Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines)

Slimano, Florian; Baudouin, Anne; Zerbit, Jérémie; Toulemonde-Deldicque, A.; Thomas-Schoemann, Audrey; Chevrier, R.; Daouphars, Mikaël; Madelaine, Isabelle; Pourroy, Bertrand; Tournamille, Jean-François; Astier, A.; Ranchon, Florence; Cazin, J. C.; Bardin, Christophe; Rioufol, Catherine

doi:10.1016/j.ctrv.2020.102063

Cited by 34 publications

(37 citation statements)

References 88 publications

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“…Minimizing contact time for these vulnerable patients in hospital and clinic settings can help reduce the risk of virus exposure and transmission, which, if infection occurs, may lead to poorer outcomes due to compromised immune systems. [46][47][48] IMscin001 is a global phase 1b/3 study in cancer immunotherapy-naive patients with locally advanced or metastatic NSCLC that has progressed on platinumbased chemotherapy. The main aim of phase 1b was to identify the dose of SC atezolizumab that would yield comparable exposure to IV atezolizumab on the basis of serum C trough at cycle 1.…”

Section: Discussionmentioning

confidence: 99%

Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

Felip

Burotto²,

Zvirbule

et al. 2021

Clinical Pharm in Drug Dev

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Intravenous (IV) atezolizumab is approved for non-small cell lung and other cancers. Subcutaneous (SC) atezolizumab coformulated with recombinant human hyaluronidase, a permeation enhancer for SC dispersion and absorption, is being developed to improve treatment options, reduce burden, and increase efficiency for patients and practitioners. IMscin001 (NCT03735121), a 2-part, open-label, global, multicenter, phase 1b/3 study, is evaluating the pharmacokinetics (PK), safety, and efficacy of SC atezolizumab. The part 1 (phase 1b) objective was determination of an SC atezolizumab dose yielding a serum trough concentration (C trough ) comparable with IV. Patients enrolled in 3 cohorts received SC atezolizumab 1800 mg (thigh) once (cohort 1), 1200 mg (thigh) every 2 weeks for 3 cycles (cohort 2), or 1800 mg (abdomen) every 3 weeks cycle 1, then cycles 2 and 3 (thigh) every 3 weeks (cohort 3). In subsequent cycles, IV atezolizumab 1200 mg every 3 weeks was administered until loss of clinical benefit. SC atezolizumab 1800 mg every 3 weeks and 1200 mg every 2 weeks provided similar C trough and area under the curve values in cycle 1 to the corresponding IV atezolizumab reference, was well tolerated, and exhibited a safety profile consistent with the established IV formulation. Exposure following SC injection in the abdomen was lower (20%, 28%, and 27% for C trough , maximum concentration, and area under the concentration-time curve from time 0 to day 21, respectively) than in the thigh. Part 1 SC and IV PK data were analyzed using a population PK modeling approach, followed by simulations. Part 2 (phase 3) will now be initiated to demonstrate that SC atezolizumab PK exposure is not lower than that of IV.

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Section: Discussionmentioning

confidence: 99%

Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

Felip

Burotto²,

Zvirbule

et al. 2021

Clinical Pharm in Drug Dev

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“…Besides these aggressive NPI protocol individualized approach is paramount as various factors like the type of cancer, stage, and prognosis, comorbidities (hypertension, diabetes remain the key risk factors for COVID-19 outcome across all diseases), performance status, treatment options, the local situation of the pandemic as it relates to the availability of ICU level of care and blood product supply in case of complications, patient's preference, and specialists' experience play important role in deciding the approach [ 128 , 129 ]. And at least until further studies are available case to case basis evaluation is most likely going to be the prevalent approached, which may be modified as the interim recommendations by hematology and oncology societies may be changed based on data available from larger cohorts of patients such as ASH, ASCO, and CIBMTR databases [ 14 , 25 , [130] , [131] , [132] ].…”

Section: Immunosuppression In Hematological Malignanciesmentioning

confidence: 99%

A review on how to do hematology consults during COVID-19 pandemic

Sahu

Černý

2021

Blood Reviews

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The ongoing COVID-19 pandemic is the most trending and talked topic across the World. From its point of origin in Wuhan, China to clinical laboratory at NIH, a mere six-month-old SARS-CoV-2 virus is keeping the clinicians, and scientists busy at various fronts. However, COVID-19 is an emerging and evolving disease and each day brings in more data, new figures, and findings from the field of clinical practice. The role of hematologists has been increasingly recognized during the current pandemic because of several reasons. Most important of them are the characteristic hematological findings of COVID-19 patients that also have prognostic implications and that were not seen in other viral infections. The treatment of hematological complications in COVID-19 patients is very challenging given the critical care setting. There are interim and limited guidelines thus far due to the novelty of the disease. As this remains to be a quite fluid situation, all the appropriate medical societies including the major hematology bodies are proposing initial and interim guidelines (e.g. ASH guideline). This puts a hematologist on consult service in a dubious position where, he/she must tailor the recommendations on case to case basis. The purpose of this review is to provide the background context about the impact of COVID-19 on the blood system and to summarize the current interim guidelines to manage the associated hematological issues in COVID-19 infection.

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“…In the era of coronavirus COVID-19, it is recommended to abandon the use of bleomycin, which causes pulmonary fibrosis and to use the EP regimen based on etoposide and cisplatin. 51 In case of non-epithelial ovarian tumors in pregnancy, many authors recommend as well to follow the routine ovarian cancer regimen which is paclitaxel and carboplatin. There were no inferior results with this regimen when considering recurrences and overall survival.…”

Section: Treatmentmentioning

confidence: 99%

Approaches to the Diagnosis and Management of Ovarian Cancer in Pregnancy

Michalczyk¹,

Cymbaluk‐Płoska²

2021

CMAR

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Ovarian cancer is one of the most common gynecological cancers diagnosed in pregnancy. Its management is often very problematic due to the proximity of the adnexa to the developing fetus and chemotherapy-related toxicity risk. Tumor markers and imagining studies play important roles in diagnosis, help differentiate benign masses from malignancy and allow to plan the treatment. Due to the physiological changes that occur in pregnancy, levels of tumor markers can be altered and reduce their diagnostic value. We review current recommendations for the management and treatment of ovarian cancer in pregnant patients considering gestational age at diagnosis, tumor histology, stage of the disease, risk of obstetrical complications, and patient’s preferences.

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Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines)

Cited by 34 publications

References 88 publications

Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

A review on how to do hematology consults during COVID-19 pandemic

Approaches to the Diagnosis and Management of Ovarian Cancer in Pregnancy

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