A multicenter LArge retrospectIve daTabase on the personalization of stereotactic ABlative radiotherapy use in lung metastases from colon-rectal cancer: The LaIT-SABR study.

INTRODUCTION: Stereotactic ablative radiotherapy (SABR) has been shown to increase survival in oligometastatic disease, but local control of colorectal metastases remains poor. We aimed to identify potential predictive factors of SBRT response through a multicenter large retrospective database and to investigate the progression to the polymetastatic disease (PMD). MATERIAL AND METHODS: The study involved 23 centers, and was approved by the Ethical Committee (Prot. Negrar 2019-ZT). 1033 lung metastases were reported. Clinical and biological parameters were evaluated as predictive for freedom from local progression-free survival (FLP). Secondary end-point was the time to the polymetastatic conversion (tPMC). RESULTS: Two-year FLP was 75.4%. Two-year FLP for lesions treated with a BED < 00 Gy, 100-124 Gy, and ≥125 Gy was 76.1%, 70.6%, and 94% (p = 0.000). Two-year FLP for lesion measuring ≤10 mm, 10-20 mm, and >20 mm was 79.7%, 77.1%, and 66.6% (p = 0.027). At the multivariate analysis a BED ≥125 Gy significantly reduced the risk of local progression (HR 0.24, 95%CI 0.11-0.51; p = 0.000). Median tPMC was 26.8 months. Lesions treated with BED ≥125 Gy reported a significantly longer tPMC as compared to lower BED. The median tPMC for patients treated to 1, 2-3 or 4-5 simultaneous oligometastases was 28.5, 25.4, and 9.8 months (p = 0.035). CONCLUSION: The present is the largest series of lung colorectal metastases treated with SABR. The results support the use of SBRT in lung oligometastatic colorectal cancer patients as it might delay the transition to PMD or offer relatively long disease-free period in selected cases. Predictive factors were identified for treatment personalization.

A multi-institutional analysis of fractionated versus single-fraction stereotactic body radiotherapy (SBRT) in the treatment of primary lung tumors: a comparison between two antipodal fractionations

Objectives Stereotactic body radiotherapy (SBRT) is a consolidate treatment for inoperable early-stage lung tumors, usually delivered in single or multi-fraction regimens. We aimed to compare these two approaches in terms of local effectiveness, safety and survival. Materials and methods Patients affected by medically inoperable early-stage lung tumor were treated at two Institutions with two different schedules: 70 Gy in ten fractions (TF) (BED10: 119 Gy) or 30 Gy in single fraction (SF) (BED10: 120 Gy). Results 73 patients were treated with SBRT delivered with two biological equivalent schedules: SF (44) and TF (29). The median follow-up was 34 months (range 3–81 months). Three-year Overall survival (OS) was 57.9%, 3-year cancer-specific survival (CSS) was 77.2%, with no difference between treatment groups. Three-year progression-free survival (LPFS) was 88.9% and did not differs between SF and TF. Overall, four cases (5.4%) of acute grade ≥ 3 pneumonitis occurred. No differences in acute and late toxicity between the two groups were detected. Conclusion SF and TF seems to be equally safe and effective in the treatment of primary inoperable lung tumors especially for smaller lesion. The SF may be preferentially offered to reduce patient access to hospital with no negative impact on tumor control and survival (AU)

A multi-institutional analysis of fractionated versus single-fraction stereotactic body radiotherapy (SBRT) in the treatment of primary lung tumors: a comparison between two antipodal fractionations.

OBJECTIVES: Stereotactic body radiotherapy (SBRT) is a consolidate treatment for inoperable early-stage lung tumors, usually delivered in single or multi-fraction regimens. We aimed to compare these two approaches in terms of local effectiveness, safety and survival. MATERIALS AND METHODS: Patients affected by medically inoperable early-stage lung tumor were treated at two Institutions with two different schedules: 70 Gy in ten fractions (TF) (BED10: 119 Gy) or 30 Gy in single fraction (SF) (BED10: 120 Gy). RESULTS: 73 patients were treated with SBRT delivered with two biological equivalent schedules: SF (44) and TF (29). The median follow-up was 34 months (range 3-81 months). Three-year Overall survival (OS) was 57.9%, 3-year cancer-specific survival (CSS) was 77.2%, with no difference between treatment groups. Three-year progression-free survival (LPFS) was 88.9% and did not differs between SF and TF. Overall, four cases (5.4%) of acute grade ≥ 3 pneumonitis occurred. No differences in acute and late toxicity between the two groups were detected. CONCLUSION: SF and TF seems to be equally safe and effective in the treatment of primary inoperable lung tumors especially for smaller lesion. The SF may be preferentially offered to reduce patient access to hospital with no negative impact on tumor control and survival.

