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1. Impact on Survival of Timing and Duration of Adjuvant Chemotherapy in Radically Resected Gastric Cancer

Author

Maria Di Bartolomeo, Filippo Pietrantonio, Eliana Rulli, Davide Poli, Rosa Berenato, Marta Caporale, Emilio Bajetta, Irene Floriani, E. Bajetta, M. Di Bartolomeo, L. Catena, M. Schiavo, G. Pinotti, I. Proserpio, G. Rosati, R. Bordonaro, S. Cordio, G. Burrafato, A.M. Bochicchio, M. Aieta, N. Fazio, F. Spada, V. Amoroso, G. Marini, H. Soto Parra, G. Novello, B. Massidda, M.T. Ionta, M. Comandè, R. Venezia, A. Bertolini, E. Menatti, L. Zanlorenzi, A. Colombo, A. Iop, S. Bonura, E. Mazza, M. Viganò, A. Ardizzoia, S. Dell'Oro, G. Lo Re, D. Santeufemia, A. Buonadonna, D. Luisi, G. Ucci, G. Di Lucca, A. Bonetti, F. Bergamo, M. Alù, F. Vastola, P. Marchetti, D.C. Corsi, E. Massa, G. Di Pinto, M. Duro, C. Oliani, M. Franchini, A. Inzoli, N. Gebbia, L. Repetto, S. Rota, L. Frontini, R. Labianca, S. Mosconi, A. Quadri, S. De Grossi, P. Bidoli, M.E. Cazzaniga, F. Villa, P. Foa, D. Ferrari, E. Aitini, C. Rabbi, S. Barni, F. Petrelli, M. Giordano, G. Luchena, M. Pirovano, A. Nasisi, V. Catalano, P. Giordani, A. Zaniboni, F. Leone, S. Ferrario, G.D. Beretta, E.T. Menichetti, D. Conte, D. Mari, R. Giannicola, C. Pierantoni, A.G. Luporini, A. Ragazzini, A. Ravaioli, D. Tassinari, M. Nicolini, D. Amadori, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, E. Bejtja, A. Falcone, L. Landi, G. Minuti, M. Cantore, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, I.M. Brunetti, M. Lencioni, M. Sisani, P. Sozzi, C. Granetto, S. Chiara, A.S. Galetto, A.S. Ribecco, A. DeCensi, L. Ciuffreda, E.E. Baldini, R. Camisa, R. Todeschini, A. Santoro, L. Rimassa, C. Carnaghi, T. Pressiani, C. Boni, E. Rondini, R. Gnoni, F. Di Costanzo, S. Gasperoni, L. Cavanna, M.A. Palladino, R. Mattioli, G. Laici, F. Pucci, M.D. Alessio, I. Bernardini, G. Tomasello, G. Baldino, R. Rossetti, S. Giaquinta, C. Pinto, F. Di Fabio, F.L. Rijas Llimpe, A.A. Brandes, M. Marzola, A.O.G. Rummo Benevento, S. Competiello, V. Montesarchio, A. Rea, B. Daniele, G. Genua, M. Licenziato, R. Casaretti, L. Silvestro, M. Montano, M.G. Sarobba, G. Sanna, G. Filippelli, G. Dima, E. Greco, M. Roselli, D. Natale, G. Condemi, G. Fumi, S. Tafuto, P. Masullo, D. Nitti, A. Marchet, G. Tiberio, G. de Manzoni, S. Nobili, G. Fiorentini, R. Mazzanti, E. Perrotta, C. Carlomagno, A. De Stefano, G. Cartenì, and M. Otero

Subjects
Male, Oncology, Cancer Research, medicine.medical_specialty, Adjuvant chemotherapy, medicine.medical_treatment, Time-to-Treatment, 03 medical and health sciences, 0302 clinical medicine, Stomach Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Combined Modality Therapy, Aged, Neoplasm Staging, Proportional Hazards Models, Postoperative Care, Chemotherapy, Proportional hazards model, business.industry, Stomach, Cancer, General Medicine, Middle Aged, medicine.disease, medicine.anatomical_structure, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Adenocarcinoma, Female, 030211 gastroenterology & hepatology, business, Adjuvant
Abstract

Purpose Adjuvant chemotherapy improves survival of patients with gastric cancer. Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S) was a phase III study comparing sequential FOLFIRI followed by docetaxel/cisplatin versus 5-fluorouracil monotherapy. The intensive regimen was not superior in terms of disease-free survival (DFS) and overall survival (OS). Methods The treatment was to be started within 8 weeks from surgery. This analysis evaluates the impact of time from surgery to chemotherapy start (TSC) on outcomes. Results Out of 1,106 randomized, 1,072 patients without major violations of eligibility criteria and receiving at least one treatment cycle were analyzed. Median TSC was 50 days. Chemotherapy was interrupted in 201 (18.8%) cases, whereas it was completed without or with modifications in 277 (25.8%) and 594 (55.4%), respectively. At a median follow-up of 56.9 months, 513 progressions and 472 deaths occurred. A longer TSC was significantly associated with longer DFS (hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.89-1.00; p = 0.05) and OS (HR 0.91; 95% CI 0.86-0.97; p = 0.004), after adjustment for treatment arm, age, sex, primary tumor site, number of resected nodes, and tumor stage. Better treatment compliance was associated with improved survival. Conclusions Our findings suggest that longer TSC had at least no detrimental effect on DFS and OS, whereas treatment completion had a protective effect. Our findings need to be confirmed prospectively.

