scholarly journals Moderately Hypofractionated Intensity Modulated Radiation Therapy with Simultaneous Integrated Boost for Prostate Cancer: Five-Year Toxicity Results from a Prospective Phase I/II Trial

Author(s):  
Anthony Ricco ◽  
Nitai Mukhopadhyay ◽  
Xiaoyan Deng ◽  
Diane Holdford ◽  
Vicki Skinner ◽  
...  

Abstract Background In this phase I/II trial, five-year physician-assessed toxicity and patient reported quality of life data is reported for patients undergoing moderately hypofractionated intensity modulated radiation therapy (IMRT) for prostate cancer using a simultaneous integrated boost (SIB) and pelvic lymph node (LN) coverage. Materials and Methods Patients with T1-T2 localized prostate cancer were prospectively enrolled, receiving risk group based coverage of prostate +/- seminal vesicles (SVs) +/- pelvic lymph nodes (LNs). Low risk (LR) received 69.6 Gy/29 fractions to the prostate, while intermediate risk (IR) and high risk (HR) patients received 72Gy/30fx to the prostate and 54Gy/30fx to the SVs. If predicted risk of LN involvement > 15%, 50.4Gy/30fx was delivered to pelvic LNs. Androgen deprivation therapy was given to IR and HR patients. Results There were 55 patients enrolled and 49 patients evaluable at a median follow up of 60 months. Included were 11 (20%) LR, 23 (41.8%) IR, and 21 (38.2%) HR patients. Pelvic LN treatment was given in 25 patients (51%). Prevalence rates of late grade 2 GI toxicity at 1, 3, and 5 years was 5.8%, 3.9%, and 5.8% respectively, with no grade 3 events. Prevalence rates of late grade 2 GU toxicity at 1, 3, and 5 years rates were 15.4%, 7.7%, and 13.5% respectively, with three grade 3 events (5.8%). The biochemical relapse free survival at 5 years was 88.3%. There were no local, regional, or distant failures, with all patients still alive at last follow up. Conclusions Moderate hypofractionation of localized prostate cancer utilizing a SIB technique and LN coverage produces tolerable acute/late toxicity. Given equivalent efficacy between moderate hypofractionation schedules, the optimal regimen will be determined by long-term toxicity reported from both the physician and patient perspective.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 299-299
Author(s):  
Anthony Ricco ◽  
Nitai Mukhopadhyay ◽  
Diane Holdford ◽  
Vicki Skinner ◽  
Siddharth Saraiya ◽  
...  

299 Background: This study reports the 5 year toxicity and efficacy data of a phase I/II trial of moderately hypofractionated intensity modulated radiation therapy (IMRT) for localized prostate cancer utilizing a simultaneous integrated boost and pelvic lymph node (LN) coverage. Methods: Men with localized prostate cancer were prospectively enrolled and received IMRT to the prostate +/- seminal vesicles (SVs) +/- LNs based on National Comprehensive Cancer Network (NCCN) guidelines. Low-risk (LR) patients received 69.6 Gy in 29 fractions to the prostate alone; intermediate-risk (IR) and high-risk (HR) patients received 72Gy to the prostate, 54Gy to the SVs, and 50.4Gy to LNs (if risk of LN involvement > 15% by the Roach formula) all in 30 fractions. IR and HR patients received androgen deprivation therapy. Results: Fifty-five patients were enrolled and 49 patients evaluable with a median follow up of 60 months. There were 11 (20%) LR, 23 (41.8%) IR, and 21 (38.2%) HR patients. Twenty-five patients (51%) received prostate and LN treatment. At 5 years, the cumulative incidence of late grade 2+ gastrointestinal (GI) and genitourinary (GU) toxicity was 22.6% and 38.2% respectively. Prevalence rates of late grade 2 GI toxicity at 1, 3, and 5 years was 5.8%, 3.9%, and 5.8% respectively. Late grade 2+ GI toxicities that did not resolve by 60 months included 3 out of 52 patients (5.8%). Prevalence rates of late grade 2 GU toxicity at 1, 3, and 5 years rates were 15.4%, 7.7%, and 13.5% respectively. There were 3 patients (5.8%) who experienced grade 3 GU toxicity and no grade 3 GI toxicities. The biochemical relapse free survival at 5 years for the cohort was 88.3%. There were no local, regional, or distant failures, with all patients still alive at last follow up. Conclusions: Moderate hypofractionation of localized prostate cancer utilizing a simultaneous integrated boost and LN coverage produces excellent biochemical control and acceptable acute/late toxicity. This phase I/II trial adds to maturing data with 5 year outcomes which justify its use for cost and patient convenience factors. Clinical trial information: NCT01117935.


2020 ◽  
pp. 1639-1646
Author(s):  
Muhammad Atif Mansha ◽  
Tabinda Sadaf ◽  
Asmara Waheed ◽  
Amna Munawar ◽  
Asma Rashid ◽  
...  

