Abstract: PURPOSE: To evaluate the role of chemotherapy combined with curative radiotherapy in breast cancer patients who presented with recurrent ipsilateral supraclavicular lymph node metastases (ISLM) without "nonregional disease," we designed an observational study performed prospectively. PATIENTS AND METHODS: Forty-four consecutive patients with ISLM from breast cancer as part of recurrent regional disease without distant metastases were included in this study. All patients received chemotherapy with doxorubicin-based schema or paclitaxel for six courses and curative radiotherapy (60 Gy/30 fractions of 2 Gy/5 days a week). An "involved field" radiation was delivered during the interval between the third and fourth chemotherapy course; hormonal therapy was given based on receptor status. RESULTS: The rate of overall clinical response after chemotherapy and radiotherapy was 94.9%. Median time to progression and overall survival were 28 and 40 months, respectively; the 5-year actuarial overall survival and disease-free survival rates were 35% (95% confidence interval, 19-51) and 20% (95% confidence interval, 6-34), respectively. CONCLUSION: A curative course of intravenous chemotherapy and radical irradiation is feasible in patients with ISLM. All patients presenting recurrence in supraclavicular nodes should be treated with definitive locoregional treatments and systemic therapy because the outcomes are better than might be historically assumed.
Abstract: The purpose of this phase II trial was to investigate the use of paclitaxel and cisplatin in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), to evaluate tumor response, time to progression, survival, and toxicity of this regimen. Patients with recurrent and/or metastatic HNSCC received 175 mg/mq paclitaxel (PTX) administered as a 3-h intravenous infusion on day 1 and 75 mg/mq cisplatin (CDDP) as a 30(') intravenous infusion on day 2; cycles were repeated every 21 days. From February 1997 to February 2000, 36 patients (18 with locoregionally recurrent disease, 8 with deemed inoperable locally advanced disease, and 8 with metastatic disease) with a median age of 60 years (range 38-73 years) were enrolled. The patients evaluable were 34 for toxic effects, length of survival, and tumor response. The overall response was 41.1%, with two (5.8%) complete responders (CR) and 12 (35.3%) partial responders (PR), 10 (29.4%) patients had stable disease and 10 (29.4%) progressed. The median time to progression (TTP) was 5 months (range 1-49 months), and the median overall survival was 11 months (range 1-53 months). The 1-year-, the 2-year-, and the 3-year-survival rate were 38.2, 17.6 and 14.6, respectively. Up to date of the statistical evaluation four patients were still alive. According to the World Health Organization (WHO) criteria, transient G3 neutropenia and anaemia occurred in seven (20.5%) and four (11.7%) patients, respectively. The predominant non-haematologic toxicities were alopecia and fatigue: Twenty-three (67.6%) patients had G3 alopecia, two patients (5.8%) G3 fatigue and 10 (29.4%) G2, eight (23.5%) G2 myalgia, eight (23.5%) G2 nausea/vomiting, and two (5.8%) G2 mucositis. There were no G4 toxicity and any treatment-related death. Paclitaxel plus cisplatin combination is an active regimen with an acceptable safety profile in recurrent/metastatic HNSCC. This regimen, according to our opinion, is a valid alternative to infusional fluorouracil (5FU)/cisplatin. In fact up to date we can confirm, in taxane era, that paclitaxel, as single agent or in combination, produce response rates similar to cisplatin/5FU regimen, but with more manageable toxicity, especially in the subset of patients with 0-1 ECOG-PS and incurable or locoregional recurrent HNSCC, with short outpatient administration too.
Abstract: BACKGROUND: In the treatment of bone metastases, the choice of radiation fractionation, total radiation dose, delivery technique, and imaging studies before treatment varies among radiation oncologists. Surveys on this issue, using case scenarios, have been published by groups from Europe, North America, and Australia-New Zealand. Our objective was to analyze retrospectively the "real" practice in nine radiotherapy centers located in Sicily. METHOD: A questionnaire including 17 items was distributed to 30 practicing radiation oncologists working in seven departments of four Sicilian cities (Messina, Catania, Ragusa and Palermo) during a meeting of the Sicilian Division of the Associazione Italiana Radioterapia Oncologica (AIRO). Participants were asked to answer the questions using a card for every patient treated with external beam irradiation from 1 January to 31 December, 2000. RESULTS: Six centers returned the questionnaires; 332 cards were valuable for a total of 5644 responses. All six responding departments used linear accelerators for treatment delivery. The most common dose fractionation was 30 Gy in 10 fractions and the most common technique used was opposed parallel local fields. Before the start of irradiation a bone scan was performed in 325 of the 332 (98%) patients treated and CT and/or MRI was performed in 320 (96%); surprisingly, standard roentgenograms were used in only 142 of 332 patients (42.8%). CONCLUSION: The "real" radiation practice for bone metastases in the region of Sicily confirms the results of the previously reported international surveys: there is a clear preference for fractionated treatment and local field therapy. The results of randomized studies, which demonstrated both the efficacy and the feasibility of a single 6-8 Gy fraction in the palliation of bone metastases, have little or no impact on the pattern of practice.
