A prospective feasibility study of a 1-mm bolus for postmastectomy radiotherapy

Abstract Background The optimal chest wall bolus regimen for postmastectomy radiotherapy (PMRT) remains unknown. We aimed to prospectively evaluate the use of a 1-mm-thick daily tissue-equivalent bolus in patients who received PMRT using thermoluminescent dosimeters (TLDs) and skin toxicity assessment. Methods Patients with a 1-mm-thick daily bolus during PMRT were prospectively enrolled at The Juntendo University Hospital. The surface dose was measured in vivo under the 1-mm-thick bolus on the chest wall. We assessed the acute skin toxicity weekly during PMRT, and 1, 2, 4, and 12 weeks after the completion of PMRT. Results A total of 19 patients aged 32–79 years old received PMRT from July 2019 to January 2020. All patients completed the protocol treatment without interruptions, and the median follow-up was 32 weeks. In vivo dosimetry analysis revealed surface doses between 77 and 113% of the prescribed dose, with a mean of 92% of the prescribed radiation dose, and a standard deviation of 7% being delivered. Grade 2 dermatitis was found in 10 patients (53%), and Grade 3 dermatitis was found in one patient (5%). All cases of Grade 2 and 3 dermatitis were improved 4 weeks after PMRT. There were no cases of Grade 4 dermatitis and no chest wall recurrences during the treatment or follow-up period. Conclusions Results confirmed the feasibility of using a 1-mm-thick daily bolus for PMRT, exhibiting an appropriate dose buildup and acceptable skin toxicity without treatment interruptions. Trial registration The University Hospital Medical Information Network Clinical Trials Registry, UMIN000035773. Registered 1 July 2019.

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A prospective feasibility study of a 1-mm bolus for postmastectomy radiotherapy

10.21203/rs.3.rs-81403/v2 ◽

2020 ◽

Author(s):

Terufumi Kawamoto ◽

Naoto Shikama ◽

Chie Kurokawa ◽

Naoya Hara ◽

Masaki Oshima ◽

...

Keyword(s):

Chest Wall ◽

Medical Information ◽

Skin Toxicity ◽

Toxicity Assessment ◽

University Hospital ◽

In Vivo Dosimetry ◽

Postmastectomy Radiotherapy ◽

Treatment Interruptions

Abstract Background: The optimal chest wall bolus regimen for postmastectomy radiotherapy (PMRT) remains unknown. We aimed to prospectively evaluate the use of a 1-mm-thick daily tissue-equivalent bolus in patients who received PMRT using thermoluminescent dosimeters (TLDs) and skin toxicity assessment.Materials and Methods: Patients with a 1-mm-thick daily bolus during PMRT were prospectively enrolled at The Juntendo University Hospital. The surface dose was measured in vivo under the 1-mm-thick bolus on the chest wall. We assessed the acute skin toxicity weekly during PMRT, and 1, 2, 4, and 12 weeks after the completion of PMRT.Results: A total of 19 patients aged 32−79 years old received PMRT from July 2019 to January 2020. All patients completed the protocol treatment without interruptions, and the median follow-up was 32 weeks. In vivo dosimetry analysis revealed surface doses between 77% and 113% of the prescribed dose, with a mean of 92% of the prescribed radiation dose, and a standard deviation of 7% being delivered. Grade 2 dermatitis was found in 10 patients (53%), and Grade 3 dermatitis was found in one patient (5%). All cases of Grade 2 and 3 dermatitis were improved 4 weeks after PMRT. There were no cases of Grade 4 dermatitis and no chest wall recurrences during the treatment or follow-up period.Conclusions: The results confirmed the feasibility of using the 1-mm-thick daily bolus for PMRT, with appropriate dose buildup and acceptable skin toxicity without treatment interruptions.Trial registration: The University Hospital Medical Information Network Clinical Trials Registry, UMIN000035773. Registered 1 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040622

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A Prospective Feasibility Study of a 1-mm bolus for Postmastectomy Radiotherapy

10.21203/rs.3.rs-130273/v1 ◽

2020 ◽

Author(s):

Terufumi Kawamoto ◽

Naoto Shikama ◽

Chie Kurokawa ◽

Naoya Hara ◽

Masaki Oshima ◽

...

