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Your search keyword '"Di Bartolomeo, M."' showing total 80 results
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80 results on '"Di Bartolomeo, M."'

1. Phase II study of capecitabine-based concomitant chemoradiation followed by durvalumab as a neoadjuvant strategy in locally advanced rectal cancer: the PANDORA trial

Author

Grassi, E., Zingaretti, C., Petracci, E., Corbelli, J., Papiani, G., Banchelli, I., Valli, I., Frassineti, G.L., Passardi, A., Di Bartolomeo, M., Pietrantonio, F., Gelsomino, F., Carandina, I., Banzi, M., Martella, L., Bonetti, A.V., Boccaccino, A., Molinari, C., Marisi, G., Ugolini, G., Nanni, O., and Tamberi, S.

Published
2023
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3. Impact of age and gender on the efficacy and safety of upfront therapy with panitumumab plus FOLFOX followed by panitumumab-based maintenance: a pre-specified subgroup analysis of the Valentino study

Author

Raimondi, A., Fucà, G., Leone, A.G., Lonardi, S., Antoniotti, C., Smiroldo, V., Amatu, A., Tampellini, M., Ritorto, G., Murialdo, R., Clavarezza, M., Zaniboni, A., Berenato, R., Ratti, M., Corallo, S., Morano, F., Di Bartolomeo, M., Di Maio, M., and Pietrantonio, F.

Published
2021
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8. RET fusions in a small subset of advanced colorectal cancers at risk of being neglected

Author

Pietrantonio, F., Di Nicolantonio, F., Schrock, A.B., Lee, J., Morano, F., Fucà, G., Nikolinakos, P., Drilon, A., Hechtman, J.F., Christiansen, J., Gowen, K., Frampton, G.M., Gasparini, P., Rossini, D., Gigliotti, C., Kim, S.T., Prisciandaro, M., Hodgson, J., Zaniboni, A., Chiu, V.K., Milione, M., Patel, R., Miller, V., Bardelli, A., Novara, L., Wang, L., Pupa, S.M., Sozzi, G., Ross, J., Di Bartolomeo, M., Bertotti, A., Ali, S., Trusolino, L., Falcone, A., de Braud, F., and Cremolini, C.

Published
2018
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11. Variant alleles in factor V, prothrombin, plasminogen activator inhibitor-1, methylenetetrahydrofolate reductase and risk of thromboembolism in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab

Author

Falvella, F S, Cremolini, C, Miceli, R, Nichetti, F, Cheli, S, Antoniotti, C, Infante, G, Martinetti, A, Marmorino, F, Sottotetti, E, Berenato, R, Caporale, M, Colombo, A, de Braud, F, Di Bartolomeo, M, Clementi, E, Loupakis, F, and Pietrantonio, F

Published
2017
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12. Bevacizumab treatment in the elderly patient with metastatic colorectal cancer

Author

Di Bartolomeo M, Maggi C, Ricchini F, Pietrantonio F, Iacovelli R, de Braud F, and Inno A

Subjects
bevacizumab, colorectal cancer, elderly, Geriatrics, RC952-954.6
Abstract

Maria Di Bartolomeo,1 Claudia Maggi,1 Francesca Ricchini,1 Filippo Pietrantonio,1 Roberto Iacovelli,1 Filippo de Braud,1 Alessandro Inno2 1Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, 2Department of Medical Oncology, Sacro Cuore-Don Calabria Hospital, Negrar, Italy Abstract: Metastatic colorectal cancer (mCRC), like many cancers, is primarily a disease of elderly people. Despite this prevalence, such patients are often excluded from randomized trials or represent a minority of enrolled patients. Moreover, the criteria for establishing benefit or side effects of treatment strategies in this population are uncertain and not well recognized. Bevacizumab improves the outcome of mCRC when used in combination with standard first-line and second-line chemotherapy and beyond the first disease progression when given with a chemotherapy backbone different from that used in the precedent line. The particular toxicity profile of this antiangiogenesis agent (in particular hypertension, thromboembolic events, hemorrhage, and renal failure) may discourage its use in elderly patients with comorbidities. Data from subgroup analyses of randomized trials and the results of recent cohort studies suggest a significant benefit from the addition of bevacizumab to standard chemotherapy for elderly patients comparable with that observed in younger patients, except for the increased risk for thromboembolic events. Age alone should not be a barrier to use of bevacizumab, and further research with a more complete geriatric assessment should investigate the role of bevacizumab in elderly patients with mCRC to avoid undertreatment of this patient population due to a ­historical conservative approach. Keywords: bevacizumab, elderly, metastatic colorectal cancer, antivascular treatment, review