Abstract: The purpose was to determine the maximum tolerated dose (MTD) of weekly paclitaxel with concurrent, daily irradiation in patients with unresectable head and neck squamous cell carcinoma previously submitted to induction chemotherapy. Patients with stage IV, and unresectable tumor and/or node/s were enrolled. Nine male patients were submitted to a course of paclitaxel 175 mg/m2 day 1 and cisplatin 75 mg/m2 day 2 given every 3 weeks for three courses. Curative radiotherapy (RT) started 3 weeks after the last cycle of chemotherapy with the goal of delivering a total dose of 66-70 Gy. During RT weekly paclitaxel was administered for 6 courses if feasible; paclitaxel was given according to a dose escalation schema in cohorts of three patients. Dose level A, 30 mg/m2; dose level B, 40 mg/m2; dose level C, 50 mg/m2. During weekly paclitaxel the major toxicity was mucositis that required a treatment break in two of three patients in dose level C; mucositis grade 4 required interruption of paclitaxel administration in all these patients. RT can be given in a continuous fashion with weekly paclitaxel after induction chemotherapy. The MTD of weekly paclitaxel was 40 mg/m2.
Abstract: PURPOSE: To determine whether magnetic resonance urography (MRU), obtained before helical computed tomography (CT) in patients with acute renal colic, can help delimit the obstructed area to be subsequently examined by a targeted CT scan, thus reducing the dose of radiation. MATERIALS AND METHODS: Patients (51) with symptoms of acute renal colic underwent MRU and a total urinary tract helical CT. CT images from the 5 cm below the level of ureteral obstruction as demonstrated by MRU were selected out. Combined interpretation of MRU and selected CT images constituted protocol A. Protocol B consisted of the entire unenhanced helical CT of the urinary tract. The two protocols were compared regarding the following points: 1) sensitivity in diagnosing the presence of obstructing urinary stones, and 2) the delivered radiation dose. RESULTS: Protocol A and protocol B had, respectively, 98% and 100% sensitivity in demonstrating ureteral stone as a cause of renal colic. Estimated average dose calculated from phantom study was 0.52 mSv for protocol A and 2.83 mSv for protocol B. Therefore, the effective radiation dose was 5.4 times lower in protocol A compared to protocol B. CONCLUSION: Combined MRU and short helical CT has a high sensitivity in detecting ureteral calculi with a reduced radiation dose.
Abstract: The purpose of this study was to evaluate the axillary node displacement away from chest wall and their anatomical location in relation to the humeral head, according to the position of the arms, when the axilla is the site of enlarged nodes. In 13 patients with enlarged axillary nodes, the anatomical span of the nodes according to two arms positions, akimbo (A) and up over the head (U), was prospectively evaluated using computed tomography (CT) and magnetic resonance imaging (MRI). The nodes were classified into two groups, i.e. the lower and upper groups. The mean distances of the lower node group from the chest wall when the patients were in A, and U positions were 3 cm and 6.4 cm, respectively (p = 0.002). The upper group nodes showed a smaller difference in the distance from the chest wall: in A position, mean 2.1 cm; in U position 2.8 cm (p = 0.03). In U position, there was always a node of the lower group that was displaced in front of the humeral head. This study demonstrates the displacement of enlarged axillary nodes according to the position of the arms. In patients with axillary node involvement, CT planning should be considered when they have their arms held up over their heads.
Abstract: Esthesioneuroblastoma (ENB) is an uncommon tumor type of neural crest origin, which, in the majority of cases, arises in the nasal cavity. We present a rare primary presentation of ENB in the sphenoidal area studied with computed tomography (CT) and magnetic resonance (MR). To our knowledge, this is the first case in which MR findings are available.
Abstract: PURPOSE: Bronchioloalveolar carcinoma (BAC) is a subtype of lung adenocarcinoma whose incidence is raising. Bronchioloalveolar carcinoma has a tendency to involve diffusely the lung. No agreement exists about whether diffuse bronchioloalveolar carcinoma has a multicentric or unicentric origin. The purpose of this work is to evaluate the correlation between intrapulmonary spread of bronchioloalveolar carcinoma and its histologic and immunohistochemical characteristics. DESIGN: Surgical specimens of 20 bronchioloalveolar carcinomas with radiologically proved evolution from focal to diffuse disease were retrieved and reviewed. Patterns of pulmonary spread were defined on the basis of CT and MR imaging examinations. Immunohistochemical studies were performed to investigate the expression of gelatinase A and alpha2-integrin. Correlation between immunohistochemical results and patterns of pulmonary spread was evaluated. Statistical evaluation was performed by using Fisher Exact Test. RESULTS: Three histological subtypes of bronchioloalveolar carcinoma were found: mucinous (11 cases), non-mucinous (3 cases), and mixed adenocarcinoma with prominent bronchioloalveolar pattern (6 cases). Three patterns of pulmonary spread were depicted radiologically: parenchymal opacification (11 cases), multiple nodules (7 cases) and mixed pattern (2 cases). Eleven out of 12 mucin-producing versus none out of 8 non-mucin producing cancers developed parenchymal opacification. The difference was statistically significant (P<0.028). A statistically significant difference was also found between the development of parenchymal opacification and the level of alpha2-integrin: 11 out of 13 tumors with negative alpha2-integrin versus none out of 7 with positive alpha2-integrin immunoreactivity (P>0.033). CONCLUSIONS: Diffuse bronchioloalveolar carcinoma may develop from a prior focal cancer. Mucinous subtype is the most prone to develop diffuse disease with parenchymal opacification, probably representing aerogenous spread. Low levels of alpha2-integrin receptors were found in bronchioloalveolar carcinoma which developed parenchymal opacification.
