Division of Medical Oncology, New York University Cancer Center, NYU Medical Center, New York, NY, USA.
Ann Surg Oncol. 2012 Feb;19(2):478-85. doi: 10.1245/s10434-011-1940-8. Epub 2011 Jul 19.
Chemoradiation after surgery for locally advanced gastric cancer improves overall and relapse-free survival compared with observation. However, locoregional recurrences remain high. Accordingly, we instituted this pilot/feasibility study, including intraperitoneal 5-fluoro-2'-deoxyuridine (IP FUDR) as part of the treatment.
Gastric/gastroesophageal junction adenocarcinoma stage Ib-IV (M0) patients who underwent R(0) resection were eligible and had IP catheters inserted at time of surgery. IP FUDR (3 g/dose/day) was given during study days 1-3 and 15-17 before combined 5-fluorouracil, leucovorin, and external beam radiation (45 Gy). Endpoints included toxicity, completion rate, locoregional recurrence, and survival.
Twenty-eight patients (22 men) were enrolled from 2002-2006 at two institutions; their median age was 59.5 years. After R(0) resection, a median 22 (range, 8-102) lymph nodes were examined, and 22 patients had positive nodes. AJCC stages were IB (n = 8), II (n = 10), IIIA (n = 5), IIIB (n = 1), and IV (n = 4). Full-dose IP FUDR and chemoradiation treatment was completed in 20 and 25 patients, respectively. At nearly 4-year median follow-up, 11 patients were disease-free, 5 were alive with disease, 7 were dead of disease, and 1 was dead from other cause; 4 have been lost to follow-up. Recurrences were local in one, intra-abdominal in six, distant in two, multiple sites in two, and unknown in one. The median relapse-free survival is 65.3 months, and the median overall survival has not yet been reached.
IP FUDR before chemoradiation after R(0) gastric cancer resection is well tolerated without compromising completion of postoperative adjuvant treatment. Larger randomized trials studying IP FUDR as part of gastric cancer multidisciplinary treatment are needed to prove efficacy in reducing regional recurrence and improving survival.
与观察相比，手术治疗局部进展期胃癌后进行放化疗可提高总生存率和无复发生存率。然而，局部区域复发率仍然很高。因此，我们进行了这项初步/可行性研究，包括腹腔内 5-氟-2'-脱氧尿苷（IP FUDR）作为治疗的一部分。
Ib-IV 期（M0）胃/胃食管交界处腺癌患者（R0 切除）符合条件，并在手术时插入腹腔导管。在研究期间，患者每天接受三次腹腔 FUDR（3 g/剂量/天），剂量为 15-17 天，然后进行 5-氟尿嘧啶、亚叶酸和外照射放疗（45 Gy）。终点包括毒性、完成率、局部区域复发和生存情况。
2002 年至 2006 年，在两个机构共招募了 28 名患者（22 名男性），中位年龄为 59.5 岁。在 R0 切除后，中位检查 22（范围为 8-102）个淋巴结，22 名患者有阳性淋巴结。AJCC 分期为 Ib（n=8）、II（n=10）、IIIA（n=5）、IIIB（n=1）和 IV（n=4）。20 名患者完成了全剂量 IP FUDR 和放化疗治疗，25 名患者完成了放化疗治疗。在近 4 年的中位随访中，11 名患者无疾病，5 名患者疾病仍在，7 名患者死于疾病，1 名患者死于其他原因，有 1 名患者失访。复发部位分别为局部 1 例、腹腔内 6 例、远处转移 2 例、多处转移 2 例、不明原因 1 例。中位无复发生存期为 65.3 个月，中位总生存期尚未达到。
在 R0 胃腺癌切除术后进行放化疗前使用腹腔 FUDR 耐受性良好，不会影响术后辅助治疗的完成。需要进行更大规模的随机试验，研究腹腔 FUDR 作为胃癌多学科治疗的一部分，以证明其在降低区域复发率和提高生存率方面的疗效。
