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1.
J Clin Oncol ; 40(25): 2946-2956, 2022 09 01.
Article in English | MEDLINE | ID: covidwho-2043160

ABSTRACT

PURPOSE: Combining standard of care (pertuzumab-trastuzumab [PH], chemotherapy) with cancer immunotherapy may potentiate antitumor immunity, cytotoxic activity, and patient outcomes in high-risk, human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We report the phase III IMpassion050 primary analysis of neoadjuvant atezolizumab, PH, and chemotherapy in these patients. METHODS: Patients with a primary tumor of > 2 cm and histologically confirmed, positive lymph node status (T2-4, N1-3, M0) were randomly assigned 1:1 to atezolizumab/placebo with dose-dense doxorubicin/cyclophosphamide, followed by paclitaxel, and PH. After surgery, patients were to continue atezolizumab/placebo and PH (total: 1 year of HER2-targeted therapy); those with residual disease could switch to ado-trastuzumab emtansine with atezolizumab/placebo. Coprimary efficacy end points were pathologic complete response (pCR; ypT0/is ypN0) rates in intention-to-treat (ITT) and programmed cell death-ligand 1 (PD-L1)-positive populations. RESULTS: At clinical cutoff (February 5, 2021), pCR rates in the placebo and atezolizumab groups in the ITT populations were 62.7% (n = 143/228) and 62.4% (n = 141/226), respectively (difference -0.33%; 95% CI, -9.2 to 8.6; P = .9551). The pCR rates in the placebo and atezolizumab groups in patients with PD-L1-positive tumors were 72.5% (n = 79/109) and 64.2% (n = 70/109), respectively (difference -8.26%; 95% CI, -20.6 to 4.0; P = .1846). Grade 3-4 and serious adverse events were more frequent in the atezolizumab versus placebo group. Five grade 5 adverse events occurred (four neoadjuvant, one adjuvant; two assigned to study treatment), all with atezolizumab. Overall, the safety profile was consistent with that of atezolizumab in other combination studies. CONCLUSION: Atezolizumab with neoadjuvant dose-dense doxorubicin/cyclophosphamide-paclitaxel and PH for high-risk, HER2-positive early breast cancer did not increase pCR rates versus placebo in the ITT or PD-L1-positive populations. PH and chemotherapy remains standard of care; longer follow-up may help to inform the long-term impact of atezolizumab.


Subject(s)
Breast Neoplasms , Neoadjuvant Therapy , Antibodies, Monoclonal, Humanized , Antineoplastic Combined Chemotherapy Protocols/adverse effects , B7-H1 Antigen/therapeutic use , Breast Neoplasms/pathology , Cyclophosphamide , Doxorubicin , Female , Humans , Neoadjuvant Therapy/adverse effects , Paclitaxel , Receptor, ErbB-2/metabolism , Trastuzumab , Treatment Outcome
2.
Breast Cancer Res Treat ; 196(1): 87-95, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2014204

ABSTRACT

AIM OF THE STUDY: The study aims to evaluate the performance of selected, high-volume, highly specialized, Italian Breast Centers at the time of COVID-19 pandemic (year 2020), compared to pre-pandemic time (year 2019), highlighting differences in terms of clinical presentation of breast cancer (BC) and therapeutic strategies. METHODS: Patients' data were provided by the Senonetwork data warehouse Senonet. In order to examine changes in the surgical and oncological management of BC patients during different phases of COVID-19 pandemic, we took advantage of a selection quality indicators (QIs). We performed the analyses in two time-frames, from July to September (Jul-Sep) (2019 versus 2020) and from October to December (Oct-Dec) (2019 versus 2020). RESULTS: Our analysis did not show any statistically significant difference in terms of diagnosis, surgical, oncological and radiation therapy procedures between the two trimesters 2019 and 2020. Nevertheless, we observed statistically significant differences, favoring 2020, when analyzing time-to surgery and time-to radiotherapy. On the other hand, we observed a significant reduction of neoadjuvant chemotherapy and we did not recollect any data on a major use of neoadjuvant endocrine therapy. CONCLUSIONS: In Italian Breast Centers, partners of Senonetwork, we could not observe any treatment delay or change in standard clinical practice for BC care during the 2020 pandemic year, compared to 2019 pre-pandemic year. This finding is in contrast with the globally reported decrease in the performance of the Italian Breast Centers due to the COVID-19 pandemic, and has to be linked to the sharp selection of Senonetwork Breast Centers.


