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D Smaniotto

Publications and source records attributed to D Smaniotto.

At least 19 recordsLinked to original sources
PubMed2005

Intraluminal brachytherapy without stenting in intrahepatic papillary cholangiocarcinoma: a case report.

A 46-year-old female patient, with mild cholestasis by a large papillary cholangiocarcinoma involving the left hepatic duct, received intraluminal brachytherapy (50 Gy at 1 cm from the source axis) with the aim to relieve biliary obstruction without stent positioning. The patient presented with haemobilia and vegetant lesions in the left main biliary duct, and thus she had a high risk of early stent obstruction. Eighteen months after the treatment the patient presented tumour progression in the controlateral hepatic lobe, but had a patent left hepatic duct, without signs of cholestasis and/or cholangitis. Based on this and other published reports, intraluminal brachytherapy may be tested in a setting different from standard setting with the aim to safely palliate jaundice in patients with intraductal tumour growth in the biliary tract.

Bile Duct Neoplasms↗
PubMed2003

Cyclooxygenase-2 (COX-2) expression in locally advanced cervical cancer patients undergoing chemoradiation plus surgery.

PURPOSE: To investigate whether cyclooxygenase-2 (COX-2) could be a marker of clinical outcome in cervical cancer patients undergoing concomitant chemoradiation plus surgery. METHODS AND MATERIALS: The study included 33 locally advanced cervical cancer patients; all underwent neoadjuvant chemoradiation, and responsive patients underwent radical surgery. Immunohistochemistry was performed with rabbit antiserum against COX-2. RESULTS: COX-2 integrated density values (IDVs) in the tumor component ranged from 1.4 to 72.3 (median 15.0); in stromal inflammatory cells, COX-2 IDVs ranged from 1.4 to 96.0 (median 16.0). A statistically significant inverse relation was found between the COX-2 IDVs of the tumor vs. the stromal inflammatory component (r = -0.52, p = 0.0017). When the ratio between COX-2 IDV in the tumor vs. the stromal compartment was 1) tumor/stroma COX-2 IDV ratio. Patients with a high tumor/stroma COX-2 IDV ratio had a shorter disease-free survival than did those with a low tumor/stroma COX-2 IDV ratio (p = 0.030). Similarly, those with a high tumor/stroma COX-2 IDV ratio had a shorter overall survival (p = 0.033). CONCLUSION: The assessment of COX-2 status in both the tumor and the stromal compartment could provide additional information in the prognostic characterization of cervical cancer patients administered concomitant chemoradiation plus surgery.

Adult↗
PubMed2003

Concomitant gemcitabine (Gemzar) and extended nodes irradiation in the treatment of pancreatic and biliary carcinoma: a phase I study.

BACKGROUND: The rationale for combining cytotoxic agents, such as gemcitabine, and radiotherapy is based on their ability to act as radiation sensitizers and to improve overall response rate. Several studies on pancreatic or biliary carcinoma evaluated the maximum tolerated dose (MTD) of gemcitabine when combined with irradiation of the macroscopic tumor. However, most of these neoplasms metastasize to the regional lymph nodes. Aim of this report is to determine the MTD of weekly gemcitabine when combined with extended field irradiation (tumor plus nodal irradiation). PATIENTS AND METHOD: 15 patients entered the study. Of these 5 patients were treated with chemoradiation after radical surgical resection. External beam radiation (ERT) was delivered to the tumor (or tumor bed) and regional lymph nodes by using a three-field technique. The initial dose of gemcitabine was 100 mg/m(2) administered as short intravenous infusion once a week. At each dose level 3 patients were treated, and if no grade 3-4 toxicity (considered as dose-limiting toxicity, DLT) was recorded, dose escalation was applied with 50 mg/m(2) increments until the MTD was established. RESULTS: All patients were evaluable for acute toxicity. There were no treatment-related deaths. No DLT occurred at the first 4 dose levels (100-250 mg/m(2)). At the 5th dose level (300 mg/m(2)), 3 patients experienced DLT: 1 had grade 3 gastrointestinal toxicity (painful erosion of gastric mucosa), 1 had uncomplicated grade 3 leukopenia and 1 grade 3 change in liver biochemistry tests. In addition, all 10 unresected patients were evaluated for response, 4 of whom had progressive disease (1 local; 2 distant; 1 local and distant) and 6 had no change. The median follow-up was 21 months. CONCLUSION: Based on this study, the recommended dose for weekly short infusional gemcitabine combined with radiation therapy to the tumor and lymph nodes is 250 mg/m(2). This value is suggestive of a correlation between acute toxicity and inclusion of lymph nodes in the irradiated volume. Moreover, different infusion modalities, as continuous infusion gemcitabine, should be tested more accurately.

