Hainsworth J D, Meluch A A, Greco F A
Sarah Cannon Cancer Center and the Minnie Pearl Cancer Research Network, Nashville, TN 37203, USA.
Semin Oncol. 1997 Dec;24(6 Suppl 19):S19-38-S19-42.
We evaluated the efficacy and toxicity of a novel chemotherapy regimen that included paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and long-term, continuous-infusion 5-fluorouracil in the treatment of cancers of the upper aerodigestive tract. In the preoperative treatment of patients with localized esophageal cancer, we administered this regimen concurrently with radiation therapy. Thirty-eight patients with biopsy-proven cancers of the head and neck or esophagus entered this trial between January 1996 and November 1996. Patients with head and neck cancers considered curable with local treatment modalities were excluded. All patients received the following chemotherapy regimen: paclitaxel 200 mg/m2 via 1-hour intravenous infusion on days 1 and 21, carboplatin at an area under the concentration-time curve of 6.0 intravenously on days 1 and 21, and 5-fluorouracil 225 mg/m2/d via continuous infusion on days 1 to 42. Patients with localized esophageal cancer also received radiation therapy beginning on day 1 (1.8 Gy/d; total dose, 45 Gy). Patients were re-evaluated at week 6; responding patients received a repeat course of treatment, except for those with localized esophageal cancer, who underwent resection at week 10. Twenty-five of 29 evaluable patients had major responses to treatment. Four of five patients with locally advanced head and neck cancer had complete clinical responses, while eight of 11 patients with metastatic disease responded. All 13 evaluable patients with localized esophageal cancer underwent resection, and nine (69%) had a pathologic complete response. Toxicity was moderate, with brief grade 3/4 leukopenia occurring in 19 patients (66%). Esophagitis occurred in five of 13 patients receiving concurrent chemotherapy and radiation therapy, but was reversible and generally occurred during the last week of radiation therapy. Other grade 3/4 toxicity was uncommon. This novel regimen of paclitaxel, carboplatin, and long-term 5-fluorouracil infusion is feasible and highly active in patients with cancers of the upper aerodigestive tract. It can be used concurrently with radiation therapy before resection for localized esophageal cancer. The high overall response rates, and particularly the high pathologic complete response rates in resected patients with esophageal cancer, are encouraging and warrant further evaluation of this regimen.
我们评估了一种新型化疗方案的疗效和毒性，该方案包括紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）、卡铂以及长期持续输注5-氟尿嘧啶，用于治疗上消化道癌症。在局限性食管癌患者的术前治疗中，我们将此方案与放射治疗同时应用。1996年1月至1996年11月期间，38例经活检证实患有头颈或食管癌的患者进入该试验。可通过局部治疗方式治愈的头颈癌患者被排除。所有患者接受以下化疗方案：第1天和第21天，紫杉醇200mg/m²，静脉输注1小时；第1天和第21天，卡铂静脉输注，浓度-时间曲线下面积为6.0；第1天至第42天，5-氟尿嘧啶225mg/m²/d持续输注。局限性食管癌患者从第1天开始还接受放射治疗（1.8Gy/d；总剂量45Gy）。患者在第6周重新评估；有反应的患者接受重复疗程治疗，但局限性食管癌患者除外，他们在第10周接受手术切除。29例可评估患者中有25例对治疗有主要反应。5例局部晚期头颈癌患者中有4例临床完全缓解，11例转移性疾病患者中有8例有反应。所有13例可评估的局限性食管癌患者均接受了手术切除，9例（69%）有病理完全缓解。毒性为中度，19例患者（66%）出现短暂的3/4级白细胞减少。13例接受同步化疗和放射治疗的患者中有5例发生食管炎，但可逆转，且一般发生在放射治疗的最后一周。其他3/4级毒性不常见。这种紫杉醇、卡铂和长期5-氟尿嘧啶输注的新型方案在上消化道癌症患者中可行且活性高。它可在局限性食管癌切除术前与放射治疗同时使用。总体反应率高，尤其是食管癌切除患者的病理完全缓解率高，令人鼓舞，值得对该方案进行进一步评估。
