Publications by authors named "David Coeffic"

15 Publications

  • Page 1 of 1

Long-term outcomes in patients with PET-predicted poor-responsive HER2-positive breast cancer treated with neoadjuvant bevacizumab added to trastuzumab and docetaxel: 5-year follow-up of the randomised Avataxher study.

EClinicalMedicine 2020 Nov 4;28:100566. Epub 2020 Nov 4.

Centre Georges-Francois Leclerc, Dijon, France.

Background: The open-label, randomised Phase 2 AVATAXHER study (NCT01142778) demonstrated that early PET assessment identified HER2-positive breast cancer patients who responded poorly to neoadjuvant docetaxel plus trastuzumab. Adding neoadjuvant bevacizumab for PET-predicted poor-responders improved pathological complete response (pCR) rates (43.8% vs 24.0%). We investigated long-term study outcomes.

Methods: Patients were treated in three groups. All patients initially received two cycles of standard neoadjuvant therapy with [¹⁸F]-FDG PET conducted before each cycle. Those with ≥70% change in the maximum standardised uptake value (∆SUVmax) received four further cycles of standard neoadjuvant therapy (PET responders). PET-predicted poor-responders (∆SUVmax <70%) were randomised (2:1) to neoadjuvant therapy with (Group A) or without (Group B) bevacizumab for cycles 3-6. All patients received one further cycle of trastuzumab before surgery plus adjuvant trastuzumab (11 cycles).

Findings: 142 patients were randomized and treated (PET responders,  = 69; Group A,  = 48; Group B,  = 25). 5-year disease-free survival rates were 90.5% (95% CI: 80.0-95.6%) in PET responders, 90.2% (95% CI: 75.9-96.2%) in Group A, and 76.0% (95% CI: 54.2-88.4%) in Group B. However, no difference was observed between randomised arms in a sensitivity analysis. During adjuvant therapy, the incidence of Grade ≥3 (Group A: 25.6%; Group B 12.5%) and serious adverse events (Group A: 18.6%; Group B 12.5%) was higher in Group A vs Group B, but with no apparent effect on cardiac events.

Interpretation: In patients with HER2-positive breast cancer, an intervention based on early PET assessment and improvement of pCR does not modify disease-free survival.

Funding: Roche France.
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http://dx.doi.org/10.1016/j.eclinm.2020.100566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649610PMC
November 2020

[Real-life study of 7-year survival in patients treated with trastuzumab for HER2+ early breast cancer].

Bull Cancer 2020 Jul - Aug;107(7-8):745-755. Epub 2020 Jun 10.

CRLCC François-Baclesse, department of medical oncology, Caen, France.

Background And Rationale: Despite improved prognosis of HER2 since the introduction of trastuzumab in the adjuvant setting of early breast cancer, disease recurrences still occur, particularly in certain patient subgroups. The objective of this real-life study conducted in France is to evaluate after 7 years, disease-free survival (DFS) and distant metastatic-free survival (MFS).

Methods: This was a multi-center, retrospective, observational study assessing early HER2+ breast cancer patients diagnosed between January 1st, 2009 and December 31st, 2010 treated with adjuvant trastuzumab. DFS and MFS were evaluated within subgroups according to hormonal and nodal status.

Results: Based on 2311 patients documented, according to nodal status, the 7-year DFS rate was significantly higher for N- than for N+ patients [87.2% vs. 66.8%; P<0.001], and the 7-year MFS rate [94.7% for N- vs. 74.9% for N+; P<0.001]. According to hormonal status, the 7-year DFS rate was significantly higher for HR+ than for HR- patients [80.5% vs. 69.2%; P<0.001], and the 7-year MFS rate [88.0% for HR+ vs. 77.7% HR-].

Conclusions: Despite the overall improvement in the prognosis of early HER2+ breast cancers, patients in the N+ and RH- subgroups have a high risk of metastatic recurrence at seven years, justifying the search for more effective treatment alternatives.
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http://dx.doi.org/10.1016/j.bulcan.2020.04.013DOI Listing
August 2020

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer.

Eur J Cancer 2018 11 26;103:184-194. Epub 2018 Sep 26.

Institut Claudius Regaud, IUCT Oncopole, Toulouse, France.

Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS).

Patients And Methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)-/HER2- BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m) or ixabepilone (40 mg/m). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy.

Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58-1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66-1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53-1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II-III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29-1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III-IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone).

Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II-III lymphocytic infiltration) requires further evaluation.
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http://dx.doi.org/10.1016/j.ejca.2018.06.025DOI Listing
November 2018

Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial.

