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1. Indicators of guideline-concordant care in lung cancer defined with a modified Delphi method and piloted in a cohort of over 5,800 cases

Author

Andreano, A, Valsecchi, M, Russo, A, Siena, S, Andruccioli, M, Ardizzoia, A, Assi, A, Baisi, A, Bedini, A, Beretta, G, Bersani, M, Bertagna, F, Berti, E, Bertolini, A, Bettini, A, Bignardi, M, Bini, F, Bna, C, Bono, F, Ottoni, D, Borghesi, A, Borghetti, P, Brunelli, A, Buffoli, A, Cacioppo, C, Calati, A, Calcagno, A, Casagrande, S, Casartelli, C, Castellani, M, Castro, A, Catalano, G, Catena, L, Ceresoli, G, Cergnul, M, Ciocia, G, Colombo, A, Conti, B, Corti, D, Cortinovis, D, Cozzi, C, Crippa, F, De Monte, A, Candis, D, De Toma, D, De Marinis, F, Dimarco, B, Di Nuovo, F, Doglioni, C, Fabbris, V, Faccioli, P, Fagnani, D, Farina, G, Fariselli, L, Filipazzi, V, Franzi, F, Frata, P, Gajate, A, Gardani, G, Gasparini, M, Giordano, M, Grignani, F, Landoni, C, Lombardi, C, Lombardi, F, Luciani, A, Maffioli, L, Marchione, R, Mariani, P, Maspero, A, Meriggi, F, Miedico, A, Morbini, P, Muriana, G, Orlandoni, G, Paris, E, Pedrazzoli, P, Pepe, G, Pezzica, E, Piccoli, F, Pinotti, G, Quadri, A, Ravasio, A, Ravenna, F, Ricchiuti, E, Rinaldo, D, Roda, G, Rossi, G, Santoro, A, Soatti, C, Stiglich, F, Tagliabue, L, Tirelli, V, Tironi, A, Tomirotti, M, Travaini, L, Ucci, G, Vaghi, A, Vanzulli, A, Veronesi, G, Vittimberga, I, Zambelli, C, Andreano A., Valsecchi M. G., Russo A. G., Siena S., Andruccioli M., Ardizzoia A., Assi A., Baisi A., Bedini A. V., Beretta G., Bersani M., Bertagna F., Berti E., Bertolini A., Bettini A., Bignardi M., Bini F., Bna C., Bono F., Ottoni D. B., Borghesi A., Borghetti P., Brunelli A., Buffoli A., Cacioppo C., Calati A., Calcagno A., Casagrande S., Casartelli C., Castellani M., Castro A., Catalano G., Catena L., Ceresoli G. L., Cergnul M., Ciocia G., Colombo A., Conti B., Corti D., Cortinovis D., Cozzi C., Crippa F., De Monte A., Candis D. D., De Toma D., De Marinis F., DiMarco B., Di Nuovo F., Doglioni C., Fabbris V., Faccioli P., Fagnani D., Farina G., Fariselli L., Filipazzi V., Franzi F., Frata P., Gajate A. M. S., Gardani G., Gasparini M., Giordano M., Grignani F., Landoni C., Lombardi C., Lombardi F., Luciani A., Maffioli L. S., Marchione R., Mariani P., Maspero A., Meriggi F., Miedico A., Morbini P., Muriana G., Orlandoni G., Paris E., Pedrazzoli P., Pepe G., Pezzica E., Piccoli F., Pinotti G., Quadri A., Ravasio A., Ravenna F., Ricchiuti E., Rinaldo D., Roda G., Rossi G., Santoro A., Soatti C. P., Stiglich F., Tagliabue L., Tirelli V., Tironi A., Tomirotti M., Travaini L. L., Ucci G., Vaghi A., Vanzulli A., Veronesi G., Vittimberga I., Zambelli C., Andreano, A, Valsecchi, M, Russo, A, Siena, S, Andruccioli, M, Ardizzoia, A, Assi, A, Baisi, A, Bedini, A, Beretta, G, Bersani, M, Bertagna, F, Berti, E, Bertolini, A, Bettini, A, Bignardi, M, Bini, F, Bna, C, Bono, F, Ottoni, D, Borghesi, A, Borghetti, P, Brunelli, A, Buffoli, A, Cacioppo, C, Calati, A, Calcagno, A, Casagrande, S, Casartelli, C, Castellani, M, Castro, A, Catalano, G, Catena, L, Ceresoli, G, Cergnul, M, Ciocia, G, Colombo, A, Conti, B, Corti, D, Cortinovis, D, Cozzi, C, Crippa, F, De Monte, A, Candis, D, De Toma, D, De Marinis, F, Dimarco, B, Di Nuovo, F, Doglioni, C, Fabbris, V, Faccioli, P, Fagnani, D, Farina, G, Fariselli, L, Filipazzi, V, Franzi, F, Frata, P, Gajate, A, Gardani, G, Gasparini, M, Giordano, M, Grignani, F, Landoni, C, Lombardi, C, Lombardi, F, Luciani, A, Maffioli, L, Marchione, R, Mariani, P, Maspero, A, Meriggi, F, Miedico, A, Morbini, P, Muriana, G, Orlandoni, G, Paris, E, Pedrazzoli, P, Pepe, G, Pezzica, E, Piccoli, F, Pinotti, G, Quadri, A, Ravasio, A, Ravenna, F, Ricchiuti, E, Rinaldo, D, Roda, G, Rossi, G, Santoro, A, Soatti, C, Stiglich, F, Tagliabue, L, Tirelli, V, Tironi, A, Tomirotti, M, Travaini, L, Ucci, G, Vaghi, A, Vanzulli, A, Veronesi, G, Vittimberga, I, Zambelli, C, Andreano A., Valsecchi M. G., Russo A. G., Siena S., Andruccioli M., Ardizzoia A., Assi A., Baisi A., Bedini A. V., Beretta G., Bersani M., Bertagna F., Berti E., Bertolini A., Bettini A., Bignardi M., Bini F., Bna C., Bono F., Ottoni D. B., Borghesi A., Borghetti P., Brunelli A., Buffoli A., Cacioppo C., Calati A., Calcagno A., Casagrande S., Casartelli C., Castellani M., Castro A., Catalano G., Catena L., Ceresoli G. L., Cergnul M., Ciocia G., Colombo A., Conti B., Corti D., Cortinovis D., Cozzi C., Crippa F., De Monte A., Candis D. D., De Toma D., De Marinis F., DiMarco B., Di Nuovo F., Doglioni C., Fabbris V., Faccioli P., Fagnani D., Farina G., Fariselli L., Filipazzi V., Franzi F., Frata P., Gajate A. M. S., Gardani G., Gasparini M., Giordano M., Grignani F., Landoni C., Lombardi C., Lombardi F., Luciani A., Maffioli L. S., Marchione R., Mariani P., Maspero A., Meriggi F., Miedico A., Morbini P., Muriana G., Orlandoni G., Paris E., Pedrazzoli P., Pepe G., Pezzica E., Piccoli F., Pinotti G., Quadri A., Ravasio A., Ravenna F., Ricchiuti E., Rinaldo D., Roda G., Rossi G., Santoro A., Soatti C. P., Stiglich F., Tagliabue L., Tirelli V., Tironi A., Tomirotti M., Travaini L. L., Ucci G., Vaghi A., Vanzulli A., Veronesi G., Vittimberga I., and Zambelli C.

