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.
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.
To evaluate the efficacy of combined radiation therapy and continuous infusion of 5-fluorouracil in patients with locally advanced carcinoma of the pancreas.
Between January 1992 and June 1999, 31 ...patients with locally advanced adenocarcinoma of the pancreas were treated in our Institute. In 20 patients, the tumor (65%) was located in the head of the pancreas and in 11 (35%) in the body or tail; 13 cases also showed involved nodes. Radiation therapy consisted in a median dose of 63 Gy in 33-36 fractions applied to the tumor and regional lymph nodes. Chemotherapy with 5-fluorouracil in continuous infusion, 250 mg/m2 daily, was administered in the first and fifth week of the radiation therapy. Thereafter, 22 patients received 3-10 cycles of adjuvant chemotherapy with same doses. Median follow-up of the series was 20 months. The toxicity of the treatment was scored according to WHO criteria. All patients underwent nutritional assessment at the time of radiochemotherapy.
The median overall survival was 15.2 months (range, 4-42). At restaging, 17 cases (55%) showed no change and 14 (45%) a partial remission. At the end of radiochemotherapy in 8 (26%) of the cases there was indication for pancreatectomy, which was executed in 4 patients. At the time of the study, 2 patients (6.4%) were surgically proven disease free. Eleven of the 13 cases (85%) presenting involved nodes showed that the enlarged lymph nodes had disappeared. Nineteen patients (61%) are alive with clinical evidence of disease anti 2 cases are alive with liver metastases; 8 patients (26%) died for disease. In 74% of cases there was complete pain control. Tolerance to the regimen was good. Nutritional assistance was evaluated and was found to be correlated to survival.
The results of the series confirm a good tolerance with low acute toxicity. Tumor down-staging and resectability rates were high, together with prolonged survival and a good quality of life.
Our objective was to determine and compare effects of sequential temozolomide vs. concomitant plus sequential temozolomide with conventional radiotherapy, in patients with newly diagnosed ...glioblastoma multiforme, comparing two independent trials. Sixty-four patients were treated on two consecutive separate phase II studies that used identical eligibility criteria and the same radiotherapy (60 Gy, 2 Gy/day, after surgery) and adjuvant temozolomide (200 mg/m/day for 5 days/28 days until progression), but differed in the absence or presence of a concomitant treatment with temozolomide (75 mg/m/day) during radiotherapy. In the first protocol (1999–2002), 21 patients (median age of 64 years) received radiotherapy alone and sequential temozolomide; in the succeeding protocol (2002–2004), 43 patients (median age of 61 years) with similar characteristics received radiotherapy with concomitant and sequential temozolomide. Median number of adjuvant cycles was five in both trials. Median survival was similar in both studies (18 vs. 17.4 months); overall survival rates at 6, 12, 18 and 24 months of all the population were 89, 69, 45 and 24%. No statistically significant differences were found among prognostic factors considered. Hematologic toxicities were mild and similar, with grade 3–4 neutropenia in 5–7% and grade 3–4 thrombocytopenia in 7–10% of patients in the sequential phases, and grade 3–4 thrombocytopenia in 7% in the concomitant phase of temozolomide. We confirmed that temozolomide combined with radiotherapy is well tolerated and provides a survival advantage compared with historical data using radiotherapy alone. Nevertheless, a concomitant use of temozolomide during radiotherapy does not seem to improve survival, although it does not increase toxicity.
To evaluate the efficacy of hypofractionated radiotherapy (HyRT) with or without image guided radiotherapy (IGRT) in intermediate risk prostate cancer.
105 patients were treated with HyRT, 43,8 Gy ...and 54,75 Gy were delivered to the seminal vescicles and to the prostate, respectively; 3,65 Gy/fraction three times weekly. All patients underwent 9 months hormonal therapy. Patient position was verified with daily kV cone beam CT in 69 patients (IGRT group). Acute and late toxicities were evaluated according to RTOG scale. Biochemical relapse was defined using PSA nadir + 2 ng/mL. The data were prospectively collected and retrospectively analyzed to evaluate the efficacy of IGRT.
After a median follow-up of 31 months the actuarial 3-year bNED was 93,7%. During RT, 10.5% and 7.6% of patients developed ≥Grade 2 rectal and urinary toxicities, respectively. The cumulative incidence of ≥Grade 2 late rectal and urinary toxicities at 3 years were 6,9%, and 10,8%, respectively. The incidence of ≥Grade 2 late rectal toxicities was significant reduced in the IGRT group (1,6% vs. 14,5%, p=0,021). Two patients developed Grade 3 urethral obstruction and one patient developed grade 3 rectal bleeding.
