A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458)

2016 ◽  
Vol 96 (2) ◽  
pp. 296-303 ◽  
Author(s):  
Walid L. Shaib ◽  
Natalyn Hawk ◽  
Richard J. Cassidy ◽  
Zhengjia Chen ◽  
Chao Zhang ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Dose Escalation ◽  
Stereotactic Body Radiation Therapy ◽  
Phase 1 ◽  
Resectable Pancreatic Cancer ◽  
Phase 1 Study ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer ◽  
Stereotactic Body Radiation

Neoadjuvant stereotactic body radiation therapy (SBRT) for borderline resectable pancreas cancer: Moffitt Cancer Center initial experience.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 302-302
Author(s):  
M. D. Chuong ◽  
R. Shridhar ◽  
M. Patel ◽  
J. Klapman ◽  
J. S. Barthel ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Induction Chemotherapy ◽  
Stereotactic Body Radiation Therapy ◽  
Pancreas Cancer ◽  
Cancer Center ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer ◽  
Stereotactic Body Radiation

302 Background: Our institution has reported a strategy of using neoadjuvant GTX (gemcitabine, docetaxel, and capecitabine) chemotherapy followed by 5FU-based intensity-modulated radiation therapy (IMRT) for borderline resectable pancreas cancer. We now report our early experience with induction chemotherapy followed by stereotactic body radiation therapy (SBRT). Methods: This retrospective review evaluates our initial 5 fraction SBRT experience in 15 patients following induction chemotherapy for borderline resectable pancreatic cancer. Staging included pancreatic protocol CT, endoscopic ultrasound, and PET/CT scan. Induction regimens consisted of GTX for 3 cycles in 12 patients and gemcitabine alone in 3. Daily SBRT was delivered to the pancreas at least 1 week after completing systemic chemotherapy. Endoscopically implanted fiducial markers and daily cone beam CT were used for image guidance. Treatment was delivered on a Varian Trilogy unit using 6-15 MV photons. Doses were selected based on dose painting the portion of tumor adjacent to the vasculature to a higher dose while meeting normal tissue constraints. The entire gross tumor received a dose of 5-6 Gy per fraction while the portion of the tumor adjacent to the vasculature resulting in the borderline designation received up to 8 Gy per fraction. Patients were re-imaged 3-4 weeks after SBRT for consideration of surgery. Results: There were no acute or late grade 3 toxicities. At the time of this analysis, not all treated patients have reached the restaging time point, but 9 of 15 (60%) were candidates for resection. Six patients have gone to resection with negative margins and without any increased complications. Two patients were found to have disease surrounding the vasculature preventing resection. One patient had cardiac issues at surgery and resection was aborted. One patient was explored and found to have liver metastases. Conclusions: Integration of SBRT in conjunction with systemic therapy is well-tolerated and appears to facilitate margin-negative resection in borderline resectable pancreatic cancer. No significant financial relationships to disclose.

The feasibility, safety, and technique of endoscopic ultrasound (EUS)-guided fiducial marker placement for stereotactic body radiation therapy (SBRT) in borderline resectable pancreatic cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 327-327 ◽  
Author(s):  
S. Vignesh ◽  
S. E. Hoffe ◽  
R. Shridhar ◽  
J. Klapman ◽  
J. S. Barthel
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Cone Beam ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer ◽  
Stereotactic Body Radiation ◽  
Apparent Change

327 Background: Fiducial markers implanted into tumors that move with respiration facilitate planning for SBRT. To date, there is little evidence regarding the safety and utility of EUS implanted markers for “borderline resectable” pancreatic cancer. Methods: This is a retrospective review of 13 patients (7 men and 6 women) with “borderline resectable” pancreatic cancer as per NCCN guidelines. EUS-guided fiducial placement for stereotactic body radiation therapy was performed between January 2009 and September 2010. Gold cylindrical fiducials (0.35mmx 10mm or 0.75 mm X 10 mm; VISICOIL) were loaded into a 22g or 19 g EUS needle. With the needle in the target, the fiducial was deployed by retracting the needle and advancing the stylet. EUS confirmed fiducial position after deployment. A mean of 3 fiducials were placed (range 1-6) per patient. Fiducial position was analyzed at 4D CT simulation and daily cone beam imaging prior to SBRT. Results: Fiducial placement was successful in all. Technical difficulty was encountered in 2 patients secondary to retained food in stomach and uncinate tumors. Smaller (10x0.35mm) fiducials were successfully placed in these 2 patients. 3 patients had abdominal pain lasting < 12 hours after fiducial placement but none had any acute complications. In 2 patients, change in fiducial position was noted on follow-up cone beam CT. This apparent change in position was related to biliary drainage, gastric distension and a pre-existing pseudocyst. Though this is not indicative of fiducial migration, it impacts radiation planning and delivery. No complications were noted at the end of a mean follow-up period of 6 months. Conclusions: EUS fiducial placement to assist with stereotactic body radiation for “borderline resectable” pancreatic cancer is safe, feasible, and technically successful in most cases. True migration did not occur but other factors may cause an apparent change in fiducial position. Further studies are planned to optimize the best configuration of fiducial placement by virtue of tumor location for SBRT planning and treatment. No significant financial relationships to disclose.

Rates of pathologic complete or near complete response following neoadjuvant chemotherapy and stereotactic body radiation therapy for borderline resectable pancreatic cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 221-221
Author(s):  
Michael Chuong ◽  
Eric Albert Mellon ◽  
Sarah Hoffe ◽  
Ravi Shridhar ◽  
Gregory M. Springett ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Neoadjuvant Treatment ◽  
Cancer Center ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Surgical Specimen ◽  
Borderline Resectable Pancreatic Cancer ◽  
Stereotactic Body Radiation

221 Background: While the clinical response from induction chemotherapy followed by stereotactic body radiation therapy (SBRT) has been reported for borderline resectable pancreatic cancer (BRPC) patients, response from a histopathologic standpoint has not been described. Methods: This single-institution retrospective review evaluated BRPC patients who completed induction gemcitabine-based chemotherapy followed by 5-fraction SBRT. All patients were restaged and underwent resection. A pathologist (B.C.) specializing in pancreatic cancer reviewed each surgical specimen and assigned two Tumor Regression Grade (TRG) scores, one from the College of American Pathologists (CAP) and one from the MD Anderson Cancer Center (MDACC). Overall survival (OS) and progression free survival (PFS) were correlated to TRG score using the Kaplan-Meier method. Results: This study evaluated 35 resected BRPC patients with a median follow up of 13.8 months (range, 6.1-24.8). All received induction gemcitabine-based chemotherapy, most commonly GTX (gemcitabine, docetaxel, capecitabine) (82%), followed by 5-fraction SBRT with a median 35 Gy (range, 30-40). TRG scores according to the CAP were as follows, from best to worst response: 0 (n=3), 1 (n=13), 2 (n=15), and 3 (n=4). TRG scores according to MDACC were as follows, from best to worst response: IV (n=3), III(M) (n=6), IIB (n=11), IIA (n=10), and I (n=5). Any neoadjuvant treatment effect according to MDACC scoring (IIA-IV vs. I) was associated with improved OS and PFS (both p=0.019). Conclusions: This study demonstrated a significant pathologic response with a gemcitabine based neoadjuvant regimen containing SBRT and suggests a survival benefit based on response as measured by the MDACC scoring system.

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