Single-institution Prospective Observational Study Research Articles

Health Outcome Preferences Among Older Adults with Multiple Myeloma Undergoing Systemic Therapy

Introduction: Multiple Myeloma (MM) is the second most common hematologic malignancy in the US; over half of patients are ≥70y at diagnosis. Prior studies have shown that treatment preferences of older adults with cancer vary based on burden/intensity of current treatment and its impact on functional and cognitive well-being in addition to anticipated survival. However, no such studies exist among older adults with MM. We sought to understand health outcome preferences in a cohort of older adults with MM. Methods: Using the Cancer and Aging Resilience Evaluation in Hematologic Malignancies Registry (NCT05556928), a single institution prospective observational study of older adults with hematologic malignancies undergoing systemic therapy, we identified patients diagnosed with multiple myeloma at age ≥50y who had undergone a geriatric assessment (GA) within 30 days of initiating a new line of therapy (1 st to 5 th line).Treatment preference was assessed using a 9-item health outcome preference attitude scale (Case et al Patient Educ Couns 2013), rating self-reported agreement with statements related to health outcomes on a Likert scale. Frailty was assessed using a deficit accumulation method as previously described (Giri S et al J Am Geriatr Soc 2023) We measured the proportion of patients reporting other outcomes being “as important” or “more important” than survival and compared the response between younger (<70y) and older (≥70y) adults. Subsequently, we built proportional odds models to study the factors associated with a greater prioritization of outcomes other than survival. All p values were two sided and the level of significance was chosen at 0.05. Results: Of the 228 patients initiating a new line of therapy between 01/2022 to 4/2023, 104 (47%) underwent treatment preference assessment. The median age at enrollment was 65y with 33% ≥70y; 62% were males, 57% whites; 19% had ISS stage 3 disease; 28% were frail on the CARE frailty index. In the younger (age <70y) vs older (age ≥70y) patients, 32% vs 77% agreed/strongly agreed with: “I would rather live a shorter life than lose my ability to take care of myself”; and 54% vs 79% agreed/strongly agreed with: “It is more important to me to maintain my thinking ability than to live as long as possible”. In multivariable models, age but not frailty, sex, race or disease stage were associated with health outcome prioritization other than survival. Each 1y increase in age was associated with and 8% (Odds Ratio 1.08; 95% CI 1.03-1.13; p value=0.001) and 4% (OR 1.04; 95% CI 1.0-1.09; p value=0.04) increased odds of rating functional independence and cognition respectively as more important than survival. Conclusions: Three out of four older adults (age>70y) with MM rated other outcomes (particularly physical function and cognitive ability) as being more important than survival. Eliciting which outcomes are the most important for older patients can help define treatment goals and improve shared decision-making. Further, interventions focusing on preserving physical and cognitive function need to be tested in this population.

Can we predict urethral length of boys? – An observational study

An additional knowledge about normal anatomy of urethra in boys can improve clinical outcome of any urological interventions. This will also reduce catheter related complications like intra vesical knotting and urethral injuries. At present there is no systematic data available which has studied the urethral length of boys. We have done this study to analyse the length of urethra in boys. The aim of the study is to measure the urethral length in Indian children from the age of 1 year till 15 years and plot a nomogram. Furthermore to analyse the influence of anthropometry on urethral length and derived a formula to predict the urethral length in boys. This is a single institution prospective observational study. After obtaining clearance from the institutional review board, a total of 180 children from the age of 1-15 were recruited for the study. The urethral length was measured during Foley's catheter removal. Other data like age, weight, and height of the patient are collected and the obtained values were analysed with SPSS software. The acquired figures were further used to derive formulae to predict urethral length. A nomogram of urethral length based on age was plotted. With collected figures, five separate formulae were derived to calculate the urethral length based on the age, height and weight. Furthermore for day-to-day use we have deduced a formulas to calculate urethral length which are simplified forms of original formulae. The length of urethra of a new-born male is 5cm, which attains 8cm by three years of age and to 17cm by adulthood. There were attempts to measure the urethral length in adults using cystoscopy, Foley's catheter and different imaging techniques like Magnetic Resonance Imaging and dynamic retrograde urethrography. Simplified formulae which has been derived from this study for clinical use is Urethral length=8.7+Age (in year) × 0.55 CONCLUSION: Our results will complement the current anatomical understanding of the urethra. This evades some rare complications of catheterisation and facilitate reconstructive procedures.

