作者: Pulte, Elizabeth Dianne ; Al-Juhaishi, Taha ; Woods, Ashley ; Morrison, Vicki A ; Shapira, Iuliana ; Theoret, Marc R ; Keiffer, Gina ; Garg, Ravin ; Norsworthy, Kelly ; Dela Cruz, Servillano ; Gupta, Rohan ; de Claro, Romeo Angelo

AbstractThe treatment landscape for acute myeloid leukemia (AML) is rapidly changing. Many new agents and lower-intensity regimens have been approved and can be safely used by hematologists and oncologists in both academic and community settings. The US Food and Drug Administration (FDA) held a virtual symposium on AML treatment in the community in November 2022. Several members of the FDA, along with practicing hematologists and oncologists in both academic and community settings, participated in the symposium. The goal of the symposium was to discuss challenges and opportunities in the treatment of patients with AML in community oncology settings. A summary of these discussions and key considerations are presented here.

2024-09-01·Gynecologic Oncology

Immunotherapy in locally advanced cervix cancer: A critical appraisal of the FDA indication based on ENGOT-CX11/GOG-3047/KEYNOTE-A18

Article

作者: Tewari, Krishnansu S ; Monk, Bradley J ; Slomovitz, Brian M ; Pothuri, Bhavana ; Randall, Leslie M ; Coleman, Robert L ; Herzog, Thomas J

The phase 2 KEYNOTE-158 trial treated 98 patients with metastatic/ recurrent cervical cancer irresp. of tumor PD-L1 expression, with single agent pembrolizumab (200 mg IV every 3 wk), 77 of whom had recurrent disease after prior chemotherapy.This was the first study to show pos. results for immunotherapy in first-line persistent, recurrent, or metastatic cervical cancer, and promulgated the incorporation of pembrolizumab into clin. practice guidelines as a preferred regimen.The phase 3 KEYNOTE-826 study evaluated the efficacy and safety of adding pembrolizumab vs. placebo to platinum-based chemotherapy, with or without bevacizumab, as first-line treatment for persistent, recurrent, or metastatic cervical cancer.It is our hope that stringent adherence to statistical methodol. is followed as the results of this and future studies become available. Our common goal is to continue to transform the therapeutic landscape to bring safe and effective treatments to our patients.

