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OBJECT The goal of this study was to evaluate advantages, risks, and failures of Gamma Knife radiosurgery (GKRS) in a large series of pediatric and adolescent patients with cerebral arteriovenous malformations (cAVMs) who were followed up for at least 36 months. METHODS Since February 1993, 100 pediatric and adolescent patients (≤ 18 years of age) with cAVMs have undergone GKRS at the authors’ institution and were followed up for at least 36 months. Forty-six patients were boys and 54 were girls; the mean age was 12.8 years (range 3–18 years). Hemorrhage, either alone or combined with seizure, was the clinical onset in 70% of cases. The mean pre-GK cAVM volume was 2.8 ml; 92% of cAVMs were Spetzler-Martin (S-M) Grades I–III. Most lesions (94%) were in eloquent or deep-seated brain regions, according to S-M classification. The parameters for mean and range in treatment planning were prescription isodose 53.8% (40%–90%); prescription dose (PD) 20.2 Gy (9.0–26.4 Gy); maximal dose (MD) 37.8 Gy (18–50 Gy); and number of shots 4.7 (1–17). On the day of GKRS, stereotactic CT or stereotactic MRI and digital subtraction angiography were used. RESULTS Obliteration rate (OR) was angiographically documented in 75 of 84 cases (89.3%) after single-session GKRS, with actuarial ORs at 3 and 5 years of 68.0% and 88.1%, respectively. A repeat treatment was performed in 7 patients (6 with obliteration), and 16 patients with cAVMs underwent staged treatment (9 of them were angiographically cured). Thus, the overall OR was 90%, with actuarial ORs at 3, 5, and 8 years of 59.0%, 76.0%, and 85.0%, respectively. Permanent symptomatic GK-related complications were observed in 11% of cases, with surgical removal of enlarged mass seen on post-RS imaging needed in 5 cases. Hemorrhage during the latency period occurred in 9% of patients, but surgical evacuation of the hematoma was required in only 1 patient. One patient died due to rebleeding of a brainstem cAVM. Radiosurgery outcomes varied according to cAVM sizes and doses: volumes ≤ 10 ml and PDs > 16 Gy were significantly associated with higher ORs and lower rates of permanent complication and bleeding during the latency period. CONCLUSIONS The data from this study reinforce the conclusion that GKRS is a safe and effective treatment for pediatric and adolescent cAVMs, yielding a high OR with minimal permanent severe morbidity and no mortality. The very low frequency of severe hemorrhages during the latency period further encourages a widespread application of RS in such patients. Univariate analysis found that modified RS-based cAVM score, nidus volume, PD, integral dose, S-M grade, and preplanned treatment (the last 2 parameters were also confirmed on multivariate analysis) significantly influenced OR. Lower S-M grades and single-session planned treatments correlated with shorter treatment obliteration interval on univariate analysis. This statistical analysis suggests that a staged radiosurgical treatment should be planned when nidus volume > 10 ml and/or when the recommended PD is ≤ 16 Gy.

Oncogenic osteomalacia (OOM) is an uncommon metabolic and bone disease caused by fibroblast growth factor 23 (FGF23), a phosphaturic factor produced by phosphaturic mesenchymal tumors (mixed connective tissue variant, PMTMCTV) characterized by phosphate leakage from kidneys and subsequent hypophosphatemia. In this paper, we present the case of a patient, 42-year-old woman affected by left side limp and pain involving lumbar spine, pelvis and hip joints, referred to the Rheumatology Department of our Hospital for the treatment of a suspected sero-negative spondilo-arthritis. During hospitalization patient began an immuno-suppressive therapy with TNF-alpha inhibitors associated with Pamidornate, Indometacin, Esomeprazole and vitamin D3. Nevertheless pain did not decrease and a new examination found a worst hypophosphatemia (1 mg/dl) with normal Ca and PTH’s plasma values. During the same check-up a painful bulge on the anterior part of the right knee was observed and the Magnetic Resonance Imaging scan revealed an ovular solid lesion in the soft tissue closed to the upper part of the patella. Histological analysis identified the lesion as a PMTMCTV. After surgical removal patient got complete recovery. We will discuss about diagnostic evaluation, differential diagnosis and treatment.