Agitation in the Trauma Bay Is an Early Indicator of Hemorrhagic Shock

IntroductionAgitation on arrival in trauma patients is known as a sign of impending demise. The aim of this study is to determine outcomes for trauma patients who present in an agitated state. We hypothesized that agitation in the trauma bay is an early indicator for hemorrhage in trauma patients. MethodsWe performed a single-institution prospective observational study from September 2018 to December 2020 that included any trauma patient who arrived agitated, defined as a Richmond Agitation-Sedation Scale of +1 to +4. Variables collected included demographics, mechanism of injury, admission physiology, blood alcohol level, toxicity screen, and injury severity. The primary outcomes were need for massive transfusion (≥ 10 units) and need for emergent therapeutic intervention for hemorrhage control (laparotomy, preperitoneal pelvic packing, sternotomy, thoracotomy, or angioembolization). ResultsOf 4657 trauma admissions, 77 (2%) patients arrived agitated. Agitated patients were younger (40 versus 46, P = 0.03), predominantly male (94% versus 66%, P < 0.0001) sustained more penetrating trauma (31% versus 12%, P < 0.0001), had a lower systolic blood pressure (127 versus 137, P < 0.0001), and a higher Injury Severity Score (17 versus 9, P < 0.0001). On multivariable logistic regression, agitation was independently associated with massive transfusion (odds ratio: 2.63 [1.20-5.77], P = 0.02) and emergent therapeutic intervention for hemorrhage control (odds ratio: 2.60 [1.35-5.03], P = 0.005). ConclusionsAgitation in trauma patients may serve as an early indicator of hemorrhagic shock, as agitation is independently associated with a two-fold increase in the need for massive transfusion and emergent therapeutic intervention for hemorrhage control.

Single-Fraction vs. Fractionated Stereotactic Radiosurgery for Vestibular Schwannomas with Frameless Radiosurgery: A Single Institution Prospective Observational Study

<h3>Purpose/Objective(s)</h3> The number of patients with small- to medium-sized vestibular schwannoma (VS), defined as under 22 mm in greatest dimension, presenting with serviceable hearing has steadily increased over the last 50 years. Thus, treatment of VS often must balance a goal of tumor control with hearing preservation and other potential side effects. Improved hearing rates have been demonstrated with the use of a lower prescription dose. The effect of fractionation in preserving hearing loss is less clear. We sought to evaluate local control and hearing preservation rates in patients treated with single-fraction versus 5-fraction frameless GKRS. <h3>Materials/Methods</h3> Prospectively enrolled patients with a radiographic diagnosis of unilateral vestibular schwannoma who underwent single-fraction or 5-fraction definitive frameless GKRS between 2017 and 2020 were retrospectively reviewed in our institutional review board (IRB) approved database. We used chi-squared tests and t-tests to compare demographic and clinical characteristics by treatment modality. We then used Kaplan-Meier methods to compare the two treatment groups' local control and hearing preservation, and evaluated the statistical significance of the differences by log rank test. <h3>Results</h3> Seventy consecutive patients were treated with single-fraction or fractionated GKRS for VS from 2017 to 2020. Forty-eight patients met inclusion criteria and were included in this analysis. Twenty-three patients underwent single-fraction treatment, and 25 patients underwent fractionated treatment in 5 fractions. Median follow-up time was 2 years for both groups. Patients who were treated with multi-fraction GKRS on average, had a larger maximal tumor diameter than those treated with single-fraction GKRS. At 2 years, radiographic local control of VS treated with single-fraction was 93% compared to 92% for multi-fraction frameless GKRS (p=0.64). No patients required salvage treatment in either group. Hearing preservation was evaluated in patients with available audiograms (13/23 single-fraction and 20/25 multi-fraction). At 2 years, hearing preservation was 46% for patients treated with single-fraction GKRS compared to 78% for patients treated with multi-fraction GKRS, not including patients censored due to lack of available audiogram (p=.06). <h3>Conclusion</h3> Single-fraction and fractionated frameless GKRS provide similar clinical and radiographic local control, while maintaining similar hearing preservation rates, in the treatment of VS.

A prospective observational study assessing the feasibility and factors affecting same-day discharge in patients undergoing robotic-assisted surgery for gynecological cancers.

