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1. P2.05-02 MAPK1/MAPK3 Mutations Enhance Immunotherapy Efficacy in Lung Squamous Cell Carcinoma (LSCC): Results of the SQUINT Trial

Author

Cappuzzo, F., primary, Fusco, F., additional, Bonanno, L., additional, Landi, L., additional, Andrikou, K., additional, Dal Maso, A., additional, Minuti, G., additional, Papi, M., additional, Metro, G., additional, Lye, W.K., additional, Ariyaratne, P., additional, Yu, Y., additional, Lau, W.M., additional, Wang, X., additional, Lucke, J., additional, Görtz, A., additional, Attili, I., additional, Piantedosi, F., additional, Pilotto, S., additional, Gori, S., additional, Rossi, G., additional, Buglioni, S., additional, Giannarelli, D., additional, and Delmonte, A., additional

Published
2023
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2. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer

Author

Heather, W, Moishe, L, Terufumi, K, Masahiro, T, Se-Hoon, L, Shugeng, G, Ke-Neng, C, Christophe, D, Margarita, M, Ekkehard, E, Gastón L, M, Olivier, B, Delvys, R, Jamie E, C, Silvia, N, Jing, Y, Steven M, K, Ayman, S, Spicer, D Marcelo Tatangelo, J, Flores, M, Pastor, A, Puig, J, Martinengo, G, Varela, M, Brocca, C, Wong, M, Hui, R, Dooms, C, Vansteenkiste, J, Demedts, I, Sibille, A, Surmont, V, Deschepper, K, Lambrechts, M, Dias, J, Rafael Martins De Marchi, P, Alves, G, Henrique Araujo, L, Matias, D, Chaves, F, Franke, F, Teixeira, C, Tabacof, J, Faria, L, Morbeck, I, Henrique Cronemberger, E, Lima, I, Sardenberg, R, de Paiva Junior, T, Dutra, C, Luiz Guimaraes, J, Begin, P, Langleben, A, Liu, G, Liberman, M, Spicer, J, Gao, S, Zhao, G, Jiang, T, Yan, X, Hu, J, Chen, J, Tan, L, Wang, Q, Li, S, Chen, K, Yang, Y, Bai, J, Ma, S, Chen, H, Chen, Q, Wang, W, Zhang, L, Zhu, Y, Vanakesa, T, Zasadny, X, Duchemann, B, Girard, N, Bylicki, O, Berard, H, Thiberville, L, Mennecier, B, Mazieres, J, Eigendorff, E, Bonnet, R, Fix, P, Reck, M, Rittmeyer, A, Reinacher-Schick, A, Wehler, T, Lehmann, M, Serke, M, Wesseler, C, Täuscher, D, Lang, S, Wermke, M, Grohe, C, Wirtz, H, Kollmeier, J, Ritgen, M, Mueller, A, Frohling, K, Vogel, G, Faehling, M, Cuffe, S, Collins, D, Delmonte, A, Gilli, M, Piantedosi, F, Ogliari, F, Bulotta, A, Gregorc, V, Gianni, L, Grisanti, S, Intagliata, S, Roca, E, Ferrari, V, Berruti, A, Cortinovis, D, Lo Russo, G, Ferrara, R, Garassino, M, Rita Migliorino, M, Novello, S, Santoro, A, Signorelli, D, Tsuboi, M, Okada, M, Kato, T, Nishio, W, Kuroda, H, Shimizu, J, Sakao, Y, Sugio, K, Horinouchi, H, Takamochi, K, Saji, H, Tanaka, F, Ikeda, N, Muto, S, Shio, Y, Suzuki, H, Hegmane, A, Cicenas, S, Zemaitis, M, Kek Pang, Y, Yew Heng, F, Leong Yu, K, Lowczak, A, Makles, K, Bryl, M, Zurawski, B, Pawlak, I, Han, J, Lee, S, Kim, J, Yong Shim, B, Cebotaru, C, Ganea, D, Scheusan, R, Ciurescu, I, Mazilu, L, Ungureanu, A, Gal, C, Ciubotaru, E, Iordan, I, Berceanu-Ion, R, Ciuleanu, T, Laktionov, K, Karaseva, N, Smagina, M, Luft, A, Afanasyev, S, Nesterova, A, Levchenko, E, Arkhipov, A, Fedenko, A, Ruff, P, Jacobs, C, Fourie, S, Carcereny, E, Calles Blanco, A, Rodriguez Abreu, D, Majem Tarruella, M, Bosch Barrera, J, Bernabe Caro, R, Nadal Alforja, E, Martnez Marti, A, Liao, B, Huang, H, Chiu, C, Wang, C, Tsai, C, Voitko, N, Kryzhanivska, A, Kolesnik, O, Levenko, O, Bondarenko, I, Trukhin, D, Ursol, G, Paramonov, V, Sokur, I, Khan, S, Arora, A, Goranov, B, Greystoke, A, Ahmed, S, Pope, T, O'Brien, M, Charu, V, Cobb, P, Costin, D, Weksler, B, Schumacher, L, Finley, G, Furqan, M, Gentzler, R, Misleh, J, Guarino, M, Halmos, B, Keresztes, R, Jain, K, Yan Lou, Y, Molina, J, Liu-Dumlao, T, Zhao, Q, Niu, J, Taysir Hammoud, Z, Rybkin, I, Cuevo, R, Fernando, H, Schiller, J, Srkalovic, G, Koontz, M, Stampleman, L, Anderson, I, Villaruz, L, Wang, S, Komiya, T, Jain, S, Starodub, A, Wakelee, H, Kishor Ganti, A, Ernani, V, Kristedja, T, O'Day, S, Radhi, S, Sangal, A, Duvivier, H, Rich, P, Kazmi, S, Pollock, T, Chaft, J, Rathnasabapathy, C, Savvides, P, Costas, K, Kaywin, P, Villalona-Calero, M, Alekshun, T, Rao, S, Siegel, R, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Gao, Shugeng, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Keller, Steven M, Samkari, Ayman, Jonathan D Marcelo Tatangelo, Marcos Flores, Andrea Pastor, Juan Puig, Gaston Martinengo, Mirta Varela, Carlos Brocca, Mark Wong, Rina Hui, Christophe Dooms, Johan Vansteenkiste, Ingel Demedts, Anne Sibille, Veerle Surmont, Koenraad Deschepper, Marc Lambrechts, Josiane Dias, Pedro Rafael Martins De Marchi, Gustavo Alves, Luiz Henrique Araujo, Danielli Matias, Fabio Chaves, Fabio Franke, Carlos Teixeira, Jacques Tabacof, Luiza Faria, Igor Morbeck, Eduardo Henrique Cronemberger, Iane Lima, Rodrigo Sardenberg, Tadeu de Paiva Junior, Carolina Dutra, Jose Luiz Guimaraes, Paul Begin, Adrian Langleben, Geoffrey Liu, Moishe Liberman, Jonathan Spicer, Shugeng Gao, Guofang Zhao, Tao Jiang, Xiaolong Yan, Jian Hu, Jun Chen, Lijie Tan, Qun Wang, Shanqing Li, Keneng Chen, Yue Yang, Jie Bai, Shaohua Ma, Haiquan Chen, Qixun Chen, Wenxiang Wang, Lanjun Zhang, Yuming Zhu, Tonu Vanakesa, Xavier Zasadny, Boris Duchemann, Nicolas Girard, Olivier