2024-08-20·Journal of Clinical Oncology

Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study

Article

作者: Juan-Vidal, Oscar ; Castro, Suellen ; Ros Martinez, Silverio ; Azuma, Koichi ; Aguilar Hernandez, Andres ; Badin, Firas ; Faehling, Martin ; Badin, Firas B ; Grossi, Francesco ; Yanagitani, Noriko ; Fields-Meehan, January ; Juan Vidal, Oscar ; Chouaid, Christos ; Lamour, Corinne ; Illum, Henrik ; Owen, Scott P ; Sabatini, Marielle ; Haggstrom, Daniel ; Azambuja, Alan ; Houck, William ; Katsaounis, Panagiotis ; Larriba, Jose ; Palmero Sanchez, Ramon ; van der Leest, Cor ; Germonpré, Paul ; Madelaine, Jeannick ; Nassabein, Rami ; Mekan, Sabeen ; Alonso Calderon, Ruben ; Muthukumar, Dakshinamoorthy ; Kloover, Jeroen ; Traynor, Anne ; Daniel Pineda Razo, Tomas ; Correa, Marcia ; Oki, Masahide ; Calles, Antonio ; Kuzma, Charles ; Sato, Yuki ; Kuyama, Shoichi ; Couraud, Sebastien ; Motola Kuba, Daniel ; Hochmair, Maximilian ; Maas, Klaar ; Dudnik, Julia ; Gil, Nuno ; Paz-Ares, Luis G ; Cecilia Bettini, Anna ; Reznick, Douglas M. ; Reznick, Douglas ; Costa, Enric ; Sobolev, Julia ; Cerea, Giulio ; Baijal, Shobhit ; Kobayashi, Haruki ; Demirci, Umut ; Laack, Eckart ; Long, Jeremy ; Bennouna, Jaafar ; Tassone, Pierfrancesco ; Zugazagoitia Fraile, Jon ; Mountzios, Giannis S. ; Baz, David ; Martinez, Laia ; Fountzilas, George ; Underhill, Craig ; Owen, Scott P. ; Borges, Giuliano ; Rittmeyer, Achim ; Silva, Eduardo ; Paz-Ares, Luis G. ; Piper, Andrew ; Eralp, Yesim ; Reinmuth, Niels ; Della-Fiorentina, Stephen ; Marcq, Marie ; Castro, Gilberto ; Ahern, Elizabeth ; Okishio, Kyoichi ; Fuentes, Jose ; Dols, Manuel ; Owen, Scott ; Steele, Nicola ; Magalhaes, Helena ; Cruz, Felipe ; Louis Pujol, Jean ; O'Byrne, Kenneth ; Gumus, Mahmut ; Cortot, Alexis ; Tibayan, Restituto ; Summers, Yvonne ; Avery, Eric ; Nechushtan, Hovav ; Owera, Rami ; Karapetis, Christos ; Denis, Fabrice ; Hiret, Sandrine ; Tonini, Giuseppe ; Mountzios, Ioannis ; Sun, Jun ; Grisanti, Salvatore ; Janicot, Henri ; Garassino, Marina ; Franke, Fábio ; Hakimian, David ; Luciani, Andrea ; Karaszewska, Boguslawa ; Bilici, Ahmet ; Felip, Enriqueta ; Walsh, William ; Cornelissen, Robin ; Connor, Charles ; Shinno, Yuki ; Ravoire, Magali ; Sakamoto, Tomohiro ; Kulkarni, Swati ; Campelo, Maria ; Greil, Richard ; Brighenti, Matteo ; Pilar Garrido Lopez, Maria ; Domingues, Isabel ; De Marinis, Filippo ; El-Maraghi, Robert ; Vergnenegre, Alain ; Lerner, Rachel ; Kotsakis, Athanasios ; Hendriks, Lizza ; Nishino, Kazumi ; Araujo, Antonio ; Lim, Farah ; Patel, Vipul ; Agustoni, Franceso ; Ichihara, Eiki ; Merimsky, Ofer ; Govaerts, Elke ; Keresztes, Roger ; Liu, Steven ; Patel, Vipul M. ; Giroux Leprieur, Etienne ; Pieters, Thierry ; Kasai, Takashi ; Dumont, Patrick ; Patel, Vipul M ; Velez-Cortes, Hector ; Pircher, Andreas ; Barrera, Joaquim ; Cheema, Parneet ; Zhang, Eric ; Takayama, Koichi ; Reznick, Douglas M ; Chin, Venessa ; Jasas, Kevin ; Menon, Smitha ; Daniel, Davey ; Fujita, Yuka ; Syrigos, Konstantinos ; Bodnar, Lubomir ; Kurkul, Charles ; Audigier Valette, Clarisse ; Watanabe, Yasutaka ; Bohnet, Sabine ; Abdelaziz, Ahmed ; Guisier, Florian ; Girard, Nicolas ; de Marinis, Filippo ; Garassino, Marina Chiara ; Mruk, Andrzej ; Carmel, Fink ; Karumanchi, Divyadeep ; Badin, Firas B. ; Maiello, Evaristo ; Alves, Paula ; Cicin, Irfan ; Pluquet, Emilie ; Faridi, Amir ; da Conceicao Fernandes Rodrigues, Ana ; Clarke, Katy ; Wender, Donald ; Domine Gomez, Manuel ; Prakash, Sucharu ; Zenke, Yoshitaka ; Baka, Sofia ; Janning, Melanie ; Percent, Ivor ; Rios-Perez, Jorge ; Gersten, Todd ; Yazici, Ozan ; Soto Parra, Hector ; Nott, Louise ; Gervais, Radj ; Carpeno, Francisco ; Fernandez de Sanmamed, Miguel ; Font, Enriqueta ; Wener, Reinier ; Kato, Terufumi ; Parente, Barbara ; Patel, Riddhi ; Baba, Tomohisa ; Debieuvre, Didier ; Demey, Wim ; Takahama, Takayuki ; Wesseler, Claas ; Mountzios, Giannis S ; Agemi, Yoko

