 Sep;52(6):471-5
AD - Department of Plastic and Reconstructive Surgery, Tokyo Women's Medical College, Japan.
In order to preserve the anal function after ano-perianal skin excision for malignancy, we have reconstructed a deep, symmetrical natal cleft using a V-Y advancement of bilateral gluteus maximus musculocutaneous flaps thinned medially and sutured to the ooccyx, anococcygeal ligament and the central tendon of the perineum. This technique was applied in three cases of Bowen's disease and two cases of Paget's disease. In all five cases, postoperative anal functions such as comfortable defecation and sensation, were well preserved, the perianal skin and underwear stayed clean, and there was no disturbance of walking or exercise.
UI - 21245394
AU - Khayat D; Gil-Delgado M; Antoine EC; Nizri D; Bastian G
TI - The role of irinotecan and oxaliplatin in the treatment of advanced colorectal cancer.
SO - Oncology (Huntingt) 2001 Apr;15(4):415-29; discussion 429-30, 433-4
AD - Pharmacokinetic Laboratory of Department of Medical Oncology Hopital de La Salpetriere Paris, France.
Colorectal carcinoma is one of the most common malignancies in the western world, and although fluorouracil (5-FU) has been used in its treatment for almost 40 years, new agents with significant activity have been introduced recently. Irinotecan (CPT-11, Camptosar), a topoisomerase I inhibitor, administered at 300 to 350 mg/m2 every 3 weeks is significantly more active than continuous-infusion 5-FU in patients who have experienced disease progression after conventional therapy with 5-FU. In comparison to best supportive care, irinotecan improves survival and preserves quality of life despite treatment-related toxicity. Moreover, the combination of irinotecan and 5-FU has been explored in a number of different schedules. In previously untreated patients, overall response rates are high. Irinotecan can also be combined with mitomycin (mitomycin-C [Mutamycin]), oxaliplatin, or raltitrexed (Tomudex). Oxaliplatin is a new-generation platinum compound that has demonstrated activity against colorectal carcinoma in preclinical trials. It has been evaluated as a single agent against advanced colorectal carcinoma in the salvage setting and also in combination with 5-FU as initial therapy for metastatic disease (where it shows significant activity). The toxicity profile of oxaliplatin (chiefly characterized by neurotoxicity) differs from that of irinotecan (primarily producing diarrhea) and the potential, therefore, exists for combining these agents or for exploiting their possible synergy with 5-FU. The introduction of these two new active agents of different pharmacologic classes promises to enable significant improvements in the treatment of patients with colorectal carcinoma.
UI - 21245399
AU - Wagman RT; Minsky BD
TI - Conservative management of rectal cancer with local excision and adjuvant therapy.
SO - Oncology (Huntingt) 2001 Apr;15(4):513-9, 524;discussion 524-8
AD - Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, USA.
The standard surgical treatment of distal, resectable, invasive rectal cancers is an abdominoperineal resection or a low anterior resection. Given the morbidity associated with these standard treatments and the frequent need for postoperative adjuvant therapy, the use of a more conservative approach, such as local excision with adjuvant therapy as primary therapy for selected cases of rectal cancer is appealing. Data from single-institution series as well as recent data from prospective, multi-institutional studies, suggest that local excision with adjuvant therapy is a reasonable alternative to radical surgery in selected patients. Local excision alone is acceptable treatment only for T1 tumors without adverse pathologic features, while local excision with adjuvant therapy is an alternative treatment for T1 tumors with adverse pathologic features and T2 tumors. Some series suggest that preoperative therapy with local excision may be a possible treatment for selected T3 tumors; however, the high local failure rates seen in T3 tumors treated with local excision and postoperative therapy cautions against this approach. Functional results with local excision are generally good, and postoperative morbidity and mortality is acceptable. In summary, the results of local excision and radiation therapy are encouraging. Randomized trials are needed to determine whether this approach has local control and survival rates comparable to those of radical surgery.
UI - 21243490
AU - Ngan SY
TI - Optimising treatment for resectable rectal cancer: is preoperative therapy beneficial?
SO - Drugs Aging 2001;18(2):79-85
AD - Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia.
Preoperative radiotherapy is becoming the standard of care for resectable locally advanced adenocarcinoma of the rectum. Its practice is no longer limited to a few specialised cancer centres. Adjuvant preoperative radiotherapy can reduce the risk of local recurrence by 50% compared with surgery alone and it has a moderate effect in improving survival. Treatment-related toxicity is superior to that after postoperative radiotherapy. Early results of preoperative radiotherapy with concurrent chemotherapy are promising, with a low toxicity profile and a high pathological response rate. Advances in technology, endorectal ultrasound and magnetic resonance imaging enable selection of appropriate patients for preoperative radiotherapy.