Bylicki, Henri Berard, Luc Thiberville, Bertrand Mennecier, Julien Mazieres, Ekkehard Eigendorff, Reiner Bonnet, Peter Fix, Martin Reck, Achim Rittmeyer, Anke Reinacher-Schick, Thomas Wehler, Markus Lehmann, Monika Serke, Claas Wesseler, Dagmar Täuscher, Susanne Lang, Martin Wermke, Christian Grohe, Hubert Wirtz, Jens Kollmeier, Mathias Ritgen, Annette Mueller, Klaus-Peter Frohling, Gunther Vogel, Martin Faehling, Sinead Cuffe, Dearbhaile Collins, Angelo Delmonte, Marina Gilli, Francovito Piantedosi, Francesca Ogliari, Alessandra Bulotta, Vanesa Gregorc, Luca Gianni, Salvatore Grisanti, Salvatore Intagliata, Elisa Roca, Vittorio Ferrari, Alfredo Berruti, Diego Cortinovis, Giuseppe Lo Russo, Roberto Ferrara, Marina Garassino, Maria Rita Migliorino, Silvia Novello, Armando Santoro, Diego Signorelli, Masahiro Tsuboi, Morihito Okada, Terufumi Kato, Wataru Nishio, Hiroaki Kuroda, Junichi Shimizu, Yukinori Sakao, Kenji Sugio, Hidehito Horinouchi, Kazuya Takamochi, Hisashi Saji, Fumihiro Tanaka, Norihiko Ikeda, Satoshi Muto, Yutaka Shio, Hiroyuki Suzuki, Alinta Hegmane, Saulius Cicenas, Marius Zemaitis, Yong Kek Pang, Fook Yew Heng, Kong Leong Yu, Anna Lowczak, Krytsyna Makles, Maciej Bryl, Bogdan Zurawski, Ireneusz Pawlak, Ji-Youn Han, Se-Hoon Lee, Jhingook Kim, Byoung Yong Shim, Cristina Cebotaru, Doina Ganea, Roxana Scheusan, Ioana Ciurescu, Laura Mazilu, Andrei Ungureanu, Cristian Gal, Elena Ciubotaru, Ingrid Iordan, Radu Berceanu-Ion, Tudor Ciuleanu, Konstantin Laktionov, Nina Karaseva, Maria Smagina, Alexander Luft, Sergey Afanasyev, Alfiya Nesterova, Evgeny Levchenko, Alexander Arkhipov, Alexander Fedenko, Paul Ruff, Conrad Jacobs, Samuel Fourie, Enric Carcereny, Antonio Calles Blanco, Delvys Rodriguez Abreu, Margarita Majem Tarruella, Joaquim Bosch Barrera, Reyes Bernabe Caro, Ernest Nadal Alforja, Alex Martnez Marti, Bin-Chi Liao, Hsu-Ching Huang, Chao-Hua Chiu, Chin-Chou Wang, Chen-Liang Tsai, Nataliia Voitko, Anna Kryzhanivska, Olena Kolesnik, Oleh Levenko, Oleksii Kolesnik, Igor Bondarenko, Dmytro Trukhin, Grygorii Ursol, Viktor Paramonov, Iryna Sokur, Sarah Khan, Arvind Arora, Bojidar Goranov, Alastair Greystoke, Samreen Ahmed, Tony Pope, Mary O'Brien, Veena Charu, Patrick Cobb, Dan Costin, Benny Weksler, Lana Schumacher, Gene Finley, Muhammad Furqan, Ryan Gentzler, Jamal Misleh, Michael Guarino, Balazs Halmos, Roger Keresztes, Kirti Jain, Yan Yan Lou, Julian Molina, Theresa Liu-Dumlao, Qing Zhao, Jiaxin Niu, Zane Taysir Hammoud, Igor Rybkin, Raymund Cuevo, Hiran Fernando, Joan Schiller, Gordan Srkalovic, Michael Koontz, Laura Stampleman, Ian Anderson, Liza Villaruz, Sarah Wang, Takefumi Komiya, Sushil Jain, Alexander Starodub, Heather Wakelee, Apar Kishor Ganti, Vinicius Ernani, Timothy Kristedja, Steven O'Day, Saba Radhi, Ashish Sangal, Herbert Duvivier, Patricia Rich, Shayma Kazmi, Theodore Pollock, Jamie Chaft, Chenthilmurugan Rathnasabapathy, Panayiotis Savvides, Kimberly Costas, Paul Kaywin, Miguel Villalona-Calero, Todd Alekshun, Kevin Chen, Suman Rao, Robert Siegel, Heather, W, Moishe, L, Terufumi, K, Masahiro, T, Se-Hoon, L, Shugeng, G, Ke-Neng, C, Christophe, D, Margarita, M, Ekkehard, E, Gastón L, M, Olivier, B, Delvys, R, Jamie E, C, Silvia, N, Jing, Y, Steven M, K, Ayman, S, Spicer, D Marcelo Tatangelo, J, Flores, M, Pastor, A, Puig, J, Martinengo, G, Varela, M, Brocca, C, Wong, M, Hui, R, Dooms, C, Vansteenkiste, J, Demedts, I, Sibille, A, Surmont, V, Deschepper, K, Lambrechts, M, Dias, J, Rafael Martins De Marchi, P, Alves, G, Henrique Araujo, L, Matias, D, Chaves, F, Franke, F, Teixeira, C, Tabacof, J, Faria, L, Morbeck, I, Henrique Cronemberger, E, Lima, I, Sardenberg, R, de Paiva Junior, T, Dutra, C, Luiz Guimaraes, J, Begin, P, Langleben, A, Liu, G, Liberman, M, Spicer, J, Gao, S, Zhao, G, Jiang, T, Yan, X, Hu, J, Chen, J, Tan, L, Wang, Q, Li, S, Chen, K, Yang, Y, Bai, J, Ma, S, Chen, H, Chen, Q, Wang, W, Zhang, L, Zhu, Y, Vanakesa, T, Zasadny, X, Duchemann, B, Girard, N, Bylicki, O, Berard, H, Thiberville, L, Mennecier, B, Mazieres, J, Eigendorff, E, Bonnet, R, Fix, P, Reck, M, Rittmeyer, A, Reinacher-Schick, A, Wehler, T, Lehmann, M, Serke, M, Wesseler, C, Täuscher, D, Lang, S, Wermke, M, Grohe, C, Wirtz, H, Kollmeier, J, Ritgen, M, Mueller, A, Frohling, K, Vogel, G, Faehling, M, Cuffe, S, Collins, D, Delmonte, A, Gilli, M, Piantedosi, F, Ogliari, F, Bulotta, A, Gregorc, V, Gianni, L, Grisanti, S, Intagliata, S, Roca, E, Ferrari, V, Berruti, A, Cortinovis, D, Lo Russo, G, Ferrara, R, Garassino, M, Rita Migliorino, M, Novello, S, Santoro, A, Signorelli, D, Tsuboi, M, Okada, M, Kato, T, Nishio, W, Kuroda, H, Shimizu, J, Sakao, Y, Sugio, K, Horinouchi, H, Takamochi, K, Saji, H, Tanaka, F, Ikeda, N, Muto, S, Shio, Y, Suzuki, H, Hegmane, A, Cicenas, S, Zemaitis, M, Kek Pang, Y, Yew Heng, F, Leong Yu, K, Lowczak, A, Makles, K, Bryl, M, Zurawski, B, Pawlak, I, Han, J, Lee, S, Kim, J, Yong Shim, B, Cebotaru, C, Ganea, D, Scheusan, R, Ciurescu, I, Mazilu, L, Ungureanu, A, Gal, C, Ciubotaru, E, Iordan, I, Berceanu-Ion, R, Ciuleanu, T, Laktionov, K, Karaseva, N, Smagina, M, Luft, A, Afanasyev, S, Nesterova, A, Levchenko, E, Arkhipov, A, Fedenko, A, Ruff, P, Jacobs, C, Fourie, S, Carcereny, E, Calles