Although robotic-assisted surgery is being increasingly used in the management of gynecologic cancers, most surgeons discharge patients on the next day of surgery citing concerns about immediate post-operative complications. Present study was conducted to evaluate the safety, factors influencing and quality of life for gynaecological cancer patients undergoing same-day discharge after robotic-assisted surgery. This is single institutional prospective observational study as pragmatic cohort including all well-selected gynecological cancer patients undergoing robotic-assisted surgery from September 2017 to June 2019. Patients were divided into two study groups [Same-day discharge (SDD) group vs. Next-day discharge (NDD) group] according to day of discharge. The entire cohort included 152 patients (38 in SDD group and 114 in NDD group). The difference between both SDD vs. NDD was significant for parameters including Age ≥ 70years (0% vs. 18.4%, p: 0.010); Operative time > 60min (39.5% vs. 60.5%, p: 0.024); patients with third-party insurance covering surgery (2.6% vs. 25.4%, p: 0.005) and place of residence ≥ 60km from hospital (13.1% vs. 51.8%, p: < 0.0001). The quality of life was similar in both groups and none of the patients required readmission or emergency room visits. Same-day discharge after robot-assisted surgery in gynecologic cancer patients is a safe and feasible option. Younger patients, short surgical time, surgery early in the day, no claim for third-party insurance, residing nearby hospital within 60km radius were influencing factors favouring same-day discharge.

Echocardiographic Assessment of Right Ventricular Systolic Function in Postoperative Tetralogy of Fallot Patients with Special Emphasis on Right Ventricular-Global Longitudinal Strain

Background: Limitations of echocardiography have long been known for the assessment of right ventricular (RV) systolic function in postoperative tetralogy of Fallot (TOF) patients. In this study, we evaluated the role of RV-global longitudinal strain (GLS) for the assessment of RV systolic function. Materials and Methods: It was a single institution prospective observational study of ninety postoperative TOF patients. Detailed 2-dimensional echocardiography along with RV-GLS using speckle tracing imaging was done at baseline and after 1 year. The children were divided into three groups based on duration since total correction, i.e., group A (6 months to 5 years), group B (6–10 years), and group C (&gt;10 years) to assess the differences in RV systolic function. Furthermore, correlation of RV-GLS with RV-fractional area change (FAC), tricuspid annular plane systolic excursion, and tricuspid valve tissue Doppler imaging s' velocity was done. Results: In group A patients, a statistically significant increase in RV systolic function was seen over a period of 1 year. However, in group B and C patients, no significant change was seen. There was a strong positive correlation of RV-GLS only with RV-FAC during the first follow-up (r = 0.41, P &lt; 0.01) and second follow-up periods (r = 0.67, P &lt; 0.01). Conclusion: RV-GLS has a strong positive correlation with RV-FAC, and it detects preclinical regional myocardial dysfunction even when the RV-FAC is normal and thus must be included in the evaluation of postoperative TOF children.

Comparison of ultrasound and magnetic resonance imaging findings in evaluation of fetal congenital anomalies: A single-institution prospective observational study

BackgroundThis study aimed to compare the ultrasound (USG) and fetal magnetic resonance imaging (MRI) findings in the evaluation of congenital fetal anomalies and to determine whether the management is changes significantly if MRI is combined with USG. MethodsIn this prospective observational cohort study, we performed fetal MRI in 90 consecutive cases of fetuses diagnosed or suspected as having congenital anomalies on a prior level II USG scan. We then compared the USG and MRI findings of each anomaly according to the diagnostic information yielded by each modality. ResultsOf 90 fetuses examined during 1 year study period, MRI and USG findings were equivalent in 13.3% of cases. MRI provided additional information in 68.8% cases, of which pregnancy management was changed in 5.6% cases. MRI provided additional information but did not change management in 63.3% of cases. USG provided additional information but did not change pregnancy management in 17.8% of cases. The difference was statistically significant with a p value of .000. ConclusionFetal MRI is a significantly better modality than USG for detecting additional findings in anomalies of specific organ systems. Because of its high diagnostic yield for central nervous system (CNS) anomalies, it can be combined with USG for this subgroup. For non-CNS anomalies of genitourinary system, thorax, or in syndromic/complex malformations/conjoint twin pregnancy, it may be used as an adjunct to USG on a case to case basis. MRI has the potential to change the pregnancy management in few cases, but benefit is small to advocate a complete integration of MRI and USG for fetal anomaly scanning at present.

