Combined radiation and chemotherapy in locally advanced rectal cancer: preliminary results.
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Adenocarcinoma↗
Biomedical subjects
V Valentini
Publications and source records attributed to V Valentini.
Carcinoma of the pancreatic head area. Therapy: intraoperative radiotherapy.
Pancreatic tumors represent a major field of application of intraoperative radiotherapy (IORT) with electron beams. First clinical studies were carried out principally on unresectable tumors and control of pain was observed in most of them. However, as for prognosis, IORT alone has yielded disappointing results. The use of IORT to boost external beam radiotherapy (ERT) frequently applied in recent trials, has improved local control but not survival rate because of the high incidence of abdominal metastasis. To-date, results of IORT used as an adjuvant to radical surgery have been controversial. As in unresectable tumors, studies have been focused on the combination IORT+ERT, however the intensification of the dose delivered to the tumor bed and the consequent better local control has not resulted in a better prognosis. A more significant contribution of IORT to the treatment of pancreatic tumors may come in the future from the combination of IORT with more effective methods in the control of the abdominal disease ("prophylactic" ERT to the liver or upper abdomen, intra-arterial or intraperitoneal chemotherapy) or from variously timed combinations with ERT (neoadjuvant ERT+IORT).
Combined Modality Therapy↗
Carcinoma of the pancreatic head area. Therapy: concomitant radiochemotherapy.
A series of studies carried out by the Gastrointestinal Tumor Study Group have shown the efficacy of the combination of external beam radiotherapy (ERT) and 5-fluorouracil (5-FU) chemotherapy (CHEM) in unresectable and resectable tumors of the exocrine pancreas. In the former in particular, this method was shown to be superior to ERT alone as well as to polychemotherapy alone. In these studies 5-FU was administered during (concomitant chemotherapy: C-CHEM) or after ERT (adjuvant chemotherapy: A-CHEM). This led several authors to consider this combined treatment as reference standard for pancreatic carcinoma. Its prognosis is still definitely poor because of the difficult local eradication as well as because of the frequent early distant spread, especially at the abdominal level (hepatic and peritoneal). An improvement of present results may stem from the combination of ERT+C-CHEM +/- A-CHEM with methods of dose intensification at the local level (e.g. IORT) concurrently with the use of treatments aiming at a better control of the abdominal spread (e.g. ERT+C-CHEM for prophylaxis of the liver or upper abdomen).
Antimetabolites, Antineoplastic↗
Radiation therapy information systems (RTISs): state of the art and new perspectives.
Information technology in radiotherapy finds three separate fields of application: direct computerization is essentially aimed at the conformation of target volume. It is present in devices used for treatment planning and execution. Indirect computerization is essentially aimed at the acquisition of patient's data relevant to the routine and clinical management and at the ready access to the acquired information. Communication networks are intended to facilitate the definition of the patient's integrated reporting, to optimize available resources and multicentric research. Present information technology in radiotherapy is based on the need for a radiation therapy information system (RTIS). It should be designed as a transverse access between the various subsystems, unified in planning, even if implemented at different times and with different technologies, ready to work on a geographic scale, now feasible with the international communication networks.
Computer Communication Networks↗
Standardization of digital radiologic images.
The need for uniform digital formats of radiologic images obtained from the human body by the various methods (CT, MRI, DF, DSA, NM) is felt by both the manufacturers and the radiologists since a long time. The ACR-NEMA standard was initially established to overcome this problem, however it was not fully satisfactory. Its up-dated version, DICOM 3 seems a more successful approach to the solution of the problem. The rationale on which DICOM 3 is based, the main guidelines with some reference to the various parts of the new standard, are analyzed. Its advantages as well as disadvantages are considered in view of a future complete integration of data and images of a radiology department within a hospital information system. In the appendix, a list of DICOM components and addresses where to find the original documentation are supplied.
Radiographic Image Enhancement↗
START: an advanced radiation therapy information system.