Blanco, A, Rodriguez Abreu, D, Majem Tarruella, M, Bosch Barrera, J, Bernabe Caro, R, Nadal Alforja, E, Martnez Marti, A, Liao, B, Huang, H, Chiu, C, Wang, C, Tsai, C, Voitko, N, Kryzhanivska, A, Kolesnik, O, Levenko, O, Bondarenko, I, Trukhin, D, Ursol, G, Paramonov, V, Sokur, I, Khan, S, Arora, A, Goranov, B, Greystoke, A, Ahmed, S, Pope, T, O'Brien, M, Charu, V, Cobb, P, Costin, D, Weksler, B, Schumacher, L, Finley, G, Furqan, M, Gentzler, R, Misleh, J, Guarino, M, Halmos, B, Keresztes, R, Jain, K, Yan Lou, Y, Molina, J, Liu-Dumlao, T, Zhao, Q, Niu, J, Taysir Hammoud, Z, Rybkin, I, Cuevo, R, Fernando, H, Schiller, J, Srkalovic, G, Koontz, M, Stampleman, L, Anderson, I, Villaruz, L, Wang, S, Komiya, T, Jain, S, Starodub, A, Wakelee, H, Kishor Ganti, A, Ernani, V, Kristedja, T, O'Day, S, Radhi, S, Sangal, A, Duvivier, H, Rich, P, Kazmi, S, Pollock, T, Chaft, J, Rathnasabapathy, C, Savvides, P, Costas, K, Kaywin, P, Villalona-Calero, M, Alekshun, T, Rao, S, Siegel, R, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Gao, Shugeng, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Keller, Steven M, Samkari, Ayman, Jonathan D Marcelo Tatangelo, Marcos Flores, Andrea Pastor, Juan Puig, Gaston Martinengo, Mirta Varela, Carlos Brocca, Mark Wong, Rina Hui, Christophe Dooms, Johan Vansteenkiste, Ingel Demedts, Anne Sibille, Veerle Surmont, Koenraad Deschepper, Marc Lambrechts, Josiane Dias, Pedro Rafael Martins De Marchi, Gustavo Alves, Luiz Henrique Araujo, Danielli Matias, Fabio Chaves, Fabio Franke, Carlos Teixeira, Jacques Tabacof, Luiza Faria, Igor Morbeck, Eduardo Henrique Cronemberger, Iane Lima, Rodrigo Sardenberg, Tadeu de Paiva Junior, Carolina Dutra, Jose Luiz Guimaraes, Paul Begin, Adrian Langleben, Geoffrey Liu, Moishe Liberman, Jonathan Spicer, Shugeng Gao, Guofang Zhao, Tao Jiang, Xiaolong Yan, Jian Hu, Jun Chen, Lijie Tan, Qun Wang, Shanqing Li, Keneng Chen, Yue Yang, Jie Bai, Shaohua Ma, Haiquan Chen, Qixun Chen, Wenxiang Wang, Lanjun Zhang, Yuming Zhu, Tonu Vanakesa, Xavier Zasadny, Boris Duchemann, Nicolas Girard, Olivier Bylicki, Henri Berard, Luc Thiberville, Bertrand Mennecier, Julien Mazieres, Ekkehard Eigendorff, Reiner Bonnet, Peter Fix, Martin Reck, Achim Rittmeyer, Anke Reinacher-Schick, Thomas Wehler, Markus Lehmann, Monika Serke, Claas Wesseler, Dagmar Täuscher, Susanne Lang, Martin Wermke, Christian Grohe, Hubert Wirtz, Jens Kollmeier, Mathias Ritgen, Annette Mueller, Klaus-Peter Frohling, Gunther Vogel, Martin Faehling, Sinead Cuffe, Dearbhaile Collins, Angelo Delmonte, Marina Gilli, Francovito Piantedosi, Francesca Ogliari, Alessandra Bulotta, Vanesa Gregorc, Luca Gianni, Salvatore Grisanti, Salvatore Intagliata, Elisa Roca, Vittorio Ferrari, Alfredo Berruti, Diego Cortinovis, Giuseppe Lo Russo, Roberto Ferrara, Marina Garassino, Maria Rita Migliorino, Silvia Novello, Armando Santoro, Diego Signorelli, Masahiro Tsuboi, Morihito Okada, Terufumi Kato, Wataru Nishio, Hiroaki Kuroda, Junichi Shimizu, Yukinori Sakao, Kenji Sugio, Hidehito Horinouchi, Kazuya Takamochi, Hisashi Saji, Fumihiro Tanaka, Norihiko Ikeda, Satoshi Muto, Yutaka Shio, Hiroyuki Suzuki, Alinta Hegmane, Saulius Cicenas, Marius Zemaitis, Yong Kek Pang, Fook Yew Heng, Kong Leong Yu, Anna Lowczak, Krytsyna Makles, Maciej Bryl, Bogdan Zurawski, Ireneusz Pawlak, Ji-Youn Han, Se-Hoon Lee, Jhingook Kim, Byoung Yong Shim, Cristina Cebotaru, Doina Ganea, Roxana Scheusan, Ioana Ciurescu, Laura Mazilu, Andrei Ungureanu, Cristian Gal, Elena Ciubotaru, Ingrid Iordan, Radu Berceanu-Ion, Tudor Ciuleanu, Konstantin Laktionov, Nina Karaseva, Maria Smagina, Alexander Luft, Sergey Afanasyev, Alfiya Nesterova, Evgeny Levchenko, Alexander Arkhipov, Alexander Fedenko, Paul Ruff, Conrad Jacobs, Samuel Fourie, Enric Carcereny, Antonio Calles Blanco, Delvys Rodriguez Abreu, Margarita Majem Tarruella, Joaquim Bosch Barrera, Reyes Bernabe Caro, Ernest Nadal Alforja, Alex Martnez Marti, Bin-Chi Liao, Hsu-Ching Huang, Chao-Hua Chiu, Chin-Chou Wang, Chen-Liang Tsai, Nataliia Voitko, Anna Kryzhanivska, Olena Kolesnik, Oleh Levenko, Oleksii Kolesnik, Igor Bondarenko, Dmytro Trukhin, Grygorii Ursol, Viktor Paramonov, Iryna Sokur, Sarah Khan, Arvind Arora, Bojidar Goranov, Alastair Greystoke, Samreen Ahmed, Tony Pope, Mary O'Brien, Veena Charu, Patrick Cobb, Dan Costin, Benny Weksler, Lana Schumacher, Gene Finley, Muhammad Furqan, Ryan Gentzler, Jamal Misleh, Michael Guarino, Balazs Halmos, Roger Keresztes, Kirti Jain, Yan Yan Lou, Julian Molina, Theresa Liu-Dumlao, Qing Zhao, Jiaxin Niu, Zane Taysir Hammoud, Igor Rybkin, Raymund Cuevo, Hiran Fernando, Joan Schiller, Gordan Srkalovic, Michael Koontz, Laura Stampleman, Ian Anderson, Liza Villaruz, Sarah Wang, Takefumi Komiya, Sushil Jain, Alexander Starodub, Heather Wakelee, Apar Kishor Ganti, Vinicius Ernani, Timothy Kristedja, Steven O'Day, Saba Radhi, Ashish Sangal, Herbert Duvivier, Patricia Rich, Shayma Kazmi, Theodore Pollock, Jamie Chaft, Chenthilmurugan Rathnasabapathy, Panayiotis Savvides, Kimberly Costas, Paul Kaywin, Miguel Villalona-Calero, Todd Alekshun, Kevin Chen, Suman Rao, and Robert Siegel