Published
2016
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2. Profiling cancer-related needs and the role of physical, practical and psychological difficulties: A latent class analysis approach

Author

Maria Marconi, Raffaella Morena, Alessandro Rossi, Claudio Verusio, Chiara Rossini, India Minelli, G Di Lucca, and Stefania Mannarini

Subjects
Gerontology, Cancer Research, Oncology, business.industry, Profiling (information science), Medicine, business, Latent class model
Abstract

e22161Background: There was an increasing attention to the humanization of oncological cares that focused on patients’ needs – which have a strong impact on quality of life. Cancer-related needs se...

Published
2018

4. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

E. Bajetta, I. Floriani, M. Di Bartolomeo, R. Labianca, A. Falcone, F. Di Costanzo, G. Comella, D. Amadori, C. Pinto, C. Carlomagno, D. Nitti, B. Daniele, E. Mini, D. Poli, A. Santoro, S. Mosconi, R. Casaretti, C. Boni, G. Pinotti, P. Bidoli, L. Landi, G. Rosati, A. Ravaioli, M. Cantore, F. Di Fabio, E. Aitini, A. Marchet, E. Rulli, M. Cropalato Di Tullio, F. Galli, E. Biagioli, I. De Simone, S. Mangano, M. Tonato, E. Zucca, M.G. Valsecchi, S. De Placido, L. Catena, M. Schiavo, I. Proserpio, R. Bordonaro, S. Cordio, G. Burrafato, A.M. Bochicchio, M. Aieta, N. Fazio, F. Spada, V. Amoroso, G. Marini, H. Soto Parra, G. Novello, B. Massidda, M.T. Ionta, M. Comandè, R. Venezia, A. Bertolini, E. Menatti, L. Zanlorenzi, A. Colombo, A. Iop, S. Bonura, E. Mazza, M. Viganò, A. Ardizzoia, S. Dell'Oro, G. Lo Re, D. Santeufemia, A. Buonadonna, D. Luisi, G. Ucci, G. Di Lucca, A. Bonetti, F. Bergamo, M. Alù, F. Vastola, P. Marchetti, D.C. Corsi, E. Massa, G. Di Pinto, M. Duro, C. Oliani, M. Franchini, A. Inzoli, N. Gebbia, L. Repetto, S. Rota, L. Frontini, A. Quadri, S. De Grossi, M.E. Cazzaniga, F. Villa, P. Foa, D. Ferrari, C. Rabbi, S. Barni, F. Petrelli, M. Giordano, G. Luchena, M. Pirovano, A. Nasisi, V. Catalano, P. Giordani, A. Zaniboni, F. Leone, S. Ferrario, G.D. Beretta, E.T. Menichetti, D. Conte, D. Mari, R. Giannicola, C. Pierantoni, A.G. Luporini, D. Tassinari, M. Nicolini, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, G. Minuti, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, M.I. Brunetti, M. Lencioni, M. Sisani, P. Sozzi, C. Granetto, S. Chiara, A.S. Galetto, A.S. Ribecco, A. DeCensi, L. Ciuffreda, E.E. Baldini, R. Camisa, R. Todeschini, L. Rimassa, C. Carnaghi, T. Pressiani, E. Rondini, R. Gnoni, S. Gasperoni, L. Cavanna, M.A. Palladino, R. Mattioli, G. Laici, F. Pucci, M.D. Alessio, I. Bernardini, G. Tomasello, G. Baldino, R. Rossetti, S. Giaquinta, F.L. Rijas Llimpe, A.A. Brandes, M. Marzola, V. Montesarchio, A. Rea, G. Genua, L. Silvestro, M. Montano, M.G. Sarobba, G. Sanna, G. Filippelli, G. Dima, E. Greco, M. Roselli, D. Natale, G. Condemi, G. Fumi, S. Tafuto, P. Masullo, G. Tiberio, G. de Manzoni, G. Fiorentini, R. Mazzanti, A. De Stefano, G. Cartenì, M. Otero, Bajetta, E, Floriani, I, Di Bartolomeo, M, Labianca, R, Falcone, A, Di Costanzo, F, Comella, G, Amadori, D, Pinto, C, Carlomagno, Chiara, Nitti, D, Daniele, B, Mini, E, Poli, D, Santoro, A, Mosconi, S, Casaretti, R, Boni, C, Pinotti, G, Bidoli, P, Landi, L, Rosati, G, Ravaioli, A, Cantore, M, Di Fabio, F, Marchet, A, for the ITACA S., Study Group, Carlomagno, C, Aitini, E, and Valsecchi, M

Subjects
medicine.medical_specialty, SURGERY, Settore MED/06 - Oncologia Medica, adjuvant treatment, Docetaxel, Gastroenterology, LEUCOVORIN, adjuvant chemotherapy, gastric cancer, Folinic acid, Bolus (medicine), Stomach Neoplasms, randomized clinical trial, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, GASTRECTOMY, business.industry, Hazard ratio, gastric cancer, adjuvant treatment, adjuvant chemotherapy, randomized clinical trial, PHASE-III TRIAL, CHEMOTHERAPY, SURGERY, S-1, ADENOCARCINOMA, GASTRECTOMY, LEUCOVORIN, PHASE-III TRIAL, ADENOCARCINOMA, Hematology, S-1, CHEMOTHERAPY, Combined Modality Therapy, Surgery, Irinotecan, Regimen, Oncology, Fluorouracil, Chemotherapy, Adjuvant, FOLFIRI, Camptothecin, Taxoids, Cisplatin, business, medicine.drug
Abstract

Background: Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV)] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer. Patients and methods: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m 2 day 1, LV 100 mg/m 2 as 2 h infusion and 5-FU 400 mg/m 2 as bolus, days 1 and 2 followed by 600 mg/m 2 /day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m 2 day 1, cisplatin 75 mg/m 2 day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm). Results: From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85–1.17; P= 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82–1.18; P= 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively. Conclusions: A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy. Clinical trial registration: ClinicalTrials.gov Identifier: NCT01640782.

