How to Balance Prognostic Factors in Controlled Phase II Trials: Stratified Permuted Block Randomization or Minimization? An Analysis of Clinical Trials in Digestive Oncology.

In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block Randomization) and minimization. First, we provide a systematic review of the treatment allocation procedure used in gastrointestinal oncology controlled phase II trials published in 2019.

Did the COVID-19 pandemic delay treatment for localized breast cancer patients? A multicenter study.

Background: Longer times between diagnosis and treatments of cancer patients have been estimated as effects of the COVID-19 pandemic. However, relatively few studies attempted to estimate actual delay to treatment at the patient level.

Objective: To assess changes in delays to first treatment and surgery among newly diagnosed patients with localized breast cancer (BC) during the COVID-19 pandemic.

Correlation between changes in nutritional status and tumor response in patients receiving immunotherapy for lung cancer (NUTIMMUNO study).

Malnutrition is a common condition in lung cancer, and it is an independent prognostic factor. The main objective of this study was to determine whether an early improvement at 3 months in the nutritional status (NS) of patients undergoing immune checkpoint inhibitor (ICI) is associated with a tumor response to treatment at 6-month follow-up. The clinical data of 106 patients initiating ICI for bronchopulmonary non-small cell lung cancer (NCSLC) were retrospectively reviewed.

Intrathecal cervical analgesia for cancer pain: a 12-year follow-up study in a comprehensive cancer center.

Background: Intrathecal analgesia plays a key role for patients suffering refractory cancer pain. Nevertheless, intrathecal drug delivery systems (IDDS), requiring a cervical catheter tip implantation, have been poorly described in medical literature.

Aims: A monocentric retrospective follow-up study was designed to evaluate results of cervical IDDS for cancer pain.

COVID-19 Infection despite Previous Vaccination in Cancer Patients and Healthcare Workers: Results from a French Prospective Multicenter Cohort (PAPESCO-19).

In a multicenter prospective cohort of cancer patients (CP; n = 840) and healthcare workers (HCWs; n = 935) vaccinated against COVID-19, we noticed the following: i/after vaccination, 4.4% of HCWs and 5.8% of CP were infected; ii/no characteristic was associated with post-vaccine COVID-19 infections among HCWs; iii/CP who developed infections were younger, more frequently women (NS), more frequently had gastrointestinal, gynecological, or breast cancer and a localized cancer stage; iv/CP vaccinated while receiving chemotherapy or targeted therapy had (NS) more breakthrough infections after vaccination than those vaccinated after these treatments; the opposite was noted with radiotherapy, immunotherapy, or hormonotherapy; v/most COVID-19 infections occurred either during the Alpha wave (11/41 HCW, 20/49 CP), early after the first vaccination campaign started, or during the Omicron wave (21/41 HCW, 20/49 CP), more than 3 months after the second dose; vi/risk of infection was not associated with values of antibody titers; vii/the outcome of these COVID-19 infections after vaccination was not severe in all cases.

Intrathecal Catheter for Chemotherapy in Leptomeningeal Carcinomatosis From HER2-Negative Metastatic Breast Cancer.

Purpose: Most oncological treatments for leptomeningeal metastasis (LM) do not cross the blood-brain barrier (BBB). One therapeutic option is intrathecal (IT) chemotherapy. Both the brain-implanted Omaya reservoir and lumbar puncture (LP) are classic routes for IT chemotherapy delivery.

Correction: Bienfait et al. Evaluation of 8% Capsaicin Patches in Chemotherapy-Induced Peripheral Neuropathy: A Retrospective Study in a Comprehensive Cancer Center. 2023, , 349.

In the original publication [...

Evaluation of 8% Capsaicin Patches in Chemotherapy-Induced Peripheral Neuropathy: A Retrospective Study in a Comprehensive Cancer Center.

Chemotherapy-induced peripheral neuropathy (CIPN) is often painful and can arise during or after the end of oncological treatments. They are mostly induced by platinum salts, taxanes, and immunotherapies. Their incidence is estimated between 19 and 85%.

Unresolved early post-operative pain trajectory predicts moderate-to-severe persistent pain after breast cancer surgery-An observational cohort study.

Background: Modelling acute post-operative pain trajectories may improve the prediction of persistent pain after breast cancer surgery (PPBCS). This study aimed to investigate the predictive accuracy of early post-operative pain (EPOP) trajectories in the development of PPBCS.

Materials & Methods: This observational study was conducted in a French Comprehensive Cancer Centre and included patients who underwent breast cancer surgery from December 2017 to November 2018.

COVID-19 Vaccination Campaign in Cancer Patients and Healthcare Workers-Results from a French Prospective Multicenter Cohort (PAPESCO-19).

In this prospective, real-life cohort study, we followed 523 cancer patients (CP) and 579 healthcare workers (HCW) from two cancer centers to evaluate the biological and clinical results of the COVID-19 vaccination campaign. Seventy percent of the CP and 90% of the HCW received an mRNA vaccine or the AZD1222 vaccine. Seropositivity was high after the first vaccine among HCW and poor among CP.

Effects of mean arterial pressure target on mottling and arterial lactate normalization in patients with septic shock: a post hoc analysis of the SEPSISPAM randomized trial.

Background: In patients with septic shock, the impact of the mean arterial pressure (MAP) target on the course of mottling remains uncertain. In this post hoc analysis of the SEPSISPAM trial, we investigated whether a low-MAP (65 to 70 mmHg) or a high-MAP target (80 to 85 mmHg) would affect the course of mottling and arterial lactate in patients with septic shock.

Methods: The presence of mottling was assessed every 2 h from 2 h after inclusion to catecholamine weaning.