START is an advanced radiation therapy information system (RTIS) which connects direct information technology present in the devices with indirect information technology for clinical, administrative, information management integrated with the hospital information system (HIS). The following objectives are pursued: to support decision making in treatment planning and functional and information integration with the rest of the hospital; to enhance organizational efficiency of a Radiation Therapy Department; to facilitate the statistical evaluation of clinical data and managerial performance assessment; to ensure the safety and confidentiality of used data. For its development a working method based on the involvement of all operators of the Radiation Therapy Department, was applied. Its introduction in the work activity was gradual, trying to reuse and integrate the existing information applications. The START information flow identifies four major phases: admission, visit of admission, planning, therapy. The system main functionalities available to the radiotherapist are: clinical history/medical report linking function; folder function; planning function; tracking function; electronic mail and banner function; statistical function; management function. Functions available to the radiotherapy technician are: the room daily list function; management function: to the nurse the following functions are available: patient directing function; management function. START is a departmental client (pc-windows)-server (unix) developed on an integrated database of all information of interest (clinical, organizational and administrative) coherent with the standard and with a modular architecture which can evolve with additional functionalities in subsequent times. For a more thorough evaluation of its impact on the daily activity of a radiation therapy facility, a prolonged clinical validation is in progress.
Medical Records Systems, Computerized↗
Telecommunications and multimedia systems in education: what developments for radiology?
What are the new perspectives for the radiologist with the development of new technologies of telecommunications? At present, when digitization of most biomedical images has become a reality, problems of remote transmission are simplified. However, telematic literacy is necessary to the radiologist. It is already possible through multimedia supports, as CD-ROM and Internet "navigation". Which are the modalities to access "the network of networks"? Through Internet, hypertexs can be consulted, databases can be accessed, programs and printings can be retrieved, electronic mail can be exchanged. The CD-ROM is a further source of knowledge, especially effective in education due to multimedia and hypertext technology. In this context in the education of the radiologist, the hypertext version of a radiology text, finds its place. It is conceived to offer to each user an individualized approach to learning.
Computer Communication Networks↗
Quality assurance procedures in radiotherapy of breast cancer.
In breast cancer, the multidisciplinary therapeutic approach is most commonly used. Radiotherapy, involving neoplastic targets and healthy tissue tolerance already modified by other treatments, in the various phases is burdened with problems and uncertainties which condition treatment quality. Within the four phases of prescription, planning, implementation and follow-up, the authors analyze some uncertainties that impact on the quality of radiation treatment complementary to conservative surgery. PRESCRIPTION: it is the phase where the radiotherapist defines the target volume and the dose to be delivered. Uncertainties remain in CTV2 definition (boost); the not frequent placement of metal clips within the surgical cavity and the not perfect correlation between surgical scar and tumor bed, make their identification not always ready. Moreover, the combination with other therapies creates problems also in dose prescription. PLANNING: in CTV1 treatment (breast) particular precautions are necessary to decrease the dose contribution at the pulmonary level and avoid that the breast advances towards the supraclavicular region in the supine position. For CTV2, the interstitial boost is indicated especially in patients with a large breast and deep cancer and in cases of non radical surgery, while external beam boost, most commonly used, is performed with electron beams including the pectoral fascia in the 90% isodose. IMPLEMENTATION: to prevent or limit the incidence of possible random and/or systematic errors during treatment, suitable procedures are required. FOLLOW-UP: it enables the assessment of therapeutic results in terms of efficacy and side-effects. Some controversies still remain on implementation modalities: intensive vs clinical.
Breast Neoplasms↗
Quality assurance in radiotherapy of neoplasms of the upper abdomen.
Neoplasms of the upper abdomen involve complex problems for radiotherapy. In fact, the anatomical structures are close to each other, lymphatic vessels are numerous and complex, there are organs of low radiation tolerance whose reciprocal position is of difficult assessment and finally there is high visceral mobility due to the diaphragmatic movements. Moreover most organs cannot be identified with the simulator and bone references are of little use. Therefore, treatment of these sites requires the routine application of quality assurance programs, checks of treatment reproducibility, in particular: In a number of clinical settings, CT study of the region (in treatment position) must be included in treatment planning and set-up with simulator and fluoroscopy. Before, during, and after radiotherapy, clinical exams and laboratory tests should be performed to assess the integrity of critical organs.