Published
2015

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

Author

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

Published
2014
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15. In‐vivo evaluations of bone regenerative potential of two novel bioactive glasses.

Author

Anesi, A., Ferretti, M., Salvatori, R., Bellucci, D., Cavani, F., Di Bartolomeo, M., Palumbo, C., and Cannillo, V.

Abstract

Due to the aging of population, materials able to repair damaged tissues are needed. Among others, bioactive glasses (BGs) have attracted a lot of interest due to their outstanding properties both for hard and soft tissues. Here, for the first time, two new BGs, which gave very promising results in preliminary in vitro‐tests, were implanted in animals in order to evaluate their regenerative potential. The new BGs, named BGMS10 and Bio_MS and containing specific therapeutic ions, were produced in granules and implanted in rabbits' femurs for up to 60 days, to test their biocompatibility and osteoconduction. Additionally, granules of 45S5 Bioglass® were employed and used as a standard reference for comparison. The results showed that, after 30 days, the two novel BGs and 45S5 displayed a similar behavior, in terms of bone amount, thickness of new bone trabeculae and affinity index. On the contrary, after 60 days, 45S5 granules were mainly surrounded by wide and scattered bone trabeculae, separated by large amounts of soft tissue, while in BGMS10 and Bio_MS the trabeculae were thin and uniformly distributed around the BG granules. This latter scenario could be considered as more advantageous, since the features of the two novel BG granules allowed for the neo‐formation of a uniformly distributed bony trabeculae, predictive of more favorable mechanical behavior, compared to the less uniform coarse trabeculae, separated by large areas of soft tissue in 45S5 granules. Thus, BGMS10 and Bio_MS could be considered suitable products for tissue regeneration in the orthopedic and dental fields. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., 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., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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29. 1205MO Updated analysis of DESTINY-Gastric02: A phase II single-arm trial of trastuzumab deruxtecan (T-DXd) in western patients (Pts) with HER2-positive (HER2+) unresectable/metastatic gastric/gastroesophageal junction (GEJ) cancer who progressed on or after trastuzumab-containing regimen

Author

Ku, G.Y., Di Bartolomeo, M., Smyth, E., Chau, I., Park, H., Siena, S., Lonardi, S., Wainberg, Z.A., Ajani, J.A., Chao, J., Barlaskar, F., Kawaguchi, Y., Qin, A., Singh, J., Meinhardt, G., and Van Cutsem, E.

Subjects
*ESOPHAGOGASTRIC junction, *TRASTUZUMAB, *METASTASIS
Published
2022
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30. Lack of Bax expression is associated with irinotecan-based treatment activity in advanced colorectal cancer patients.

Author

Pietrantonio, F., Biondani, P., Milione, M., Melotti, F., Bertarelli, G., Perrone, F., de Braud, F., Mariani, L., Fanetti, G., Cortinovis, D., and Di Bartolomeo, M.

Abstract

Background: Currently, first-line chemotherapy in advanced colorectal cancer is not tailored on predictive biomarkers. Bax proapoptotic protein may correlate to chemosensitivity and differential response to irinotecan or oxaliplatin-based combinations. Methods: Bax expression was assessed by immunohistochemistry in 49 advanced colorectal cancer patients enrolled at our institution from 2002 to 2004 within a multicenter, phase II, randomized trial of first-line UFT/leucovorin/irinotecan (TEGAFIRI) versus UFT/leucovorin/oxaliplatin (TEGAFOX). Results: Bax-positive and negative samples were 49 and 51 %. Response was significantly lower in Bax positive (25 %) as compared to Bax negative (56 %) (Odds ratio = 0.26; p = 0.03). No significant difference was noted in TEGAFOX subgroup; in TEGAFIRI arm, responses were lower in Bax positive (18 %) than Bax negative (67 %) (Odds ratio = 0.11; p = 0.03). No difference in terms of progression-free and overall survival was observed according to Bax. Conclusion: Bax-negative colorectal cancer may identify a specific phenotype of patients with significantly higher chance to respond to doublet irinotecan-based chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2013
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31. Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomised phase II study.