Abstract

BACKGROUND Among patients with resectable early-stage non-small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. METHODS We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. RESULTS A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P = 0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P = 0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points

Published
2023

3. EP08.01-030 Nivolumab+Ipilimumab Vs Platinum-Based CT+Nivolumab In Advanced Lung Squamous-Cell Carcinoma: The Randomized SQUINT Trial

Author

Delmonte, A., primary, Bonanno, L., additional, Landi, L., additional, Andrikou, K., additional, Dal Maso, A., additional, Minuti, G., additional, Papi, M., additional, Metro, G., additional, Attili, I., additional, Piantedosi, F., additional, Pilotto, S., additional, Gori, S., additional, Rossi, G., additional, Buglioni, S., additional, Giannarelli, D., additional, and Cappuzzo, F., additional

Published
2022
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4. Bone metastases and immunotherapy in patients with advanced non-small-cell lung cancer

Author

Landi, L, D'Inca, F, Gelibter, A, Chiari, R, Grossi, F, Delmonte, A, Passaro, A, Signorelli, D, Gelsomino, F, Galetta, D, Giannarelli, D, Soto Parra, H, Minuti, G, Tiseo, M, Migliorino, M, Cognetti, F, Toschi, L, Bidoli, P, Piantedosi, F, Calabro', L, Cappuzzo, F, Landi L., D'Inca F., Gelibter A., Chiari R., Grossi F., Delmonte A., Passaro A., Signorelli D., Gelsomino F., Galetta D., Giannarelli D., Soto Parra H., Minuti G., Tiseo M., Migliorino M. R., Cognetti F., Toschi L., Bidoli P., Piantedosi F., Calabro' L., Cappuzzo F., Landi, L, D'Inca, F, Gelibter, A, Chiari, R, Grossi, F, Delmonte, A, Passaro, A, Signorelli, D, Gelsomino, F, Galetta, D, Giannarelli, D, Soto Parra, H, Minuti, G, Tiseo, M, Migliorino, M, Cognetti, F, Toschi, L, Bidoli, P, Piantedosi, F, Calabro', L, Cappuzzo, F, Landi L., D'Inca F., Gelibter A., Chiari R., Grossi F., Delmonte A., Passaro A., Signorelli D., Gelsomino F., Galetta D., Giannarelli D., Soto Parra H., Minuti G., Tiseo M., Migliorino M. R., Cognetti F., Toschi L., Bidoli P., Piantedosi F., Calabro' L., and Cappuzzo F.

Abstract

Background: Bone metastases (BoM) are a negative prognostic factor in non-small-cell lung cancer (NSCLC). Beyond its supportive role, bone is a hematopoietic organ actively regulating immune system. We hypothesized that BoM may influence sensitivity to immunotherapy. Methods: Pretreated non-squamous (cohort A) and squamous (cohort B) NSCLCs included in the Italian Expanded Access Program were evaluated for nivolumab efficacy according to BoM. Results: Cohort A accounted for 1588 patients with non-squamous NSCLC, including 626 (39%) with (BoM+) and 962 (61%) without BoM (BoM-). Cohort B accounted for 371 patients with squamous histology including 120 BoM+ (32%) and 251 (68%) BoM- cases. BoM+ had lower overall response rate (ORR; Cohort A: 12% versus 23%, p < 0.0001; Cohort B: 13% versus 22%, p = 0.04), shorter progression free survival (PFS; Cohort A: 3.0 versus 4.0 months, p < 0.0001; Cohort B: 2.7 versus 5.2 months, p < 0.0001) and overall survival (OS; Cohort A: 7.4 versus 15.3 months, p < 0.0001; Cohort B: 5.0 versus 10.9 months, p < 0.0001). Moreover, BoM negatively affected outcome irrespective of performance status (PS; OS in both cohorts: p < 0.0001) and liver metastases (OS cohort A: p < 0.0001; OS Cohort B: p = 0.48). At multivariate analysis, BoM independently associated with higher risk of death (cohort A: HR 1.50; cohort B: HR 1.78). Conclusions: BoM impairs immunotherapy efficacy. Accurate bone staging should be included in clinical trials with immunotherapy.

Published
2019

5. Italian Cohort of the Nivolumab EAP in Squamous NSCLC: Efficacy and Safety in Patients With CNS Metastases

Author

Cortinovis, D, Chiari, R, Catino, A, Grossi, F, DE Marinis, F, Sperandi, F, Piantedosi, F, Vitali, M, Parra, H, Migliorino, M, Tondini, C, Tassinari, D, Frassoldati, A, Verderame, F, Pazzola, A, Cognetti, F, Palmiotti, G, Marchetti, P, Santoro, A, Giannarelli, D, Colonese, F, Delmonte, A, Cortinovis D, Chiari R, Catino A, Grossi F, DE Marinis F, Sperandi F, Piantedosi F, Vitali M, Parra HJS, Migliorino MR, Tondini C, Tassinari D, Frassoldati A, Verderame F, Pazzola A, Cognetti F, Palmiotti G, Marchetti P, Santoro A, Giannarelli D, Colonese F, Delmonte A., Cortinovis, D, Chiari, R, Catino, A, Grossi, F, DE Marinis, F, Sperandi, F, Piantedosi, F, Vitali, M, Parra, H, Migliorino, M, Tondini, C, Tassinari, D, Frassoldati, A, Verderame, F, Pazzola, A, Cognetti, F, Palmiotti, G, Marchetti, P, Santoro, A, Giannarelli, D, Colonese, F, Delmonte, A, Cortinovis D, Chiari R, Catino A, Grossi F, DE Marinis F, Sperandi F, Piantedosi F, Vitali M, Parra HJS, Migliorino MR, Tondini C, Tassinari D, Frassoldati A, Verderame F, Pazzola A, Cognetti F, Palmiotti G, Marchetti P, Santoro A, Giannarelli D, Colonese F, and Delmonte A.

