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Phase I trial of concurrent stereotactic body radiotherapy and nelfinavir for locally advanced borderline or unresectable pancreatic adenocarcinoma.


ABSTRACT: INTRODUCTION:The HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects. There have been no studies evaluating combined stereotactic body radiotherapy (SBRT) and NFV for borderline/unresectable pancreatic cancer. The primary objective of this phase I trial (NCT01068327) was to determine the maximum tolerated SBRT/NFV dose, and secondarily evaluate outcomes. METHODS:Following initial imaging, pathologic confirmation, and staging laparoscopy, subjects initially received three 3-week cycles of gemcitabine/leucovorin/fluorouracil; patients without radiologic progression received 5-fraction SBRT/NFV. Dose escalation was as follows: (1) 25?Gy/625?mg BID ×3wks; (2) 25?Gy/1250?mg BID ×3wks; (3) 30?Gy/1250?mg BID ×3wks; (4) 35?Gy/1250?mg BID ×3wks; (5) 35?Gy/1250?mg BID ×5wks; and (6) 40?Gy/1250?mg BID ×5wks. Pancreaticoduodenectomy was performed thereafter if resectable; if not, gemcitabine/leucovorin/fluorouracil was administered. RESULTS:Forty-six patients enrolled (10/2008-5/2013); 39 received protocol-directed therapy. Sixteen (41%) experienced any grade ?2 event during and 1?month after SBRT. Four grade 3 and both grade 4 events occurred in a single patient at the initial dose level. 40?Gy/1250?mg BID ×5wks was the maximum tolerated dose. Five patients had late gastrointestinal bleeding (n?=?2 superior mesenteric artery pseudo-aneurysm, n?=?1 disease progression, n?=?1 lower GI tract, n?=?1 unknown location). The median overall survival was 14.4?months. Six (15%) patients recurred locally; median local failure-free survival was not reached. The median distant failure-free survival was 11?months, and median all failure-free survival was 10?months. CONCLUSIONS:Concurrent SBRT (40?Gy)/NFV (1250?mg BID) for locally advanced pancreatic cancer is feasible and safe, although careful attention to treatment planning parameters is recommended to reduce the incidence of late gastrointestinal bleeding.

SUBMITTER: Lin C 

PROVIDER: S-EPMC6400311 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Phase I trial of concurrent stereotactic body radiotherapy and nelfinavir for locally advanced borderline or unresectable pancreatic adenocarcinoma.

Lin Chi C   Verma Vivek V   Ly Quan P QP   Lazenby Audrey A   Sasson Aaron A   Schwarz James K JK   Meza Jane L JL   Are Chandrakanth C   Li Sicong S   Wang Shuo S   Hahn Stephen M SM   Grem Jean L JL  

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology 20181220


<h4>Introduction</h4>The HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects. There have been no studies evaluating combined stereotactic body radiotherapy (SBRT) and NFV for borderline/unresectable pancreatic cancer. The primary objective of this phase I trial (NCT01068327) was to determine the maximum tolerated SBRT/NFV dose, and secondarily evaluate outcomes.<h4>Methods</h4>Following initial imaging, pathologic confirmation, and staging laparoscopy, subjects init  ...[more]

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