Author

Bajetta, E., Di Bartolomeo, M., Buzzoni, R., Mariani, L., Zilembo, N., Ferrario, E., Lo Vullo, S., Aitini, E., Isa, L., Barone, C., Jacobelli, S., Recaldin, E., Pinotti, G., and Iop, A.

Subjects
*URACIL, *COLON cancer, *FOLINIC acid, *METASTASIS, *CANCER, *ANTINEOPLASTIC agents, *CAMPTOTHECIN, *COLON tumors, *COMPARATIVE studies, *FLUOROURACIL, *HETEROCYCLIC compounds, *RESEARCH methodology, *MEDICAL cooperation, *ORGANOPLATINUM compounds, *RESEARCH, *EVALUATION research, *RANDOMIZED controlled trials, RECTUM tumors
Abstract

This randomised phase II study evaluates the safety and efficacy profile of uracil/tegafur/leucovorin combined with irinotecan (TEGAFIRI) or with oxaliplatin (TEGAFOX). One hundred and forty-three patients with measurable, non-resectable metastatic colorectal cancer were randomised in a multicentre study to receive TEGAFIRI (UFT 250 mg m(-2) day days 1-14, LV 90 mg day days 1-14, irinotecan 240 mg m(-2) day 1; q21) or TEGAFOX (UFT 250 mg m(-2) day days 1-14, LV 90 mg day days 1-14, oxaliplatin 120 mg m(-2) day 1; q21). Among 143 randomised patients, 141 were analysed (68 received TEGAFIRI and 73 TEGAFOX). The main characteristics of the two arms were well balanced. The most common grade 3-4 treatment-related adverse events were neutropenia (13% of cases with TEGAFIRI; 1% in the TEGAFOX group). Diarrhoea was prevalent in the TEGAFIRI arm (16%) vs TEGAFOX (4%). Six complete remission (CR) and 19 partial remission (PR) were recorded in the TEGAFIRI arm (odds ratio (OR): 41.7; 95% confidence limit (CL), 29.1-55.1%), and six CR and 22 PR were recorded in the TEGAFOX group, (OR: 38.9; 95% CL, 27.6-51.1). At a median time follow-up of 17 months (intequartile (IQ) range 12-23), a median survival probability of 20 and 19 months was obtained in the TEGAFIRI and TEGAFOX groups, respectively. Median time to progression was 8 months for both groups. TEGAFIRI and TEGAFOX are both effective and tolerable first-line therapies in MCRC patients. The employment of UFT/LV given in doublet combination is interesting and the presented data appear comparable to equivalent infusion regimens described in the literature. The safety profile of the two combinations also allows an evaluation with other biological agents such as monoclonal antibodies. [ABSTRACT FROM AUTHOR]

Published
2007
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32. Chromogranin A, neuron specific enolase, carcinoembryonic antigen, and hydroxyindole acetic acid evaluation in patients with neuroendocrine tumors.

Author

Bajetta, Emilio, Ferrari, Leonardo, Martinetti, Antonia, Celio, Luigi, Procopio, Giuseppe, Artale, Salvatore, Zilembo, Nicoletta, Di Bartolomeo, Maria, Seregni, Ettore, Bombardieri, Emilio, Bajetta, E, Ferrari, L, Martinetti, A, Celio, L, Procopio, G, Artale, S, Zilembo, N, Di Bartolomeo, M, Seregni, E, and Bombardieri, E

Published
1999
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37. Randomized phase II noncomparative trial of oral and intravenous doxifluridine plus levo-leucovorin in untreated patients with advanced colorectal carcinoma.

