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1. Safety and efficacy of sunitinib in patients from Italy with metastatic renal cell carcinoma: final results from an expanded-access trial

Author

E. Fea, Kolette D. Fly, Davide Tassinari, Umberto Basso, Ke Zhang, Fabio Calabrò, Donatello Gasparro, Roberto Labianca, Giacomo Cartenì, Giovanni Lo Re, Enzo Maria Ruggeri, Libero Ciuffreda, Cristina Masini, Camillo Porta, Andrea Bonetti, Sergio Bracarda, Cora N. Sternberg, Subramanian Hariharan, Giampietro Gasparini, Vittorio Ferrari, and Barbara Capaccetti

Subjects
Oncology, Compassionate Use Trials, Male, Cancer Research, Indoles, Kaplan-Meier Estimate, urologic and male genital diseases, Renal cell carcinoma, Sunitinib, Incidence, Anemia, General Medicine, Middle Aged, female genital diseases and pregnancy complications, Kidney Neoplasms, Treatment Outcome, Italy, Hypertension, Female, medicine.drug, Adult, Diarrhea, medicine.medical_specialty, Neutropenia, education, Antineoplastic Agents, Dysgeusia, Disease-Free Survival, Drug Administration Schedule, Internal medicine, medicine, Carcinoma, Humans, In patient, Pyrroles, Carcinoma, Renal Cell, Aged, Stomatitis, business.industry, Expanded access trial, Leukopenia, Sunitinib malate, medicine.disease, Thrombocytopenia, Clinical trial, Asthenia, business, Follow-Up Studies
Abstract

Objectives: Patients with metastatic renal cell carcinoma (mRCC) received sunitinib in a global expanded-access program (EAP). Here, we report the efficacy and safety results for the EAP subpopulation in Italy. Methods: Patients ≥18 years old with previously treated or treatment-naïve mRCC received oral sunitinib 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors). Safety was regularly assessed. Results: A total of 521 patients participated, including 40% aged ≥65 years, 11% with an Eastern Cooperative Oncology Group performance status ≥2, 14% with non-clear cell RCC, and 11% with brain metastases. The median treatment duration and posttreatment follow-up were 7.4 and 12.3 months, respectively. The objective response rate was 12%, and the median progression-free and overall survival was 9.1 and 27.2 months, respectively. 514 patients (99%) discontinued treatment; reasons included death (17%), nonresponse (46%), or adverse events (AEs; 13%). The most common any-grade treatment-related AEs were asthenia (44%, plus 15% reporting fatigue), thrombocytopenia and stomatitis (both 37%), diarrhea (36%), mucosal inflammation (29%), hypertension (26%), and dysgeusia (25%). The most common grade 3/4 treatment-related AEs were thrombocytopenia (10%), asthenia (9%, plus 3% reporting fatigue), neutropenia, stomatitis (both 6%), and hypertension (5%). Conclusion: In a large population of Italian mRCC patients, sunitinib had a manageable safety profile and encouraging efficacy.