Background: Women with early stage disease not only have a better prognosis, but also have the opportunity to preserve their breasts. Despite the positive evidence and outcomes for breast-conserving therapy (BCT), many women are unable or unwilling to undergo 5–7 weeks of external-beam radiotherapy (EBRT). We report the results of a single-institution phase II trial of accelerated partial breast irradiation (APBI) using a single dose of intraoperative electron radiotherapy (IOERT) in patients with low risk early stage breast cancer. Methods and materials: From July 2006 to December 2009, 226 patients suitable for BCT were enrolled in a phase II trial with IOERT as radical treatment immediately after surgical resection. All patients had biopsy proven cancer. After the surgeon temporarily re-approximated the excision cavity, a dose of 21 Gy using IOERT was delivered to the tumor bed with a margin of 2 cm laterally. Results: No acute reactions were reported after irradiation. Three patients experienced a transient edema. In 7 others a haematoma was observed. No cases of liponecrosis were observed. With a mean follow-up of 49 months (range 31–66 months), only one case of local recurrence has been reported. The observed toxicity was considered acceptable. As to cosmetic results, at 6 months after the end of IORT, 71/226 patients (31.4.%) had a score of 2 for symmetry and contour (asymmetry exhibited by 1/3 or less of volume breast), while 19/226 (8.4%) had a score 3 (asymmetry greater than 1/3 of breast volume). These findings remained unchanged at the following examinations. No breast oedema, discoloration at site or scar prominence were observed. Discussion: IOERT has significant advantages compared to other post-operative APBI approaches. The surgical re-approximation of the tumor bed, combined with the high quality of electron beam radiation, generates substantially more uniform dose distributions. IOERT offers the advantage of an excellent delineation of the tumor bed under visual control and high sparing of normal tissue, including the skin. IOERT delivers a very high biologically dose at the time of the surgery, when residual tumor cells are more rapidly proliferating. IOERT is insensitive to chemotherapy sequencing since all of the radiation is given during the surgery. IOERT offers low-risk women the possibility of a one-day procedure to treat their cancer and preserve their breast. The results of our study are very encouraging compared with other series with IOERT or APBI. The absolute recurrence rate of 0.4% and the recurrence rate per year of 0.2% of the present study are lower compared to the ones from the largest series with IOERT ever published (3.6% and 1.2%, respectively) (1). Conclusion: APBI using a single dose of IOERT can be delivered safely in women with early, low risk breast cancer. A longer follow-up is needed to ascertain its efficacy compared to that of the current standard treatment of whole breast irradiation. References 1. Veronesi U, Orecchia R, Luini A, et al. Intraoperative radiotherapy during breast conserving surgery: a study on 1,822 cases treated with electrons. Breast Cancer Res Treat 2010; 124:141–151. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P4-16-08.

Background We report the results of a single-institution, phase II trial of accelerated partial breast irradiation (APBI) using a single dose of intraoperative electron radiation therapy (IOERT) in patients with low-risk early stage breast cancer. Methods and Materials A cohort of 226 patients with low-risk, early stage breast cancer were treated with local excision and axillary management (sentinel node biopsy with or without axillary node dissection). After the surgeon temporarily reapproximated the excision cavity, a dose of 21 Gy using IOERT was delivered to the tumor bed, with a margin of 2 cm laterally. Results With a mean follow-up of 46 months (range, 28-63 months), only 1 case of local recurrence was reported. The observed toxicity was considered acceptable. Conclusions APBI using a single dose of IOERT can be delivered safely in women with early, low-risk breast cancer in carefully selected patients. A longer follow-up is needed to ascertain its efficacy compared to that of the current standard treatment of whole-breast irradiation.

In a previous work we have developed a biosensor able to detect the Sarin gas at a concentration of 0.1 mg/m 3 with only 30 s of incubation time [1]. In this work, we modified the biosensor in order to integrate it into a miniaturized prototype. The prototype is composed of the cell in which is inserted the biosensor, a little fan able to sampling air and an electronic circuit. The circuit is able to apply the potential, to register the current, to turn on-off the fan and eventually give an alarm. The system was tested with paraoxon with satisfactory results.

