Publications by authors named "Lea Saban Roche"

6 Publications

  • Page 1 of 1

Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study).

Support Care Cancer 2021 Jan 7. Epub 2021 Jan 7.

Medical Oncology Department, Lucien Neuwirth Cancer Institute, 108 bis Avenue Albert Raimond, 42270, Saint Priest en Jarez, France.

Purpose: The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life.

Methods: A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018.

Results: Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC à 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point.

Conclusions: In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD.

Trial Registration: Clinical trial registration is NCT02459483. Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.
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January 2021

Withholding the Introduction of Anti-Epidermal Growth Factor Receptor: Impact on Outcomes in RAS Wild-Type Metastatic Colorectal Tumors: A Multicenter AGEO Study (the WAIT or ACT Study).

Oncologist 2020 02 2;25(2):e266-e275. Epub 2019 Oct 2.

Department of Gastroenterology, Cochin Hospital, Paris, France.

Background: Patients with RAS wild-type (WT) nonresectable metastatic colorectal cancer (mCRC) may receive either bevacizumab or an anti-epidermal growth factor receptor (EGFR) combined with first-line, 5-fluorouracil-based chemotherapy. Without the RAS status information, the oncologist can either start chemotherapy with bevacizumab or wait for the introduction of the anti-EGFR. Our objective was to compare both strategies in a routine practice setting.

Materials And Methods: This multicenter, retrospective, propensity score-weighted study included patients with a RAS WT nonresectable mCRC, treated between 2013 and 2016 by a 5-FU-based chemotherapy, with either delayed anti-EGFR or immediate anti-vascular endothelial growth factor (VEGF). Primary criterion was overall survival (OS). Secondary criteria were progression-free survival (PFS) and objective response rate (ORR).

Results: A total of 262 patients (129 in the anti-VEGF group and 133 in the anti-EGFR group) were included. Patients receiving an anti-VEGF were more often men (68% vs. 56%), with more metastatic sites (>2 sites: 15% vs. 9%). The median delay to obtain the RAS status was 19 days (interquartile range: 13-26). Median OS was not significantly different in the two groups (29 vs. 30.5 months, p = .299), even after weighting on the propensity score (hazard ratio [HR] = 0.86, 95% confidence interval [CI], 0.69-1.08, p = .2024). The delayed introduction of anti-EGFR was associated with better median PFS (13.8 vs. 11.0 months, p = .0244), even after weighting on the propensity score (HR = 0.74, 95% CI, 0.61-0.90, p = .0024). ORR was significantly higher in the anti-EGFR group (66.7% vs. 45.6%, p = .0007).

Conclusion: Delayed introduction of anti-EGFR had no deleterious effect on OS, PFS, and ORR, compared with doublet chemotherapy with anti-VEGF.

Implications For Practice: For RAS/RAF wild-type metastatic colorectal cancer, patients may receive 5-fluorouracil-based chemotherapy plus either bevacizumab or an anti-epidermal growth factor receptor (EGFR). In daily practice, the time to obtain the RAS status might be long enough to consider two options: to start the chemotherapy with bevacizumab, or to start without a targeted therapy and to add the anti-EGFR at reception of the RAS status. This study found no deleterious effect of the delayed introduction of an anti-EGFR on survival, compared with the introduction of an anti-vascular endothelial growth factor from cycle 1. It is possible to wait one or two cycles to introduce the anti-EGFR while waiting for RAS status.
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February 2020

[Posterior Reversible Encephalopathy Syndrome (PRES): About 4 cases].

Presse Med 2019 Oct 22;48(10):1026-1031. Epub 2019 Oct 22.

Institut de cancérologie Lucien-Neuwirth, département d'oncologie médicale, 108, bis avenue Albert-Raimond, 42271 Saint Priest en Jarez, France.

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October 2019

Intensification of induction chemotherapy before consolidation chemoradiotherapy improves progression-free survival and time without treatment in patients with locally advanced pancreatic cancers.

Oncotarget 2018 Aug 10;9(62):31999-32009. Epub 2018 Aug 10.

Hepatogastroenterology Department, University Hospital of Saint-Etienne, Saint-Etienne, France.

Aims: To assess the interest of induction chemotherapy (ICT) intensification before chemoradiotherapy (CRT) in patients with locally advanced pancreatic cancer.