Gynecol Oncol 2017 Jan 18;144(1):65-71. Epub 2016 Nov 18.

GINECO and Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu - Oncologie, 1 Place du Parvis Notre-Dame - Place Jean-Paul II, 75004 Paris, France.

Background: The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).

Methods: Patients with PROC were randomised to receive investigator-selected single-agent chemotherapy alone or with bevacizumab. Post-hoc exploratory analyses assessed efficacy, safety and patient-reported outcomes according to age <65 versus ≥65years.

Results: In the 133 patients (37%) aged ≥65years, baseline hypertension was more frequent and ascites was less common than in patients <65years. The magnitude of PFS benefit from bevacizumab was similar in patients ≥65 versus <65years (hazard ratio 0.44 [95% CI, 0.31-0.64] versus 0.49 [95% CI, 0.37-0.64], respectively, treatment-age interaction p=0.58), with similar improvements in response rates. Grade≥3 hypertension was more common with bevacizumab than chemotherapy alone in both subgroups, and more common in older than younger patients irrespective of treatment. However, there was no excess of other adverse events of specific interest for bevacizumab, including venous thromboembolic events, in older patients. More patients receiving bevacizumab in the younger but not the older subgroup showed improved gastrointestinal/abdominal symptoms.

Conclusion: In exploratory analyses, PFS and response rate improvement with bevacizumab were consistent in older and younger patients. Grade≥3 hypertension was more common in elderly bevacizumab-treated patients; careful monitoring is recommended. Overall, bevacizumab-containing therapy was well tolerated in a selected population aged ≥65years, suggesting a favourable benefit:risk profile. However, geriatric assessments are needed to improve selection of elderly patients potentially gaining symptom and quality of life improvements from bevacizumab-containing therapy.

Clinical Trials Registration: ClinicalTrials.govNCT00976911.
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http://dx.doi.org/10.1016/j.ygyno.2016.11.006DOI Listing
January 2017

Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial.

Lancet Oncol 2014 Dec 30;15(13):1493-1502. Epub 2014 Oct 30.

Department of Nuclear Medicine, Centre Georges-Francois Leclerc, Dijon, France.

Background: An effective and well tolerated treatment is needed for patients with early HER2-positive breast cancer who do not achieve a pathological complete response after neoadjuvant therapy. The AVATAXHER trial aimed to predict pathological complete response early with the use of PET and to investigate whether the addition of bevacizumab could improve the proportion of patients achieving a pathological complete response in patients unlikely to respond to treatment.

Methods: AVATAXHER was a randomised, open-label, non-comparative, multicentre phase 2 study that enrolled women (≥18 years of age) with early-stage HER2-positive breast cancer from 26 oncology centres in France. Patients initially received two cycles of neoadjuvant docetaxel (100 mg/m(2) intravenously every 3 weeks) plus trastuzumab (8 mg/kg intravenously every 3 weeks then 6 mg/kg intravenously every 3 weeks for the second course). Before the first and second cycles, [(18)F]-fluorodeoxyglucose (FDG) PET was done and the change in standardised uptake value was used to predict pathological complete response in each patient. Patients who were predicted to be responders on PET continued to receive standard therapy. Predicted non-responders were randomly assigned (2:1) to receive four cycles of docetaxel (100 mg/m(2) intravenously every 3 weeks) and trastuzumab (6 mg/kg intravenously every 3 weeks) plus bevacizumab (15 mg/kg intravenously every 3 weeks; group A) or continue on docetaxel plus trastuzumab alone (group B). Randomisation was open label and was done by an adaptive minimisation method. Although investigators and patients were aware of group assignment, the anatomo-pathologist in charge of centralised review of surgical samples and lymph nodes was masked to treatment assignment. The primary endpoint was centrally assessed pathological complete response according to the Chevallier classification. Efficacy analyses were done in the intention-to-treat population. Safety analyses in this Article were done on all patients who received at least one dose of treatment starting from cycle 3. Survival outcomes are not yet mature. This study is registered with ClinicalTrials.gov (NCT01142778) and EUDRACT (2009-013410-26).

Findings: Between May 19, 2010, and Oct 1, 2012, 152 patients were recruited for the study. Ten patients were subsequently excluded, leaving 142 patients in the intention-to-treat population. Of these 142 patients, 69 were predicted by [(18)F]-FDG PET to be treatment responders after two cycles of treatment. The 73 predicted non-responders were randomly assigned to group A (n=48) and group B (n=25). Pathological complete responses were noted in 37 (53·6%, 95% CI 41·2-65·7) of the PET responders, 21 (43·8%, 29·5-58·8) of those in group A, and six (24·0%, 9·4-45·1) of those in group B. Incidences of grade 3-4 adverse events were similar in all three groups. The most common grade 3-4 adverse events were neutropenia (four in PET responders, five in group A, and three in group B), febrile neutropenia (one, three, and one, respectively), and myalgia (four, none, and one, respectively). Overall, 24 serious adverse events were reported in 15 patients (PET responders: nine events in four [6%] of 67 patients; group A: 14 events in ten [21%] of 47 patients; group B: one event in one [4%] of 25 patients). No deaths occurred during the study.

