Citations 2
COVID-19 in patients with neuroendocrine neoplasms: 2-year results of the INTENSIVE study
Fazio, Nicola , Gervaso, Lorenzo , Hálfdánarson, Þorvarður R. , Eiring, Rachel A. , Stocchetti, Benedetta Lombardi , Grozinsky‐Glasberg, Simona , Gross, David J. , Walter, Thomas , Robelin, Patrick, Bagnardi, Vincenzo , Antonuzzo, Lorenzo , Sparano, Clotilde , Gelsomino, Fabio, Rossi, Maura , Cives, Mauro , Kakil, I. R., Hamid, Hytam, Squadroni, M., Koumarianou, Anna, Boselli, S., Tamayo, Darina, Mazzon, Cristina, Rubino, Manila , Spada, Francesca , Sonbol, Mohamad, Grozinsky-Glasberg, Simona , Sparano, Clotilde , Massironi, Sara , Hofland, Johannes , Halfdanarson, Thorvardur R , Eiring, Rachel A , Antonuzzo, Lorenzo , Sonbol, Mohamad Bassam , Pusceddu, Sara , Prinzi, Natalie , Lombard‐Bohas, Catherine , Frassoni, Samuele , Gelsomino, Fabio , Bongiovanni, Alberto , Ranallo, Nicoletta , Tafuto, Salvatore , Chirco, Alessandra, Salvia, Anna La , Hernando, Jorge , Hofland, Johannes
Endocrine-Related Cancer | March 17, 2023 | Volume: 30 | Issue: 6 | Pages: No page available
We conducted a retrospective/prospective worldwide study on patients with neuroendocrine neoplasms (NENs) and a molecularly proven SARS-CoV-2 positivity. Preliminary results regarding 85 patients of the INTENSIVE study have been published in 2021. Now we are reporting the 2-year analysis.Here, we are reporting data from consecutive patients enrolled between 1 June 2020, and 31 May 2022. Among the 118 contacted centers, 25 were active to enroll and 19 actively recruiting at the time of data cut-off for a total of 280 patients enrolled. SARS-CoV-2 positivity occurred in 47.5% of patients in 2020, 35.1% in 2021, and 17.4% in 2022. The median age for COVID-19 diagnosis was 60 years. Well-differentiated tumors, non-functioning, metastatic stage, and gastroenteropancreatic (GEP) primary sites represented most of the NENs. COVID-19-related pneumonia occurred in 22.8% of the total, with 61.3% of them requiring hospitalization; 11 patients (3.9%) needed sub-intensive or intensive care unit therapies and 14 patients died (5%), in 11 cases (3.9%) directly related to COVID-19. Diabetes mellitus and age at COVID-19 diagnosis > 70 years were significantly associated with COVID-19 mortality, whereas thoracic primary site with COVID-19 morbidity. A significant decrease in both hospitalization and pneumonia occurred in 2022 vs 2020. In our largest series of NEN patients with COVID-19, the NEN population is similar to the general population of patients with NEN regardless of COVID-19. However, older age, non-GEP primary sites and diabetes mellitus should be carefully considered for increased COVID-19 morbidity and mortality. Relevant information could be derived by integrating our results with NENs patients included in other cancer patients with COVID-19 registries.
Adjuvant nab -Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial
Tempero, Margaret A. , Pelzer, Uwe , Oh, Do‐Youn , Li, Chung‐Pin , Tortora, Giampaolo , Chang, Heung-Moon, Lopez, Charles D. , Bekaii‐Saab, Tanios , Ko, Andrew H. , Santoro, Armando , Noel, Marcus Smith , Dean, Andrew , Riess, Hanno, Philip, Philip, Moore, Malcolm J. , Goldstein, David , Ferrara, Stefano, Bruchec, Yvan Le, Lu, Brian , Epstein, Richard A. , Vasey, Paul L., Shapiro, Jeremy, Burge, Matthew , Chua, Yu Jo , Harris, Marion , Prager, Gerald W. , Dittrich, Christian , Längle, Friedrich, Philipp‐Abbrederis, Kathrin, Greil, Richard , Stöger, Herbert, Girschikofsky, Michael , Kuehr, Thomas, Laethem, Jean–Luc Van, Laurent, Stéphanie , Ko, Yoo Joung, Dowden, Scot, Kavan, Petr , Tehfe, Mustapha Édouard, Kubala, Eugen, Kohoutek, Milan, Yilmaz, Mette, Parner, Vibeke K., Salminen, Tapio , Soveri, Leena‐Maija , Korkeila, Eija, Taı̈eb, Julien , Artru, Pascal , Guimbaud, Rosine , Turpin, Antony, Kunzmann, Volker , Kreth, Florian, Oettle, Helmut, Karthaus, Meinolf , Folprecht, Gunnar , Kullmann, Frank , Reiser, Marcel , Heinemann, Volker , Wörns, Marcus‐Alexander , Schulz, H. , Garlipp, Benjamin , Chan, Lam Stephen, Juhász, Balázs , Landherr, László, Pintér, Tamás , Kahán, Zsuzsanna , McDermott, Raymond, Power, Derek G. , Siena, Salvatore, Milella, Michèle , Bagalá, Cinzia, Roila, Fausto, Fanello, Silvia, Wilmink, Johanna W. , Groot, Jan Willem de, Creemers, G.J., Rodrigues, Tânia , Tai, David , Mercadé, T. Macarulla, Medina, Manuel Hidalgo, Mena, Alfredo Carrato, Santasusana, Joan Maurel, Oncala, Maria Jose Flor, Martín, Carlos Gómez , Muñoz, Andrés, García, Ruth Vera, Alés, Inmaculada, Rivera, Fernando , Sastre, Javier , Wu, Cheng‐Chung, Tien, Yu‐Wen , Chan, De-Chuan , Hwang, Tsann‐Long , Evans, Jeffry, Wadsley, Jonathan , Chiorean, E. Gabriela , Bendell, Johanna C. , Kindler, Hedy L. , Fernando, Nishan H., Beg, Muhammad Shaalan , LoConte, Noelle K. , Posey, James , Malhotra, Rajat, Sohal, Davendra , Brenner, Warren, Womack, Mark, Seth, Rahul , lyer, Renuka, Bahary, Nathan , Marsh, Robert , Chua, Cynthia C., Reeves, J. N. , Manji, Gulam A. , Sahai, Vaibhav , Messersmith, Wells A. , Zakari, Ahmed, Bullock, Andrea J. , Musher, Benjamin , Kim, Edward , Bajor, David J., Huyck, Tim, Hatoum, Hassan , Xiong, Henry, Pasche, Boris , Lacy, Jill , Olowokure, Olugbenga, Cohn, Allen Lee, Richards, Donald , Martin, Robert C.G. , Paulson, Andrew Scott , Fanta, Paul T. , Krishnamurthi, Smitha , Fuloria, Jyotsna, McDermott, Ray , Turpin, Anthony , O'Reilly, Eileen M , Winter, Jordan Michael , Oh, Do-Youn , Li, Chung-Pin , Tortora, Giampaolo , Bekaii-Saab, Tanios S , Santoro, Armando , Park, Joon Oh , Dean, Andrew , Van Cutsem, Eric , Berlin, Jordan D. , Tabernero, Josep , Biankin, Andrew V , LoConte, Noelle , Taieb, Julien , McDermott, Ray , Prager, Gerald W , Sahai, Vaibhav , O’Reilly, Eileen M. , Frassineti, Giovanni Luca , Shan, Yan‐Shen , Cutsem, Eric Van , Tabernero, Josep , Li, Mingyu , Zhang, George , Biankin, Andrew V. , Reni, Michele , Vasey, Paul, Pavlakis, Nick , Tebbutt, Niall C. , Längle, Friedrich, Dhani, Neesha C. , Tehfe, Mustapha , Pfeiffer, Per , Osterlund, Pia J. , Tougeron, David , Caroli‐Bosc, François‐Xavier , Walter, Thomas , Bachet, Jean‐Baptiste , Block, Andreas, Venerito, Marino , Trojan, Jörg , Lerch, Markus M. , Schulz, Holger, Yau, Thomas , Juhasz, Balazs, Bodoky, Gyorgy , Gianni, Luca , Siena, Salvatore , Falcone, Alfredo , Berardi, Rossana , Costanzo, Francesco Di , Ardizzoni, Andrea , Maiello, Evaristo , Barroso, Eduardo , Sarmento, Cristina, Chee, Cheng Ean , López López, Rafael , Sáez, Berta Laquente, Chan, De‐Chuan , Evans, Jeffry, Corrie, Pippa G. , Cardin, Dana B. , Noonan, Anne M. , George, Thomas J. , Arena, Francis P. , McWilliams, Robert R. , Seth, Rahul, Ramirez, Robert A. , Reeves, James, El-Khoueiry, Anthony B. , Weaver, Robert, Dreicer, Robert , Borad, Mitesh J. , Huyck, Timothy K., Xiong, Henry Q., Oberstein, Paul E.
Journal of Clinical Oncology | December 15, 2022 | Volume: 41 | Issue: 11 | Pages: 2007-2019
PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430 ). METHODS We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m 2 ) + gemcitabine (1,000 mg/m 2 ) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. RESULTS Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 ( nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P = .02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 ( nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P = .0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P = .0091). Eighty-six percent ( nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. CONCLUSION The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.