Markers of Cardiotoxicity in Early Breast Cancer Patients Treated With a Hypofractionated Schedule: A Prospective Study.

PURPOSE: To evaluate, in a series of early breast cancer (BC) patients treated with hypofractionated adjuvant radiotherapy (RT), whether N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I assay measurements can predict acute clinical or preclinical cardiotoxicity. PATIENTS AND METHODS: The study comprised 44 consecutive patients, who underwent conservative surgery with or without (neo)adjuvant chemotherapy and hypofractionated adjuvant RT. The RT schedule consisted in a total dose of 42.4 Gy in 16 fractions administered 5 days per week. Twenty-one patients received a subsequent boost to the tumor bed consisting of a total dose of 10 Gy in 4 fractions delivered via a direct electron field. All patients underwent 12-lead electrocardiogram, echocardiogram, and cardiac clinical examinations before RT to assess cardiovascular risk factors; these examinations were repeated yearly for 5 consecutive years. High-sensitivity cardiac troponin I and NT-proBNP were analyzed from serum samples at baseline, after delivery of the fourth and 16th RT fractions, and 12 months after treatment completion. RESULTS: No increase in cardiac troponin I and B-type natriuretic peptide levels related to left breast irradiation was observed. No statistical difference in NT-proBNP and high-sensitivity troponin I levels between left- and right-sided BC was found. An increase was observed of B-type natriuretic peptide levels at baseline, during treatment, and until 12 months after RT related to hypertension, with the P value near to the .05 threshold for age and chemotherapy. CONCLUSION: Conformational hypofractionated RT in left-sided BC may not cause acute myocardial damage. Early cardiac screening may be used to identify patients with cardiologic risk factors, patients who are older than 60 years, and patients who received chemotherapy that could result in clinically relevant cardiac pathologies.

Local and metastatic curative radiotherapy in patients with de novo oligometastatic prostate cancer.

The aim of this observational study is to investigate whether local consolidative treatment delivered to the primary site and metastatic tumour burden may add survival benefit to de novo oligometastatic prostate cancer (Oligo-PCa) patients. We retrospectively reviewed all Oligo-PCa patients treated with radiotherapy to the primary tumor sites and metastatic tumor burden at our institution between March 2010 and June 2019. All patients having ≤ 5 metastases involving nodes and/or bones, loco-regional and/or extra-pelvic sites, were included. Most of the patients had started androgen deprivation therapy with or without docetaxel as standard of care before radiotherapy. The Kaplan Meier analysis was performed to estimate survival outcomes. The univariate analysis tested possible prognostic factors increasing the rate of biochemical relapse. We analysed 37 Oligo-PCa patients. Twenty-eight (75.7%) had loco-regional metastases, in 9 patients (24.3%) the metastatic tumour burden was extra-pelvic. Nineteen (51.4%) had bone metastases, 21 (56.8%) nodal involvement and 7 (18.9%) both. Twenty (54.1%) had a single metastasis. The median follow-up was 55.5 months. The median overall survival (OS) was 68.8 months, the 2- and 5-year OS rates were 96.9% and 65.4%. The median biochemical relapse free survival (b-RFS) was 58 months and the 2- and 5-year b-RFS rates were 73.3% and 39.3%. The 2- and 5-year local relapse free survival rates were 93.9% and 83.7%. On the univariate analysis post-treatment PSA level ≤ 1 ng/ml was significantly related with the b-RFS (p = 0.004). Curative approach in Oligo-PCa patients involving both the primary tumor and metastatic sites may be feasible and well tolerate. Many patients presented longer survival and PSA at first follow-up was the most important prognostic factor. Further trials are needed to confirm our results and to evaluate if patients with PSA at first follow-up > 1 ng/ml may benefit from further treatments.

Salvage radiotherapy with simultaneous integrated boost in non small-cell lung cancer patients with mediastinal relapse after surgery: a pilot study.