PURPOSE The open-label, phase III EVOKE-01 study evaluated sacituzumab govitecan (SG) versus standard-of-care docetaxel in metastatic non–small cell lung cancer (mNSCLC) with progression on/after platinum-based chemotherapy, anti–PD-(L)1, and targeted treatment for actionable genomic alterations (AGAs). Primary analysis is reported. METHODS Patients were randomly assigned 1:1 (stratified by histology, best response to last anti–PD-(L)1–containing regimen, and AGA treatment received or not) to SG (one 10 mg/kg intravenous infusion on days 1 and 8) or docetaxel (one 75 mg/m2 intravenous infusion on day 1) in 21-day cycles. Primary end point was overall survival (OS). Key secondary end points were investigator-assessed progression-free survival (PFS), objective response rate, patient-reported symptom assessment, and safety. RESULTS In the intention-to-treat population (SG, n = 299; docetaxel, n = 304), 55.4% had one previous line of therapy. Median follow-up was 12.7 months (range, 6.0-24.0). The primary end point was not met. There was a numerical OS improvement for SG versus docetaxel (median, 11.1 v 9.8 months; hazard ratio [HR], 0.84 [95% CI, 0.68 to 1.04]; one-sided P = .0534), consistent across squamous and nonsquamous histologies. Median PFS was 4.1 versus 3.9 months (HR, 0.92 [95% CI, 0.77 to 1.11]). An OS benefit was observed for SG (n = 192) versus docetaxel (n = 191) in mNSCLC nonresponsive to last anti–PD-(L)1–containing regimen (3.5-month median OS increase; HR, 0.75 [95% CI, 0.58 to 0.97]); this was consistent across histologies. Among patients receiving SG and docetaxel, 6.8% and 14.2% discontinued because of treatment-related adverse events (TRAEs), respectively; 1.4% and 1.0%, respectively, had TRAEs leading to death. CONCLUSION Although statistical significance was not met, OS numerically improved with SG versus docetaxel, which was consistent across histologies. Clinically meaningful improvement in OS was noted in mNSCLC nonresponsive to last anti–PD-(L)1–containing regimen. SG was better tolerated than docetaxel and consistent with its known safety profile, with no new safety signals.

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2024-10-25

·PRNewswire

Oncology Leaders Unite: Florida Cancer Specialists & Research Institute 2024 Clinical Summit Focuses on Innovation and Patient-Centered Care