Abstract

Background: To identify indicators of guideline-concordant care in lung cancer, to implement such indicators with cancer registry data linked to health databases, and to pilot them in a cohort of patients from the cancer registry of the Milan Province. Methods: Thirty-four indicators were selected by revision of main guidelines by cancer epidemiologists, and then evaluated by a multidisciplinary panel of clinicians involved in lung cancer care and working on the pathway of lung cancer diagnosis and treatment in the Lombardy region, Italy. With a modified Delphi method, they assessed for each indicator the content validity as a quality measure of the care pathway, the degree of modifiability from the health professional, and the relevance to the health professional. Feasibility was assessed using the cancer registry and the routine health records of the Lombardy region. Feasible indicators were then calculated in the cohort of lung cancer patients diagnosed in 2007–2012 derived from the cancer registry of the Milan Province. Criterion validity was assessed reviewing clinical records of a random sample of 114 patients (threshold for acceptable discordance ≤20%). Finally, reliability was evaluated at the provider level. Results: Initially, 34 indicators were proposed for evaluation in the first Delphi round. Of the finally 22 selected indicators, 3 were not feasible because the required information was actually not available. The remaining 19 were calculated on the pilot cohort. After assessment of criterion validity (3 eliminated), 16 indicators were retained in the final set and evaluated for reliability. Conclusion: The developed and piloted set of indicators is now available to implement and monitor, over time, quality initiatives for lung cancer care in the studied health system.

Published
2021

2. Efficacy and Safety of Anti-PD-1 Immunotherapy in Patients Aged ≥ 75 Years With Non–small-cell Lung Cancer (NSCLC): An Italian, Multicenter, Retrospective Study

Author

Luciani, A, Marra, A, Toschi, L, Cortinovis, D, Fava, S, Filipazzi, V, Tuzi, A, Cerea, G, Rossi, S, Perfetti, V, Rossi, A, Giannetta, L, Sala, L, Finocchiaro, G, Pizzutilo, E, Carelli, S, Agustoni, F, Cergnul, M, Zonato, S, Siena, S, Bidoli, P, Ferrari, D, Luciani A., Marra A., Toschi L., Cortinovis D., Fava S., Filipazzi V., Tuzi A., Cerea G., Rossi S., Perfetti V., Rossi A., Giannetta L., Sala L., Finocchiaro G., Pizzutilo E. G., Carelli S., Agustoni F., Cergnul M., Zonato S., Siena S., Bidoli P., Ferrari D., Luciani, A, Marra, A, Toschi, L, Cortinovis, D, Fava, S, Filipazzi, V, Tuzi, A, Cerea, G, Rossi, S, Perfetti, V, Rossi, A, Giannetta, L, Sala, L, Finocchiaro, G, Pizzutilo, E, Carelli, S, Agustoni, F, Cergnul, M, Zonato, S, Siena, S, Bidoli, P, Ferrari, D, Luciani A., Marra A., Toschi L., Cortinovis D., Fava S., Filipazzi V., Tuzi A., Cerea G., Rossi S., Perfetti V., Rossi A., Giannetta L., Sala L., Finocchiaro G., Pizzutilo E. G., Carelli S., Agustoni F., Cergnul M., Zonato S., Siena S., Bidoli P., and Ferrari D.

Abstract

This study was conducted in the setting of advanced non–small-cell lung cancer in older patients. It is a multicenter retrospective analysis on very old persons that explores the efficacy and the safety of anti-programmed cell death protein 1 therapy. Older patients seem to tolerate immunotherapy as well as younger patients with comparable efficacy. This is a relevant message for everyday clinical practice.

Published
2020

3. Effect on quality of life of cisplatin added to single-agent chemotherapy as first-line treatment for elderly patients with advanced non-small cell lung cancer: Joint analysis of MILES-3 and MILES-4 randomised phase 3 trials

Author

Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, Gridelli C., Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, and Gridelli C.

Abstract

Objectives: To evaluate the effect on quality of life (QOL)of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC)enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods: Advanced NSCLC pts, >70 years old, performance status (PS)0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional analyses. Intention-to-treat strategy was applied. Analyses were adjusted for baseline QOL, stage, performance status, gender, age, size of centre, trial, histotype and non-platinum companion drug. Results: Overall, 458/531 pts (86%)answered baseline questionnaire and missing rates over treatment were slightly higher among patients receiving cisplatin. Mean change in sore mouth after cycle 2 was worse with cisplatin (P = 0.02). The size of differences between arms was in the small-medium range for peripheral neuropathy and alopecia (0.25 and 0.31 after one and 0.28 and 0.36 after two cycles, respectively)and for nausea/vomiting, sore mouth and dysphagia after two cycles (0.26, 0.38 and 0.25, respectively)always in the direction of worsening with cisplatin. Using a 10% change from baseline as clinically relevant threshold to categorize response, there was no significant difference between the arms. Time to deterioration of sore mouth and alopecia, with progression/death as competitive risk, was shorter with cisplatin (HR 1.72 95%CI 1.02–2.89, P = 0.04 and HR 1.84 95%CI 1.09–3.10, P = 0.02, respectively). Conclusion: The addition of cisplatin to single agent chemotherapy worsens sore mouth and alopecia and does not improve any QOL items in elderly patients with advanced NSCLC.

Published
2019

4. 1712P Safety and efficacy of influenza and pneumococcal vaccines in cancer patients on active therapy: A prospective study

Author

La Verde, N.M., primary, Dalu, D., additional, Ridolfo, A.L., additional, Cona, M.S., additional, De Francesco, D., additional, Riva, A., additional, Antinori, S., additional, Rota, S., additional, Tricella, C., additional, Oldani, S., additional, Fasola, C., additional, Ferrario, S., additional, Gambaro, A., additional, Filipazzi, V., additional, Chizzoniti, D., additional, Cattaneo, M., additional, Di Carlo, F., additional, Stocchetti, B. Lombardi, additional, Tosca, N., additional, and Galli, M., additional

Published
2021
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5. Outcomes of First-Generation EGFR-TKIs Against Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Post Hoc Analysis of the BE-POSITIVE Study

