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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 weekly x 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 587-592 |
| Number of pages | 6 |
| Journal | Journal of Surgical Oncology |
| Volume | 101 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jun 1 2010 |
Fingerprint
Keywords
- Gemcitabine
- Pancreatic cancer
- Radiotherapy
ASJC Scopus subject areas
- Surgery
- Oncology
Cite this
}
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. / Landry, Jerome; Catalano, Paul J.; Staley, Charles; Harris, Wayne; Hoffman, John; Talamonti, Mark; Xu, Natalie; Cooper, Harry; Benson III, Al B.
In: Journal of Surgical Oncology, Vol. 101, No. 7, 01.06.2010, p. 587-592.Research output: Contribution to journal › Article
TY - JOUR
T1 - 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
AU - Landry, Jerome
AU - Catalano, Paul J.
AU - Staley, Charles
AU - Harris, Wayne
AU - Hoffman, John
AU - Talamonti, Mark
AU - Xu, Natalie
AU - Cooper, Harry
AU - Benson III, Al B
PY - 2010/6/1
Y1 - 2010/6/1
N2 - 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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 weekly x 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.
AB - 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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 weekly x 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.
KW - Gemcitabine
KW - Pancreatic cancer
KW - Radiotherapy
UR - http://www.scopus.com/inward/record.url?scp=77952028206&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77952028206&partnerID=8YFLogxK
U2 - 10.1002/jso.21527
DO - 10.1002/jso.21527
M3 - Article
C2 - 20461765
AN - SCOPUS:77952028206
VL - 101
SP - 587
EP - 592
JO - Journal of Surgical Oncology
JF - Journal of Surgical Oncology
SN - 0022-4790
IS - 7
ER -