Duruisseaux M.,Center Hospitalier University Grenoble Alpes |
Besse B.,Gustave Roussy |
Cadranel J.,Tenon Hospital |
Perol M.,Leon Berard Cancer Center |
And 17 more authors.
Oncotarget | Year: 2017
Overall survival (OS) with the anaplastic lymphoma kinase (ALK) inhibitor (ALKi) crizotinib in a large population of unselected patients with ALK-positive non-smallcell lung cancer (NSCLC) is not documented. We sought to assess OS with crizotinib in unselected ALK-positive NSCLC patients and whether post-progression systemic treatments affect survival outcomes. ALK-positive NSCLC patients receiving crizotinib in French expanded access programs or as approved drug were enrolled. We collected clinical and survival data, RECIST-defined progressive disease (PD) and post-PD systemic treatment efficacy. We performed multivariable analysis of OS from crizotinib initiation and PD under crizotinib. At time of analysis, 209 (65.7%) of the 318 included patients had died. Median OS with crizotinib was 16.6 months. The line of crizotinib therapy did not impact survival outcomes. Of the 263 patients with PD, 105 received best supportive care, 74 subsequent drugs other than next-generation ALKi and 84 next-generation ALKi. Nextgeneration ALKi treatment correlated with better survival outcomes in multivariate analysis. These patients had a median post-PD survival of 25.0 months and median OS from metastatic disease diagnosis of 89.6 months. Unselected ALK-positive NSCLC patients achieve good survival outcomes with crizotinib therapy. Next-generation ALKi may provide survival improvement after PD under crizotinib.
PubMed | Center Azureen Of Cancerologie, Kantar Health, Clinique Clementville, Clinique Saint Pierre and 8 more.
Type: Journal Article | Journal: European journal of cancer care | Year: 2016
The question of returning to work and pursuing professional activity during cancer treatment is an increasingly important consideration. The present work focuses on factors affecting the feasibility of maintaining professional activity during treatment for breast cancer, for women who wished to do so. Written questionnaires were collected from 216 patients between March and November 2012. Since the onset of their treatment, 31.4% of the women (68/216) had not been on sick-leave. The main factors associated with the pursuit of professional activity were: considering the availability of their physician to answer questions as unimportant [OR=18.83 (3.60-98.53); P0.05]; considering the diagnosis of cancer as likely to have a weak impact on career perspectives [OR=4.07 (2.49-6.64); P0.05]; not having any children in the household [OR=3.87 (2.38-6.28); P0.05]; being in a managerial position [OR=3.13 (1.88-5.21); P0.05]. Negative predictive factors were: physician mentioning adverse effects of the treatment [OR=0.31 (0.16-0.58); P0.05], and patient rating workload as high [OR=0.26 (0.15-0.46); P0.05]. As a result of advances in therapeutic strategies, more patients will expect healthcare professionals, as well as employers and occupational health societies, to prioritise issues pertaining to the maintenance of professional activities during cancer treatment.
Goncalves A.,Institute Paoli Calmettes |
Goncalves A.,Aix - Marseille University |
Pierga J.-Y.,University of Paris Descartes |
Ferrero J.-M.,Center Antoine Lacassagne |
And 17 more authors.
Annals of Oncology | Year: 2015
Background: Inflammatory breast cancer (IBC) is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5-fluorouracil (D-5FU) regimen after preoperative dose-intense (DI) epirubicin- cyclophosphamide (EC) and locoregional treatment in IBC patients. Patients and methods: PEGASE 07 was a national randomized phase III open-label study involving 14 hospitals in France. Women with nonmetastatic IBC were eligible and randomly assigned to receive either four cycles of DI EC (E 150 mg/m2 and C 4000 mg/m2 every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (arm A) or the same treatment followed by four cycles of D-5FU (D 85 mg/m2, day 1 and 5FU 750mg/m2/day continuous infusion, days 1-5 every 3 weeks) administered postradiotherapy (arm B). Patients with hormone receptor-positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary end point. Secondary end points included tolerance, pathological complete response (pCR) rate, and overall survival (OS). Results: Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months [95% confidence interval (CI) 58.4-60.3] in arm A and 60.5 months (95% CI 58.3- 61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95% CI 43.9-64.7) in arm A and 55.5% (95% CI 44.3-65.3) in arm B [hazard ratio (HR) = 0.94 (0.61-1.48); P = 0.81]. Identical results were observed for 5-year OS: 70.2% (95% CI 59.1-78.8) in arm A and 70% (95% CI 58.8-78.7) in arm B [HR = 0.93 (0.55-1.60); P=0.814]. Following DI EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival. Conclusion: The addition of D-5FU after preoperative DI EC and standard local therapy did not improve DFS in IBC. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Marthey L.,University Paris - Sud |
Sa-Cunha A.,Haut Leveque Hospital |
Blanc J.F.,Saint Andre Hospital |
Gauthier M.,Anticancer Center Gf Leclerc |
And 14 more authors.