Association of human papillomavirus in penile cancer: A single-center analysis.

ABSTRACTIntroduction:Human papillomavirus (HPV) is a known risk factor of penile cancer (PeCa). However, studies evaluating its true association are limited. In this study, we aimed to estimate HPV prevalence and its true association with PeCa in terms of molecular biological activities.Materials and Methods:This single-institutional prospective observational study was conducted between June 2016 and August 2019. We included 40 men with PeCa as a study group and 20 age-matched uncircumcised men who underwent circumcision for phimosis as a control group. Both the groups underwent deoxyribonucleic acid isolation for HPV subtyping followed by evaluation of relative E6/E7 messenger ribonucleic acid (mRNA) expression profile and relative telomerase activity in tissue samples. HPV-16 and -18 were categorized as high-risk, whereas HPV-6 and -11 were categorized as low-risk subtypes.Results:The mean (±standard deviation) age of PeCa was 51 ± 15.9 years. The majority of patients had stage II disease, and the most common procedure done was partial penectomy. The overall prevalence of HPV in PeCa was 42.5% (n = 17) as compared to 20% (n = 4) in controls. Among the subtypes, the most common subtype was HPV-16 noted in 33.3% (8/24) of cases, followed by HPV-18 in 29.2% (7/24) of cases. PeCa tissues had a significantly higher relative E7 mRNA expression for HPV-18 than the control group (P = 0.016). The mean relative telomerase activity was significantly higher in the PeCa tissues than the control group (138.66 vs. 14.46, P < 0.001). A significantly higher relative telomerase activity was noted in the PeCa tissues positive for high-risk HPV subtypes than controls (141.90 vs. 14.46, P = 0.0008), but not between high-risk HPV-positive and HPV-negative PeCa cases (141.90 vs. 137.03, P = 0.79). High-risk subtypes were not associated with tumor stage (P = 0.76) or lymph node metastasis (P = 0.816).Conclusions:HPV was associated in 42.5% of PeCa cases based on our experience from a single institution. PeCa tissues had a higher relative E7 mRNA expression for HPV-18 and relative telomerase activity as compared to controls suggesting their potential role as surrogate markers of virus-induced tumorigenesis.

Evaluation of a 3D-Printed Transoral Robotic Surgery Simulator Utilizing Artificial Tissue.

Transoral robotic surgery (TORS) poses challenges for operators in training, with limited robot access on a platform requiring distinct surgical skills. Few simulators exist, and current virtual reality training modules exclude head and neck simulations. This study evaluates the construct validity for a novel low-cost TORS simulator. Single institution prospective observational study. Using 3D-printed oral cavity structures and replaceable artificial tissue components, a modular TORS simulator was constructed for short-duration hands-on simulations with the da Vinci SI robot. Sixteen surgeons of differing robotic skill levels, no experience (novice), prior experience, and formal robot training, participated in simulated tonsil and tongue base tumor resections. Video recordings of each participant were graded by a blinded robotically trained surgeon using a 35-point Global Evaluative Assessment of Robotic Surgery (GEARS) criterion adapted for the TORS simulator. Operators reporting formal robotic training or prior robot experience achieved significantly higher mean total GEARS scores compared to novice operators (32 vs. 20.5; P < .001). Overall, mean total GEARS scores correlated with reported experience level; novice operators scored 54% of total points at 19 (4.5), operators with prior experience scored 82.3% of total points at 28.8 (2.6), and robotically trained operators scored 97.1% of total points at 34 (1.7). With a GEARS criterion, our simulator successfully differentiated novice from experienced and robotically trained operators of the da Vinci SI robot during simulated tonsillectomy and base of tongue resections. These findings support the construct validity of this prototype simulator and offer a foundation for further testing of predictive validity. 2 Laryngoscope, 132:1588-1593, 2022.

Clinical profile and outcome of COVID-19 in haematological malignancies: experience from tertiary care centre in India.

