Publications by authors named "Laetitia Stefani"

12 Publications

  • Page 1 of 1

Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical-surgical procedures: the PROADAPT pilot study protocol.

BMJ Open 2021 Apr 2;11(4):e042960. Epub 2021 Apr 2.

Geriatrics Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France

Background: Ageing is associated with an increased prevalence of comorbidities and sarcopenia as well as a decline of functional reserve of multiple organ systems, which may lead, in the context of the disease-related and/or treatment-related stress, to functional deconditioning. The multicomponent 'Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning risk and Accompaniment of Patients' Trajectories (PROADAPT)' intervention was developed multiprofessionally to implement prehabilitation in older patients with cancer.

Methods: The PROADAPT pilot study is an interventional, non-comparative, prospective, multicentre study. It will include 122 patients oriented to complex medical-surgical curative procedures (major surgery or radiation therapy with or without chemotherapy). After informed consent, patients will undergo a comprehensive geriatric assessment and will be offered a prehabilitation kit that includes an advice booklet with personalised objectives and respiratory rehabilitation devices. Patients will then be called weekly and monitored for physical and respiratory rehabilitation, preoperative renutrition, motivational counselling and iatrogenic prevention. Six outpatient visits will be planned: at inclusion, a few days before the procedure and at 1, 3, 6 and 12 months after the end of the procedure. The main outcome of the study is the feasibility of the intervention, defined as the ability to perform at least one of the components of the programme. Clinical data collected will include patient-specific and cancer-specific characteristics.

Ethics And Dissemination: The study protocol was approved by the Ile de France 8 ethics committee on 5 June 2018. The results of the primary and secondary objectives will be published in peer-reviewed journals.

Trial Registration Number: NCT03659123. Pre-results of the trial.
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April 2021

Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial.

BMC Cancer 2020 Oct 9;20(1):975. Epub 2020 Oct 9.

CHRU de Besançon, Besançon, France.

Background: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease.

Methods: QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program.

Discussion: The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life.

Trial Registration: This trial was registered in since May 2017 ( NCT03169075 ).
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October 2020

Interventions to improve physical performances of older people with cancer before complex medico-surgical procedures: Protocol for an umbrella review of systematic reviews and meta-analyses.

Medicine (Baltimore) 2020 Sep;99(39):e21780

Geriatric Unit, Lyon-Sud Hospital.

Background: Current demographics lead increasing older cancer patients to undergo complex medico-surgical procedures, with substantial risk of decompensations and deconditioning. The Prehabilitation & Rehabilitation in Oncology: Adaptation to Disease and Accompaniment of Patients' Trajectories (PROADAPT) project is currently being developed with the aim of improving care, through standardized care pathways guided by existing evidence and implementation programs. A working group will specifically focus on improvement of physical performances before such procedures. These interventions may have been developed in different contexts: before surgery in large, before carcinologic surgery or complex medical interventions (chemotherapy, radiotherapy), or in primary care for elderly patients to prevent sarcopenia and frailty. Post-surgical interventions are out of the scope of this review. The objective of this review is to summarize the level of evidence to support physical reconditioning interventions and identify areas where further work is required.

Methods: This umbrella review will include moderate to high quality systematic reviews, meta-analysis, and pre-existing umbrella or meta-reviews. Two reviewers will independently search the following databases: PubMed/MedLine, Cochrane Library, Embase, and CINAHL. Research strategy will use diverse keywords used to refer to the concepts of "prehabilitation," "preoperative exercise," or "preoperative rehabilitation," with prespecified inclusion and exclusion criteria and only systematic reviews selection. The distinct types of interventions presented using PRISMA guidelines and a narrative reporting of results. A focus will be made on outcomes such as physical performances, quality of life, autonomy in everyday activities, or number of hospital bed days.

Ethics And Dissemination: Ethical approval is not required for such an umbrella review. Our review will be submitted for publication in a peer-reviewed international journal using open access option if available. It will be complementary to reviews focused on hospital discharge of older people.

Prospero Registration Number: CRD42020100110.
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September 2020

Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial.