Interpretation: In patients with HER2-positive breast cancer, early PET assessment can help to identify non-responders to neoadjuvant docetaxel plus trastuzumab therapy. In these patients, the addition of bevacizumab can increase the proportion of patients achieving a pathological complete response. This potential new role for PET and the activity of bevacizumab in this setting need to be confirmed in larger phase 3 trials.

Funding: Roche France.
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http://dx.doi.org/10.1016/S1470-2045(14)70475-9DOI Listing
December 2014

Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial.

BMC Cancer 2012 Dec 17;12:603. Epub 2012 Dec 17.

Centre Léon Bérard, 28 rue Laennec, Lyon Cedex 08, 69373, France.

Background: Chemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens.

Methods: Chemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071 clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance.

Results: From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course).

Conclusion: This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.
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http://dx.doi.org/10.1186/1471-2407-12-603DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582626PMC
December 2012

Bevacizumab plus microtubule targeting agents in heavily pre-treated ovarian cancer patients: a retrospective study.

Bull Cancer 2011 Oct;98(9):80-9

CHU Hautepierre, Department of Oncology & Hematology, Strasbourg, France.

OBJECTIVES. As vascular endothelial growth factor (VEGF) is expressed in ovarian cancer, we assessed the efficacy and safety of bevacizumab (a monoclonal antibody targeting VEGF) plus microtubule targeting agents for heavily pre-treated ovarian carcinoma patients. METHODS. We retrospectively reviewed 43 patients with recurrent epithelial ovarian carcinoma. Combined treatment included bevacizumab with paclitaxel in 32 (74%), docetaxel in 10 (23%), and vinorelbine in one (2.3%) patients, respectively. RESULTS. The median number of combined treatment was six cycles (range 1-29). On RECIST criteria, the objective response rate (ORR) was 40% (16% CR and 24% PR). Clinical benefit (complete response [CR] plus partial response [PR] and stable disease [SD] lasting ≥ 3 months) was 74% (CI95%: 46.7-77%). Median duration of treatment and overall survival were 3.9 months (range 0.2-14.4 months) and 20.1 months (CI95%: 13.8-20.1) respectively. No toxic death was reported. Grade 3-4 toxicity occurred in 30% of patients. Gastrointestinal perforations and fistula occurred in 3 (7%) and 6 (14%) patients, respectively. CONCLUSION. Although being active in terms of ORR, bevacizumab plus microtubule targeting agents - mainly taxanes - leads to a high rate of gastro-intestinal perforations and fistula in heavily pre-treated ovarian carcinoma patients.
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http://dx.doi.org/10.1684/bdc.2011.1436DOI Listing
October 2011

Final results of ERASME-4: a randomized trial of first-line docetaxel plus either capecitabine or epirubicin for metastatic breast cancer.

Oncology 2011 6;80(3-4):262-8. Epub 2011 Jul 6.

Département de Cancérologie Médicale et Unité INSERM U590Centre Léon Bérard, 28 rue LaënnecFR–69373 Lyon Cedex 08, France.

Objective: To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC).

Patients And Methods: Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m(2) twice daily, days 1-14; docetaxel 75 mg/m(2), day 1) or ET (epirubicin 75 mg/m(2), day 1; docetaxel 75 mg/m(2), day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design.

Results: Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months' median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience.

Conclusion: Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.
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http://dx.doi.org/10.1159/000329066DOI Listing
September 2011

[Node negative breast cancer. Beyond international consensus: a pragmatic approach].

Bull Cancer 2011 Jul;98(7):807-25

Centre Jean-Perrin, service de pathologie, 58, rue Montalembert BP 392, 63011 Clermont-Ferrand, France.