Published
2014

2. Subject Index Vol. 71, 2006

Author

Maurizio Bifulco, Inés de Torres, Lara Maria Pasetto, G. Ascione, Bruno Costa, Aziz Karaoglu, Graziella Pinotti, Francesco Perrone, Yoshihiko Maehara, Giovanni Marini, Hai-Rong Wang, J.-M. Ferrero, Deling Yin, V. Georgoulias, Ramya Varadarajan, Roberto Bordonaro, Federica Papi, B. Navalpotro, Eiko Yamamoto, S. Agelaki, Jordi Giralt, Yasuhiro Ito, Daniela Massi, E. Chamorey, Tsunehiro Oyama, Gabriella Ferrandina, Roberto Buzzoni, N. Vardakis, Roberto Sorio, Nancy Watroba, Bagi R. Janarthanan, L. Frigerio, I. Raoust, S. Zonato, Huaiping Wang, Yogeshwer Shukla, Hideyuki Murata, Santiago Ramón y Cajal, Akira Miyauchi, Sandro Barni, Enrico Aitini, Roberto Labianca, Jihnhee Yu, Giulia Lo Russo, Paolo Scollo, Dionyssios Katsaros, Makoto Kammori, Madhulika Singh, Toru Tase, Motoki Nagata, M. Lallement, N. Kentepozidis, Kiyosumi Shibata, M. Takenoyama, F. Ettore, Michela Ballardini, Toru Takano, Laura Cerezo, Menotti Calvani, Pierfranco Conte, Tadao Takano, Takeshi Hanagiri, Sandro Pignata, Salvatore Palazzo, Giampietro Gasparini, Steven S.S. Poon, Giovanna Scarfone, C. Chapellier, Satoru Iida, Hiroaki Kajiyama, Genny Leporatti, Maurie Markman, D. Marussi, Ren-Rong OuYang, Fang-Yuan Chen, Hiroyuki Tsuji, Rossella Lauria, A. Karampeazis, Serena Sestini, Chun-Hong Gu, Eduardo Hermosilla, Stephen B. Edge, Valter Torri, Maria Di Bartolomeo, Yongping Cai, Torello Lotti, Seiji Nomura, L. Uziel, G. Favalli, Yo-ichi Yamashita, Franco Odicino, Hideki Tokunaga, Junko Aida, Neetu Kalra, Luigi Dogliotti, S. Oldani, D. Ferrari, Akihiro Nawa, V. Reyes, Alessandra Vernaglia Lombardi, A. Luciani, Manuel de las Heras, Giuseppe Schieppati, Yosuke Kuroda, Kosei Yasumoto, Marina Cazzaniga, Giuseppe Comella, Luigi Selvaggi, Benedetta D'Attoma, Koichi Tomoda, Manel Armengol, Emilio Bajetta, Yuhua Zhang, Mikio Terauchi, Liliana Mereu, E. Papadimitraki, Antonella Orlando, Arpine Gevorgyan, Erkan Topkan, Toshio Yamashita, Erminia Ferrario, D. Mavroudis, Sahdeo Prasad, Shinji Itoh, Rie Kurabayashi, Yuichi Wada, Luigi Manzione, Kazuhiko Ino, Fumitaka Kikkawa, Mario Dini, Hidekazu Yamada, L. Vamvakas, Antonio Ardizzoia, Hua Zhong, Toshiya Inoue, Naotaka Izumiyama, Kiyoshi Ito, Enrico Breda, Giovanna Magni, I. Peyrottes, Nobuo Yaegashi, Yoko Takagi, Vincenzo De Giorgi, Hiroyuki Uetake, Silvana Chiara, Jian-Yi Zhu, Yuzo Shimode, Hironobu Sasano, Kenji Nagata, Jun Ichi Akahira, Donato F. Altomare, Akira Sato, Dotti Katia, Kenichi Sugihara, Ryuji Ohta, Satoyo Hosono, Hisaya Yukawa, A. Courdi, I. Gioulbasanis, Keiji Kato, Sergi Benavente, Kosuke Yoshinaga, Bruno Massidda, Uma Singh, Kenji Sugio, C. Balu-Maestro, Hitoshi Niikura, S. Caldiera, Xiaofang Zhang, Salvatore Tumolo, Anna Maria Bochicchio, E. Espin, Stefano Cascinu, Dai Kitagawa, Gengyin Zhou, Shinji Morita, Luigi Mariani, Giovanna Marforio, Akinobu Taketomi, Giovanni Cicero, Mitsuhiko Kashio, Maria Gabriella Caruso, Fulan Wei, Ken-ichi Nakamura, Jie-Yin Han, Nicoletta Zilembo, Fabio Ghezzi, Masafumi Toyoshima, Michio Kaminishi, Takayoshi Kiba, Tadahiro Nozoe, Shinichi Aishima, Satoru Nagase, R. Largillier, P. Foa, M. Ignatiadis, and Maria Notarnicola