Summary of phase II–III trials in LAPC (*CT combined with HT). GEM: Gemcitabine, CDDP: cisplatin, 5FU: 5-fluoracil, Oxa: Oxaliplatin. Tabelle 5. Zusammenfassung der Phase-II/III-Studien bei LAPC (*CT Kombiniert mit HT). GEM: Gemcitabin, CDDP: Cisplatin, 5FU: 5-Fluoracil, Oxa: Oxaliplatin. Study Patients (n)CT RT 1-year OSMedian OS (months) Moertel, 1981 86 5FU 60 Gy/30 F 46% 11.4GITSG, 1988 22 5FU 54 Gy/27 F 41% 9.7Ishii, 1997 20 5FU 50.4 Gy/28 F 42% 10.3Kornek, 2000 38 5FU - CDDP 55 Gy/28 F 53% 14Crane, 2001 51 GEM 30 Gy/10 F 10.3Louvet, 2002 30 GEMOX 47% 11.5El - Rayes, 2003 16 GEM - CDDP - 5FU 35% 10.3Cohen, 2005 55 5FU - Mitomycin C 59.4 Gy/33 F 8.4Haddock, 2007 47 GEM - CDDP 50.4 Gy/25 F 40% 10.2Huguet, 2007 128 GEM/GEMOX FOLFUGEM 65 Gy/38 F 47% 65%11.7 15Chauffert, 2008 119 GEM 5FU - CDDP 60 Gy/30 F 13 8.6Loehrer, 2008 74 GEM 1000 mg/mqGEM 600 mg/mq50.4 Gy/25 F 9.2 11Issels*, 2008 22 GEM - CDDP 16.9Ishikawa*, 2008 7 GEM 10.9Wilkowski, 2009 95 5FU GEM - CDDP GEM - CDDP 50 Gy/25 F 50 Gy/25 F 50 Gy/25 F 9.6 9.3 7.3Goldstein, 2009 48 GEM - OXA - 5FU 54 Gy/27 F 15.4Viret, 2009 51 DOCETAXEL - CDDP 54 Gy/27 F 9.6Colucci, 2010 199 GEM 8.3

Delineation of clinical target volume (CTV) is still controversial in glioblastomas. In order to assess the differences in volume and shape of the radiotherapy target, the use of pre-operative vs post-operative/pre-radiotherapy T(1) and T(2) weighted MRI was compared.4 CTVs were delineated in 24 patients pre-operatively and post-operatively using T(1) contrast-enhanced (T1(PRE)CTV and T1(POST)CTV) and T(2) weighted images (T2(PRE)CTV and T2(POST)CTV). Pre-operative MRI examinations were performed the day before surgery, whereas post-operative examinations were acquired 1 month after surgery and before chemoradiation. A concordance index (CI) was defined as the ratio between the overlapping and composite volumes.The volumes of T1(PRE)CTV and T1(POST)CTV were not statistically different (248 ± 88 vs 254 ± 101), although volume differences100 cm(3) were observed in 6 out of 24 patients. A marked increase due to tumour progression was shown in three patients. Three patients showed a decrease because of a reduced mass effect. A significant reduction occurred between pre-operative and post-operative T(2) volumes (139 ± 68 vs 78 ± 59). Lack of concordance was observed between T1(PRE)CTV and T1(POST)CTV (CI = 0.67 ± 0.09), T2(PRE)CTV and T2(POST)CTV (CI = 0.39 ± 0.20) and comparing the portion of the T1(PRE)CTV and T1(POST)CTV not covered by that defined on T2(PRE)CTV images (CI = 0.45 ± 0.16 and 0.44 ± 0.17, respectively).Using T(2) MRI, huge variations can be observed in peritumoural oedema, which are probably due to steroid treatment. Using T(1) MRI, brain shifts after surgery and possible progressive enhancing lesions produce substantial differences in CTVs. Our data support the use of post-operative/pre-radiotherapy T(1) weighted MRI for planning purposes.

