Chembio DPP COVID-19 IgM/IgG Serological Testing: Laboratory Validation, Guidelines, and Recommendations.

BACKGROUND: On January 30, 2020, WHO declared COVID-19 a pandemic. In this article we describe our experience at Richmond University Medical Center with Chembio serological IgM, IgG testing. METHODS: In this prospective cohort study of patients and hospital employees, we utilized Chembio COVID-19 IgM/IgG serological testing in addition to Cepheid RT-PCR analysis. RESULTS: We evaluated the performance of Chembio serological test for IgM and IgG as an employee screening tool in a community hospital setting. The total number of currently asymptomatic employees screened was 1,866 from the Richmond University Medical Center. The non-exposed group included 1,253 (67.1%) employees with no significant clinical history and non-reactive IgM and IgG antibodies. The convalescent group included 255 (13.7%) of the employees with elevation of IgG only, 18 (1%) employees with past history of positive PCR and COVID-19 who currently have non-reactive IgM and IgG antibodies or demonstrate elevated IgG only, followed by 3 employees (< 1%) with no past clinical history who demonstrated reactive IgM and IgG antibodies and negative follow up by PCR. The reported 14.9% exposure/convalescent rate is lower than the reported 20% by the Department of Health and Governor Andrew Cuomo and may represent a better utilization of personal protective equipment, better hand washing techniques, and better disinfection procedures combined with strict social distancing. CONCLUSIONS: Chembio's performance is satisfactory; however, hospitals must design their own policies addressing: who needs to be screened and who will interpret the results as well as constructing management algorithms for employees with no previous history and current double positive antibodies.

Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study.

BACKGROUND: Rectum-sparing approaches appear to be appropriate in rectal cancer patients with a major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The aim of the present study is to evaluate the effectiveness of rectum-sparing approaches at 2 years after the completion of neoadjuvant treatment. STUDY DESIGN: Patients with rectal adenocarcinoma eligible to receive neoadjuvant therapy will be prospectively enrolled. Patients will be restaged 7-8 weeks after the completion of neoadjuvant therapy and those with mCR (defined as absence of mass, small mucosal irregularity no more than 2 cm in diameter at endoscopy and no metastatic nodes at MRI) or cCR will be enrolled in the trial. Patients with mCR will undergo local excision, while patients with cCR will either undergo local excision or watch and wait policy. The main end point of the study is to determine the percentage of rectum preservation at 2 years in the enrolled patients. CONCLUSION: This protocol is the first prospective trial that investigates the role of both local excision and watch and wait approaches in patients treated with neoadjuvant therapy for rectal cancer. The trial is registered at clinicaltrials.gov (NCT02710812).

Bowel function and quality of life after local excision or total mesorectal excision following chemoradiotherapy for rectal cancer.

BACKGROUND: Local excision for rectal cancer is expected to offer a better functional outcome than conventional surgery. The aim of the present study was to compare quality of life and bowel function in patients with rectal cancer who underwent either local excision or conventional surgery after chemoradiotherapy. METHODS: This was a retrospective multicentre study. Patients who underwent local excision were compared with those who had mesorectal excision. Quality of life and bowel function were investigated using validated questionnaires (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29 and Memorial Sloan-Kettering Cancer Center Bowel Function Instrument) at a median follow-up of 49 (range 13-95) months. Further analysis was undertaken of data from patients who underwent local excision alone compared with those requiring subsequent radical surgery. Statistical significance was set at P < 0·010. RESULTS: The mean constipation score was significantly better in the local excision group than in the mesorectal excision group (3·8 (95 per cent c.i. 0·3 to 7·2) versus 19·8 (12·1 to 27·4); P < 0·001). Compared with patients who underwent mesorectal excision, those who had local excision had less sensation of incomplete emptying (mean score 3·7 (3·4 to 4·0) versus 2·8 (2·5 to 3·1); P < 0·001) and second bowel movements within 15 min (mean score 3·6 (3·3 to 3·9) versus 3·0 (2·7 to 3·3); P = 0·006). Patients who underwent local excision alone scored better than those who had mesorectal excision, particularly for bowel function, who, in turn, scored better than patients requiring subsequent radical surgery following local excision. CONCLUSION: Patients who underwent local excision had a better quality of life and bowel function than those who underwent mesorectal excision.

Transanal endoscopic microsurgery for the treatment of selected patients with distal rectal cancer: 15 years experience.

