Phase I Trial Evaluating the Safety of Preoperative Gemcitabine/nab-Paclitaxel With Concurrent Radiation Therapy for Borderline Resectable Pancreatic Cancer

Pancreas ◽  
2018 ◽  
Vol 47 (9) ◽  
pp. 1135-1141 ◽  
Author(s):  
Hidenori Takahashi ◽  
Hirofumi Akita ◽  
Tatsuya Ioka ◽  
Hiroshi Wada ◽  
Akira Tomokoni ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Phase I ◽  
Phase I Trial ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer

scholarly journals Phase I Study of Nab–Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer

2017 ◽  
Vol 37 (2) ◽  
pp. 853-858 ◽  
Author(s):  
KEN-ICHI OKADA ◽  
SEIKO HIRONO ◽  
MANABU KAWAI ◽  
MOTOKI MIYAZAWA ◽  
ATSUSHI SHIMIZU ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase I ◽  
Neoadjuvant Therapy ◽  
Phase I Study ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer

Neoadjuvant chemoradiotherapy with S-1 in patients with borderline resectable pancreatic cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 302-302 ◽  
Author(s):  
Masashi Hattori ◽  
Tsutomu Fujii ◽  
Masaya Suenaga ◽  
Suguru Yamada ◽  
Mitsuro Kanda ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Neoadjuvant Chemoradiotherapy ◽  
Venous System ◽  
Pathological Examination ◽  
Visceral Artery ◽  
Portal Venous System ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer

302 Background: The aim of this study was to investigate the efficacy and safety of neoadjuvant chemoradiotherapy (NACRT) with S-1 (oral fluoropyrimidine) followed by surgery for the treatment of borderline resectable pancreatic cancer that involved the major visceral artery or the portal venous system. Methods: Twenty-eight patients with pancreatic cancers that abutted the SMA in 10, the CHA in 7, the both SMA and CHA in 1, and occluded the SMV/PV in 10 were treated with NACRT at a single institution. Radiation therapy was delivered at a total dose of 50.4 Gy in 28 fractions. S-1 was administered orally at a dose of 80 mg/m(2)/day for 14 consecutive days followed by a 7-day rest period during radiation therapy. After radiotherapy and 2 courses of S-1, restaging was done to evaluate secondary resectability. Results: Of the all patients, 25 underwent a full course of NACRT, and NACRT terminated in 3 patients because of grade 3 leukopenia in 2 and tumor bleeding in 1. Partial response was achieved in 3 patients and stable disease in 22. Twenty-four patients (86%) underwent surgical resection, and all had margin-negative (R0) resections. Only two patients (8%) had major morbidity as Clavien-Dindo’s classification III or more, and there was no operative or in-hospital mortality. Pathological examination revealed that more than 50% of tumor cells had disappeared in 14 cases and all cases achieved Evans’ score IIa and more. Conclusions: Neoadjuvant chemoradiation with S-1 was feasible and promising therapy for borderline resectable pancreatic cancer that involves the major artery or the portal venous system.

Prospective phase I study of nab-paclitaxel plus gemcitabine with concurrent MR-guided IMRT in patients with locally advanced or borderline resectable pancreatic cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS480-TPS480
Author(s):  
Jeffrey R. Olsen ◽  
Parag J. Parikh ◽  
Todd A. DeWees ◽  
Lindsey Olsen ◽  
William G. Hawkins ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase I ◽  
Dose Level ◽  
Phase I Study ◽  
Locally Advanced ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer ◽  
Cine Mr ◽  
Patient Reported