Author

Bajetta, Emilio, Di Bartolomeo, Maria, Somma, Luisa, Moreschi, Monica, Comella, Giuseppe, Turci, Daniele, Gebbia, Vittorio, Scanni, Alberto, Bordogna, Gianni, Stampino, Corrado Gallo, Bajetta, E, Di Bartolomeo, M, Somma, L, Moreschi, M, Comella, G, Turci, D, Gebbia, V, Scanni, A, Bordogna, G, and Stampino, C G

Published
1996
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40. P.3.e.011 - Endocannabinoid system genes regulation in schizophrenia.

Author

Di Bartolomeo, M., Stark, T., Dell’Osso, B., Pucci, M., Ruda-Kucerova, J., Pekarik, V., Drago, F., Sulcova, A., Mechoulam, R., Altamura, A.C., Maccarrone, M., Micale, V., and D’Addario, C.

Subjects
*GENETIC regulation, *GENETICS of schizophrenia, *NEUROTRANSMITTERS, *GENE expression, *LABORATORY rats
Published
2016
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42. 1451P Neoadjuvant and adjuvant pembrolizumab (pembro) + chemotherapy (chemo) for locally advanced gastric or gastroesophageal junction (G/GEJ) cancer: Patient-reported outcomes (PROs) from the phase III KEYNOTE-585 study.

Author

Shitara, K., Rha, S.Y., Wyrwicz, L.S., Oshima, T., Karaseva, N., Osipov, M., Yasui, H., Yabusaki, H., Afanasyev, S., Park, Y-K., Al-Batran, S-E., Yoshikawa, T., Yanez Weber, P.E., Di Bartolomeo, M., Lonardi, S., Guan, Y., Valderrama, A., Shih, C-S., Fang, X., and Bang, Y-J.

Subjects
*ESOPHAGOGASTRIC junction, *PATIENT reported outcome measures, *CANCER prognosis, *PEMBROLIZUMAB, *CANCER chemotherapy
Published
2024
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43. 398P Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): Additional analysies from 45-month (mo) follow-up of CheckMate 648.

Author

Adenis, A., Chau, I., Ajani, J.A., Kitagawa, Y., Xu, J., Wyrwicz, L.S., Motoyama, S., Ogata, T., Kawakami, H., Hsu, C-H., El Hajbi, F., Di Bartolomeo, M., Braghiroli, M.I., Holtved, E., Murphy, M. Blum, Zhang, J., Hu, N., Matsumura, Y., Kato, K., and Doki, Y.

Subjects
*SQUAMOUS cell carcinoma, *NIVOLUMAB, *IPILIMUMAB, *CANCER chemotherapy
Published
2024
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44. Etoposide, doxorubicin and cisplatin (EAP) treatment in advanced gastric carcinoma: a multicentre study of the Italian Trials in Medical Oncology (I.T.M.O.) Group

Author

Bajetta, E., Di Bartolomeo, M., de Braud, F., Bozzetti, F., Bochicchio, A.M., Comella, P., Fagnani, D., Farina, G., Ferroni, C., Franchi, R., Gebbia, V., Ianniello, G., Iirillo, A., Pinotti, G., Schieppati, G., Ucci, G., Visini, M., Zaniboni, A., Buzzoni, R., Casartelli, C., and Nelli, P.

Published
1994
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45. LBA3 Final analysis of the phase III KEYNOTE-585 study of pembrolizumab plus chemotherapy vs chemotherapy as perioperative therapy in locally-advanced gastric and gastroesophageal junction cancer.

Author

Shitara, K., Rha, S.Y., Wyrwicz, L.S., Oshima, T., Karaseva, N., Osipov, M., Yasui, H., Yabusaki, H., Afanasyev, S., Park, Y-K., Al-Batran, S-E., Yoshikawa, T., Yanez Weber, P.E., Di Bartolomeo, M., Lonardi, S., Fang, X., Shih, C-S., Bhagia, P., and Bang, Y-J.