Abstract: Radiotherapy (RT) is widely used in the management of lung cancer but age-oriented randomized trials are lacking in older-unfit patients. We started a prospective study to evaluate the toxicity and efficacy of definitive RT in very old-unfit patients with non-small cell lung cancer (NSCLC) in clinical stage IIIA, according to AJCC 1988. Forty patients, age > or = 75 years, Karnofsky Performance status (KPS) > or = 60, unfit to receive an aggressive combined treatment, were entered in the study. Each patient had one or more comorbidities, and the Charlson score was greater than two in 7/40. All patients were treated with radiation fields encompassing the primary tumor and grossly involved lymph nodes. A median radiation dose of 60 Gy/2 Gy day/5 days a week, was delivered. The 40 patients have been followed up, including those who died, for a potential median time of 4.6 years. As results, no treatment-related mortality, and clinically insignificant acute morbidity was recorded: in 28/40 cases a mild esophagitis occurred. Two patients showed a clinical radiation pneumonitis (RP). Late normal tissue damage was represented by lung fibrosis (40/40 patients). The treatment was efficacy since each patient obtained some clinical benefit from it. Median survival (MS) was 19 months (range 5-68); the 3 and 5-year actuarial survival was 18 and 12%, respectively. In conclusion, we think that older patients with concomitant illness can be submitted to curative 'involved field' irradiation and the results observed in this trial encourage to use curative RT in older subjects with local-regionally advanced NSCLC and co-morbid condition.
Abstract: Diarrhoea is a severe side-effect of radiotherapy on the pelvic area. It is due to acute enteric damage. We aimed at determining the ability of a highly concentrated freeze-dried living bacteria compound (VSL/3) to reduce these side-effects in 190 patients receiving radio therapy on the pelvic area. A total of 95 patients received radiotherapy alone and 95 were also administered VSL/3 bags, at doses of one bag three times a day beginning on the first day of the radiotherapy treatment. The same diet was indicated for both groups. All patients were irradiated for 6 to 7 weeks, with Linac X-6 MV or 15 MV through a box multiportal technique with the lower limit of the fields below the obturator foramina, upper limit at L5-S1, lateral limit 1.5 cm beyond the innominate hip. The total radiated dose ranged from 60 to70 Gy for a daily dose of 180 cGy. Gastroenteric toxicity was rated in WHO degrees. Two patients receiving radiotherapy alone had to discontinue the treatment due to acute enteritis. Toxicity was found in 52 (50.6%) patients with radiotherapy alone vs 36 (30.5%) patients receiving VSL/3. None of them had to discontinue radiotherapy. Toxicity of degrees 3 or 4 was found in 28 patients receiving radiotherapy alone vs 7 with VSL/3. These preliminary data suggest the effectiveness of VSL/3 in preventing the occurrence of diarrhoea in patients submitted to radiotherapy with a direct and indirect improvement of their quality of life and a good tolerance.
Abstract: AIMS AND BACKGROUND: There is no standard treatment for elderly-unfit patients with muscle-invasive bladder cancer. Pelvic irradiation alone is an usual approach in this instance, and some reports have demonstrated that curative radiotherapy is feasible in elderly patients. To our knowledge, no data exist about the feasibility of a curative treatment in elderly patients with concomitant illness and a Charlson Comorbidity Index (an index of comorbidity that includes age) greater than 2. The main purpose of the present study was to establish the feasibility of irradiation in a cohort of elderly patients in poor general condition. METHODS: The records of 45 elderly-unfit patients (median age, 75 years; range, 70-85), with a comorbid Charlson score >2, treated with curative dose, planned continuous-course, external beam radiotherapy for muscle-invasive bladder cancer were reviewed. The patients were treated to a median total dose of 60 Gy (range, 56-64), with an average fractional dose of 190 +/- 10 cGy using megavoltage (6-15 MV). All patients were treated with radiation fields encompassing the bladder and grossly involved lymph nodes with a radiographic margin of at least 1.5 cm. RESULTS: No treatment-related mortality and clinically insignificant acute morbidity was recorded. No patient was hospitalized during or after the irradiation because of gastrointestinal or urogenital side effects. In one patient a week rest from therapy was necessary due a febrile status. Median survival was 21.5 months; overall 3- and 5-year survival was 36% and 19.5%, respectively. CONCLUSIONS: Elderly-unfit patients with comorbidities and >70 years of age can be submitted to radical pelvic irradiation. The results observed in this retrospective analysis have encouraged us to use non-palliative radiotherapy doses in these patients with muscle-invasive bladder cancer.