There is limited evidence on various clinical aspects of SARS-CoV-2 infection in patients with haematological cancers. The risk factors, prognosis, and outcome of patients with haematological cancers with coexistent COVID-19 need to be explored in different subsets of population. A single-institutional prospective observational study was conducted at a tertiary level medical institute in North India. The clinical details of the recruited patients having haematological malignancies and diagnosed with COVID-19 between 15 March 2020 and 31 May 2021 were prospectively collected through the electronic patient database system. The outcomes with respect to 28-day and 56-day mortality and the associated risk factors for prognostication were analysed. Of the 5750 hospital admissions (inpatient and day-care) during the study period, two hundred and forty-two patients (4.2%) were diagnosed with COVID-19. Acute leukaemia was the most common haematological malignancy, seen in 117 (48.3%) patients. Eighty-nine (36.8%) patients had moderate-to-severe COVID-19 while 153 (63.2%) patients presented with mild infection. The 28-day and 56-day mortality rates in our cohort were 13.3% and 19.8% respectively. Amongst the risk factors associated with poor outcome, the severity of COVID-19 (HR = 1.8, 95% CI 1.16–10.35; p = 0.04), presence of secondary infection (HR = 2.1, 95% CI 2.45–21.3; p = 0.023), and need for invasive mechanical ventilation (HR = 2.3, 95% CI 1.8–18.43; p = 0.01) were prognostically significant on multivariate log rank analysis. The risk of SARS-CoV-2 infection does not increase with haematological malignancies; however, the outcome remains poor in patients with severe COVID-19, requirement of invasive mechanical ventilation, and pre-existing bacterial/fungal infection at presentation.

Comparison of Postoperative Quality of Life and Pain with and without a Metal Rib Spreader in Patients Undergoing Lobectomy through Axillary Mini-Thoracotomy for Stage I Lung Cancer.

Purpose: To evaluate postoperative patient-reported quality of life (QOL) and pain with and without a metal rib spreader (MRS) in patients with stage I lung cancer who underwent lobectomy through axillary mini-thoracotomy (AMT).Methods: This single-institution prospective observational study enrolled patients between January 2015 and April 2018. Their QOL and pain were evaluated using the EQ-5D and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 items (QLQ-C30). The EQ-5D was completed preoperatively (Pre) and on days 1/3/5/7 (D1/3/5/7), at 1 month (M1), and at 1 year postoperatively (Y1). The EORTC QLQ-C30 was completed at Pre, M1, and Y1.Results: The data of 140 patients were analyzed (video-assisted without MRS: VA/noMRS: 67, AMT with MRS: AMT/MRS: 73). Although the AMT/MRS group had more preoperative comorbidities, longer operative times, and more blood loss than the VA/noMRS group, the EQ-5D visual analog scale scores were not significantly different at any assessment point (Pre/D1/D3/D5/D7/M1/Y1) (VA/noMRS: 82/48/60/67/73/77/85, AMT/MRS: 80/46/60/66/73/76/85). Postoperative pain in the EQ-5D descriptive system and the EORTC QLQ-C30 was comparable between the groups.Conclusion: VA/noMRS and AMT/MRS showed similar postoperative QOL and pain scores, indicating that MRS negligibly impacts the postoperative QOL and pain.

Our experience with the management of penile fracture: a single institutional prospective observational study in eighteen patients over a two-year period

Background: Penile fracture is a not an unusual encounter in urological emergency. The condition results from disruption of the tunica albuginea which envelops the corpora cavernosa as a result of any condition which leads to the sudden rise of intra-cavernosal pressure. The study was designed to analyse the clinical spectrum and complication of penile fracture.Methods: This is a prospective observational study undertaken from April, 2019 to March, 2021on 18 patients. The demographic profile of all the patients, aetiology of penile fracture, management strategies and pre-operative sexual functions were documented. Erectile function was evaluated using international index of erectile function (IIEF).Results: Seventeen out of 18 patients (94.44%) gave a history of injury during sexual intercourse. Out of the seventeen patients with history of injury following sexual intercourse, only 9 (52.94%) were married. 15 (93.75%) had disruption of the tunica albuginea in the ventrolateral position with 10 patients (66.66%) on the right side. Patients were followed up in the OPD after 2 weeks and then at 6 month and 1-year intervals. At 12 months postop, none of the patients complained of sexual inactivity. Average time to return to sexual activity was 3.2 months. Two patients complained of penile curvature &gt;20 degree. Six patients complained of penile nodule at the site of repair.Conclusions: Penile fracture is a urological emergency which is primarily diagnosed clinically. Prompt diagnosis and surgical exploration gives good outcome in terms of preservation of sexual function.

