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Clinical Trial
. 2015 Dec;90(3):410-6.
doi: 10.1016/j.lungcan.2015.11.009. Epub 2015 Nov 7.

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

Hideki Kusagaya  1 , Naoki Inui  2 , Masato Karayama  3 , Tomoyuki Fujisawa  1 , Noriyuki Enomoto  1 , Shigeki Kuroishi  4 , Yutaro Nakamura  1 , Hiroyuki Matsuda  5 , Koshi Yokomura  6 , Naoki Koshimizu  7 , Mikio Toyoshima  8 , Shiro Imokawa  9 , Takashi Yamada  10 , Toshihiro Shirai  11 , Hiroshi Hayakawa  12 , Takafumi Suda  1
Affiliations
Clinical Trial

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

Hideki Kusagaya et al. Lung Cancer. 2015 Dec.

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.

Keywords: Antiemetic; Aprepitant; Carboplatin; Chemotherapy-induced nausea and vomiting; Non-small-cell lung cancer; Palonosetron.

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