Abdominal Neoplasms↗
Quality assurance program in radiotherapy for carcinoma of the uterine cervix.
Some uncertainties which impact on the quality of exclusive radiation therapy of carcinoma of the cervix and the operational procedures followed to lower treatment inaccuracies, are analyzed. In particular the following phase of radiation therapy are considered: prescription: indication for the dose and volume to be treated with external beam radiotherapy (ERT) or intracavitary brachytherapy (BRT) according to the different forms; planning: definition of procedures for ERT and BRT optimization; implementation: analysis of systems for checking reproducibility and treatment tolerance; follow-up: planning of clinico-instrumental controls of disease evolution and late toxicity.
Female↗
Quality assurance procedures in radiotherapy of rectal neoplasms.
Major uncertainties which impact on pre- or postoperative radiotherapy of rectal neoplasms and operational measures taken to lower the risks in prescription, planning, delivery and follow-up of radiotherapy, are examined. In prescription, major problems related with the selection of treatment dose and volumes, are considered. In planning, irradiation techniques and systems for intestinal loop displacement from treatment site, are analyzed. In dose delivery, methods used to ensure treatment reproducibility and support care, are examined. Finally, in follow-up procedures used in the evaluation of disease progress, late side-effects, and life quality, are discussed.
Humans↗
Organ preservation in carcinoma of the anal canal.
Over a 9-year period, 52 patients with anal carcinoma were observed: there were 18 males and 34 females (ratio: 1:1.9); mean age was 62 years. In 37 patients (71%) the neoplasm origin was in the anal canal, in the margin in 14 (27%) and a coaclogenic form was located in the lower rectum in one. 39 patients (75%) showed an epidermoid carcinoma and 13 (25%) an adenocarcinoma. Treatment consisted in two cycles of 5FU (1000 mg/m2/24 h, day 1-4), mitomycin C (10 mg/m2 bolus, day 1) plus radiotherapy (23.4 Gy, split course with 4- week rest). At 6-8 weeks, brachytherapy was performed for epidermoid lesions of the anal canal and margin while adenocarcinomas were referred to surgery. Sphincter preservation at 5 years was 64%. In epidermoid carcinomas sphincter preservation was 69% vs 45% in adenocarcinomas (p = 0.17). In patients treated with a curative intent and presenting with epidermoid carcinoma of the anal canal, sphincter preservation was 77% vs no patient with adenocarcinoma of the anal canal. In 53% of patients with epidermoid carcinoma of the anal margin there was sphincter preservation. Overall 5-year survival was 62%, better for epidermoid carcinoma (69% vs 36%; p = 0.02) but similar as for the site (anal canal:62%; anal margin:60%).
Adenocarcinoma↗
Organ preservation in rectal cancer.
Treatment of distal rectal cancer is aimed at sphincter preservation. Three trials were conducted to this purpose. They differed for T stage selection and therapy. Two of the trials are now completed, while patients are still recruited for the third trial. 21 T2 patients were selected for the first series and treated with local excision plus postoperative radiotherapy. External beam radiotherapy (ERT) was delivered at the dose of 45 Gy. Grade 3-4 (RTOG) acute toxicity was 5%; late toxicity was never observed. Sphincter function was rated as excellent or good in all patients. Sphincter preservation was achieved in 86% of cases. In the T3 FUMIR trial, 83 patients with extraperitoneal rectal cancer (T3) were treated with concomitant mitomycin C (10 mg/m2, day 1) plus 5FU (1000 mg/m2 days 1-4) plus ERT (38Gy). Grade 3-4 acute toxicity (RTOG) was 13%; late toxicity was never observed. Sphincter function was rated excellent or good in 96% of patients; sphincter preservation was achieved in 66% of patients with a lesion at less than 50 mm from the internal anal orifice. In the T3 PLAFUR trial, 19 patients with extraperitoneal rectal cancer (T3) were treated with concomitant cisplatin (60mg/m2, day 1 and 28) plus 5FU (1000 mg/m2 days 1-4 and 28-32) plus ERT (50.4 Gy). Grade 3-4 (RTOG) acute toxicity was 5%; late toxicity was never observed. Sphincter function was rated excellent or good in 93% of patients. Sphincter preservation was achieved in 73.7% of patients; in particular, in 55.6% of those with a lesion at less than 50 mm from the internal anal orifice. Combined modality therapies are showing the ability of sphincter preservation in patients with distal rectal cancer. Ongoing studies will identify the patients who are candidates for this therapeutic approach and the most suitable combined treatment.