Author

Pilotto, S, Rossi, A, Vavalà, T, Follador, A, Tiseo, M, Galetta, D, Morabito, A, Di Maio, M, Martelli, O, Caffo, O, Piovano, P, Cortinovis, D, Zilembo, N, Casartelli, C, Banna, G, Ardizzoia, A, Barzelloni, M, Bearz, A, Genestreti, G, Mucciarini, C, Filipazzi, V, Menis, J, Rizzo, E, Barbieri, F, Rijavec, E, Cecere, F, Spitaleri, G, Bria, E, Novello, S, Pilotto S, Rossi A, Vavalà T, Follador A, Tiseo M, Galetta D, Morabito A, Di Maio M, Martelli O, Caffo O, Piovano PL, Cortinovis D, Zilembo N, Casartelli C, Banna GL, Ardizzoia A, Barzelloni ML, Bearz A, Genestreti G, Mucciarini C, Filipazzi V, Menis J, Rizzo E, Barbieri F, Rijavec E, Cecere F, Spitaleri G, Bria E, Novello S., Pilotto, S, Rossi, A, Vavalà, T, Follador, A, Tiseo, M, Galetta, D, Morabito, A, Di Maio, M, Martelli, O, Caffo, O, Piovano, P, Cortinovis, D, Zilembo, N, Casartelli, C, Banna, G, Ardizzoia, A, Barzelloni, M, Bearz, A, Genestreti, G, Mucciarini, C, Filipazzi, V, Menis, J, Rizzo, E, Barbieri, F, Rijavec, E, Cecere, F, Spitaleri, G, Bria, E, Novello, S, Pilotto S, Rossi A, Vavalà T, Follador A, Tiseo M, Galetta D, Morabito A, Di Maio M, Martelli O, Caffo O, Piovano PL, Cortinovis D, Zilembo N, Casartelli C, Banna GL, Ardizzoia A, Barzelloni ML, Bearz A, Genestreti G, Mucciarini C, Filipazzi V, Menis J, Rizzo E, Barbieri F, Rijavec E, Cecere F, Spitaleri G, Bria E, and Novello S.

Abstract

Non-small-cell lung cancer harboring uncommon epidermal growth factor receptor (EGFR) mutations (any mutation other than deletion 19 or substitution of leucine by arginine at codon 858) presents a variable sensitivity to EGFR-tyrosine kinase inhibitors. With the final aim to enrich knowledge about uncommon EGFR mutations, we performed a post hoc analysis of the beyond progression after tyrosine kinase inhibitor in EGFR-positive non-small-cell lung cancer patients (BE-POSITIVE) trial. Thirty-five patients were included of the original 312 EGFR-mutated cases. The results of our analysis support the existence of a strong heterogeneity within patients harboring uncommon EGFR mutations, which implies the necessity to stratify the subgroups of rare mutations in individual entities with different clinical perspectives. Background: Beyond progression after tyrosine kinase inhibitor in EGFR-positive non-small-cell lung cancer patients (BE-POSITIVE) was the first Italian multicenter observational study that reported the outcomes of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) in a “real-life” Caucasian EGFR-mutated non-small-cell lung cancer (NSCLC) population. The sharing of multi-institutional experiences represents a crucial strategy to enrich knowledge about uncommon EGFR mutations. Therefore, we performed a post hoc analysis of the BE-POSITIVE study. Patients and Methods: Data of advanced NSCLC patients with uncommon EGFR mutations who received first-line first-generation EGFR-TKIs in 24 Italian Hospitals were collected. In this analysis we aimed to evaluate overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) of EGFR-TKIs in NSCLC patients harboring uncommon EGFR mutations. Results: Thirty-five patients harboring uncommon EGFR mutations (any mutation other than deletion 19 or substitution of leucine by arginine at codon 858) were included of the original 312 EGFR-mutated cases. Most of them

Published
2018

6. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials

Author

Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F., Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, and Perrone F.

Abstract

Purpose: To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods: Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed a of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results: From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion: The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.

Published
2018

10. BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients: Results from a multicenter Italian observational study

Author

Vavalà, T, Follador, A, Tiseo, M, Galetta, D, Morabito, A, Di Maio, M, Martelli, O, Caffo, O, Piovano, P, Cortinovis, D, Zilembo, N, Casartelli, C, Banna, G, Ardizzoia, A, Barzelloni, M, Bearz, A, Genestreti, G, Mucciarini, C, Filipazzi, V, Menis, J, Rizzo, E, Barbieri, F, Rijavec, E, Cecere, F, Bria, E, Spitaleri, G, Rossi, A, Novello, S, Vavalà T, Follador A, Tiseo M, Galetta D, Morabito A, Di Maio M, Martelli O, Caffo O, Piovano PL, Cortinovis D, Zilembo N, Casartelli C, Banna GL, Ardizzoia A, Barzelloni ML, Bearz A, Genestreti G, Mucciarini C, Filipazzi V, Menis J, Rizzo E, Barbieri F, Rijavec E, Cecere F, Bria E, Spitaleri G, Rossi A, Novello S., Vavalà, T, Follador, A, Tiseo, M, Galetta, D, Morabito, A, Di Maio, M, Martelli, O, Caffo, O, Piovano, P, Cortinovis, D, Zilembo, N, Casartelli, C, Banna, G, Ardizzoia, A, Barzelloni, M, Bearz, A, Genestreti, G, Mucciarini, C, Filipazzi, V, Menis, J, Rizzo, E, Barbieri, F, Rijavec, E, Cecere, F, Bria, E, Spitaleri, G, Rossi, A, Novello, S, Vavalà T, Follador A, Tiseo M, Galetta D, Morabito A, Di Maio M, Martelli O, Caffo O, Piovano PL, Cortinovis D, Zilembo N, Casartelli C, Banna GL, Ardizzoia A, Barzelloni ML, Bearz A, Genestreti G, Mucciarini C, Filipazzi V, Menis J, Rizzo E, Barbieri F, Rijavec E, Cecere F, Bria E, Spitaleri G, Rossi A, and Novello S.

Abstract

Objectives: Non-small-cell-lung-cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations develop drug resistance after 9-12 months of EGFR tyrosine kinase inhibitors (TKIs) therapy pointing out the issue of the second-line treatment choice. Materials and methods: From June 2009 until May 2013 patients affected by advanced NSCLC harbouring EGFR mutations receiving first-line TKI were collected mainly retrospectively in 24 Italian Centers. Primary objective was to describe the percentage of EGFR mutated patients receiving second-line therapy after progression to first-line EGFR-TKIs assessing the type, the activity in terms of objective response rate (ORR), efficacy in terms of progression free survival (PFS) and overall survival (OS), and safety of second-line treatment. Secondary objective was to describe the efficacy of first-line EGFR-TKIs. Results: 312 patients were included. Most of them were females (203, 65.1%), never smokers (200, 64.1%), with adenocarcinoma histology (290, 92.9%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 186 and 97 cases (59.6% and 31.1%), respectively. At data cut-off, 274 patients (95.1%) received any second-line treatment (including best supportive care or local treatments only). A total of 163 patients received second-line systemic therapy with an ORR of 20.9% (95% CI:14.62-27.10), a median PFS and OS of 4.7 (95% CI:3.81-5.26) and 24.5 (95% CI:21.65-27.37) months, respectively. Grade 3-4 hematological and non-hematological toxicities were reported in 9% and 6.3% of 144 patients treated with chemotherapy while non-hematological toxicity was reported in 4 cases of the 17 patients receiving second-line target agents. Conclusions: BE-Positive is the first multicenter observational study reporting outcomes of therapies in a "real-life Caucasian EGFR-mutated population", highlighting the need of further researches about new treatment strategies in this setting.

