Division of Medical Oncology and Hematology, Princess Margaret Hospital, University of Toronto, 610 University Avenue, Toronto, Ontario, Canada.
Am J Clin Oncol. 2012 Jun;35(3):255-60. doi: 10.1097/COC.0b013e31820dbdcc.
Despite the efficacy of gemcitabine-platinum regimen, the outcome of patients with recurrent and/or metastatic nasopharyngeal carcinoma (RM NPC) is poor. A phase II trial was conducted to determine the efficacy of erlotinib, given as maintenance therapy after gemcitabine-platinum chemotherapy in patients with RM NPC.
Patients were treated with gemcitabine 1000 mg/m on days 1 and 8 as well as cisplatin 70 mg/m on day 1 (or carboplatin area under curve 5 on day 1, if contraindication to cisplatin) 3 weeks. After 6 chemotherapy cycles (or before in case of progression), patients were switched to erlotinib 150 mg/d 4 weeks. Primary end point was time to progression in patients without progressive disease after 6 chemotherapy cycles and treated with maintenance erlotinib. Epstein-Barr virus DNA plasma levels, measured using quantitative real-time polymerase chain reaction, were correlated with outcome.
Of 20 enrolled patients, 19 patients received 96 chemotherapy cycles. Fifteen patients were switched to erlotinib and received 36 cycles (range: 1 to 6 cycles). Safety profiles observed with the chemotherapy combination and erlotinib were those expected. Of 12 patients evaluable for response to erlotinib, all progressed except 3 patients (25%) who had stable disease for 3, 4, and 7 months, respectively. Median time to progression was 6.9 months for 13 patients without progressive disease after 6 chemotherapy cycles and treated with erlotinib. No correlation was identified between Epstein-Barr virus DNA plasma levels and clinical outcome.
Maintenance or second-line therapy with erlotinib after chemotherapy was not effective in RM NPC. Historical comparison with patients treated with the same chemotherapy alone until progression suggests that it may be detrimental to stop chemotherapy after 6 cycles if disease did not progress.
尽管吉西他滨联合铂类方案有效，但复发性和/或转移性鼻咽癌（RM NPC）患者的预后仍然较差。进行了一项 II 期临床试验，以确定吉西他滨联合铂类化疗后给予厄洛替尼维持治疗在 RM NPC 患者中的疗效。
患者接受吉西他滨 1000 mg/m 第 1 和 8 天以及顺铂 70 mg/m 第 1 天（或卡铂 AUC 5 第 1 天，如果顺铂禁忌）每 3 周 1 次。在 6 个化疗周期后（或在进展前），患者转换为厄洛替尼 150 mg/d 4 周。主要终点是在没有进展性疾病的患者中无进展生存期，这些患者在接受维持性厄洛替尼治疗后进展。使用实时定量聚合酶链反应测量的 Epstein-Barr 病毒 DNA 血浆水平与结果相关。
20 名入组患者中，19 名患者接受了 96 个化疗周期。15 名患者转换为厄洛替尼并接受了 36 个周期（范围：1 至 6 个周期）。化疗联合厄洛替尼的安全性与预期相符。在 12 名可评估厄洛替尼疗效的患者中，除 3 名患者（25%）分别稳定 3、4 和 7 个月外，所有患者均进展。在没有进展性疾病且接受厄洛替尼治疗的 6 个化疗周期后的 13 名患者中，中位无进展生存期为 6.9 个月。未发现 Epstein-Barr 病毒 DNA 血浆水平与临床结局之间存在相关性。
在 RM NPC 患者中，化疗后使用厄洛替尼维持或二线治疗无效。与单独接受相同化疗直至进展的患者进行历史比较表明，如果疾病没有进展，在 6 个周期后停止化疗可能有害。