Adenocarcinoma↗
Organ preservation in locally advanced carcinoma of the uterine cervix.
In the treatment of locally advanced carcinoma of the uterine cervix the multimodal therapeutic approach is useful to improve overall survival and disease-free survival. Two studies of concomitant radiochemotherapy were conducted. In the first, recurrences of gynecologic tumors were treated, in the second primary tumors of the uterine cervix. In the first study 29 patients, of whom 15 with endometrial cancer recurrence, 10 with cervical cancer recurrence and 4 with vulvar cancer recurrence were treated with FUMIR schedule (5-FU and mitomycin C plus concomitant radiotherapy to the pelvis in two cycles of 23.4 Gy) and subsequent brachytherapy boost. In the second study 17 patients, of whom 14 evaluable, were treated with external beam radiotherapy (ERT 40 Gy) and concomitant chemotherapy (5-FU and CDDP). Before and after treatment the patients were examined with MRI. After radiochemotherapy radical hysterectomy and histology of surgical specimen was performed. Results of first study were as follows: acute G1-G2 (RTOG) hematologic toxicity 56%, G3 4%; G1-G2 gastrointestinal 54%, G1-G2 skin 29%; G1-G2 rectum 24%; G1-G2 bladder 25%; G1-G2 vagina 30%. Local control, overall survival and disease-free survival at 24 months were 45%, 76% and 67%, respectively. Results of the second study showed 9/14 patients with complete response and 4/4 patients with partial response (93%), no change in 1, with 100% MRI accuracy as compared to histology. Based on these results a phase III clinical trial was planned in primary cancer of the uterine cervix using concomitant radiochemotherapy (CDDP + 5-FU) plus intracavitary brachytherapy for organ preservation.
Adult↗
Radiotherapy, local control and survival in carcinomas of the exocrine pancreas.
Local recurrence affects approximately 50% of patients undergoing surgery for pancreatic adenocarcinoma. To lower the incidence of locoregional recurrence, the combination with surgery of adjuvant radiotherapy has been proposed. The latter is based on external radiotherapy (ERT), intraoperative radiotherapy (IORT) or their combination. To evaluate the impact on local control and survival, results achieved in a a group of patients undergoing surgical resection and combined adjuvant radiotherapy, are analyzed. 17 patients with adenocarcinoma of the exocrine pancreas were treated with a therapeutic protocol based on pancreatectomy and intraoperative radiotherapy (IORT) to the tumor bed (10 Gy) followed by postoperative radiotherapy (50 Gy); 9 patients underwent also preoperative radiotherapy (5 Gy) to the pancreas and liver. With a median follow-up of 45 months, in 3 patients (17.6%) local recurrence was observed while 12 patients (70.6%) showed liver metastases or peritoneal spread. Median survival was 17.5 months and actuarial survival at 2 and 5 years was 41.2% and 11.2%, respectively. As compared to a moderate local control, the prognosis of patients undergoing surgical resection remained disappointing. Thus, the effort of improving results with new therapeutic modalities as preoperative radiochemotherapy and adjuvant chemotherapy, seems justified.
Adenocarcinoma↗
Radiation, hormonotherapy, survival and local control in prostatic carcinoma.
