Conservative surgical treatment in rectal cancer after complete pathological response to neoadjuvant treatment. Prospective observational study.

In 2012 we started a prospective observational study at San Giovanni Addolorata Hospital in Rome for patients with rectal cancer with complete response to neoadjuvant therapy (nCRT). In our, IRB approved protocol, patients are evaluated at time 0 by physical, endoscopic, pathological and radiological examinations. 6 weeks after completion of nCRT they are re-evaluated. In case of persistence or progression of disease patients undergo surgery with Total Mesorectal Excision. In case of complete or major clinical response they are re-evaluated at 12 weeks and subjected to transanal surgical excision to confirm complete pathological response (pCR). If tumor is found in the transanal excision specimen the patient is operated upon whereas patients with pCR are followed up at 3 months interval.

[Use of filgrastim, granulocyte colony stimulating factor (G-CSF), in radiotherapy to reduce drop-outs because of radiogenic leukopenia]. / Impiego del filgrastim, fattore stimolante le colonie granulocitarie (G-CSF), nella radioterapia allo scopo di ridurne le interruzioni per leucopenie radioindotte.

Radiotherapy patients are at risk of developing leukopenia, which risk depends on the irradiated volume, the rate of irradiated bone marrow and the radiation dose. Radiogenic leukopenia may cause radiotherapy drop-out, with consequent effects, on local tumor control and clinical outcome. The introduction of granulocyte growth factors, such as filgrastim, has permitted to accelerate normal neutrophil count recovery in irradiation-related neutropenia both in vitro and animal models; clinical experience in humans is still lacking, relative to both indications and scheduling. In the Oncologic Radiotherapy Department of Treviso Hospital, 31 patients irradiated for Hodgkin disease, rectal cancer and other malignancies, who presented leukopenia requiring treatment discontinuation, were given filgrastim to assess its actual effect in avoiding further drop-outs and to compare two administration schedules (2 or 3 vials, 30 MIU, weekly). Filgrastim treatment was continued throughout the radiotherapy cycles, for 1 to 5 weeks. Eighteen patients had received previous chemotherapy and 11 were undergoing concurrent 5-fluorouracil chemotherapy-irradiation. A mean 203% increase in leukocyte count was observed (136% in the patients treated with 2 vials/week and 274% in those receiving 3 vials/week); this increase was more apparent in women that in men (256% versus 91%) and slightly higher in patients 50 years old and with target volumes < 5000 ml. Filgrastin treatment was well tolerated by all patients, with no discontinuations due to adverse effects; 9 patients (29%) reported skeletal pain, which was marked in 2 of them only. Eighty percent of patients completed all the radiotherapy cycles with no discontinuation, while 6 patients dropped out because leukopenia persisted. Biweekly filgrastim administration was effective to prevent unscheduled radiotherapy discontinuation in 75% of patients and triweekly administration was effective in 86% of patients. In our experience, filgrastim administration was well tolerated and effective in decreasing the irradiation drop-outs caused by treatment-related leukopenia. Since this drug is rather expensive, we decided to use routinely the lower dosage of biweekly administration (with one vial given on Friday and Saturday, to permit neutrophil recovery during the day off) and to reserve the higher dosage (3 vials a week) to the patients with large body areas, big target volumes and persistent leukopenia during previous chemotherapy.

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.

Organ preservation in the treatment of brain tumors.

Within the many histological forms, the preservation of function in the central nervous system has always been predominant. However, the limited or null therapeutic interval for high grade gliomas enables organ preservation in small neoplasms only. In case of favorable histology (e.g. dysgerminoma, low grade small glioma), organ preservation is feasible with adequate techniques. When local control is predominant (e.g. neoplasms of eye) the techniques are long known but applied in very few Centers.

[Computerization experience in a day hospital of integrated radiochemotherapy]. / Esperienza di informatizzazione in un day hospital di radiochemioterapia integrata.

INTRODUCTION: We report on a cost-effective easy-access software developed for the functional integration of the clinical records and history of oncologic patients with the management of the Day Hospital of the Radiotherapy Department of the University Hospital A. Gemelli, in Rome. MATERIAL AND METHODS: The software was designed to archive the clinical records and history of oncologic patients and the relative chemotherapy, to manage the examination scheduling, to draw up nursing files with the planned therapy and to make statistical analyses of the department activity. Five forms are available: the patient form, recording patient data; the admission form, recording the type of therapy (e.g., chemotherapy, tests, medical examinations, etc.), the relative cost and chemotherapy protocol, detailing for instance the type of drug; the nursing file, detailing chemotherapy schedule and the dilution of each drug; the menu, to select and retrieve any record. The minimum configuration requires a 386 Intel CPU, 4 Mb RAM and 4 Mb free on the hard disk. The software is the File Maker Pro 2.1 for Windows which can interact with Apple Macintosh computers. RESULTS: Since October, 1995, we have saved the clinical records of 272 oncologic outpatients (2415 entries in all), with a mean of 201/month. This computer system permitted us to save and retrieve data for both clinical and didactic purposes and to plan our activity. CONCLUSIONS: One year after it was implemented and used in clinical practice, the system is a cost-effective and user-friendly tool for the management of the Radiochemotherapy Day Hospital of our Radiotherapy Department.