Subjects
Cancer Research, Index (economics), Oncology, Statistics, Subject (documents), General Medicine, Mathematics
Published
2006
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3. Contents Vol. 71, 2006

Author

Roberto Buzzoni, Bagi R. Janarthanan, A. Luciani, Manuel de las Heras, Eiko Yamamoto, Roberto Sorio, Nancy Watroba, Genny Leporatti, Makoto Kammori, D. Marussi, Koichi Tomoda, Uma Singh, Yosuke Kuroda, I. Raoust, A. Karampeazis, Yongping Cai, Hiroyuki Tsuji, G. Ascione, Takeshi Hanagiri, Chun-Hong Gu, Eduardo Hermosilla, Valter Torri, G. Favalli, S. Oldani, Luigi Selvaggi, Toru Takano, Laura Cerezo, Motoki Nagata, Kenji Sugio, C. Balu-Maestro, Vincenzo De Giorgi, Yoshihiko Maehara, Deling Yin, Giovanni Marini, Toshiya Inoue, J.-M. Ferrero, M. Lallement, Tsunehiro Oyama, Kiyoshi Ito, Santiago Ramón y Cajal, Gabriella Ferrandina, N. Kentepozidis, Toru Tase, N. Vardakis, C. Chapellier, Ramya Varadarajan, B. Navalpotro, Akihiro Nawa, V. Georgoulias, Dionyssios Katsaros, Kosei Yasumoto, Akira Sato, Dotti Katia, Michio Kaminishi, M. Takenoyama, F. Ettore, Menotti Calvani, Huaiping Wang, Satoru Iida, Hiroaki Kajiyama, Fang-Yuan Chen, Jihnhee Yu, Maurie Markman, Akira Miyauchi, Sandro Barni, Seiji Nomura, Pierfranco Conte, Paolo Scollo, Liliana Mereu, Madhulika Singh, E. Papadimitraki, S. Caldiera, V. Reyes, Alessandra Vernaglia Lombardi, Benedetta D'Attoma, Satoru Nagase, Maria Di Bartolomeo, Ren-Rong OuYang, L. Frigerio, E. Chamorey, Giovanna Magni, S. Zonato, Antonella Orlando, Rossella Lauria, I. Peyrottes, Maria Gabriella Caruso, Yogeshwer Shukla, Jie-Yin Han, Luigi Manzione, Mario Dini, Hiroyuki Uetake, Nobuo Yaegashi, Nicoletta Zilembo, Keiji Kato, Steven S.S. Poon, Giovanna Scarfone, L. Vamvakas, Toshio Yamashita, Shinji Itoh, Rie Kurabayashi, Yuichi Wada, Jian-Yi Zhu, Stephen B. Edge, L. Uziel, Sergi Benavente, Fumitaka Kikkawa, Hidekazu Yamada, S. Agelaki, Tadao Takano, Kenichi Sugihara, Roberto Labianca, Giulia Lo Russo, Neetu Kalra, Giuseppe Schieppati, Erminia Ferrario, Hideyuki Murata, Torello Lotti, Marina Cazzaniga, Giuseppe Comella, I. Gioulbasanis, Silvana Chiara, Michela Ballardini, Yuzo Shimode, Kosuke Yoshinaga, Bruno Massidda, Hironobu Sasano, Junko Aida, Serena Sestini, Roberto Bordonaro, Luigi Dogliotti, D. Mavroudis, Yoko Takagi, Franco Odicino, Mikio Terauchi, Jun Ichi Akahira, Manel Armengol, Ryuji Ohta, Sandro Pignata, Kenji Nagata, Federica Papi, Enrico Aitini, Jordi Giralt, Hideki Tokunaga, Arpine Gevorgyan, Kazuhiko Ino, Satoyo Hosono, Hisaya Yukawa, A. Courdi, Akinobu Taketomi, Hua Zhong, Bruno Costa, Giovanni Cicero, Mitsuhiko Kashio, Maria Notarnicola, Ken-ichi Nakamura, Maurizio Bifulco, Donato F. Altomare, Fabio Ghezzi, Masafumi Toyoshima, Dai Kitagawa, Inés de Torres, Lara Maria Pasetto, Enrico Breda, Gengyin Zhou, Graziella Pinotti, Luigi Mariani, Giovanna Marforio, Salvatore Palazzo, Giampietro Gasparini, M. Ignatiadis, Tadahiro Nozoe, Shinichi Aishima, Takayoshi Kiba, Erkan Topkan, Sahdeo Prasad, Aziz Karaoglu, R. Largillier, P. Foa, Fulan Wei, Yasuhiro Ito, Antonio Ardizzoia, Naotaka Izumiyama, Salvatore Tumolo, Kiyosumi Shibata, Anna Maria Bochicchio, E. Espin, Stefano Cascinu, Yo-ichi Yamashita, Hitoshi Niikura, Hai-Rong Wang, D. Ferrari, Daniela Massi, Xiaofang Zhang, Emilio Bajetta, Yuhua Zhang, Shinji Morita, and Francesco Perrone