Keyword(s):

Chest Wall ◽

Medical Information ◽

Skin Toxicity ◽

Toxicity Assessment ◽

University Hospital ◽

In Vivo Dosimetry ◽

Postmastectomy Radiotherapy ◽

Treatment Interruptions

Abstract Background: The optimal chest wall bolus regimen for postmastectomy radiotherapy (PMRT) remains unknown. We aimed to prospectively evaluate the use of a 1-mm-thick daily tissue-equivalent bolus in patients who received PMRT using thermoluminescent dosimeters (TLDs) and skin toxicity assessment.Methods: Patients with a 1-mm-thick daily bolus during PMRT were prospectively enrolled at The Juntendo University Hospital. The surface dose was measured in vivo under the 1-mm-thick bolus on the chest wall. We assessed the acute skin toxicity weekly during PMRT, and 1, 2, 4, and 12 weeks after the completion of PMRT.Results: A total of 19 patients aged 32−79 years old received PMRT from July 2019 to January 2020. All patients completed the protocol treatment without interruptions, and the median follow-up was 32 weeks. In vivo dosimetry analysis revealed surface doses between 77% and 113% of the prescribed dose, with a mean of 92% of the prescribed radiation dose, and a standard deviation of 7% being delivered. Grade 2 dermatitis was found in 10 patients (53%), and Grade 3 dermatitis was found in one patient (5%). All cases of Grade 2 and 3 dermatitis were improved 4 weeks after PMRT. There were no cases of Grade 4 dermatitis and no chest wall recurrences during the treatment or follow-up period.Conclusions: The results confirmed the feasibility of using the 1-mm-thick daily bolus for PMRT, with appropriate dose buildup and acceptable skin toxicity without treatment interruptions.Trial registration: The University Hospital Medical Information Network Clinical Trials Registry, UMIN000035773. Registered 1 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040622

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A prospective feasibility study of a 1-mm bolus for postmastectomy radiotherapy

10.21203/rs.3.rs-81403/v1 ◽

2020 ◽

Author(s):

Terufumi Kawamoto ◽

Naoto Shikama ◽

Chie Kurokawa ◽

Naoya Hara ◽

Masaki Oshima ◽

...

Keyword(s):

Chest Wall ◽

Medical Information ◽

Skin Toxicity ◽

University Hospital ◽

In Vivo Dosimetry ◽

Postmastectomy Radiotherapy ◽

Thermoluminescent Dosimeters ◽

Tissue Equivalent

Abstract BackgroundThere remains wide variation in the use of chest wall boluses for postmastectomy radiotherapy (PMRT). Therefore, we aimed to prospectively evaluate the use of a 1-mm-thick daily tissue-equivalent bolus in patients who received PMRT using thermoluminescent dosimeters (TLDs) and skin toxicity assessment.Materials and MethodsWe collected data from patients with a 1-mm-thick daily bolus during PMRT at The Juntendo University Hospital. The surface dose was measured in vivo under the 1-mm-thick bolus on the chest wall. We assessed the acute skin toxicity weekly during PMRT, and 1, 2, 4, and 12 weeks after the completion of PMRT.ResultsA total of 19 patients aged 32 − 79 years old received PMRT from July 2019 to January 2020. All patients completed the protocol treatment without interruptions, and the median follow-up was 32 weeks. In vivo dosimetry analysis revealed surface doses between 77% and 113% of the prescribed dose, with a mean of 92% of the prescribed radiation dose, and a standard deviation of 7% being delivered. Grade 2 dermatitis was found in 10 patients (53%), and Grade 3 dermatitis was found in one patient (5%). All cases of Grade 2 and 3 dermatitis were improved 4 weeks after PMRT. There were no cases of Grade 4 dermatitis and no chest wall recurrences during the treatment or follow-up period.ConclusionsThe 1-mm-thick daily bolus is a feasible regimen for PMRT, with appropriate dose buildup and acceptable skin toxicity without treatment interruptions.Trial registrationThe University Hospital Medical Information Network Clinical Trials Registry, UMIN000035773. Registered 1 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040622

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Skin dose effects of postmastectomy chest wall radiation therapy using brass mesh as an alternative to a bolus.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.27_suppl.157 ◽

2012 ◽

Vol 30 (27_suppl) ◽

pp. 157-157

Author(s):

Erin Healy ◽

Shawnee Anderson ◽

Jing Cui ◽

Laurel Beckett ◽

Allen M. Chen ◽

...