Aged↗
PubMed2001

Preoperative chemoradiation with raltitrexed ('Tomudex') for T2/N+ and T3/N+ rectal cancers: a phase I study.

The use of raltitrexed ('Tomudex') as concomitant chemotherapy during preoperative radiotherapy in chemonaïve patients with stage II/III rectal cancer has been examined in this study and its recommended dose in conjunction with radiotherapy investigated. Forty-five Gray (Gy) of radiotherapy (1.8 Gy daily, 5 days per week) was delivered to the posterior pelvis, followed by a 5.4 Gy boost. Single doses of raltitrexed (2.0, 2.5 and 3.0 mg/m(2)) were administered on days 1, 19 and 38. Only 1 of the 15 patients entered experienced a dose limiting toxicity (DLT) (grade 3 leucopenia) at the 3.0 mg/m(2) dose level. The overall response rate was 80% (five complete responses, seven partial responses). These preliminary data suggest that raltitrexed is a well tolerated and effective treatment when combined with preoperative radiotherapy in patients with stage II/III rectal cancer. The recommended dose of raltitrexed for future phase II studies will be 3.0 mg/m(2).

Adenocarcinoma↗
PubMed2000

Combined modality treatment in unresectable extrahepatic biliary carcinoma.

PURPOSE: Cancers of the extrahepatic biliary tract are rare. Surgical resection is considered the standard treatment, but is rarely feasible. Several reports of combined modality therapy, including external beam radiation, often combined with chemotherapy and intraluminal brachytherapy, have been published. The purpose of this study was to evaluate the effect of chemoradiation plus intraluminal brachytherapy on response, local control, survival, and symptom relief in patients with unresectable or residual extrahepatic biliary carcinoma. METHODS AND MATERIALS: From February 1991 to December 1997, 20 patients (14 male, 6 female; mean age 61 +/- 12 years; median follow-up 71 months) with unresectable (16 patients) or residual (4 patients), nonmetastatic extrahepatic bile tumors (common bile duct, 8; gallbladder, 1; Klatskin, 11) received external beam radiation (39.6-50.4 Gy); in 19 patients, 5-fluorouracil (96-h continuous infusion, days 1-4 at 1,000 mg/m(2)/day) was also administered. Twelve patients received a boost by intraluminal brachytherapy using (192)Ir wires of 30-50 Gy, prescribed 1 cm from the source axis. RESULTS: During external beam radiotherapy, 8 patients (40%) developed grade 1-2 gastrointestinal toxicity. Four patients treated with external-beam plus intraluminal brachytherapy had a clinical response (2 partial, 2 complete) after treatment. For the total patient group, the median survival and time to local progression was 21.2 and 33.1 months, respectively. Distant metastasis occurred in 10 (50%) patients. Two patients who received external beam radiation plus intraluminal brachytherapy developed late duodenal ulceration. Two patients with unresectable disease survived more than 5 years. CONCLUSION: Our data suggest that chemoradiation plus intraluminal brachytherapy was relatively well-tolerated, and resulted in reasonable local control and median survival. Further follow-up and additional research is needed to determine the ultimate efficacy of this regimen. New chemoradiation combinations and/or new treatment strategies (neoadjuvant chemoradiation) may contribute, in the future, to improve these results.

Adult↗
PubMed2000

Phase I-II trial of preoperative chemoradiation in locally advanced cervical carcinoma.