Aims and background Hyperthermia, the heating of tumors to 41.5–43 °C, could be today considered the fourth pillar of the treatment of cancer. Employed for 20 years in Europe, the USA and Asia, hyperthermia, used in addition to radiotherapy, chemotherapy and surgery, increases both local control and overall survival, restores the chance of the surgery for inoperable tumors and allows a new low-dosage treatment of relapsed cancers previously treated with high radiotherapy dosage without increasing toxicity. Methods Hyperthermia can be either superficial, produced by a microwave generator, or regional, produced by a radiofrequency applicator with multiple antennas, which emanate a deep focalized or interstitial heating. Results The results are confirmed by phase III randomized trials, with level 1 evidence. A review of the international literature on hyperthermia, the experience of the University Hospital of Verona Radiotherapy Department (Italy) and a summary of the Symposium regarding the Evolution of Clinical Hyperthermia plus Radiotherapy during the Twentieth Congress of the French Society of Radiation Oncology (SFRO) are presented. Conclusions Hyperthermia is an important treatment modality in cancer treatment and its results are strongly supported by criteria of evidence-based medicine. Fifteen years of experience of the Radiation Oncology Department in Verona confirms the positive results obtained with international prospective trials, with level 1 evidence. Hyperthermia appears to be the fourth pillar beside surgery, radiotherapy and chemotherapy. Free full text available at www.tumorionline.it

To evaluate the safety of delivering pre-operative regional hyperthermia (HT) plus an intensified chemo-radiotherapy (CRT) regimen in patients suffering from locally advanced rectal cancer.Between June 2000 and April 2006, 76 patients with locally advanced (cT3-4 N0/+) rectal adenocarcinoma were treated with HT plus CRT. HT was given once a week, to a total of five treatments, 1 to 4 h after radiotherapy (50 Gy with 2-Gy fractions for 5 weeks, plus a 10-Gy boost on the tumour bed, with the same fractionation schedule). Chemotherapy consisted in 5FU 200 mg/m(2) continuous infusion throughout the 6 weeks of irradiation and OXA 45 mg/m(2) in a weekly bolus. Surgery followed 4 to 6 weeks after the completion of HT plus CRT.HT plus CRT was generally well tolerated. At pathologic examination, there was a pathologic complete response (pCR) (ypT0 ypN0) in 18 out of 76 patients (23.6%), a partial response (PR) in 34/76 ones (44.7%) and a stable disease (SD) in 20/76 (26.3%) ones; 4/76 patients (5.2%) had a progression disease (PD) (distant metastases) at the time of surgery. Good predictors of a longer disease-free survival (DFS) were in order ypN status (log-rank test: p = 0.0008), ypT status (p = 0.002) and pCR (p = 0.03).Preoperative CRT combined with regional HT yielded acceptable toxicity. The rate of pCR was encouraging, although further studies are needed to prove the long-term efficacy of adding HT to CRT.

Purpose We performed a new phase II trial enrolling patients with newly diagnosed high-grade glioma (HGG) to test the efficacy of a weekly alternating temozolomide (TMZ) schedule after surgery and concomitant chemoradiotherapy. Methods From January 2005 to January 2007, 34 patients (21 men, 13 women; age range 30–70, mean age 53) were enrolled. There were 32 glioblastoma multiforme and two anaplastic astrocytoma. Each patient after surgery received standard concurrent chemoradiotherapy. After a 4-week break, patients were then to receive 12 cycles of 1-week-on/1-week-off TMZ, with 75 mg/m2 for the first cycle, 100 mg/m2 for the second, 125 mg/m2 for the third, and 150 mg/m2 from the fourth to the 12th. Hematological toxicity was monitored every week during concomitant chemoradiotherapy and then every 4 weeks. Results After 12 months from the end of radiotherapy, the overall survival (OS) rate was 59% (20/38), distributed as follows: 60% (18/30) for recursive partitioning analysis (RPA) class 4 patients and 33% (1/3) for RPA class 6 patients; the only RPA class 1 patient was alive and disease free at the time of writing. Median OS was 13 months [95% confidence interval (CI) 11.02–14.98 months]. Hematological toxicity was seen in six patients (18%): grade 1 neutropenia in four, grade 2 thrombocytopenia in one, and grade 4 thrombocytopenia plus grade 1 neutropenia in one. There was one case of opportunistic infection (Pneumocystis carinii pneumonitis). Conclusion The toxicity of the TMZ dose-dense regimen was very low. Results seem to be encouraging for RPA lower classes (patients with good prognostic factors).