Keyword(s):

Radiation Therapy ◽

Skin Reaction ◽

Chest Wall ◽

Radiation Treatment ◽

Skin Toxicity ◽

In Vivo Dosimetry ◽

Skin Dose ◽

Tissue Equivalent ◽

Dose Effects

157 Background: The use of brass mesh as an alternative to a bolus is relatively uncommon in post-mastectomy chest wall radiation therapy (PMRT). This study aimed to characterize the skin dose effects of using 2mm fine brass mesh as an alternative to the traditional tissue-equivalent bolus during chest wall PMRT. Methods: Data was collected from patients who received PMRT using brass mesh at UC Davis Medical Center’s Department of Radiation Oncology between January 2008 and June 2011. Several patient characteristics including age, body habitus, and ethnicity were analyzed along with several disease and treatment characteristics to determine whether or not they had an impact on the skin reaction observed during radiation treatment. In addition to assessing skin toxicity visually using standardized National Cancer Institute scores (NCIS), surface doses were measured for 16 of the 48 patients (33%) to quantify radiation exposure to the chest wall. Results: 48 female patients aged 28-83 received PMRT using brass mesh. As expected, the severity of skin toxicity increased with subsequent doses of radiation with all patients beginning treatment with no skin reaction (NCIS = 0) and the majority of patients completing treatment with either faint to moderate erythema (N = 19, 40%, NCIS = 1) or moderate to brisk erythema (N = 23, 48%, NCIS = 2). In vivo dosimetry analysis revealed surface doses between 81% and 110% of the prescribed dose, with an average of 99% of the prescribed radiation dose being delivered and a standard deviation of 10%. Conclusions: For post-mastectomy chest wall radiation therapy, brass mesh is an effective alternative to the tissue-equivalent bolus. The brass mesh achieved moderate erythema in the majority of patients at the end of treatment and the surface dose was validated using in vivo dosimetry.

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P005 Rheumatology virtual clinics during COVID-19: are our patients satisfied?

Rheumatology ◽

10.1093/rheumatology/keab247.004 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Fajer A Altamimi ◽

Una Martin

Keyword(s):

Medical Information ◽

Worker Safety ◽

University Hospital ◽

Free Text ◽

Risk Of Infection ◽

Further Training ◽

Return Envelope ◽

The Right ◽

Reduced Risk

Abstract Background/Aims Telemedicine can be broadly defined as the use of telecommunication technologies to provide medical information and services. It can be audio, visual, or text. Its use has increased dramatically during the COVID-19 pandemic to ensure patient and healthcare worker safety. Any healthcare professional can engage with it. It carries benefits like reduced stress and expense of traveling, maintenance of social distancing, and reduced risk of infection. There are some potential drawbacks such as lack of physical examination, liability and technological issues. Methods A questionnaire was sent to 200 patients, selected from different virtual clinics (new and review, doctor and ANP led) run between March and May 2020 in the rheumatology department of University Hospital Waterford. We formulated 14 questions to cover the following aspects: demography, the purpose of the consult, punctuality, feedback, medico-legal concerns, and free text for comments. A self-addressed return envelope was included. Results 83 responses were received. 2 were excluded. The ratio of females to male respondents was 59: 41, with the majority over 60 years old. The main appointment type was review 67 (83%). 80% of patients were called either before or at the time of their scheduled appointment. The vast majority (98.8%) of our patients had confidence in our data protection and trusted our system to maintain their confidentiality. 95% stated that they felt comfortable, were given enough time to explain their health problem and felt free from stress. The respondents who preferred attending the clinic in person (17 in total) compared to the virtual were mostly follow up patients- 12 vs. 5 new. Conclusion Patient satisfaction among those surveyed was high, despite having to introduce the service abruptly during the COVID-19 pandemic. There are many improvements we can adopt to improve our service and even maintain after the pandemic as a way of communicating with our stable patients. As we are covering a large geographical catchment, we can continue to implement the virtual clinic for some appointments. We should prioritize our efforts on identifying the right patient and the type of service we can offer, further training of staff, and increasing awareness of the patients as to how to get the most out of a virtual appointment. Disclosure F.A. Altamimi: None. U. Martin: None. C. Sheehy: None.

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Novel Urinary Glycan Biomarkers Predict Cardiovascular Events in Patients With Type 2 Diabetes: A Multicenter Prospective Study With 5-Year Follow Up (U-CARE Study 2)

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.668059 ◽

2021 ◽

Vol 8 ◽

Author(s):

Koki Mise ◽

Mariko Imamura ◽

Satoshi Yamaguchi ◽

Mayu Watanabe ◽

Chigusa Higuchi ◽

...