Subject(s)
Breast Neoplasms , COVID-19 , Breast , Breast Neoplasms/diagnosis , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , COVID-19/epidemiology , Female , Humans , Italy/epidemiology , Neoadjuvant Therapy , Pandemics
3.
Anticancer Res ; 42(9): 4529-4533, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2010567

ABSTRACT

BACKGROUND/AIM: Many patients with locally advanced cancer of the esophagus or esophagogastric junction receive definitive or neoadjuvant radiochemotherapy. Patient anticipation of this treatment can cause or aggravate distress and sleep disorders. This study aimed to identify the prevalence of sleep disorders and risk factors. PATIENTS AND METHODS: Thirty-eight patients assigned to radio-chemotherapy were retrospectively evaluated for pre-treatment sleep disorders. Investigated characteristics included age; sex; performance score; comorbidity index; previous malignancies; family history; distress score; emotional, physical or practical problems; tumor site; histology and grading; tumor stage; planned treatment; and relation to 2019 Coronavirus pandemic. RESULTS: Sleep problems were reported by 15 patients (39.5%). Significant associations were found for higher distress scores (p=0.016) and greater numbers of emotional problems (p<0.0001). A trend was observed for greater numbers of physical problems (p=0.176). CONCLUSION: The prevalence of sleep problems was high. Risk factors were found that can help identify patients requiring psychological support already prior to radio-chemotherapy.


Subject(s)
Adenocarcinoma , Esophageal Neoplasms , Sleep Wake Disorders , Adenocarcinoma/pathology , Combined Modality Therapy , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/radiotherapy , Esophagectomy , Esophagogastric Junction/pathology , Humans , Neoadjuvant Therapy/adverse effects , Retrospective Studies , Sleep Wake Disorders/epidemiology , Sleep Wake Disorders/etiology , Sleep Wake Disorders/pathology
4.
JAMA Netw Open ; 5(8): e2225118, 2022 08 01.
Article in English | MEDLINE | ID: covidwho-1971183

ABSTRACT

Importance: In response to an increase in COVID-19 infection rates in Ontario, several systemic treatment (ST) regimens delivered in the adjuvant setting for breast cancer were temporarily permitted for neoadjuvant-intent to defer nonurgent breast cancer surgical procedures. Objective: To examine the use and compare short-term outcomes of neoadjuvant-intent vs adjuvant ST in the COVID-19 era compared with the pre-COVID-19 era. Design, Setting, and Participants: This was a retrospective population-based cohort study in Ontario, Canada. Patients with cancer starting selected ST regimens in the COVID-19 era (March 11, 2020, to September 30, 2020) were compared to those in the pre-COVID-19 era (March 11, 2019, to March 10, 2020). Patients were diagnosed with breast cancer within 6 months of starting systemic therapy. Main Outcomes and Measures: Estimates were calculated for the use of neoadjuvant vs adjuvant ST, the likelihood of receiving a surgical procedure, the rate of emergency department visits, hospital admissions, COVID-19 infections, and all-cause mortality between treatment groups over time. Results: Among a total of 10 920 patients included, 7990 (73.2%) started treatment in the pre-COVID-19 era and 7344 (67.3%) received adjuvant ST; the mean (SD) age was 61.6 (13.1) years. Neoadjuvant-intent ST was more common in the COVID-19 era (1404 of 2930 patients [47.9%]) than the pre-COVID-19 era (2172 of 7990 patients [27.2%]), with an odds ratio of 2.46 (95% CI, 2.26-2.69; P < .001). This trend was consistent across a range of ST regimens, but differed according to patient age and geography. The likelihood of receiving surgery following neoadjuvant-intent chemotherapy was similar in the COVID-19 era compared with the pre-COVID-19 era (log-rank P = .06). However, patients with breast cancer receiving neoadjuvant-intent hormonal therapy were significantly more likely to receive surgery in the COVID-19 era (log-rank P < .001). After adjustment, there were no significant changes in the rate of emergency department visits over time between patients receiving neoadjuvant ST, adjuvant ST, or ST only during the ST treatment period or postoperative period. Hospital admissions decreased in the COVID-19 era for patients who received neoadjuvant ST compared with adjuvant ST or ST alone (P for interaction = .01 for both) in either setting. Conclusions and Relevance: In this cohort study, patients were more likely to start neoadjuvant ST in the COVID-19 era, which varied across the province and by indication. There was limited evidence to suggest any substantial impact on short-term outcomes.