UI - 21254747
AU - Wang WS; Lin JK; Lin TC; Chiou TJ; Liu JH; Fan FS; Yen CC; Chen WS;
TI - Jiang JK; Yang SH; Wang HS; Chen PM Carcinoembryonic antigen in monitoring of response to systemic chemotherapy in patients with metastatic colorectal cancer.
SO - Int J Colorectal Dis 2001 Apr;16(2):96-101
AD - Division of Medical Oncology, Department of Medicine, Veterans General Hospital Taipei and National Yang-Ming University School of Medicine, Taipei 11217, Taiwan.
The response to chemotherapy of solid tumors is generally assessed by measuring tumors visualized by imaging. However, the response assessment based on imaging is not always feasible because patients often have disease not measurable by imaging, such as diffuse peritoneal dissemination. We evaluated the correlation between the change on imaging and change in CEA levels for assessing chemotherapeutic response colorectal carcinoma, all of whom had measurable lesions. Forty patients received oral tegafur-uracil (300 mg/m2/day) plus folinic acid (60 mg/day) for 4 weeks, repeated every 5 weeks, as the firstline treatment. Another 96 patients received either a weekly intravenous bolus injection of 5-fluorouracil (400 mg/m2) plus folinic acid (20 mg/m2), or an intravenous bolus injection of 5-fluorouracil (425 mg/m2) plus folinic acid (20 mg/m2) for 5 consecutive days every month. Responders, based on CEA assessment, were defined as those with a greater than 50% drop in CEA level for more than 4 weeks. The pretreatment CEA levels were elevated beyond the normal cutoff value in 110 (81%) patients. A response rate of 18.4% (95% CI, 11.9-24.9%), including 8 complete remissions and 17 partial remissions, was achieved according to imaging studies. The response rate assessed by CEA was 25% (34/136). Sixteen responders (47%) based on CEA had no remission on imaging. The sensitivity of change in CEA levels in the prediction of true responders and progressive diseases on imaging were 72% and 81%, respectively. In terms of the positive predictive value, change in CEA levels in the prediction of true responders and progressive disease on imaging were 53% and 85%, respectively. Patients with remarkable falls on CEA levels survived significantly longer than nonresponders (P < 0.001, log-rank test). At follow-up of 48 months the median survival for responders and nonresponders assessed by CEA was 28 months and 13 months, respectively. These data suggest that measurement of CEA levels might be helpful in monitoring chemotherapeutic response when imaging study is unsuitable for assessing the response in clinical practice. Furthermore, measurement of CEA levels may be helpful in determining the prognosis of patients with metastatic colorectal cancer receiving chemotherapy.
UI - 21271574
AU - Ooi BS; Eu KW; Seow-Choen F
TI - Primary anorectal malignant melanoma: clinical features and results of surgical therapy in Singapore--a case series.
SO - Ann Acad Med Singapore 2001 Mar;30(2):203-5
AD - Department of Colorectal Surgery, Singapore General Hospital, 1 Hospital Drive, Singapore 169608.
INTRODUCTION: Primary malignant melanoma arising from the anorectum is uncommon. The natural history of anorectal malignant melanoma is that of a very poor prognosis with early dissemination of disease. Successful surgical treatment has been rare. The present series reviews the clinical features and results of surgical management of patients with anorectal malignant melanoma treated in the Department of Colorectal Surgery, Singapore General Hospital. MATERIALS AND METHODS: Data for all patients treated for anorectal malignant melanoma during an 11-year period from 1989 to 1999 were reviewed. The age, sex, presenting symptoms, duration of symptoms prior to diagnosis, size of tumour, extent of disease, type of surgery and length of survival were analysed. RESULTS: Four men and 2 women, ranging in age from 31 to 81 years with histologically proven primary anorectal malignant melanoma, were included in the study. The most common (67%) presenting symptom was rectal bleeding. The mean tumour size was 2.5 cm (range 1 to 5 cm). All underwent abdomino-perineal resection. Three died of disseminated disease within 17 months while the other 3 were still alive at the time of this study; the longest up to 6.5 years from the time of diagnosis. CONCLUSION: The prognosis of primary anorectal malignant melanoma is poor. However, it is worthwhile treating aggressively as long-term survivor may be encountered in some.
UI - 21375555
AU - Bondar' GV; Ladur AI; Psaras GG
TI - [Radical combined colonic resection for cancer recurrence]
SO - Klin Khir 2001 Mar;(3):53-5
Experience of reoperative radical combined colonic resection for colonic cancer in 9 patients was presented. There were no complications, nor mortality. The preoperative radiation therapy and chemotherapy conduction had permitted to create an optimal conditions for the surgical intervention performance, which promoted the patients life span increase and improved its quality significantly.
UI - 21338536
AU - Nakamura T; Ohno M; Tabuchi Y; Kamigaki T; Fujii H; Yamagishi H; Kuroda
TI - Y; Kansai Carmofur Study Group Optimal duration of oral adjuvant chemotherapy with Carmofur in the colorectal cancer patients: the Kansai Carmofur Study Group trial III.