Keyword(s):

Type 2 Diabetes ◽

Medical Information ◽

Information Criterion ◽

Cox Proportional Hazards ◽

University Hospital ◽

Net Reclassification Improvement ◽

Patients With Diabetes ◽

High Mannose

Background: Although various biomarkers predict cardiovascular event (CVE) in patients with diabetes, the relationship of urinary glycan profile with CVE in patients with diabetes remains unclear.Methods: Among 680 patients with type 2 diabetes, we examined the baseline urinary glycan signals binding to 45 lectins with different specificities. Primary outcome was defined as CVE including cardiovascular disease, stroke, and peripheral arterial disease.Results: During approximately a 5-year follow-up period, 62 patients reached the endpoint. Cox proportional hazards analysis revealed that urinary glycan signals binding to two lectins were significantly associated with the outcome after adjustment for known indicators of CVE and for false discovery rate, as well as increased model fitness. Hazard ratios for these lectins (+1 SD for the glycan index) were UDA (recognizing glycan: mixture of Man5 to Man9): 1.78 (95% CI: 1.24–2.55, P = 0.002) and Calsepa [High-Man (Man2–6)]: 1.56 (1.19–2.04, P = 0.001). Common glycan binding to these lectins was high-mannose type of N-glycans. Moreover, adding glycan index for UDA to a model including known confounders improved the outcome prediction [Difference of Harrel's C-index: 0.028 (95% CI: 0.001–0.055, P = 0.044), net reclassification improvement at 5-year risk increased by 0.368 (0.045–0.692, P = 0.026), and the Akaike information criterion and Bayesian information criterion decreased from 725.7 to 716.5, and 761.8 to 757.2, respectively].Conclusion: The urinary excretion of high-mannose glycan may be a valuable biomarker for improving prediction of CVE in patients with type 2 diabetes, and provides the rationale to explore the mechanism underlying abnormal N-glycosylation occurring in patients with diabetes at higher risk of CVE.Trial Registration: This study was registered with the University Hospital Medical Information Network on June 26, 2012 (Clinical trial number: UMIN000011525, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013482).

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Radiochromic film in vivo dosimetry predicts early the risk of acute skin toxicity for brachytherapy partial breast irradiation

Physics in Medicine and Biology ◽

10.1088/1361-6560/ab7c2f ◽

2020 ◽

Vol 65 (8) ◽

pp. 085001

Author(s):

Gerson M Struik ◽

Jeremy Godart ◽

Taco M Klem ◽

Thalat T Monajemi ◽

James Robar ◽

...

Keyword(s):

Skin Toxicity ◽

Radiochromic Film ◽

In Vivo Dosimetry ◽

Partial Breast Irradiation ◽

Breast Irradiation ◽

Acute Skin Toxicity

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Final results of multicenter phase Ib/ II study of biweekly trifluridine/tipiracil with bevacizumab combination for patients with mCRC refractory to standard therapies (BiTS study).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.121 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 121-121

Author(s):

Masato Nakamura ◽

Hironaga Satake ◽

Koji Oba ◽

Masahito Kotaka ◽

Yoshinori Kagawa ◽

...

Keyword(s):

Phase Ii ◽

Primary Endpoint ◽

Statistical Power ◽

Medical Information ◽

Treatment Options ◽

Dose Intensity ◽

University Hospital ◽

Phase Ib ◽

Multicenter Phase

121 Background: We have conducted the multicenter, phase Ib/II study to assess the activity and safety of biweekly Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) combination for pts with metastatic colorectal cancer (mCRC) who were refractory or intolerant to standard therapies, and the primary endpoint of investigator assessed progression-free survival rate at 16 weeks (16w-PFS) was met [Kotaka M, ASCO-GI 2018]. We show longer follow-up data from this prospective study. Methods: Patients with unresectable mCRC; refractory or intolerant to standard chemotherapies were enrolled. Phase Ib part is designed to determine the recommended phase II dose (RP2D), and the treatment was determined as biweekly FTD/TPI (70mg/m2/day on day 1-5, every 2 weeks) with BEV (5mg/kg, every 2 weeks). The primary endpoint in phase II part was a 16w-PFS with a hypothesis of 15% considered unacceptable and 38.7% deemed promising. Given a one-sided α of 0.025 and statistical power of 90%, a minimum of 40 pts were required for phase II part. This trial registered in University Hospital Medical Information Network, number UMIN000029198. Results: From October 2017 to January 2018, totally 46 pts were enrolled. Nine patients (20.5 %) received regorafenib before enrollment. Of the 44 eligible pts, 16w-PFS rate was 40.9 %. With a median follow up of 15.36 months (range, 2.79-16.93), median PFS was 4.29 months (95% CI: 2.54 to 5.83), median TTF was 4.16 months (95% CI: 2.39 to 5.82), and median OS was 10.86 months (95% CI:8.32 to 13.68), respectively. Disease control rate was 59.1 % (95%CI: 43.3 to 73.7 %). Patients received the study treatment for a median of 6.5 cycles (range, 1 to 24). The median relative dose intensity of FTD/TPI and BEV was 80.9% (range: 44.0 to 100%), 81.5% (range: 50.0 to 100%), respectively. Common grade 3 or higher adverse events were hypertension (40.9%), neutropenia (11.4 %) and leucopenia (11.4 %). Conclusions: An update analysis confirmed that biweekly FTD/TPI plus BEV showed promising anti-tumor effect with acceptable less toxicities, and might be one of the treatment options for patients with heavily treated mCRC. Clinical trial information: UMIN000029198.