Abstract

Background/Aim: Brain metastases are an additional challenge in patients with non-small-cell lung cancer (NSCLC) because most chemotherapy agents cannot cross the blood–brain barrier. Nivolumab has demonstrated efficacy in patients with advanced squamous NSCLC, but because patients with central nervous system (CNS) metastases are typically excluded from registration trials, ‘field-practice’ data are needed. Patients and Methods: Patients in the Italian cohort of the Expanded Access Program (EAP) who had CNS metastases at baseline were analyzed. Results: Thirty-seven patients with CNS metastases received a median of six doses of nivolumab. Three patients (8%) had grade 3-4 adverse events and one patient discontinued due to an adverse event. The objective response rate was 19%. Median overall survival was 5.8 (95% confidence interval=1.9-9.8) months and median progression-free survival was 4.9 (95% confidence interval=2.7-7.1) months. Conclusion: The safety and efficacy of nivolumab in patients with CNS metastases appear to be similar to those seen in the overall EAP cohort in Italy.

Published
2019

6. Nivolumab and brain metastases in patients with advanced non-squamous non-small cell lung cancer

Author

Crino, L, Bronte, G, Bidoli, P, Cravero, P, Minenza, E, Cortesi, E, Garassino, M, Proto, C, Cappuzzo, F, Grossi, F, Tonini, G, Sarobba, M, Pinotti, G, Numico, G, Samaritani, R, Ciuffreda, L, Frassoldati, A, Bregni, M, Santo, A, Piantedosi, F, Illiano, A, De Marinis, F, Tamberi, S, Giannarelli, D, Delmonte, A, Crino L., Bronte G., Bidoli P., Cravero P., Minenza E., Cortesi E., Garassino M. C., Proto C., Cappuzzo F., Grossi F., Tonini G., Sarobba M. G., Pinotti G., Numico G., Samaritani R., Ciuffreda L., Frassoldati A., Bregni M., Santo A., Piantedosi F., Illiano A., De Marinis F., Tamberi S., Giannarelli D., Delmonte A., Crino, L, Bronte, G, Bidoli, P, Cravero, P, Minenza, E, Cortesi, E, Garassino, M, Proto, C, Cappuzzo, F, Grossi, F, Tonini, G, Sarobba, M, Pinotti, G, Numico, G, Samaritani, R, Ciuffreda, L, Frassoldati, A, Bregni, M, Santo, A, Piantedosi, F, Illiano, A, De Marinis, F, Tamberi, S, Giannarelli, D, Delmonte, A, Crino L., Bronte G., Bidoli P., Cravero P., Minenza E., Cortesi E., Garassino M. C., Proto C., Cappuzzo F., Grossi F., Tonini G., Sarobba M. G., Pinotti G., Numico G., Samaritani R., Ciuffreda L., Frassoldati A., Bregni M., Santo A., Piantedosi F., Illiano A., De Marinis F., Tamberi S., Giannarelli D., and Delmonte A.

Abstract

Objectives: Brain metastases are common among patients with non-squamous non-small-cell lung cancer (NSCLC) and result in a poor prognosis. Consequently, such patients are often excluded from clinical trials. In Italy an expanded access program (EAP) was used to evaluate nivolumab efficacy and safety in this subpopulation outside a clinical trial. Materials and methods: In this EAP, nivolumab was available for patients with non-squamous NSCLC in progression after at least one systemic treatment for stage IIIB/IV disease. Nivolumab 3 mg/kg was administered intravenously every 2 weeks. Patients with brain metastases could be included if they were asymptomatic, neurologically stable and either off corticosteroids or on a stable or decreasing dose of ≤10 mg/day prednisone. Results: 409 out of 1588 patients included had asymptomatic or controlled brain metastases. A median of 7 doses (range 1–45) were delivered. Median follow-up was 6.1 months (range 0.1–21.9). The disease control rate was 39%: 4 patients had a complete response, 64 a partial response and 96 showed stable disease. At baseline, 118 patients were on corticosteroids and 74 were undergoing concomitant radiotherapy. The median overall survival in this subpopulation was 8.6 months (95% CI: 6.4–10.8). 337 discontinued treatment for various reasons, 23 (7%) of whom due to adverse events, in line with that observed in the overall population and in previous studies. Conclusions: Our results confirm that nivolumab is active in non-squamous NSCLC patients with brain metastases, despite their poor prognosis. Its safety profile is also concordant with results in the EAP overall population and in patients with other malignancies.

Published
2019

13. P2.04-49 Nivolumab Plus Ipilimumab (NI) Versus Chemotherapy Plus Nivolumab (CN) in Squamous Cell Lung Cancer (SqCLC): The SQUINT Trial

Author

Landi, L., primary, Bonanno, L., additional, Delmonte, A., additional, Papi, M., additional, Stati, V., additional, Minotti, V., additional, Bennati, C., additional, D'Incà, F., additional, Migliorino, M., additional, Gori, S., additional, Santo, A., additional, Piantedosi, F., additional, Russo, A., additional, and Cappuzzo, F., additional

Published
2019
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14. Nivolumab plus ipilimumab (NI) versus chemotherapy plus nivolumab (CN) in squamous cell lung cancer (SqCLC): The SQUINT trial

Author

Landi, L., primary, Bonanno, L., additional, Delmonte, A., additional, Maximilian, P., additional, Stati, V., additional, Minotti, V., additional, Bennati, C., additional, D’Incà, F., additional, Migliorino, M.R., additional, Gori, S., additional, Santo, A., additional, Piantedosi, F., additional, Russo, A., additional, and Cappuzzo, F., additional

Published
2019
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16. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients

Author

Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Perrone F, MILES Investigators, SIGNORIELLO, Giuseppe, Gridelli, C, De Maio, E, Barbera, S, Sannicolo, M, Piazza, E, Piantedosi, F, Brancaccio, L, Morabito, A, Maione, P, Renda, F, Signoriello, Giuseppe, Perrone, F, and Miles, Investigators

