TY - JOUR
T1 - Endorectal Brachytherapy Boost After External Beam Radiation Therapy in Elderly or Medically Inoperable Patients With Rectal Cancer
T2 - Primary Outcomes of the Phase 1 HERBERT Study
AU - Rijkmans, Eva C.
AU - Cats, Annemieke
AU - Nout, Remi A.
AU - van den Bongard, Desiree H. J. G.
AU - Ketelaars, Martijn
AU - Buijsen, Jeroen
AU - Rozema, Tom
AU - Franssen, Jan-Huib
AU - Velema, Laura A.
AU - van Triest, Baukelien
AU - Marijnen, Corrie A. M.
PY - 2017/7/15
Y1 - 2017/7/15
N2 - Purpose: To evaluate the toxicity and efficacy of the combination of external beam radiation therapy (EBRT) followed by high-dose-rate endorectal brachytherapy (HDREBT) boost in elderly and medically inoperable patients with rectal cancer.Methods and Materials: A phase 1 dose-escalation study was performed. Treatment consisted of EBRT (13 x 3 Gy) followed by 3 weekly brachytherapy applications 6 weeks later. The HDREBT dose started at 5 Gy per fraction, increasing with 1 Gy per fraction if dose-limiting toxicity (DLT, defined as grade >= 3 proctitisResults: Thirty-eight patients with a median age of 83 years were included in the study. Thirty-two were evaluable for DLT and late toxicity and 33 for response evaluation. Maximum delivered dose was 8 Gy per fraction, resulting in a recommended dose of 7 Gy per fraction. Response occurred in 29 of 33 patients (87.9%), with 60.6% complete response (CR). The L-PFS and OS rates were 42% and 63%, respectively, at 2 years. Patients with CR showed a significantly improved L-PFS (60% at 2 years, P=.006) and a trend in improved OS (80% at 2 years, P=.11). Severe late toxicity occurred in 10 of 32 patients.Conclusion: We found that HDREBT after EBRT results in a high overall response rate, with improved L-PFS for patients with a CR. The high observed rate of severe late toxicity requires further evaluation of the risks and benefits of an HDREBT boost. (C) 2017 Elsevier Inc. All rights reserved.
AB - Purpose: To evaluate the toxicity and efficacy of the combination of external beam radiation therapy (EBRT) followed by high-dose-rate endorectal brachytherapy (HDREBT) boost in elderly and medically inoperable patients with rectal cancer.Methods and Materials: A phase 1 dose-escalation study was performed. Treatment consisted of EBRT (13 x 3 Gy) followed by 3 weekly brachytherapy applications 6 weeks later. The HDREBT dose started at 5 Gy per fraction, increasing with 1 Gy per fraction if dose-limiting toxicity (DLT, defined as grade >= 3 proctitisResults: Thirty-eight patients with a median age of 83 years were included in the study. Thirty-two were evaluable for DLT and late toxicity and 33 for response evaluation. Maximum delivered dose was 8 Gy per fraction, resulting in a recommended dose of 7 Gy per fraction. Response occurred in 29 of 33 patients (87.9%), with 60.6% complete response (CR). The L-PFS and OS rates were 42% and 63%, respectively, at 2 years. Patients with CR showed a significantly improved L-PFS (60% at 2 years, P=.006) and a trend in improved OS (80% at 2 years, P=.11). Severe late toxicity occurred in 10 of 32 patients.Conclusion: We found that HDREBT after EBRT results in a high overall response rate, with improved L-PFS for patients with a CR. The high observed rate of severe late toxicity requires further evaluation of the risks and benefits of an HDREBT boost. (C) 2017 Elsevier Inc. All rights reserved.
KW - COMPLETE CLINICAL-RESPONSE
KW - CONTACT RADIOTHERAPY
KW - NEOADJUVANT CHEMORADIATION
KW - ORGAN PRESERVATION
KW - INTEGRATED-BOOST
KW - ADENOCARCINOMA
KW - EXPERIENCE
KW - CHEMORADIOTHERAPY
KW - ENDOCAVITARY
KW - TOMOTHERAPY
U2 - 10.1016/j.ijrobp.2017.01.033
DO - 10.1016/j.ijrobp.2017.01.033
M3 - Article
C2 - 28366579
SN - 0360-3016
VL - 98
SP - 908
EP - 917
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 4
ER -