We sought to evaluate the efficacy and safety data of a combination regimen using weekly irinotecan in combination with capecitabine and concurrent radiotherapy (CapIri-RT) as neoadjuvant treatment ...in rectal cancer in a phase-II trial. Patients with rectal cancer clinical stages T3/4 Nx or N+ were recruited to receive irinotecan (50 mg m(-2) weekly) and capecitabine (500 mg m(-2) bid days 1-38) with a concurrent RT dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the completion of chemoradiation. A total of 36 patients (median age 62 years; m/f: 27:9) including three patients with local recurrence were enclosed onto the trial. The median distance of the tumour from the anal verge was 5 cm. The main toxicity observed was (NCI-CTC grades 1/2/3/4 (n)): Anaemia 23/9/-/-; leucocytopenia 12/7/7/2, diarrhoea 13/15/4/-, nausea/vomiting 9/10/2/-, and increased activity of transaminases 3/3/1/-. One patient had a reversible episode of ventricular fibrillation during chemoradiation, most probably caused by capecitabine. The relative dose intensity was (median/mean (%)): irinotecan 95/91, capecitabine 100/92). Thirty-four patients underwent surgery (anterior resection n=25; abdomino-perineal resection n=6; Hartmann's procedure n=3). R0-resection was accomplished in all patients. Two patients died in the postoperative course from septic complications. Pathological complete remission was observed in five out of 34 resected patients (15%), and nine patients showed microfoci of residual tumour (26%). After a median follow-up of 28 months one patient had developed a local recurrence, and five patients distant metastases. Three-year overall survival for all patients with surgery (excluding three patients treated for local relapse or with primary metastatic disease) was 80%. In summary, preoperative chemoradiation with CapIri-RT exhibits promising efficacy whereas showing managable toxicity. The local recurrence and distant failure rates observed after a median 28 months are low compared with standard 5-fluorouracil based therapy.
Besides surgery, radiotherapy plays its well-established part in the multimodality treatment of soft-tissue sarcomas. It can be delivered before or after surgery with similar control rates. Adjuvant ...radiotherapy increases the local control rates as well as the overall survival in intermediate or high-grade soft-tissue sarcomas. Due to the complex and sophisticated nature of the treatment, patients should be referred to specialised centres where modern radiotherapeutic options like intensity modulated radiotherapy and image-guided radiotherapy can be offered.
Abstract The purpose of the study was to assess whether postoperative changes in the tumour bed after intraoperative radiotherapy (IORT) with low-energy X-rays complicate the mammographic evaluation. ...54 patients receiving breast-conserving surgery and IORT were compared to a control group of 48 patients with conventional breast-conserving treatment. All patients were included in routine follow-ups (≥3 years) with mammography accompanied by ultrasound. By retrospective consensus reading the mammographic changes in the tumour bed were classified as absent, low or distinct. Using the same grading it was classified whether mammographic evaluation was complicated due to postoperative changes. Focusing the yearly follow-ups within a period of four years, distinct changes were found significantly more often after IORT (52–62% vs. 7–30%). After IORT the evaluation was significantly more often distinctly complicated in each follow-up, except for year 1 (16–21% vs. 0–8%). In the IORT group the distribution of findings was nearly stable over time. In the control group it changed over time and a distinctly complicated evaluation was no longer seen in the follow-ups of years 3 and 4. Overall, further non-routine diagnostic procedures due to unclear findings in the tumour bed became necessary in 7% (IORT) vs. 8% (control group) of the patients ( p = 0.86). Evaluation of mammograms is complicated after IORT. In contrast to conventionally treated patients postoperative changes and difficulties of evaluation do not decrease over time. Overall, after IORT the diagnostic uncertainty does not seem to be increased in ultrasound supported mammographic follow-ups. The topic needs further evaluation with larger study samples.
The aim of this study was to evaluate mammographic and sonographic changes at the surgical site within the first 2 years after IORT as a boost followed by whole-breast radiotherapy (WBRT), compared ...with a control group treated with WBRT alone. All patients had breast-conserving surgery for early-stage breast cancer. Group A: n = 27, IORT (20 Gy) followed by WBRT (46 Gy). Group B (control group): n = 27, WBRT alone (56-66 Gy). Mammography: fat necrosis in 14 group A versus four group B patients (P < 0.001); parenchymal scarring classified as unorganized at the last follow-up in 16 vs seven cases, respectively (P = 0.03). Ultrasound: overall number of patients with circumscribed findings 27 vs 18 (P < 0.001); particular hematomas/seromas in 26 vs 13 patients (P < 0.001). Synopsis of mammography and ultrasound: overall postoperative changes were significantly higher classified in group A (P = 0.01), but not judged to have a significantly higher impact on interpretation. Additional diagnostic procedures, due to unclear findings at the surgical site, were performed on four patients of both groups. Within the first 2 years after IORT as a boost, therapy-induced changes at the original tumor site are significantly more pronounced compared with a control group. There is no evidence that the interpretation of findings is complicated after IORT.
Abstract The purpose of this study was to assess mammographic and sonographic findings in a long-term follow-up (≥3 years) after breast-conserving surgery (BCS) and IORT, either applied as boost or ...exclusively. Follow-up-findings of 54 patients were retrospectively evaluated and compared to a control group of 48 patients, treated with BCS and whole-breast radiotherapy. After IORT patients had a higher incidence of fat necroses manifesting as oil cysts in the late follow-up mammograms ( n = 31 vs n = 8); furthermore, oil cysts were larger in the IORT group (median 4.5 vs 1.4 cm2 ). In 25 IORT patients the oil cysts arose from partially organized hematomas/seromas, which in this group were generally more frequent ( n = 38 vs n = 9) and larger (median 3.6 vs 1.8 cm2 ). After IORT a decreasing incidence of hematomas/seromas was reciprocal to an increasing incidence of oil cysts, and the size of both entities correlated with each other. Liquid lesions with polypoid inner wall thickening on ultrasound, attributed to organized hematomas/seromas or fat necroses, appear more frequently after IORT ( n = 15 vs n = 1). In conclusion, IORT is associated with a high incidence of large oil cysts, which arise from likewise large partially organized wound cavities. On ultrasound pronounced partial organization with polypoid inner wall thickening is a frequent finding in those cavities.
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