Subjects
Cancer Research, Oncology, General Medicine
Published
2006
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4. The role of 5-fluorouracil (5-FU) reintroduction with irinotecan or oxaliplatin in truly 5-FU-refractory advanced colorectal cancer patients

Author

A. Zaniboni, Mario Scartozzi, Francesco Graziano, Roberto Labianca, Giampietro Gasparini, Vincenzo Catalano, Giordano D. Beretta, Rossana Berardi, Sandro Barni, Alberto Sobrero, and Stefano Cascinu

Subjects
Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Antimetabolites, Antineoplastic, Organoplatinum Compounds, Colorectal cancer, medicine.drug_class, medicine.medical_treatment, Irinotecan, Thymidylate synthase, Antimetabolite, Drug Administration Schedule, health services administration, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, neoplasms, Aged, Retrospective Studies, Chemotherapy, biology, business.industry, General Medicine, Middle Aged, medicine.disease, digestive system diseases, Oxaliplatin, stomatognathic diseases, Treatment Outcome, Fluorouracil, Drug Resistance, Neoplasm, biology.protein, Disease Progression, Camptothecin, Female, business, Colorectal Neoplasms, therapeutics, Progressive disease, medicine.drug
Abstract

Objectives: Although several evidences have demonstrated a synergistic activity of 5-fluorouracil with irinotecan and oxaliplatin, thus explaining the use of this drug combination in the first-line treatment of advanced colorectal cancer, the need for the reintroduction of 5-FU in the second-line setting is more questionable. Methods: We retrospectively evaluated the outcome of patients developing progressive disease while on an infusional 5-FU-based front-line chemotherapy and subsequently treated with one of the four following chemotherapy regimens: irinotecan, oxaliplatin and irinotecan or oxaliplatin both combined with the de Gramont schedule (LV5-FU2). Results: 225 patients (137 males and 88 females), were eligible for analysis. Second-line chemotherapy consisted of irinotecan in 79 patients (35%, group A), oxaliplatin in 47 patients (21%, group B), irinotecan with LV5-FU2 in 53 patients (24%, group C) and oxaliplatin with LV5-FU2 in the remaining 46 cases (20%, group D). The response rate to second-line chemotherapy was obtained in 6/79 patients (8%) in group A, in 4/47 patients (9%) in group B, in 11/53 patients (21%) in group C and in 10/46 patients (22%) in group D (p = 0.04). Conclusions: These data suggest that reintroduction of 5-FU could increase irinotecan and oxaliplatin activity in patients progressing during a 5-FU-based first-line chemotherapy.

Published
2004

5. Gastrointestinal stromal tumors: should they be treated with the same systemic chemotherapy as other soft tissue sarcomas?