AN INDIAN PROSPECTIVE STUDY OF DOCETAXEL THERAPY IN CRPC: CAN PRETREATMENT FACTORS PREDICT THE RESPONSE

Introduction: Studies on the effects of chemotherapy in Indian Castration-Resistant Prostate Cancer (CRPC) patients are very limited and world data is inconsistent. The purpose of the present study is to assess the effects of Docetaxel therapy in CRPC in Indian patients in terms of survival benet, both progression-free survival, and overall survival. This study also analyzes the effects of various factors on the survival of CRPC patients. Methodology: This is a single institutional prospective observational study. CRPC patients were treated with Docetaxel and followed till death as the primary endpoint or till the end of the study. Survivals were calculated with the Kaplan Meier method. Factors affecting survival were analyzed with univariate and multivariate analysis by log-rank t-test and Cox proportion hazard regression analysis. Result: Out of enrolled 101 patients, 78 were treated with Docetaxel. A decline in PSA (&gt;50% reduction) was observed in 61.54%. Radiological response of regression noted in 40 % Nuclear Bone Scan and 19.23% CT/MRI by RECIST criteria. Progression-free survival and overall survival with Docetaxel (n=78) were 11.8 and 21 months respectively. Hemoglobin less than 11 gm%, Alkaline phosphatase more than 115 IU/dl, PSAmore than 14 ng/ml, Gleason score more than 7 and duration from diagnosis of carcinoma prostate to CRPC less than 24 months, the number of chemotherapy cycles less than 6 were all found to be signicantly associated with poor overall survival in univariate analysis while only Hemoglobin (P=0.0159) showed an independent association with overall survival in multivariate analysis. Conclusion: Overall and progression-free survival of CRPC patients with Docetaxel is 21 &amp; 11.8 months respectively. Hemoglobin, Alkaline phosphatase, PSA, Gleason score, Docetaxel cycle, and duration from diagnosis of carcinoma prostate to CRPC were found to be signicantly associated with poor overall survival.

Quality of Life in Patients with Nasal Obstruction after Septoplasty: A Single Institution Prospective Observational Study.

Introduction Nasal obstruction is a common symptom in otorhinolaryngological practice. It can impact significantly on the quality of life of the individual. Objective The primary goal of the present study was to evaluate quality of life after septoplasty in adults with nasal obstruction. A secondary goal was to assess the effectiveness of septoplasty. Methods This was a single institution prospective observational study. Patients had experienced septal deviation and symptomatic nasal obstruction with no benefit from medical treatment. There were 51 patients who completed the Nasal Obstruction Symptom Evaluation (NOSE-POL) scale as well as theVisual Analogue Scale (VAS) before undergoing septoplasty, 3 months later, and finally 7 months after surgery. Patients evaluated changes in their nasal obstruction and changes in their quality of life using the Clinical Global Impression Scale (CGI-S). Results There was a significant improvement in nasal obstruction after septoplasty. Before septoplasty, the mean score on NOSE was 60.3 ± 20.4; 3 months after surgery, it was 32.9 ± 16.8; and 7 months after surgery it was 39.6 ± 33.2. The VAS results also proved a significant enhancement in nasal obstruction after septoplasty. Patients reported an improvement in nasal obstruction as well as a positive change in quality of life, confirming the effectiveness of septoplasty. Conclusions In patients with deformed septum, septoplasty contributes to high satisfaction of the patient and a compelling improvement in disease-specific quality of life. The NOSE-POL questionnaire is a useful tool for measuring the outcomes of this procedure.

Chemotherapeutic drug-induced nail changes: A prospective observational study

Background: Nail changes associated with chemotherapeutic drugs are common and can compromise the quality of life of cancer patients if left overlooked by a clinician. Aim: The aim of this study was to study the common pattern of nail changes caused by chemotherapeutic drugs. Materials and Methods: A single-institutional prospective observational study was conducted for patients with histopathologically proven malignancy without prior nail changes undergoing first-line systemic chemotherapy. Analysis of frequency distribution and associations of categorical variables was performed by Chi-square test and multivariate analysis, using IBM SPSS statistics version 21 for Windows. P ≤ 0.05 was considered statistically significant. Results: The incidence of nail changes in the present study was 42% (182 out of 434 cases). Nail changes were commonly observed following 1–2 cycles of chemotherapy, and most of them were Grade 1 changes. The most common nail change observed was chromonychia (49%), followed by onychorrhexis (29%). Chemotherapeutic drugs frequently associated were taxane (65.3%) and platinum compounds (57.7%). Nail changes found associated with taxane included the largest varieties, i.e., chromonychia, onychorrhexis, splinter hemorrhage, Terry′s nail, half-and-half nail, Beau′s lines, onychodystrophy, and paronychia. Nail changes associated with platinum drugs were onychorrhexis and chromonychia. Adriamycin, bleomycin, vinblastine, and dacarbazine regimen was associated with leukonychia. Adriamycin and cyclophosphamide both were independently associated with chromonychia. Conclusion: A knowledge of chemotherapy-induced nail changes can avoid inadvertent diagnostic interventions and improve the quality of life by timely and proper patient counseling.