BACKGROUND: 5-Fluorouracil and cisplatin are characterized by in vitro synergism as well as radiosensitization. A phase I-II study was carried out on patients with invasive cervical carcinoma (FIGO IIB-IIIA) undergoing concomitant chemoradiation with 5-fluorouracil and cisplatin followed by radical surgery. METHODS: Twenty-six patients of 53 years median age, 24 with IIB tumor and 2 with IIIA tumor, all with squamous carcinoma, entered the study. The chemoradiation protocol included external radiotherapy to the pelvis: 39.6 Gy (180 cGy/daily); 5-fluorouracil: 1 g/m(2)/daily, in continuous intravenous infusion days 1-4 and 27-30; cisplatin: 20 mg/m(2)/daily days 1-4 and 27-30. Four weeks after the end of chemoradiotherapy, patients underwent restaging and then radical surgery with pelvic and lumboaortic lymphadenectomy. RESULTS: Twenty-six patients are evaluable for acute toxicity and 24 are evaluable for objective and pathologic response. Grade 3-4 thrombocytopenia or leukopenia was observed in 6 patients and grade 3 acute gastrointestinal toxicity in 3. After chemoradiation CR and PR were observed in 64 and 36% of cases, respectively (CR + PR = 100%). Two patients were excluded from surgery for other diseases. The remaining 24 patients were operated on; 23/24 patients showed negative section margins. The histology of the surgical specimen showed the absence of disease in 13 patients (54.2%), microscopic residual tumor in 4 patients (16.6%), residual disease </=1 cm in 5 patients, and residual disease >1 cm in 2 patients. Median follow up was 33 months. Two-year actuarial local control was 91.7%. CONCLUSIONS: This study showed a particularly high rate of pathologic responses (complete + Tmic: 70.8%) and local control (2 years = 91.7%) in patients with advanced cervical cancer undergoing moderate doses of radiotherapy with concomitant chemotherapy followed by radical surgery.

Adult↗
PubMed1998

Cervical cancer response to neoadjuvant therapy: MR imaging assessment.

PURPOSE: To determine the accuracy of magnetic resonance (MR) imaging in evaluating the invasive cervical carcinoma response to concurrent chemotherapy and radiation therapy. MATERIALS AND METHODS: MR imaging was performed before and after concurrent chemotherapy and radiation therapy in 18 patients with locally invasive cervical carcinoma. Surgery followed neoadjuvant therapy in all patients. The presence of a lesion, signal intensity, zonal anatomy integrity, vaginal and parametrial invasion, and lymph node enlargement was determined. Posttreatment MR and histopathologic findings were correlated. RESULTS: Fourteen patients had histopathologic confirmation of MR findings: Twelve had true-negative and two had true-positive findings. (Two had microscopic neoplastic foci beyond the spatial resolution of MR images; these foci do not change surgical treatment planning and probably do not influence prognosis. Therefore, these two patients were considered to have complete response). Four patients had false-positive findings; the hyperintense lesion on posttreatment MR images was due to a tunnel cluster pattern (focal hyperplasia of the endocervical glands with inflammation) in three patients and necrosis in one patient, without any evidence of neoplastic tissue. Thirty-three of 36 parametrial halves and 67 of 72 vaginal fornices were correctly interpreted on posttreatment images. Involvement of three parametrial halves and five fornices was overestimated at MR, because edema or inflammation was not distinguishable from tumor. CONCLUSION: MR imaging is 78% accurate in evaluation of tumor response; in 22% of patients, however, benign conditions were not distinguishable from tumor.

Adult↗
PubMed1997

[The anal canal: 2 cycles of radiochemotherapy and boost brachytherapy].