Subjects
Male, Pulmonary and Respiratory Medicine, Antimetabolites, Antineoplastic, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Pulmonary toxicity, medicine.medical_treatment, Phases of clinical research, Kaplan-Meier Estimate, Deoxycytidine, Gastroenterology, Carcinoma, Non-Small-Cell Lung, Internal medicine, Humans, Medicine, Infusions, Intravenous, Lung cancer, Aged, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Lung Cancer, gemcitabine, Phase 2 study, medicine.disease, Gemcitabine, Surgery, Oncology, Toxicity, Female, business, Febrile neutropenia, medicine.drug
Abstract

Summary Background Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). A prolonged constant infusion (10 mg/m2/min) has been proposed as a way to improve its efficacy. Aim of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion in the treatment of elderly patients with advanced NSCLC. Patients and methods Patients aged 70 years or older, with stage IV or IIIB (effusion/supraclavicular nodes) NSCLC, good performance status (0 or 1 according to ECOG classification) who had never received chemotherapy were eligible. Gemcitabine was administered at the dose of 1200 mg/m2 by prolonged infusion (10 mg/m2/min) on days 1 and 8 of each cycle. Courses were repeated every 21 days, for a maximum of 6 cycles, unless disease progression or severe toxicity. A single stage phase 2 design was applied, with 51 patients required to estimate a 25% ± 10% response rate. Ten responses were required to define the treatment as active. Results Fifty-one patients were enrolled, with a median age of 76 years (range 70–83). Two complete responses and seven partial responses were observed, for an overall response rate of 17.6% (95% exact C.I.: 8.4–30.9%). The median time to disease progression was 16.1 weeks (95% C.I.: 11.1–20.6) and the median overall survival was 41.3 weeks (95% C.I.: 27.6–50.6). There were 2 toxic deaths, due to bleeding and liver toxicity, and one patient had an ischemic stroke. Other non-haematological toxicities were: fatigue (44% of patients), grade 2–3 pulmonary toxicity (8%), grade 2–3 hepatic toxicity (16%). Nausea and stomatitis were mild and no cases of cardiac toxicity were observed. Haematological toxicity was mild, with no case of febrile neutropenia. Conclusion Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design and should no longer be of interest for the treatment of elderly patients with advanced NSCLC.

Published
2008

17. P1.01-53 Bone Metastases and Efficacy of Immunotherapy in Patients with Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Author

Landi, L., primary, D'Incà, F., additional, Cortesi, E., additional, Chiari, R., additional, Grossi, F., additional, Delmonte, A., additional, De Marinis, F., additional, Signorelli, D., additional, Dazzi, C., additional, Sperandi, F., additional, Catino, A., additional, Giannarelli, D., additional, Soto Parra, H., additional, Minuti, G., additional, Bordi, P., additional, Migliorino, M.R., additional, Palla, A., additional, Tonini, G., additional, Cognetti, F., additional, Santoro, A., additional, Tassinari, D., additional, Scoppola, A., additional, Bidoli, P., additional, Piantedosi, F., additional, Maio, M., additional, Crinò, L., additional, and Cappuzzo, F., additional

Published
2018
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18. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferraù, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolò, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, V, Altavilla, G, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, Enrico, D'Auria, Giuliana, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, Cazzaniga, M., MAIONE P, PERRONE F, GALLO C, MANZIONE L, PIANTEDOSI F, BARBERA S, CIGOLARI, ROSETTI F, PIAZZA E, ROBBIATI SF, BERTETTO O, NOVELLO S, MIGLIORINO MR, FAVARETTO A, SPATAFORA M, FERRAU F, FRONTINI L, BEARZ A, REPETTO L, GRIDELLI C, BARLETTA E, BARZELLONI ML, IAFFAIOLI RV, DE MAIO E, DI MAIO M, DE FEO G, SIGORIELLO G, CHIODINI P, CIOFFI A, GUARDASOLE V, ANGELINI V, ROSSI A, BILANCIA, GERMANO D, LAMBERTI A, PONTILLO V, BRANCACCIO L, RENDA F, ROMANO F, ESANI G, GAMBARO A, VINANTE O, AZZARELLO G, CLERICI M, BOLLINA R, BELLONI P, SANNICOLO M, CIUFFREDA L, PARELLO G, CABIDDU M, SACCO C, SIBAU A, PORCILE G, CASTIGLIONE F, OSTELLINO O, MONFARDINI S, STEFANI M, SCAGLIOTTI G, SELVAGGI G, DE MARINIS F, MARTELLI O, GASPARINI G, MORABITO A, GATTUSO D, COLUCCI G, GALETTA D, GIOTTA F, GEBBIA V, ET AL, Maione, P, Perrone, F, Gallo, Ciro, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, and Gridelli, C.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Activities of daily living, Health Status, carcinoma, Vinblastine, Vinorelbine, Deoxycytidine, older people, Quality of life, Instrumental activitie, Carcinoma, Non-Small-Cell Lung, Internal medicine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, validation, Proportional hazards model, business.industry, QLQ-C30, Age Factors, Cancer, clinical trial, Prognosis, medicine.disease, Gemcitabine, Comorbidity, humanities, comorbidity, Oncology, Quartile, Quality of Life, Physical therapy, impact, Geriatric oncology, Female, business, Randomized-trial, medicine.drug
Abstract

Purpose To study the prognostic value for overall survival of baseline assessment of functional status, comorbidity, and quality of life (QoL) in elderly patients with advanced non—small-cell lung cancer treated with chemotherapy. Patients and Methods Data from 566 patients enrolled onto the phase III randomized Multicenter Italian Lung Cancer in the Elderly Study (MILES) study were analyzed. Functional status was measured as activities of daily living (ADL) and instrumental ADL (IADL). The presence of comorbidity was assessed with a checklist of 33 items; items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (EORTC QLQ-C30) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency. For IADL and QoL, three categories were defined using first and third quartiles as cut points. Comorbidity was summarized using the Charlson scale. Analysis was performed by Cox model, and stratified by treatment arm. Results Better values of baseline QoL (P = .0003) and IADL (P = .04) were significantly associated with better prognosis, whereas ADL (P = .44) and Charlson score (P = .66) had no prognostic value. Performance status 2 (P = .006) and a higher number of metastatic sites (P = .02) also predicted shorter overall survival. Conclusions Pretreatment global QoL and IADL scores, but not ADL and comorbidity, have significant prognostic value for survival of elderly patients with advanced non—small-cell lung cancer who were treated with chemotherapy. Using these scores in clinical practice might improve prognostic prediction for treatment planning.

