Cargando…
A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial
OBJECTIVE: The optimal perioperative chemotherapy for lower rectal cancer with lateral pelvic lymph node metastasis remains unclear. We evaluated the efficacy and safety of perioperative mFOLFOX6 in comparison with postoperative mFOLFOX6 for rectal cancer patients undergoing total mesorectal excisio...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354501/ https://www.ncbi.nlm.nih.gov/pubmed/35640246 http://dx.doi.org/10.1093/jjco/hyac080 |
_version_ | 1784763086480080896 |
---|---|
author | Ohue, Masayuki Iwasa, Satoru Mizusawa, Junki Kanemitsu, Yukihide Shiozawa, Manabu Nishizawa, Yusuke Ueno, Hideki Katsumata, Kenji Yasui, Masayoshi Tsukamoto, Shunsuke Katayama, Hiroshi Fukuda, Haruhiko Shimada, Yasuhiro |
author_facet | Ohue, Masayuki Iwasa, Satoru Mizusawa, Junki Kanemitsu, Yukihide Shiozawa, Manabu Nishizawa, Yusuke Ueno, Hideki Katsumata, Kenji Yasui, Masayoshi Tsukamoto, Shunsuke Katayama, Hiroshi Fukuda, Haruhiko Shimada, Yasuhiro |
author_sort | Ohue, Masayuki |
collection | PubMed |
description | OBJECTIVE: The optimal perioperative chemotherapy for lower rectal cancer with lateral pelvic lymph node metastasis remains unclear. We evaluated the efficacy and safety of perioperative mFOLFOX6 in comparison with postoperative mFOLFOX6 for rectal cancer patients undergoing total mesorectal excision with lateral lymph node dissection. METHODS: We conducted an open label randomized phase II/III trial in 18 Japanese institutions. We enrolled patients with histologically proven lower rectal adenocarcinoma with clinical pelvic lateral lymph node metastasis who were randomly assigned (1:1) to receive postoperative mFOLFOX6 (12 courses of intravenous oxaliplatin [85 mg/m(2)] with L-leucovorin [200 mg/m(2)] followed by 5-fluorouracil [400 mg/m(2), bolus and 2400 mg/m(2), continuous infusion, repeated every 2 weeks]) or perioperative mFOLFOX6 (six courses each preoperatively and postoperatively). The primary endpoint was overall survival (OS). The trial is registered with Japan Registry of Clinical Trials, number jRCTs031180230. RESULTS: Between May 2015, and May 2019, 48 patients were randomized to the postoperative arm (n = 26) and the perioperative arm (n = 22). The trial was terminated prematurely due to poor accrual. The 3-year OS in the postoperative and perioperative groups were 66.1 and 84.4%, respectively (HR 0.58, 95% CI [0.14–2.45], one-sided P = 0.23). The pathological complete response rate in the perioperative group was 9.1%. Grade 3 postoperative surgical complications were more frequently observed in the perioperative arm (50.0 vs. 12.0%). One treatment-related death due to sepsis from pelvic infection occurred in the postoperative group. CONCLUSIONS: Perioperative mFOLFOX6 may be an insufficient treatment to improve survival of lower rectal cancer with lateral pelvic lymph node metastasis. |
format | Online Article Text |
id | pubmed-9354501 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-93545012022-08-09 A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial Ohue, Masayuki Iwasa, Satoru Mizusawa, Junki Kanemitsu, Yukihide Shiozawa, Manabu Nishizawa, Yusuke Ueno, Hideki Katsumata, Kenji Yasui, Masayoshi Tsukamoto, Shunsuke Katayama, Hiroshi Fukuda, Haruhiko Shimada, Yasuhiro Jpn J Clin Oncol Original Article OBJECTIVE: The optimal perioperative chemotherapy for lower rectal cancer with lateral pelvic lymph node metastasis remains unclear. We evaluated the efficacy and safety of perioperative mFOLFOX6 in comparison with postoperative mFOLFOX6 for rectal cancer patients undergoing total mesorectal excision with lateral lymph node dissection. METHODS: We conducted an open label randomized phase II/III trial in 18 Japanese institutions. We enrolled patients with histologically proven lower rectal adenocarcinoma with clinical pelvic lateral lymph node metastasis who were randomly assigned (1:1) to receive postoperative mFOLFOX6 (12 courses of intravenous oxaliplatin [85 mg/m(2)] with L-leucovorin [200 mg/m(2)] followed by 5-fluorouracil [400 mg/m(2), bolus and 2400 mg/m(2), continuous infusion, repeated every 2 weeks]) or perioperative mFOLFOX6 (six courses each preoperatively and postoperatively). The primary endpoint was overall survival (OS). The trial is registered with Japan Registry of Clinical Trials, number jRCTs031180230. RESULTS: Between May 2015, and May 2019, 48 patients were randomized to the postoperative arm (n = 26) and the perioperative arm (n = 22). The trial was terminated prematurely due to poor accrual. The 3-year OS in the postoperative and perioperative groups were 66.1 and 84.4%, respectively (HR 0.58, 95% CI [0.14–2.45], one-sided P = 0.23). The pathological complete response rate in the perioperative group was 9.1%. Grade 3 postoperative surgical complications were more frequently observed in the perioperative arm (50.0 vs. 12.0%). One treatment-related death due to sepsis from pelvic infection occurred in the postoperative group. CONCLUSIONS: Perioperative mFOLFOX6 may be an insufficient treatment to improve survival of lower rectal cancer with lateral pelvic lymph node metastasis. Oxford University Press 2022-05-30 /pmc/articles/PMC9354501/ /pubmed/35640246 http://dx.doi.org/10.1093/jjco/hyac080 Text en © The Author(s) 2022. Published by Oxford University Press. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Ohue, Masayuki Iwasa, Satoru Mizusawa, Junki Kanemitsu, Yukihide Shiozawa, Manabu Nishizawa, Yusuke Ueno, Hideki Katsumata, Kenji Yasui, Masayoshi Tsukamoto, Shunsuke Katayama, Hiroshi Fukuda, Haruhiko Shimada, Yasuhiro A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title | A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title_full | A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title_fullStr | A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title_full_unstemmed | A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title_short | A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II/III randomized controlled trial |
title_sort | randomized controlled trial comparing perioperative vs. postoperative mfolfox6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (jcog1310): a phase ii/iii randomized controlled trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354501/ https://www.ncbi.nlm.nih.gov/pubmed/35640246 http://dx.doi.org/10.1093/jjco/hyac080 |
work_keys_str_mv | AT ohuemasayuki arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT iwasasatoru arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT mizusawajunki arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT kanemitsuyukihide arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT shiozawamanabu arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT nishizawayusuke arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT uenohideki arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT katsumatakenji arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT yasuimasayoshi arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT tsukamotoshunsuke arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT katayamahiroshi arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT fukudaharuhiko arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT shimadayasuhiro arandomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT ohuemasayuki randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT iwasasatoru randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT mizusawajunki randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT kanemitsuyukihide randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT shiozawamanabu randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT nishizawayusuke randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT uenohideki randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT katsumatakenji randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT yasuimasayoshi randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT tsukamotoshunsuke randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT katayamahiroshi randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT fukudaharuhiko randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial AT shimadayasuhiro randomizedcontrolledtrialcomparingperioperativevspostoperativemfolfox6forlowerrectalcancerwithsuspectedlateralpelviclymphnodemetastasisjcog1310aphaseiiiiirandomizedcontrolledtrial |