BACKGROUND: Local therapy for early rectal cancer is a valid alternative to the classical radical operation, which has a higher morbidity and mortality rate. The use of high-dose preoperative radiation appears to enhance the options for sphincter-saving surgery even for T2-T3 rectal cancer patients with effective local control. The authors report their experience with transanal endoscopic microsurgery (TEM) used to manage selected cases of distal rectal cancer without evidence of nodal or distant metastasis (N0-M0). METHODS: The study enrolled 196 patients with rectal cancer (51 T1, 84 T2, and 61 T3). All the patients staged preoperatively as T2 and T3 underwent preoperative high-dose radiotherapy, and since 1997, patients younger than 70 years in good general condition also have undergone preoperative chemotherapy. RESULTS: Minor complications were observed in 17 patients (8.6%) and major complications in only 3 patients (1.5%). The definitive histology was 33 pT0 (17%), 73 pT1 (37%), 66 pT2 (34%), and 24 pT3 (12%). Eight patients (5 pT2 and 3 pT3) experienced local recurrence (4.1%). The rectal cancer-specific survival rate at the end of the follow-up period was 100% for pT1, 90% for pT2, and 77% for pT3 patients. CONCLUSIONS: Patients with T1 cancer and favorable histologic features may undergo local excision alone, whereas those with T2 and T3 rectal cancer require preoperative radiochemotherapy. The results in the authors' experience after TEM appear not to be substantially different in terms of local recurrence and survival rate from those described for conventional surgery.

Anemia may influence the outcome of patients undergoing neo-adjuvant treatment of rectal cancer.

BACKGROUND: We hypothesized that anemia could represent one of the major factors influencing the outcome of patients undergoing neo-adjuvant treatment of rectal cancer. PATIENTS AND METHODS: This analysis included all the consecutive patients who underwent neo-adjuvant treatment (chemotherapy and/or radiotherapy) before surgery for rectal cancer in three oncology/radiotherapy departments from June 1996 to December 2003. RESULTS: Three hundred and seventeen patients were eligible for our analysis. Median age at diagnosis was 64 years (range 26-88 years); male/female ratio was 184/133. Two hundred and eighty-five patients (89.9%) were diagnosed with adenocarcinoma, while 32/317 (10.1%) with mucinous adenocarcinoma. Neo-adjuvant treatments carried out were as follows: radiotherapy alone in 75/317 patients (23.7%), radiotherapy plus chemotherapy in 242/317 patients (76.3%). At univariate and multivariate analysis, only the hemoglobin (Hb) level (group 1: < or=12 g/dl versus group 2: >12 g/dl) resulted in a significant factor for disease-free survival. The role of the Hb level seemed to be confirmed further by the clinical downstaging obtained in approximately 55% of patients in group 2, in comparison with 35% of the patients achieving a significant downstaging in group 1. CONCLUSION: Our results indicated that anemia could represent an important parameter able to influence the outcome in patients receiving neo-adjuvant treatment of rectal cancer.

Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study.

BACKGROUND: The aim of the study was to evaluate tolerance and efficacy of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally advanced, resectable, rectal cancer. PATIENTS AND METHODS: Fifty-three patients with potentially resectable T3, N0-2 (87%) and T4, N0-2 (13%) rectal cancer were treated with capecitabine (825 mg/m2, twice daily for 7 days/week) and concomitant RT (50.4 Gy/28 fractions). Patients underwent surgery after 6-8 weeks followed, upon physician's indications, by 4-months adjuvant capecitabine. The primary end point was to determine the rate of pathologic complete response. Secondary end points were to assess the rate of clinical response and the safety profile. RESULTS: All patients but two completed the RT programme and 47 (89%) received 81%-100% of the capecitabine dose (100% of dose in 72% patients, 81%-95% in 17% patients and 48%-74% in 11% of patients). No patient had grade 4 toxicity. Grade 3 toxicity occurred in six patients (11%) and consisted mainly of leucopenia (4%) and hand-foot syndrome (4%). Mild or moderate toxicity was common and included leucopenia (72%), diarrhea (40%), proctitis (34%) and skin toxicity (20%). The overall clinical response rate was 58% and the downstaging rate was 57%, with a pathologic complete response rate of 24%. Among 34 patients with low-lying tumors (

Feasibility of preoperative chemoradiation in rectal cancer patients aged 70 and older.