From 1988 to 1996, twenty-six patients with epidermoid anal cancer were examined at the Radiotherapy Department of Università Cattolica del S. Cuore, Rome. At diagnosis, 13 patients were stage II, 11 patients were stage III, 2 patients had a small recurrence after local excision. All the patients were treated with concomitant radiochemotherapy followed by a brachytherapy boost. Treatment was carried out in two cycles 4-5 weeks apart. Chemotherapy consisted of 5FU (1,000 mg/sqm, continuous infusion over the first 4 days) and Mitomycin C (10 mg/sqm on day 1, bolus administration). Radiotherapy was administered with two AP opposed coaxial beams of the same size. The target was T and inguinal, external, internal and common iliac lymph nodes. The total dose for each cycle was 23.4 Gy, administered with conventional fractionation and a daily dose of 180 cGy. Four-six weeks after the end of cycle 2, the patients received a boost of interstitial brachytherapy. During concomitant radiochemotherapy, grade 3-4 (RTOG-EORTC scale) acute hematologic and cutaneous toxicities were observed in 15% and 4% of patients, respectively; treatment was discontinued in 4 patients. Complete response was observed in 21 patients (81%) and partial response in 5 (19%). The later underwent surgery, namely local excision in 1 patient and abdominoperineal resection in 4 patients. The median observation period of our study population was 45 months. Five-year actuarial local control of the 26 patients was 88%. Five year actuarial survival was 75% and sphincter conservation 77%. Our results confirm the data reported by Cummings of Princess Margaret Hospital, who observed low toxicity when the two cycles of concomitant radiochemotherapy are split. Randomized phase-III studies should clarify the potential role of the new radiochemotherapy combinations which should be compared with reference treatments providing repeatable results and low toxicity. Our treatment may make a reference for more innovative combinations of radiochemotherapy.

Adult↗
PubMed1996

Role of intraluminal brachytherapy in extrahepatic bile duct and pancreatic cancers: is it just for palliation?

PURPOSE: To evaluate intraluminal brachytherapy (ILBT) in patients with extrahepatic bile duct or pancreatic cancers. MATERIALS AND METHODS: Thirty-one patients (aged 33-87 years) with unresectable extrahepatic bile duct (n = 18) or pancreatic (n = 13) cancer received ILBT exclusively or as part of a definitive treatment regimen. ILBT was performed with transhepatic percutaneous drainage in four patients and with endoscopic retrograde cholangiopancreatography in 27. Fourteen patients with no metastases, an Eastern Cooperative Oncology Group performance score of < or = 2, and good hematologic parameters received combined modality treatment: 30-Gy ILBT and 45-Gy external-beam radiation therapy with continuous infusion of fluorouracil. Seventeen patients underwent 50-Gy ILBT alone for palliation. RESULTS: No direct treatment-related acute toxic reactions were seen. Three patients had cholangitis early in the study. Three patients had late gastrointestinal bleeding. Jaundice was palliated in all patients (n = 29); pain, in 11 of 13 patients. The survival rate in patients with extrahepatic bile duct cancer was 62% (five of eight) at 2 years for combined modality treatment. No patient with pancreatic cancer lived for longer than 2 years. CONCLUSION: ILBT is an effective palliative treatment of unresectable extrahepatic bile duct and pancreatic cancers. Results suggest a possible "curative" role in specific clinical settings when properly integrated with other treatments.

Adult↗
PubMed1993

[Experience with the combined diagnosis and therapy of locally advanced carcinoma of the uterine cervix (stage FIGO IIB-III). Transrectal ultrasonography and CT in the staging and in follow-up after therapy. Preliminary results].

The diagnosis, staging, therapy and follow-up of advanced epidermoid cervical carcinoma (FIGO stages IIB-III) have been studied in our university since January 1990. By December 1992, a team of specialists including radiologists, radiotherapists, gynecologists and pathologists divided 54 patients into two random treatment groups: group A patients, after systemic chemotherapy (CDP, 2 cycles) and diagnostic reevaluation, underwent radical surgery; group B patients received conventional radiotherapy alone (ERT 45 Gy+IRT or END-RT 20-25 Gy). All patients were examined by means of transrectal US (TRUS) and CT, after clinical examination under sedation, at staging and during the follow-up. The exams were performed periodically for group B patients and after systemic chemotherapy for group A patients. Imaging findings were compared with pathology only in group A. All imaging results were filed. The results confirm some literature data--e.g., 62% diagnostic accuracy for CT and 69% for TRUS, with higher diagnostic accuracy of the latter to evaluate cervical volume and to diagnose local relapses. As for parametrial involvement, both imaging methods tend to understage the early involvement, but only CT tends to overstage the lesions, especially in irradiated patients, due to fibrosclerosis phenomena. TRUS exhibited 69% accuracy, 70% sensitivity and 69% specificity, versus 61%, 62% and 60%, respectively, for CT; clinical examination under sedation had 58%, 60% and 60%, respectively. Both TRUS and CT are faster than endoscopic methods in evaluating vesical and/or rectal involvement. Lymph node metastases at staging, especially those in lumboaortic locations, proved to be unfavorable prognostic signs, as demonstrated by lumboaortic lymph node relapses in 5 group B patients (only 2 of them presented with lymph node metastases at staging; 3 patients had micronodules near the renal vessels), in spite of good local response after radiotherapy. In conclusion, we would like to point out that our team has had an MR unit at its disposal only recently: since the method is considered as the gold standard of imaging, especially in this kind of lesions, the study is still in progress.