Purpose: Hyperthermia has been used in several trials to treat pelvic cancers without excessive toxicity and with positive results. The aim of this study was to evaluate feasibility and results in terms of biochemical recurrence-free, disease-free survival, overall survival, and treatment toxicity profile of hyperthermia combined with radiotherapy in locally advanced high risk prostate cancer. Patients and methods: From November 1998 to December 2004, 144 patients with locally advanced prostate cancer (LAPC) were enrolled in a phase II study. They were treated using conformal radiotherapy (CRT) plus local hyperthermia (LHT) and androgen suppression therapy (AST). Treatment modalities consisted of: 1) CRT with a mean dose of 74 Gy (2 Gy/ fraction/5 fractions per week); 2) LHT: one session per week during the first, second, third, and fourth week of the radiotherapy course; 3) AST was administered as neo-adjuvant and adjuvant therapy in more than 60% of patients. Results: The median follow-up time was 51.7 months. Four patients were lost at follow-up. Of 140 evaluated patients, four died because of intercurrent diseases and 12 because of progression of disease. Patients were evaluated in terms of five-year overall survival (87%), and five-year biochemical progression-free survival (49%). No significant side effects, except symptoms related to AST have been reported. No late grade 3 toxicity occurred. Conclusions: In advanced high risk prostatic cancer, hyperthermia is feasible and well tolerated. It may be useful to enhance the radiotherapy efficacy at intermediate dose in order to avoid higher doses of irradiation which increases acute and late sequelae. The advantage of LHT combined with CRT should be confirmed by a randomized phase III trial, comparing irradiation plus AST with or without hyperthermia.

Background: Intraoperative radiotherapy during breast-conserving surgery is being studied as an alternative to 6 weeks of external beam radiotherapy (EBRT) for low-risk women; it can be delivered using electrons (intraoperative electron radiotherapy, IOERT) or 50-kV X-rays. Materials and Methods: We analyzed both single institutional and randomized studies involving single-fraction IOERT treatments. Rates for ipsilateral breast tumor recurrences, disease-specific survival, and overall survival were obtained. Results: IOERT had true 5-year recurrence rates of < 1.5% for ASTRO (American Society for Radiation Oncology) and ESTRO (European Society for Therapeutic Radiology and Oncology) suitable women, or for low-risk women as defined by the ELIOT trial. Women with ductal carcinoma in situ eligible for breast-conserving therapy, older women that currently receive no EBRT, and younger women with favorable biology are additional potential candidates. Conclusion: ASTRO suitable and ESTRO good women for accelerated partial breast irradiation are low-risk groups. Higher-risk women with favorable biology might also be suitable candidates for IOERT, providing the tumor biology can be determined prior to surgery. For intraoperative radiotherapy using 50-kV X-rays, follow-up was too short to assess the effectiveness of the treatment.

Although the evidence for the benefit of adding temozolomide (TMZ) to radiotherapy (RT) is limited to glioblastoma patients, there is currently a trend toward treating anaplastic astrocytomas (AAs) with combined RT + TMZ. The aim of the present study was to describe the patterns of care of patients affected by AA and, particularly, to compare the outcome of patients treated exclusively with RT with those treated with RT + TMZ. Data of 295 newly diagnosed AAs treated with postoperative RT ± TMZ in the period from 2002 to 2007 were reviewed. More than 75% of patients underwent a surgical removal. All the patients had postoperative RT; 86.1% of them were treated with 3D-conformal RT (3D-CRT). Sixty-seven percent of the entire group received postoperative chemotherapy with TMZ (n = 198). One-hundred sixty-six patients received both concomitant and sequential TMZ. Prescription of postoperative TMZ increased in the most recent period (2005-2007). One- and 4-year survival rates were 70.2% and 28.6%, respectively. No statistically significant improvement in survival was observed with the addition of TMZ to RT (P = .59). Multivariate analysis showed the statistical significance of age, presence of seizures, Recursive Partitioning Analysis classes I-III, extent of surgical removal, and 3D-CRT. Changes in the care of AA over the past years are documented. Currently there is not evidence to justify the addition of TMZ to postoperative RT for patients with newly diagnosed AA outside a clinical trial. Results of prospective and randomized trials are needed.