In the present study, we report results of 28 rectal cancer patients, aged 70 years and older, treated with preoperative radiotherapy and 5FU concomitant chemotherapy. Twenty-eight out of 136 patients treated in our Department between 1997 and 2004 aged > or = 70 years, mean 73 (range 70-81); 3 T2, 18 T3, 7 T4; 15 N0, 5N1, 8 N2; Radiotherapy (5040 cGy, 28 fractions) was delivered combined with 5FU - based concomitant chemotherapy. Compliance to chemoradiotherapy was excellent. Major acute toxicity (> or = G3) evaluation showed haematological Grade 3 only in 2 patients. No severe acute Gastrointestinal toxicity was observed. All patients underwent surgery without severe perioperative complications. Complete pathological response pT0 was found in 3 patients (11%). Overall T downstaging occurred in 61% of the cases. Mean follow up was 34 months (range 4- 84). Kaplan Meier Overall Survival and Disease Free Survival at 5 years were 74% (95% CI 54 -95) and 65% (95% CI 38-93), respectively. Only 1 patient showed G3 diarrhea according to CTCAE that interfered with his Quality of Life and required hospitalization. In conclusion, concomitant radiochemotherapy 5FU based is safe in rectal cancer patients aged > or = 70 with a good tumour downstaging (61% of patients) and excellent feasibility. No treatment related death was observed.

Cost- and time-sparing simplified conformal therapy for prostate cancer: is it feasible?

PURPOSE: It was hypothesized that using a simplified technique of volumes profiles determination (STVPD) based on CT data sets (correlate and projection) would increase the target dose without increasing the bladder and rectal dose obtained by conventional simulation techniques. To test this hypothesis, patients referred for radical radiation treatment for prostate carcinoma were prospectively evaluated by performing treatment planning using standard simulation, with (SSB) and without corner blocks (SSWB), STVPD, and 3D beam's eye view. METHODS AND MATERIALS: Twenty-one patients with prostate carcinoma (stage B: 7; stage C: 14) underwent four treatment planning procedures where the field arrangement was defined by standard simulation (SSB and SSWB), STVPD, and 3D beam's eye view (BEV) with a four field (10 MV photons) box technique. Dose-volume histograms (DVHs) for the planning target volume (PTV), bladder, and rectum (relatives to the four techniques) were generated for all patients and compared; average percentage dose to the bladder and rectum were also calculated. RESULTS: STVPD and 3D BEV treated an increased percentage of PTV at 95% isodose level, in comparison to standard simulation (with and without blocks). No statistically significant differences were found between the two techniques. A significant reduction of irradiated bladder volume was found between 3D BEV and STVPD versus simulation with and without blocks (mean percentage dose: 77.3%, 81.8%, 93.5%, and 92.6% respectively). No marked differences were recorded in rectal irradiation (mean percentage dose: 53.1%, 53.7%, 51.9%, and 50.2% respectively). Time required for treatment planning (excluding CT scan and definitive simulation) was less than 15 minutes for STVPD and more than 120 minutes for 3D BEV. CONCLUSION: Our results confirm the inadequacy of standard simulation. It is possible, with conformal therapy, to increase the dose to the PTV, decreasing the irradiated volume of the bladder. The absence of sparing effect in the rectum is discussed. Using a box technique, STVPD can be used routinely to define the PTV in patients with prostate cancer, reducing the time required for treatment planning, with dosimetric results similar to those of 3D BEV.

Cancer of the anal canal and local control.

Concomitant radiochemotherapy is the standard treatment of squamous cell carcinoma of the anal canal. It can afford a high local control rate though the same impact has not been observed on survival. A few reports have concerned the impact of local control on distant metastases and survival. From 1988 to 1998 at the "Divisione di Radioterapia" of the "Università Cattolica del S. Cuore" of Rome 30 patients with squamous cell carcinoma of the anal canal were treated for cure. Treatment consisted of two cycles of radiotherapy (23.4 Gy) with a 4-5 week split in each cycle. 5FU (100 mg/sqm/24 h) was administered in continuous infusion for the first 4 days of therapy; mitomycin C (10 mg/sqm bolus) was administered on day 1, 4-6 weeks after the end of cycle 2 of concomitant radiochemotherapy, patients received a boost of interstitial brachytherapy. Local control on T of all patients was 84% at 5 years. Six patients showed locoregional recurrence: 3 recurrences on T and 4 disease progressions in locoregional lymph nodes. 3 of 6 patients underwent salvage surgery. The initial extent of the disease, the patient's age and brachytherapy boost did not have a statistically significant influence on local control. Two of the 30 patients showed liver metastases, and at their appearance, one patient was free of local disease while the other showed locoregional progression after Miles' operation for salvage. The metastasis-free interval was not significantly influenced by local control, although at 5 years, 96% of patients with local control of T were free of metastases vs 75% of those with recurrence on T (p = 0.22). Overall actuarial survival at 5 years was 75%. The behavior of survival in our experience seemed to be significantly influenced by local control: in the group with local control, 5-year survival was 85% vs 40% of patients with local recurrence (p = 0.01).