BACKGROUND: The aim of our study was to evaluate feasibility, toxicity profile and local control of salvage intensity modulated radiotherapy (IMRT) delivered with simultaneous integrated boost (SIB) associated or not to concomitant weekly cisplatin in patients affected by NSCLC with mediastinal nodal recurrence after surgery. Patterns of recurrence, outcomes and prognostic factors were assessed. METHODS: Fourteen consecutive patients received 25 fractions of 50Gy/2Gy to the elective nodal stations and boost up to 62.5Gy/2.5Gy to the macroscopic lymph node metastases. Concomitant weekly cisplatin (40 mg/m2) was administered to 8 (57.1%) patients. RESULTS: Five (35.7%) patients experienced grade 2 pneumonitis and 5 (35.7%) patients had grade 2 esophagitis. One case of grade 3 pneumonitis occurred and was successfully treated with antibiotics and steroids with no sequelae. No patient recurred locally in the boost volume (local control 100%). Loco-regional control was 79% with 3 patients that developed nodal recurrence principally marginal to the elective volume. Seven patients developed distant metastases. Median PFS was 7 months. The nodal involvement of station 7 was associated to a significantly lower median metastasis-free survival (4 months vs. not reached, p = 0.036). CONCLUSIONS: Salvage radiotherapy with IMRT-SIB is a feasible and a well-tolerated treatment option for mediastinal recurrent NSCLC after surgery. The role of more intensified radiation regimens and association to systemic therapy remain to be evaluated in larger cohorts.

30 Gy single dose stereotactic body radiation therapy (SBRT): Report on outcome in a large series of patients with lung oligometastatic disease.

OBJECTIVES: To evaluate the local control (LC) and long term adverse effects in a series of patients with lung metastases who received 30 Gy in single dose with stereotactic technique. MATERIALS AND METHODS: Between December 2008 and April 2016, a total of 166 lung metastases in 129 patients affected by oligometastatic disease were treated at our Institution with stereotactic body radiotherapy (SBRT). Mainly, the primary tumors were non small-cell lung cancer and colorectal cancer (45.2% and 28.8%, respectively). Prognostic factors were also assessed. RESULTS: The median follow-up was 38 months. Local progression occurred in 24 (14.4%) lesions in 21 patients. Intra-thoracic progression (new lung lesions or thoracic lymph node metastases) occurred in 59 (45.7%) patients. Forty-five (34.8%) patients had distant progression after a median time of 14 months. The 3- and 5-years local relapse-free survival (LPFS) were 80.1% and 79.2% (median not reached), respectively. One-hundred forty-eight patients were evaluated for late toxicity (follow-up >6 months): 51 (34.4%) patients had grade ≤2 fibrosis, 11 (7.4%) patients experienced grade 3 fibrosis. Two (1.3%) cases of rib fracture occurred. One case of toxic death (grade 5) has been reported. Median OS was 39 months. At the univariate analysis, lesion diameter ≤18 mm correlated significantly with a longer LPFS (p = 0.001). At the multivariate analysis, lesion diameter <18 mm was predictive for longer LPFS (p = 0.006). Also, oligometastases from primary colorectal cancer was a significant predictive factor for worse LPFS (p = 0.041) and progression-free survival (p = 0.04). CONCLUSIONS: To our knowledge, the current study represents the largest series on the use of SBRT 30 Gy single dose for lung metastases. Our results confirm the effectiveness and safety of this schedule administered in selected oligometastatic patients. Further prospective series could better validate these results.

Clinical and technical characteristics of intraoperative radiotherapy. Analysis of the ISIORT-Europe database.

BACKGROUND: A joint analysis of clinical data from centres within the European section of the International Society of Intraoperative Radiation Therapy (ISIORT-Europe) was undertaken in order to define the range of intraoperative radiotherapy (IORT) techniques and indications encompassed by its member institutions. MATERIALS AND METHODS: In 2007, the ISIORT-Europe centres were invited to record demographic, clinical and technical data relating to their IORT procedures in a joint online database. Retrospective data entry was possible. RESULTS: The survey encompassed 21 centres and data from 3754 IORT procedures performed between 1992 and 2011. The average annual number of patients treated per institution was 42, with three centres treating more than 100 patients per year. The most frequent tumour was breast cancer with 2395 cases (63.8 %), followed by rectal cancer (598 cases, 15.9 %), sarcoma (221 cases, 5.9 %), prostate cancer (108 cases, 2.9 %) and pancreatic cancer (80 cases, 2.1 %). Clinical details and IORT technical data from these five tumour types are reported. CONCLUSION: This is the first report on a large cohort of patients treated with IORT in Europe. It gives a picture of patient selection methods and treatment modalities, with emphasis on the main tumour types that are typically treated by this technique and may benefit from it.