Annals of Surgical Oncology | Year: 2015
Background: First-line treatment with FOLFIRINOX significantly increases overall survival (OS) in patients with metastatic pancreatic adenocarcinoma (PA) compared with gemcitabine. The aim of this observational cohort was to evaluate the tolerability and efficacy of this regimen in unresectable locally advanced PA (LAPA).Patients and Methods: From February 2010 to February 2012, all consecutive patients from 11 French centers treated by FOLFIRINOX for a histologically proven LAPA were prospectively enrolled. Unresectability was defined independently by each center’s multidisciplinary staff at diagnosis. Absence of metastatic disease was confirmed by chest-abdomen-pelvis computed tomography scan. FOLFIRINOX was delivered every 2 weeks as previously reported until progressive disease, major toxicity, or consolidation treatment by radiotherapy and/or surgery.Results: Seventy-seven patients were enrolled. They received a median number of five cycles (1–30). Grade 3–4 toxicities were neutropenia (11 %), nausea (9 %), diarrhea (6 %), fatigue (6 %), and anemia (1 %). Grade 2–3 sensory neuropathy occurred in 25 % of patients. No toxic death was reported and only 6 % of patients had to stop treatment because of toxicity. Disease control rate was 84 with 28 % of objective response (Response Evaluation Criteria in Solid Tumors). Seventy-five percent of patients received a consolidation therapy: 70 % had radiotherapy and 36 % underwent a surgical resection, with a curative intent. Within the whole cohort, 1-year OS rate was 77 % (95 % CI 65–86) and 1-year progression-free survival rate was 59 % (95 % CI 46–70).Conclusion: First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile. These promising results will have to be confirmed in a phase III randomized trial. © 2014, Society of Surgical Oncology.
Peyrade F.,Center Regional Of Lutte Contre Le Cancer Of Nice |
Jardin F.,University of Rouen |
Thieblemont C.,Hopital Saint Louis |
Thyss A.,Center Regional Of Lutte Contre Le Cancer Of Nice |
And 17 more authors.
The Lancet Oncology | Year: 2011
Background: Diffuse large B-cell lymphoma is a common cancer in elderly patients. Although treatment has been standardised in younger patients, no prospective study has been done in patients over 80 years old. We aimed to investigate the efficacy and safety of a decreased dose of CHOP (doxorubicin, cyclophosphamide, vincristine, and prednisone) chemotherapy with a conventional dose of rituximab in elderly patients with diffuse large B-cell lymphoma. Methods: We did a prospective, multicentre, single-arm, phase 2 study of patients aged over 80 years who had diffuse large B-cell lymphoma. Patients were included from 38 centres in France and Belgium. All patients received six cycles of rituximab combined with low-dose CHOP (R-miniCHOP) at 3-week intervals. Patients received 375 mg/m2 rituximab, 400 mg/m2 cyclophosphamide, 25 mg/m2 doxorubicin, and 1 mg vincristine on day 1 of each cycle, and 40 mg/m2 prednisone on days 1-5. The primary endpoint was overall survival, both unadjusted and adjusted for treatment and baseline prognostic factors. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, NCT01087424. Findings: 150 patients were enrolled between Jan 9, 2006, and Jan 23, 2009 and 149 were included in the intention-to-treat analyses. Median age was 83 years (range 80-95). After a median follow-up of 20 months (range 0-45), the median overall survival was 29 months (95% CI 21 to upper limit not reached); 2-year overall survival was 59% (49-67%). In multivariate analyses, overall survival was only affected by a serum albumin concentration of 35 g/L or less (hazard ratio 3·2, 95% CI 1·4-7·1; p=0·0053). Median progression-free survival was 21 months (95% CI 13 to upper limit not reached), with a 2-year progression free survival of 47% (38-56). 58 deaths were reported, 33 of which were secondary to lymphoma progression. 12 deaths were attributed to toxicity of the treatment. The most frequent side-effect was haematological toxicity (grade ≥3 neutropenia in 59 patients; febrile neutropenia in 11 patients). Interpretation: R-miniCHOP offers a good compromise between efficacy and safety in patients aged over 80 years old. R-miniCHOP should be considered as the new standard treatment in this subgroup of patients. Funding: Groupe d'Etude des Lymphomes de l'Adulte (GELA). © 2011 Elsevier Ltd.