Apart from therapeutic advances related to new treatments, our practices in the management of early breast cancer have been modified by to key organizational settings (1) mass screening, substantially altering the presentation and epidemiology of breast cancer and (2) the development of guidelines to ensure that any patient management is in agreement with the demonstrated impact in the adjuvant treatment. In daily practice, the impact of screening and guidelines recommendations has put us now in a paradoxical situation: while the majority of non-metastatic breast cancers treated in the hexagon are node negative, most of the results of clinical studies on chemotherapy and targeted therapies today arise from populations predominantly node positive. Therefore, it seemed legitimate to convene a working group around a reflection on the directions of adjuvant chemotherapy in a growing node negative population in order to better respond to the questions of the field oncologists, trying to address the discrepancies between different existing guidelines.
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http://dx.doi.org/10.1684/bdc.2011.1395DOI Listing
July 2011

Adjuvant docetaxel/cyclophosphamide in breast cancer patients over the age of 70: results of an observational study.

Crit Rev Oncol Hematol 2011 Dec 11;80(3):466-73. Epub 2011 May 11.

Department of Medical Oncology, Centre Hospitalier Lyon-Sud and Université de Lyon, France.

This retrospective observational study was designed to describe feasibility and tolerance of adjuvant Taxotere®/cyclophosphamide (TC) chemotherapy in women aged over 70 years with early breast cancer. Data including geriatric evaluations were collected from the medical charts of 110 patients from 14 oncology institutions in France who had completed adjuvant systemic TC (91% received at least 4 cycles). Median age was 73 years (range 70-85), 51% of patients had breast conserving surgery, 42% had a tumor smaller than 2cm and 33% had positive nodes. Geriatric assessment was performed by oncologists in 88% of patients; 55% were considered fit, 5% had geriatric syndrome and 10% had more than three comorbidities. Neutropenia was reported in 15% of patients, including febrile neutropenia and/or grade 4 in 5% for each. Primary prophylactic G-CSF was given to 49% of patients. In a selected population of elderly patients, 4 cycles of adjuvant TC is feasible without major toxicity, confirming the US Oncology trial data.
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http://dx.doi.org/10.1016/j.critrevonc.2011.04.001DOI Listing
December 2011

Multicenter phase II trial of neoadjuvant therapy with trastuzumab, docetaxel, and carboplatin for human epidermal growth factor receptor-2-overexpressing stage II or III breast cancer: results of the GETN(A)-1 trial.

J Clin Oncol 2007 Jul 21;25(19):2678-84. Epub 2007 May 21.

Department of Oncology, CAC G.F. Leclerc and IFR 100, Dijon, France.

Purpose: Trastuzumab plus chemotherapy has become the standard of care for human epidermal growth factor receptor-2 (HER-2) -positive breast cancer. Trastuzumab-based preoperative systemic therapy (PST; neoadjuvant therapy) also appears promising, warranting further investigation.

Patients And Methods: Patients with HER-2-positive, stage II/III, noninflammatory, operable breast cancer requiring a mastectomy (but who wanted to conserve the breast) received trastuzumab 4 mg/kg (day 1), followed by 2 mg/kg weekly, plus docetaxel 75 mg/m2 every 3 weeks, and carboplatin (area under curve, 6) for six cycles before surgery. The primary end point was pathologic complete response (pCR) rate, determined from surgical specimens.

Results: Seventy patients were enrolled. Most patients had clinical T2/T3 tumors (100%) or clinical N1/2 nodes (53%). Sixty-seven patients (96%) completed six cycles of therapy, one patient withdrew due to progressive disease, and two patients withdrew for toxicity. A complete or partial objective clinical response occurred in 95% of patients (85% and 10%, respectively). Surgery was breast conservative in 45 (64%) of 70 patients. In an intent-to-treat analysis, tumor and nodal pCR were seen in 27 (39%) of 70 patients. Centralized retrospective analysis of HER-2 status demonstrated a 43% pCR rate in the 24 of 56 confirmed HER-2-overexpressing (3+) and/or fluorescence in situ hybridization-positive tumors. Treatment was generally well tolerated. Grade 3/4 neutropenia and febrile neutropenia were uncommon (2%). Two patients withdrew prematurely due to a transient, asymptomatic decrease in left ventricular ejection fraction. No symptomatic cardiac dysfunction occurred.

Conclusion: PST with trastuzumab plus docetaxel and carboplatin achieved promising efficacy, with a good pCR rate and favorable tolerability in stage II or III HER-2-positive breast cancer.
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http://dx.doi.org/10.1200/JCO.2006.09.9994DOI Listing
July 2007

A phase II study of an oxaliplatin/vinorelbine/5-fluorouracil combination in patients with anthracycline-pretreated and taxane-pretreated metastatic breast cancer.

Anticancer Drugs 2006 Oct;17(9):1067-73

Centre François Baclesse, Caen, France.