SO - Int J Oncol 2001 Aug;19(2):291-8
AD - First Department of Surgery, Kobe University School of Medicine, 7-5-2 Kusunkoki-cho, Chuo-ku, Kobe 650-0017, Japan. email@example.com
A multi-institutional study was performed to evaluate the appropriate duration of oral administration of Carmofur (1-hexylcarbamoyl-5-fluorouracil, HCFU), a 5-fluorouracil (5-FU) derivative, for postoperative adjuvant chemotherapy in patients with colorectal cancer undergoing curative operation. Patients were divided into two: i) short duration group receiving 6 months of HCFU administration and ii) long duration group receiving 1 year of the administration, using a centralized registration system. Among 364 patients entered in this study, 293 evaluable cases were analyzed to investigate the appropriate duration of adjuvant oral chemotherapy. No statistical differences were found in the cumulative 5-year disease-free or survival rates between the groups. However, the actual duration of oral HCFU administration differed in the patients of short and long duration groups from the protocol. Namely, more than 70% of the patients received a different duration of oral adjuvant chemotherapy in each of the groups. Therefore, apart from this division of two groups, correlation between the actual duration of oral HCFU administration and the prognosis was examined in these patients. As a result, it was suggested that oral adjuvant chemotherapy with HCFU would be effective in colon cancer patients when the duration of administration exceeded 330 days. In rectal cancer patients, however, adjuvant chemotherapy with HCFU alone was considered to be not sufficient to affect the prognosis.
UI - 21338544
AU - Uchida K; Hayashi K; Kuramochi H; Takasaki K
TI - Changes in intratumoral thymidylate synthase (TS) and dihydropyrimidine dehydrogenase (DPD) mRNA expression in colorectal and gastric cancer during continuous tegafur infusion.
SO - Int J Oncol 2001 Aug;19(2):341-6
AD - Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawadachou, Shinjuku-ku, Tokyo 162-8666, Japan.
Thymidylate synthase (TS) is the target enzyme of 5-fluorouracil (5-FU), and dihydropyrimidine dehydrogenase (DPD) is the key enzyme in the 5-FU catabolic pathway. We wanted to determine whether the TS and DPD mRNA expression levels of gastric and colorectal cancer patients would be affected by tegafur (futrafur:FT)-based chemotherapy and whether changes in their expression might be responsible for patient outcome. Thirty-five patients with resectable advanced primary gastric cancer and 36 patients with resectable advanced primary colorectal cancer were the subjects of this study. They all underwent neoadjuvant chemotherapy with protracted infusion of FT alone or FT plus low doses of cisplatin. The TS and DPD mRNA expression levels of endoscopic biopsy specimens before chemotherapy and surgical specimens after chemotherapy were measured by TaqMan reverse transcription-PCR assay using glyceraldehyde-3-phosphate dehydrogenase (GAPDH) as the internal standard. There was a significant difference in the DPD mRNA levels during chemotherapy in the colorectal cancers. Although the TS and DPD levels were unrelated to any conventional histopathological grade factors, colorectal cancer patients whose surgical specimens contained lower TS and DPD mRNA levels had longer disease-free intervals. The results of this study suggest that FT may affect DPD mRNA expression in colorectal cancer patients, that TS/DPD expression can be regarded as an independent prognostic factor, and that colorectal cancer patients with low TS and low DPD mRNA are candidates for FT-based adjuvant chemotherapy. In addition, quantitative analysis of the change in TS/DPD mRNA in surgical specimens during FT-based chemotherapy might be a more accurate means of predicting the post-operative disease-free interval of colorectal cancer patients than analysis of endoscopic specimens before chemotherapy. There also seems to be a relation between regulation of TS and DPD during FT chemotherapy. Elucidation of the mechanisms regulating TS and DPD mRNA expression might make it possible to predict sensitivity and/or toxicity to FT.
UI - 21403178
AU - Liu J; Kolar C; Lawson TA; Gmeiner WH
TI - Targeted drug delivery to chemoresistant cells: folic acid derivatization of FdUMP enhances cytotoxicity toward 5-FU-resistant human colorectal tumor cells.
SO - J Org Chem 2001 Aug 24;66(17):5655-63
AD - Eppley Institute, University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, USA.