Published
2014

5. Significant Association Between VEGF-A and ABCB1 Polymorphisms and Survival in Metastatic Pancreatic Adenocarcinoma (MPA) patients (Pts) treated with Maintenance Sunitinib (MS)

Author

Francesca Bergamo, Elisa Giovannetti, Michele Reni, Carmen Belli, Alessandro Passardi, Anna Novarino, G. Di Lucca, Henk M.W. Verheul, Stefano Cereda, Laura Ferrari, Reni, M, Giovannetti, E, Cereda, S, Belli, C, Passardi, A, Di Lucca, G, Ferrari, L, Bergamo, F, Novarino, A, and Verheul, Hm

Subjects
medicine.medical_specialty, Predictive marker, Performance status, Sunitinib, business.industry, Induction chemotherapy, Hematology, medicine.disease, Gastroenterology, Confirmatory trial, Oncology, Pharmacokinetics, Internal medicine, Genotype, medicine, business, Progressive disease, medicine.drug
Abstract

A randomised multi-centre phase II trial explored the role of MS in pts with MPA without progressive disease (PD) after induction chemotherapy (CT), using an observation only group (O) as calibration arm [Reni et al. Proc ASCO 2012]. The aim of this present study was to identify genetic polymorphisms related to pharmacokinetics and pharmacodynamics of sunitinib that are associated with outcome. Adult pts with pathologic diagnosis of MPA, performance status (PS) >50%, no PD after 6 months of CT were randomized to O (arm A) or MS at 37.5 mg daily until PD or a maximum of 6 months (arm B). Functional polymorphisms of 6 genes involved in sunitinib activity, metabolism and transport (VEGFA, VEGFR-2, CYP3A5, CYP1A1, ABCB1, ABCG2) were studied in genomic DNA from baseline blood samples, using PCR Taqman®-probes-based assays. Associations of genotypes with overall survival (OS) and progression-free survival (PFS) were evaluated by Log-rank test. Genotyping was successfully performed in all the DNA samples of 43 consenting pts of 55 enrolled in the trial (78%; arm A/B: 83%/73%; p = 0.39). Significantly longer OS was observed in 7 pts harbouring the ABCB1 3435TT genotype (group-1; median OS 20 months) as compared to 36 pts with 3435CC/CT genotype (group-2; median OS 7 months; p = 0.027). Median OS was 26 months in 4 group-1 arm B pts, 7 months in 15 group-2 arm B pts (p = 0.12); 16 months in 3 group-1 arm A pts and 9 months in 21 group-2 arm A pts (p = 0.67). No OS difference was observed in 28 pts harbouring the VEGFA -634GC-CC genotype (group-3; median OS 10 months) as compared to 15 pts with -634GG genotype (group-4; median OS 8 months; p = 0.15). However, median OS was 13 months in 13 group-3 arm B pts, 6 months in 6 group-4 arm B pts (p = 0.016); 9 months in 15 group 3 arm A pts and 11 months in 9 group 4 arm A pts (p = 0.67). These results suggest that polymorphisms of genes involved in expression of the main ligand for VEGFR2 (VEGFA 634G > C) and of efflux transporters (ABCB1 3435C > T) are promising candidates as predictive marker for selecting pts with MPA who may benefit of MS. Given the small sample size of these analyses, a larger confirmatory trial is necessary and appears worthwhile. Disclosure All authors have declared no conflicts of interest.

