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Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer

Verwaal, Vic J LU ; van Ruth, Serge ; de Bree, Eeclo ; van Sloothen, Gooike W ; van Tinteren, Harm ; Boot, Henk and Zoetmulder, Frans A N (2003) In Journal of clinical oncology : official journal of the American Society of Clinical Oncology 21(20). p.43-3737
Abstract

PURPOSE: To confirm the findings from uncontrolled studies that aggressive cytoreduction in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) is superior to standard treatment in patients with peritoneal carcinomatosis of colorectal cancer origin.

PATIENTS AND METHODS: Between February 1998 and August 2001, 105 patients were randomly assigned to receive either standard treatment consisting of systemic chemotherapy (fluorouracil-leucovorin) with or without palliative surgery, or experimental therapy consisting of aggressive cytoreduction with HIPEC, followed by the same systemic chemotherapy regime. The primary end point was survival.

RESULTS: After a median follow-up period of 21.6 months, the median... (More)

PURPOSE: To confirm the findings from uncontrolled studies that aggressive cytoreduction in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) is superior to standard treatment in patients with peritoneal carcinomatosis of colorectal cancer origin.

PATIENTS AND METHODS: Between February 1998 and August 2001, 105 patients were randomly assigned to receive either standard treatment consisting of systemic chemotherapy (fluorouracil-leucovorin) with or without palliative surgery, or experimental therapy consisting of aggressive cytoreduction with HIPEC, followed by the same systemic chemotherapy regime. The primary end point was survival.

RESULTS: After a median follow-up period of 21.6 months, the median survival was 12.6 months in the standard therapy arm and 22.3 months in the experimental therapy arm (log-rank test, P =.032). The treatment-related mortality in the aggressive therapy group was 8%. Most complications from HIPEC were related to bowel leakage. Subgroup analysis of the HIPEC group showed that patients with 0 to 5 of the 7 regions of the abdominal cavity involved by tumor at the time of the cytoreduction had a significantly better survival than patients with 6 or 7 affected regions (log-rank test, P <.0001). If the cytoreduction was macroscopically complete (R-1), the median survival was also significantly better than in patients with limited (R-2a), or extensive residual disease (R-2b; log-rank test, P <.0001).

CONCLUSION: Cytoreduction followed by HIPEC improves survival in patients with peritoneal carcinomatosis of colorectal origin. However, patients with involvement of six or more regions of the abdominal cavity, or grossly incomplete cytoreduction, had still a grave prognosis.

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author
; ; ; ; ; and
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma/drug therapy, Chemotherapy, Adjuvant, Colorectal Neoplasms/drug therapy, Combined Modality Therapy, Female, Humans, Hyperthermia, Induced, Injections, Intraperitoneal, Male, Middle Aged, Palliative Care, Peritoneal Neoplasms/secondary, Treatment Outcome
in
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
volume
21
issue
20
pages
7 pages
publisher
American Society of Clinical Oncology
external identifiers
  • pmid:14551293
  • scopus:0142087625
ISSN
0732-183X
DOI
10.1200/JCO.2003.04.187
language
English
LU publication?
no
id
7d9ea221-ebc3-4e7b-a1bb-877112164e60
date added to LUP
2022-04-04 17:20:05
date last changed
2024-06-18 21:23:39
@article{7d9ea221-ebc3-4e7b-a1bb-877112164e60,
  abstract     = {{<p>PURPOSE: To confirm the findings from uncontrolled studies that aggressive cytoreduction in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) is superior to standard treatment in patients with peritoneal carcinomatosis of colorectal cancer origin.</p><p>PATIENTS AND METHODS: Between February 1998 and August 2001, 105 patients were randomly assigned to receive either standard treatment consisting of systemic chemotherapy (fluorouracil-leucovorin) with or without palliative surgery, or experimental therapy consisting of aggressive cytoreduction with HIPEC, followed by the same systemic chemotherapy regime. The primary end point was survival.</p><p>RESULTS: After a median follow-up period of 21.6 months, the median survival was 12.6 months in the standard therapy arm and 22.3 months in the experimental therapy arm (log-rank test, P =.032). The treatment-related mortality in the aggressive therapy group was 8%. Most complications from HIPEC were related to bowel leakage. Subgroup analysis of the HIPEC group showed that patients with 0 to 5 of the 7 regions of the abdominal cavity involved by tumor at the time of the cytoreduction had a significantly better survival than patients with 6 or 7 affected regions (log-rank test, P &lt;.0001). If the cytoreduction was macroscopically complete (R-1), the median survival was also significantly better than in patients with limited (R-2a), or extensive residual disease (R-2b; log-rank test, P &lt;.0001).</p><p>CONCLUSION: Cytoreduction followed by HIPEC improves survival in patients with peritoneal carcinomatosis of colorectal origin. However, patients with involvement of six or more regions of the abdominal cavity, or grossly incomplete cytoreduction, had still a grave prognosis.</p>}},
  author       = {{Verwaal, Vic J and van Ruth, Serge and de Bree, Eeclo and van Sloothen, Gooike W and van Tinteren, Harm and Boot, Henk and Zoetmulder, Frans A N}},
  issn         = {{0732-183X}},
  keywords     = {{Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma/drug therapy; Chemotherapy, Adjuvant; Colorectal Neoplasms/drug therapy; Combined Modality Therapy; Female; Humans; Hyperthermia, Induced; Injections, Intraperitoneal; Male; Middle Aged; Palliative Care; Peritoneal Neoplasms/secondary; Treatment Outcome}},
  language     = {{eng}},
  month        = {{10}},
  number       = {{20}},
  pages        = {{43--3737}},
  publisher    = {{American Society of Clinical Oncology}},
  series       = {{Journal of clinical oncology : official journal of the American Society of Clinical Oncology}},
  title        = {{Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer}},
  url          = {{http://dx.doi.org/10.1200/JCO.2003.04.187}},
  doi          = {{10.1200/JCO.2003.04.187}},
  volume       = {{21}},
  year         = {{2003}},
}