The aim of this phase II study was to evaluate safety and efficacy of an oxaliplatin/vinorelbine/5-fluorouracil (FON) combination in anthracycline and taxane-pretreated metastatic breast cancer patients. The following treatment was given: on day 1 of a 21-day cycle, oxaliplatin 130 mg/m (2-h intravenous infusion); on days 1 and 5, vinorelbine [dose level (DL) 1: 17.5 mg/m; DL2: 22 mg/m]; on days 1-5, continuous infusion 5-fluorouracil (DL1: 600 mg/m/day; DL2: 750 mg/m/day). Forty-seven patients were treated (DL1: 43; DL2: 4). Median age was 54 years; 68% had liver metastases, 53% were taxane refractory/resistant and 38% were anthracycline refractory/resistant. Patients received a median of six treatment cycles. Of 46 eligible patients, 16 had partial response; the overall response rate was 34.8% (95% confidence interval 21.3-50.3%), 11 had stable disease lasting more than 4 months. Median follow-up was 13.0 months, median time to progression 5.7 months and estimated overall survival 18.8 months. DL2 was too toxic with three patients having grade 3-4 toxicity, including one death. At DL1, 26 patients (60%) experienced grade 3-4 neutropenia (six febrile neutropenia) and eight had grade 3 oxaliplatin-specific peripheral neuropathy after a median of 646.4 mg/m oxaliplatin (range 124-1619 mg/m). Oxaliplatin (130 mg/m, day 1)/vinorelbine (17.5 mg/m, days 1,5)/5-fluorouracil (600 mg/m/day, days 1-5) demonstrate encouraging activity and a manageable safety profile in anthracycline- and taxane-pretreated metastatic breast cancer patients.
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http://dx.doi.org/10.1097/01.cad.0000231475.77159.aaDOI Listing
October 2006

Stage-related changes in functional capacity in Hodgkin's disease: assessment by cardiopulmonary exercise testing before initiation of treatment.

Ann Hematol 2006 Dec 13;85(12):857-61. Epub 2006 Sep 13.

UCP.X, Laboratoire de Physiopathologie de l'Exercice, Grenoble, France.

Our aim was to examine indices of cardiorespiratory capacity at rest and during exercise before initiation of therapy for Hodgkin's disease. We prospectively studied 24 patients divided into two groups according to the disease stage. Group 1 included eight patients in stage IA and four in stage IIA; group 2 included four patients in stage IIB, six in stage III, and two in stage IV. All patients underwent detailed cardiopulmonary evaluations at rest using electrocardiogram, echocardiogram, spirometry, and measurement of pulmonary diffusing capacity (DLCO), and during exercise using a cardiopulmonary exercise test. Groups 1 and 2 were similar with respect to sex distribution (eight women and four men in each), mean age (35+/-36 vs37+/-4.6 years), body mass index, and hemoglobin concentration (12.7+/-0.2 vs 12.1+/-0.3 g l-1). All patients had a normal cardiovascular status. All patients in group 1 had normal cardiorespiratory measurements at rest and during exercise. Forced vital capacity was significantly lower in group 2 (84.8+/-2.7% predicted) than in group 1 (105+/-3%, P<0.0001), without abnormalities in DLCO or in resting and exercise oxygen diffusion. Likewise, percentage predicted VO2max (65+/-4 vs 97+/-6, P<0.0002), oxygen pulse at peak exercise (0.12+/-0.01 vs 0.17+/-0.01, P<0.001), and DeltaVO2/DeltaW slope (8.4+/-0.3 vs 10.2+/-0.4, P<0.003) were significantly lower in group 2 than in group 1. Functional capacity during exercise was markedly reduced in patients suffering from Hodgkin's disease in advanced stages. This loss of exercise capacity appeared mainly related to a peripheral disorder.
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http://dx.doi.org/10.1007/s00277-006-0174-5DOI Listing
December 2006

[Adjuvant therapy for breast cancer patients: treatment decision tree from a French cancer network].

Bull Cancer 2002 Oct;89(10):897-903

Centre Léon-Bérard, 28, rue Laennec, 69373 Lyon cedex 08, France.

Although the benefit of adjuvant therapy has largely been demonstrated for patients with local breast cancer, therapeutic indications remain controversial. The French regional cancer network Oncora investigated the decision-making process for this disease. Based on a thorough review of the literature, the risk of relapse and the potential benefit of adjuvant treatments for each group of patients were evaluated. A consensus decision-tree was drawn in which chemotherapy is proposed only to patients in whom it is expected to decrease the risk of relapse by at least 5 %. This approach, based on a widely accepted decision-making model, makes it possible to offer all patients of the network homogeneous treatment options. However, due to the subjectivity of risk/benefit estimations, patients themselves should become more involved in the decision-making process.
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October 2002