High-Dose Robotic Stereotactic Body Radiotherapy in the Treatment of Patients With Prostate Cancer: Preliminary Results in 26 Patients.

BACKGROUND: Stereotactic body radiotherapy (SBRT) can emulate high dose rate brachytherapy (HDR-BRT) dose fractionation. We report our preliminary results using SBRT in monotherapy or pre-external-beam radiotherapy (EBRT) boost in patients with localized prostate cancer (LpC). The primary end point was the evaluation of both acute and late toxicities; secondary end point was the observation of prostate-specific antigen (PSA) nadir. PATIENTS AND METHODS: Patients with LpC having prostate volume ≤90 cm(3) were enrolled in the present study. Patients were treated with SBRT alone or in combined modality (SBRT + EBRT). SBRT was performed using a CyberKnife System (Accuray Incorporated, Sunnyvale, California) and fiducial tracking system. RESULTS: From February 2008 to July 2013, 21 patients for monotherapy (38 Gy/4 fractions) and 5 for combined modality (9.5 Gy/2 fractions plus 46 Gy/23 fractions EBRT) were enrolled. Androgen deprivation therapy (ADT) was administered in 16 of the 26 patients. The median pretreatment PSA was 9.4 (range, 4.5-14.3) ng/mL. All patients completed the planned therapy. Acute Grade 1 toxicity was observed in 18 patients, genitourinary (GU) in 12 / 26 patients, and gastrointestinal (GI) in 6 / 26 patients. Acute Grade 2 GU toxicity was reported in 1 / 26 patients, and Grade 2 GI toxicity was observed in 2 / 26 patients. The median PSA nadir was 0.15 (range, 0.02 = 1.4) ng/mL. Late toxicities were observed in 5 / 26 patients: Grade 1 GU (3 of 26), Grade 2 GU (1 of 26), and Grade 1 GI (1 of 26). Median follow-up was 21.5 (range, 8-65) months. CONCLUSIONS: Our preliminary results of SBRT "simulating" HDR for LpC confirm a minimal toxicity and an optimal PSA response. The PSA nadirs appear comparable with HDR-BRT.

Effects of fluconazole in the prophylaxis of oropharyngeal candidiasis in patients undergoing radiotherapy for head and neck tumour: results from a double-blind placebo-controlled trial.

Fluconazole is recommended in the prophylaxis of oropharyngeal candidiasis (OPC) in patients undergoing radiotherapy for head-neck tumours; however, the actual effectiveness of fluconazole in this setting remains unclear. Adult patients with cervico-cephalic carcinoma submitted to radical or adjuvant radiotherapy were randomized to 100 mg fluconazole (n = 138) or matched placebo (n = 132) oral suspension once daily from the sixth session of radiotherapy up to the end of treatment. The final analysis of the investigation showed a higher rate of the OPC outbreak-free survival in the fluconazole compared with placebo (P = 0.008 in the log-rank test). The mean time (95% CI) to OPC outbreak was 56 (53-59) days in the fluconazole group and 47 (43-51) days with placebo. The mean duration of radiotherapy was 43.5 and 39.9 days, respectively in the two groups (P = 0.027). Adverse effects were reported in 70.3% of patients in the fluconazole group and in 67.4% with placebo. The results showed prophylaxis with fluconazole given in irradiated patients with head-neck tumours significantly reduces the rate and the time to development of OPC compared with placebo.

Use of probiotics for prevention of radiation-induced diarrhea.

AIM: To investigate the efficacy of a high-potency probiotic preparation on prevention of radiation-induced diarrhea in cancer patients. METHODS: This was a double-blind, placebo-controlled trial. Four hundred and ninety patients who underwent adjuvant postoperative radiation therapy after surgery for sigmoid, rectal, or cervical cancer were assigned to either the high-potency probiotic preparation VSL#3 (one sachet t.i.d.,) or placebo starting from the first day of radiation therapy. Efficacy endpoints were incidence and severity of radiation-induced diarrhea, daily number of bowel movements, and the time from the start of the study to the use of loperamide as rescue medication. RESULTS: More placebo patients had radiation-induced diarrhea than VSL#3 patients (124 of 239 patients, 51.8%, and 77 of 243 patients, 31.6%; P<0.001) and more patients given placebo suffered grade 3 or 4 diarrhea compared with VSL#3 recipients (55.4% and 1.4%, P<0.001). Daily bowel movements were 14.7 +/- 6 and 5.1 +/- 3 among placebo and VSL#3 recipients (P<0.05), and the mean time to the use of loperamide was 86 +/- 6 h for placebo patients and 122 +/- 8 h for VSL#3 patients (P<0.001). CONCLUSION: Probiotic lactic acid-producing bacteria are an easy, safe, and feasible approach to protect cancer patients against the risk of radiation-induced diarrhea.

Induction chemotherapy to weekly paclitaxel concurrent with curative radiotherapy in stage IV (M0) unresectable head and neck squamous cell carcinoma: a dose escalation study.

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.

Prophylaxis of diarrhoea in patients submitted to radiotherapeutic treatment on pelvic district: personal experience.

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.

Ipsilateral supraclavicular lymph nodes metastases from breast cancer as only site of disseminated disease. Chemotherapy alone vs. induction chemotherapy to radical radiation therapy.