Published
2005

19. P1.01-053 Italian Nivolumab Expanded Access Programme (EAP): Data from Patients with Advanced Non-Squamous NSCLC and Brain Metastases

Author

Crinò, L., primary, Bidoli, P., additional, Ulivi, P., additional, Minenza, E., additional, Cortesi, E., additional, Garassino, M., additional, Cappuzzo, F., additional, Grossi, F., additional, Tonini, G., additional, Sarobba, M.G., additional, Pinotti, G., additional, Numico, G., additional, Samaritani, R., additional, Ciuffreda, L., additional, Frassoldati, A., additional, Bregni, M.B., additional, Santo, A., additional, Piantedosi, F., additional, Illiano, A., additional, De Marinis, F., additional, and Delmonte, A., additional

Published
2017
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20. P1.01-065 Treatment Beyond Progression with Nivolumab in Patients with Advanced Non-Squamous NSCLC: Results from the Italian Expanded Access Program

Author

Cortesi, E., primary, Grossi, F., additional, Chiari, R., additional, Azzarello, G., additional, Berardi, R., additional, Tassinari, D., additional, Palmiotti, G., additional, Verusio, C., additional, Ardizzoia, A., additional, Fioretto, L., additional, Livi, L., additional, Giusti, S., additional, Bearz, A., additional, Ceresoli, G., additional, Piantedosi, F., additional, Frassoldati, A., additional, Ricevuto, E., additional, Fasola, G., additional, Marchetti, P., additional, and Puppo, G., additional

Published
2017
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24. 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

25. La chemioterapia sequenziale nel trattamento del cancro del polmone non a piccole cellule (NSCLC) in operabile

Author

CAPUTO F, PIANTEDOSI F, GILLI M, PONTILLO A, TURCO A, CAMPBELL S, BIANCO, Andrea, Caputo, F, Piantedosi, F, Gilli, M, Pontillo, A, Turco, A, Campbell, S, and Bianco, Andrea

Abstract

Sequential treatment with antiblastic drugs allow to utilise different agents at the optimal dosage avoiding the addition of side effects. Furthermore this modality of treatment may override the phenomena of pharmaco-resistance. We have designed a clinical trial to explore the efficacy and tolerability of the following sequential schedule: Cisplatin at a dose of 80 mg/m2 on day 1 and vinorelbin 25 mg/m2 on day 1-8 every 3 weeks were administered. After three courses of the above schedule the patients have been re-staged. Patients with CR, PR or SD have than received 3 courses of docetaxel 75 mg/m2 on day 1 every 3 weeks, whilst progressive diseases patients discontinued the study. 53 pts with unresectable NSCLC have been enrolled. 43 males, 10 females; mean age 56; stage III B: 20 (38%), stage IV: 33 (62%); PS 1: 32, PS 2: 21; adenocarcinoma: 19 (35%), squamous: 12 (22,6%); NSCLC: 22 (41,5%). The sequential treatment cisplatin/vinorelbin followed by docetaxel demonstrates, in our study, good activity (41,6%) with satisfactory toxicity and may represents a feasible alternative for treatment of advanced/metastatic NSCLC. Il trattamento sequenziale con farmaci antiblastici consente di utilizzare differenti agenti al dosaggio ottimale evitando effetti indesiderati addizionali. Tale modalità di trattamento può inoltre superare i fenomeni di farmacoresisteanza. Abbiamo disegnato uno studio clinico allo scopo di verificare l’efficacia e la tollerabilità della seguente schedula sequenziale: 3 cicli di chemioterapia con Cisplatino al dosaggio di 80 mg/m2 al giorno 1, Vinorelbina alla dose di 25 mg/m2 nei giorni 1 e 8 ogni 21 giorni. In caso SD, RP o risposta completa RC il paziente veniva sottoposto ad ulteriori 3 cicli di chemioterapia con Docetaxel alla dose di 75 mg/m2 ogni 21 giorni per 3 cicli. In caso di PD il paziente usciva dallo studio. Sono stati arruolati 53 pazienti con diagnosi di NSCLC. 43 maschi e 10 femmine; età mediana 56 anni; stadio IIIB: 20 (38%), stadio IV 33 (62%); PS 0- 1: 32 pazienti e PS 2: 21 pazienti; Adenocarcinoma 19 (35%) Squamoso 12 (22.6%) altre forme 22 (41.5%) Il trattamento sequenziale cisplatino/vinorelbina seguito da docetaxel ha dimostrato una buona attività (41,6%)con una soddisfacente tossicità e può rappresentare una alternativa per il trattamento del NSCLC avanzato/metastatico.

Published
2006

26. Regimi di chemioterapia senza derivati del platino in pazienti con neoplasia polmonare non a piccole cellule (NSCLC) avanzata/metastatica (stadio IIIB/IV): efficacia dell’associazione Gemcitabina, Ifosamide, Paclitaxel (GIT)

Author

Caputo F, Piantedosi F. V, Chianca P, Pontillo V, Pontillo A, Gilli M, Ferrigno F, BIANCO, Andrea, MAZZARELLA, Gennaro, Caputo, F, Piantedosi, F. V., Chianca, P, Pontillo, V, Mazzarella, Gennaro, Pontillo, A, Gilli, M, Ferrigno, F, and Bianco, Andrea

Published
2006

29. Italian cohort of nivolumab Expanded Access Programme (EAP): efficacy and safety data from a real-world population

Author

Crinò, L., primary, Bidoli, P., additional, Delmonte, A., additional, Grossi, F., additional, de Marinis, F., additional, Sperandi, F., additional, Piantedosi, F., additional, Vitali, M., additional, Soto Parra, H., additional, Scagnoli, S., additional, Minuti, G., additional, Calabrò, L., additional, Tiseo, M., additional, Turci, D., additional, Quadrini, S., additional, Antonelli, P., additional, Manzo, A., additional, Prediletto, I., additional, Giannarelli, D., additional, and Galetta, D., additional

Published
2016
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30. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial

Author

GRIDELLI C, PERRONE F, CIGOLARI S, ROSSI A, PIANTEDOSI F, BARBERA S, FERRAU F, PIAZZA E, ROSETTI F, CLERICI M, BERTETTO O, ROBBIATI SF, FRONTINI L, SACCO C, CASTIGLIONE F, FAVARETTO A, NOVELLO S, MIGLIORINO MR, GASPARINI G, GALETTA D, IAFFAIOLI RV, GEBBIA V, MILES INVESTIGATORS, GALLO, Ciro, Gridelli, C, Perrone, F, Gallo, Ciro, Cigolari, S, Rossi, A, Piantedosi, F, Barbera, S, Ferrau, F, Piazza, E, Rosetti, F, Clerici, M, Bertetto, O, Robbiati, Sf, Frontini, L, Sacco, C, Castiglione, F, Favaretto, A, Novello, S, Migliorino, Mr, Gasparini, G, Galetta, D, Iaffaioli, Rv, Gebbia, V, and Miles, Investigators

Published
2003

32. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Author

Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology

Subjects
Nephrology, Oncology, Male, Cancer Research, mTOR inhibitor, Settore MED/06 - Oncologia Medica, Medizin, Advanced kidney cancer, RAD001, REACT, 0302 clinical medicine, Renal cell carcinoma, Receptors, 80 and over, Treatment Failure, Neoplasm Metastasis, Aged, 80 and over, 0303 health sciences, Vascular Endothelial Growth Factor, Sirolimus, Young Adult, Antineoplastic Agents, Humans, Aged, Immunosuppressive Agents, Protein Kinase Inhibitors, Receptors, Vascular Endothelial Growth Factor, Kidney Neoplasms, Adult, Carcinoma, Renal Cell, Middle Aged, Female, 3. Good health, 030220 oncology & carcinogenesis, Safety, medicine.drug, medicine.medical_specialty, SECOND LINE THERPAY, Second-line therapy, Everolimus, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, 030304 developmental biology, business.industry, Carcinoma, Renal Cell, medicine.disease, Surgery, Clinical trial, Expanded access, business, Kidney cancer
Abstract

BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.