Subject(s)
Breast Neoplasms , COVID-19 , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Breast Neoplasms/etiology , COVID-19/epidemiology , Chemotherapy, Adjuvant , Cohort Studies , Female , Humans , Middle Aged , Neoadjuvant Therapy , Ontario/epidemiology , Retrospective Studies
6.
PLoS One ; 17(4): e0267410, 2022.
Article in English | MEDLINE | ID: covidwho-1883697

ABSTRACT

PURPOSE: In the context of the COVID-19 outbreak, the European Association of Urology (EAU) guidelines Rapid Reaction Group provided recommendations to manage muscle invasive bladder cancer (MIBC) based on priority levels: neoadjuvant chemotherapy (NAC) should be avoided for patients with T2-3N0M0 MIBC. This meta-analysis aims to evaluate the efficacy of NAC compared with radical cystectomy (RC) alone in improving the overall survival (OS) of patients with T2-4aN0M0 MIBC. MATERIALS AND METHODS: A systematic review was performed according to the PRISMA guidelines. The PubMed/Medline, EMBASE, and Cochrane Library databases were searched. The primary outcome was OS of patients with T2-4aN0M0 MIBC, and the secondary outcome was OS of patients with only T2N0M0 MIBC. RESULTS: Eight studies were included in this meta-analysis. Overall, the quality of all studies was relatively high, and little publication bias was demonstrated. The OS was significantly better in the NAC with RC group than in RC alone (HR, 0.79; 95% CI, 0.68-0.92; p = 0.002). A subgroup analysis was performed on only patients with T2N0M0 MIBC, and five studies were included. There was no difference in the OS between the NAC with RC and the RC alone groups (HR, 0.83; 95% CI, 0.69-1.01 p = 0.06). CONCLUSIONS: As recommended by the EAU guidelines Rapid Reaction Group, patients with T2N0M0 MIBC should strongly consider omitting NAC until the end of the COVID-19 pandemic. Whether to omit NAC in T3-4aN0M0 MIBC needs further discussion, and studies targeting only T2-3N0M0 MIBC are expected to proceed further.


Subject(s)
COVID-19 , Urinary Bladder Neoplasms , Urology , Cystectomy , Female , Humans , Male , Neoadjuvant Therapy , Neoplasm Invasiveness , Pandemics , Retrospective Studies , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/surgery
7.
JAMA Surg ; 156(4): 398, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1733824
9.
Surgery ; 171(5): 1209-1214, 2022 05.
Article in English | MEDLINE | ID: covidwho-1692860

ABSTRACT

BACKGROUND: COVID-19 has significantly impacted healthcare worldwide. Lack of screening and limited access to healthcare has delayed diagnosis and treatment of various malignancies. The purpose of this study was to determine the effect of the first year of the COVID-19 pandemic on sphincter-preserving surgery in patients with rectal cancer. METHODS: This was a single-center retrospective study of patients undergoing surgery for newly diagnosed rectal cancer. Patients operated on during the first year of the COVID-19 pandemic (March 2020-February 2021) comprised the study group (COVID-19 era), while patients operated on prior to the pandemic (March 2016-February 2020) served as the control group (pre-COVID-19). RESULTS: This study included 234 patients diagnosed with rectal cancer; 180 (77%) patients in the pre-COVID-19 group and 54 patients (23%) in the COVID-19-era group. There were no differences between the groups in terms of mean patient age, sex, or body mass index. The COVID-19-era group presented with a significantly higher rate of locally advanced disease (stage T3/T4 79% vs 58%; P = .02) and metastatic disease (9% vs 3%; P = .05). The COVID-19-era group also had a much higher percentage of patients treated with total neoadjuvant therapy (52% vs 15%; P = .001) and showed a significantly lower rate of sphincter-preserving surgery (73% vs 86%; P = .028). Time from diagnosis to surgery in this group was also significantly longer (median 272 vs 146 days; P < .0001). CONCLUSION: Patients undergoing surgery for rectal cancer during the first year of the COVID-19 pandemic presented later and at a more advanced stage. They were more likely to be treated with total neoadjuvant therapy and were less likely candidates for sphincter-preserving surgery.