Published
2012

6. TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)

Author

Alain Duhamel, A. Tsuburaya, Mali Okada, S. Kuwabara, H. Hasegawa, A.L. Cohn, Anne Thirot-Bidault, J.R. Delgado, O.U. Unal, J. Isaacson, S. Khudayorov, Sue Ward, N. Mueller, Riccardo Lencioni, Giovanni Abbadessa, D. Takahari, T. Watanabe, Luca Faloppi, Y. Hamamoto, Julia Hocke, Elwyn Loh, M. Aizawa, E. Trejo, A. Novarino, A. Ohtsu, K. Okita, M.J. Flor, Riccardo Giampieri, C. Rose, D. Gonzalez-De-Castro, H. Isayama, M. Esaki, Jean-Pierre Bronowicki, S. Cereda, S. Hironaka, A. Sawaki, I. Iwanicki-Caron, L. Ferrari, J. Stephenson, F. Gerevini, E. Francois, T. Okusaka, S. De Minicis, Cristian Loretelli, S.Y. Roh, A. González-Vicente, F. Richard, H. Tuyev, A. Laforest, K. Lin, M. Milic´evic´, Chunming Li, Wolfgang Eisterer, P. Basile, Mohamed Gasmi, S. Hazama, M. Botta, Seiji Kawazoe, Jean-Luc Raoul, Y. Jiang, I. Trouilloud, B. Nagy, E. del Valle, Satoshi Yuki, K.W. Park, Hanno Riess, M. Bartosiewicz, L. Rolfe, H. Fang, E. Gardner, A. Benedetti, A. Carrato, E. Vasile, Takayuki Kii, N. Suzuki, Y. Shimada, S.F. Ang, S. Fushida, V. Vaccaro, Y. Liu, E. Castanon Alvarez, Y. Ozaki, D. Mirabelli, Ozgur Ozyilkan, J.E. Battley, C.H.S. Kim, N. Weijl, B. Bui, J.C. Sabourin, M. Hejna, Raymond Miller, N. Besova, Jinhui Xu, Ian Chau, J.-L. Van Laethem, Eric Vibert, Philippe Mathurin, H. Yabusaki, Melissa Frizziero, J. Soberino García, S. Salvagni, M. Zhu, Christoph Schuhmacher, Y. Yamada, A. Hubert, R. Libener, S.T. Dimoudis, Jonathan Wadsley, J. Martinez-Galan, Coskun U, V. Karavasilis, Cem Parlak, N. Jain, T. Gamucci, Elisa Giovannetti, R. Gupta, Suleyman Buyukberber, Jose Javier Sanchez, Taro Tokui, Kenneth K. Tanabe, V. Nerich, G. Dyson, Y. Kawachi, J. Reis-Filho, Junichi Sakamoto, A. Mohar-Betancourt, Masahide Mori, Aytug Uner, S. Martin Algarra, C.-J. Yen, J.J. Critchfield, Y. Naomoto, Julien Taieb, Young Seon Hong, Hironori Yamaguchi, S. Jiao, Alan P. Venook, C. Pericay, R.H. Wilson, D. Ferrari, Peter R. Galle, S. Falcon, Emilio Bria, L. Paz-Ares, Anna Tomezzoli, S. Al-Batran, G. Luppi, Jean-Marie Boher, I. Park, F. De Vita, Roland Leung, M. Abdelwahab, A. Ravaioli, Takuya Suzuki, C. Szczylik, C. González-Rivas, Sarita Dubey, Y. Miyashita, J.Y. Lim, Y. Chen, F. El Hajbi, Ichinosuke Hyodo, Tsutomu Chiba, C. Kondo, S. Ye, Thomas Aparicio, M. Nesrine, T. Ganten, T. Nishina, G. Grazi, A.C. Dupont-Gossard, I. Oze, F. Nosrati, J.H. Yook, C. Yoo, N.A. Adu-Aryee, M. Choi, Narikazu Boku, P. Chan, John Bridgewater, A. Gimenez-Capitan, Hamim Zahir, R. Hela, T. Villegas, Stefano Barbi, György Bodoky, D. Degiovanni, Y. Honma, A. Croitoru, K. Koufuji, Lorenza Rimassa, A. Tsuji, Yueyang Shen, Nathan Bahary, S. Abdelwahab, N. Matsuura, Parsee Tomar, L. Yu, Mohammed Elbassiouny, B. Ryoo, S. Adachi, Jean-Robert Delpero, V.D.N.K. Vanderpuye, S.T. Oh, E. Samantas, Amit Bahl, N. Karachaliou, Thierry Lecomte, S. Yoshino, H. Hahn, A. Matsuki, K. Nakamura, D.S. Johnston, M. Del Prete, Per Stål, R. Greil, Dirk Arnold, K. Ridwelski, J. Zhao, K. Shirouzu, Meltem Baykara, G. De Manzoni, I. Lang, K. Aoyagi, A. Fukutomi, Joji Kitayama, Antonieta Salud, K. Beecham, Y. Inoue, Armando Santoro, R. Rosell, P. Malfertheiner, Tsutomu Fujii, Jeong-Yeol Park, S. Taylor, K. Nakajima, Matus Studeny, H. Jiang, M. Shimada, O. Abdelrhman, Camillo Porta, P. Ballesteros, S. Lecleire, K. Han, G. Svegliati Baroni, Michitaka Nagase, François Paye, W. Rodriguez Pantigoso, M.M. Eatock, H.C. Toh, M. Ikeda, Hironori Ishigami, N. Stankovic, H. Kumada, K. Shitara, X. Zhang, E. Arevalo, R. Poon, M. Allard, Y.-Y. Lin, D. Egamberdiev, Shin'ichi Miyamoto, P. Afchain, Harpreet Wasan, Mitesh J. Borad, J. Blay, Dong Sup Yoon, H. Kawai, L. Jin, Margaret Sheehan, T. Otsuji, M. Lichinitser, Ahmet Ozet, R. Savage, Heind Smith, L. Zubiri, Tim Meyer, Erkan Topkan, Ross C. Donehower, Joanne Chiu, T. Tsuda, P. Jimenez Fonseca, U. Selek, N. Musha, B. Liu, A. Magnusson, S.C. Sharma, C. Purcell, H. Wong, E. Lucchini, Jean-Marc Phelip, E. Jeon, J. Fujita, Kelly S. Oliner, W. Schelman, W. Mao, S. Hato, A-L Cheng, D.-L. Ou, Tarek Sahmoud, J. Waters, Jorge A. Marrero, David Malka, P. Xavier, M. Haibo, S. Takiguchi, Q. Pan, S. Ohkawa, J. Kizaki, I.P. Le, A. Roveta, D.H. Koo, H.J. Kim, H. Choi, T. Göhler, A. Gelibter, C. Borg, X. Qiang, Masaya Suenaga, Ozan Cem Guler, Niall C. Tebbutt, M. Emi, S. Ota, N. Nagata, S. Iwasa, Mira Ayadi, K. Matsuo, Henk M.W. Verheul, Christoph C. Zielinski, S. Choo, M.W. Büchler, René Adam, M. Pistelli, J.A. Gonzalez, Charles S. Fuchs, G. Vallati, G. Pentheroudakis, S. Tokunaga, U. Demirci, Lin Shen, B. Heyd, X. Zhou, T. Ioka, Toshiyoshi Fujiwara, O. Testori, Y.S. Park, A. Allen, Rakesh Kapoor, Bruno Daniele, T. Hirai, Z. Lakkis, I.B. Tan, Y-K Kang, S.A. Aledavood, N. Reynoso, F. Serejo, Sergio Ricci, Jennifer Gansert, M. Miyagi, S. Santi, A. Parthan, A C Wotherspoon, L. Chaigneau, Sumera Rizvi, M.G. Fabrini, Véronique Vendrely, W. Su, V. Shalenkov, L. Tu, G. Numico, Joon