scholarly journals Ozone Therapy in the Management of Persistent Radiation-Induced Rectal Bleeding in Prostate Cancer Patients

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Bernardino Clavo ◽  
Norberto Santana-Rodriguez ◽  
Pedro Llontop ◽  
Dominga Gutierrez ◽  
Daniel Ceballos ◽  
...  

Introduction. Persistent radiation-induced proctitis and rectal bleeding are debilitating complications with limited therapeutic options. We present our experience with ozone therapy in the management of such refractory rectal bleeding.Methods. Patients (n=12) previously irradiated for prostate cancer with persistent or severe rectal bleeding without response to conventional treatment were enrolled to receive ozone therapy via rectal insufflations and/or topical application of ozonized-oil. Ten (83%) patients had Grade 3 or Grade 4 toxicity. Median follow-up after ozone therapy was 104 months (range: 52–119).Results. Following ozone therapy, the median grade of toxicity improved from 3 to 1 (p<0.001) and the number of endoscopy treatments from 37 to 4 (p=0.032). Hemoglobin levels changed from 11.1 (7–14) g/dL to 13 (10–15) g/dL, before and after ozone therapy, respectively (p=0.008). Ozone therapy was well tolerated and no adverse effects were noted, except soft and temporary flatulence for some hours after each session.Conclusions. Ozone therapy was effective in radiation-induced rectal bleeding in prostate cancer patients without serious adverse events. It proved useful in the management of rectal bleeding and merits further evaluation.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1295-1295
Author(s):  
Louis Fehrenbacher ◽  
Jonathan A. Polikoff ◽  
Robert Hermann ◽  
Haresh Jhangiani ◽  
Jean Bjerke ◽  
...  

Abstract The addition of rituximab (R) therapy significantly improves PFS in patients with relapsedl/refractory disease responding after CHOP as well as responders after R-CHOP induction (van Oers, 2005). The aim of this study was to assess, in patients with previously untreated indolent NHL, the safety, efficacy and PK of additional R therapy in responders to R-CHOP induction. Between 10/01 and 08/06, 102 patients aged 28–84 (mean 57 yr) yrs with Ann Arbor Stage III (28.4%) or IV (71.6%) indolent NHL were treated on this Phase II single-arm, open-label, multi-center, community-based trial. Baseline LDH and β2 microglobulin were above normal in 20.6% and 66.3% of patients, respectively. Treatment consisted of 6 cycles of R-CHOP (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2, and doxorubicin 50 mg/m2 all IV on Day 1 of each 21-day cycle; prednisone 100 mg/d po Days 1–5; and R 375 mg/m2 IV 2–3 days prior to first dose of CHOP and thereafter on Day 1 of each cycle). Patients with ongoing response (CR/CRu or PR) received R 375 mg/m2 weekly x 4, repeated every 6 months x 2 yrs, for a total of up to 16 R doses, within 28 days after completion of R-CHOP. Median follow-up was 39 mos. ORR after R-CHOP was 86.3% (95% CI: 78.3, 92.1), with CR/CRu 48% (95% CI: 38.0, 58.2). As measured from initiation of R-CHOP, PFS at 2 and 3 yrs was 75.2% (95% CI: 64.0, 83.3) and 67.3% (95% CI: 54.6, 77.2), respectively. OS at 2 and 3 yrs was 92.9% (95% CI: 85.7, 96.6) and 89.4% (95% CI: 81.2, 94.2), respectively. Infusion-related toxicity with R given after R-CHOP was less frequent than seen with R-CHOP in this study. The overall incidence of serious adverse events during R therapy given after R-CHOP was 8.5%, including 3 NCI-CTC grade 3/4 events: viral encephalitis (n=1), patellar fracture (n=1) & development of colon cancer (n=1). Serum R concentrations were collected over serial timepoints from 12 patients. Both pre- and end of infusion serum R concentrations were similar across cycles 2–4 of R therapy given after R-CHOP. R concentration was higher just prior to infusion of the first R dose given after R-CHOP due to residual concentration from the R-CHOP treatment. Concentrations were very low (< 10 ug/mL) just prior to initiation of the subsequent R cycles. During R therapy given after R-CHOP, serum R concentrations were similar to those previously reported during R monotherapy treatment (Berinstein, 1998). In summary, this study demonstrated that R therapy given after R-CHOP to be generally well-tolerated, and associated with 75.2% PFS and 92.9% OS at 2 yrs, and 67.3% PFS and 89.4% OS at 3 yrs. Moreover, the current study demonstrates that PK data from R induction can be extrapolated to R given after R-CHOP. The benefit of adding additional R therapy to responders to R-chemotherapy will be addressed in the analysis of the ongoing Phase III PRIMA study, wherein patients with advanced follicular lymphoma who respond to R-chemotherapy induction are randomized to receive further R therapy vs. observation.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 215-215
Author(s):  
M. Mehra ◽  
Y. Wu ◽  
R. Dhawan