Subject(s)
COVID-19 , Rectal Neoplasms , COVID-19/epidemiology , Humans , Neoadjuvant Therapy , Neoplasm Staging , Pandemics , Rectal Neoplasms/pathology , Rectal Neoplasms/surgery , Referral and Consultation , Retrospective Studies , Treatment Outcome
10.
Clin Cancer Res ; 27(16): 4486-4490, 2021 08 15.
Article in English | MEDLINE | ID: covidwho-1691214

ABSTRACT

While COVID-19 vaccine distribution has addressed vulnerabilities related to age and comorbidities, there is a need to ensure vaccination of patients with cancer receiving experimental and routine treatment, where interruption of treatment by infection is likely to result in inferior outcomes. Among patients with cancer, those undergoing neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy (Adj chemo) for early breast cancer (EBC) are at particularly high risk for inferior outcomes, in part, because optimal timing of chemotherapy is essential for promoting distant disease-free survival. COVID-19 data from the ongoing multicenter I-SPY 2 trial of NAC for EBC provides a window into the magnitude of the problem of treatment interruption, not only for the trial itself but also for routine Adj chemo. In the I-SPY 2 trial, 4.5% of patients had disruption of therapy by COVID-19, prior to wide vaccine availability, suggesting that nationally up to 5,700 patients with EBC were at risk for adverse outcomes from COVID-19 infection in 2020. To address this problem, vaccine education and public engagement are essential to overcome hesitancy, while equity of distribution is needed to address access. To accomplish these goals, healthcare organizations (HCO) need to not only call out disinformation but also engage the public with vaccine education and find common ground for vaccine acceptance, while partnering with state/local governments to improve efficiency of vaccine distribution. These approaches are important to improve trial access and to reduce susceptibility to COVID-19, as the pandemic could continue to impact access to clinical trials and routine cancer treatment.


Subject(s)
Breast Neoplasms/drug therapy , COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Vaccination , Clinical Trials as Topic , Female , Health Education , Healthcare Disparities , Humans , Neoadjuvant Therapy
11.
Ann R Coll Surg Engl ; 104(8): 624-631, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1673999

ABSTRACT

INTRODUCTION: The COVID-19 pandemic resulted in a significant disruption of colorectal cancer (CRC) care pathways. This study evaluates the management and outcomes of patients with primary locally advanced or recurrent CRC during the pandemic in a single tertiary referral centre. METHODS: Patients undergoing elective surgery for advanced or recurrent CRC with curative intent between March 2020 and March 2021 were identified. Following first multidisciplinary team discussion patients were broadly classified into two groups: straight to surgery (n=22, 45%) or neoadjuvant therapy followed by surgery (n=27, 55%). Primary outcome was COVID-19-related complication rate. RESULTS: Forty-nine patients with a median age of 66 years (interquartile range: 54-73) were included. No patients developed a COVID-19 infection or related complication during hospital admission. Significant delays were identified in the treatment pathway of patients in the straight to surgery group, mostly due to delays in referral from external centres. Nine of 22 patients in the straight to surgery group had evidence of tumour progression compared with 3 of 27 in the neoadjuvant group (p=0.015839). Seven of 27 patients in the neoadjuvant group showed evidence of tumour regression. During the study, surgical waiting times were reduced, and more operations were performed during the second wave of COVID-19. CONCLUSION: This study suggests that it is possible to mitigate the risks of COVID-19-related complications in patients undergoing complex surgery for locally advanced and recurrent CRC. Delay in surgical intervention is associated with tumour progression, particularly in patients who may not have neoadjuvant therapy. Efforts should be made to prioritise resources for patients requiring time-sensitive surgery for advanced and recurrent CRC.