Author

Mauro Antimi, Paolo G. Casali, Gaetano Apice, Salvatore Toma, Guido Biasco, Tommaso De Pas, Filippo de Braud, Antonella Romanini, Bruno Massidda, Roberto Labianca, Christian Massacesi, A. Tucci, Massimo Aglietta, and Alessandro Comandone

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Pathology, Stromal cell, Antibiotics, Antineoplastic, business.industry, Systemic chemotherapy, Soft tissue, Sarcoma, General Medicine, Survival Analysis, Treatment Outcome, Italy, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Ifosfamide, Stromal Cells, business, Gastrointestinal Neoplasms, Retrospective Studies
Published
2003

6. Retraction Statement. Paper by Takai et al.: Oncology 2006;70:97-105, (DOI: 10.1159/000092585)

Author

E. Fea, Yoshihiro Matsuno, Yuka Kobayashi, Armand Bensussan, Hervé Curé, Chikara Kunisaki, Utano Tomaru, Sergio Bracarda, Donatello Gasparro, Hirotoshi Akiyama, Satz Mengensatzproduktion, Qian Wang-Lopez, Keiichi Kubota, Florence A. Plaza, Camillo Porta, Fabrice Kwiatkowski, Barbara Capaccetti, Vittorio Ferrari, Anthony Fields, Kichizo Kaga, Hirochika Makino, Ryo Takagawa, Rio Honma, Bruce Reeder, Jun Kimura, Itaru Endo, Satoshi Takeuchi, Ken-ichi Inoue, Giovanni Lo Re, Adnan Zaidi, Umberto Basso, Subramanian Hariharan, Shahid Ahmed, Hidetaka Ono, Kolette D. Fly, Yasushi Shimizu, Catherine Abrial, Kazumi Akimoto, Davide Tassinari, Nayyer Iqbal, Takashi Kosaka, Norisuke Shibuya, Giacomo Cartenì, Genki Tanaka, Mitsuyoshi Ota, Tong Zhu, Paul de Boissieu, Andrea Bonetti, Ke Zhang, Giampietro Gasparini, Ichiro Kinoshita, Sarah Mombelli, Enzo Maria Ruggeri, Eiji Miyoshi, Cristina Masini, Fabio Calabrò, Roberto Labianca, Naoyuki Taniguchi, Cora N. Sternberg, Hirotoshi Dosaka-Akita, Anne Leis, Druckerei Stückle, Amane Kanazawa, Selliah Chandra-Kanthan, Christian Garbar, Punam Pahwa, and Libero Ciuffreda

Subjects
Cancer Research, Pathology, medicine.medical_specialty, Oncology, business.industry, Statement (logic), Family medicine, Medicine, General Medicine, business
Published
2015
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7. A cisplatinum-cyclophosphamide regimen in advanced ovarian cancer: reporting 5-year results

Author

M. Vinci, G. Dallavalle, B. Cesana, M. Clerici, M.C. Locatelli, R. Carcione, G. Luporini, Roberto Labianca, C. Pasquinucci, and A. D’Antona

Subjects
Oncology, Adult, Cancer Research, medicine.medical_specialty, endocrine system diseases, Cyclophosphamide, medicine.medical_treatment, Ovary, Drug Administration Schedule, Metastasis, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Stage (cooking), Aged, Ovarian Neoplasms, Chemotherapy, Advanced ovarian cancer, business.industry, General Medicine, Middle Aged, medicine.disease, female genital diseases and pregnancy complications, Surgery, Regimen, medicine.anatomical_structure, Female, Cisplatin, Ovarian cancer, business, medicine.drug, Follow-Up Studies
Abstract