Abstract: Management of delayed emesis (DE) remains unsatisfactory, and only 50% of the patients achieve complete protection. Cisapride is a strong prokinetic gastrointestinal drug that could have a role in the prevention of DE. We enrolled 31 adult naive outpatients who were scheduled to receive cisplatin chemotherapy at doses of > or = 75 mg/m2. All patients received the same prophylactic treatment for acute emesis (20 mg dexamethasone and 8 mg ondansetron i.v.) and, as preventive therapy for DE, oral cisapride, 10 mg every 8 h on days 2-4, combined with dexamethasone i.m., 8 mg twice daily on days 2 and 3, and 4 mg twice daily on day 4. All patients were evaluable for activity. Complete protection from acute vomiting was 80.7%, from nausea 71% and from nausea/vomiting 64.5%. The overall protection from DE (days 2-4) was 74.1% for vomiting, 64.5% for nausea and 58% for nausea/vomiting. In our study the combination of cisapride and dexamethasone was effective, giving 58% of complete protection from DE, and it is therefore worthy of further studies.
Abstract: Bone metastases are a common event in advanced cancer. Breast, lung, prostate and thyroid neoplasms have striking osteotropism. Bone metastatic cancer may be associated with catastrophic consequences for the patients. Therefore, new strategies are warranted in order to reduce the incidence of bone metastases and to palliative established skeletal disease. External beam radiation therapy, endocrine treatments, chemotherapy, bisphosphonates and radioisotopes are all important. Bisphosphonates have become the treatment of choice for tumor-induced hypercalcaemia and more recently they have been used alone or in combination with cytotoxic agents in the palliative treatment of patients with bone metastases. The results are encouraging. Currently, new bisphosphonates that are a hundred times more powerful with respect to clodronate and pamidronate are under investigation. The treatment of metastases to bone and mechanisms of pain relief after radiation therapy are poorly understood. Up to date, there are not standard criteria for the irradiation of bone metastases and bone pain relief may be reached using a variety of fractionation schemes. Radionuclide therapy is the systemic use of radioisotopes for bone pain. It is currently regarded as suitable for comparison with wide-field irradiation, but appears to have major disadvantages in terms of pain relief and toxicity.
Abstract: BACKGROUND: To define the role of radiotherapy (RT) in the treatment of ipsilateral supraclavicular lymph-nodes metastases (ISLM) from breast cancer as only site of disseminated disease, we started a prospective non-randomized clinical trial in 1989. Here we report the final results with a median follow-up of 8.75 years. PATIENTS AND METHODS: Thirty-seven patients (pts), with ISLM from breast cancer, were consecutively enrolled into two arms. Arm A (18 pts): chemotherapy (CT) for six courses. Arm B (19 pts): CT for three courses followed by RT to the site of ISLM at 'radical' dose of 50-60 Gy. RESULTS: In arm A, a median Time to Progression (TtP) of 7 months with a median Overall Survival (OS) of 28 months was recorded. In comparison, patients in arm B had a longer median TtP with 20 months as well as a better median OS with 41 months, respectively. An actuarial five-year disease-free survival of 5.5% was obtained in arm A vs. 21% in arm B. A statistically significant difference in TtP was demonstrated between the two groups (P = 0.01). CONCLUSIONS: These data demonstrate that a better event-free survival could be achieved in patients with ISLM submitted to induction CT and radical irradiation. This also translated into a longer survival although this did not achieve statistical significance. We want to stress the importance of local control by RT since it does imply that not all of these patients have micrometastases at the time of relapse in the supraclavicular fossa.
Abstract: The purpose of this study is to describe the magnetic resonance (MR) features of bronchioloalveolar carcinoma. MR examinations of 18 patients with proven bronchioloalveolar carcinoma were reviewed. Detection at computed tomography (CT) and pathologic confirmation were the entry criteria. Nine patients had a solitary nodule, three patients a lobar consolidation, and six patients had diffuse disease. For each patient, both breath-hold T2-weighted fast spin-echo, and breath-hold T1-weighted gradient-echo images, before and after injection of gadolinium, were available. Nine patients with pulmonary consolidation or diffuse disease had also heavily T2-weighted MR imaging (Haste or TSE 240; Siemens, Erlangen, Germany). MR imaging showed pulmonary abnormalities in 17 of 18 patients. Unenhanced T1-weighted and T2-weighted images depicted tumor in 16 of 18 patients. Contrast-enhanced T1-weighted images showed tumor in 17 of 18 patients. In no case did MR imaging depict abnormalities corresponding to the ground-glass opacities seen on CT scans. In three patients with mucinous bronchioloalveolar carcinoma, heavily T2-weighted images showed lesions isointense with respect to static fluid of the human body. In conclusion, the ability of MR imaging in detecting small nodules and ground-glass opacities is limited. However, heavily T2-weighted sequences are able to show the presence of mucin. This is useful information because mucinous bronchioloalveolar carcinoma carries a poor prognosis.
