Kimura Hiroaki, Yamamoto Norio, Shirai Toshiharu, Nishida Hideji, Hayashi Katsuhiro, Tanzawa Yoshikazu, Takeuchi Akihiko, Igarashi Kentaro, Inatani Hiroyuki, Shimozaki Shingo, Kato Takashi, Aoki Yu, Higuchi Takashi, Tsuchiya Hiroyuki
Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa, 920-8641, Japan.
Cancer Med. 2015 Mar;4(3):333-41. doi: 10.1002/cam4.373. Epub 2014 Dec 23.
The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV.
本研究的首要目的是评估由5-羟色胺3(5-HT3)受体拮抗剂、神经激肽-1(NK-1)受体拮抗剂(NK-1RAs)和地塞米松组成的联合止吐疗法用于治疗骨肉瘤和软组织肉瘤中多种高致吐风险(HER)抗癌药物所致呕吐的疗效。第二个目的是在一项随机、单盲交叉研究中比较单次使用帕洛诺司琼和连续使用格拉司琼的有效性。采用单一随机方法将符合条件的患者分配至帕洛诺司琼组或格拉司琼组。帕洛诺司琼组患者在第1和第3个化疗疗程接受帕洛诺司琼方案治疗,在第2和第4个疗程接受格拉司琼方案治疗。所有患者均接受NK-1RA和地塞米松治疗。接受帕洛诺司琼方案的患者在第1天给予0.75mg帕洛诺司琼,接受格拉司琼方案的患者在第1至5天每天两次给予3mg格拉司琼。本研究中的所有24例患者均接受了至少4个化疗疗程。共评估了96个疗程的止吐治疗。总体而言,完全缓解(CR)率(无呕吐发作且未使用救援药物)为34%,而总控制率(CR加无恶心)为7%。单次使用帕洛诺司琼和连续使用格拉司琼之间未观察到显著差异。对于骨肉瘤和软组织肉瘤中多种HER药物化疗期间化疗所致恶心和呕吐(CINV)的控制,三联药物联合止吐治疗并不充分。本研究还表明,连续使用格拉司琼在治疗CINV方面并不劣于单次使用帕洛诺司琼。