Montpellier Academic Hospital

Montpellier, France

Montpellier Academic Hospital

Montpellier, France

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Gridelli C.,S Giuseppe Moscati Hospital | De Marinis F.,San Camillo Forlanini Hospital | Pujol J.-L.,Montpellier Academic Hospital | Reck M.,Krankenhaus Grosshansdorf | And 13 more authors.
Journal of Thoracic Oncology | Year: 2012

INTRODUCTION: In a phase III, randomized, double-blind study (PARAMOUNT), maintenance pemetrexed demonstrated significant benefit in advanced non-small-cell lung cancer (NSCLC). We present safety, resource use, and quality of life (QoL) results. METHODS: After four 21-day cycles of pemetrexed-cisplatin (N = 939), patients with advanced nonsquamous NSCLC, whose disease had not progressed and who had a performance status of 0/1, were randomized 2:1 (N = 539) to maintenance pemetrexed 500 mg/m plus best supportive care or placebo plus best supportive care every 21 days until disease progression or unacceptable toxicity. QoL was measured using the EuroQol 5-dimensional questionnaire (EQ-5D). RESULTS: Frequently reported grade 3 to 4 drug-related toxicities with maintenance pemetrexed versus placebo were anemia (4.5% versus 0.6%; p = 0.016), fatigue (4.2% versus 0.6%; p = 0.016), and neutropenia (3.6% versus 0.0%; p < 0.006). No significant differences in drug-related grade 3 to 5 toxicities were observed with long-term pemetrexed exposure (>6 cycles), except grade 3 to 4 neutropenia, which did not result in increased infections. Patients on maintenance pemetrexed required more transfusions (13.4% versus 5.0%; p = 0.003), granulocyte colony- or granulocyte-macrophage colony-stimulating factors (5.3% versus 0.0%; p <0.001), anti-infectives (25.3% versus 16.7%; p = 0.028), and hospitalizations because of study drug (8.4% versus 3.3%, p = 0.028) than placebo-treated patients did. No significant treatment-by-time interactions, overall treatment differences, or clinically relevant changes from baseline were observed in EQ-5D scores during treatment. CONCLUSIONS: Long-term use of continuation maintenance pemetrexed was well tolerated; resource use was low, corresponding with known pemetrexed toxicities. The EQ-5D results demonstrate that patients tolerate long-term maintenance pemetrexed without worsening QoL. Copyright © 2012 by the International Association for the Study of Lung Cancer.


Scagliotti G.V.,University of Turin | Gridelli C.,S Giuseppe Moscati Hospital | de Marinis F.,Italian National Cancer Institute | Thomas M.,Internistische Onkologie Der Thoraxtumoren Thoraxklinik Im Universitatsklinikum Heidelberg | And 9 more authors.
Lung Cancer | Year: 2014

Objectives: Two phase III trials of advanced NSCLC patients were compared to examine relative efficacy and safety of differing treatment regimens. The JMDB trial investigated first-line pemetrexed-cisplatin (pemetrexed 500mg/m2 plus cisplatin 75mg/m2 every 21 days; maximum: 6 cycles). The PARAMOUNT phase III trial compared maintenance pemetrexed versus placebo after patients with nonsquamous NSCLC completed 4 cycles of first-line pemetrexed-cisplatin without disease progression. Methods: Overall survival (OS) and progression-free survival (PFS), analyzed by Kaplan-Meier and Cox methods, and toxicity rates were compared between the PARAMOUNT arms and a selected homogeneous population from JMDB: 346 patients with disease and prior treatment characteristics matching the PARAMOUNT population. Results: Outcomes for the PARAMOUNT placebo arm were similar to the JMDB homogeneous group (median PFS: 5.6 versus 6.2 months, p = 0.117, HR = 1.16; median OS: 14.0 versus 14.2 months, p = 0.979, HR = 1.00). The PARAMOUNT maintenance pemetrexed group had statistically superior efficacy compared with the JMDB homogeneous group (median PFS: 7.5 versus 6.2 months, p<. 0.00001, HR = 0.66; median OS: 16.9 versus 14.2 months, p = 0.003, HR = 0.75). Patients who received pemetrexed maintenance (median 4 cycles, range 1-44) following 4 cycles of pemetrexed-cisplatin exhibited a higher incidence of drug-related serious adverse events compared with JMDB patients (median 6 cycles of pemetrexed-cisplatin) (10.6% versus 2.9%); grade 3/4 fatigue and renal toxicity were also higher in the pemetrexed arm of PARAMOUNT. Conclusions: The across-trial comparison of a relevant JMDB study population with the two arms of the PARAMOUNT study supported the efficacy of the pemetrexed continuation maintenance strategy and suggested the results are not influenced by limiting the pemetrexed-cisplatin induction treatment to four cycles. Although longer exposure to pemetrexed-cisplatin or maintenance pemetrexed increased some toxicities, the overall incidence remained low, underscoring the relative safety of these treatment regimens. © 2014 Published by Elsevier Ireland Ltd.