Female↗
PubMed1991

Interstitial brachytherapy for pancreatic cancer: report of seven cases treated with 125I and a review of the literature.

Since 1975, seven groups of investigators have reported clinical results of interstitial brachytherapy (IBT) for pancreatic cancer. The reports are comprised of data from 254 patients, 21 of whom died in the postoperative period for an overall operative mortality rate of 8.7%. Operative mortality rate range from 0% to 32% in individual reports. Most patients have been treated with 125I, although 25 patients were treated with 198Au seeds. Most investigators report combining IBT with external beam radiation therapy (EBRT) +/- adjuvant chemotherapy. In general, IBT has been associated with considerable morbidity. Median patient survival time has not exceeded 15 months. This report describes an additional seven patients with locally unresectable pancreatic cancer, without distant metastases, treated primarily with 60 to 100 Gy matched peripheral dose (MPD) by 125I IBT. One patient died postoperatively of a pulmonary embolus. Four of the remaining six patients were also treated with modest doses (10.5 to 30 Gy) of EBRT late in the course of the disease for local tumor progression. One developed a pancreaticocutaneous fistula, and one developed exacerbation of pre-existing diabetes mellitus. The median patient survival time from the date of IBT was 7 months (range: 0 to 21 months). One patient is alive without clinical evidence of cancer 9 months after IBT.

Adenocarcinoma↗
PubMedDate not supplied

Prognostic significance of anemia and role of erythropoietin in radiation therapy.

Anemia represents a common finding in cancer patients, especially at an advanced stage. Anemia has an impact on the quality of life and at the same time seems to markedly limit the disease control that can be achieved with radiotherapy. The results of a series of clinical studies published in the last decade allow some general observations: 1. the administration of erythropoietin, especially if associated to ferrous sulfate is able to increase hemoglobulin levels in cancer patients undergoing radiation therapy (combined with concomitant chemotherapy); 2. erythropoietin stimulation of hemoglobin in anemia decreases the need for blood transfusion in cancer patients; 3. tumor response to radiation therapy appears to be enhanced by erythropoietin-induced hemoglobulin increase. Further clinical studies are required for assessment of indications, identification of optimal administration modalities, cost-analysis of this promising therapy for patients undergoing radiation therapy.

Anemia↗
PubMedDate not supplied

[Preoperative radiochemotherapy in pancreatic cancer: preliminary results].

AIMS AND BACKGROUND: The prognosis of pancreatic cancer remains poor. Surgery, when feasible, is rarely curative. Radiation therapy (RT) and concomitant 5-fluorouracil (5-FU) have been shown to improve survival in locally advanced pancreatic cancer. In an attempt to improve resectability and disease control, we used preoperative chemoradiation in a combined modality therapy protocol. The purpose of this study was to evaluate our initial results in terms of acute toxicity and response. METHODS: From October 1995 to May 1998, 20 patients (11 males, 9 females; mean age, 60.1 years; median follow-up, 28 months) with unresectable (12 patients) or resectable (8 patients) non-metastatic pancreatic tumors, received external beam radiation (39.6 Gy) plus 5-FU (96 hours continuous infusion, days 1-4 at 1000 mg/m2/day). After 4 weeks, patients were evaluated for surgical resection. In resected patients, electron-beam intraoperative radiation therapy (10 Gy) was given before reconstruction. Thereafter, in resected patients, adjuvant chemotherapy was prescribed (6 courses: 5-FU, mitomycin C, adriamicine). RESULTS: During chemoradiation, no patients developed grade 3-4 acute toxicity. Three out of twelve (25%) patients with unresectable tumors had tumor downstaging. No patients showed partial or complete responses. Four out of twenty patients (20%) had minimal tumor response. Three patients showed disease progression after chemoradiation (liver or peritoneal metastases). Nine patients underwent surgical resection and IORT, with 1 postoperative death. The median survival time for the 20 patients was 9.4 (18.5 and 8.3 months in resected and unresected patients, respectively). CONCLUSION: Our preliminary results suggest that preoperative 5-FU chemoradiation was well tolerated and may result in tumor downstaging but the response-rate is still low. Based on the impact of surgical resection on survival, an improvement in local response rate is necessary.