PubMed | Clinique Armoricaine de Radiologie, University of Versailles, Center Hospitalier, Reims University Hospital Center and 10 more.
Type: Clinical Trial, Phase II | Journal: Molecular cancer therapeutics | Year: 2015
High-dose FOLFIRI has an acceptable safety profile and promising efficacy. UDP-glucuronosyltransferase: (UGT1A1) polymorphism may be predictive of toxicity and efficacy of irinotecan. This phase II study aimed to evaluate the combination of high-dose FOLFIRI plus bevacizumab in patients with previously untreated metastatic colorectal cancer (MCRC) based on their UGT1A1 genotype. Patients with the UGT1A1 *1/*1 (group 1) or *1/*28 (group 2) genotype received bevacizumab plus high-dose FOLFIRI every 2 weeks. Using the Bryant and Day design with objective response rate and toxicity as the primary endpoints, 54 patients in each group were required with a planned interim analysis after inclusion of 17 patients per group. We planned to stop the trial at the interim analysis if 7 patients exhibited an objective response (OR) and/or 3 patients exhibited severe toxicity. At the interim analysis, ORs were higher than the number expected: 52.9% (group 1) and 58.8% (group 2). More than three toxic events occurred in both groups and, according to the interim analysis rule, the trial was closed due to unacceptable toxicity. Recruitment was stopped when 86 patients were included and an analysis on overall population was done for overall survival (OS) and progression-free survival (PFS). The median PFS was 10.7 months (group 1) and 10.4 months (group 2). The median OS was 25.5 months (group 1) and 23.9 months (group 2). This trial does not support the use of the intensive treatment with HD-FOLFIRI plus bevacizumab combination for MCRC in patients with the UGTA1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*28 genotype.
PubMed | Institute Paoli Calmettes, University of Hradec Kralove, University of Lyon, Reims University Hospital Center and 11 more.
Type: Journal Article | Journal: American journal of hematology | Year: 2016
An adverse prognostic impact of statin use in lymphoma was first suspected from in vitro data showing an impairment of anti-CD20 antibody binding. However, further clinical studies suggested an improved outcome associated with their use in hematological malignancies. In particular, a survival benefit was reported for patients with follicular lymphoma on statins. Our objective was to assess the outcome of follicular lymphoma patients treated in the PRIMA study with immunochemotherapy according to the use of statins. Among the 1,217 patients enrolled in the PRIMA study, 1,135 were included in the present study. Concomitant treatments at registration were available for all patients. Among those 1,135 patients, 119 were on statins (10.5%) at diagnosis. Adverse events frequencies, event-free survival (EFS), time to next lymphoma treatment (TTNLT), time to next chemotherapy (TTNCT), and overall survival (OS) were evaluated according to the use of statins. The rates of overall and specific cardiovascular adverse events between the two groups of patients were comparable both during induction and maintenance. Outcome in terms of response rates or EFS, TTNLT, TTNCT, and OS were similar regardless of the use of statins (P=0.57, P=0.85, P=0.30, and P=0.43, respectively) in univariate analysis and after further adjustments for potential confounding factors in multivariate analysis. In conclusion, statin use does not impact the prognosis of patients with follicular lymphoma treated with immunochemotherapy.