Subjects
*ESOPHAGOGASTRIC junction, *PEMBROLIZUMAB, *CANCER chemotherapy
Published
2024
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46. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma.

Author

Doki, Y., Ajani, J. A., Kato, K., Xu, J., Wyrwicz, L., Motoyama, S., Ogata, T., Kawakami, H., Hsu, C.-H., Adenis, A., El Hajbi, F., Di Bartolomeo, M., Braghiroli, M. I., Holtved, E., Ostoich, S. A., Kim, H. R., Ueno, M., Mansoor, W., Yang, W.-C., and Liu, T.

Abstract

Background: First-line chemotherapy for advanced esophageal squamous-cell carcinoma results in poor outcomes. The monoclonal antibody nivolumab has shown an overall survival benefit over chemotherapy in previously treated patients with advanced esophageal squamous-cell carcinoma.Methods: In this open-label, phase 3 trial, we randomly assigned adults with previously untreated, unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma in a 1:1:1 ratio to receive nivolumab plus chemotherapy, nivolumab plus the monoclonal antibody ipilimumab, or chemotherapy. The primary end points were overall survival and progression-free survival, as determined by blinded independent central review. Hierarchical testing was performed first in patients with tumor-cell programmed death ligand 1 (PD-L1) expression of 1% or greater and then in the overall population (all randomly assigned patients).Results: A total of 970 patients underwent randomization. At a 13-month minimum follow-up, overall survival was significantly longer with nivolumab plus chemotherapy than with chemotherapy alone, both among patients with tumor-cell PD-L1 expression of 1% or greater (median, 15.4 vs. 9.1 months; hazard ratio, 0.54; 99.5% confidence interval [CI], 0.37 to 0.80; P<0.001) and in the overall population (median, 13.2 vs. 10.7 months; hazard ratio, 0.74; 99.1% CI, 0.58 to 0.96; P = 0.002). Overall survival was also significantly longer with nivolumab plus ipilimumab than with chemotherapy among patients with tumor-cell PD-L1 expression of 1% or greater (median, 13.7 vs. 9.1 months; hazard ratio, 0.64; 98.6% CI, 0.46 to 0.90; P = 0.001) and in the overall population (median, 12.7 vs. 10.7 months; hazard ratio, 0.78; 98.2% CI, 0.62 to 0.98; P = 0.01). Among patients with tumor-cell PD-L1 expression of 1% or greater, a significant progression-free survival benefit was also seen with nivolumab plus chemotherapy over chemotherapy alone (hazard ratio for disease progression or death, 0.65; 98.5% CI, 0.46 to 0.92; P = 0.002) but not with nivolumab plus ipilimumab as compared with chemotherapy. The incidence of treatment-related adverse events of grade 3 or 4 was 47% with nivolumab plus chemotherapy, 32% with nivolumab plus ipilimumab, and 36% with chemotherapy alone.Conclusions: Both first-line treatment with nivolumab plus chemotherapy and first-line treatment with nivolumab plus ipilimumab resulted in significantly longer overall survival than chemotherapy alone in patients with advanced esophageal squamous-cell carcinoma, with no new safety signals identified. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 648 ClinicalTrials.gov number, NCT03143153.). [ABSTRACT FROM AUTHOR]

Published
2022
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47. The prognostic impact of primary tumour location in patients with stage II and stage III colon cancer receiving adjuvant therapy. A GISCAD analysis from three large randomised trials.

Author

Cascinu, S., Poli, D., Zaniboni, A., Lonardi, S., Labianca, R., Sobrero, A., Rosati, G., Di Bartolomeo, M., Scartozzi, M., Zagonel, V., Pella, N., Banzi, M., and Torri, V.