Published
2016

11. Immunotherapy in elderly patients (≥ 75 yrs) with advanced non-small cell lung cancer (NSCLC): A multicenter Italian experience

Author

Luciani, A., primary, Toschi, L., additional, Fava, S., additional, Cortinovis, D., additional, Filipazzi, V., additional, Tuzi, A., additional, Marra, A., additional, Rossi, S., additional, Rossi, A., additional, Blasi, M., additional, Violati, M., additional, Sala, L., additional, Agustoni, F., additional, Bidoli, P., additional, Zonato, S., additional, and Ferrari, D., additional

Published
2018
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12. Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial

Author

Gridelli C., Gallo C., Morabito A., Iaffaioli R. V., Favaretto A., Isa L., Barbera S., Gamucci T., Ceribelli A., Filipazzi V., Maione P., Rossi A., Barletta E., Signoriello S., De Maio E., Piccirillo M. C., Di Maio M., Rocco G., Vecchione A., Perrone F., Cesare Gridelli, Paolo Maione, Antonio Rossi, Ciro Gallo, Giuseppe Signoriello, Paolo Chiodini, Simona Signoriello, Francesco Perrone, Massimo Di Maio, Maria Carmela Piccirillo, Ermelinda De Maio, Jane Bryce, Alessandro Morabito, Raffaele Costanzo, Gaetano Rocco, Rosario Vincenzo Iaffaioli, Emiddio Barletta, Roberta Formato, Aldo Vecchione, Adolfo Favaretto, Giulia Pasello, Cristina Magro, Luciano Isa, Raffaele Venezia, Mario Comandè, Santi Barbera, Francesco Renda, Antonio Volpintesta, Teresa Gamucci, Maria Anna Giampaolo, Giovanni Mansueto, Anna Ceribelli, Ilaria Carbone, Domenica Pellegrini, Virginio Filipazzi, Elena Piazza, Sabrina Ferrario, Vittorina Zagonel, Giuditta di Isernia, Marco Ciaparrone, Francovito Piantedosi, Fabiana Vitiello, Nicolò Borsellino, Maria Elia Vitale, Luigi Brancaccio, Sergio Spina, Maria Rosaria Valerio, Raffaella Felletti, Salvatore Tafuto, Marianna Giampaglia, Rita Migliorino, Francesco Rosetti, Francesco Carrozza, Nestore Rossi, Mario Spatafora, Manlio Mencoboni, Ernest Marshall, Gridelli, C, Gallo, Ciro, Morabito, A, Iaffaioli, Rv, Favaretto, A, Isa, L, Barbera, S, Gamucci, T, Ceribelli, A, Filipazzi, V, Maione, P, Rossi, A, Barletta, E, Signoriello, Simona, De Maio, E, Piccirillo, Mc, Di Maio, M, Rocco, G, Vecchione, A, Perrone, F., Gridelli C., Gallo C., Morabito A., Iaffaioli R.V., Favaretto A., Isa L., Barbera S., Gamucci T., Ceribelli A., Filipazzi V., Maione P., Rossi A., Barletta E., Signoriello S., De Maio E., Piccirillo M.C., Di Maio M., Rocco G., Vecchione A., Perrone F., and Cesare Gridelli, Paolo Maione, Antonio Rossi, Ciro Gallo, Giuseppe Signoriello, Paolo Chiodini, Simona Signoriello, Francesco Perrone, Massimo Di Maio, Maria Carmela Piccirillo, Ermelinda De Maio, Jane Bryce, Alessandro Morabito, Raffaele Costanzo, Gaetano Rocco, Rosario Vincenzo Iaffaioli, Emiddio Barletta, Roberta Formato, Aldo Vecchione, Adolfo Favaretto, Giulia Pasello, Cristina Magro, Luciano Isa, Raffaele Venezia, Mario Comandè, Santi Barbera, Francesco Renda, Antonio Volpintesta, Teresa Gamucci, Maria Anna Giampaolo, Giovanni Mansueto, Anna Ceribelli, Ilaria Carbone, Domenica Pellegrini, Virginio Filipazzi, Elena Piazza, Sabrina Ferrario, Vittorina Zagonel, Giuditta di Isernia, Marco Ciaparrone, Francovito Piantedosi, Fabiana Vitiello, Nicolò Borsellino, Maria Elia Vitale, Luigi Brancaccio, Sergio Spina, Maria Rosaria Valerio, Raffaella Felletti, Salvatore Tafuto, Marianna Giampaglia, Rita Migliorino, Francesco Rosetti, Francesco Carrozza, Nestore Rossi, Mario Spatafora, Manlio Mencoboni, Ernest Marshall

Subjects
Oncology, Male, Lung Neoplasms, Deoxycytidine, Carboplatin, chemistry.chemical_compound, Elderly, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Carcinoma, Small Cell, Multivariate Analysi, Etoposide, Platinum compounds, Aged, 80 and over, Area under the curve, SCLC, Vinorelbine, Prognosis, Gemcitabine, Aged, Cisplatin, Disease-Free Survival, Female, Humans, Multivariate Analysis, Proportional Hazards Models, Quality of Life, Treatment Outcome, Vinblastine, Platinum compound, Toxicity, medicine.drug, Human, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Prognosi, Internal medicine, medicine, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, Carcinoma, Small Cell, Surgery, Lung Neoplasm, chemistry, Proportional Hazards Model, business
Abstract

Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention. © 2011 by the International Association for the Study of Lung Cancer.