Dohollou N.,Polyclinique Bordeaux Nord Aquitaine |
Rudzky C.,Ed Innov Sante
Oncologie | Year: 2012
Therapeutic education in oncology is a recent phenomenon, and one which is likely to become more advertised and talked about in themonths to come.We already understand the term well; however, all too often it is mixed in and combined with personal information. It was important for us to carefully go over the history of therapeutic education, the concept and its principles in relation to clearly identified chronic diseases, such as asthma, diabetes and renal failure. We also wanted to emphasise the different recommendations given by the French National Authority for Health (HAS) and the Hospital, Patient, Health and Territory Act promoting this concept in the in the field of oncology, and highlight that it is very beneficial and that it has already been introduced by oncology teams. All that is required is to structure and formalise the teaching and ongoing support of selfcare or adjustment skills by the cancer patient, with the help of teams trained in ETP (therapeutic education). We have chosen to illustrate this concept through adjuvant breast cancer therapy (in the non-metastatic phase, because in this case the notion of chronic illness is obvious), as continuing with a physical activity or weight control become independent prognostic factors, which are just as important as the initial clinical or histological prognostic features. © Springer-Verlag France 2012.
PubMed | Polyclinique Bordeaux Nord Aquitaine
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016
16027 Background: Standard docetaxel-based treatment for mHRPC is not without toxicity, especially in older, poor health status patients. We evaluated the efficacy and safety of combined estramustine, paclitaxel, and tegafur-uracil (ETU) in this population.This Gehan 2-stage study aimed to recruit 60 chemonaive patients with progressive disease after hormone therapy (new metastatic lesions or PSA progression). Patients received iv paclitaxel 80mg/m58 patients (median age 71 years [range 43-84], 67% with 2 lines of hormone therapy, 71% with PS >1) were evaluable for safety. Median Gleason score was 8, median PSA was 221ng/mL and 96% of patients had bone metastases. Patients received a mean of 7 cycles (range 1-22). Response to treatment is shown in the table ; 51% and 27% of patients were alive at 12 and 18 months, respectively. ETU was well tolerated, with grade 3/4 anemia, neutropenia, and thrombocytopenia in 9%, 2%, and 2% of patients, respectively. Main non-hematologic side effects (all grades) were alopecia (36%), diarrhea (32%), nausea/vomiting (17%), neuropathy (12%), and skin toxicity (12%). There was no hand-foot syndrome. The addition of tegafur-uracil did not add to the toxicity of paclitaxel-estramustine.The combination of estramustine, paclitaxel, and tegafur-uracil (ETU) is a very promising treatment, with durable responses in patients with mHRPC. ETU is well tolerated, with no life-threatening adverse events or hand-foot syndrome. This combination is an attractive treatment option for patients with mHRPC. [Table: see text] [Table: see text].
Mangione R.,Collège de France |
Lelong N.,University Pierre and Marie Curie |
Fontanges M.,Collège de France |
Amat S.,Collège de France |
And 3 more authors.
Ultrasound in Obstetrics and Gynecology | Year: 2011
Objective To evaluate the ability to confidently identify intracranial translucency (IT) in a clinical practice and following specific training of 10 operators. Methods Two experienced observers reviewed 11-13-week nuchal translucency (NT) images for IT visibility in (1) a series of 50 randomly selected images obtained by 10 skilled operators certified by the Collège Français d'Echographie Foetale (CFEF) (retrospective analysis) and (2) a series of 315 images obtained by 10 different operators following specific training for IT visualization (prospective analysis). We calculated proportions of images for which IT was deemed visible and the agreement between the two observers. Data were also stratified by Herman and CFEF quality-score intervals. Results In the retrospective analysis, IT was visualized by both reviewers in 52% of images, with a moderate level of agreement (k = 0.63). The rate of IT visualization by both reviewers increased very slightly to 56-58% when only considering images with the best NT quality-control scores. Following specific training of the operators the proportion of images for which both reviewers could identify the fourth ventricle increased to 85%, but the level of agreement remained moderate (k = 0.66). When considering images with the best NT quality-control scores, IT visualization by both reviewers increased to 91-92%. Conclusions In a clinical practice that focuses on NT measurement IT cannot be visualized in a substantial proportion of the images obtained, which limits the utility of this approach for the early prenatal diagnosis of open spina bifida. However, the ability to identify the fourth ventricle significantly increases following specific training. Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.