Support Care Cancer 2019 May 7;27(5):1879-1889. Epub 2018 Sep 7.

Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.

Purpose: Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy might allow a better management of hot flushes (HF).

Methods: In this multicenter randomized double-blind placebo-controlled phase III study ( NCT01246427), we enrolled ≥ 18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS ≥ 10 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre- and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization.

Results: Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).

Conclusions: The efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.
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May 2019

Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP).

Blood 2018 08 6;132(7):707-716. Epub 2018 Jul 6.

INSERM, Centre d'Investigation Clinique 1408, Saint-Etienne, France.

The need to accurately identify cancer outpatients at high risk of thrombotic complications is still unmet. In a prospective, multicenter cohort study (ONCOlogie et Chambres ImPlantables [ONCOCIP]), consecutive adult patients with a solid tumor and implanted port underwent 12-month follow-up. Our primary objective was to identify risk factors for (1) catheter-related thrombosis, defined as ipsilateral symptomatic upper-limb deep-vein thrombosis with or without pulmonary embolism, and (2) venous thromboembolism other than catheter-related, defined as any symptomatic superficial- or deep-vein thrombosis (other than catheter-related) or pulmonary embolism, and incidental pulmonary embolism. All events were objectively confirmed and centrally adjudicated. Rate assessments integrated competing risk of death. Overall, 3032 patients were included (median age: 63 years; women: 58%). The most frequent cancer locations were breast (33.7%), lung (18.5%), and colorectal (15.6%), cancer being metastatic in 43.2% of patients. Most patients (97.1%) received chemotherapy. By 12 months, 48 (1.6%) patients had been lost to follow-up and 656 (24.6%) had died; 3.8% (n = 111) of patients had experienced catheter-related thrombosis, and 9.6% (n = 276) venous thromboembolism other than catheter-related. By multivariate analysis, use of cephalic vein for catheter insertion predicted catheter-related thrombosis, whereas ongoing antiplatelet therapy was protective; risk factors for venous thromboembolism other than catheter-related were advanced age, previous venous thromboembolism, cancer site, and low hemoglobin level or increased leukocyte count before chemotherapy. In conclusion, this large prospective cohort study showed a high rate of venous thromboembolism in patients with a solid tumor and implanted port. Risk factors for catheter-related thrombosis differed from those for venous thromboembolism not catheter-related. This trial was registered at as #NCT02025894.
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August 2018

Treatment patterns and survival in an exhaustive French cohort of pazopanib-eligible patients with metastatic soft tissue sarcoma (STS).

BMC Cancer 2017 Feb 7;17(1):111. Epub 2017 Feb 7.

Centre Léon-Bérard, University Claude Bernard Lyon I, 28 rue Laennec, 69008, Lyon, France.

Background: The French EMS study prospectively collected exhaustive data from STS patients diagnosed in the Rhone-Alpes region from 2005 to 07.

Methods: The database included diagnosis/histology, surgery, radiotherapy, systemic treatments and treatment response. Treatment patterns and outcomes of patients with metastatic disease, excluding adipocytic sarcoma and GIST were analyzed.

Results: Of 888 total patients, 145 were included based on having metastatic disease and appropriate subtypes. All patients received treatment with systemic therapy being most common (74%, n = 107), followed by radiotherapy (30%, n = 44) and surgery (23%, n = 33). Doxorubicin, alone or in combination, was the most common first line systemic therapy (65%, n = 46). Drugs without license in sarcoma were used in 38-83% of treatments depending on treatment line. 24% of frontline patients demonstrated an objective response, decreasing to 11% objective responses in second line but no responses were documented beyond second line, with median PFS declining with each additional line. Median PFS also declined in patients receiving surgery compared to those receiving no surgery (8-15 m vs 5 m). Median OS from metastatic diagnosis for patients receiving systemic therapy was double that of patients without systemic treatment (24 m vs 12 m, p = 0.007).

Conclusions: Outcomes in this population were poor and declined with successive treatment. However, results suggest that further anticancer therapies in recurrent sarcoma might be beneficial.
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February 2017

Geriatric factors analyses from FFCD 2001-02 phase III study of first-line chemotherapy for elderly metastatic colorectal cancer patients.