The following paper reports the evaluation of 53 consecutive patients with advanced ovarian epithelial carcinoma (FIGO stage III-IV), treated between October 1984 and December 1987 with immediate or delayed cytoreduction surgery and chemotherapy. Combination chemotherapy consisted of cisplatinum 45 mg/m2 i.v. for 2 consecutive days and cyclophosphamide 900 mg/m2 i.v. on the second day, administered every 28 days for a maximum of 8 courses. Objective responses were observed in 35 of 50 evaluable patients (70%), 17 (34%) of whom were pathological complete remissions (pCR). For patients with minimal residual disease before chemotherapy a higher pCR rate was achieved (10/20 vs. 7/30; p = N.S.). Median survival time of all patients was 29 months; subjects with minimal residual disease and good performance status before treatment had higher survival (48 vs. 22 months-p0.05 and 29 vs. 9 months-p0.05, respectively). Median time to progression was 25 months. After a median follow-up of 60 months, 15 (28%) patients were alive, 14 of whom disease-free. Toxicity was moderate with a particularly low incidence of nephrotoxicity and no case of serious long-lasting neuropathy. These findings suggest that the described combination has an efficacy comparable to other CDDP-containing combinations, using 2, 3 or more drugs, with a low incidence of acute serious toxicities and of disabling delayed sequelae.

Published
1993

8. Contents, Vol. 37, Supplement 1, 1980

Author

Claudio Praga, S. Kerpel-Fronius, Z. Mechl, Anton Roth, Abraham Goldin, M. Pavone-Macaluso, G. Turi, A.B. Syrkin, George Weber, E. Farkas, W. Arnold, I. Pályi, O. Csuka, E. Király, E. Institoris, E. Csányi, Lucilla Tedeschi, János Szántó, G.B. Ingargiola, T. Horváth, H. Naundorf, Ch. Nowak, László Kopper, L. Hegedüs, É. Gáti, Z. Matějovský, Roberto Labianca, István Bodrogi, Federico Spreafico, B. Töttössy, Ž. Maričić, S. Somfai-Relle, E. Mihich, A. Malíř, Paolo Fraschini, Dujmović I, Beretta G, J. Csetényi, J. Sugar, Krsto Kolarić, A.V. Kiselev, Tanneberger S, S. Eckhardt, I.P. Horváth, Karoly Lapis, I. Hindy, Hegedüs C, L. Holczinger, and G. Ringwald

Subjects
Cancer Research, Oncology, General Medicine
Published
1980
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9. Cardiac toxicity from antitumor therapy

Author

Gianni Beretta, Claudio Praga, and Roberto Labianca

Subjects
Cancer Research, business.industry, Clinical course, Antineoplastic Agents, Heart, General Medicine, Pharmacology, Bioinformatics, Antitumor therapy, Oncology, Doxorubicin, Cardiac toxicity, cardiovascular system, Medicine, Animals, Humans, business
Abstract

A review is made concerning cardiac toxicity from antitumor agents. The pattern, clinical course and fate of cardiac drug-related phenomena are considered. Special attention is drawn to new attempts to better understand, and possibly prevent, such a treatment limiting side-effect.

Published
1980

10. Epirubicin treatment of advanced breast carcinoma with the weekly low-dose regimen

Author

D. Tabiadon, Roberto Labianca, C Locatelli, Paolo Fraschini, G Luporini, and Gianni Beretta

Subjects
Oncology, Adult, Cancer Research, medicine.medical_specialty, Palliative care, Heart Diseases, Advanced breast, Breast Neoplasms, Drug Administration Schedule, Internal medicine, medicine, Carcinoma, Humans, Doxorubicin, Neoplasm Metastasis, Aged, Epirubicin, Response rate (survey), business.industry, Incidence (epidemiology), Palliative Care, General Medicine, Middle Aged, medicine.disease, Regimen, Female, business, medicine.drug
Abstract

Authors describe the results obtained with weekly low-dose (20 or 30 mg/total) of intravenous bolus epirubicin, used as second line chemotherapy, after CMF, in 29 advanced breast carcinoma patients. 29% objective response rate (1 complete + 6 partial responses) has been observed in 24 evaluable patients, with median response duration of 4 months (range 1-7+). The discrete response rate and the minimal incidence of side effects call for further studies and more extensive evaluation of epirubicin given alone or in combination through this new treatment schedule.

Published
1987

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