ABSTRACT
Background: SARS-COV-2 anti-Spike IgG response following mRNA vaccination (BNT162b2) is suboptimal and highly variable in MM patients. Patients and Methods: We report here a single-institution retrospective analysis of 127 consecutive patients with symptomatic MM (71 males, 56 females), [median age 69.5 years (range 45-85)], 63 patients with untreated MM and 64 patients with MM refractory to one or more previous treatment lines. Myeloma therapies included PI+IMiD combos, IMiD-based regimens, PI-based regimens, anti-CD38 mAb-based therapies, antibody-drug conjugates (Belantamab Mafodotin monotherapy), dexamethasone and high dose melphalan. Anti-spike IgG antibody were detected also in 50 healthy volunteers. Patients with symptomatic MM and healthy controls received two dose of COVID-19 mRNA vaccine (Pfizer BioNTech) on days 1 and 21 between 29 April and 15 May 2021. Patients with prior history of SARS-CoV-2 were excluded from analysis. Quantitative determination of anti-spike S1/S2 IgG antibody was performed at 4 weeks from vaccination completion (LIAISONR SARS-COV-2 S1/S2 IgG, LIAISONR). It was previously established a threshold >15 AU/ml of anti-Spike IgG which was related to neutralizing activity of anti-SARS-COV-2 antibodies. Results: Sixty-five out of 127 patients were evaluable for response. Antispike IgG antibody were detected in 50/65 (76.9%) MM patients, defined as responders [177 AU/mL (range 26.4 - 1430)]. 23.1% of MM patients, defined as non-responders, failed to respond at two doses of COVID-19 mRNA vaccine [3.8 AU/mL (range 0.65 - 9.33)]. Seroprotection rate at cutoff of 15 AU/mL was 100% in controls [249 AU/mL (range 104 - 2430)]. No statistically significant differences were found between the two subgroups of patients for myeloma disease phase (relapse/refractory MM vs. untreated symptomatic MM), LDH, residual gammaglobulin levels, WBC, ANC, lymphocytic response, age and sex (Tab. 2). Conversely, plasmacytosis, B2M and haemoglobin concentration were associated with a different response to vaccine. Patients with extreme plasmacytosis (60.0 20.3 vs. 28.218.8 meanSD;p <0.001) (Tab. 2) had a mean titer less than 15 AU/ml of anti-Spike IgG compared with patients with a low plasmacytosis, who, conversely, showed significantly higher mean titers of anti-Spike IgG. B2M was significantly higher in non-responders compared to responders (4.6 4.1 vs. 3.23.6 mean SD;p = 0.006) (Tab. 2). Haemoglobin value was significantly lower in non-responders compared to responders (10.8 1.8 vs. 12.11.8 mean SD;p = 0.008) (Tab. 2). Multivariate analysis confirmed the bone marrow infiltration pattern and haemoglobin value as statistically significant variables. In addition, in the present cohort, the myeloma treatment, including high-dose melphalan and autologous stem cell transplantation, have not been associated with SARS-CoV-2 infection. Conclusions: In our experience, significant fraction of MM patients (23.1%) does not developed any detectable anti-Spike IgG after two dose of COVID-19 mRNA vaccine. Lack of IgG response associated with three statistically significant variables: extreme plasmacytosis, B2M, and haemoglobin concentration. In the subgroup of patients with good response to vaccine, after a median follow-up of 7 months from second dose of COVID-19 mRNA vaccine, no cases of COVID-19 occurred. .
