Evaluation of palonosetron and dexamethasone with or without aprepitant to prevent carboplatin-induced nausea and vomiting in patients with advanced non-small-cell lung cancer

被引:40
作者
Kusagaya, Hideki [1 ]
Inui, Naoki [1 ,2 ]
Karayama, Masato [1 ,3 ]
Fujisawa, Tomoyuki [1 ]
Enomoto, Noriyuki [1 ]
Kuroishi, Shigeki [4 ]
Nakamura, Yutaro [1 ]
Matsuda, Hiroyuki [5 ]
Yokomura, Koshi [6 ]
Koshimizu, Naoki [7 ]
Toyoshima, Mikio [8 ]
Imokawa, Shiro [9 ]
Yamada, Takashi [10 ]
Shirai, Toshihiro [11 ]
Hayakawa, Hiroshi [12 ]
Suda, Takafumi [1 ]
机构
[1] Hamamatsu Univ Sch Med, Dept Internal Med, Div 2, Hamamatsu, Shizuoka 4313192, Japan
[2] Hamamatsu Univ Sch Med, Dept Clin Pharmacol & Therapeut, Hamamatsu, Shizuoka 4313192, Japan
[3] Hamamatsu Univ Sch Med, Dept Clin Oncol, Hamamatsu, Shizuoka 4313192, Japan
[4] Ensyu Hosp, Dept Resp Med, Hamamatsu, Shizuoka 4300929, Japan
[5] Japanese Red Cross Shizuoka Hosp, Dept Resp Med, Shizuoka 4200853, Japan
[6] Seirei Mikatahara Gen Hosp, Dept Resp Med, Hamamatsu, Shizuoka 4338558, Japan
[7] Fujieda Municipal Gen Hosp, Dept Resp Med, Fujieda, Shizuoka 4268677, Japan
[8] Hamamatsu Rosai Hosp, Dept Resp Med, Hamamatsu, Shizuoka 4348525, Japan
[9] Iwata City Hosp, Dept Resp Med, Iwata 4388550, Japan
[10] Shizuoka City Shizuoka Hosp, Dept Resp Med, Shizuoka 4208630, Japan
[11] Shizuoka Prefectural Gen Hosp, Dept Resp Med, Shizuoka 4200881, Japan
[12] Tenryu Hosp, Dept Resp Med, Hamamatsu, Shizuoka 4348511, Japan
基金
日本学术振兴会;
关键词
Antiemetic; Aprepitant; Carboplatin; Chemotherapy-induced nausea and vomiting; Non-small-cell lung cancer; Palonosetron; CHEMOTHERAPY-INDUCED NAUSEA; MODERATELY EMETOGENIC CHEMOTHERAPY; PLACEBO-CONTROLLED TRIAL; RANDOMIZED PHASE-III; DOUBLE-BLIND; ANTAGONIST APREPITANT; ANTIEMETIC TREATMENT; GUIDELINE UPDATE; DELAYED NAUSEA; THERAPY;
D O I
10.1016/j.lungcan.2015.11.009
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objectives: Although antiemetic management has improved, better control of chemotherapy-induced nausea and vomiting (CINV), particularly during the delayed phase, is needed. The benefit of combination therapy using dexamethasone and the second-generation 5-hydroxytryptamine-3 receptor antagonist palonosetron compared with that of other such receptor antagonists in carboplatin-based chemotherapy is unclear. The effectiveness of adding aprepitant for CINV treatment in moderate emetogenic chemotherapy is also unknown. We compared the efficacy and safety of triple antiemetic therapy using aprepitant, palonosetron, and dexamethasone with that of double antiemetic therapy using palonosetron and dexamethasone in patients with advanced non-small-cell lung cancer receiving carboplatin-containing chemotherapy. Methods: Chemotherapy-naive patients with non-small-cell lung cancer were enrolled in this prospective controlled study. Eighty patients were randomly assigned to groups receiving either double antiemetic therapy with palonosetron and dexamethasone, or triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone. Complete response rate (no vomiting episode and no rescue therapy) was evaluated as the primary endpoint during the 5-day post-chemotherapy period. Results: The aprepitant add-on and double therapy groups showed overall complete response rates of 80.5% (95% confidence interval [CI]: 68.4-92.6%) and 76.9% (95% CI: 63.7-90.1%; odds ratio [OR]: 0.81; 95% CI; 0.27-2.36; p =0.788), respectively. Complete responses in the acute and delayed phases and overall incidences of treatment-related adverse events were similar between groups. Conclusion: According to the selection design, triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone was not considered as an option for further studies. (c) 2015 Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:410 / 416
页数:7
相关论文
共 29 条
[1]   A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy [J].