Eur J Cancer 2017 03 5;74:98-108. Epub 2016 Nov 5.

CHU Le Bocage and INSERM U866 Dijon, France. Electronic address:

Aim: Several predictors of metastatic colorectal cancer (mCRC) outcomes have been described. Specific geriatric characteristics could be of interest to determine prognosis.

Method: Elderly patients (75+) with previously untreated mCRC were randomly assigned to receive infusional 5-fluorouracil-based chemotherapy, either alone (FU) or in combination with irinotecan (IRI). Geriatric evaluations were included as an optional procedure. The predictive value of geriatric parameters was determined for the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).

Results: From June 2003 to May 2010, the FFCD 2001-02 randomised trial enrolled 282 patients. A baseline geriatric evaluation was done in 123 patients; 62 allocated to the FU arm and 61 to the IRI arm. The baseline Charlson index was ≤1 in 75%, Mini-Mental State Examination was ≤27/30 in 31%, Geriatric Depression Scale was >2 in 10% and Instrumental Activities of Daily Living (IADL) was impaired in 34% of the patients. Multivariate analyses revealed that no geriatric parameter was predictive for ORR or PFS. Normal IADL was independently associated with better OS. The benefit of doublet chemotherapy on PFS differed in subgroups of patients ≤80 years, with unresected primary tumour, leucocytes >11,000 mm and carcinoembryonic antigen >2N. There was a trend towards better OS in patients with normal IADL.

Conclusion: The autonomy score was an independent predictor for OS. A trend toward a better efficacy of doublet chemotherapy in some subgroups of patients was reported and should be further explored.
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March 2017

Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients.

J Clin Oncol 2013 Apr 4;31(11):1464-70. Epub 2013 Mar 4.

Gastroenterology, Avicenne Hospital, AP-HP, Université Paris 13, Sorbonne Paris Cité, 125 rue de Stalingrad, 93000 Bobigny, France.

Purpose: Elderly patients form a heterogeneous population. Evaluation of geriatric factors may help evaluate a patient's health status to better adapt treatment.

Patients And Methods: Elderly patients with previously untreated metastatic colorectal cancer (mCRC) were randomly assigned to receive fluorouracil (FU) -based chemotherapy either alone or in combination with irinotecan (IRI) in the Fédération Francophone de Cancérologie Digestive (FFCD) 2001-02 study. Sites participating in the geriatric substudy completed geriatric screening tools to perform prognostic factor analyses for treatment safety during the first 4 months after treatment initiation.

Results: The geriatric score was calculated in 123 patients (44%). Median age was 80 years (range, 75 to 91 years). The Charlson comorbidity index was ≤ 1 in 75%, Mini-Mental State Examination (MMSE) score was ≤ 27/30 in 31%, and Instrumental Activities of Daily Living (IADL) showed impairment in 34% of the patients. Seventy-one patients (58%) had grade 3 to 4 toxicity, 41 (33%) had a dose-intensity reduction of more than 33%, and 54 (44%) had at least one unexpected hospitalization during the first 4 months after starting treatment. In multivariate analysis, significant predictive factors for grade 3-4 toxicity were IRI arm (odds ratio [OR], 5.03), MMSE ≤ 27/30 (OR, 3.84), and impaired IADL (OR, 4.67); for dose-intensity reduction of > 33%, the significant predictive factors were alkaline phosphates > 2 × upper limit of normal (OR, 4.16) and IRI arm (OR, 6.85); and for unexpected hospitalization, significant predictive factors were MMSE ≤ 27/30 (OR, 4.56) and Geriatric Depression Scale ≤ 2 (OR, 5.52).

Conclusion: Geriatric factors (MMSE and IADL) are predictive of severe toxicity or unexpected hospitalization (MMSE) in a randomized prospective phase III study in mCRC. These results suggest that cognitive function and autonomy impairment should be taken into account when choosing a regimen for chemotherapy.
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April 2013

Could ovarian choriocarcinoma be detected by maternal serum screening for Down syndrome?