The combination of concomitant external beam radiotherapy (ERT) and neoadjuvant hormonotherapy was shown to be able to significantly improve local control and disease-free survival in locally advanced prostatic carcinoma. (RTOG study 8610). Aim of this analysis was to assess the clinical results observed in a population of patients undergoing this combined treatment and, more particularly, to examine the prognostic impact of local control. 84 patients (T2: 47%, T3: 49.4%, T4: 3.6%) underwent concomitant ERT (dose to pelvic volume: 45 Gy; mean dose to prostatic volume: 65 Gy) and neoadjuvant hormonotherapy (flutamide: 250 mg three times/daily for 30 days; LH-RH analogue: 1 oral dose every 28 days starting 2 months prior to radiotherapy and for its whole duration). With a median follow-up of 36 months, 3.6% of patients were deceased; hematogenous metastases and local disease progression were recorded in 16.7% and 4.8% of patients, respectively. Local disease progression was shown to be significantly correlated with the incidence of metastases. In fact, the actuarial incidence of metastases at 5 years was 100% and 27% in patients with and without local recurrence (p = 0.0043) respectively. Overall, metastases-free local and biochemical recurrence-free survival was 89.2%, 66.5%, 85.0% and 41.9% respectively. At univariate analysis (logrank) the clinical stage (T) was shown to be significantly correlated with the incidence of metastases (p = .0004) and local progression (p < .0001). In conclusion, this study has confirmed the low rate of local progression with the combination of hormonotherapy and radiotherapy and the significant correlation of local control with the incidence of hematogenous metastases.
Adenocarcinoma↗
Radiotherapy, local control and survival in cervical carcinoma.
The natural history of cervical carcinoma is characterized by a close correlation between local control and survival. Local eradication of the disease is justified for the obvious impact on the quality of life as well as on long-term survival. A series of analyses carried out in the last decades have elucidated the role of a number of prognostic factors in local control. Among treatment modalities applied to attain this aim, particular interest has been focused in recent years on concomitant radiation and chemotherapy. While some experiences have shown promising results, the precise role of this combination will be defined based on the outcomes of some randomized studies now in progress. Among the modalities of concomitant radiation and chemotherapy, some authors have proposed the following sequence: neoadjuvant chemotherapy and surgical resection. It is an aggressive approach potentially associated to major side-effects. This therapeutic modality will require an accurate assessment of clinical results both in terms of clinical response, local control and effects on organ function and quality of life.
Antineoplastic Agents↗
Radiotherapy and local control in rectal cancer.
Recurrence is a stage in the natural history of rectal cancer. Preoperative radiotherapy or postoperative radiochemotherapy lower the rate of recurrence, improving local control. From 1980 to 1997, at the "Divisione di Radioterapia" of the "Università Cattolica del S. Cuore" of Rome 380 patients with rectal cancer of early clinical stage T2-3, candidates for surgery for cure, underwent radiation therapy. 119 patients underwent postoperative radiotherapy (45-50 Gy); 45 patients underwent "sandwich" radiotherapy (45 Gy:27 Gy before and 28 Gy after surgery), of whom 7 were treated with preoperative radiotherapy alone; 145 patients underwent preoperative concomitant radiochemotherapy according to 3 different protocols, radiotherapy (38 Gy) combined with mitomycin C and 5-FU; radiotherapy (50.4 Gy) combined with cisplatin and 5-FU; radiotherapy (45 Gy) combined with 5-FU and folinic acid. 71 patients were treated with preoperative radiotherapy (38 Gy) combined with IORT (10 Gy). Median follow-up was 6 years. Overall local control was 85% at 3 years, 83% at 5 years, 81% at 10 years. The rate of local control at 5 years was: 76% for postoperative radiotherapy, 83% for "sandwich" radiotherapy, 84% for preoperative radiochemotherapy and 93% for preoperative radiotherapy combined with IORT. Local control was shown to be significantly better with preoperative treatment as compared to postoperative treatment (p = 0.02). The incidence of metastases was 35% in the patients with local recurrence and 16% in those with local control. The difference in survival was highly significant in patients with local control as compared to those with local recurrence: at 5 years 87% and 32% respectively. Patients with local control showed a lower incidence of metastasis and a better survival.
Antineoplastic Combined Chemotherapy Protocols↗