Methods: Charts of patients treated between February 2010 and November 2016 with consolidation capecitabin based-CRT were retrospectively reviewed in this bicentric study. Patients who underwent Gemcitabine as ICT (Group G) were compared to patients treated with intensive ICT (group I). Primary objectives were progression-free survival (PFS), defined as the time from the first day of ICT to progression or last follow-up, and Time without treatment (TWT), as the time from the last day of CRT to progression.

Results: Patients' characteristics were balanced between group I (Folforinox: = 24; GemOx: = 6) and group G ( = 16) including mean age (63.7 vs 68.1 years), and performance status (PS 0-1 :90% vs 93.7%). Median PFS (17.8 months vs 12 months; = 0.02) and TWT (7.4 months vs 2.5 months = 0.01) were statistically better in group I vs group G. These results remained statistically and clinically significant by comparing Folfirinox subgroup to Gemcitabine. A trend to a better median overall survival was observed in group I (20.4 months) vs group G (18.3 months; = 0.07). After adjusting for ICT duration, PS, and CA19.9 level, ICT intensification remains independently prognostic. Toxicity profile was in accordance with Literature.

Conclusion: This study shows ICT intensification before CRT is an interesting approach in patients with locally advanced pancreatic cancer. Further studies are needed to confirm these results, and to assess the specific role of CRT in this setting.
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August 2018

[Validation of a questionnaire assessing patients' adherence and skill level of management for oral capecitabine treatment].

Bull Cancer 2016 Mar 23;103(3):241-51. Epub 2016 Feb 23.

Centre Hygée, institut de cancérologie Lucien-Neuwirth, 108 bis, avenue A.-Raimond, 42270 Saint-Priest-en-Jarez, France; CIC-EC, Inserm 1408, 42000 Saint-Étienne, France. Electronic address:

Introduction: There is a plea for the development of tools allowing the screening of fragile patients under oral chemotherapy. Such tools would identify patients with difficulties for being adherent or for having low side effects management skills. The aim of this study is to validate psychometric characteristics of a questionnaire assessing patients' adherence and skill level of management for oral capecitabine treatment.

Methods: Questionnaire's psychometric validation study. Prospective monocentric cohort. Cases-simulated questionnaire was constructed, according to recommendations, from the results of a socio-anthropological study. Validation phases included: a pre-testing and a field-testing including acceptability, scale reliability and internal consistency were conducted involving experts and patients sample.

Results: Pre-testing excluded 1 item. Acceptability phase included 15 patients, who did not change any of the questions. Reliability and internal consistency were tested with 67 patients. Cancer site did not statistically influence questionnaire answers. No correlation was identify with the analyse performed for the internal consistency testing.

Conclusion: This questionnaire has shown to be a valid tool for the assessment of the adherence and side effect management skill for patients with capecitabine treatment. It can easily be uses as a screening tool for prescribers. It can also be used as an evaluation tool for a therapeutic education programme in this field.
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March 2016

Randomized phase III trial comparing induction chemotherapy followed by radiotherapy to concomitant chemoradiotherapy for laryngeal preservation in T3M0 pyriform sinus carcinoma.

Acta Otolaryngol 2010 ;130(1):150-5

Department of Otolaryngology - Head and Neck Surgery, Saint-Etienne University Hospital Center, Loire Cancer Institute, Saint-Etienne, France.

Conclusions: Conventional radiotherapy with concurrent cisplatin is significantly superior to induction cisplatin fluorouracil chemotherapy followed by radiotherapy in terms of laryngeal preservation in patients with T3 hypopharyngeal carcinoma. Despite a high rate of laryngeal preservation no survival benefit was recorded in this selected population.

Objectives: To compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death, and survival rates.

Patients And Methods: Seventy-one adult patients with previously untreated resectable T3 pyriform sinus squamous cell carcinoma were enrolled in the multicenter prospective randomized phase III trial. They were evaluated for organ preservation, survival rates, and toxic reactions.

Results: The rates of laryngeal preservation at 2 years were 68% for the induction chemotherapy (IC) group and 92% for the chemoradiotherapy (CR) group (p = 0.016). At 2 years, the event-free survival rates were 36% and 41% for the IC group and CR group, respectively.
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October 2010