Abstract: PURPOSE: To evaluate the best position of the arms in mantle field for Hodgkin's disease. METHODS AND MATERIALS: In 12 patients, with surgical clips placed at the time of an axillary dissection for breast cancer, the radiological projection of the clips according to three arm positions was prospectively evaluated: akimbo (A), extended (E), and up over the head (U). The surgical clips were arbitrarily separated into two groups: lower and upper. In each patient, the distance between the surgical clips and chest wall was measured, and the possibility of shielding the lungs and humeral heads was evaluated. RESULTS: The mean displacement of the lower clips away from the chest wall when the patients were in A, E, and U positions was 2.5, 3.0, and 4.6 cm, respectively. The upper group clips showed a lower difference in distance from chest wall. In the U position, there was always a clip of the lower group that projected over the humeral head, making it impossible to block this structure. CONCLUSION: In the A position, there is the possibility of blocking the humeral head, but it is necessary to irradiate more lung parenchyma. Type E treatment setup allows the shielding of both lung and humeral head, while maintaining adequate margins around the axillary nodes. In the U position, there is a greater possibility of shielding the lung parenchyma, but it is impossible to block the humeral heads.
Abstract: The role of chemotherapy in metastatic gastric cancer (MGC) is predominantly palliative, therefore regimens with mild toxicity and acceptable activity should be preferred. The combination of etoposide, leucovorin and 5-fluorouracil (ELF) is suitable chemotherapy in this situation. We have enrolled 33 patients with MGC, using the following chemotherapy schedule: l-leucovorin 150 mg/m2 10 minute i.v., followed by etoposide 120 mg/m2 50 minute i.v., followed by 5-fluorouracil 500 mg/m2 10 minute i.v. on days 1-3, every 22 days. All patients are valuable for response, toxicity and survival. Two patients achieved complete response (6%), 10 patients (30%) had a partial response (PR), 9 patients (27%) had stabilization of disease (SD) and 12 patients had disease progression (PD). The median survival for all patients was 6 months (range, 1 to 40+). ELF was well tolerated, the main toxicity being myelosuppression. No toxic deaths occurred. In conclusion, the ELF regimen in our trial demonstrated, in this kind of patient, moderate activity in the absence of relevant toxicity, confirming its suitability in patients in generally poor condition.
Abstract: Mucosal malignant melanoma (MMM) of the nasal cavity and paranasal sinuses is rare and has a poor prognosis. The rarity of MMM of the ethmoid is also noteworthy and primary treatment has been, till now, surgery and/or radiotherapy (RT). Here we report a case of MMM arising in the ethmoid of a caucasian man and treated with hypofractionated RT. A 32 year-old man presented with symptoms of cephalalgia, obstruction and nasal bleeding; a computed tomography (CT) showed a large mass that involved ethmoid, left orbit and roof of the nasal cavity. After biopsy, a MMM was found. Chest radiography demonstrated the presence of multiple lung metastases and still the patient was submitted to palliative radiotherapy according to 0-7-21 regimen with a total dose of 24Gy/3 fraction/21dd, dose per fraction 8Gy. The patient was asymptomatic one month after the end of RT and three months later a CT demonstrated a partial remission. The patient died 17 months after the initiation of RT for disseminated disease, without clinical signs of tumoral regrowth in the irradiated site. This case confirms the efficacy and the safety of 0-7-21 RT regimen; the absence of symptoms after 17 months and the poor prognosis encourage the use of RT as primary treatment for MMM of the head and neck.
Abstract: BACKGROUND: The optimal treatment for locoregionally recurrent rectal cancer after curative surgery has not yet been defined. The definition of prognostic factors could lead to the selection of an aggressive therapeutic approach in patients with favourable prognosis alone. PATIENTS AND METHODS: The records of thirty-nine ambulatory pts, 15 female and 24 male, with diagnosis of locoregionally recurrent rectal cancer (LRRC) after curative surgery and treated with radiotherapy were retrospectively analyzed. The following factors were analyzed for their ability to predict the clinical response and outcome for LRRC: age, sex, initial tumor grading, primary surgical approach, initial primary tumor stage according to Dukes' classification, disease free survival (time to primary surgery and detection of a LRRC), pelvic-perineal structure affected by recurrence, total radiation dose, chemotherapy with fluorouracil, symptomatic response to the therapy, locoregional symptomatic re-recurrence, systemic progression disease. RESULTS: In the univariate analysis, predictive factors for survival, were graded (G1-2 vs G3 p = 0.04), Dukes' stage at first diagnosis (A-B vs C p = 0.01), and site of pelvic-perineal recurrence (Pelvic mass alone yes vs no p = 0.01; Nerve and/or Osseous involvement yes vs no p < 0.001). Following therapy for LRRC, a better survival was observed in pts with a complete symptomatic response (complete remission vs partial remission vs no change p < 0.001), without a further locoregional symptomatic re-recurrence (re-recurrence, yes vs no p = 0.001) and/or appearance of metastatic disease (yes vs no p < 0.001).