Published
2012

14. Genetic Factors Associated with Platinum Toxicity: A Preliminary Study

Author

De Troia, B., primary, Davide, D., additional, Filipazzi, V., additional, Isabella, L., additional, Tosca, N., additional, Ferrario, S., additional, Gambaro, A., additional, Somma, L., additional, Fasola, C., additional, Pellegrini, I., additional, Bombonati, G., additional, Damiani, E., additional, Cheli, S., additional, Falvella, F.S., additional, Clementi, E., additional, de Francesco, D., additional, and Cattaneo, M.T., additional

Published
2017
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15. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003

16. MEDICAL TREATMENT CHOICES OF PATIENTS AFFECTED BY ADVANCED NSCLC IN ROUTINE CLINICAL PRACTICE: RESULTS FROM THE ITALIAN OBSERVATIONAL 'SUN' (SURVEY ON THE LUNG CANCER MANAGEMENT) STUDY

Author

Gridelli C, ARDIZZONI, ANDREA, Bajetta E, Barni S, Crino L, Caprioli A, Filipazzi V, Lorusso V, De Marinis F., Gridelli C, Ardizzoni A, Bajetta E, Barni S, Crino L, Caprioli A, Filipazzi V, Lorusso V, and De Marinis F

Subjects
Advanced NSCLC Observational study Chemotherapy Platin-based chemotherapy Pemetrexed Docetaxel Targeted therapy Erlotinib, respiratory tract diseases
Abstract

Lung cancer is the most common cancer in the world today, in terms of both incidence and mortality. Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers, and the majority of people diagnosed with NSCLC have locally advanced or metastatic disease. Treatment algorithms have rapidly changed in the last 10 years because of the introduction of new chemotherapeutic and targeted agents in clinical practice. SUN is a 1-year longitudinal observational multicenter study that has consecutively enrolled patients affected by stage IIIB or IV NSCLC with the aim to describe the pattern of care and evolving approaches in the treatment of advanced NSCLC. 987 consecutive NSCLC patients were enrolled between January 2007 and March 2008 at the 74 participating centers throughout Italy and a 12-month follow-up was performed. Cyto-histological diagnosis was performed mainly by broncoscopy with only 24% by CT-scan guided fine-needle aspiration biopsy. 91.4% of the patients received a first-line medical treatment and 8.6% supportive care only. Median age of patients receiving first-line treatment was 66 years. First-line chemotherapy consisted of a single agent in 20% of patients and combination chemotherapy in 80%. The most frequently used chemotherapy regimens were cisplatin plus gemcitabine and carboplatin plus gemcitabine. Median survival of patients receiving first-line chemotherapy was 9.1 months. 32% percent of patients received a second-line treatment that consisted of chemotherapy in 71% of cases and erlotinib in 29%. Overall third-line treatment was given to 7.3% of patients. These results showed a pattern of care for advanced NSCLC that reflects the current clinical practice in Italy at the study time with a high adherence to the International guidelines by the Italian Oncologists.

Published
2010

17. The impact of antithrombotic prophylaxis on infectious complications in cancer patients with central venous catheters: an observational study

Author

Fagnani D, Bertolini A, Catena L, Tomirotti M, Visini M, Alatri A, De Paoli A, Aondio GM, Milani M, Arpaia G, Cimminiello C, Franchi R, Porta C, Pugliese P, Borgonovo K, Duro M, Ardizzoia A, Filipazzi V, Isa L, Vergani C, Carpenedo M, VIALE, PIERLUIGI, Fagnani D, Bertolini A, Catena L, Tomirotti M, Visini M, Alatri A, De Paoli A, Aondio GM, Milani M, Arpaia G, Cimminiello C, Franchi R, Porta C, Pugliese P, Borgonovo K, Duro M, Ardizzoia A, Filipazzi V, Isa L, Vergani C, Carpenedo M, and Viale P

Subjects
Male, Catheterization, Central Venous, medicine.medical_specialty, Prosthesis-Related Infections, medicine.medical_treatment, central venous catheter, PROPHYLAXIS, Cohort Studies, Fibrinolytic Agents, Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Antithrombotic, medicine, Humans, Prospective Studies, Neoplasm Staging, business.industry, Incidence (epidemiology), Warfarin, Hematology, General Medicine, Odds ratio, Heparin, Low-Molecular-Weight, Middle Aged, medicine.disease, Surgery, Catheter, Venous thrombosis, Treatment Outcome, Italy, Regression Analysis, Female, Complication, business, Central venous catheter, Follow-Up Studies, medicine.drug
Abstract

Infections in cancer patients after implantation of a central venous device (CVD) are not infrequent and are potentially serious. The possibility of limiting this complication with antithrombotic drugs is still debated. For this observational study, we recorded the routine management of CVD in cancer patients in 18 oncology centers in Lombardy (northern Italy), assessing the effect of antithrombotic prophylaxis on catheter-related infections. Out of 1410 patients enrolled, 451 received antithrombotic prophylaxis continuously after implantation of the central line. During a median follow-up of 30 months, 57 catheter-related infections were reported in the 1390 patients seen at least once at follow-up visits (4.1 % of the whole series), giving an overall incidence of 0.10 infections per 1000 catheter days. This complication was significantly more frequent among patients with an indwelling central venous catheter, or peripherally inserted catheter, than among those with a port device, and the group not given antithrombotic prophylaxis had 0.14 infective complications/1000 CVD days compared with 0.05/1000 CVD days (odds ratio 2.4; 95% confidence interval 1.7-5.0) for those treated. Antithrombotic prophylaxis protected against infections at the catheter exit site and track but not against systemic infections. Confirming earlier evidence, this study found a reduction in catheter-related infections in patients given antithrombotic prophylaxis. However, this reduction, reflecting local infections, seems unlikely to be one of the mechanisms explaining the lower mortality among our patients treated with anticoagulants.

Published
2009

22. Activity of rituximab in extranodal marginal zone lymphomas (MALT-type)

Author

Conconi A, Thieblemont C, Martinelli G, Ferreri AJM, Devizzi L, Peccatori F, Filipazzi V, Dietrich PY, Gianni MA, Cavalli F, Zucca E., PONZONI , MAURILIO, Conconi, A, Thieblemont, C, Martinelli, G, Ferreri, Ajm, Devizzi, L, Peccatori, F, Ponzoni, Maurilio, Filipazzi, V, Dietrich, Py, Gianni, Ma, Cavalli, F, and Zucca, E.

Published
2001

23. A multicenter, randomised, phase 3 trial comparing fixed dose versus toxicity-adjusted dose of cisplatin + etoposide in advanced SCLC patients (pts). The STAD-1 trial

Author

Daniele, G., primary, Morabito, A., additional, Favaretto, A., additional, Filipazzi, V., additional, Rossi, A., additional, Gebbia, V., additional, Castiglione, F., additional, Cavanna, L., additional, Maiello, E., additional, Valmadre, G., additional, Costanzo, R., additional, Manzo, A., additional, Bonanno, L., additional, Piazza, E., additional, Maione, P., additional, Mancuso, G., additional, Di Maio, M., additional, Piccirillo, M.C., additional, Gallo, C., additional, Perrone, F., additional, and Gridelli, C., additional

Published
2015
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27. Supportive care in patients with advanced non-small-cell lung cancer

Author

DI MAIO, Massimo, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, De Maio, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolò, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, V, Altavilla, G, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, Giorgio Vittorio, Novello, Silvia, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, De Marinis, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferraù, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, Di Costanzo, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nisticò, C, Aschelter, A, Foa, P., DI MAIO, M, Perrone, F, Gallo, Ciro, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, and Gridelli, C.

