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Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5‐fluorouracil, and cisplatin followed by radiotherapy and 5‐fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma
Author(s) -
Landry Jerome,
Catalano Paul J.,
Staley Charles,
Harris Wayne,
Hoffman John,
Talamonti Mark,
Xu Natalie,
Cooper Harry,
Benson Al B.
Publication year - 2010
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.21527
Subject(s) - medicine , gemcitabine , fluorouracil , radiation therapy , pancreatic cancer , cisplatin , adenocarcinoma , toxicity , chemotherapy , surgery , gastroenterology , cancer
Abstract Purpose A randomized phase II trial (E1200) was designed to assess toxicities and surgical resection rates in two neoadjuvant gemcitabine‐based chemoradiation regimens in patients with borderline resectable pancreatic cancer. The trial was terminated early due to poor accrual. Patients and Methods Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m 2 IV weekly for 6 weeks, with radiation to 50.4 Gy followed by surgical resection. Arm B patients (n = 11) received preoperative gemcitabine 175 mg/m 2 on days 1, 5, 29, and 33, cisplatin 20 mg/m 2 on days 1–5 and 29–32, 5‐FU 600 mg/m 2 on days 1–5 and 29–32, followed by radiation with continuous infusion 5‐FU 225 mg/m 2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m 2 weekly × 3 for five cycles. Results Three patients in arm A, and two patients in arm B were resected. Hematologic toxicity was comparable between the two arms except more patients in arm B developed grade 3 or 4 thrombocytopenia than those in arm A. Arm B had fewer grade 1‐2 GI toxicities although more patients (45%) experienced grade 3–4 GI toxicity. Conclusions This phase II trial showed that both regimens were tolerable, and resectability and survival were comparable to previous studies. J. Surg. Oncol. 2010; 101:587–592. © 2010 Wiley‐Liss, Inc.