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
Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
Medientyp:
E-Artikel
Titel:
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
Beteiligte:
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.
Erschienen:
American Society of Clinical Oncology (ASCO), 2014
Beschreibung:
<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>