Meningiomas account for 16%-25% of all intracranial tumors, and quite often they rank amongst the most frequent neuro-oncological diagnostic subgroups in European or American registries (4, 5, 8, 54) As regards their natural history, (23, 29, 46, 55, 56, 59, 61) the few reported series of conservatively managed symptomatic meningiomas–bearing adequate FUhave documented a consistent progression in approximately one-third of patients, although in a wide spectrum of variability (TABLE 1).

We report a case of relapsed high-risk non-metastatic medulloblastoma in a 14-year-old boy, which was treated with intensity-modulated radiotherapy (IMRT) and temozolomide (TMZ). At the age of 11, the patient underwent an MRI-confirmed incomplete resection of a fourth-ventricle medulloblastoma, followed by conventional chemotherapy, craniospinal irradiation (55.8 Gy, 1.8 Gy/fraction) and then myeloablative chemotherapy followed by peripheral blood progenitor cell rescue. After 18 months of complete remission following the completion of chemotherapy, MRI showed a 2.5-cm mass in the olfactory notch. The patient underwent IMRT (45 Gy, 1.8 Gy/fraction) with concomitant administration of TMZ (180 mg/m2, 5 days every 21 days), which was well tolerated. After 5 cycles of TMZ, MRI showed complete remission with no evidence of the mass. TMZ was continued for another 5 cycles and then stopped. At 14 months from the completion of IMRT, a new MRI scan showed multiple nodular relapses around the fourth ventricle and the patient is currently treated with oral etoposide.

143 Background: We report the results of a single-institution phase II trial of accelerated partial breast irradiation (APBI) using a single dose of intraoperative electron radiotherapy (IOERT) in patients with low-risk early-stage breast cancer. Methods: From July 2006 to December 2009, 226 patients suitable for BCT were enrolled in a phase II trial with IOERT as radical treatment immediately after surgical resection. All patients had biopsy-proven cancer. After the surgeon temporarily re-approximated the excision cavity, a dose of 21 Gy using IOERT was delivered to the tumor bed with a margin of 2 cm laterally. Results: No acute reactions were reported after irradiation. Three patients experienced a transient edema. In 7 others a haematoma was observed. No cases of liponecrosis were observed. With a mean follow-up of 49 months (range 31-66 months), only one case of local recurrence has been reported. The observed toxicity was considered acceptable. As to cosmetic results, at 6 months after the end of IORT, 71/226 patients (31.4.%) had a score of 2 for symmetry and contour (asymmetry exhibited by 1/3 or less of volume breast), while 19/226 (8.4%) had a score 3 (asymmetry greater than 1/3 of breast volume). These findings remained unchanged at the following examinations. No breast oedema, discoloration at site or scar prominence were observed. Conclusions: IOERT offers the advantage of an excellent delineation of the tumor bed under visual control and high sparing of normal tissue, including the skin. IOERT delivers a very high biologically dose at the time of the surgery, when residual tumor cells are more rapidly proliferating. IOERT is insensitive to chemotherapy sequencing since all of the radiation is given during the surgery. The absolute recurrence rate of 0.4% and the recurrence rate per year of 0.2% of the present study are very encouraging. APBI using a single dose of IOERT can be delivered safely in women with early, low-risk breast cancer. A longer follow-up is needed to ascertain its efficacy compared to that of the current standard treatment of whole breast irradiation.