215 Background: Docetaxel is standard of care among late-stage prostate cancer patients. We analyzed patterns of health care resource utilization (RU) among patients before and after exposure to docetaxel using a large commercial claims database. Methods: A random sample of patients (N = 336) with a diagnosis of prostate cancer (ICD 9 code: 185.X) and a claim for docetaxel (2003–2009) was identified from the PharMetrics database, a nationally representative, non-payer-owned integrated commercial U.S. claims database. All patients had ≥ 12 months of enrollment prior to initiation of docetaxel. Patients were followed from their first docetaxel claim until lost to follow-up or June 30, 2009 (censored). RU was defined as all-cause hospitalization, ER, physician, and ambulatory visits. Incidence rates were derived. Results: Mean age of patients was 67.9 years (SD 10.6); mean number of docetaxel prescriptions was 9.9 (SD 10.3). Mean time to study end/lost to follow-up was 15.41 (SD 12.49) months from the index date. The table shows health care RU for the 12 months before, and over the follow-up period after docetaxel initiation. Hospitalizations, ER, physician, and ambulatory visits were significantly higher in the follow-up period. The average length of hospital stay was significantly longer after docetaxel treatment (8.2 vs 5.5 days). Prior to docetaxel, two-thirds of the patients were on hormonal therapy; 51% on analgesics, and 31% on bisphosphonates. After docetaxel, the proportions were 62%, 58%, and 54%, respectively. Conclusions: The significantly higher RU with disease progression in prostate cancer patients suggests a need for new treatment options that can effectively manage and improve patient outcomes. [Table: see text] [Table: see text]


2021 ◽  
pp. 20200997
Author(s):  
Wonguen Jung ◽  
Sung Shine Shim ◽  
Kyubo Kim

Objectives: To evaluate the computed tomography (CT) findings of acute radiation pneumonitis (RP) in breast cancer patients undergoing postoperative radiotherapy, and to analyze clinico-dosimetric factors associated with acute RP. Methods: Between 2015 and 2017, 61 patients with breast cancer who underwent follow-up chest CT at 3 months after radiotherapy were analyzed. The degree of acute RP on CT was evaluated by the change of extent and scoring system (grade 0, no RP; Grade 1, ground-glass opacities (GGOs); Grade 2, GGOs and/or consolidations; Grade 3, clear focal consolidation; Grade 4, dense consolidation). The dosimetric parameters were calculated from the dose-volume histogram of RT. Results: The acute RP on CT was scored as follows: grade 0, in 37.7%, Grade 1 in 13.1%, Grade 2 in 44.3%, and Grade 3 in 4.9%. The median extent of RP in patients with Grades 1 to 3 was 6.2 ml (range, 0.2–95.9). There were no clinico-dosimetric factors significantly associated with the presence of RP or its severity. One patient developed symptomatic RP. Conclusions: This study showed no correlation between acute RP and clinico-dosimetric factors, and acute RP based on CT findings were much more common than symptomatic RP. Advances in knowledge: CT findings of acute RP or extent of RP were not significantly related to clinico-dosimetric factors in breast cancer patients.


2021 ◽  
Author(s):  
Esmail Jafari ◽  
Abdul Latif Amini ◽  
Hojjat Ahmadzadehfar ◽  
Dara Bagheri ◽  
Majid Assadi

Abstract Background The aim of this study was to determine the probable cardiotoxicity following radionuclide therapy (RNT), specifically peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE and radioligand therapy (RLT) with 177Lu-PSMA by evaluation of serum troponin I and cardiac profile change during a follow-up time. Materials and Methods Patients with prostate cancer and neuroendocrine tumours (NETs) referred for PRRT and RLT, respectively, were enrolled in this study. The cardiac profiles of the patients were evaluated by a cardiologist and a cardiac history was obtained from all patients. Also, troponin I was measured before and 48 hours after treatment. Results In this retrospective study for assessment of RLT associated cardiotoxicity, 24 patients were evaluated with a median age of 64 years (27–99 years) including 13 NET patients and 11 prostate cancer patients. Patients were followed up for 4 to 31 months which no cardiovascular problem was observed. In evaluation of troponin I, 39 RNT cycles were evaluated. In all patients, the value of troponin I was in normal range. In all patients, the median values of serum troponin I before and after treatment were 0.2 ± 0.02 (range: 0.00–0.42) and 0.28 ± 0.02 (range: 0.00–0.46) ng/ml, respectively (p > 0.05). In the prostate cancer patients, the median values of serum troponin I before and after treatment were 0.26 ± 0.04 (0.04–0.42) and 0.30 ± 0.04 (0.00–0.41) ng/ml, respectively (p > 0.05). In the NET patients, the median values of serum troponin I before and after treatment were 0.18 ± 0.03 (0.00–0.42) and 0.17 ± 0.03 (0.00–0.46) ng/ml, respectively (p > 0.05). Conclusion PRRT with 177Lu-DOTATATE and RLT with 177Lu-PSMA as emerging therapeutic modalities have no significant cardiotoxicity. However, further well-designed studies are recommended.