Current chemotherapy protocols that include fluoropyrimidines, such as 5-fluorouracil (5-FU), are limited by the development of chemoresistance during the course of treatment. Our laboratory has developed a novel class of fluoropyrimidines, FdUMP[N], that are oligodeoxynucleotides (ODNs) composed of some number, N, of 5-fluoro-2'-deoxyuridine-5'-O-monphosphate (FdUMP) nucleotides. Novel synthetic procedures are described that permit conjugation of folic acid to the 5'-OH of FdUMP via a phosphodiester linkage using automated synthesis. The synthetic methods developed are generally applicable for ODN conjugation with folic acid. The folic acid conjugate FA-FdUMP showed improved cytotoxicity toward human colorectal tumor cells (H630), and 5-FU-resistant colorectal tumor cells (H630-10). Enhanced cytotoxicity was observed for FA-FdUMP relative to nonconjugated FdUMP for cells grown under folate-restricted conditions, consistent with cellular uptake being, in part, receptor-mediated. Folate receptor alpha (FRalpha) mRNA was shown by RT-PCR to be overexpressed 26.3-fold in 5-FU-resistant H630-10 cells relative to H630 cells. Thus, FA-FdUMP[N] may prove useful for the treatment of 5-FU-resistant malignancies.
UI - 21443831
AU - Stocchi L; Nelson H; Sargent DJ; O'Connell MJ; Tepper JE; Krook JE;
TI - Beart R Jr; North Central Cancer Treatment Group Impact of surgical and pathologic variables in rectal cancer: a United States community and cooperative group report.
SO - J Clin Oncol 2001 Sep 15;19(18):3895-902
AD - Division of Colon and Rectal Surgery, Cancer Center Statistics Unit, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
PURPOSE: Substantial and successful effort has been focused on decreasing the risk of local failure after rectal cancer surgery through the use of adjuvant therapies. Our study examined data from studies conducted by United States cooperative groups to investigate the impact of surgical and pathologic variables in rectal cancer outcomes. PATIENTS AND METHODS: Surgical and pathologic reports from 673 patients with stage II/III rectal cancer enrolled onto three adjuvant clinical trials were reviewed for tumor and surgical variables. Additional information on individual institutions and operating surgeon was collected. Variables were tested for association with 5-year local recurrence and survival after adjustment for adjuvant treatments and other important prognostic factors. RESULTS: Five-year local recurrence and survival rates were 16% and 59%, respectively. Surgeons treating more than 10 study cases had lower local recurrence rates than those treating < or = 10 (11% v 17%, P =.02). Free radial margins also correlated with local recurrence (P =.01). Type of surgery, distal margins, and tumor radial spread were not significant. Tumor adherence to adjacent structures predicted local recurrence (35% v 14%, P <.001) and survival (30% v 63%, P <.001), regardless of en bloc resection. Although T and N classification predicted survival (P <.001), only N classification correlated with local recurrence. The number and percentage of positive nodes correlated with survival, but only the percentage independently predicted local recurrence. Several pathologic and surgical variables were reported suboptimally. CONCLUSION: Moderate variability in outcomes among surgeons was detected in this high-risk population. Efforts to improve surgical results will require changes in reporting practices to allow for more accurate assessment of the quality of surgery.
UI - 21452843
AU - Andre T; Louvet C; Maindrault-Goebel F; Gramont AD
TI - [Oxaliplatin in combination with 5-fluoro-uracil and folinic acid as treatment of metastatic colorectal cancer]
SO - Bull Cancer 2001 Aug;88 Spec No():S20-5
AD - Hopital Tenon, 4, rue de la Chine, 75020 Paris, France.
Unusual aspect of the development of oxaliplatin was that substantial evidence of its activity was gathered when used in combination with protracted infusion of 5FU combined with leucovorin, preceeding the formal demonstration of its single activity in this disease. Phase II trials in previously treated patients by 5FU, have shown response rate of 10% with oxaliplatin in monotherapy and 18,4 to 58% with chronomodulated or bimonthly regimen combining oxaliplatin, 5FU and leucovorin. These trials have confirmed additive or synergistic antitumoral effects of this combination. Dose intensity of oxaliplatin may be important in determining the efficacy of the triple agent regimen. For previously untreated patients, Folfox4 (LV5FU2 + 85 mg/m2 of oxaliplatin) and chronomodulated regimen have obtained objective response rate ranged from 51 to 66%, with progression-free survival between 8.2 and 11 months and overall survival from 16 to 19 months. A better use of oxaliplatin in combination with 5FU and leucovorin may decrease the dose-limiting toxicity, i.e. the usually transient sensory neurotoxicity. Patients with initially unresectable metastases treated with this three-drug combination could sometimes underwent complete metastases surgery. Several studies are currently in progress either to confirm the high activity of the LV5FU-oxaliplatin combination or to define a strategy based on the best sequence or the best combinations with the other available drugs, irinotecan and raltitrexed.
UI - 21452845
AU - Ducreux M; Fizazi K; Seitz JF; Becouarn Y; Armand JP
TI - [Oxaliplatin in combination with non fluoropyrimidine drugs in colorectal cancer]
SO - Bull Cancer 2001 Aug;88 Spec No():S35-9
AD - Unite de gastroenterologie, Institut Gustave-Roussy, rue Camille-Desmoulins, 94805 Villejuif Cedex.