Subject(s)
COVID-19 , Colorectal Neoplasms , Aged , COVID-19/epidemiology , Colorectal Neoplasms/pathology , Humans , Neoadjuvant Therapy , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Pandemics
12.
Breast ; 62 Suppl 1: S17-S24, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1611638

ABSTRACT

Neoadjuvant treatment (NAT) has become an option in early stage (stage I-II) breast cancer (EBC). New advances in systemic and targeted therapies have increased rates of pathologic complete response increasing the number of patients undergoing NAT. Clear benefits of NAT are downstaging the tumor and the axillary nodes to de-escalate surgery and to evaluate response to treatment. Selection of patients for NAT in EBC rely in several factors that are related to patient characteristics (i.e, age and comorbidities), to tumor histology, to stage at diagnosis and to the potential changes in surgical or adjuvant treatments when NAT is administered. Imaging and histologic confirmation is performed to assess extent of disease y to confirm diagnosis. Besides mammogram and ultrasound, functional breast imaging MRI has been incorporated to better predict treatment response and residual disease. Contrast enhanced mammogram (CEM), shear wave elastography (SWE), or Dynamic Optical Breast Imaging (DOBI) are emerging techniques under investigation for assessment of response to neoadjuvant therapy as well as for predicting response. Surgical plan should be delineated after NAT taking into account baseline characteristics, tumor response and patient desire. In the COVID era, we have witnessed also the increasing use of NAT in patients who may be directed to surgery, unable to have it performed as surgery has been reserved for emergency cases only.


Subject(s)
Breast Neoplasms , COVID-19 , Axilla/pathology , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/pathology , Breast Neoplasms/therapy , Female , Humans , Lymph Nodes/pathology , Neoadjuvant Therapy/methods , Neoplasm Staging
13.
Breast Dis ; 41(1): 1-3, 2022.
Article in English | MEDLINE | ID: covidwho-1604128

ABSTRACT

During the first hit of SARS-COVID pandemic, an important reorganization of Healthcare Services has been done, and new protocols and pathways to protect frail patients like oncological patients were designed. The second hit of pandemic had stressed these new pathways and suggests to health-workers some improvements for safer management of patents.We reported our experience in organizing the clinical pathway of neoadjuvant therapy candidate patients based on the execution of sentinel lympho-node biopsy and the placement of implantable venous access port in the same access to operating room before neoadjuvant chemotherapy suggesting a possible organizational model. In the period October-December 2020 we have included in this new type of path twelve patients and we have not registered any cases of COVID among the patients included. We think this new path, adopted amid the second hit, will be useful for all Breast Units that are facing the challenge of guaranteeing the highest standards of care in a historical moment where the health emergency occupies the efforts of health workers and the economic resources of health systems.


Subject(s)
Antineoplastic Agents/administration & dosage , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Catheterization, Central Venous/methods , Infection Control/methods , Patient Safety , Sentinel Lymph Node Biopsy/methods , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/standards , Central Venous Catheters , Chemotherapy, Adjuvant , Critical Pathways , Female , Humans , Infection Control/standards , Mastectomy , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Sentinel Lymph Node Biopsy/standards
14.
Ann R Coll Surg Engl ; 104(7): e197-e201, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1542158

ABSTRACT

Perioperative oncological therapies resulting in pathological complete response (pCR) in diffuse-type distal gastric adenocarcinoma are extremely rare. We report a case of locally advanced (cT3 N2 M0) diffuse-type distal gastric adenocarcinoma treated with 'total neoadjuvant' FLOT (eight cycles), due to the COVID-19 pandemic, and laparoscopic radical subtotal gastrectomy with D2 lymphadenectomy. The patient demonstrated a progressive radiological response on positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro-d-glucose integrated with computed tomography (18F-FDG PET-CT) and pCR in the resected specimen (ypT0 N0). As far as we are aware, this is the first case of pCR in locally advanced T3 N2 diffuse distal gastric cancer to be reported in the literature. It introduces a novel approach of total neoadjuvant chemotherapy with 18F-FDG PET-CT to assess response, combined with radical minimally invasive surgical management to provide optimal care for patients with gastric cancer.