2021 ◽  
Author(s):  
Kilian Schiller ◽  
Sabrina Dewes ◽  
Lisa Pfetsch ◽  
Marco MME Vogel ◽  
Michal Devecka ◽  
...  

Abstract PURPOSE: Effective tumor control in prostate cancer demands elevated radiation doses given its low alpha/beta ratio. We investigated in primary and recurrent prostate cancer whether dose-escalated-radiation therapy (DE-RT) based on 68Ga-PSMA-PET positive lesions yields increased toxicity. METHODS: We evaluated 90 patients (salvage DE-RT: 67 patients, DE-re-RT: 11 patients, definite DE-RT: 12 patients) who were treated based on a pre-treatment hybrid 68Ga-PSMA. Findings from pre-treatment hybrid 68Ga-PSMA-PET could result in an adaption of radiation planning. Common Toxicity Criteria of Adverse Effects (Version 4.03) were used to assess toxicity, this was done before the initiation and at the end of DE-RT, as well as at the first and last follow-up (F/U) examination. We evaluated the change in toxicity for each interval for the collective as well as in a per-patient analysis.RESULTS: Findings in 68Ga-PSMA-PET-imaging resulted in a change of TNM-stage in 61.1% and an adapted treatment concept in 71.1% of patients. When comparing overall toxicity before DE-RT and at the last follow-up, 5.9% treatment-related side effects (grade 1-3) occurred with 1.7% of them being severe (grade 3). In a patient-centered approach we examined the intra-individual changes in toxicity before and after DE-RT. At the last F/U, the majority out of 80 patients (range: 61.3-93.8%) stated unchanged toxicity rates compared to the toxicity examined at the initiation of RT.CONCLUSION: The rate of treatment-related toxicity (grade 1-2) due to DE-RT in our cohort is 4.2%. For grade 3 toxicity it is 1.7%, respectively. The overall level of toxicity is highest during and shortly after completion of DE-RT (+7.4%) and improves over time until the last reported F/U (+5.9%). Compared to historical data, the toxicity profile of DE-RT is not increased. Therefore it is possible to apply DE-RT with the aim to increase tumor control by precisely treating all involved areas according to PSMA-PET-imaging.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hiromichi Ishiyama ◽  
Hideyasu Tsumura ◽  
Hisato Nagano ◽  
Motoi Watanabe ◽  
Eiichi Mizuno ◽  
...  

AbstractTo report outcomes and risk factors of ultrahypofractionated (UHF) radiotherapy for Japanese prostate cancer patients. This multi-institutional retrospective analysis comprised 259 patients with localized prostate cancer from 6 hospitals. A total dose of 35–36 Gy in 4–5 fractions was prescribed for sequential or alternate-day administration. Biochemical failure was defined according to the Phoenix ASTRO consensus. Toxicities were assessed using National Cancer Institute Common Toxicity Criteria version 4. Tumor control and toxicity rates were analyzed by competing risk frames. Median follow-up duration was 32 months (range 22–97 months). 2- and 3-year biochemical control rates were 97.7% and 96.4%, respectively. Initial prostate-specific antigen (p < 0.01) and neoadjuvant androgen deprivation therapy (p < 0.05) were identified as risk factors for biochemical recurrence. 2- and 3-year cumulative ≥ Grade 2 late genitourinary (GU) toxicities were 5.8% and 7.4%, respectively. Corresponding rates of gastrointestinal (GI) toxicities were 3.9% and 4.5%, respectively. Grade 3 rates were lower than 1% for both GU and GI toxicities. No grade 4 or higher toxicities were encountered. Biologically effective dose was identified as a risk factor for ≥ Grade 2 late GU and GI toxicities (p < 0.05). UHF radiotherapy offered effective, safe treatment for Japanese prostate cancer with short-term follow-up. Our result suggest higher prescribed doses are related to higher toxicity rates.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 120-120
Author(s):  
Mitchell Steven Anscher ◽  
Michael G. Chang ◽  
Drew Moghanaki ◽  
Mihaela Rosu ◽  
Ross Mikkelsen ◽  
...  