Abstract: PURPOSE: An overall check of the whole dosimetry procedure by intracavitary in vivo dosimetry, using n-type silicon diode dosimeter, was performed during 6-MV x-ray irradiation of the vaginal vault. The dose delivered to the isocenter by all treatment fields was evaluated. METHODS AND MATERIALS: The diode dosimeter was calibrated against an ion chamber and tissue maximum ratio, field size factor, SSD factor, and temperature dependence studies were performed. Diode system accuracy, linearity, and reproducibility were also tested. Patients' dose data were collected and comparision was made with respect to treatment-planning dose calculations. Ten patients with cervical cancer and endometrial cancer were treated with surgery and irradiation. During the boost to the vaginal vault, a diode was inserted by an intravaginal device and the vaginal vault was the isocenter of the four fields. The field size generally was not larger than 10 x 10 cm2. RESULTS: Diode-measured "tissue maximum ratio" agreed to within 1% with those measured with an ion chamber in field from 7 x 7 to 10 x 10 cm2. The diode also exhibited a temperature dependence of 0.1% degrees C(-1). For 10 patients treated with a 6-MV beam, the agreement with treatment-planning dose calculations was shown to be better than +/-4%. CONCLUSION: The good accuracy and reproducibility of the diode system shows that determination of the dose at isocenter, for patients treated in the pelvic region, can be performed with n-type diodes accurately. On the other hand, in the vaginal vault boost, external-beam radiotherapy is delivered accurately and in vivo dosimetry is really not indicated.
Abstract: BACKGROUND: Radiation-induced emesis is an event linked to the release of serotonin during abdominal irradiation. Ondansetron is able to prevent emesis, but an optimal scheme has not yet been established. The aim of our study was to evaluate the efficacy of an escalating dose of oral ondansetron (Oral OND) in the prevention of emesis induced by fractionated radiotherapy. PATIENTS AND METHODS: We enrolled 30 patients who underwent fractionated radiotherapy involving the upper abdomen which received this schedule of antiemetic therapy: phase A Oral OND 4 mg p.o. immediately after irradiation (RT) with a dose < or = 20 Gy; phase B Oral OND 8 mg p.o. immediately after RT with dose > 20 Gy and < 30 Gy; phase C Oral OND 8 mg p.o. every 12 hours starting immediately after RT with a dose > or = 30 Gy. RESULTS: During phase A we obtained a 100% of CR in all 30 patients. In phase B 22 CR (92%) and 2 MR (8%). In phase C on a total of 11 patients we recorded 6 CR (55%), 3 MR (27%) and 2 F (18%). The toxicity was mild. CONCLUSION: Our data confirm the efficacy and safety of Oral OND and, moreover, show the possibility to reduce the cost without compromising the activity.
Abstract: BACKGROUND: Radical oxygen species (ROS) are known to mediate cytotoxic anticancer activity by modifying the cellular homeostatic redox balance. The aim of the study is to evaluate whether cancer patients show more ROS after radio/chemotherapy. METHODS: ROS were evaluated in 32 oncologic untreated patients. Blood samples were collected both before and after the end of radio/chemotherapy. Spectrophotometric detection of ROS was performed by using d-ROMs test (Diacron). RESULTS: After therapy all patients showed a marked increase in ROS (378 +/- 35 U Carr) compared to values measured before therapy (269 +/- 62 U Carr, p < 0.0001). This result was more evident during the first course of therapy. No significant differences were observed between patients who received radio or chemotherapy. CONCLUSIONS: In conclusion both radio and chemotherapy induce oxidative stress by increasing radical oxygen species, exceeding the antioxidative capacities of cancer patients. This is useful for therapeutic purposes but may enhance the cytotoxicity induced by therapy.
Abstract: The aim of this study was to evaluate three active agents, bleomycin (BLM), epirubicin and carboplatin in a new combination (BECA) in terms of feasibility, activity and toxicity in patients with recurrent and metastatic squamous cell carcinoma of the head and neck. From April 1992 to February 1993 15 pts (12M/3F), median age 53 years, all pretreated (6 surgery + radiotherapy; 3 radiotherapy + chemotherapy; 6 radiotherapy), were treated with BLM 15 mg/m2 days 1-14; epirubicin 30 mg/m2 days 1-14 and carboplatin 300 mg/m2 day 1 every 28 days. In the 14 evaluable pts we observed 1 complete response, CR (7.1%), 4 partial responses, PR (28.6%), 5 stable disease, SD and 4 disease progression, PD with an overall response of 35.7%. The treatment was globally well tolerated, 1 pt with grade 3 leukopenia and 1 pt with grade 3 thrombocytopenia, 1 pt with grade 3 emesis and 1 pt with grade 3 mucositis. At the last follow-up the duration of CR was 34 months, the duration of PRs were respectively 22-10-10-7 months, but the SD ranged from 4 to 6 months. The overall median survival was 8 months (3-36), 14 for responders and 4 for non-responders. This final report seems to confirm the activity and efficacy of the BECA regimen, suitable for outpatient administration with an overall response equal to other more aggressive combinations.