After decades of exclusive use of fluorouracil in the treatment of metastatic colorectal cancer, three new drugs, among them oxaliplatin, have recently shown interesting results. Oxaliplatin has an activity when it is given alone but this drug is particularly interesting for combination chemotherapy because it has a favourable toxicity profile without important haematologic or digestive toxicities and because it has a convenient schedule of administration (short infusion every two or three weeks). Phases I and II studies have demonstrated the feasibility of the combination of raltitrexed and oxaliplatin. A recent phase II study has evaluated the efficacy of this new combination in 71 non pre-treated patients. The observed response rate was high: 59.5%. The combination of oxaliplatin and irinotecan has been assessed in three phase I studies (two with a three-weekly schedule and the last one with a biweekly schedule). These studies have determined the doses which could be used in further phase II studies, these doses were close to the doses used in monotherapy. Results of the efficacy of the three-weekly schedule are available only in second line therapy, with 42% of objective response rate in 36 patients. The dose intensity was maintained with the use of hematopoietic growth factors. These new combinations with oxaliplatin give us the opportunity to treat the patient with schedules excluding fluorouracil which has a variable metabolism.
UI - 21452847
AU - Bugat R
TI - [Oxaliplatin tolerance in the treatment of metastatic colorectal cancers]
SO - Bull Cancer 2001 Aug;88 Spec No():S45-9
AD - Institut Claudius-Regaud, 20-24, rue du Pont-Saint-Pierre, 31052 Toulouse.
Oxaliplatin is a new platinum compound with a 1,2-diaminocyclohexane (DACH) carrier ligand. It has recently been developed in metastatic colorectal cancer treatment, where it is generally combined with 5FU and leucovorin. Safety data in this indication concern over 1,700 patients, who received 12,500 cycles during clinical trials. Oxaliplatin appears to be relatively well tolerated and easy to handle, even on an outpatient basis. Gastrointestinal toxicity is common, but controllable and rarely severe or long-lasting. Haematological and mucosal tolerance is satisfactory, and oxaliplatin does not seem to have renal toxicity. Neurological side effects are the drug's limiting toxicity and can present as acute neurotoxicity (dysesthesiae), which is rapidly reversible, or sometimes as a longer-lasting effect, correlated in this case with the cumulative dose and leading to functional impairment in 10 to 20% of patients after 6 cycles or more. Neurological symptoms improve in the vast majority of cases after treatment is stopped. In this situation, it is even possible to restart oxaliplatin treatment. Good patient information and dose adjustments should allow us to manage the majority of neurological toxicity associated with oxaliplatin administration.
UI - 21452841
AU - Laadem A; Cvitkovic E
TI - [Oxaliplatin: a first DACH-platinum in oncology]
SO - Bull Cancer 2001 Aug;88 Spec No():S9-13
AD - 18-20, rue Pasteur, 94278 Kremlin-Bicetre Cedex.
Around 3,000 cisplatin analogues have been synthetised over the past 30 years but only half a dozen are presently in clinical development, while only two (cisplatin and carboplatin) have been available prior to the recent European registration of oxaliplatin. Oxaliplatin is a new platinum salt belonging to the DACH (diaminocyclohexane) platinum family, and is the only such cisplatin analogue that has entered clinical development and achieved approval for marketing. During its development, oxaliplatin has aroused lively interest due, firstly, to its in vitro and in vivo antitumoral activity, especially in cisplatin-resistant models and cell lines expressing resistance genes, and, secondly, to its good clinical tolerance, the absence of renal or auditory toxicity being combined with a low hematotoxicity. Combined with other antitumoral agent cytotoxic agents (5FU, raltitrexed, irinotecan or cisplatin), oxaliplatin produces an additive and often synergistic cytotoxic effect. The oxaliplatin-5FU +/- FA combination is now well established in metastatic colorectal cancer. Regarding its particular cytotoxic characteristics and its activity in mismatch repair deficient cells (which are resistant to cisplatin and carboplatin), oxaliplatin is shows potential in a large variety of solid tumor types, notably in association with other cytotoxic agents, thus opening the path to a wider range of indications.
UI - 21468604
AU - Bensmaine; de Gramont A; Brienza S; Marty M; Levi F; Ducreux M; Francois
TI - E; Gamelin E; Bleiberg H; Bleuzen P; Simon J; Cvitkovic E Factors predicting for efficacy of oxaliplatin in combination with 5-fluorouracil (5-FU)+/-folinic acid (FA) in a compassionate-use cohort of 370 5-FU-resistant advanced colorectal cancer (CRC) patients.
SO - Eur J Cancer 2000 Dec;36(18):2335-43
AD - Cvitkovic and Associates, Kremlin-Bicetre, France.
