Hideki Kusagaya1, Naoki Inui2, Masato Karayama3, Tomoyuki Fujisawa1, Noriyuki Enomoto1, Shigeki Kuroishi4, Yutaro Nakamura1, Hiroyuki Matsuda5, Koshi Yokomura6, Naoki Koshimizu7, Mikio Toyoshima8, Shiro Imokawa9, Takashi Yamada10, Toshihiro Shirai11, Hiroshi Hayakawa12, Takafumi Suda1. 1. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan. 2. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan. Electronic address: inui@hama-med.ac.jp. 3. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan; Department of Clinical Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan. 4. Department of Respiratory Medicine, Ensyu Hospital, 1-1-1 Chuou, Hamamatsu 430-0929, Japan. 5. Department of Respiratory Medicine, Japanese Red Cross Shizuoka Hospital, 8-2 Otemachi, Shizuoka 420-0853, Japan. 6. Department of Respiratory Medicine, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Hamamatsu 433-8558, Japan. 7. Department of Respiratory Medicine, Fujieda Municipal General Hospital, 4-1-11 Surugadai, Fujieda 426-8677, Japan. 8. Department of Respiratory Medicine, Hamamatsu Rosai Hospital, 25 Shougen-cho, Hamamatsu 434-8525, Japan. 9. Department of Respiratory Medicine, Iwata City Hospital, 513-2 Ohkubo, Iwata 438-8550, Japan. 10. Department of Respiratory Medicine, Shizuoka City Shizuoka Hospital, 10-93 Ote-cho, Shizuoka 420-8630, Japan. 11. Department of Respiratory Medicine, Shizuoka General Hospital, 4-27-1 Kita-ando, Shizuoka 420-0881, Japan. 12. Department of Respiratory Medicine, Tenryu Hospital, 4201-2 Oro, Hamamatsu 434-8511, Japan.
Abstract
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-naïve 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.
RCT Entities:
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-naïve 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.
Authors: Karin Jordan; Luisa Blättermann; Axel Hinke; Carsten Müller-Tidow; Franziska Jahn Journal: Support Care Cancer Date: 2017-08-31 Impact factor: 3.603
Authors: Paul J Hesketh; Ian D Schnadig; Lee S Schwartzberg; Manuel R Modiano; Karin Jordan; Sujata Arora; Dan Powers; Matti Aapro Journal: Cancer Date: 2016-05-13 Impact factor: 6.860