TPS480 Background: Radiotherapy (RT) for locally advanced and borderline resectable pancreatic cancer (LABPC) is controversial as potential local control benefits are often obscured by high rates of distant progression. However, local failure remains a significant cause of morbidity among patients without distant progression after initial chemotherapy, although toxicity concerns may limit delivery of optimal systemic therapy concurrent with RT. Given known systemic efficacy and radiosensitization effects of nab-paclitaxel (A) with gemcitabine (G), we initiated a phase I study of nab-paclitaxel with gemcitabine (AG) and concurrent intensity modulated radiation therapy with magnetic resonance guidance (MR-IMRT) for LABPC. Methods: A planned 24 patients with LABPC will be enrolled to a phase I dose escalation trial using the Time-to-Event Continual Reassessment Method (TITE-CRM) design. Following one lead-in cycle of GA, MR-IMRT is administered daily with concurrent weekly GA for a total of 25 fractions in 5 weeks. The initial dose levels for RT and AG, respectively, are: 40 Gy MR-IMRT, 75 mg/m2 A and 600mg/m2 G. The maximum possible dose level is 60 Gy MR-IMRT, 100mg/m2 A and 1000mg/m2 G. To reduce toxicity risk, MR-IMRT volumes include the primary tumor only, with cine-MR used for intra-fraction tumor tracking in place of fiducial markers. The primary endpoint is determination of the maximum tolerated dose level, with secondary endpoints including rate of conversion to resectable disease, progression- free survival, overall survival, and patient reported quality of life. Clinical trial information: NCT02283372.

Radiation therapy in borderline resectable pancreatic cancer: A review

Surgery ◽  
2022 ◽  
Author(s):  
Kevin M. Turner ◽  
Aaron M. Delman ◽  
Jordan R. Kharofa ◽  
Milton T. Smith ◽  
Kyuran A. Choe ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Borderline Resectable Pancreatic Cancer

Efficacy and feasibility of chemotherapy and radiation therapy for borderline resectable pancreatic cancer in elderly patients.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 320-320
Author(s):  
Nicholas Figura ◽  
Alex Cruz ◽  
Eric Albert Mellon ◽  
Michael Chuong ◽  
Sarah Hoffe ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Neoadjuvant Chemotherapy ◽  
Ct Scan ◽  
Tumor Board ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Cox Regression Analysis ◽  
Borderline Resectable Pancreatic Cancer

320 Background: To date there have been few studies evaluating the efficacy and tolerability of aggressive neoadjuvant chemotherapy and radiation therapy (RT) for patients ≥70 years of age with borderline resectable pancreatic cancer (BRPC). Methods: We performed a retrospective review of our institutional experience treating BRPC from 2006 to June 2012. All patients were staged with a pancreas protocol CT scan, endoscopic ultrasound, and PET/CT scan. The diagnosis of BRPC was confirmed by our GI Tumor Board prior to treatment. Our institutional preference for preoperative chemotherapy included gemcitabine, paclitaxel and capecitabine (GTX). RT techniques included intensity modulated radiation therapy (IMRT) or stereotactic body radiation therapy (SBRT). Restaging scans were performed after RT completion and patients were then considered for surgical resection. The data was analyzed using Kaplan-Meier and Cox regression analysis. Results: This study included 72 BRPC patients with a median age of 65 years (range 36-87). 24 patients (33%) were ≥70 years old. Median follow up for all patients was 12.7 months. 56 patients (77%) received preoperative GTX. Of the patients ≥70 years, 7 were treated with IMRT and 17 with SBRT, compared to 8 who were treated with IMRT and 40 with SBRT in the younger cohort. In the older group, 11 patients (46%) underwent surgery with all attaining microscopically negative margins (R0), compared with 32 patients that underwent surgery in the younger cohort (61.7%), 29 of which received R0 margins (90.6%). Median survival for patients ≥70 years old was 12.6 months compared to 12.8 months for the younger patients. There was no difference in overall survival (p =.606) or progression free survival (p = .312) between the two groups. Multivariate analysis showed that surgery in the entire group was significantly associated with an improvement in overall survival (p = .011). Conclusions: Our data indicates that aggressive neoadjuvant chemotherapy and RT is equally effective for older patients. Neoadjuvant therapy for BRPC should not be withheld basely solely on patient age.

Sign in / Sign up

Export Citation Format

Share Document