ABSTRACT
Background: The COVID-19 pandemic resulted in the use of telemedicine for evaluation and management visits in radiation oncology departments to decrease in-person interactions. The primary objective of this study is to evaluate the utility of telemedicine for patient consultation and its effect on radiotherapy simulation and treatment processes. Methods: A standardized simulation requisition directive was used for all consults (telemedicine and inperson) undergoing simulation for external beam radiation therapy at a single tertiary care institution from January to December 2020. These directives were reviewed at daily multidisciplinary peer review meetings;modifications occurring as a result of this review were prospectively recorded in a departmental quality database. Descriptive statistics were used to identify characteristics associated with consultation type. Mann Whitney and Chisquare tests were used to compare continuous and categorical variables. Results: 1500 consecutive patients were reviewed in this prospective peer review process;444 (29.6%) had telemedicine visits preceding simulation and 1056 (70.4%) had in-person consults. The median time between physician simulation order and date of simulation was 5 days (IQR: 2-11 days) for telemedicine visits and 4 days (IQR: 1-8 days) for in-person consults (p<0.05). Significant differences were observed in telemedicine usage across months (p<0.05) with the highest percentage in July, September, and August (50%, 45.9% and 45%, respectively). As a result of prospective multidisciplinary peer review, 397 modifications in 290 simulations were recorded in total;101/444 (22.7%) telemedicine simulations had modifications compared to 189/1056 (17.9%) following inperson consultation (p<0.05). The most common modifications for telemedicine visits resulted from immobilization device changes (n=32, 23.5%), arm positioning (n=19, 14.0%), and changes in the radiotherapy care path (n=17, 12.5%). For telemedicine consults, the median radiotherapy fraction dose was 2.66 Gy (2-4 Gy) and median fraction number was 16 (5-28). There was no difference for fractionation preference between telemedicine and in person consults (p=0.084). Seven (1.6%) telemedicine visits and 7 (0.7%) in-person consults needed resimulation during the entire study period (p=0.136). Conclusions: Telemedicine is a powerful tool with the potential to revolutionize the radiation oncology daily practice. In the initial learning phase, it appears that there is a higher frequency of simulation modifications for patients evaluated by telemedicine. Therefore, as departmental processes incorporate telemedicine in the future, thorough attention is needed to encourage review of common modifications as well as identify patients at high risk of error at time of simulation who may also benefit from in-person evaluation prior to simulation.
ABSTRACT
The primary objective of this study is to evaluate the utility and value of an institutional, multi-disciplinary peer review process prior to radiotherapy simulation. Over a period of 3 months and through an iterative process, a standardized simulation requisition directive (SSRD) was developed, piloted, modified, and subsequently implemented for all patients treated with external beam radiotherapy at a single tertiary care institution from January to December 2020. The SSRDs were reviewed at a daily multi-disciplinary peer review conference ("morning huddle");modifications in the simulation process consequential to the review were prospectively recorded in a quality database. Descriptive statistics were used to identify characteristics associated with modifications. Independent sample t test and Chi-square test were used to compare continuous and categorical variables. A total of 1500 consecutive SSRDs were prospectively reviewed and met inclusion criteria for this study. The median time between the physician SSRD order and date of simulation was 4 days (Range: 0-97 days), and the majority of patients were treated with curative intent (n = 872, 58%). A total of 369 modifications on 269 (17.9%) simulation directives were recorded and parsed into 17 categories. The most common modifications resulted from omission of pregnancy testing orders (n = 92, 24.9%), immobilization device changes (n = 88, 23.8%), changes in the radiotherapy care path (n = 56, 15.1%), and arm positioning (n = 43, 11.6%). Modifications were less likely to occur if the directives were entered within 1 week of simulation (15.6% vs. 21.7%, P = 0.0028). Significant differences were also observed across tumor sites (P = 0.0091) with the highest modification rates observed for stomach, esophagus, and pelvis sites (40%, 30%, and 26.9% modified, respectively). A significant change in department workflow and clinic visits occurred in March 2020 as a result of COVID-19, with transition to virtual platforms. An increased rate of simulation directive modifications was also observed for patients simulated after these changes were implemented (April – December 2020 19.3% vs. Jan – March 2020 13.5%, P = 0.013). No differences in modification rates were observed by modality, i.e., photon or proton therapy (P = 0.20). Overall, with this prospective peer review process, only 14 patients (0.9%) needed re-simulation during the entire study period. Prospective peer review prior to simulation in radiotherapy identifies actionable change in approximately 18% of procedures, and results in an extremely low, < 1% rate of re-simulation. SSRDs ordered > 1 week before from simulation and gastrointestinal and pelvic sites were at higher risk of requiring modifications during peer review. As departmental processes transition to virtual meeting platforms, more thorough attention is needed to identify patients at higher risk of simulation modifications. [ABSTRACT FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)