Medical Oncology, Caritas St. Elizabeth's Medical Center of Boston, HOQ Room 223, 736 Cambridge Street, Boston, MA 02135, USA.
Support Care Cancer. 2009 Aug;17(8):1065-70. doi: 10.1007/s00520-008-0545-7. Epub 2008 Dec 6.
To assess the efficacy of adding aprepitant to a 5-HT(3) antagonist and dexamethasone as salvage antiemetic therapy for breast cancer patients receiving their initial cycle of an anthracycline and cyclophosphamide (AC) and failing to achieve complete control of emesis.
Eligibility: breast cancer patients receiving their first cycle of AC.
standard dose of a 5-HT(3) antagonist and dexamethasone 8-10 mg IV/PO on day 1 prior to cycle 1 of AC and dexamethasone 4 mg bid on days 2 and 3. Patients without complete control (no emesis, no nausea, or rescue antiemetics) during cycle 1 could proceed to cycle 2. During cycle 2, patients received AC and identical antiemetics (except dexamethasone 4 mg qd on days 2 and 3) plus aprepitant 125 mg PO day 1 and 80 mg PO days 2 and 3. Primary endpoint: complete control, 0-120 h after chemotherapy.
Sixty-two patients received cycle 1 of AC. Complete control cycle 1: 13 patients (21%; 95%CI, 12-33%). Of the 49 patients eligible for cycle 2, four elected not to continue on study. Of the 45 patients receiving cycle 2, 44 were evaluable. Complete control and complete response (no emesis, no rescue) for the 5-day study period improved from 0% to 18% (p = 0.14) and 7% to 36% (p = 0.02) on cycles 1 and 2, respectively.
In breast cancer patients receiving AC, the addition of aprepitant to a 5-HT(3) antagonist and dexamethasone during cycle 2 of treatment improved antiemetic outcome. Although the improvement in the primary endpoint of complete control during cycle 2 was not significant, all secondary endpoints such as complete response and no emesis rates were significantly better during cycle 2. The extent of antiemetic control during cycle 2 was numerically inferior to the results achieved in a phase III trial employing aprepitant with cycle 1 of AC chemotherapy, suggesting that the preferred approach is to include aprepitant with the initial cycle of AC chemotherapy.
评估在接受初始蒽环类和环磷酰胺（AC）化疗周期的乳腺癌患者中，在标准的 5-HT3 拮抗剂和地塞米松补救性止吐治疗的基础上加用阿瑞匹坦作为挽救性止吐治疗的疗效，这些患者未能完全控制呕吐。
入选标准：接受首次 AC 化疗周期的乳腺癌患者。
标准剂量的 5-HT3 拮抗剂和地塞米松在第 1 天 AC 化疗前 8-10mg IV/PO 给药，第 1 天和第 3 天给予地塞米松 4mg bid。第 1 周期未完全控制（无呕吐、无恶心或使用解救性止吐药物）的患者可进入第 2 周期。第 2 周期患者接受 AC 和相同的止吐药物（第 2 天和第 3 天除外给予地塞米松 4mg qd），加用阿瑞匹坦 125mg PO 第 1 天和 80mg PO 第 2 天和第 3 天。主要终点：化疗后 0-120 小时的完全控制。
62 例患者接受了第 1 周期的 AC 化疗。第 1 周期完全控制：13 例（21%；95%CI，12-33%）。49 例有资格进入第 2 周期的患者中，有 4 例选择不继续研究。45 例接受第 2 周期的患者中，44 例可评估。第 1 周期和第 2 周期的 5 天研究期间，完全控制和完全缓解（无呕吐、无解救）的比例分别从 0%提高到 18%（p=0.14）和从 7%提高到 36%（p=0.02）。
在接受 AC 化疗的乳腺癌患者中，在第 2 周期的治疗中加用地塞米松和阿瑞匹坦可改善止吐效果。尽管第 2 周期完全控制的主要终点改善无统计学意义，但所有次要终点，如完全缓解和无呕吐率，在第 2 周期均显著改善。第 2 周期的止吐控制程度在数值上低于使用阿瑞匹坦的 III 期临床试验中第 1 周期 AC 化疗的结果，表明首选方法是在初始 AC 化疗周期中加入阿瑞匹坦。