Seong Park, J.H. Kim, Hope E. Uronis, Mustafa Benekli, I. Aoyama, M. Gauthier, S. Lazzarelli, W. Liguigli, N. Atsushi, H. Kastrissios, J. Thaler, Z. Zou, T. Tsujinaka, S. Barbero, F. Fiteni, Irene Kührer, Aldo Scarpa, C. Desauw, J.F. Seitz, Takahiro Horimatsu, R. von Roemeling, T. Yamamoto, H.R. Alexander, Timothy Iveson, F.M. Negri, Ermek Tangsakar, Pascal Artru, Jia Zhang, S. Lee, Satoshi Morita, E. Garralda, M. Moore, J. Lee, M. Seilanian Tousi, J. Gornet, Yasuhiro Kodera, Werner Scheithauer, L. Marthey, D. Atanackovic, P. Zhao, D. Wang, I. Davidenko, T.S. Waddell, S. Takeda, N. Fan, R. Kawabata, M. Raponi, Giampaolo Tortora, M. Ogasawara, B. Gruenberger, Guido Gerken, Ivan Borbath, N. Fuse, Denis Smith, Emmanuel Mitry, Vikki Tang, I. Stilidi, Min-Hee Ryu, Tulay Akman, C. Saffery, Roopinder Gillmore, K. Ligier, R. Coriat, T. Namikawa, L. Sun, R. Xu, Gary Middleton, W. Tröger, F. Keil, Bruno Chauffert, K. Achilles, David Cunningham, H. Raies, M.Y. Teo, Y. Hamai, S. Tjulandin, I. Boukovinas, J. Kazakin, J. Beebe-Dimmer, Pippa Corrie, J.A. Ortega, A. Cueff, C. Costa, V. Da Prat, Y. Tanaka, F. Rivera, K. Hashimoto, Tianshu Liu, K. Kato, J.C. Plaza, G. Fountzilas, N. Chaiet, Byung Sik Kim, K. Ueda, Pierre Laurent-Puig, Y.-C. Cheng, Mendel Jansen, T. Salman, C. Papandreou, T. Carothers, H. Van Vlierberghe, M. Rios, S. Barni, Y. Arai, G. Afc, Julia Klech, Bryan C. Fuchs, S.T. Fan, A. Falcone, J-B. Bachet, Y. Fujiwara, S. Navruzov, Fumihiko Kanai, H. Shiah, J. Xia, N. Xu, X. Garcia del Muro, M. Lucchesi, Jae Yong Cho, A. Leon, W. Jin, C. Eng, A.U. Yilmaz, L.-T. Chen, Laurent Bedenne, I. Vynnychenko, Brian Schwartz, J. Ruíz Vozmediano, Toshihiro Tanaka, Jinwan Wang, F. Musante, C. Belli, K. Imanaka, W. Fang, J.P. Fusco, S. Gupta, Daniel H. Palmer, M. Ninomiya, N. Ryuge, M. Djuraev, B. Benzidane, H. Yasui, P.G. Betta, M. Sanon, J. Mizusawa, M. Hou, H. Pan, Y. Osaki, Darren Sigal, E. Schott, J. Rodriguez, E. Wöll, S. Nakamori, Anthony F. Shields, Yasuo Ohashi, M. Raikou, M.W. Bennett, Zhilong Zhao, G. Colucci, R. Stauber, M. Nakamura, T. Nguyen, Xin Li, C. Greco, K. Hanazaki, C. Mao, Y. Matsumura, S. Emoto, Maristella Bianconi, Yoon Ho Ko, E. Trusilova, J. Coombs, H. Iwase, V.A. Gorbunova, M. Lencioni, M. Svrcek, S. Leo, Mahmoud Ellithy, N. Silvestris, Y.H. Min, N. Urata, A. Sainato, K. Yoshimura, U. Boggi, D.C. Huang, T. Tsuzuki, S.H. Hong, K. Ikeda, Mohammed Shaker, Olivier Turrini, Arsene-Bienvenu Loembe, Jaffer A. Ajani, G. Pelletier, Stefano Cascinu, F. Bergamo, I.T. Unek, T. Di Palma, H. Li, Maria Lamar, H. Inagaki, M. Ratti, M. Iida, F. Pons Valladares, S. Caponi, A. Sa-Cunha, A. Passardi, J. Wei, S. Azevedo, W. Wang, S. Luelmo, M. Brighenti, A. Mezlini, Y. Zheng, S. Reddy, M. Milella, S. Nered, D. Li, Carsten Bokemeyer, Manabu Muto, C. Krüger, X.J. Sun, T. Ueno, M. Harrison, F. Cognetti, Y. Kida, M. Kobayashi, S. Akamaru, G. Leonard, Y. Inaba, A. Jayaram, Özgür Ekinci, Y. Bai, F. Subtil, Wasaburo Koizumi, M.A. Fridrik, Pierre Michel, R.C. Turkington, D. Galun, N. De Lio, A. Le Cesne, L. Toppo, Thorsten Füreder, R. Poli, V. Moiseyenko, Jean-Louis Jouve, Y. Lu, A. Babaev, N. Okumura, Isamu Okamoto, G.C. Ruiz, I. Oztop, T. Isobe, W. Fischbach, A. Takashima, Alessandro Bittoni, Y-C Chang, K. Yamaguchi, Vincent J. Picozzi, K. Muro, M. Sebagh, Y. Shindo, S. Beghelli, M. Skoblar Vidmar, Alessandra Mandolesi, M. Reni, K. Nishikawa, Marine Gilabert, Y. Maeda, Francesco Massari, E.B. Ruiz, K. Pan, H. Lou, H.S. Won, C. Diaz, J.P. O'Brien, Shuichi Kaneko, C. Gomez-Martin, J. Sgouros, A. Funakoshi, W. Figg, F. Chai, M.S. Pino, X. Pivot, K. Anvari, J. Turnes, M. Reif, F. Lopez-Rios, W. Cheung, David P. Ryan, M. Oka, I. Varthalitis, A. Deptala, Masatoshi Kudo, F. Romeder, J. Qian, J. Hihara, T. Shibata, T. Yamatsuji, B. Gonzalez-Astorga, B. Allani, Y. Tsuji, J. Liu, Thomas Yau, S. Lim, F. Grosso, Y.D. Zheng, R. Passalacqua, J. Chen, I. Sperduti, H. C. Kwon, C. Cappelli, C. Guettier, O. Nematov, Lanjun Zhou, C. Caparello, F. Bonnetain, R. Ferrara, A. Nashimoto, A. Schumann, Richard Martin Bambury, C. Mazzara, T. Aramaki, B. Saracino, M. Takagi, G. Di Lucca, Philip A. Philip, A. Aloui, Philippe Bachellier, N. Hirabayashi, S. Osanto, S. So, N. Fukushima, K.-H. Yeh, Y. Aoki, M. Baretti, Y-L. Gong, Koichiro Yamakado, C.-H. Hsu, R. Buder, D.G. Power, H. Matsumoto, Chiara Costantini, Y. Xu, G. Tomasello, A. Lopez Pousa, D.K. Lee, F. Di Fiore, O. Polat, K. Suzuki, L. Arbea, R. McDermott, S.-H. Kim, E. Toure, O. Bouche, A. Zaanan, T. Hamaguchi, Mary Geitona, M.H. Tan, M. Antonietti, Italo Bearzi, Juan W. Valle, D. Castaing, H. Shoji, Eylem Pınar Eser, Mario Scartozzi, R. Abdul Rahman, Yukinori Kurokawa, F. Pardo, T. Sasatomi, Y. Kimura, Suguru Yamada, K. El Ouagari, F. Mosca, Yuichiro Doki, A.O. Singh, Goro Nakayama, Lara Lipton, H.J. An, B. Kato, Y. Ezoe, M. Salem, Samantha Bersani, B. Paule, O.E. Carranza Rua, Gabriela Kornek, L. Gray, S. Tamura, J.-F. Blanc, and L. Ginocchi