COVID-19 Infections in Cancer Patients Were Frequently Asymptomatic: Description From a French Prospective Multicenter Cohort (PAPESCO-19).

Background: Cancer patients (CPs) are considered more vulnerable and as a high mortality group regarding COVID-19. In this analysis, we aimed to describe asymptomatic COVID (+) CPs and associated factors.

Methods: We conducted a prospective study in CPs and health care workers (HCWs) in 4 French cancer centers (PAPESCO [] study).

Impact of Iron-Deficiency Management on Quality of Life in Patients with Cancer: A Prospective Cohort Study (CAMARA Study).

Background: Iron deficiency (ID) is very common in patients with solid tumors and may cause symptoms such as fatigue. However, its impact on clinical outcomes is poorly described. The aim of this prospective monocentric cohort study was to evaluate the evolution of quality of life (QoL) of these patients after iron supplementation.

Prognostic Value of Metabolic, Volumetric and Textural Parameters of Baseline [F]FDG PET/CT in Early Triple-Negative Breast Cancer.

(1) Background: triple-negative breast cancer (TNBC) remains a clinical and therapeutic challenge primarily affecting young women with poor prognosis. TNBC is currently treated as a single entity but presents a very diverse profile in terms of prognosis and response to treatment. Positron emission tomography/computed tomography (PET/CT) with F-fluorodeoxyglucose ([F]FDG) is gaining importance for the staging of breast cancers.

Peripheral Neuropathic Pain Following Breast Cancer: Effectiveness and Tolerability of High-Concentration Capsaicin Patch.

Purpose: Data supporting the use of high-concentration capsaicin patches (HCCPs) in breast cancer (BC) patients and BC survivors (BCSs) with peripheral neuropathic pain (PNP) are limited. This observational study evaluated the effectiveness and safety of HCCP applications in BCSs/BC patients with PNP.

Patients And Methods: Data from all patients treated with HCCP in the pain department of a French comprehensive cancer centre were collected from 01-Jan-2014 to 14-Oct-2020.

Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial.

Background: Pulmonary complications are an important cause of morbidity and mortality after surgery. We evaluated the clinical effectiveness of noninvasive ventilation (NIV) in preventing postoperative acute respiratory failure.

Methods: This is an open, multicentre randomised trial that included patients at high risk of postoperative pulmonary complications after elective or semi-urgent surgery with an Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score ≥45.

A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial).

Introduction: Resistance to trastuzumab in breast cancer is an ongoing challenge. Clinical and biological effects of co-targeting HER2 and mammalian target of rapamycin (mTOR) in patients with HER2-positive early operable breast cancer via the addition of everolimus to preoperative trastuzumab were evaluated in a phase II randomised study.

Methods: Patients were randomised 1:1 to receive trastuzumab (4 mg/kg initial dose then 2 mg/kg weekly for 5 weeks) alone or combined with everolimus (10 mg/day for 6 weeks) and then underwent surgery.

Anosmia but Not Ageusia as a COVID-19-Related Symptom among Cancer Patients-First Results from the PAPESCO-19 Cohort Study.

Cancer patients may fail to distinguish COVID-19 symptoms such as anosmia, dysgeusia/ageusia, anorexia, headache, and fatigue, which are frequent after cancer treatments. We aimed to identify symptoms associated with COVID-19 and to assess the strength of their association in cancer and cancer-free populations. The multicenter cohort study PAPESCO-19 included 878 cancer patients and 940 healthcare workers (HCWs).

Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome.

Background: Differences in physiology of ARDS have been described between COVID-19 and non-COVID-19 patients. This study aimed to compare initial values and longitudinal changes in respiratory system compliance (C), oxygenation parameters and ventilatory ratio (VR) in patients with COVID-19 and non-COVID-19 pulmonary ARDS matched on oxygenation.

Methods: 135 patients with COVID-19 ARDS from two centers were included in a physiological study; 767 non-COVID-19 ARDS from a clinical trial were used for the purpose of at least 1:2 matching.

First Evaluation Switching From Ropivacaine to Highly Concentrated Bupivacaine in Intrathecal Mixtures for Cancer Pain.

Background: Intrathecal drug delivery is widely used for intractable cancer pain treatment. A combination of drugs with morphine and bupivacaine is recommended in first line therapy. In France, we use ropivacaine 10 mg/mL instead of bupivacaine 5 mg/mL, the only concentration available.

G Protein-coupled Receptors in Radioiodine-refractory Thyroid Cancer in the Era of Precision Medicine.

Context: Radioiodine-refractory thyroid cancers have poor outcomes and limited therapeutic options (tyrosine kinase inhibitors) due to transient efficacy and toxicity of treatments. Therefore, combinatorial treatments with new therapeutic approaches are needed. Many studies link G protein-coupled receptors (GPCRs) to cancer cell biology.

Success and risks of pregnancy after breast cancer.

Introduction: Breast cancer is the most common cancer in women worldwide. The number of childbearing-age women diagnosed with early breast cancer (eBC) is increasing, raising questions over their subsequent fertility.

Purpose: The main objective of this study was therefore to assess, in a cohort of eBC patients with pregnancy desire, the rate of live births achieved spontaneously or by assisted reproductive technology.

The EPICURE study: a pilot prospective cohort study of heterogeneous and massive data integration in metastatic breast cancer patients.

Background: Breast cancer is the most common cancer in women and the first cancer concerning mortality. Metastatic breast cancer remains a disease with a poor prognosis and about 30% of women diagnosed with an early stage will have a secondary progression. Metastatic breast cancer is an incurable disease despite significant therapeutic advances in both supportive cares and targeted specific therapies.