The importance of lymph node retrieval and lymph node ratio following preoperative chemoradiation of rectal cancer.

AIM: Preoperative chemoradiation (CRT) for rectal cancer decreases the number of examined lymph nodes (NELN) found in the resected specimen. However, the prognostic role of lymph node evaluation including overall numbers and the lymph node ratio (LNR) in patients having preoperative CRT have not yet been defined. The study has assessed the influence of CRT on the NELN and on lymph node number and LNR on the survival of patients with rectal cancer. METHOD: Between 2003 and 2011, 508 patients with nonmetastatic rectal cancer underwent mesorectal excision. Of these 123 (24.2%) received preoperative CRT. Univariate and multivariate analysis was performed to define the role of NELN and LNR as prognostic indicators of survival. RESULTS: Neoadjuvant CRT significantly reduced the NELN (P < 0.0001). Disease-free survival (DFS) and overall survival (OS) of patients with fewer or more than 12 nodes retrieved did not differ statistically. Node-negative patients with six or fewer lymph nodes were significantly associated with a poor DFS and OS on univariate analysis (P = 0.03 and P = 0.03). LNR significantly influenced the DFS and OS on multivariate analysis [DFS, P = 0.0473, hazard ratio (HR) 2.4980, 95% confidence interval (CI) 1.2631-9.4097; OS, P = 0.0419, HR 1.1820, 95% CI 1.1812-10,710]. CONCLUSION: The cut-off of 12 lymph nodes does not influence survival and should not be considered for cancer-specific prediction of patients having neoadjuvant CRT. In contrast LNR is an independent prognostic predictor of DFS and OS in such patients.

External-beam radiotherapy and/or HDR brachytherapy in postoperative endometrial cancer patients: clinical outcomes and toxicity rates.

PURPOSE: The objectives of this study were to evaluate local disease control, overall survival (OS), disease-free survival (DFS) and local relapse-free survival (LRFS) in patients with endometrial cancer undergoing adjuvant vaginal brachytherapy (VBT )± external-beam radiotherapy (EBRT). MATERIALS AND METHODS: From September 2007 to February 2011, 40 patients with endometrial cancer were retrospectively analysed. Surgery consisted of total hysterectomy and bilateral salpingo-oophorectomy without node dissection (16 patients) or with bilateral pelvic node dissection (24 patients). The stage distribution was as follows: two IA, nine IB, 12 IC, five IIA, eight IIB, two IIIA and two IIIC. Thirty-four patients underwent EBRT and VBT. Six patients received VBT alone. RESULTS: Median follow-up was 26 months. The 5-year OS and DFS were 96.4% and 86.9%, respectively. No local recurrence was observed. Four patients presented distant disease (three had lung metastases and one had hepatic node metastases). Acute EBRT-related toxicities were seen in 15 (38%) patients. We recorded late toxicities in 14 patients (35%). There was no evidence of grade 3-4 toxicity. CONCLUSIONS: Adjuvant EBRT and/or VBT in patients with endometrial cancer showed good outcomes in terms of local disease control, with an acceptable toxicity profile.

[Curative radiotherapy in patients with anal cancer: clinical outcomes and prognostic factors in a single-institution experience]. / Risultati clinici e fattori prognostici dopo radioterapia curativa nei pazienti con cancro anale: l'esperienza di una singola istituzione.