Subjects
*CANCER patient psychology, *COLON tumors, *COMBINED modality therapy, *COMPARATIVE studies, *CONFIDENCE intervals, *EVALUATION of medical care, *MULTIVARIATE analysis, *SURVIVAL analysis (Biometry), *DESCRIPTIVE statistics, *PROGNOSIS
Abstract

Abstract Purpose Because the role of the primary tumour location in the adjuvant setting has not been clearly established in colon cancer, we analysed the clinical outcome according to the primary tumour location from three Italian trials assessing adjuvant therapy in colon cancer. Patients and methods Overall survival (OS) and disease-free survival (DFS) were assessed globally and in each trial, according to right-sided, transverse and left-sided primary colon cancer. Analysis was planned to provide overall and stage-specific results. Results Individual data of 5239 patients were included in this analysis. The right-sided tumours were 1540 (29%), tumours originating in the transverse were 815 (16%) and left-sided tumours were 2884 (55%). At the multivariate analysis, DFS findings from the comparison of the right-sided versus left-sided tumours (hazard ratio [HR] = 1.00; 95% confidence interval [CI] = 0.89–1.14) were not statistically associated with clinical outcomes in the overall population. On the contrary, OS findings, from the comparison of the right-sided versus left-sided tumours, were significantly associated with outcomes (HR = 1.20; 95% CI = 1.04–1.39). In stage II patients, there was no difference in terms of DFS and OS among the three different tumour locations, whereas in stage III patients, the left-sided tumours showed an improved prognosis in terms of OS (HR: 1.36 95% CI = 1.14–1.62, p < 0.001). Conclusion This is the largest analysis demonstrating a prognostic effect of the tumour location on patients with colon cancer receiving adjuvant chemotherapy. Nevertheless, the effect is limited to OS in stage III colon cancer. In stage II tumours, the primary location has a lesser impact. The transverse tumours should be prognostically considered in between the right-sided and left-sided tumours. Highlights • The primary tumour location has a prognostic effect even on patients with colon cancer receiving an adjuvant chemotherapy. • The effect is limited to overall survival in stage III colon cancer. • The transversum tumours should be prognostically considered between right-sided and left-sided tumours. [ABSTRACT FROM AUTHOR]

Published
2019
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48. LBA74 Pembrolizumab plus chemotherapy vs chemotherapy as neoadjuvant and adjuvant therapy in locally-advanced gastric and gastroesophageal junction cancer: The phase III KEYNOTE-585 study.

Author

Shitara, K., Rha, S.Y., Wyrwicz, L.S., Oshima, T., Karaseva, N., Osipov, M., Yasui, H., Yabusaki, H., Afanasyev, S., Park, Y-K., Al-Batran, S-E., Yoshikawa, T., Yanez Weber, P.E., Di Bartolomeo, M., Lonardi, S., Fang, X., Shih, C-S., Bhagia, P., and Bang, Y-J.

Subjects
*NEOADJUVANT chemotherapy, *ESOPHAGOGASTRIC junction, *CANCER chemotherapy, *PEMBROLIZUMAB
Published
2023
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49. P-167 Type 2 diabetes as a predictive and prognostic factor in advanced pancreatic cancer: Preliminary results of the Italian, observational PANCAKE study.

Author

Nichetti, F., Pretta, A., Franza, A., Andena, P., Puzzoni, M., Grelli, G., Lai, E., Pircher, C., Mariani, S., Bartalini, L., Vivaldi, C., Scartozzi, M., Mariani, L., Di Bartolomeo, M., de Braud, F., and Niger, M.

Subjects
*TYPE 2 diabetes, *PANCREATIC cancer, *PROGNOSIS, *SCIENTIFIC observation
Published
2023
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50. 1206P HER2 copy number variation (CNV), HER2 expression and primary resistance mechanisms in patients (pts) with HER2-positive metastatic gastric or gastroesophageal junction cancer (mGC/GEJC) receiving first-line chemotherapy (CT) + trastuzumab (T) +/- pertuzumab (P) in the JACOB trial

Author

Pietrantonio, F., Berrino, E., Manca, P., S.E. Bellomo, Raimondi, A., Corso, S., Morano, F., Migliore, C., Niger, M., Marchiò, C., Di Bartolomeo, M., Restuccia, E., Lambertini, C., Tabernero, J., and Giordano, S.

Subjects
*ESOPHAGOGASTRIC junction, *TRASTUZUMAB, *CANCER chemotherapy, *METASTASIS
Published
2022
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