Actuarial Analysis↗
PubMedDate not supplied

Economic and organizational aspects in the management of prostate cancer.

In the last decade a rapid increase in the incidence of prostate cancer was observed. The reasons for this increase are associated to the progressive population aging, especially in the developed countries as well as to the growing number of identified cases with the widespread use of prostate specific antigen. A number of aspects of the disease are still to be considered in depth: the natural history of the disease in patients with early diagnosis, the potential costs of screening programs in financial, social and psychologic terms, the effectiveness and especially cost-effectiveness of different treatments and follow-up for local and advanced forms. Because of the long natural history of prostate cancer and the effectiveness of hormonal treatments used as salvage after failure of primary therapy, the differences in survival among the various therapeutic options, from radical prostatectomy to radiotherapy, or simple clinical control in selected cases are probably minor. This is the reason why future clinical studies should necessarily be based on multidimensional evaluations, taking into account the clinical outcome as well as the quality of life and costs of the different treatment modalities examined.

Combined Modality Therapy↗
PubMedDate not supplied

Research trends in the treatment of prostatic neoplasms.

Prostatic carcinoma, in the male population ranks first as incidence and second as cause of oncologic mortality. In the last decades, significantly better clinical results were achieved both in diagnosis and therapy. The latter covers a broad range of possibilities, including standard surgery, nerve-sparing surgery, combined surgery and hormonotherapy, cryosurgery, external beam radiotherapy, brachytherapy, conformal radiotherapy, combined hormone and radiation therapy, as well as conventional hormonotherapy. However, there is still much controversy on the role of the screening, the most appropriate staging modalities, the most adequate treatment in the various presentations of the disease. The present trends of the clinical research in this field are directed towards the identification of factors involved in the onset of this neoplasm and the possibility of decreasing its incidence with programs of chemoprevention, the identification of new biological markers able to assess the biological potential of the disease, the comparison between the main treatment modalities of localized carcinoma (surgery, brachytherapy, external beam radiotherapy) and the definition of parameters predictive of the response to the various treatments to better personalize the therapy of the single patient, the development of treatments based on genetic therapy and of effective systemic therapies able to control the hormone-resistant advanced disease and to clarify the impact of the different therapies on the quality of life and health care costs.

Humans↗
PubMedDate not supplied

Research trends in the treatment of neoplasms of the exocrine pancreas.

To-date, the therapeutic standards, defined by randomized studies for carcinoma of the exocrine pancreas are disappointing. Obviously, there is much interest in the improvement of these results based on the evidence of additional clinical trials. To identify some trends in the clinical research in this field, some characteristics of 31 ongoing trials, described in the web site of the National Cancer Institute were examined. 28/31 trials are coordinated by Centers of the U.S.A. and 3/31 trials specifically concern symptom palliation. Excluding the latter, 4 trials enroll patients with operable neoplasms, 8 with inoperable tumors, 4 with metastatic neoplasm and 12 involve both latter categories. Four of the 5 phase I or I-II studies concern concomitant radiochemotherapy of inoperable neoplasms; the 16 phase II studies and the 7 phase III studies involve the use of different combined modality therapies in all patient categories. Overall, 18 trials test innovative treatment modalities (new drugs, immunotherapy, monoclonal antibodies). Eight trials include the evaluation of the quality of life between endpoints. Based on this assessment of some of the ongoing clinical trials, hopefully, there will be: 1. a greater interest in the prospective therapies for this neoplasm, especially at the European level, considering the high incidence of this disease; 2. more careful attention to the possibility of downstaging of locally advanced neoplasms considering the present, proven possibility to achieve better clinical responses in pancreatic carcinoma; 3. a more widespread interest in the establishment of parameters for the quality of life, considering the frequently "palliative" intent of available therapies.

Clinical Trials as Topic↗