Intraoperative ultrasonography (I.US) has been introduced in order to overcome the limits of the preoperative imaging modalities (notably, ultrasonography and computed tomography), both in pancreatic cancer diagnosis and staging. The authors' experience encompasses 32 cases, selected according to the following criteria: lesions that could not be detected both preoperatively and at surgical exploration; lesions detected but not properly characterized, requiring differential diagnosis between cancer and pancreatitis; tumoral lesions with a perspective of radical surgery, in which the preoperative judgment of resectability had to be verified. In the only case of the first group, I.US allowed the identification of a small cancer in a jaundiced patient. In the 11 cases of the second group, I.US-guided fine-needle aspiration biopsy showed three cancers; however, among the other 8 lesions classified as pancreatitis there was one false negative diagnosis (a tumoral mass with liver metastases was demonstrated by computed tomography 6 mo later). Regarding the intraoperative staging of the proven cancers (20 cases of the third group; 4 cases of the first and second groups), I.US changed the planned surgical approach in 9 cases (showing vascular involvement or detecting liver metastases and enlarged lymph nodes not seen preoperatively); in 12 cases it confirmed the possibility of radical surgery. Finally, in the remaining 3 cases, I.US provided dubious information: only vascular dissection during surgery could achieve a correct evaluation, ruling out vascular involvement and thus allowing tumor resection.

1572 Background: The efficacy of temozolomide (TMZ) is strictly related to the possibility to reach and maintain high and prolonged cellular drug concentrations in the target tissue. Evidence exists demonstrating that the achievement of this goal and the subsequent activity of TMZ are categorically schedule dependent. Aim of the present randomized phase II study is to verify whether a treatment schedule with TMZ appropriately modified induces better response rates along with a decrease of mielotoxicity as compared to the conventional one. Methods: Twenty patients (5 F/15 M), median age of 53 years (range 35–74), median Karnofsky PS 90 (range 70–100), with GBM in progression after surgery and adjuvant RT have been treated as follows: Schedule A - TMZ for 5 days in a 28-day cycle, at the dose of 150 mg/m2/d at the first cycle and of 200 mg/m2/d thereafter, up to a total of 8 cycles. Schedule B - TMZ for 7 days alternating with 7 days of rest up to a total of 12 cycles: the starting dose of TMZ at the first cycle was 50 mg/m2/d with progressive serial dose escalations of 25 mg/m2/d in the subsequent ones until the achievement of the dose of 150 mg/m2/d at the 5th cycle, and then keeping this regimen until the 12th cycle. Results: They are summarized in the table : Severe thrombocytopenia and stomatitis have been observed only in patients treated with Schedule A. Conclusions: These preliminary results, which deserve to be confirmed in a larger sample size, indicate that the treatment with TMZ on alternate week basis is strongly interesting and promising. In spite of the modality and the small number of patients included in this study, which doesn’t allow a direct comparison between two different treatments, it should be noted that schedule B achieved a 2-year OS and PFS rate of 40% and 20% respectively, compared to 10% and 0% of schedule A. [Table: see text] No significant financial relationships to disclose.

Aims and background Our previous survey showed that the patterns of postoperative radiotherapy (PORT) for head and neck cancer (HNC) in Italy might be suboptimal. A prospective observational study was therefore designed to evaluate this issue in greater detail. Methods All radiotherapy centers involved in the HNC Working Group of the Italian Radiation Oncology Association were asked to enter into the study all patients treated with PORT during a 6-month period. Results A total of 200 patients were accrued by 24 centers from December 2008 to May 2009. Larynx (38%) and oral cavity (34%) were the most common primary sites. The median time between surgery and the start of radiotherapy was 69 days (range, 25–215 days). Seventy-nine percent of cases with no evidence of risk factors for local recurrence were treated with high-dose radiotherapy to the primary site. In about 75% of cases the pN0 neck was included in the target volume. Concomitant chemotherapy was delivered to about 60% of patients with major risk factors and 21% of patients with no risk factors. Conclusions Three issues emerged from our study as potential targets for future investigations: the impact on clinical outcome of the interval between surgery and the start of PORT; factors driving radiation oncologists to overtreat volumes at low risk of recurrence; and problems associated with the delivery of concomitant chemotherapy.