PURPOSE: Our aim was to retrospectively analyse a series of patients with anal cancer treated with curative intent at a single institute in terms of survival and local disease control. MATERIALS AND METHODS: Forty-two patients with anal cancer were treated with primary radiotherapy with or without concurrent chemotherapy. The influence of the prognostic factors on overall (OS), disease-free (DFS), disease-specific (DSS), colostomy-free (CFS) and metastasis-free (MFS) survival was evaluated. RESULTS: Nine patients had stage I, 15 stage II, four stage IIIA and 14 stage IIIB disease. Tumour progression/ persistence occurred in five patients (12%). The 5-year OS, DSS, DFS, CFS and MFS were 72.7%, 84.2%, 85.7%, 81.1% and 87.1%, respectively. On univariate analysis, T stage emerged as highly significant for OS, DSS, CFS and DFS, whereas N status was a significant prognostic factor for DSS. On multivariate analysis, T stage was a significant prognostic factor for OS and CFS. CONCLUSIONS: Our data support the view that combined chemoradiation treatment of anal cancer is feasible and may provide survival benefits with an acceptable rate of adverse effects. We should consider T and N stages as important prognostic factors for survival.

Acute toxicity in 14 patients with locally advanced head and neck squamous cell carcinoma treated with concurrent cetuximab and radiotherapy.

PURPOSE: The authors report acute toxicity in 14 patients with locally advanced head and neck squamous cell carcinoma treated with radiotherapy and cetuximab. MATERIALS AND METHODS: Data collection was performed prospectively on patients treated from September 2007 to March 2009. Treatment consisted of 64.8-70 Gy radiotherapy in conventional fractions and cetuximab. RESULTS: Two out of 14 patients did not complete the planned combined treatment; radiotherapy was temporarily suspended in six other patients. Seven of 12 patients received cetuximab until the end of radiotherapy. Treatment breaks were principally due to severe acute cutaneous or mucous toxicity. Any grade acneiform rash occurred in all patients. In-field G3-4 cutaneous toxicity occurred in five (36%) patients and G3-4 mucous toxicity in seven (50%). One patient died of sepsis. CONCLUSIONS: In our experience, severe acute toxic reactions are common in patients treated with radiotherapy and concurrent cetuximab, resulting in frequent breaks or incomplete treatment with potential reduction in disease control.

Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma.

The aim of this paper is to evaluate the efficacy of fractionated stereotactic radiotherapy (FSRT) and concomitant temozolomide (TMZ) as a salvage treatment option in patients with recurrent glioblastoma (GBM). Between May 2006 and December 2009, 36 patients with recurrent GBM received FSRT plus concomitant TMZ at University of Rome La Sapienza, Sant' Andrea Hospital. All patients had Karnofsky performance score ≥60 and were previously treated with standard conformal radiotherapy (RT) (60 Gy) with concomitant and adjuvant TMZ for 6-12 cycles. The median time interval between primary RT and reirradiation was 14 months. At the time of recurrence, all patients received FSRT plus concomitant daily TMZ at the dose of 75 mg/m(2), given 7 days per week from the first day of RT. Radiation dose was 37.5 Gy delivered in 15 fractions over 3 weeks. Median overall survival after FSRT was 9.7 months, and the 6- and 12-month survival rates were 84 and 33%, respectively. The median progression-free survival (PFS) was 5 months, and 6- and 12-month PFS rates were 42 and 8%, respectively. In univariate analysis, KPS (P = 0.04), the interval between primary RT and reirradiation (P = 0.02), and O6-methylguanine-DNA-methyltransferase (MGMT) methylation status at the time of diagnosis (P = 0.009) had an effect on survival; however, in multivariate analysis, only MGMT methylation was statistically significant (P = 0.03). In general, FSRT was well tolerated and the treatment was completed in all patients. Neurological deterioration due to radiation-induced necrosis occurred in three patients (8%). FSRT plus concomitant TMZ is a feasible treatment option associated with survival benefits and low risk of complications in selected patients with recurrent GBM. The potential advantages of combined chemoradiation schedules in patients with recurrent GBM need to be explored in future studies.

Stereotactic radiosurgery plus whole-brain radiotherapy for treatment of multiple metastases from non-small cell lung cancer.