Subjects
Adult, Male, concomitant drugs, Cancer Research, medicine.medical_specialty, Aging, Palliative care, Lung Neoplasms, medicine.medical_treatment, Vinorelbine, Vinblastine, Deoxycytidine, Clinical, Quality of life, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, polypharmacotherapy, medicine, Humans, Lung cancer, Survival rate, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Palliative Care, Middle Aged, medicine.disease, Gemcitabine, Surgery, Survival Rate, supportive care, lung cancer, Oncology, Concomitant, Quality of Life, Antiemetics, Female, Cisplatin, business, medicine.drug
Abstract

The present study describes supportive care (SC) in patients with advanced non-small-cell lung cancer (NSCLC), evaluating whether it is affected by concomitant chemotherapy, patient's performance status (PS) and age. Data of patients enrolled in three randomised trials of first-line chemotherapy, conducted between 1996 and 2001, were pooled. The analysis was limited to the first three cycles of treatment. Supportive care data were available for 1185 out of 1312 (90%) enrolled patients. Gastrointestinal drugs (45.7%), corticosteroids (33.4%) and analgesics (23.8%) were the most frequently observed categories. The mean number of drugs per patient was 2.43; 538 patients (45.4%) assumed three or more supportive drugs. Vinorelbine does not produce substantial variations in the SC pattern, while cisplatin-based treatment requires an overall higher number of supportive drugs, with higher use of antiemetics (41 vs 27%) and antianaemics (10 vs 4%). Patients with worse PS are more exposed to corticosteroids (42 vs 30%). Elderly patients require drugs against concomitant diseases significantly more than adults (20 vs 7%) and are less frequently exposed to antiemetics (12 vs 27%). In conclusion, polypharmacotherapy is a relevant issue in patients with advanced NSCLC. Chemotherapy does not remarkably affect the pattern of SC, except for some drugs against side effects. Elderly patients assume more drugs for concomitant diseases and receive less antiemetics than adults.

Published
2004

28. Supportive care in patients with advanced non small cell lung cancer

Author

DI MAIO, M, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolo, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, G, Novello, S, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, DE MARINIS, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferrau, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, DI COSTANZO, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nistico, C, Aschelter, A, and Foa, P.

Published
2003

39. 50 Chemotherapy in metastatic non-small cell lung cancer: Results and quality of life

Author

Candido, P., primary, Pavia, G.F., additional, Frontini, L., additional, Zonato, S., additional, Rho, B., additional, Filipazzi, V., additional, Raina, A., additional, Scapaticci, R., additional, Isa, L., additional, Clerici, M., additional, Giorgetti, M.C., additional, Gambaro, A., additional, Ferrario, S., additional, Cattaneo, M.T., additional, and Piazza, E., additional

Published
1997
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43. Granulocyte colony-stimulating factors used in clinical practice: Polonord Registry-Based Cohort Italian Study

Author

Fagnani, D., Isa, L., Verga, M. F., Nova, P., Casartelli, C., Filipazzi, V., Danova, M., Farina, G., Pugliese, P., Fava, S., Bertolini, A., Cimminiello, C., Boracchi, P., Giuseppe Marano, and Panzarino, C.

Subjects
0301 basic medicine, Male, Cancer Research, Lung Neoplasms, Filgrastim, Lymphoma, Antineoplastic Agents, Breast Neoplasms, Lenograstim, Polyethylene Glycols, 03 medical and health sciences, 0302 clinical medicine, Granulocyte Colony-Stimulating Factor, Humans, Prospective Studies, Registries, Aged, Febrile Neutropenia, General Medicine, Middle Aged, Recombinant Proteins, Hospitalization, Drug Combinations, 030104 developmental biology, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Female, Guideline Adherence
Abstract

Granulocyte colony-stimulating factors are widely used to reduce myelotoxicity of chemotherapy and to allow its regular administration. National and international guidelines regulate their use. The aim of the study was to evaluate the use of pegfilgrastim and filgrastim/lenograstim in clinical practice, adherence to ASCO and ESMO guidelines, chemotherapy-related complications and adverse reactions.Data from 645 consecutive patients and 3,150 chemotherapy administrations, receiving granulocyte colony-stimulating factors, as primary/secondary prophylaxis or therapeutic use, for the first time during a line of chemotherapy, were recorded from 08/2008 to 08/2011, in 10 Lombardy Italian cancer centers. Patients and chemotherapy administrations data were examined in a multiple logistic regression analysis model.Adherence to guidelines: primary prophylaxis, pegfilgrastim and filgrastim/ lenograstim 66%/47% (P = 0.002); secondary prophylaxis, 19.0%/26.8%; but 56.8%/ 53.6% including patients at high risk of febrile neutropenia with grade 3-4 neutropenia. Correct timing start (administration 24-72 h after chemotherapy): pegfilgrastim and filgrastim/lenograstim, 93.2%/61.5% (P0.0001).Results suggest the more correct administration of pegfilgrastim as primary prophylaxis and timing start, compared to filgrastim/lenograstim. In secondary prophylaxis, the use of granulocyte colony-stimulating factors is extended beyond guideline recommendations to support patients at high risk of febrile neutropenia and to guarantee dose intensity. These outcomes suggest both the need of educational activities and the development of predictive tools to better define high risk patients and the use of granulocyte colony-stimulating factors.

45. Efficacy and Safety of Anti-PD-1 Immunotherapy in Patients Aged ≥ 75 Years With Non-small-cell Lung Cancer (NSCLC): An Italian, Multicenter, Retrospective Study

Author

Francesco Agustoni, Massimiliano Cergnul, V. Filipazzi, Andrea Luciani, Sabrina Rossi, Antonio Marra, Elio Gregory Pizzutilo, Alessandro Tuzi, Paolo Bidoli, Diego Cortinovis, Salvatore Siena, Sergio Fava, Luca Toschi, Giovanna Finocchiaro, Antonio Rossi, Stephana Carelli, S. Zonato, Daris Ferrari, Giulio Cerea, Vittorio Perfetti, Luca Sala, Laura Giannetta, Luciani, A, Marra, A, Toschi, L, Cortinovis, D, Fava, S, Filipazzi, V, Tuzi, A, Cerea, G, Rossi, S, Perfetti, V, Rossi, A, Giannetta, L, Sala, L, Finocchiaro, G, Pizzutilo, E, Carelli, S, Agustoni, F, Cergnul, M, Zonato, S, Siena, S, Bidoli, P, and Ferrari, D

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, non-small cell lung cancer (NSCLC), Adenocarcinoma of Lung, B7-H1 Antigen, 03 medical and health sciences, Elderly, 0302 clinical medicine, Antineoplastic Agents, Immunological, Internal medicine, Carcinoma, Non-Small-Cell Lung, PD-1, medicine, Humans, Lung cancer, Aged, Retrospective Studies, Aged, 80 and over, Performance status, business.industry, Proportional hazards model, Incidence (epidemiology), Cancer, Retrospective cohort study, medicine.disease, Prognosis, Clinical trial, Survival Rate, 030104 developmental biology, Italy, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Female, Immunotherapy, business, Follow-Up Studies
Abstract