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Automatic Record Hash Coding and Linkage for Epidemiological Follow-up Data Confidentiality

Methods of Information in Medicine ◽

10.1055/s-0038-1634527 ◽

1998 ◽

Vol 37 (03) ◽

pp. 271-277 ◽

Cited By ~ 46

Author(s):

H. Bouzelat ◽

F. A. Allaert ◽

A. M. Benhamiche ◽

J. Faivre ◽

L. Dusserre ◽

...

Keyword(s):

Record Linkage ◽

Hash Function ◽

Medical Information ◽

University Hospital ◽

Second Step ◽

Data Confidentiality ◽

Digestive Cancers ◽

Follow Up Studies ◽

Dictionary Attacks

AbstractA protocol is proposed to allow linkage of anonymous medical information within the framework of epidemiological follow-up studies. The protocol is composed of two steps; the first concerns the irreversible transformation of identification data, using a one-way hash function which is used after spelling processing. To avoid dictionary attacks, two large random files of keys, called pads, are introduced. The second step consists in the linkage of files rendered anonymous. The weight given to each linkage field is estimated by a mixture model, the likelihood of which being maximized with the Expectation and Maximization (EM) algorithm. The performance of this method has been assessed by comparing record linkage, based on exclusive use of the automatic procedure, with a manual linkage, obtained by the Burgundy Registry of Digestive Cancers. The result of the linkage of a file of 2,847 cancers with a file of 388,614 hospitalization stays in the Dijon university hospital showed a sensitivity of 97% and a specificity of 93%.

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Long-term outcomes of antibiotic combination therapy for ulcerative colitis

Therapeutic Advances in Chronic Disease ◽

10.1177/20406223211028790 ◽

2021 ◽

Vol 12 ◽

pp. 204062232110287

Author(s):

Yuriko Nishikawa ◽

Nobuhiro Sato ◽

Shintaro Tsukinaga ◽

Kan Uchiyama ◽

Shigeo Koido ◽

...

Keyword(s):

Ulcerative Colitis ◽

Side Effects ◽

Adverse Events ◽

Medical Information ◽

Compliance Rate ◽

University Hospital ◽

Open Label ◽

Antibiotic Combination

Aims: An antibiotic combination of amoxicillin, tetracycline and metronidazole (ATM) is effective for ulcerative colitis (UC), but this regimen is discontinued in some cases due to adverse events. This study aimed to assess a revised combination, namely, amoxicillin, fosfomycin and metronidazole (AFM), in UC patients with the goal of reducing side effects while maintaining therapeutic efficacy. Methods: A prospective open-label trial was undertaken in 104 adult UC patients. A combination of oral amoxicillin (1500 mg), fosfomycin (3000 mg) and metronidazole (750 mg) was administered to patients daily for 2–4 weeks in addition to their conventional medication. Clinical assessment was performed using the Lichtiger index before treatment and at 0, 3, 6, 9 and 12 months and 2 and 3 years. Endoscopic evaluation was performed using the Mayo score before treatment and at 3 and 12 months. Results: The compliance rate was 99.2%. Response and remission rates were 80.8% and 63.5% at completion, 73.1% and 64.4% at 3 months, and 39.4% for both at 12 months, respectively. Of the 41 patients who were in remission at 12 months, 63.4% maintained that status until the 2-year follow-up. Similarly, 69.2% of those in remission at 2 years remained relapse free at the 3-year follow-up. Side effects were observed in 44.2% of the participants. Fever occurred in one patient (1.0%), which was lower than the rate observed with ATM therapy. Conclusion: These results indicate that AFM therapy induces remission and is appropriate for long-term maintenance of UC while producing fewer and milder adverse events than ATM therapy. Clinical trials: This study was registered in the University Hospital Medical Information Network (No. R000046546).

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