BACKGROUND: The aim of this study was to evaluate local control and survival rates after stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) for the treatment of multiple brain metastases from non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Between June 2004 and September 2008, sixty-six patients with multiple brain metastases from NSCLC were enrolled in this prospective study. All patients were required to have 2-3 brain metastases and Karnofsky performance status (KPS) > or = 70. WBRT treatment dose was 30 Gy in 10 fractions followed by SRS. A matched control population treated with WBRT alone to a dose of 30 Gy in 10 fractions was used for comparison. RESULTS: The median survival was 10.3 months in the WBRT plus SRS group and 7.2 months in the WBRT group (p=0.005). The 6-month and 12-month survival rates were 90% and 38% in the SRS plus WBRT group and 84% and 19% in the WBRT group (p=0.01). Stable extracranial disease and KPS were significant predictive factors of survival in both groups (p=0.001). Death due to neurological causes occurred in 18% and 35% of patients treated with WBRT plus SRS and WBRT (p=0.02), respectively. Disease control in the brain was 10 months in the SRS plus WBRT group and 7 months in the WBRT group (p=0.001); the 6-month and 12-month control rates were 82% and 42% for WBRT plus SRS, and 75% and 18% for WBRT (p=0.001), respectively. The 6-month and 12-month control rates of treated lesions (local control) were 90% and 47% in the WBRT group, and 100% and 93% in the WBRT plus SRS group (p=0.001). CONCLUSION: WBRT plus SRS is a safe, minimally invasive and well-tolerated treatment for patients with up to three brain metastases from NSCLC. The treatment is associated with longer survival and better disease control in comparison with WBRT alone. Survival benefits need to be confirmed by large randomized studies.

Hypofractionated radiotherapy followed by adjuvant chemotherapy with temozolomide in elderly patients with glioblastoma.

OBJECTIVES: The optimal treatment for elderly patients (age >70 years) with glioblastoma (GBM) remains controversial. We conducted a prospective trial in 43 consecutive elderly patients with GBM treated with hypofractionated radiotherapy (RT) followed by adjuvant temozolomide. PATIENTS AND METHODS: Forty-three patients 70 years of age or older with a newly diagnosed GBM and a Karnofsky performance status (KPS) > or = 60 were treated with hypofractionated RT (6 fractions of 5 Gy each for a total of 30 Gy over 2 weeks) followed by up to 12 cycles of adjuvant temozolomide (150-200 mg/m(2) for 5 days during each 28 day cycle). The HRQOL was assessed with the EORTC Quality of Life Questionnaire C30. The primary endpoint was overall survival (OS). Secondary endpoints included progression free survival (PFS), toxicity and quality of life. RESULTS: The median OS was 9.3 months and the median PFS was 6.3 months. The 6 and 12 month survival rates were 86% and 35%, respectively. The 6 and 12 month PFS rates were 55% and 12%, respectively. In multivariate analysis KPS was the only significant independent predictive factor of survival (P = 0.008). Neurological deterioration occurred during or after RT in 16% of patients and was resolved in most cases with the use of steroids. Grade 3-4 hematologic toxicity occurred in 28% of patients during the adjuvant chemotherapy treatment with temozolomide. The treatment had no negative effect on HRQOL, however, fatigue (P = 0.02) and constipation (P = 0.01) scales worsened over time. CONCLUSIONS: Hypofractionated RT followed by temozolomide may provide survival benefit maintaining a good quality of life in elderly patients with GBM. It may represent a reasonable therapeutic approach especially in patients with less favourably prognostic factors.

Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma in elderly patients.

OBJECTIVES: The optimal treatment for elderly patients (age > 70 years) with glioblastoma remains controversial. We conducted a prospective trial in 32 consecutive elderly patients with glioblastoma who underwent surgery followed by radiotherapy (RT) plus concomitant and adjuvant temozolomide. PATIENTS AND METHODS: 32 patients 70 years of age or older with a newly diagnosed glioblastoma and a Karnofsky performance status (KPS) > or = 70 were treated with RT (daily fractions of 2 Gy for a total of 60 Gy) plus temozolomide at the dose of 75 mg/m(2) per day followed by six cycles of adjuvant temozolomide (150-200 mg/m(2) for 5 days during each 28-day cycle). The primary endpoint was overall survival (OS). Secondary endpoints included progression free survival (PFS) and toxicity. RESULTS: The median OS was 10.6 months and the median PFS was 7 months. The 6-month and 12-month survival rates were 91% and 37%, respectively. The 6-month and 12-month PFS rates were 56% and 16%, respectively. In multivariate analysis KPS was the only significant independent predictive factor of survival (P = 0.01). Adverse effects were mainly represented by neurotoxicity (40%), which resolved in most cases with the use of steroids, and Grade 3-4 hematologic toxicity in 28% of patients. Chemotherapy was stopped in 2 patients, delayed in 9 patients and reduced in 4 patients. CONCLUSIONS: Standard RT plus concomitant and adjuvant temozolomide is a feasible treatment for elderly patients with newly diagnosed glioblastoma who present with good prognostic factors.