120 Background: Late radiation induced rectal injury remains an issue. Large population based studies indicate an incidence of at least 15%. Statins have been shown to reduce the risk of late radiation injury in animal models. The purpose of this study was to prospectively test lovastatin as a potential protector against radiation induced rectal injury, particularly bleeding. Methods: Eligible patients included men with adenocarcinoma of the prostate who were to be treated with radiation therapy with curative intent. Patients receiving primary radiation therapy (external beam alone, brachytherapy alone, or a combination of both) or post-prostatectomy radiation were eligible, as long as the minimum dose to the rectum was 60 Gy. Patients began lovastatin 20-80 mg/d on day 1 of radiation. Lovastatin was continued for 1 year and patients were followed for an additional year. Patients were seen at 1, 2, 4, 6, 9, 12, 18, 21 and 24 months after treatment. At each follow-up, they were assessed for GI, GU and erectile complications using both patient reported (IIEF, EPIC) and physician reported (CTCAE v3) instruments. The primary endpoint of the study was the incidence of rectal bleeding at 24 months (Grade 2 or higher). Results: From April 2007 through May 2013, 73 patients were enrolled. 21 patients either withdrew or were removed from the study due to noncompliance with the lovastatin regimen or toxicity from the drug. Patients who withdrew or were removed were replaced, in order to achieve the target number of 53 evaluable patients with complete 2-year follow-up. A total of 50 patients are evaluable. All but 2/50 evaluable patients achieved the 24-month follow-up goal. At 24 months, there were a total of 4 patients with rectal bleeding attributable to radiation; 3 were grade 2 and 1 was grade 3 (4/48=8%). Conclusions: The incidence of rectal bleeding at 2 years in this population of patients receiving lovastatin during and after radiation therapy for prostate cancer was less than expected based on historical controls. These data suggest that statins may be useful to protect patients from radiation induced rectal injury. Clinical trial information: NCT00580970.


2021 ◽  
Vol 94 (1124) ◽  
pp. 20210242
Author(s):  
Olivier Chapet ◽  
Corina Udrescu ◽  
Sylvie Bin ◽  
Evelyne Decullier ◽  
Pascal Fenoglietto ◽  
...  

Objectives: The present multicenter Phase II study evaluated the rate of late grade ≥2 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum. Methods: Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR/IMRT-IGRT. 20 fractions of 3.1 Gy were delivered, 5 days per week for a total dose of 62 Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4). Results: Median pretreatment prostate-specific antigen was 8 ng ml−1. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed. Late grade ≥2 GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3–4 toxicities. Among the 30 patients completing the 36 months’ visit, none still had a grade ≥2 GI toxicity. Late grade ≥2 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade ≥2 GU toxicity at 36 months. The biochemical relapse rate (nadir +2 ng ml−1) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort. Conclusion: Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years. Advances in knowledge: With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4 GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up.


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuhei Miyasaka ◽  
Hidemasa Kawamura ◽  
Hiro Sato ◽  
Nobuteru Kubo ◽  
Tatsuji Mizukami ◽  
...  

Abstract Background The optimal management of clinical T4 (cT4) prostate cancer (PC) is still uncertain. At our institution, carbon ion radiotherapy (CIRT) for nonmetastatic PC, including tumors invading the bladder, has been performed since 2010. Since carbon ion beams provide a sharp dose distribution with minimal penumbra and have biological advantages over photon radiotherapy, CIRT may provide a therapeutic benefit for PC with bladder invasion. Hence, we evaluated CIRT for PC with bladder invasion in terms of the safety and efficacy. Methods Between March 2010 and December 2016, a total of 1337 patients with nonmetastatic PC received CIRT at a total dose of 57.6 Gy (RBE) in 16 fractions over 4 weeks. Among them, seven patients who had locally advanced PC with bladder invasion were identified. Long-term androgen-deprivation therapy (ADT) was also administered to these patients. Adverse events were graded according to the Common Terminology Criteria for Adverse Event version 5.0. Results At the completion of our study, all the patients with cT4 PC were alive with a median follow-up period of 78 months. Grade 2 acute urinary disorders were observed in only one patient. Regarding late toxicities, only one patient developed grade 2 hematuria and urinary urgency. There was no grade 3 or worse toxicity, and gastrointestinal toxicity was not observed. Six (85.7%) patients had no recurrence or metastasis. One patient had biochemical and local failures 42 and 45 months after CIRT, respectively. However, the recurrent disease has been well controlled by salvage ADT. Conclusions Seven patients with locally advanced PC invading the bladder treated with CIRT were evaluated. Our findings seem to suggest positive safety and efficacy profiles for CIRT.


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