PURPOSE To report the chronic toxicity and disease outcomes attributable to intensity-modulated radiation therapy (IMRT) in patients with cervical cancer. METHODS AND MATERIALS Between January 2014 and December 2018, a retrospective review of medical records of patients with cervical cancer who received radiation therapy with IMRT was performed. Disease and treatment-related details were documented. Follow-up notes were reviewed, and severity of late toxicities was recorded. Overall survival (OS) and disease-free survival (DFS) at 3 years were estimated. RESULTS A total of 222 patients’ records were reviewed. Mean age was 50.7 years. Median follow-up duration was 33 months (range, 2-70 months). The most common toxicity was vaginal stricture (grade 2, n = 59, 26.6%; grade 3, n = 4, 1.80%), followed by proctitis (grade 2, n = 24; 10.8%; grade 3, n = 7; 3.20%). Seven patients (grade 2, n = 5, 2.3%; grade 3, n = 2; 0.90%) developed cystitis, and only 5 (grade 2; 2.3%) were found to have colitis. None of the patients had grade 4 or grade 5 toxicities. There was a significant difference in late complications in patients with nodal disease or those who underwent prior surgery ( P < .05). Three-year OS and DFS rates were 79.7% and 81.9%, respectively. Patients with tumor size > 5 cm and those with pelvic lymph node metastasis had poor survival rates ( P < .05). CONCLUSION IMRT is an effective and well-tolerated technique that should be considered in patients with lymph node disease and in postoperative patients. There is an inverse relationship between tumor size and nodal involvement with respect to OS and DFS.


Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3868
Author(s):  
Masahiro Onishi ◽  
Hidemasa Kawamura ◽  
Kazutoshi Murata ◽  
Tatsuro Inoue ◽  
Hiroto Murata ◽  
...  

This study aimed to evaluate clinical outcomes and the toxicity of intensity-modulated radiation therapy with simultaneous integrated boost (SIB-IMRT) combined with androgen-deprivation therapy for clinically node-positive (cN1) prostate cancer. We retrospectively analyzed 97 patients with cN1 prostate cancer who received SIB-IMRT between June 2008 and October 2017 at our hospital. The prescribed dosages delivered to the prostate and seminal vesicle, elective node area, and residual lymph nodes were 69, 54, and 60 Gy in 30 fractions, respectively. Kaplan–Meier analysis was used to determine 5-year biochemical relapse-free survival (bRFS), relapse-free survival (RFS), overall survival (OS), and prostate cancer-specific survival (PCSS). Toxicity was evaluated using the Common Terminology Criteria for Adverse Events ver. 4.0. Over a median follow-up duration of 60 months, the 5-year bRFS, RFS, OS, and PCSS were 85.1%, 88.1%, 92.7% and 95.0%, respectively. Acute Grade 2 genito-urinary (GU) and gastro-intestinal (GI) toxicities were observed in 10.2% and 2.1%, respectively, with no grade ≥3 toxicities being detected. The cumulative incidence rates of 5-year Grade ≥2 late GU and GI toxicities were 4.7% and 7.4%, respectively, with no Grade 4 toxicities being detected. SIB-IMRT for cN1 prostate cancer demonstrated favorable 5-year outcomes with low incidences of toxicity.


2020 ◽  
Vol 13 (6) ◽  
Author(s):  
Farzad Allameh ◽  
Morteza Fallah Karkan ◽  
Amir Hossein Rahavian ◽  
Bahram Mofid ◽  
Samira Azghandi ◽  
...  

Background: At present, there is a lack of evidence concerning urinary complications caused by intensity-modulated radiation therapy (IMRT) used for the management of prostate cancer (PCa). Objectives: This study aimed at identifying the nature and severity of post-IMRT urinary symptoms in patients with PCa. Methods: This prospective study was performed with consecutive patients, who had clinically localized PCa (cT1c-cT2c) and had undergone IMRT treatment from 2016 to 2019. At 1, 6, and 12 months of follow-up, medical history, physical information, prostate-specific antigen values, International Prostate Symptom Score (IPSS), medication use, Radiation Therapy Oncology Group (RTOG), acute and late toxicity, and Q max were collected. Results: A total of 127 patients with a mean age of 71.04 ± 7.1 years received IMRT and underwent 12 months of follow-up. The mean IPSSs at baseline versus those at 1, 6, and 12 months after IMRT was 14.5 ± 6.8 versus 13.3 ± 6.1, 12.3 ± 5.3, and 10.4 ± 4.2, respectively (P < 0.000). The mean prostate volume was 38.2 ± 12.1 cc. At the last follow-up, 31 patients (24.4%) took genitourinary (GU) medications. Conclusions: This study showed that the majority of GU side effects caused by primary IMRT for PCa treatment are transient. Treatment triggered an acute increase in obstructive urinary symptoms, which peaked during the first month after IMRT. In most patients, in the course of 6 months, symptoms returned to baseline.


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