Univariate and multivariate analyses were performed on data from 370 5-fluorouracil (5-FU)-resistant advanced colorectal cancer patients treated with oxaliplatin (Eloxatin)/5-FU+/-folinic acid (FA) to identify prognostic factors for oxaliplatin-based treatment. The response rate was 14.6% (95% confidence interval (CI): 11.0-18.2%), median time to progression was 4.3 months (95% CI: 3.9-4.7), and median overall survival 9.7 months (95% CI: 8.5-10.8). Multivariate analysis indicated < 2 prior chemotherapy regimens, bi-weekly treatment administration schedule (versus tri-weekly) and continuous chronomodulated delivery (CCM) as significantly associated (P < 0.05) with a higher overall response rate. Performance status (PS) < 2, having only one involved organ, biweekly schedule and CCM were associated (P < 0.05) with a longer time to progression. Good PS, one involved organ, low alkaline phosphatase (AP) serum levels, bi-weekly schedule and CCM were significantly correlated with longer overall survival, while confirming the efficacy of oxaliplatin/5-FU+/-FA in this indication.
UI - 21190904
AU - Damle B; Ravandi F; Kaul S; Sonnichsen D; Ferreira I; Brooks D; Stewart
TI - D; Alberts D; Pazdur R Effect of food on the oral bioavailability of UFT and leucovorin in cancer patients.
SO - Clin Cancer Res 2001 Mar;7(3):517-23
AD - Department of Metabolism and Pharmacokinetics, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton and Hopewell, New Jersey 08543, USA. firstname.lastname@example.org
UFT is composed of tegafur (FT), a prodrug of 5-fluorouracil (5-FU), and uracil in a fixed combination (1:4). In conjunction with leucovorin, UFT is being developed for the first-line oral treatment of metastatic colorectal cancer. The effect of food on the oral bioavailability of UFT (2 x 100 mg capsules; dose in terms of FT) and leucovorin (2 x 15 mg tablets) was evaluated in a single-dose, randomized, two-way crossover study. Patients (n = 25) were assigned to receive both drugs after an overnight fast or 5 min after completion of a high-fat meal (721 calories) with a 3-day washout period between treatments; then they were permitted to continue on oral UFT/leucovorin therapy for safety assessment. UFT (300 mg/m2/day as three divided doses) and leucovorin (90 mg/day as three divided doses) were given for 28 days. After a 7-day rest, the 28-day cycle was repeated. Pharmacokinetics (n = 22 patients) were determined for FT, 5-FU, uracil, leucovorin, and 5-methyltetrahydrofolate (an active metabolite of leucovorin). The absence of food-effect on peak plasma concentration (CMAX) and the area under the curve (AUC) was concluded if the 90% confidence interval for the ratio of the treatment means was entirely contained in 0.75-1.33. Administration of UFT with food resulted in a 34% decrease in CMAX of FT, whereas the AUC of FT remained unchanged. Food decreased the CMAX and AUC values of uracil and 5-FU by 37-76%. On the contrary, the CMAX and AUC values of leucovorin and 5-methyltetrahydrofolate were increased by 14-60% with food. Time to reach CMAX for all analytes was significantly (P < or = 0.001) delayed by food. Except for the AUCs of FT, the statistical criterion for concluding a lack of food-effect was not met. These data suggest that UFT/leucovorin should not be dosed simultaneously with food. It is recommended that food should not be consumed for 1 h before and after an oral dose of UFT and leucovorin in a manner similar to pivotal Phase III trials. The 28-day oral regimen of UFT and leucovorin was generally well tolerated in the population studied.
UI - 21271455
AU - Rains N; Cannan RJ; Chen W; Stubbs RS
TI - Development of a dendritic cell (DC)-based vaccine for patients with advanced colorectal cancer.
SO - Hepatogastroenterology 2001 Mar-Apr;48(38):347-51
AD - Wakefield Gastroenterology Centre and Research Institute, Wellington, New Zealand.
BACKGROUND/AIMS: An ability to induce a specific immune response to cancer would provide an important new dimension in its management. We report our initial work investigating the safety and efficacy of a dendritic cell vaccine in patients with colorectal cancer. METHODOLOGY: Fifteen (15) patients with advanced colorectal cancer had vaccines prepared from autologous dendritic cells pulsed with tumor RNA and keyhole limpet hemocyanin. Vaccines were administered intravenously and patients were observed in hospital for 2 days. Thereafter, consultations were at monthly intervals at which time booster doses were given to a total of 4. Patients were monitored with weekly blood tests, including carcinoembryonic antigen, and 3-monthly computed tomography scans. RESULTS: Flow cytometry confirmed dendritic cell phenotype and in vitro function was confirmed by mixed lymphocyte reaction. No major adverse effects were observed. Eleven of 13 patients tested developed a positive keyhole limpet hemocyanin skin test and in 7 the carcinoembryonic antigen fell suggesting some in vivo anticancer effect. To date no dramatic clinical responses have been observed but follow-up is very short. CONCLUSIONS: The therapy was well tolerated. Dendritic cells were verified by phenotype and in vitro function. The positive keyhole limpet hemocyanin skin test confirms in vivo function by effective vaccination to keyhole limpet hemocyanin. Demonstration of any anticancer efficacy will require further follow-up.