HyRT represents a well-tolerated treatment able to achieve a high bNED. The use of daily IGRT is beneficial for reducing the incidence of late toxicities.
A prospective clinical study to determine efficacy and feasibility of a brief course or standard course of anthracycline-based chemotherapy and consolidation radiation therapy in non-Hodgkin's ...lymphoma patients over 60 years of age.
Twenty-five consecutive patients with stage I-IE intermediate to high-grade non-Hodgkin's lymphoma aged 60 and older were treated in an outpatient setting in the Radiotherapy Oncology and Hematology units. All patients had a performance status of 0-1 according to WHO criteria. The survival end points, ie, overall survival, disease-free survival and event-free survival, were considered. Lactate dehydrogenase value, nodal versus extranodal localization and dose intensity were assessed as risk factors for disease-free and overall survival. A comparison using logrank analysis with a well-matched group of stage I-IE non-Hodgkin's lymphoma patients aged less than 60 years was performed.
The 5-year overall and disease-free survival rates were 90% and 86%, respectively. There was no statistical difference with respect to the younger population regarding these survival end points. Finally, the 5-year event-free survival was 85% and 86% for elderly and younger patients, respectively, without statistical difference (P = 0.41). Neither acute nor late toxicity (G3-G4) was observed during chemotherapy and radiotherapy treatment and the follow-up in the elderly group.
We confirm the efficacy and feasibility of a full-dose combined chemoradiotherapy in elderly patients with a good performance status with localized I-IE intermediate to high-grade non-Hodgkin's lymphoma.
To evaluate efficacy and toxicity of hypofractionated intensity-modulated simultaneous integrated boost (IMRT-SIB) and image-guided (IGRT) radiotherapy in the treatment of high-risk prostate cancer ...patients.
Eighty-two patients with high-risk prostate cancer were analysed. An IMRT treatment was planned delivering 68.75 Gy to the prostate, 55 Gy to the seminal vesicles and positive nodes and 45 Gy to the pelvis in 25 fractions. The first 59 patients received 4 weekly fractions whereas the last 23 patients received 5 weekly fractions. All patients were submitted to hormonal therapy.
The median follow-up was 31 months. Acute grade 1-2 gastrointestinal (GI) toxicity rates were 13.4%. Grade 1-2 and grade 3 genitourinary (GU) toxicity rates were 22% and 1.2%, respectively.Grade 1 and 2 GI late toxicity rates were 1.2%. No grade ≥3 toxicity was recorded. Grade 1 GU late toxicity rate was 2.4%. No grade ≥2 toxicity was recorded.No significant difference was calculated in terms of acute and late toxicity between the group treated 4 or 5 times weekly.The actuarial 3-years Overall survival and Freedom from biochemical failure were 98.6% and 91.3%, respectively.
The present study demonstrated that hypofractionated IGRT-IMRT-SIB in patients with high-risk prostate cancer is efficient with acceptable toxicity profile. Outcome in terms of survival are promising, but longer follow-up is needed.
To analyze the tumor control, survival outcomes, and toxicity after stereotactic radiosurgery (SRS) for skull base metastases from systemic cancer involving the anterior visual pathway.
We have ...analyzed 34 patients (23 females and 11 males, median age 59 years) who underwent multi-fraction SRS for a skull base metastasis compressing or in close proximity of optic nerves and chiasm. All metastases were treated with frameless LINAC-based multi-fraction SRS in 5 daily fractions of 5 Gy each. Local control, distant failure, and overall survival were estimated using the Kaplan-Meier method calculated from the time of SRS. Prognostic variables were assessed using log-rank and Cox regression analyses.
At a median follow-up of 13 months (range, 2-36.5 months), twenty-five patients had died and 9 were alive. The 1-year and 2-year local control rates were 89% and 72%, and respective actuarial survival rates were 63% and 30%. Four patients recurred with a median time to progression of 12 months (range, 6-27 months), and 17 patients had new brain metastases at distant brain sites. The 1-year and 2-year distant failure rates were 50% and 77%, respectively. On multivariate analysis, a Karnofsky performance status (KPS) >70 and the absence of extracranial metastases were prognostic factors associated with lower distant failure rates and longer survival. After multi-fraction SRS, 15 (51%) out of 29 patients had a clinical improvement of their preexisting cranial deficits. No patients developed radiation-induced optic neuropathy during the follow-up.
Multi-fraction SRS (5 x 5 Gy) is a safe treatment option associated with good local control and improved cranial nerve symptoms for patients with a skull base metastasis involving the anterior visual pathway.
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