Radiation therapy for oncological emergencies.

AIMS AND BACKGROUND: Radiation therapy holds a fundamental role in oncological emergencies such as superior vena cava syndrome, spinal cord compression and endocranial hypertension. The purpose of our study was, by comparing schedules of treatment, to confirm the efficacy of hypofractionated radiation therapy. METHODS: From January 1994 to December 1998, 43 patients with superior vena cava syndrome, 37 patients with metastatic spinal cord compression and 108 patients with endocranial hypertension secondary to metastasis were treated at our institution. In the group of patients with superior vena cava syndrome, radiotherapy schedules were: 4 Gy x 5 to a total dose of 20 Gy (23 patients) and 3 Gy x 10 to a total dose of 30 Gy (20 patients). In the group of patients with spinal cord compression, radiation schedules were: 3 Gy x 10 to a total dose of 30 Gy (15 patients); 4 Gy x 5 to a total dose of 20 Gy (12 patients); a single fraction of 8 Gy in 10 cases, repeated after 1 week in 7 responder cases to a total dose of 16 Gy. 5 out of 37 patients were underwent to laminectomy plus stabilization of the spine and post-operative radiotherapy. In the group of patients with endocranial hypertension, radiotherapy schedules were: 6 Gy x 2 to a total dose of 12 Gy (53 patients), repeated after 4 weeks in 34 responder patients and 3 Gy x 10 to a total dose of 30 Gy (55 patients). RESULTS: The patients with superior vena cava syndrome, revaluated after 4 weeks at the end of treatment, obtained a partial remission of symptomatology in 73.9% with 20 Gy and in 75% with 30 Gy. The patients with spinal cord compression obtained symptomatic relief in 73.3% with 30 Gy, in 66.6% with 20 Gy and in 70% of cases treated with 8 Gy. The patients with endocranial hypertension obtained symptomatic relief in 64.1% with 12 Gy and in 63.3% with 30 Gy. CONCLUSION: Histology, pretreatment and performance status were important prognostic factors for the response to therapy. Our results demonstrated no significant difference among different schedules of radiotherapy and confirmed the importance of radiotherapy for oncological emergencies: it improves the quality of life and, in responding patients, is associated with a longer survival time.

Prognostic features and treatment outcome in patients with nasopharyngeal carcinoma: an experience of 20 years.

BACKGROUND: The best treatment of Nasopharyngeal Carcinoma (NPC) is still an open question. The purpose of this retrospective study was to determine risk factors that affect locoregional control and treatment outcome of NPC patients after radiotherapy, with or without chemotherapy. METHODS: Between January 1976 and December 1996, 66 consecutive patients (stage I = 0; stage II = 13; stage III = 32; stage IV = 21) were given definitive radiotherapy at a single Institution. Concurrent or adjuvant chemotherapy was also given to 14 of them (21%). Multivariate analysis was performed to evaluate age, T stage, N stage, radiotherapy dose, histology, chemotherapy bone of skull erosions or cranial nerve palsies and base of skull involvement as prognostic factors of locoregional control and overall survival. RESULTS: By the end of January 2000, after a median follow-up of 66 months and a minimal follow-up of 36 months, the event-free overall survival rate of 5 years was 48% and the overall survival 54%. Risk factor analysis revealed that radiotherapy dose, age and stage were the most important factors for overall survival of these patients. The 5 year overall survival was 89% for stage II and 49% for stage III-IV (p = 0.004), 62% for dose higher than 60 Gy and 20% for dose below 60 Gy (p = 0.007), 62% for age below 65 years and 36% for age higher than 65 years (p = 0.027). The concurrent or adjuvant chemotherapy did not have prognostic significance. CONCLUSIONS: We confirm the need to determine the risk factors in patients with NPC. The choice of treatment, whether radiotherapy alone, at dose > 60 Gy, or radiotherapy plus chemotherapy, should be made after identification of patients with high risk disease, suitable for the combined modality.