Dick Vitale To Present Inspiring Keynote Address FORT MYERS, Fla., Oct. 25, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) will host its 2024 Clinical Summit this week in Orlando, a three-day gathering attended by physicians, clinical practice providers and executive leaders of the statewide practice. Continue Reading This week, Florida Cancer Specialists & Research Institute (FCS) hosts its 2024 Clinical Summit in Orlando, bringing together physicians, clinical providers, and leaders to enhance patient care in community oncology. The summit features in-depth programs like Dr. Neil Love’s Research to Practice® and a keynote by cancer survivor and sports icon Dick Vitale, focusing on resilience and innovation in cancer care. Lucio N. Gordan, MD, FCS president and managing physician, said, "Our annual Clinical Summit is a high-value opportunity for us to strengthen connections, review progress on significant strategic initiatives and share pertinent information on best practices in patient care and breakthrough advancements resulting from our clinical research program. This investment of time is further demonstration of our shared commitment as a leader in community oncology to ensure that patients have convenient access to world-class cancer care." An in-depth session, Dr. Neil Love's Research to Practice® program, custom designed for FCS providers, will help bridge the gap between research and patient care and assist in clinical decision-making through access to the opinions and perspectives of internationally recognized cancer clinical investigators. Additional workshop topics range from a review of clinical AI tools to compliance education training focused on documentation, culture and preventing medical errors. Keynote speaker for the 2024 FCS Clinical Summit is Dick Vitale, college basketball's top ambassador and analyst for ABC Sports and ESPN. During an inspiring fireside chat, Vitale will reveal his unique perspective for tackling difficult challenges through the eyes of a coach, a sports analyst and as an FCS patient. After surviving multiple bouts of cancer, Vitale has shared openly the details of his journey with cancer. The Dick Vitale Gala, held annually in Sarasota, Florida, has raised $93 million for the V Foundation's Dick Vitale Pediatric Cancer Research Fund. "Mr. Vitale is revered for his enthusiasm, passionate style and his "Vitale-isms," said FCS Chief Executive Officer Nathan H. Walcker. "Talking with him about his experiences will enrich us all, as we strive daily to provide each patient with exceptional care and personalized treatment." FCS will also welcome 19 oncology fellows from across the state as special guests at the Clinical Summit. Fellows have been invited to participate in special networking sessions with FCS physicians, clinicians and research leaders as well as an exhibitor fair with over 90 vendors. FCS Assistant Managing Physician David Wenk, MD, noted, " The FCS Clinical Summit is an ideal setting for young physicians to build relationships with their colleagues and gain valuable insights into the many dynamic facets of community oncology." More than 250 physicians and 280 nurse practitioners and physician assistants provide care to patients with all forms of cancer and blood disorders at nearly 100 FCS locations across Florida. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCO会议临床研究免疫疗法

2024-10-23

·PRNewswire

Florida Cancer Specialists & Research Institute Shares Patient-Centered Treatment Advancements in Medically-Integrated Oncology Practice at Pharmacy Summit