Is chemoradiation feasible in elderly patients? A study of 17 patients with anorectal carcinoma.

BACKGROUND: Cancer in the elderly is becoming an increasing public health problem. Nevertheless, several authors have noted the relative lack of information regarding the treatment of cancer in the elderly. The aim of this study was to determine the tolerance of concomitant chemoradiation in patients age > or = 75 years with anorectal carcinoma. METHODS: The patients were selected for treatment on the basis of the absence of major concurrent diseases, normal blood count values, good cardiac and renal function, and good general condition (defined as not requiring personal assistance). Seventeen patients (8 men and 9 women with a median age of 79 years [range, 75-90 years]) were treated with concomitant chemoradiation (bolus mitomycin C, 10 mg/m2 on Day 1 and continuous infusion 5-fluorouracil [5-FU], 1000 mg/m2 for 24 hours on Days 1-4 [FUMIR]). The doses and volumes of pelvic radiation therapy ranged between 38-45 grays according to the primary tumor site and the intent of treatment (curative vs. palliative). RESULTS: The total incidence of Radiation Therapy Oncology Group Grade 3 acute toxicity was 18% (3 of 17 patients). Only 1 patient (6%) was unable to complete the treatment course. With a median follow-up of 26 months, no severe late toxicity was recorded. Sixteen of 17 had >50% reduction in the greatest dimension of the lesion, 6 patients had a complete response (2 rectal and 4 anal tumors), and 12 patients preserved their sphincter function. Of the four patients who had presented with pelvic pain, all had pain relief. Of the six patients who had presented with rectal bleeding, the bleeding was controlled in five patients. CONCLUSIONS: Concomitant chemoradiation according to the FUMIR schedule used in selected patients age > or = 75 years with anorectal carcinoma can be performed safely.

Organ preservation in carcinoma of the anal canal.

Over a 9-year period, 52 patients with anal carcinoma were observed: there were 18 males and 34 females (ratio: 1:1.9); mean age was 62 years. In 37 patients (71%) the neoplasm origin was in the anal canal, in the margin in 14 (27%) and a coaclogenic form was located in the lower rectum in one. 39 patients (75%) showed an epidermoid carcinoma and 13 (25%) an adenocarcinoma. Treatment consisted in two cycles of 5FU (1000 mg/m2/24 h, day 1-4), mitomycin C (10 mg/m2 bolus, day 1) plus radiotherapy (23.4 Gy, split course with 4- week rest). At 6-8 weeks, brachytherapy was performed for epidermoid lesions of the anal canal and margin while adenocarcinomas were referred to surgery. Sphincter preservation at 5 years was 64%. In epidermoid carcinomas sphincter preservation was 69% vs 45% in adenocarcinomas (p = 0.17). In patients treated with a curative intent and presenting with epidermoid carcinoma of the anal canal, sphincter preservation was 77% vs no patient with adenocarcinoma of the anal canal. In 53% of patients with epidermoid carcinoma of the anal margin there was sphincter preservation. Overall 5-year survival was 62%, better for epidermoid carcinoma (69% vs 36%; p = 0.02) but similar as for the site (anal canal:62%; anal margin:60%).

[The anal canal: 2 cycles of radiochemotherapy and boost brachytherapy]. / Canale anale: due cicli di radiochemioterapia concomitante e sovradosaggio con brachiterapia.

