Lin, Chi;
Sasson, Aaron R.;
Ly, Quan P.;
Schwarz, James K.;
Are, Chandrakanth;
Kos, Beth M;
Lazenby, Audrey J;
Ketcham, Marsha A;
Sehi, Eugene D;
Grem, Jean L.
Survival outcome of a phase I trial: Hypofractionated stereotactic body radiation therapy concurrent with nelfinavir following gemcitabine and 5FU in patients with locally advanced pancreatic adenocarcinoma
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Media type:
E-Article
Title:
Survival outcome of a phase I trial: Hypofractionated stereotactic body radiation therapy concurrent with nelfinavir following gemcitabine and 5FU in patients with locally advanced pancreatic adenocarcinoma
Contributor:
Lin, Chi;
Sasson, Aaron R.;
Ly, Quan P.;
Schwarz, James K.;
Are, Chandrakanth;
Kos, Beth M;
Lazenby, Audrey J;
Ketcham, Marsha A;
Sehi, Eugene D;
Grem, Jean L.
imprint:
American Society of Clinical Oncology (ASCO), 2014
Description:
<jats:p> 284 </jats:p><jats:p> Background: We analyzed overall survival (OS) of patients enrolled in a phase I trial of hypo-fractionated stereotactic body radiation therapy (HFSBRT) concurrent with nelfinavir as part of neoadjuvant chemoradiation regimen in patients with borderline resectable and unresectable pancreatic adenocarcinoma. Methods: Forty-six patients (pts) with borderline resectable or unresectable pancreatic adenocarcinoma without metastasis were enrolled between October 2008 and May 2013 and treated with 3 cycles of Gemcitabine/5-Fluorouracil followed by 5-fraction-HFSBRT/Nelfinavir. [Dose escalation: 1)25Gy/625mgBIDx3week(wk); 2)25Gy/1250mgBIDx3wk; 3)30Gy/1250mgBIDx3wk; 4)35Gy/1250mgBIDx3wk; 5)35Gy/1250mgBIDx5wk; 6)40Gy/1250mgBIDx5wk] Surgery was performed within 4-8 wk for those down staged to resectable disease. Survival was evaluated using the K-M method. Results: The median follow-up is 12 months (M) [5-38]. The median OS (MOS) for the group is 15M [12-17]. The MOS for 13 patients with resected tumor is significantly higher than those with unresectable tumor (21M [12-29] vs. 14M [10-17]), Log-Rank p=0.02). Among patients with unresectable tumor, the MOS for those (22 pts) who received ≥ 35 Gy is significant higher than those (11 pts) who received < 35 Gy (16M [12.5-22] vs. 10M [4-15], Log-Rank p=0.006). During and 1.5M post HFSBRT, ≥ grade 3 GI, hematologic and other toxicities were 2.6%, 2.6% and 13% respectively. Postoperative ≥ grade 3 GI, hematologic and other toxicities were 8%, 8% and 24%, respectively. [Number]=95%CI. Conclusions: Overall survival in patients with resectable disease after HFSBRT/Nelfinafir is higher than those with unresectable disease. Among those who continue to have unresectable disease after HFSBRT/Nelfinavir, overall survival is higher in those who received 35-40 Gy than those who received < 35 Gy. Clinical trial information: NCT01068327. </jats:p>