Subject(s)
Adenocarcinoma , COVID-19 , Stomach Neoplasms , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/drug therapy , Adenocarcinoma/surgery , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Fluorodeoxyglucose F18/therapeutic use , Gastrectomy/methods , Humans , Neoadjuvant Therapy , Pandemics , Positron Emission Tomography Computed Tomography , Stomach Neoplasms/drug therapy , Stomach Neoplasms/pathology , Stomach Neoplasms/surgery
15.
Clin Colorectal Cancer ; 21(2): e117-e125, 2022 06.
Article in English | MEDLINE | ID: covidwho-1540465

ABSTRACT

BACKGROUND: Since the beginning of the COVID-19 pandemic, multiple changes to the provision of cancer care has been introduced to maximize patient safety and protect staff. We aimed to identify factors influencing clinicians' decision on treatment modification during the initial phase of the pandemic, and to assess its impact on outcomes in patients with colorectal cancer. PATIENTS AND METHODS: Electronic records of patients seen in a large United Kingdom tertiary cancer center was reviewed. The frequency and type of changes to systemic anticancer therapy , as well as the factors predicting clinicians' decision were assessed. RESULTS: A total of 418 patients; mean age 63 ± 12 years and 57% male were included. More than half of the patients had modification to their treatment; with treatment delay (21%) or cancellation (10%), being the most common. Majority of patients on neoadjuvant treatment (97%) proceeded with treatment, with some form of treatment modification in 20%. Half of patients on adjuvant treatment had their treatment plan modified. Overall, a change in treatment was more likely in older patients (OR 1.028 [95% CI 1.010-1.047]; P = .002), and in patients who had already received higher number of cycles of systemic anticancer therapy (OR 1.040 [95% CI 1.016-1.065]; P = .001). A change in treatment was less likely further out of the first national lockdown (OR 0.837 [95% CI 0.758-0.925]; P < .001). Patients on third-line treatment were most likely to have alterations to their treatment plan (69%, n=33/48). CONCLUSION: During the first wave of COVID-19 in the United Kingdom, clinicians adapted clinical practice in accordance to local and national guidance, especially amongst older patients and those on third-line treatment. Further real-world data are needed to document the important impact of changes to treatment on outcomes in patients with cancer.


Subject(s)
COVID-19 , Colorectal Neoplasms , Aged , Colorectal Neoplasms/drug therapy , Communicable Disease Control , Female , Humans , Male , Middle Aged , Neoadjuvant Therapy , Pandemics
16.
Ann Surg Oncol ; 29(4): 2231-2239, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1528704

ABSTRACT

INTRODUCTION: The COVID-19 pandemic caused delays in breast cancer management forcing clinicians to potentially alter treatment recommendations. This study compared breast cancer stage at diagnosis and rates of neoadjuvant therapy among women presenting to our institution before and during COVID-19. METHODS: Retrospective chart review of patients with a new breast cancer diagnosis from March 2020-August 2020 (during-COVID-19) were compared with March 2019-August 2019 (pre-COVID-19). We compared stage at diagnosis, clinical/demographic features, and neoadjuvant therapy use between the time periods. RESULTS: A total of 573 patients included: 376 pre-COVID-19, 197 during-COVID-19. Method of cancer detection was by imaging in 66% versus 63% and by physical findings/symptoms in 34% versus 37% of patients comparing pre-COVID-19 to during-COVID-19, p = 0.47. Overall clinical prognostic stage did not differ significantly (p = 0.39) between the time periods, nor did cM1 disease (2% in each period); 23% pre-COVID-19 and 27% during-COVID-19 presented with cN+ disease (p = 0.38). Neoadjuvant therapy use was significantly higher during-COVID-19 (39%) versus pre-COVID-19 (29%, p = 0.02) driven by increased neoadjuvant endocrine therapy (NET) use (7% to 16%, p = 0.002), whereas neoadjuvant chemotherapy use did not change (22% vs. 23%, p = 0.72). In HR+/HER2- disease, NET use increased from 10% pre-COVID-19 to 23% during-COVID-19 (p = 0.001) with a significant increase in stage I patients (7 to 22%, p < 0.001) and nonsignificant increases in stage II (18 to 23%, p = 0.63) and stage III (9 to 29%, p = 0.29). CONCLUSIONS: Breast cancer stage at diagnosis did not differ significantly during-COVID-19 compared with pre-COVID-19. More patients during-COVID-19 were treated with NET, which was significantly increased in stage I HR+/HER2- disease.