From 1988 to 1996, twenty-six patients with epidermoid anal cancer were examined at the Radiotherapy Department of Università Cattolica del S. Cuore, Rome. At diagnosis, 13 patients were stage II, 11 patients were stage III, 2 patients had a small recurrence after local excision. All the patients were treated with concomitant radiochemotherapy followed by a brachytherapy boost. Treatment was carried out in two cycles 4-5 weeks apart. Chemotherapy consisted of 5FU (1,000 mg/sqm, continuous infusion over the first 4 days) and Mitomycin C (10 mg/sqm on day 1, bolus administration). Radiotherapy was administered with two AP opposed coaxial beams of the same size. The target was T and inguinal, external, internal and common iliac lymph nodes. The total dose for each cycle was 23.4 Gy, administered with conventional fractionation and a daily dose of 180 cGy. Four-six weeks after the end of cycle 2, the patients received a boost of interstitial brachytherapy. During concomitant radiochemotherapy, grade 3-4 (RTOG-EORTC scale) acute hematologic and cutaneous toxicities were observed in 15% and 4% of patients, respectively; treatment was discontinued in 4 patients. Complete response was observed in 21 patients (81%) and partial response in 5 (19%). The later underwent surgery, namely local excision in 1 patient and abdominoperineal resection in 4 patients. The median observation period of our study population was 45 months. Five-year actuarial local control of the 26 patients was 88%. Five year actuarial survival was 75% and sphincter conservation 77%. Our results confirm the data reported by Cummings of Princess Margaret Hospital, who observed low toxicity when the two cycles of concomitant radiochemotherapy are split. Randomized phase-III studies should clarify the potential role of the new radiochemotherapy combinations which should be compared with reference treatments providing repeatable results and low toxicity. Our treatment may make a reference for more innovative combinations of radiochemotherapy.

Quality assurance program in radiotherapy for carcinoma of the uterine cervix.

Some uncertainties which impact on the quality of exclusive radiation therapy of carcinoma of the cervix and the operational procedures followed to lower treatment inaccuracies, are analyzed. In particular the following phase of radiation therapy are considered: prescription: indication for the dose and volume to be treated with external beam radiotherapy (ERT) or intracavitary brachytherapy (BRT) according to the different forms; planning: definition of procedures for ERT and BRT optimization; implementation: analysis of systems for checking reproducibility and treatment tolerance; follow-up: planning of clinico-instrumental controls of disease evolution and late toxicity.

Quality assurance procedures in radiotherapy of brain tumors.

Within the wide range of brain tumor types and their various radiotherapy treatments, quality assurance (QA) criteria play a major role. Attention should be paid to the definition of GTV, CTV, PTV, relevant to 3D stereotactic radiotherapy. In fact the need for delivering high doses with acceptable toxicity, requires an interdisciplinary evaluation of the clinical case as well as a millimetric precision and safety. Conventional treatments with collimated beams are however extensively studied and errors and deviations which may impact on treatment protocol, are identified. Possible GTV and CTV under-and overestimation is described by various authors who point out the useful support of sophisticated diagnostic and therapeutic equipment. It is stressed that follow-up helps in the reappraisal of the many items of a QA program to detect errors in set-up or implementation as well as possible inadequacies in the initial treatment planning.

START: an advanced radiation therapy information system.

START is an advanced radiation therapy information system (RTIS) which connects direct information technology present in the devices with indirect information technology for clinical, administrative, information management integrated with the hospital information system (HIS). The following objectives are pursued: to support decision making in treatment planning and functional and information integration with the rest of the hospital; to enhance organizational efficiency of a Radiation Therapy Department; to facilitate the statistical evaluation of clinical data and managerial performance assessment; to ensure the safety and confidentiality of used data. For its development a working method based on the involvement of all operators of the Radiation Therapy Department, was applied. Its introduction in the work activity was gradual, trying to reuse and integrate the existing information applications. The START information flow identifies four major phases: admission, visit of admission, planning, therapy. The system main functionalities available to the radiotherapist are: clinical history/medical report linking function; folder function; planning function; tracking function; electronic mail and banner function; statistical function; management function. Functions available to the radiotherapy technician are: the room daily list function; management function: to the nurse the following functions are available: patient directing function; management function. START is a departmental client (pc-windows)-server (unix) developed on an integrated database of all information of interest (clinical, organizational and administrative) coherent with the standard and with a modular architecture which can evolve with additional functionalities in subsequent times. For a more thorough evaluation of its impact on the daily activity of a radiation therapy facility, a prolonged clinical validation is in progress.