Evans Douglas B, Varadhachary Gauri R, Crane Christopher H, Sun Charlotte C, Lee Jeffrey E, Pisters Peter W T, Vauthey Jean-Nicolas, Wang Huamin, Cleary Karen R, Staerkel Gregg A, Charnsangavej Chusilp, Lano Elizabeth A, Ho Linus, Lenzi Renato, Abbruzzese James L, Wolff Robert A
Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
J Clin Oncol. 2008 Jul 20;26(21):3496-502. doi: 10.1200/JCO.2007.15.8634.
We conducted a phase II trial to assess the outcomes of patients who received preoperative gemcitabine-based chemoradiation and pancreaticoduodenectomy (PD) for stage I/II pancreatic adenocarcinoma.
Eligible patients with pancreatic head/uncinate process adenocarcinoma and radiographically defined potentially resectable disease received chemoradiation with 7 weekly intravenous (IV) infusions of gemcitabine (400 mg/m(2) IV over 30 minutes) plus radiation therapy (30 Gy in 10 fractions over 2 weeks). Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and, in the absence of disease progression, were taken to surgery.
The study enrolled 86 patients. At the time of restaging, disease progression or a decline in performance status precluded 13 patients from surgery. Seventy-three (85%) of 86 patients were taken to surgery, extrapancreatic disease was found in nine, and 64 (74%) of 86 underwent a successful PD. Median overall survival (86 patients) was 22.7 months with a 27% 5-year survival. Median survival was 34 months for the 64 patients who underwent PD and 7 months for the 22 unresected patients (P < .001). The 5-year survival for those who did and did not undergo PD was 36% and 0%, respectively.
Preoperative gemcitabine-based chemoradiation followed by restaging and evaluation for surgery separated the study population into two different subsets: patients likely to benefit from PD (n = 64) and those in whom surgery would be unlikely to provide clinical benefit (n = 22). Furthermore, the encouraging overall survival observed in this large trial supports the continued investigation of gemcitabine-based preoperative therapy in resectable pancreatic cancer.
我们开展了一项II期试验，以评估接受术前吉西他滨为基础的放化疗及胰十二指肠切除术（PD）治疗的I/II期胰腺腺癌患者的预后。
符合条件的胰头/钩突腺癌患者且影像学检查确定为潜在可切除疾病者，接受7周每周1次静脉输注吉西他滨（400mg/m²静脉输注30分钟）加放射治疗（2周内分10次给予30Gy）的放化疗。患者在放化疗完成后4至6周进行重新分期，若疾病无进展，则接受手术。
该研究纳入86例患者。重新分期时，疾病进展或体能状态下降使13例患者无法接受手术。86例患者中有73例（85%）接受了手术，9例发现有胰腺外疾病，86例中有64例（74%）成功进行了胰十二指肠切除术。86例患者的中位总生存期为22.7个月，5年生存率为27%。64例接受胰十二指肠切除术患者的中位生存期为34个月，22例未接受手术患者的中位生存期为7个月（P < 0.001）。接受和未接受胰十二指肠切除术患者的5年生存率分别为36%和0%。
术前以吉西他滨为基础的放化疗，随后进行重新分期及手术评估，将研究人群分为两个不同亚组：可能从胰十二指肠切除术中获益的患者（n = 64）和手术不太可能带来临床获益的患者（n = 22）。此外，在这项大型试验中观察到的令人鼓舞的总生存期支持继续研究以吉西他滨为基础的术前治疗在可切除胰腺癌中的应用。