UI - 21271476
AU - Chiappa A; Zbar AP; Bertani E; Biella F; Audisio RA; Staudacher C
TI - Surgical outcomes for colorectal cancer patients including the elderly.
SO - Hepatogastroenterology 2001 Mar-Apr;48(38):440-4
AD - Department of Emergency Surgery, Surgical Oncology, University of Milan, S. Raffaele Scientific Institute, Milan, Italy. email@example.com
BACKGROUND/AIMS: The aim of this study was to compare the short- and long-term outcome of older and younger colorectal cancer patients resected for cure. METHODOLOGY: Three hundred and forty-six consecutive colorectal cancer patients who underwent some form of surgery were analyzed. One hundred and forty-four patients were < 65 years old (group 1), 151 patients were 65-79 years old (group 2), and 51 patients were 80 years or more (group 3). RESULTS: The overall perioperative mortality rate was 1.7% (n = 6). The median length of hospital stay was 19 days (range: 3-86 days). By univariate analysis, intraoperative bleeding (500 mL or more) (P = 0.009), duration of operations (240 min or more) (P = 0.03), and the presence of rectal cancer (P = 0.001), were strongly associated with higher incidence of postoperative complications. In multiple logistic regression analysis, only rectal cancer (P = 0.02) was significantly associated with serious postoperative complications. No age-related difference was noted concerning 5-year cancer-specific survival rates for patients with < 65, 65-79, and > or = 80 years who underwent surgery for cure (85%, 76%, and 69%, respectively) (P = 0.3). Using logistic regression analysis, tumor stage (P = 0.0001) and perioperative blood transfusions (500 mL or more) (P = 0.05) were strongly associated with outcome. CONCLUSIONS: Colorectal curative surgery for malignancy can be performed safely in the elderly with acceptable morbidity and mortality rates and long-term survival.
UI - 21274207
AU - Sailer M; Fein M; Fuchs KH; Bussen D; Grun C; Thiede A
TI - Morphologic changes of the anal sphincter musculature during and after temporary stool deviation.
SO - Langenbecks Arch Surg 2001 Apr;386(3):183-7
AD - Department of Surgery, University School of Medicine Wurzburg, Germany. firstname.lastname@example.org
BACKGROUND AND AIMS: Temporary stool deviation, using a stoma, is a well-known surgical principle to protect low colorectal or coloanal anastomoses. The purpose of this study was to evaluate any morphologic changes with regard to the anal sphincter muscles during and after temporary ileostomy. PATIENTS AND METHODS: Forty-four patients with rectal carcinomas were studied prospectively. All patients underwent low anterior resection. Reconstruction was performed using either a coloanal pouch or a straight end-to-end anastomosis. A protective stoma was fashioned in all 44 patients (ileostomy n=41; colostomy n=3). Stoma closure was carried out after a median of 85 days (41-330 days). Using a standard protocol, anal-sphincter thickness [m. puborectalis, external anal sphincter (EAS) and internal anal (IAS) sphincter] was assessed by means of endoanal ultrasonography preoperatively, at the time of stoma closure, and every 3 months thereafter for 1 year. RESULTS: The diameter of the puborectal muscle decreased from a median preoperative value of 6.3 mm to 5.7 mm at the time of stoma closure (P=0.03). After 3 months, 6.2 mm was measured. This value remained stable for the complete follow-up period. Similar results were recorded for the EAS. The IAS thickness remained stable throughout the study period, measuring between 2.1 mm and 2.4 mm. CONCLUSION: Temporary stool deviation does lead to morphologic changes of the anal sphincter. While the smooth muscle remains unchanged, the striated counterpart undergoes atrophic transformation. However, after passage reconstruction, i.e., stoma closure, a rapid regeneration of the voluntary muscles is observed.
UI - 21274209
AU - Willis S; Kasperk R; Braun J; Schumpelick V
TI - Comparison of colonic J-pouch reconstruction and straight coloanal anastomosis after intersphincteric rectal resection.