Abstract: BACKGROUND: Supraclavicular lymph node metastases (SLM) as the only site of metastatic disease from breast cancer is a rare and a poor prognostic event. In order to evaluate the role of Radiotherapy (RT) with "radical dose" to the supraclavicular fossa, we carried out a non randomized clinical trial comparing systemic therapy alone to integrated and aggressive treatment (systemic therapy plus radiotherapy). The primary end-point was time to progression (TTP). The second end-point was the overall survival (OS). METHODS: From 1/1/1989 to 31/12/1994 37 patients (with or without the presence of locoregional disease) were enrolled into two arms, of the study, but were allowed, when giving their consent, to change the arm of the study which they had been originally allotted to. Arm A, 18 patients, 15 evaluable: chemo +/- hormonotherapy for 6 courses; after the second course, if local progression disease was present, the pts. were submitted to RT and removed from the study (3 patients). Arm B, 19 patients all evaluable: chemo +/- hormonotherapy for 3 courses followed by RT with "radical" dose. Results were analyzed on 30/11/1995 and no interim analysis was performed. The potential median follow up for all patients was 56.5 months (range 11-83 months): for Arm A 61 months (range: 12-82); for Arm B 53 months (range: 11-83). The two groups were homogeneous and balanced, without statistical differences. RESULTS: Median TTP was 12.5 months in Arm A and 19.5 months in Arm B (p = 0.064). Median overall survival (OS) was 27.5 months in Arm A and 48 months in Arm B. T-status to the time of the diagnosis was found to be independent prognostic factor for TTP (p = 0.0029). Disease-free interval from diagnosis to recurrence was found to be a significant prognostic factor for OS (p = 0.009). CONCLUSION: The results in Arm B demonstrated the opportunity of a long term control in this subset of patients. Therefore we suggest the start of a wider multicenter study in order to define the biological significance of SLM, its importance in staging breast cancer and to consider the optimum treatment.
Abstract: BACKGROUND: Vinorelbine is active in a variety of malignancies. The most common side effects are leukopenia and granulocytopenia, moreover Vinorelbine is a vescicant and venous irritant, the incidence of the latter being 10-26% in patients who received VNB as a 20-30 minute peripheral infusion. To prevent venous toxicity we have carried out a study in order to evaluate the efficacy of Defibrotide in this issue. MATERIALS AND METHODS: 41 patients were enrolled in the study, the experimental schedule was: Defibrotide 400 mg on 250 cc of normal saline iv, after 15 minutes of infusion, we delivered quick, brief and repeated pulses of Vinorelbine through the plastic tube followed by remaining Defibrotide: For grading venous irritation we used the scale by Rittenberg et al. RESULTS: A total of 360 infusion were delivered, the incidence of any venous irritation was 5% and maximum grade 2. No severe toxicity was recorded. CONCLUSION: These data show that Defibrotide might serve as a therapeutic drug to prevent vascular toxicity by Vinorelbine.
Abstract: The wedge factor was experimentally determined as a function of field size and phantom depth for 6-MV X-rays; measurements were performed on a linear accelerator with a motorized wedge filter (universal wedge, nominal wedge angle = 60 degrees). As a result of our experimental work, we can state that: 1) The wedge factor increases linearly with phantom depth (0.275%/cm), almost independent of field size; this change was experimentally related to the beam "hardening" caused by the high Z value of wedge material, as shown by the increase in wedged-field PDD with respect to the corresponding open-field PDD. Neglecting this variation can induce systematic errors in delivered dose, especially when deep-seated tumors are treated with wedge fields. 2) The wedge factor changes, for rectangular fields, according to the "equivalent square law", and not to the dimension in the wedged direction.
Abstract: About two-thirds of the patients with squamous cell carcinoma of the head and neck (SCCHN) are diagnosed when the disease is in a locoregionally advanced stage. If surgery is not advisable, radiotherapy is the only treatment presently available to obtain radicality. In order to improve the therapeutic efficacy of radiotherapy (RT), chemotherapy has been associated with it with the aim of eradicating possible micrometastatic foci outside the radiotherapic fields and to enhance the cytotoxic effects of radiation. Results with concomitant chemoradiotherapy have been encouraging. We carried out a phase II study with the combination of carboplatin 300 mg/m2 every 21 days and RT at conventional doses in SCCHN stage IV (non M1). We obtained an overall response of 85.7% with an 18-month survival of 70%. The toxicity was moderate. These results encourage us to continue the accural of patients.
Abstract: BACKGROUND: Most chemotherapic treatments are carried out on an outpatient basis. In such patients the prevention and control of emesis is important. Granisetron is a specific and extremely potent 5-HT3 antagonist available as an oral formulation. We have carried out an open randomized crossover study in patients receiving moderately emetogenic chemotherapy. MATERIALS AND METHODS: 30 patients were randomized to receive one of the two oral dose regimens of GRAN. Treatment A = 1 mg of GRAN initially and 12 hours after the first; treatment B = a single 2 mg dose of GRAN. RESULTS. An overall good response for vomiting was reached in 70% and 86.7% respectively of patients receiving treatments A and B (p = 0.0625). Good response to nausea was reached in 73.3% of the patients with treatment A and in 76.7% with treatment B (p = 1). 68.3% of patients did not record chemoinduced emesis. CONCLUSION: We believe that oral GRAN alone is an active and safe drug for the prevention of acute chemoinduced emesis.