Subject(s)
Breast Neoplasms , COVID-19 , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/therapy , COVID-19/epidemiology , Female , Humans , Neoadjuvant Therapy , Pandemics , Receptor, ErbB-2 , Retrospective Studies
17.
Front Immunol ; 12: 710375, 2021.
Article in English | MEDLINE | ID: covidwho-1518483

ABSTRACT

The unique environment of the lungs is protected by complex immune interactions. Human lung tissue-resident memory T cells (TRM) have been shown to position at the pathogen entry points and play an essential role in fighting against viral and bacterial pathogens at the frontline through direct mechanisms and also by orchestrating the adaptive immune system through crosstalk. Recent evidence suggests that TRM cells also play a vital part in slowing down carcinogenesis and preventing the spread of solid tumors. Less beneficially, lung TRM cells can promote pathologic inflammation, causing chronic airway inflammatory changes such as asthma and fibrosis. TRM cells from infiltrating recipient T cells may also mediate allograft immunopathology, hence lung damage in patients after lung transplantations. Several therapeutic strategies targeting TRM cells have been developed. This review will summarize recent advances in understanding the establishment and maintenance of TRM cells in the lung, describe their roles in different lung diseases, and discuss how the TRM cells may guide future immunotherapies targeting infectious diseases, cancers and pathologic immune responses.


Subject(s)
Lung Diseases/immunology , Lung/immunology , /immunology , Animals , Humans , Lymphocytes, Tumor-Infiltrating/immunology , Mice , Neoadjuvant Therapy , Vaccines/immunology
18.
Technol Cancer Res Treat ; 20: 15330338211035037, 2021.
Article in English | MEDLINE | ID: covidwho-1484272

ABSTRACT

BACKGROUND: Oncotype Dx (ODx) is a genomic assay which estimates the risk of distant recurrence and predicts adjuvant chemotherapy benefit in early stage breast cancer patients. Most ODx data is derived from excisional specimens. AIM: We assess the utility of ODx on core needle biopsies (CNB) and measure its impact on neoadjuvant treatment decisions, particularly in patients with clinically complicated situations. METHODS: Consecutive ODx results on breast CNBs with invasive carcinoma from 2012-2020 at 3 tertiary care hospitals with dedicated Breast Health Centers were reviewed. Clinical indications to perform ODx on CNB were recorded through a review of patients' electronic medical records. Clinicopathologic features, surgical or oncologic modalities and follow-up data were recorded. RESULTS: Three distinct clinical indications for performing ODx on CNB in 85 ER+ invasive breast carcinomas were identified: 1) Excisions with insufficient tissue to perform ODx, 2) adjudicate neoadjuvant therapy versus primary surgical resection, and 3) select neoadjuvant chemotherapy (NAC) versus neoadjuvant endocrine therapy (NET). Primary surgery was selected in patients with low score RS (<18), and NET was preferred in patients with intermediate or high RS (>18). NET was preferred over NAC in patients with low RS (<18). CONCLUSION: This study shows that CNB ODx RS helps guide treatment decisions in a neoadjuvant setting along with other contributing factors such as the presence of pathogenic mutations, node positivity, patient age, and comorbidities. The use of ODx on CNB is furthermore valuable in the midst of the COVID-19 pandemic for early breast cancer patients to administer effective therapy in a timely manner.