Former Olympian & FCS Patient Shares Her Champion's Mindset FORT MYERS, Fla., Oct. 23, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) pharmacy experts, executives and a former patient have key roles in the NCODA 2024 Fall Summit this week in Orlando. They join fellow oncology professionals from around the globe to share the latest insights on the many ways that medically-integrated oncology practices are optimizing patient care. Continue Reading FCS pharmacy experts and executive leaders will have a large presence at the NCODA 2024 Fall Summit in Orlando over the coming days where they will share the latest insights on best practices for optimizing patient care in medically integrated oncology practices. Lucio N. Gordan, MD, FCS president and managing physician, will make opening remarks to kick off the multi-day gathering at the welcome reception hosted by FCS. Dr. Gordan is a member of the event's steering committee and FCS Associate Director of Pharmacy Clinical Services Chris Elder, PharmD, BCOP, is NCODA Fall Summit committee chair. Four-time Olympian, cancer survivor and author Chaunté Lowe is the Summit's keynote speaker. Chaunté was diagnosed with breast cancer in 2019, at the height of her career as a world champion high jumper. She continued her training while undergoing treatment under the care of FCS medical oncologist Muhammad Imam, MD. She continues to share her inspiring message about resilience as a highly sought-after motivational speaker. "The FCS in-house medically integrated pharmacy, Rx To Go Pharmacy, works exclusively within our statewide practice to provide an advanced level of personalized assistance to patients who are being treated with oral chemotherapy drugs," said Dr. Gordan. "There is no better reflection of our commitment to enhancing the patient experience and patient outcomes than the testimonials of individuals like Ms. Lowe, who continue to live rich and fulfilling lives." Nathan H. Walcker, FCS chief executive officer, said, "We are proud once again to actively participate in sharing our best practices and to draw from the experiences of our colleagues to further enhance patient care." Additional FCS participants at the NCODA 2024 Fall Summit are Paul Chadwick, FCS chief value and procurement officer, who will present NCODA's Non-Profit Partner Update, Chris Elder, PharmD, BCOP, FCS associate director of pharmacy clinical services will host a welcome reception on Friday morning, Nicole Bentivegna, PharmD, BCOP, FCS manager of clinical pharmacy services, is a panelist for NCODA PQI in Action: Practical Strategies to Transform Oncology Care and is also leading the clinical session, Vonjo's Voyage: Navigating Thrombocytopenia in Myelofibrosis and Jeanine Ewing, PharmD, BCOP, FCS clinical oncology pharmacist will be a booth speaker for the Sarclisa PQI in Action: Sarclisa in 1q21+ Multiple Myeloma. FCS physicians, clinicians, pharmacists and leaders maintain active participation with NCODA through the following committees: Lucio N. Gordan, MD, FCS president and managing physician – Executive Council, Executive Accreditation Council, Forum/Summit Steering Committee Paul Chadwick, FCS chief value and procurement officer – Executive Council Austin Cox, PharmD, FCS senior director of trade relations, Rx To Go – Executive Council, Chair, Treatment Support Kit Committee Kristen Boykin, PharmD, BCPS, BCOP, FCS director of Pharmacy operations – IV Chemotherapy Education (IVE) Committee Chris Elder, PharmD, BCOP, FCS associate director of pharmacy clinical services – Summit Planning Committee Jeanine Ewing, PharmD, BCOP, FCS clinical oncology pharmacist – IV Chemotherapy Education (IVE) Committee Aisha Grant, PharmD, BCOP, BCPS, FCS clinical oncology pharmacist – IV Chemotherapy Education (IVE) Committee Lauren Trisler, PharmD, FCS clinical oncology pharmacist – Positive Quality Intervention (PQI) Committee Rx To Go is accredited by URAC for Specialty Pharmacy, Accreditation Commission for Health Care (ACHC) with Oncology Distinction, and dually accredited by the National Association of Boards of Pharmacy® (NABP®) for specialty pharmacy and digital pharmacy practice. NCODA is a globally recognized not-for-profit organization dedicated to building a patient-centered, medically integrated community of health care providers whose focus is to innovate the continuity of cancer care so that every patient receives the maximum benefit from their cancer treatment. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-10-01

·PRNewswire

Florida Cancer Specialists & Research Institute Welcomes Board-certified Medical Oncologist and Hematologist Yasir Khan, MD to Lee County

FORT MYERS, Fla., Oct. 1, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) is pleased to welcome board-certified medical oncologist and hematologist Yasir Khan, MD to its Lee County team of cancer experts. He is providing care to patients at the FCS Colonial and Estero locations. Continue Reading Board-certified medical oncologist and hematologist Yasir Khan, MD joins the Florida Cancer Specialists & Research Institute Lee County team of cancer experts. He is providing care to patients at the FCS Colonial and Estero locations. "FCS has held a significant presence in Lee County since our practice was founded in Fort Myers more than 40 years ago," said Nathan H. Walcker, FCS chief executive officer. "We continue to enhance and expand our clinical capabilities to support the continued rapid growth in the Southwestern Florida community so that patients have convenient access to the highest quality care close to home." Dr. Khan received his medical degree from Dow Medical College, Karachi City, Pakistan. He was named chief resident during his internal medicine residency training at Jefferson Abington Hospital in Abington, Pennsylvania and completed a fellowship in oncology/hematology at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania. FCS President & Managing Physician Lucio N. Gordan, MD, said, "Dr. Khan is highly trained in the most advanced cancer treatments, with a special interest in malignant hematology, particularly lymphomas and leukemia. Above all, he understands the impact of cancer on his patients and continuously strives to enhance their well-being while ensuring they achieve the best outcomes. We are delighted to welcome him to FCS." Learn more about Dr. Khan and his practice here: About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED