Stereotactic MR-guided on-table adaptive radiation therapy (SMART) for borderline resectable and locally advanced pancreatic cancer: A multi-center, open-label phase 2 study

被引：49

作者：

Chuong, Michael D. ^{[1
,17
]}

Lee, Percy ^{[2
]}

Low, Daniel A. ^{[3
]}

Kim, Joshua ^{[4
]}

Mittauer, Kathryn E. ^{[1
]}

Bassetti, Michael F. ^{[5
]}

Glide-Hurst, Carri K. ^{[5
]}

Raldow, Ann C. ^{[6
]}

Yang, Yingli ^{[6
]}

Portelance, Lorraine ^{[7
]}

Padgett, Kyle R. ^{[7
]}

Zaki, Bassem ^{[8
]}

Zhang, Rongxiao ^{[8
]}

Kim, Hyun ^{[9
]}

Henke, Lauren E. ^{[9
]}

Price, Alex T. ^{[9
]}

Mancias, Joseph D. ^{[10
]}

Williams, Christopher L. ^{[10
]}

Ng, John ^{[11
]}

Pennell, Ryan ^{[11
]}

Pfeffer, M. Raphael ^{[12
]}

Levin, Daphne ^{[12
]}

Muellerm, Adam C. ^{[13
]}

Mooneym, Karen E. ^{[13
]}

Kellyn, Patrick ^{[14
]}

Shahn, Amish P. ^{[14
]}

Boldrini, Luca ^{[15
]}

Placidi, Lorenzo ^{[15
]}

Fuss, Martin ^{[16
]}

Parikh, Parag Jitendra ^{[4
]}

机构：

[1] Baptist Hlth South Florida, Miami Canc Inst, Miami, FL USA

[2] City Hope Natl Med Ctr, Los Angeles, CA USA

[3] UCLA Dept Radiat Oncol, Los Angeles, CA USA

[4] Henry Ford Hlth Canc, Detroit, MI USA

[5] Univ Wisconsin, Dept Human Oncol, Madison, WI USA

[6] UCLA David Geffen Sch Med, Dept Radiat Oncol, Los Angeles, CA USA

[7] Miller Sch Med, Sylvester Comprehens Canc Ctr, Miami, FL USA

[8] Dartmouth Hitchcock Med Ctr, Sect Radiat Oncol, Lebanon, NH USA

[9] Washington Univ, Sch Med, St Louis, MO USA

[10] Harvard Med Sch, Brigham & Womens Hosp, Dana Farber Canc Inst, Dept Radiat Oncol, Boston, MA USA

[11] Weill Cornell Med, Sandra & Edward Meyer Canc Ctr, New York, NY USA

[12] Assuta Med Ctr, Tel Aviv, Israel

[13] Thomas Jefferson Univ, Sidney Kimmel Canc Ctr, Dept Radiat Oncol, Philadelphia, PA USA

[14] Orlando Hlth Canc Inst, Orlando, FL USA

[15] Fdn Policlin Univ A Gemelli IRCCS, Dept Radiol Radiat Oncol & Hematol, Rome, Italy

[16] ViewRay Inc, Denver, CO USA

[17] Miami Canc Inst, Dept Radiat Oncol, 8900 N Kendall Dr, Miami, FL 33176 USA

来源：

RADIOTHERAPY AND ONCOLOGY | 2024年 / 191卷

关键词：

Pancreatic neoplasms; Adenocarcinoma; Radiotherapy; Induction chemotherapy; I TRIAL; DOSE-ESCALATION; ONLINE; RADIOTHERAPY; SURVIVAL; CHEMOTHERAPY; MALIGNANCIES; GEMCITABINE;

D O I：

10.1016/j.radonc.2023.110064

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background and purpose: Radiation dose escalation may improve local control (LC) and overall survival (OS) in select pancreatic ductal adenocarcinoma (PDAC) patients. We prospectively evaluated the safety and efficacy of ablative stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC). The primary endpoint of acute grade > 3 gastrointestinal (GI) toxicity definitely related to SMART was previously published with median follow-up (FU) 8.8 months from SMART. We now present more mature outcomes including OS and late toxicity. Materials and methods: This prospective, multi-center, single-arm open-label phase 2 trial (NCT03621644) enrolled 136 patients (LAPC 56.6 %; BRPC 43.4 %) after > 3 months of any chemotherapy without distant progression and CA19-9 <= 500 U/mL. SMART was delivered on a 0.35 T MR-guided system prescribed to 50 Gy in 5 fractions (biologically effective dose10 [BED10] = 100 Gy). Elective coverage was optional. Surgery and chemotherapy were permitted after SMART. Results: Mean age was 65.7 years (range, 36-85), induction FOLFIRINOX was common (81.7 %), most received elective coverage (57.4 %), and 34.6 % had surgery after SMART. Median FU was 22.9 months from diagnosis and 14.2 months from SMART, respectively. 2-year OS from diagnosis and SMART were 53.6 % and 40.5 %, respectively. Late grade > 3 toxicity definitely, probably, or possibly attributed to SMART were observed in 0 %, 4.6 %, and 11.5 % patients, respectively. Conclusions: Long-term outcomes from the phase 2 SMART trial demonstrate encouraging OS and limited severe toxicity. Additional prospective evaluation of this novel strategy is warranted.

引用

页数：15

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