Introduction Non–small-cell lung cancer (NSCLC) is predominantly a disease of the elderly population. Over the past few years, immunotherapy with monoclonal antibodies named checkpoint inhibitors (ICIs) greatly improved the clinical management of a significant proportion of patients with metastatic NSCLC. However, pivotal trials excluded older patients, although, given the favorable clinical profile of ICIs, this treatment may be revealed to be a most valuable option also for these patients. To this aim, a multicenter retrospective analysis was performed on patients aged ≥ 75 years with NSCLC treated with anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) immunotherapy. Material and Methods Inclusion criteria were: diagnosis of locally advanced or metastatic NSCLC (stage IIIB or IV, according to the American Joint Committee on Cancer (AJCC) classification system, version 8.0); age ≥ 75 years; treatment with anti-PD-1/PD-L1 monoclonal antibodies in first or subsequent lines of treatment; absence of epidermal growth factor receptor-activating mutations or anaplastic lymphoma kinase and ROS-1 rearrangements. The primary endpoints of the study were the efficacy, in terms of overall response rate, progression-free survival, and overall survival, and safety, by means of evaluations of the incidence of immune-related adverse events. Results Eighty-six patients were considered for the final analysis; 71 (82.6%) were male. The mean age was 78.5 years (range, 75-86 years; SD, 3.12 years). Of the 86 patients, 69 (80.2%) of patients had a performance status of 0 or 1. The overall median progression-free survival was 5.6 months (range 1-36 months; SD, 7.5 months,) whereas the median overall survival was 10.1 months (range, 1.7-34.8 months; SD, 8 months). At the Cox regression analysis, the only parameter significantly associated with survival was the smoking status (P = .008). No difference in survival was found between patients younger and older than 80 years. Conclusions In the present real-world retrospective cohort, efficacy and toxicity profiles of ICIs in older patients with advanced NSCLC were comparable with those observed in younger patients enrolled in clinical trials.

Published
2019

46. Cisplatin-based first-line treatment of elderly patients with advanced non-small-cell lung cancer: Joint analysis of MILES-3 and MILES-4 phase III trials

Author

Ferdinando Riccardi, Roberto Bordonaro, Maria Carmela Piccirillo, Gaetano Rocco, Simona Signoriello, V. Filipazzi, Cesare Gridelli, Vittorio Gebbia, Fortunato Ciardiello, Manlio Mencoboni, Francesco Rosetti, Paolo Maione, Fabrizio Nelli, Francesco Perrone, Fabrizio Artioli, Domenico Bilancia, Alessandro Morabito, Roberto Bianco, Saverio Cinieri, Ciro Gallo, Laura Bonanno, Diego Cortinovis, Vittorio Fregoni, Silvana Leo, Raffaele Costanzo, Marco Angelo Burgio, Andrea Luciani, Luigi Cavanna, Giuditta di Isernia, Gennaro Daniele, Gridelli, C., Morabito, A., Cavanna, L., Luciani, A., Maione, P., Bonanno, L., Filipazzi, V., Leo, S., Cinieri, S., Ciardiello, F., Burgio, M. A., Bilancia, D., Cortinovis, D., Rosetti, F., Bianco, R., Gebbia, V., Artioli, F., Bordonaro, R., Fregoni, V., Mencoboni, M., Nelli, F., Riccardi, F., Di Isernia, G., Costanzo, R., Rocco, G., Daniele, G., Signoriello, S., Piccirillo, M. C., Gallo, C., Perrone, F., Gridelli, Cesare, Morabito, Alessandro, Cavanna, Luigi, Luciani, Andrea, Maione, Paolo, Bonanno, Laura, Filipazzi, Virginio, Leo, Silvana, Cinieri, Saverio, Ciardiello, Fortunato, Burgio, Marco Angelo, Bilancia, Domenico, Cortinovis, Diego, Rosetti, Francesco, Bianco, Roberto, Gebbia, Vittorio, Artioli, Fabrizio, Bordonaro, Roberto, Fregoni, Vittorio, Mencoboni, Manlio, Nelli, Fabrizio, Riccardi, Ferdinando, di Isernia, Giuditta, Costanzo, Raffaele, Rocco, Gaetano, Daniele, Gennaro, Signoriello, Simona, Piccirillo, Maria Carmela, Gallo, Ciro, and Perrone, Francesco

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, Phases of clinical research, Kaplan-Meier Estimate, Pemetrexed, Deoxycytidine, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Carcinoma, Non-Small-Cell Lung, medicine, advanced non small cell lung cancer (NSCLC), elderly patients, cisplatin, MILES 3, MILES 4, Progression-free survival, Lung cancer, Survival rate, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, medicine.disease, Gemcitabine, Lung Neoplasm, 030104 developmental biology, Treatment Outcome, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Quality of Life, Female, Cisplatin, business, medicine.drug, Human
Abstract

Purpose To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non–small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed α of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.

Published
2018

47. Rationale and Design of MILES-3 and MILES-4 Studies: Two Randomized Phase 3 Trials Comparing Single-Agent Chemotherapy Versus Cisplatin-Based Doublets in Elderly Patients With Advanced Non–Small-Cell Lung Cancer

Author

Antonio Rossi, Massimo Di Maio, Saverio Cinieri, Ciro Gallo, Claudia Sandomenico, V. Filipazzi, Cesare Gridelli, Adolfo Favaretto, Francesco Perrone, Raffaele Costanzo, Marco Angelo Burgio, Luigi Cavanna, Silvana Leo, Roberto Bianco, Alessandro Morabito, Fortunato Ciardiello, Roberto Bordonaro, Gridelli, C, Rossi, A, Di Maio, M, Leo, S, Filipazzi, V, Favaretto, Ag, Burgio, Ma, Cinieri, S, Bianco, R, Ciardiello, Fortunato, Cavanna, L, Bordonaro, R, Costanzo, R, Sandomenico, C, Gallo, Ciro, Perrone, F, and Morabito, A.

Subjects
Male, Pulmonary and Respiratory Medicine, Oncology, Cancer Research, medicine.medical_specialty, Guanine, Lung Neoplasms, medicine.medical_treatment, Pemetrexed, Adenocarcinoma, advanced NSCLC, elderly, Deoxycytidine, law.invention, Glutamates, Quality of life, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Prospective Studies, Lung cancer, Aged, Neoplasm Staging, Cisplatin, Chemotherapy, business.industry, Prognosis, medicine.disease, Gemcitabine, Survival Rate, Research Design, Lymphatic Metastasis, Quality of Life, Female, business, Follow-Up Studies, medicine.drug
Abstract