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.

[Quality radiotherapy in rectal cancer]. / La radioterapia di qualità nel cancro del retto.

The quality of radiotherapy significantly impacts on the results of treatment, in patients with rectal carcinoma, especially in terms of acute and late toxicity. Based on this assumption, the Italian Association of Radiation Oncology (AIRO) formulated a document aimed to define the standards of radiation treatment for rectal carcinomas. Two different levels of standard were described: a first level, considered as "minimal requirement", and a second level, considered as "optimal treatment". A retrospective evaluation, based on a questionnaire, revealed that in 1996, in most Italian Centers, patients affected by rectal carcinoma received radiation treatment within the first level of proposed standards. A subsequent analysis concerned the evaluation of the level of treatments applied in 2000. In this paper the radiotherapy standards proposed by the AIRO are described in the different phases of the radiation treatment.

What is the best position of the arms in mantle field for Hodgkin's disease?

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.

Prognostic factors in ambulatory patients with inoperable locoregionally recurrent rectal cancer following curative surgery.

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).

[Role of computerized tomography in the evaluation of extraductal extension of hilar cholangiocarcinoma]. / Ruolo della tomografia computerizzata nella valutazione dell'estensione extra-duttale del colangiocarcinoma ilare.

This study was aimed at assessing the role of CT in the investigation of extraductal spread of hilar cholangiocarcinoma. October 1990 to November 1993, twenty-one patients with hilar cholangiocarcinoma were examined. The diagnosis was made on the basis of the following CT findings: intrahepatic bile ducts dilatation, nonunion of the right and the left bile ducts, normal size of extrahepatic bile ducts and the tumor depicted "per se". As for extraductal spread, we considered parenchymal invasion, involvement of vascular structures and parenchymal, lymph node and peritoneal metastases. In all cases CT demonstrated intrahepatic bile duct dilatation and nonunion at the confluence. CT demonstrated a hypodense mass in 10/21 cases and an isodense mass in 11/21 cases. Portal vein involvement was detected in 7/10 cases and hepatic artery involvement was correctly suspected in 1/8 cases; CT demonstrated parenchymal and lymph node metastases in 1/6 and 2/7 cases. In conclusion, CT proved to be a valuable technique, like PTC and US, to assess tumor resectability.

[Antalgic radiotherapy in lumbosacral carcinomatous neuropathies]. / La radioterapia antalgica nelle neuropatie carcinomatose lombosacrali.

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.

[Extra-abdominal spread of pelvic neoplasms. CT evaluation and radiotherapeutic implications]. / Diffusione extra-addominale delle neoplasie pelviche. Valutazione TC ed implicazioni radioterapiche.

Meyers and other authors have described the extra-abdominal spread of inflammatory abdominal diseases. Conversely, little attention has been paid to the extra-abdominal spread of pelvic neoplasms. The authors have detected, by means of CT, 17 cases of extra-abdominal neoplastic spread in a series of 203 patients with pelvic neoplasms. Neoplastic spread involved the inguinal region in 1 case, the buttock in 6 cases, and the ischiorectal fossa and/or perineum in 12 cases, with more than one region involved in some patients. In such cases CT showed the extension of tumoral tissue beyond the muscular walls of the pelvis. Recurrent pelvic carcinomas are the most common neoplasms spreading outside the pelvis. Surgical obliteration of the pelvic fasciae can explain such a behavior. Differential diagnosis is to be made with inflammatory pelvic diseases with extrapelvic spread. When a pelvic tumor spreads outside the pelvis it can be seen as a primitive gluteal or inguinal or perineal mass. CT demonstration of such an insidious event is mandatory for both a correct diagnosis and radiation treatment planning.

[Carcinomatous neuropathy in recurrent rectal carcinoma. The results of radiotherapy and the role of CT]. / La neuropatia carcinomatosa nel carcinoma rettale recidivo. Risultati della radioterapia e ruolo della TC.

More than 60% of the patients with recurrent rectal carcinoma complain of pain after radical surgery. Pelvic carcinomatous neuropathy (PCN) is a frequent cause of pain in such patients. Although the effectiveness of radiotherapy in the palliative treatment of local recurrences of rectal carcinoma is well recognized, its results in PCN are less known. The authors have evaluated the results of high-energy radiotherapy in 12 patients with recurrent rectal carcinoma and PCN, who were treated with doses between 35 and 55 Gy. Although the survival of these patients is always poor, about 50% of them achieved a significant and prolonged palliative result by radiation treatment. In patients with PCN, CT is an effective tool to detect recurrences, define their volume and relationship to critical organs, show sites of neural involvement, and optimize radiation treatment planning.

[Radioisotopic study of some organs after radiotherapy of the upper abdomen (author's transl)]. / Studio radioisotopico di alcuni organi dopo radioterapia dell'addome superiore.

The authors present the results of a study carried on 25 cases (Hodgkin patients) performing before and after standardized radiotherapy on retroperitoneal lymph nodes (45 Gy): - radionephrography and determination of renal plasmatic flux and glomerular filtration; - liver scintigraphy by colloids and 99Tcm-HIDA and liver functional tests by 131I-Bengal rose; - pancreas scintigraphy. Focal damage of the hepatic left lobe in younger patients and transitory impairment of some renal functional tests have been observed.