Prenat Diagn 2007 Jul;27(7):682-4

The incidence of ovarian malignancies during gestation ranges from 1 in 8000 to 1 in 20,000 deliveries. Ovarian malignancies that produce human chorionic gonadotropin (hCG) are limited to germ cell tumors, of which dysgerminoma is the most frequent (45%) malignant type encountered in pregnant patients, the others being ovarian choriocarcinoma and mixed germ cell tumors (Boulay and Podczaski, 1998). In women of childbearing age, it is hard to distinguish between metastatic choriocarcinoma on a complete mole and primary ovarian choriocarcinoma. Treatment is based on adnexectomy followed by chemotherapy. Given the extreme rarity of these tumors, the long-term prognosis is difficult to establish. Had the diagnosis for our patient been made during pregnancy, the therapeutic approach would have been discussed in terms of gestational age. In the last trimester, we could have suggested cesarean section followed by adnexectomy, and then chemotherapy. In the second-trimester, chemotherapy could have been discussed, although the fetal toxicity of cisplatin chemotherapy is not firmly defined (Ferrandina et al., 2005). This treatment is an alternative to termination of pregnancy. We retrospectively studied maternal serum biochemistry so as to assess the possibility of a diagnosis of ovarian choriocarcinoma at the time of maternal serum screening for Down syndrome.
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July 2007

Protocol for the treatment of malignant inoperable bowel obstruction: a prospective study of 80 cases at Grenoble University Hospital Center.

J Pain Symptom Manage 2006 Jun;31(6):502-12

Unité de Recherche et de Soutien en Soins Palliatifs (G.L., M.-L.V.) and Oncologie Médicale (L.S.), Departement de Cancerologie et d'Hematologie, France.

A prospective protocol for treatment of malignant inoperable bowel obstruction was implemented at Grenoble University Hospital Center for 4 years. All 80 episodes of obstruction resulted from peritoneal carcinomatosis and none could expect another treatment cure. The protocol comprised three successive stages. Stage I included treatment for 5 days with a corticosteroid, antiemetic, anticholinergic, and analgesic. Stage II provided a somatostatin analogue if vomiting persisted. After 3 days, Stage III provided a venting gastrostomy. Obstruction relief with symptom control was obtained by medical treatment in 29 cases and symptom control occurred alone in an additional 32 cases. Ten patients were relieved by venting gastrostomy. Symptom control without permanent nasogastric tube (NGT) placement occurred in 72 episodes (90%). Eight patients with refractory vomiting were obliged to continue the NGT until death. Fifty-eight obstruction episodes (73%) were controlled in 10 days or less. Median time before gastrostomy was 17 days. Median survival was 31 days. This series suggests that a staged protocol for the treatment of inoperable malignant bowel obstruction is highly effective in relieving symptoms. A subgroup experiences relief of obstruction using this approach.
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June 2006

The effectiveness of trastuzumab (Herceptin) combined with chemotherapy for gastric carcinoma with overexpression of the c-erbB-2 protein.

Gastric Cancer 2005 ;8(4):249-52

Department of Oncology and Haematology, University Hospital, BP 217-38043 Grenoble Cedex 9, France.

The c-erbB-2 protein is overexpressed in 7% of gastric cancer cases, suggesting that anti-c-erbB-2 antibody therapy (trastuzumab; Herceptin) could be used. We report here a 28-year-old woman with metastatic gastric cancer overexpressing c-erbB-2 (3 + strong membrane staining on immunohistochemistry) who was treated with trastuzumab in combination with chemotherapy. A complete response was obtained with a combination of trastuzumab and oxaliplatin and was maintained with trastuzumab alone for 18 months. The patient relapsed and chemotherapy (capecitabine, docetaxel) was combined with the anti-c-erbB-2 antibody. The patient survived for 4 years with metastatic disease controlled for 2 years by immunochemotherapy. We conclude that the combination of trastuzumab and chemotherapy is efficient in the treatment of metastatic gastric carcinoma with overexpression of the c-erbB-2 protein.
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February 2006