SO - Langenbecks Arch Surg 2001 Apr;386(3):193-9
AD - Chirurgische Universitatsklinik und Poliklinik der RWTH Aachen, Germany. email@example.com
The tendency towards sphincter-preserving resection for distal rectal cancers has led to the technique of straight coloanal anastomosis (CAA) and colonic J-pouch anal anastomosis (CPA) after low anterior resection. The aim of the present study was to compare complication rate, anorectal physiology and functional results after both types of reconstruction after ultra-low intersphincteric resection. A total of 31 patients who had undergone CPA were followed up prospectively using anorectal manometry and a standardised questionnaire and were compared with 63 patients who had undergone CAA and were followed up in the same way. The complication rate after CPA did not differ significantly from that after CAA. One year postoperatively, the median stool frequency and urgency were reduced after CPA (1.7+/-2.2/day; 7% vs. 2.4+/-3.6/day; 14%; P<0.05). Three months after colostomy/ileostomy closure, the maximum tolerable volume, threshold volume and compliance were decreased after CAA when compared with CPA (55+/-12, 34+/-12, and 3.9+/-0.3 ml/mmHg vs. 85+/-21, 53+/-11 and 6.2 ml/mmHg, respectively; P<0.05). Anal manometry revealed no significant differences in the anal resting and squeeze pressure. One year postoperatively, continence also did not differ significantly between CPA and CAA. Colonic J-pouch reconstruction seems to be superior to the straight coloanal anastomosis, especially during the first postoperative year. In view of the often poor prognosis of the patients, it is the reconstruction of choice after ultra-low resections of the rectum.
UI - 21283761
AU - Bauhofer A; Lorenz W; Stinner B; Rothmund M; Koller M; Sitter H; Celik
TI - I; Farndon JR; Fingerhut A; Hay JM; Lefering R; Lorijn R; Nystrom PO; Schafer H; Schein M; Solomkin J; Troidl H; Volk HD; Wittmann DH; Wyatt J; Lucerne Group for Consensus-assisted Development of the Study Protocol on Prevention of Abdominal Sepsis: Example G-CSF Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.
SO - Inflamm Res 2001 Apr;50(4):187-205
AD - Institute of Theoretical Surgery, Philipps-University Marburg, Germany. firstname.lastname@example.org
GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. CONCLUSION: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.
UI - 21366962
AU - Bondar' GV; Basheev VKh; Psaras GG; Zolotukhin SE; Borota AV; Efimochkin
TI - OE [Modern aspects of treatment of colonic cancer, complicated by ileus. Part II. Treatment of colonic cancer, complicated by ileus]
SO - Klin Khir 2000 Sep;(9):20-1
The results of treatment of 364 patients with colonic cancer, complicated by ileus. In 165 patients with partial ileus the radical operative interventions were performed, palliative--in 61 and symptomatic--in 83; with complete ileus--in 30.9 and 16 patients accordingly. Application of the interintestinal anastomoses formation methods, elaborated in the clinic, had permitted to perform primarily-restorational operations in 81.9% of patients with partial ileus and in 61.5%--with complete one, obtaining satisfactory immediate results. Insufficiency of the duplicature anastomosis sutures had occurred in 5 (2.2%) of colonic cancer patients, suffering partial ileus.
UI - 21407978
AU - O'Mahony C; Law C; Gollnick HP; Marini M
TI - New patient-applied therapy for anogenital warts is rated favourably by patients.
SO - Int J STD AIDS 2001 Sep;12(9):565-70
AD - Department of Genito-Urinary Medicine, The Countess of Chester Hospital, Countess of Chester Health Park, Liverpool Road, Chester CH2 1UL, UK. email@example.com
Our objective was to determine patient attitudes to having genital warts, and their perceptions of their treatment with imiquimod and other therapies. As an adjunct to a clinical trial in which patients with external genital warts were treated with imiquimod 5% cream until their warts cleared or for up to 16 weeks, quantitative questionnaires consisting of multiple choice questions and 5-point rating scales were completed prior to, and at the end, of the study period. Pre-study and post-study questionnaires were completed by 902 and 629 patients, respectively. Patients expressed a definite concern about genital warts. The majority of patients (70%) had been previously treated for genital warts, and expressed dissatisfaction with their previous therapies. Of patients treated with imiquimod in this study, 82% reported that their warts decreased in size; this occurred within the first 4 weeks for 78% of patients. Sixty-one per cent of patients perceived that their warts completely cleared within the 16-week treatment period. Patients rated imiquimod 5% cream as better than other genital wart therapies in terms of overall satisfaction, time to clearance, convenience and lack of associated pain. In conclusion, patients rated imiquimod 5% cream as an effective treatment which clears warts in an acceptable length of time causing minimal pain and is convenient to use.
UI - 21424856
AU - Baker D
TI - Current surgical management of colorectal cancer.
SO - Nurs Clin North Am 2001 Sep;36(3):579-92, xi-xii
AD - Department of Surgery Johns Hopkins Hospital, Baltimore, Maryland 21287, USA. firstname.lastname@example.org
Colorectal cancer is the leading cause of death from gastrointestinal malignancies in the United States. Recent emphasis on screening of high-risk and no-risk individuals in addition to careful postoperative surveillance has decreased the incidence and improved the quality of life of survivors. Although multimodality approaches to treating colorectal cancer are favored, surgical resection continues to be the mainstay for a cure. This article reviews current surgical approaches and advances based on evidence for best practice.
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