Subjects
medicine.medical_specialty, Gastrointestinal tumors, Performance status, business.industry, Hematology, Severe hypoxia, Neutropenia, medicine.disease, Rash, Gastroenterology, Discontinuation, Non colorectal, Oncology, Internal medicine, Toxicity, medicine, medicine.symptom, business
Abstract

Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G + T arm. The primary efficacy endpoint was a comparison of progression-free survival (PFS) between the combination arms and G alone (80% power to detect 50% improvement in PFS with one-sided alpha of 10%). Summary PFS outcome has previously been reported; more detailed PFS as well as the initial overall survival (OS) data are presented. Results 214 pts were treated; 164 (77%) Stage IV and 50 (23%) Stage IIIB. Median age 65 (range 29-86); 126 M/88 F; 40% ECOG 0/60% ECOG 1. Receiving 6 or more cycles: 32% G; 45% G + T240; 55% G + T340. Median PFS was 3.6 mo in G vs 5.5 mo in G + T240 (p = 0.031) and 6.0 mo in G + T340 (p = 0.008). Poorer prognostic factors (older age, poorer performance status, reduced albumin) were associated with larger treatment effect. Median OS was 7.0 mo in G vs 9.0 in G + T240 and 9.5 mo in G + T340. RECIST best response was 12% in G vs 17% in G + T240 and 27% in G + T340. CA19-9 decreases were significantly greater G + T340. A >50% CA19-9 decrease was 52% with G vs 50% with G + T240 and 70% with G + T340. AEs leading to discontinuation were: 16% G, 15% G + T240 and 11% G + T340. Rash (45% in G + T340) and stomatitis (36% in G + T340) were greater in combination, 4 pts Grade 3 rash. Grd 3/4 thrombocytopenia were 11% G, 39% G + T240 and 59% G + T340 and Grd 3/4 neutropenia were 28% G, 56% G + T240 and 59% G + T340. Conclusions The combination of G plus TH-302 improved the efficacy of G. A TH-302 dose of 340 mg2 was identified for future studies. Skin and mucosal toxicity and myelosuppression were the most common TH-302 related AEs with no increase in treatment discontinuation. Disclosure All authors have declared no conflicts of interest.