Helical tomotherapy for prostate cancer radiation therapy: An audit of early toxicity and quality of life

Radiation plays a major role in the management of localized prostate cancer (CaP). There are limited studies reporting the quality of life (QOL) and toxicity with CaP tomotherapy. This is a single-institutional prospective observational study evaluating the acute toxicity and QOL of patients with CaP receiving tomotherapy from May 2018 to October 2019. Toxicity assessed using radiation therapy oncology group toxicity grading. QOL assessed using International Prostate Symptom Score (IPSS) and QOL score. A total number of 74 patients received radiation therapy (RT), of which 25 had postoperative RT and 49 had radical RT. The median age was 71 years. During RT, 8 (10.8%) had Grade 2 gastrointestinal (GI) and 4 (5.4%) had Grade 2 genito urinary (GU) toxicities. At 3 months, 1 (1.4%) had Grade 2 GI, 1 (1.4%) had Grade 2 GU, and 1 (1.4%) had Grade 3 GU toxicities. At 6 months, 1 patient had Grade 2 GU and no Grade 2 GI toxicity noted. In postoperative RT Group, 2 (8%) Grade 2 GI and 1 (1.4%) Grade 2 genitourinary toxicity reported during radiation. At 3 months, 1 (1.4%) Grade 2 GI, 1 (1.4%) G2 GU, and 1 (1.4%) G3 GU toxicities noted. At 6 months, no ≥ Grade 2 noted. In radical RT group, during radiation 6 (12.2%) Grade 2 GI and 3 (6.1%) Grade 2 GU recorded. At 3 and 6 months, no ≥ Grade 2 GI/GU toxicity was recorded. No Grade 3/Grade 4 observed in radical RT group. One patient in radical RT and one in postoperative RT had severe IPSS symptom score. Results are comparable to reported studies. Our initial clinical experience with helical tomotherapy in CaP confirms lower rate of toxicities and no significant worsening of QOL with RT.

High-Dimensional Characterization of the Systemic Immune Landscape Informs on Synergism Between Radiation Therapy and Immune Checkpoint Blockade

Improved antitumor responses have been observed in patients after combination radiation therapy (RT) and immune checkpoint blockade (ICB). Whether these clinical responses are linked to the host systemic immune system has not been elucidated. In this single-institution prospective observational study, peripheral blood was longitudinally collected from 10 patients with metastatic disease who had responded to anti-PD-1/anti-PD-L1 ICB and received RT (8-50 Gy in 1-5 fractions) upon disease progression at the following timepoints: baseline (pre-RT), 1 to 2 weeks post-RT, and post-ICB (cycle 1) on reintroduction post-RT. To thoroughly characterize the interaction between combined RT-ICB and the host immune system, we performed high-dimensional, mass cytometry-based immunophenotyping of circulating lymphocytes using a 40-marker panel addressing lineage, differentiation, activation, trafficking, cytotoxicity, and costimulatory and inhibitory functions. Phenotypic expression of circulating lymphocytes was compared across patients and time points and correlated with post-RT tumor responses. Foremost, we demonstrated excellent posttreatment clinical responses, including 4 local responses with >50% reduction in radiated tumor size, 1 out-of-field response, and 4 patients who resumed ICB for >1 year. Baseline and post-RT immune states were highly heterogeneous among patients. Despite this interindividual heterogeneity in baseline immune states, we observed a systemic immune reaction to RT-ICB common across patients, histology, and radiation sites; a subset of pre-existing Ki-67+ CD8+ T cells were increased post-RT and further expanded upon reintroduction of ICB post-RT (2.3-fold increase, P = .02). Importantly, RT did not alter the phenotypic profile of these Ki-67+ CD8+ T cells, which was characterized by a distinct activated and differentiated effector phenotype. Collectively, these findings point toward a sustained reinvigoration of host antitumor immunity after RT-ICB and suggest an expansion in activated Ki-67+ CD8+ T cells as a possible demonstration of this synergy, thereby providing new insights that may support the development of optimal sequencing strategies.