Subject(s)
Breast Neoplasms, Male/diagnosis , Breast Neoplasms/diagnosis , Carcinoma, Ductal, Breast/diagnosis , Neoplasm Recurrence, Local , Adult , Aged , Aged, 80 and over , Biomarkers, Tumor/genetics , Biopsy, Large-Core Needle , Breast Neoplasms/pathology , Breast Neoplasms, Male/pathology , Carcinoma , Carcinoma, Ductal, Breast/pathology , Combined Modality Therapy , Electronic Health Records , Female , Gene Expression Profiling/methods , Genomics , Hormones/therapeutic use , Humans , Male , Medical Oncology , Middle Aged , Neoadjuvant Therapy , Neoplasm Invasiveness , Retrospective Studies , Treatment Outcome
19.
Crit Care ; 25(1): 363, 2021 10 18.
Article in English | MEDLINE | ID: covidwho-1477449

ABSTRACT

BACKGROUND: Zinc is a trace element that plays a role in stimulating innate and acquired immunity. The role of zinc in critically ill patients with COVID-19 remains unclear. This study aims to evaluate the efficacy and safety of zinc sulfate as adjunctive therapy in critically ill patients with COVID-19. METHODS: Patients aged ≥ 18 years with COVID-19 who were admitted to the intensive care unit (ICU) in two tertiary hospitals in Saudi Arabia were retrospectively assessed for zinc use from March 1, 2020 until March 31, 2021. After propensity score matching (1:1 ratio) based on the selected criteria, we assessed the association of zinc used as adjunctive therapy with the 30-day mortality. Secondary outcomes included the in-hospital mortality, ventilator free days, ICU length of stay (LOS), hospital LOS, and complication (s) during ICU stay. RESULTS: A total of 164 patients were included, 82 patients received zinc. Patients who received zinc sulfate as adjunctive therapy have a lower 30-day mortality (HR 0.52, CI 0.29, 0.92; p = 0.03). On the other hand, the in-hospital mortality was not statistically significant between the two groups (HR 0.64, CI 0.37-1.10; p = 0.11). Zinc sulfate use was associated with a lower odds of acute kidney injury development during ICU stay (OR 0.46 CI 0.19-1.06; p = 0.07); however, it did not reach statistical significance. CONCLUSION: The use of zinc sulfate as an additional treatment in critically ill COVID-19 patients may improve survival. Furthermore, zinc supplementation may have a protective effect on the kidneys.


Subject(s)
COVID-19/drug therapy , COVID-19/mortality , Critical Illness/therapy , Neoadjuvant Therapy/methods , Zinc Sulfate/therapeutic use , Aged , Female , Humans , Male , Middle Aged , Propensity Score , Retrospective Studies , Saudi Arabia , Survival Rate
20.
Surgery ; 171(3): 666-672, 2022 03.
Article in English | MEDLINE | ID: covidwho-1475071

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, guidelines recommended that breast cancer centers delay estrogen receptor-positive breast cancer surgeries with neoadjuvant endocrine therapy. We aimed to evaluate pathologic upstaging of breast cancer patients affected by these guidelines. METHODS: Female patients with stage I/II breast cancer receiving neoadjuvant endocrine therapy were prospectively identified and were matched to a historical cohort of stage I/II estrogen receptor-positive breast cancer patients treated with upfront surgery ≤35 days. Primary outcomes were pathologic T and N upstaging versus clinical staging. RESULTS: After matching, 28 neoadjuvant endocrine therapy and 48 control patients remained. Median age in each group was 65 (P = .68). Most patients (78.6% and 79.2%) had invasive ductal carcinoma with a clinical tumor size of 0.9 cm vs 1.7 cm (P = .056). Time to surgery was 68 days in the neoadjuvant endocrine therapy group and 26.5 days in the control (P < .001). A total of 23 neoadjuvant endocrine therapy patients (82.1%) had the same or lower pT-stage compared with 31 (64.5%) control patients (P = .115). Only 3 (10.7%) neoadjuvant endocrine therapy patients had increased pN-stage vs 14 (29.2%) control patients (P = .063). CONCLUSION: Despite 2.5-times longer delays, patients with early-stage estrogen receptor-positive breast cancer receiving neoadjuvant endocrine therapy did not experience pathologic upstaging during the COVID-19 pandemic. These findings may support the use of neoadjuvant endocrine therapy in similar patients if delays to surgery are projected.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/surgery , COVID-19 , Carcinoma, Ductal, Breast/surgery , Time-to-Treatment/statistics & numerical data , Aged , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/metabolism , Case-Control Studies , Female , Humans , Mastectomy/statistics & numerical data , Middle Aged , Neoadjuvant Therapy , Prospective Studies , Receptors, Estrogen/metabolism
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