Mazieres J.,University Paul Sabatier | Pujol J.-L.,Montpellier Academic Hospital | Kalampalikis N.,University of Lyon | Bouvry D.,Avicenne Hospital | And 6 more authors.
Journal of Thoracic Oncology | Year: 2015

Introduction: To evaluate the perception of lung cancer in the general population to identify obstacles in patient-doctor communications. Methods: A prospective nationwide survey was conducted using a questionnaire and lexical approaches given to 2200 healthy subjects selected within a representative polling database. Results: Of the 1469 subjects eligible for full analysis, most were well informed regarding the epidemiological changes to lung cancer and the main risk factors. The overall survival of patients with lung cancer (32%) was overestimated, and the survival of patients with early stages of lung cancer was underestimated (52%). Lung cancer was identified as a severe disease (82%) with a worse prognosis than other cancers. Most of the population was aware of the main treatments available, except for targeted therapy. Using lexical analyses, we observed that a major proportion considered lung cancer to be a tobacco-induced, life-threatening disease that involved major treatment, and a minor proportion considered it to be an environmentally induced disease. Compared with breast cancer, lung cancer was characterized by a greater feeling of guilt and was more frequently associated with lifestyle. Conclusions: We have identified knowledge gaps in the perception of lung cancer and have highlighted a need for a public information campaign on lung-cancer screening to promote the good survival rate from early-stage disease and the progress achieved with new therapeutic strategies. © 2014 by the International Association for the Study of Lung Cancer.


Jacot W.,Montpellier Academic Hospital | Jacot W.,Montpellier Cancer Center | Pujol J.-L.,Montpellier Academic Hospital | Chakra M.,Montpellier Academic Hospital | And 4 more authors.
Lung Cancer | Year: 2012

Introduction: In small cell lung cancer (SCLC), despite the high response rates induced by platinum-based first line chemotherapies, relapse happens in 85% of the first-line responding tumors. Since 1992 we used a combination of epirubicin and ifosfamide (EI) as a non-cross-resistant regimen in relapsed or refractory SCLC. With the topotecan approval in second line treatment, this combination has been moved from the second line to the third line setting. Methods: Patients presenting with a relapsed or refractory, histologically proven, SCLC were considered for this combination associating ifosfamide 3g/m 2 day 1-2 with uroprotection using mesna, and epirubicin 90mg/m 2 day 1 given every four weeks until progression or unacceptable toxicity. Results: Seventy patients were accrued between September 1992 and August 2010 (seven women). Median age was 56. years. Performance Status was 0, 1, 2 and 3 for 16 (23%), 25 (35%), 20 (29%) and 9 (13%) patients respectively. Proportion of refractory, resistant and sensitive tumors was 20, 21 and 59% respectively. Median time from first line chemotherapy until progression was 90. days (range 5-1720. days). Forty-four patients were treated in second line setting whereas the 26 others have had received two lines at time of accrual. A total of 203 cycles were delivered (median 2 cycles, range: 1-6). Fifteen patients (21.4%) achieved an objective response (including one complete), and 10% had a stable disease. Median overall survival was 3.9. months (95% confidence interval: 3.3-5.1). Overall NCI-CTC grade 3 and 4 toxicity was mainly hematological: neutropenia (71% of the patients, febrile neutropenia 9.4% of the cycles), thrombocytopenia (23%), and anemia (22%). In univariate analysis, previous anthracyclines treatment was associated with a trend towards shorter survival (median overall survival 3.9 versus 4.6. months, p= 0.12). In multivariate analysis, only a high serum NSE level and presence of brain metastases were independent prognostic variables. Conclusion: The EI combination is an active regimen in relapsed or refractory SCLC. The trend towards a greater activity of this regimen in patients not pretreated using anthracyclines suggests that class of agents should be tested in SCLC relapsing after the etoposide-platinum standard regimen. © 2011 Elsevier Ireland Ltd.


PubMed | Montpellier Academic Hospital
Type: Journal Article | Journal: Lung cancer (Amsterdam, Netherlands) | Year: 2012

In small cell lung cancer (SCLC), despite the high response rates induced by platinum-based first line chemotherapies, relapse happens in 85% of the first-line responding tumors. Since 1992 we used a combination of epirubicin and ifosfamide (EI) as a non-cross-resistant regimen in relapsed or refractory SCLC. With the topotecan approval in second line treatment, this combination has been moved from the second line to the third line setting.Patients presenting with a relapsed or refractory, histologically proven, SCLC were considered for this combination associating ifosfamide 3 g/m(2) day 1-2 with uroprotection using mesna, and epirubicin 90 mg/m(2) day 1 given every four weeks until progression or unacceptable toxicity.Seventy patients were accrued between September 1992 and August 2010 (seven women). Median age was 56 years. Performance Status was 0, 1, 2 and 3 for 16 (23%), 25 (35%), 20 (29%) and 9 (13%) patients respectively. Proportion of refractory, resistant and sensitive tumors was 20, 21 and 59% respectively. Median time from first line chemotherapy until progression was 90 days (range 5-1720 days). Forty-four patients were treated in second line setting whereas the 26 others have had received two lines at time of accrual. A total of 203 cycles were delivered (median 2 cycles, range: 1-6). Fifteen patients (21.4%) achieved an objective response (including one complete), and 10% had a stable disease. Median overall survival was 3.9 months (95% confidence interval: 3.3-5.1). Overall NCI-CTC grade 3 and 4 toxicity was mainly hematological: neutropenia (71% of the patients, febrile neutropenia 9.4% of the cycles), thrombocytopenia (23%), and anemia (22%). In univariate analysis, previous anthracyclines treatment was associated with a trend towards shorter survival (median overall survival 3.9 versus 4.6 months, p=0.12). In multivariate analysis, only a high serum NSE level and presence of brain metastases were independent prognostic variables.The EI combination is an active regimen in relapsed or refractory SCLC. The trend towards a greater activity of this regimen in patients not pretreated using anthracyclines suggests that class of agents should be tested in SCLC relapsing after the etoposide-platinum standard regimen.

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