Published
2012

34. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancerreceiving chemotherapy: a prognostic analysis of the multicenter Italian lungcancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolo, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, E, D'Auria, G, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, and Cazzaniga, M.

Published
2005

38. Anemia management with epoetin beta in anemic patients with cancer receiving chemotherapy: Pananemia observational study on clinical practice.

Author

Del Prete, S., primary, Piantedosi, F., additional, Rocco, D., additional, Riccardi, F., additional, Vincenzi, B., additional, Bianco, M., additional, Savastano, C., additional, Montesarchio, V., additional, Matarese, M., additional, Sabia, A., additional, Illiano, A., additional, Pisano, A., additional, Biglietto, M., additional, Pistolese, G., additional, Leo, L., additional, Maiorino, L., additional, Febbraro, A., additional, and Addeo, R., additional

Published
2011
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40. Two consecutive phase 1–2 studies of cisplatin (P)-based 1st-line chemotherapy (CT) in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC). The MILES-2P studies

Author

Perrone, F., primary, Illiano, A., additional, Piantedosi, F. V., additional, Bearz, A., additional, Favaretto, A., additional, Lorusso, V., additional, Manzione, L., additional, Iaffaioli, R. V., additional, Valerio, M. R., additional, and Gridelli, C., additional

Published
2006
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41. Supportive care in patients with advanced non-small-cell lung cancer

Author

Di Maio, M, primary, Perrone, F, additional, Gallo, C, additional, Iaffaioli, R V, additional, Manzione, L, additional, Piantedosi, F V, additional, Cigolari, S, additional, Illiano, A, additional, Barbera, S, additional, Robbiati, S F, additional, Piazza, E, additional, Ianniello, G P, additional, Frontini, L, additional, Veltri, E, additional, Castiglione, F, additional, Rosetti, F, additional, De Maio, E, additional, Maione, P, additional, and Gridelli, C, additional

Published
2003
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42. Chemotherapy for Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) Phase III Randomized Trial

Author

Gridelli, C., primary, Perrone, F., additional, Gallo, C., additional, Cigolari, S., additional, Rossi, A., additional, Piantedosi, F., additional, Barbera, S., additional, Ferrau, F., additional, Piazza, E., additional, Rosetti, F., additional, Clerici, M., additional, Bertetto, O., additional, Robbiati, S. F., additional, Frontini, L., additional, Sacco, C., additional, Castiglione, F., additional, Favaretto, A., additional, Novello, S., additional, Migliorino, M. R., additional, Gasparini, G., additional, Galetta, D., additional, Iaffaioli, R. V., additional, and Gebbia, V., additional

Published
2003
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43. A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study

Author

Frasci, G, primary, Nicolella, G, additional, Comella, P, additional, Carreca, I, additional, DeCataldis, G, additional, Muci, D, additional, Brunetti, C, additional, Natale, M, additional, Piantedosi, F, additional, Russo, A, additional, Palmeri, S, additional, Comella, G, additional, and Panza, N, additional

Published
2001
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44. Gemcitabine (GEM) — Cisplatin (COOP) — Vinorelbine (VNR) combination in advanced non-small-cell lung cancer (NSCLC). A phase II randomized study

Author

Comella, P., primary, Panza, N., additional, Frasci, G., additional, Pacilio, C., additional, Nicolella, G.P., additional, Natale, M., additional, De Cataldis, G., additional, Manzione, L., additional, Bilancia, D., additional, Cioffi, R., additional, Micillo, E., additional, Maiorino, L., additional, Lorusso, V., additional, lanniello, G.P., additional, Della Vittoria, M., additional, Piantedosi, F., additional, Perchard, J., additional, and Comella, G., additional

Published
1997
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45. 231 Gemcitabine (GEM)-cisplatin (CDDP)-vinorelbine (VNR) combination in advanced non-small-cell lung cancer (NSCLC). A phase II randomized study

Author

Comella, P., primary, Panza, N., additional, Frasci, G., additional, Pacilio, C., additional, Nicolella, G.P., additional, Natale, M., additional, De Cataldis, G., additional, Manzione, L., additional, Bilancia, D., additional, Cioffi, R., additional, Micillo, E., additional, Maiorino, L., additional, Lorusso, V., additional, Ianniello, G.P., additional, Della Vittoria, M., additional, Piantedosi, F., additional, Perchard, J., additional, Gravina, A., additional, and Comella, G., additional

Published
1997
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46. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.

Author

Gridelli, C., Gallo, C., Di Maio, M., Barletta, E., Illiano, A., Maione, P., Salvagni, S., Piantedosi, F. V., Palazzolo, G., Caffo, O., Ceribelli, A., Falcone, A., Mazzanti, P., Brancaccio, L., Capuano, M. A., Isa, L., Barbera, S., and Perrone, F.

Subjects
CLINICAL trials, DOCETAXEL, LUNG cancer, QUALITY of life, DIARRHEA, FEBRILE neutropenia
Abstract

Docetaxel (75 mg m(-2) 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m(-2) for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, < or =75 years, ECOG PS < or =2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77-1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival. [ABSTRACT FROM AUTHOR]

Published
2004
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48. H-Prune through GSK-3β interaction sustains canonical WNT/β-catenin signaling enhancing cancer progression in NSCLC

Author

Carotenuto M, De Antonellis P, Liguori L, Benvenuto G, Magliulo D, Alonzi A, Turino C, Attanasio C, Damiani V, Am, Bello, Vitiello F, Pasquinelli R, Terracciano L, Federico A, Fusco A, Freeman J, Trevor Dale, Decraene C, Chiappetta G, Piantedosi F, Carotenuto, M, De Antonellis, P, Liguori, L, Benvenuto, G, Magliulo, D, Alonzi, A, Turino, C, Attanasio, C, Damiani, V, Bello, Am, Vitiello, F, Pasquinelli, R, Terracciano, L, Federico, A, Fusco, A, Freeman, J, Dale, Tc, Decraene, C, Chiappetta, G, and Zollo, M

49. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: The multicenter Italian lung cancer in the elderly study (MILES) phase III randomized trial

Author

Gridelli, C., Perrone, F., Gallo, C., Cigolari, S., Rossi, A., Piantedosi, F., Barbera, S., Ferraù, F., Piazza, E., Rosetti, F., Clerici, M., Bertetto, O., Robbiati, S. F., Frontini, L., Sacco, C., Castiglione, F., Adolfo Favaretto, Novello, S., Migliorino, M. R., Gasparini, G., Galetta, D., Iaffaioli, R. V., Gebbia, V., Celano, A., Schiavon, S., Illiano, A., Raucci, C. A., Caruso, M., Foa, P., Tonini, G., Curcio, C., and Cazzaniga, M.

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