RESUMEN
Purpose: Bulky tumor remains as a challenge to surgery, chemotherapy and conventional radiation therapy. Hence, in efforts to overcome this challenge, we designed a novel therapeutic paradigm via strategy of Stereotactic Central/Core Ablative Radiation Therapy (SCART).), which is based on the principles of SBRT (stereotactic body radiation therapy and spatially fractionated radiation therapy (SFRT). We intend to safely deliver an ablative dose to the core of the tumor and with a low dose at tumor edge. The purpose of the phase 1 study was to determine dose-limiting toxicities (DLT)s and the Maximum Tolerated Dose (MTD) of SCART. Methods and materials: We defined a SCART-plan volume inside the tumor, which is proportional to the dimension of tumor. VMAT/Cyberknife technique was adopted. In the current clinical trial; Patients with biopsy proven recurrent or metastatic bulky cancers were enrolled. The five dose levels were 15 Gy X1, 15Gy X3, 18GyX3, 21GyX3 and 24GyX3, while keeping the whole tumor GTV's border dose at 5Gy each fraction. There was no restriction on concurrent systemic chemotherapy agents. Results: 21 patients were enrolled and underwent SCART. All 21 patients have eligible data for study follow-up. Radiotherapy was well tolerated with all treatment completed as scheduled. The dose was escalated for two patients to 24GyX3. No grade 3 or higher toxicity was observed in any of the enrolled patients. The average age of patients was 66 years (range: 14-85) and 13 (62%) patients were male. The median SCART dose was 18Gy (range: 15 - 24). Six out of the 18 patients with data for overall survival (OS) died, and the median time to death was 16.3 months (range: 1 - 25.6). The mean percent change for tumor shrinkage between first visit volumes and post-SCART volumes was 49.5% (SD: 40.89, p-value:0.009). Conclusion: SCART was safely escalated to 24 GyX 3 fractions, which is the maximum Tolerated Dose (MTD) for SCART. This regimen will be used in future phase II trials.
RESUMEN
Currently, there are no specific recommendations regarding the management of the synchronous tumours due to the lack of either specific guidelines or individuals' clinical experiences relative to these clinical situations. In the presence of a locally advanced double primary tumour and with the lymph node metastases in addition, from the radiotherapeutical point of view, it must be challenging to manage this complicated situation that requires a more delicate treatment planning, due to higher doses prescribed to greater volumes concomitantly with the chemotherapy. A 68-year-old Caucasian male with a synchronous intermediate-risk prostate adenocarcinoma and locally advanced anal canal carcinoma underwent IMRT-SIB with concomitant chemotherapy at our institute. Two years after the treatment, the restaging CT and MRI scan showed no evidence of the disease and the patient reported no significant gastrointestinal or genitourinary toxicity. Our experience is unique, since it is the first report on using the IMRT-SIB technique simultaneously with chemotherapy in the management of the synchronous prostate and anal canal carcinomas. Therefore, we find it important to provide the current literature with the results from our experience which show good feasibility, efficacy, and tolerability of the definitive concomitant IMRT-SIB-chemotherapy for the synchronous anal canal cancer and prostate cancer.