Exploring optimal examination to detect occult anastomotic leakage after rectal resection in patients with diverting stoma

BackgroundWhen considering “early stoma closure”, both standardized inclusion/exclusion criteria and standardized methods to assess anastomosis are necessary to reduce the risk of occult anastomotic leakage (AL). However, in the immediate postoperative period, neither have the incidence and risk factors of occult AL in patients with diverting stoma (DS) been clarified nor have methods to assess anastomosis been standardized. The aim of this study was to elucidate the incidence and risk factors of occult AL in patients who had undergone rectal resection with DS and to evaluate the significance of computed tomography (CT) following water-soluble contrast enema (CE) to detect occult anastomotic leakage.MethodsThis was a single institutional prospective observational study of patients who had undergone rectal resection with the selective use of DS between May and October 2019. Fifteen patients had undergone CE and CT to assess for AL on postoperative day (POD) 7, and CT was performed just after CE. Univariate analysis was performed to assess the relationship between preoperative variables and the incidence of occult AL on POD 7.ResultsThe incidence of occult AL on postoperative day 7 was 6 of 15 (40%). Hand-sewn anastomosis, compared with stapled anastomosis, was a significant risk factor. Five more cases with occult AL that could not be detected with CE could be detected on CT following CE; CE alone had a 33% false-negative radiological result rate.ConclusionsHand-sewn anastomosis appeared to be a risk factor for occult AL, and CE alone had a high false-negative radiological result rate. When considering the introduction of early stoma closure, stapled anastomosis and CT following CE could be an appropriate inclusion criterion and preoperative examination, respectively.

Comprehensive genomic profiling for chemotherapy-naïve advanced gastrointestinal malignancies.

832 Background: From June, 2019, two comprehensive genomic profiling (CGP) assays, "FoundationOne CDx" and “OncoGuide NCC Oncopanel”, were reimbursed by the national insurance system in Japan for patients who were refractory to standard chemotherapy. However, their clinical utility for chemotherapy-naïve cancer patients is unknown. Methods: We conducted a single institutional prospective observational study to evaluate the clinical utility of FoundationOne CDx assay (Cambridge, MA, USA) for the patients with chemotherapy-naïve advanced gastrointestinal malignancies. Patients with adequate H.E. sample were registered in this study. Primary outcome was the detection rate of at least one actionable/druggable cancer genomic alterations. The evidence levels were classified according to clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (Edition 1.0) (Sunami K. Cancer Sci. 2018). Results: From October 2018 to June 2019, a total of 238 patients were screened and the following 158 patients were registered: colorectal cancer (n = 60), gastric cancer (n = 19), esophageal cancer (n = 23), pancreatic cancer (n = 30), biliary tract cancer (n = 11), rare gastrointestinal malignancies (n = 15). The CGP data were obtained for 113 patients . Median turn-around time was 14 days (range 10-247 days). Actionable/druggable cancer genomic alterations were observed in 113 patients (100%)/ 65 patients (57.5%), respectively. Clinically relevant biomarkers and genomic alterations were identified in 22 patients (19.5%); BRCA2 (n = 4), ERBB2 (n = 4) , BRAF (n = 3) , EGFR (n = 3), FGFR2 (n = 2), MET (n = 2), NTRK (n = 2) , MSI-H (n = 2 ), TMB-high (n = 2), ALK (n = 1) , KIT (n = 1) and ROS1 (n = 1). Of note, novel biomarkers such as ROS1- GOPC fusion and PALB2 rearrangement were obtained in the patients with esophageal squamous cell carcinoma. Conclusions: This is the first study to evaluate the clinical utility of CGP in patient with chemotherapy-naïve advanced gastrointestinal malignancies. Our result indicated that CGP might provide a chance of potentially effective drugs as a novel approach in precision cancer medicine. Clinical trial information: UMIN000034830.

MDCT evaluation of fractures injuries of joints in patients with lower extremity trauma: A single institution prospective observational study

MDCT evaluation of fractures injuries of joints in patients with lower extremity trauma: A single institution prospective observational study