Aapro, M. ;
Rugo, H. ;
Rossi, G. ;
Rizzi, G. ;
Borroni, M. E. ;
Bondarenko, I. ;
Sarosiek, T. ;
Oprean, C. ;
Cardona-Huerta, S. ;
Lorusso, V. ;
Karthaus, M. ;
Schwartzberg, L. ;
Grunberg, S. .
ANNALS OF ONCOLOGY, 2014, 25 (07) :1328-1333
[2]   Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy [J].
Aapro, M. ;
Fabi, A. ;
Nole, F. ;
Medici, M. ;
Steger, G. ;
Bachmann, C. ;
Roncoroni, S. ;
Roila, F. .
ANNALS OF ONCOLOGY, 2010, 21 (05) :1083-1088
[3]   American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer [J].
Azzoli, Christopher G. ;
Baker, Sherman, Jr. ;
Temin, Sarah ;
Pao, William ;
Aliff, Timothy ;
Brahmer, Julie ;
Johnson, David H. ;
Laskin, Janessa L. ;
Masters, Gregory ;
Milton, Daniel ;
Nordquist, Luke ;
Pfister, David G. ;
Piantadosi, Steven ;
Schiller, Joan H. ;
Smith, Reily ;
Smith, Thomas J. ;
Strawn, John R. ;
Trent, David ;
Giaccone, Giuseppe .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (36) :6251-6266
[4]  
Basch E, 2011, J CLIN ONCOL, V29, P4189, DOI [10.1200/JOP.2011.000397, 10.1200/JCO.2010.34.4614]
[5]   Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment [J].
Bloechl-Daum, Brigitte ;
Deuson, Robert R. ;
Mavros, Panagiotis ;
Hansen, Mogens ;
Herrstedt, Jorn .
JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (27) :4472-4478
[6]   Neurokinin-1 Receptor Antagonists for Chemotherapy-Induced Nausea and Vomiting: A Systematic Review [J].
dos Santos, Lucas Vieira ;
Souza, Fabiano Hahn ;
Brunetto, Andre Tesainer ;
Sasse, Andre Deeke ;
da Silveira Nogueira Lima, Joao Paulo .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2012, 104 (17) :1280-1292
[7]   Antiemesis Clinical Practice Guidelines in Oncology [J].
Ettinger, David S. ;
Armstrong, Debra K. ;
Barbour, Sally ;
Berger, Michael J. ;
Bierman, Philip J. ;
Bradbury, Bob ;
Ellis, Georgianna ;
Kirkegaard, Steve ;
Kloth, Dwight D. ;
Kris, Mark G. ;
Lim, Dean ;
Michaud, Laura Boehnke ;
Nabati, Lida ;
Noonan, Kim ;
Rugo, Hope S. ;
Siler, Darby ;
Sorscher, Steven M. ;
Stelts, Sundae ;
Stucky-Marshall, Lisa ;
Todaro, Barbara ;
Urba, Susan G. .
JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2012, 10 (04) :456-485
[8]   Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron [J].
Gralla, R ;
Lichinitser, M ;
Van der Vegt, S ;
Sleeboom, H ;
Mezger, J ;
Peschel, C ;
Tonini, G ;
Labianca, R ;
Macciocchi, A ;
Aapro, M .
ANNALS OF ONCOLOGY, 2003, 14 (10) :1570-1577
[9]  
Grote Thomas, 2006, J Support Oncol, V4, P403
[10]   Effectiveness of a single-day three-drug regimen of dexamethasone, palonosetron, and aprepitant for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic chemotherapy [J].
Grunberg, Steven M. ;
Dugan, Matthew ;
Muss, Hyman ;
Wood, Marie ;
Burdette-Radoux, Susan ;
Weisberg, Tracey ;
Siebel, Marisa .
SUPPORTIVE CARE IN CANCER, 2009, 17 (05) :589-594