Published
2012
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7. Intensive chemotherapy with recombinant-human granulocyte-macrophage colony stimulating factor (r-hu-gm-csf) for small cell lung cancer (sclc): a pilot study

Author

Magda Marcatti, A. Borri, C. Besana, E. Bucci, Giovanni Citterio, Claudio Rugarli, F. Inversi, S. Tognella, Consuelo Corti, G. Di Lucca, and Moreno Tresoldi

Subjects
Oncology, medicine.medical_specialty, Ifosfamide, business.industry, medicine.medical_treatment, Hematopoietic growth factor, Neutropenia, medicine.disease, Chemotherapy regimen, Carboplatin, Radiation therapy, chemistry.chemical_compound, Granulocyte macrophage colony-stimulating factor, chemistry, Internal medicine, Immunology, Toxicity, medicine, business, medicine.drug
Abstract

Systemic chemotherapy is the treatment of choice for patients with small cell lung cancer (sclc), Myelosuppression is the limiting toxicity related to most comnbination regimens in sclc, inducing substantial morbidity, frequent dose reductions, and delay in administrating subsequent cycles. Vp-16, Ifosfamide and Carboplatin are all highly active as single agents against sclc, with a ramge of objective response between 60 % and 75 %, A combination of these 3 drugs (with concurrent chest radiotherapy) showed impressive activity) > 90 % objective response rate) in a previous report by another group (Smith, 1990), at the cost of a 100 % incidence of grade III-IV neutropenia, with 7 % therapyrelated deaths and dose reductions required for 72 % of patients. The association of recombinant human granolocyte-macrophage colony stimulating factor (r-hu-gm-csf) to a chemotherapy regimen consisting of Carboplatin and Vp-16 could allow higher doses of cytotoxic drugs to be given, possibly resulting in much higher complete response rates, even in extended disease (Morstyn, 1989). Basing on these data, we designed a pilot study on the association of r-hu-gm-csf to intensive chemotherapy.

Published
1994
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8. Treatment of advanced renal cell cancer with sequential intravenous recombinant interleukin-2 and subcutaneous alpha-interferon

Author

C. Rugarli, A. Borri, E. Ghislandi, G. Landonio, G. Citterio, P. Matteucci, C. Fortis, M. Tresoldi, S. Tognella, C. Baiocchi, C. Besana, E. Bucci, and G. Di Lucca

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Time Factors, Alpha interferon, Gastroenterology, Subcutaneous injection, Oliguria, Internal medicine, medicine, Humans, Carcinoma, Renal Cell, Interferon alfa, Aged, Cardiotoxicity, business.industry, Remission Induction, Interferon-alpha, Heart, Middle Aged, Kidney Neoplasms, Recombinant Proteins, Surgery, Regimen, Treatment Outcome, Oncology, Toxicity, Interleukin-2, Female, medicine.symptom, business, Intramuscular injection, medicine.drug
Abstract

Starting from in vitro studies suggesting synergistic antitumour activity against renal cell ceancer (RCC) of recombinant interleukin-2 (rIL-2) and α-interferon (IFN), a phase II trial was initiated to test the clinical activity of this combination. The two cytokines were administered sequentially, with the aim of reducing the risk of additive toxicity and enhancing the immunological reaction against the tumour. The original treatment schedule consisted of rIL-2 18 × 10 6 U/m 2 /day by continuous intravenous infusion for 120 h days 1–5, and α-IFN 2b, at a flat dose of 9 sx 10 6 U by subcutaneous or intramuscular injection thrice in a week, from day 8 to 28. Treatment was planned to be continued for six or more 28-day cycles, depending on clinical response. 12 patients were treated according to this schedule; as some cardiovascular toxicity was experienced in this set of patients, 11 further patients were treated with half-dose rIL-2 (i.e. 9 × 10 6 U/m 2 /day). 17 out of 23 enrolled patients completed at least one cycle of treatment and were evaluated for response. We observed six major responses [one complete response (CR) + five partial responses (PR)] for an objective response rate of 35% [95% confidence interval (CI) 17–59%]. 5 additional patients achieved stabilisation of disease; one of them reached CR after surgical extirpation of a lung mass. Sites of response included lung, nodes and bone. Duration of response is 12+ months for CR; 17, 16, 12+, 9 and 9 months for PRs. Median survival is 16 months. Response was not significantly different between full-dose and half-dose rIL-2. Considering stable disease (SD) as responses, there seemed to be a higher chance of response for patients with smaller tumour burden ( P = 0.032). The toxicity of rIL-2 treatment, mainly cardiovascular, was substantial; 9 patients experienced severe cardiotoxicity, consisting of major arrhythmias, myocardial ischaemia, reduction of ejection fraction measured with heart radionuclide scan, and were excluded from continuing treatment. Other rIL-2-related toxicities forcing exclusion from the study were severe thrombocytopenia (1 case), and generalised exfoliative dermatitis requiring steroids (1 case). Otherwise, treatment was well tolerated; rIL-2-related toxicities promptly recovered after rIL-2 discontinuation in the majority of cases, and no treatment-related deaths were reported. The half-dose rIL-2 regimen was significantly less toxic in terms of hypotension ( P = 0.014), fever ( P = 0.014), oliguria ( P = 0.042), serum creatinine elevation ( P = 0.009) and prothrombin time elongation ( P = 0.038). α-IFN was not related to major toxicities. We conclude that the sequential administration of rIL-2 by continuous intravenous infusion and α-IFN by intramuscular or subcutaneous injection following our treatment schedule is feasible and active in RCC. Recombinant IL-2 9 × 10 6 U/m 2 /day seems to be equally effective and less toxic than 18 × 10 6 U/m 2 /day. However, cardiovascular toxicity remains a major problem; particularly, arrhythmias and ischaemic events are poorly predictable and preventable.

Published
1994

9. Autoimmune thyroiditis following interleukin-2 and LAK cell therapy for metastatic renal cell carcinoma: correlation with tumor regression

Author

Consuelo Corti, Silvia Heltai, Claudio Rugarli, Magda Marcatti, Carlo Besana, Marco Foppoli, Maria Grazia Sabbadini, and G. Di Lucca

Subjects
Interleukin 2, endocrine system, Cancer Research, endocrine system diseases, medicine.medical_treatment, Immunotherapy, Adoptive, Thyroiditis, 030218 nuclear medicine & medical imaging, Autoimmune thyroiditis, 03 medical and health sciences, 0302 clinical medicine, Renal cell carcinoma, Carcinoma, Medicine, Humans, Neoplasm Metastasis, Killer Cells, Lymphokine-Activated, Carcinoma, Renal Cell, Lymphokine-activated killer cell, business.industry, Thyroid, Histocompatibility Antigens Class II, Thyroiditis, Autoimmune, General Medicine, Immunotherapy, medicine.disease, Kidney Neoplasms, Recombinant Proteins, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Immunology, Cancer research, Interleukin-2, business, medicine.drug
Abstract

A 63-year-old woman receiving recombinant interleukin-2 (rlL-2) + lymphokine activated killer cells for metastatic renal cell carcinoma developed autoimmune thyroiditis with clinical hypothyroidism and high titer anti-thyroglobulin and anti-microsomal antibodies. The onset of thyroid dysfunction was associated with tumor regression and resulted in complete response at the end of the treatment. Cytologic and cytofluorimetric studies on thyroid tissue showed two distinct populations, mainly consisting of small lymphocytes and large thyrocytes, and the latter expressed MHC class II antigens. After completion of rlL-2 treatment, hypothyroidism gradually decreased until resolution; complete tumor remission lasted 18 months. Mechanisms underlying the association between autoimmune thyroiditis and cancer regression are discussed.

Published
1991

10. 580 Assessment of interleukin-2-induced cardiovascular toxicity by cardiac echocardiography

Author

E. Rossetti, Giovanni Citterio, Claudio Rugarli, Ugo Scaglietti, G. Di Lucca, S.E. Chierchia, Moreno Tresoldi, and Gabriele Fragasso

Subjects
Cardiovascular toxicity, Interleukin 2, Cancer Research, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Melanoma, Treatment withdrawal, Physical examination, medicine.disease, Discontinuation, Oncology, Internal medicine, Anesthesia, Toxicity, medicine, Cardiology, Cell cancer, business, medicine.drug
Abstract

Cardiovascular toxicity related to i. v. administration of Interleukin2 (IL-2) is the main cause of treatment withdrawal and it is unpredictable on the base of standard pre-treatment evaluations including history, physical examination and EKG. We performed this study to investigate the value of Cardiac Ultra Sono Scan (CUSS) in the detection and prediction of such toxicity. The study included 19 patients (15 males, 4 females, median age: 51, tumor type: 10 advanced renal cell cancer, 9 malignant melanoma) scheduled to receive multiple cycles of IL-2 by continuous i. v. infusion at the dose of 18 MIU/m 2 /day for 96 hours. Data were recorded from 31 IL-2 infusions: a marked impairment of diastolic function was observed in all cases, but in a subset of cycles (12/31) this function was already impaired at the pre-treatment determination, and this was significantly correlated with the onset of major cardiovascular side-effects conditioning treatment discontinuation ( P P

Published
1995
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11. A phase II study of continuous intravenous infusion (CIVI) recombinant IL-2 and subcutaneous α-interferon by sequential administration in advanced renal cell cancer

Author

E. Ghislandi, A. Borri, G. Landonio, Giovanni Citterio, C. Besana, G. Di Lucca, C. Baiocchi, Moreno Tresoldi, Claudio Rugarli, E. Bucci, Claudio Fortis, and B Brando

Subjects
Cancer Research, medicine.medical_specialty, α interferon, business.industry, Phases of clinical research, Pharmacology, law.invention, Oncology, law, Recombinant DNA, Medicine, Cell cancer, business, Intensive care medicine
Published
1993
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12. A single-centre experience with continuous intravenous infusion of recombinant interleukin-2 ± lak cells in metastatic renal cell cancer

Author

E. Bucci, G. Di Lucca, Elisabetta Ferrero, A Schönheit, Magda Marcatti, Giovanni Citterio, Giuseppe Consogno, Claudio Rugarli, Marco Foppoli, Consuelo Corti, C. Besana, Moreno Tresoldi, A. Borri, and Claudio Fortis

Subjects
Cancer Research, medicine.medical_specialty, Single centre, Lymphokine-activated killer cell, Oncology, business.industry, medicine, Recombinant interleukin-2, Cancer research, business, Metastatic renal cell cancer, Surgery
Published
1993
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