Background Platinum-based chemotherapy is the cornerstone of treatment of advanced non-small-cell lung cancer (NSCLC) patients, but the efficacy of adding cisplatin to single-agent chemotherapy remains to be demonstrated in prospective phase III trials dedicated to elderly patients. Furthermore, the superiority of cisplatin/pemetrexed over cisplatin/gemcitabine in non-squamous NSCLC has not been confirmed prospectively. We present the rationale and design of two open-label, multicenter, randomized phase III trials for elderly patients with advanced NSCLC∶ Multicenter Italian Lung cancer in the Elderly Study (MILES)-3 and MILES-4. The aim is to evaluate the efficacy of adding cisplatin to single-agent chemotherapy (both trials) and the efficacy of pemetrexed versus gemcitabine in non-squamous tumors (MILES-4). Patients and Methods Both trials are dedicated to first-line therapy of patients older than 70 years with advanced NSCLC, ECOG performance status 0-1. In the MILES-3 trial, patients are randomized in a 1∶1 ratio to gemcitabine or cisplatin/gemcitabine. In the MILES-4 study patients with non-squamous histology are randomized, in a factorial design with 1∶1∶1∶1 ratio, to four arms: gemcitabine (A), cisplatin/gemcitabine (B), pemetrexed (C), cisplatin/pemetrexed (D). Two comparisons are planned∶ A+C vs B+D to test the role of cisplatin; A+B vs C+D to test the role of pemetrexed. Primary endpoint of both trials is overall survival. Secondary and exploratory endpoints include progression-free survival, response rate, toxicity, and quality of life. Conclusions MILES-3 and MILES-4 results will add important evidence about the role of cisplatin-based doublets and pemetrexed in the first-line therapy of elderly patients with advanced NSCLC.

Published
2014

48. Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type

Author

Pierre-Yves Dietrich, Fedro A. Peccatori, Catherine Thieblemont, Stefania Dell'Oro, Maurilio Ponzoni, Alessandro M. Gianni, Annarita Conconi, Giovanni Martinelli, Emanuele Zucca, Andrés J.M. Ferreri, Giancarlo Pruneri, Liliana Devizzi, Bertrand Coiffier, Franco Cavalli, Virginio Filipazzi, Ennio Pedrinis, Conconi, A, Martinelli, G, Thieblemont, C, Ferreri, Ajm, Devizzi, L, Peccatori, F, Ponzoni, Maurilio, Pedrinis, E, Dell'Oro, S, Pruneri, G, Filipazzi, V, Dietrich, Py, Gianni, Am, Coiffier, B, Cavalli, F, and Zucca, E.

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Settore MED/06 - Oncologia Medica, medicine.medical_treatment, Immunology, Phases of clinical research, Antineoplastic Agents, Biochemistry, Gastroenterology, Antibodies, Monoclonal, Murine-Derived, Internal medicine, medicine, Humans, Adverse effect, Aged, Aged, 80 and over, Chemotherapy, Helicobacter pylori, business.industry, Antibodies, Monoclonal, MALT lymphoma, Lymphoma, B-Cell, Marginal Zone, Cell Biology, Hematology, Middle Aged, Prognosis, medicine.disease, Chemotherapy regimen, Surgery, Lymphoma, Treatment Outcome, Female, Rituximab, business, Mucosa-associated lymphoid tissue, medicine.drug
Abstract

The clinical activity of rituximab has been evaluated in a phase 2 study in both untreated and relapsed mucosa-associated lymphoid tissue (MALT) lymphomas. Treatment consisted of 4 standard (375 mg/m(2)) weekly doses. Thirty-five patients were enrolled, and 34 completed the treatment program. The primary lymphoma location was stomach in 15 patients, and extragastric in 20. Eleven patients had previously been treated with chemotherapy. At study entry 12 patients had Ann Arbor stage I-E, 3 had stage IIE, and 20 had stage IV disease. The overall response rate was 73% (95% confidence interval, 56%-87%), with 15 complete responses and 10 partial responses, and the response rate was significantly higher in the chemotherapy-naive patients, who had an 87% response rate compared with 45% of the previously treated patients (P = .03). The median response duration was 10.5 months. At a median follow-up of 15 months, 9 patients (26%) relapsed. The median time to treatment failure was 14.2 months in the whole series, but it was significantly longer (22 versus 12 months) in the chemotherapy-naive patients compared with those who had prior chemotherapy (P = .001). most adverse events were of mild to moderate severity with no grade 4 toxicity. This study indicates that rituximab is safe with significant activity in MALT lymphomas. (C) 2003 by The American Society of Hematology.

Published
2003

49. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies

Author

V. Filipazzi, Alessandro Morabito, Cesare Gridelli, Sergio Federico Robbiati, Francesco Perrone, Vito Lorusso, Paolo Maione, Franco Vito Piantedosi, Luigi Manzione, Adolfo Favaretto, Alfonso Illiano, Francesco Carrozza, Alessandra Bearz, Ciro Gallo, Rosario Vincenzo Iaffaioli, Gridelli, C, Maione, P, Illiano, A, Piantedosi, Fv, Favaretto, A, Bearz, A, Robbiati, Sf, Filipazzi, V, Lorusso, V, Carrozza, F, Iaffaioli, Rv, Manzione, L, Gallo, Ciro, Morabito, A, and Perrone, F.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.drug_class, medicine.medical_treatment, Phases of clinical research, Vinorelbine, Vinblastine, Antimetabolite, Gastroenterology, Deoxycytidine, Disease-Free Survival, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Lung cancer, Aged, Cisplatin, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Middle Aged, medicine.disease, Gemcitabine, Surgery, Treatment Outcome, Oncology, Feasibility Studies, Female, business, medicine.drug
Abstract

Purpose Two phase I/II trials were done to evaluate the feasibility of cisplatin combined with gemcitabine or vinorelbine in elderly patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Patients with advanced NSCLC who were older than 70 years of age and who had a performance status of 0 to 1 were eligible. Cisplatin was given on day 1 (a starting dose of 50 mg/m2 with increasing increments of 10 mg/m2 at each level) and gemcitabine (1,000 mg/m2) or vinorelbine (25 mg/m2) on days 1 and 8. Cycles were repeated every 21 days. A two-stage flexible optimal design was applied in the phase II study, and unacceptable toxicity was the primary end point. Results Overall, 159 patients were enrolled: 38 in phase I and 121 in phase II studies. Cisplatin was feasible at 60 mg/m2 with gemcitabine and at 40 mg/m2 with vinorelbine. With the former combination, 50 of 60 (83.3%) patients were treated without unacceptable toxicity; objective responses were reported in 26 of 60 patients (43.5%; 95% CI, 30.6 to 56.8); median progression-free and overall survivals were 25.3 and 43.6 weeks, respectively. With the latter combination, 50 (82.0%) of 61 patients were treated without unacceptable toxicity; objective responses were reported in 22 of 61 patients (36.1%; 95% CI, 24.2 to 49.4); median progression-free and overall survivals were 21.1 and 33.1 weeks, respectively. Conclusion Both cisplatin (60 mg/m2) plus gemcitabine and cisplatin (40 mg/m2) plus vinorelbine are feasible and active in the treatment of elderly patients with advanced NSCLC. The former combination, which provides a higher dose of cisplatin, deserves comparison versus single-agent chemotherapy in this setting of patients.

Published
2007

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