Abstract: Lumbosacral carcinomatous neuropathy (LCN) may be caused by infiltration or compression of the lumbosacral plexi and nerves from intrapelvic or paraaortic neoplasms. The authors submitted 23 patients complaining of LCN with CT documented intrapelvic or paraaortic tumors to palliative radiotherapy. Megavoltage external beam irradiation was administered using a 6-MV linear accelerator. Treatment field sizes ranged from 56 cm2 to 235 cm2 (mean: 150.54 cm2) and encompassed only the site where the disease involved the lumbosacral plexus or its branches. > or = 3 Gy/day fractions were used. Twenty-one of 22 assessable patients (95.4%) obtained LCN pain relief; 19 (86.3%) obtained complete LCN pain relief. The median time to pain progression (TPP) was 150 days (range: 39-510 days). The median survival was 165 days. Seven patients were LCN pain-free at death. Two patients are alive and LCN pain-free. The remaining 12 patients had recurrent LCN pain: four of them were reirradiated at the site of previous neuropathy and only two had partial relief again. The authors conclude that it is advisable to submit to palliative radiotherapy the inoperable disseminated and/or recurrent cancer patients complaining of LCN, to use large fractions not to occupy the extant time of their already short life-expectancy, and to design small fields to avoid acute side-effects.
Abstract: The authors report their own experience in obtaining pain relief in 13 recurrent or disseminated cancer patients affected by lumbosacral carcinomatous neuropathy (LCN). The site, where the disease involved the lumbosacral plexus or its branches, was palliatively irradiated with a few large fractions. The average duration of response was 196 days. Median survival (uncensored) was 185 days (range 47-636 days).
Abstract: We define a solitary pulmonary noncalcified nodule (NPS) as a single focal rounded or ovoid lesion in the lung parenchyma, less than 4 cm in diameter, without associated adenopathy, atelectasis or pneumonia. An NPS, in the absence of a known primary malignancy, can be lung cancer (NPSM), a metastasis of unknown origin (NPSMT), or a benign lesion (NPSB). The best approach to the management of NPS and the value of CT are still controversial and uncertain. The finding on cross-section CT of a bronchus leading directly to, or contained within, the nodule is called "positive CT bronchus sign" (CT-BS). Our study was aimed at investigating the usefulness of CT bronchus sign, as studied on thin-slice (2 mm thick) CT sections, in order to establish the most appropriate diagnostic sequence in patients with solitary noncalcified pulmonary nodules (NPS). We evaluated 47 NPS (9 NPSB, 34 NPSM and 4 NPSMT) with thin-slice CT to detect the presence of CT bronchus sign. Seventeen cases had CT-BS (15 NPSM; 1 NPSB; 1 NPSMT); of them, 13 were diagnosed by means of transbronchial biopsy and brushing (TBB). Only one case (NPSM) of the 30 (19 NPSM; 3 NPSMT; 8 NPSB) without CT-BS, was diagnosed by TBB. TBB was negative in the 9 NPSB. The CT-BS is not pathognomonic of malignancy; in fact, the sign was observed in NPSB (one tuberculoma) too. Our results suggest that the CT bronchus sign is valuable in predicting the success of TBB in malignant solitary pulmonary nodules. On the other hand, it seems to be useless for NPSB. Therefore, to establish the most appropriate diagnostic sequence, thin-section CT should be performed in each patient with peripheral noncalcified lung lesions to plan whether TBB or transthoracic needle aspiration should come next. If biopsy results are poor, either surgery or the "wait and watch for growth" approaches can be suggested. The choice can be guided by the presence of predisposing factors for cancer or infection.
Abstract: The authors report a patient with iatrogenic dissemination of hepatocellular carcinoma (HCC). A 65-year-old Caucasian man was found to have a moderately well-differentiated HCC diagnosed by laparoscopy and biopsy; the patient had atypical left liver lobe resection. Thirty-three months after definitive surgery a double relapse was found at the site of the previous laparoscopy and at the surgical scar; no other metastases were found. Surgical procedure for removal of these lesions was performed, and the patient received complementary radiation therapy. At 30 months of follow-up, the patient is alive and disease free. The risk of neoplastic seeding through biopsy and improved safety in surgical techniques justify the omission of diagnostic biopsy in patients who have surgical procedures.
Abstract: The definition of the methods for localizing the booster field used in the conservative treatment of early breast cancer is often blurred in several studies in the current literature. This paper is aimed at reporting a surgical-radiological method more objective than the clinico-anamnestic one used, so far, for planning the booster field. To this purpose 33 patients underwent conservative surgery in healthy tissue and radiopaque clips were inserted at the margins of the excision cavity. The booster field as defined with clinico-anamnestic standards was then simulated and later verified by a radiation therapy simulator. The clinical fields thus set up were correct in 15/33 cases. The authors discuss their results and compare them with literature data. The importance of the use of the surgical-radiological method to localize the booster field is stressed.
Abstract: Carcinomatous involvement of the pelvic nerves (Pelvic Carcinomatous Neuropathy-PCN-) causes disabling sensorial and motor disturbances of the lower extremities. Recurrent rectal carcinomas are the most common cause of PCN because surgical obliteration of the perirectal fascia. In 31 cases of PCN Authors describe the types of the neoplasm and the sites of involvement of the pelvic nerves evaluating clinical syndromes and Computed Tomography. The results of radiotherapy (doses between 36-56 Gy) in 14 cases of PCN by recurrent rectal cancer are also reported. Although the survival of such patients is poor, radiotherapy has obtained a good palliative result in 50% of them. Personalization of radiation treatment planning is advisable in order to avoid acute side-effects.
