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Pseudomyxoma peritonei: a need to establish evidence-based standard of care--is this the right trial?

Chua TC, Al-Mohaimeed K, Liauw W, Morris DL - Ann. Surg. Oncol. (2009)

View Article: PubMed Central - PubMed

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Pseudomyxoma peritonei follows the perforation of a mucinous appendiceal or ovarian neoplasm which leads to intraperitoneal dissemination of mucinous implants that range in viscosity from purely liquid to a semisolid-like texture and that form on the peritoneal surfaces of the abdominal wall and visceral organs... Though the epithelial cells within the mucin proliferate and result in production of mucin, it rarely invades and hence does not metastasize into the blood stream or lymphatics... Cytoreductive surgery and perioperative intraperitoneal chemotherapy comprising hyperthermic intraperitoneal chemotherapy (HIPEC) with or without postoperative intraperitoneal chemotherapy (EPIC) has been unanimously regarded as the standard of care in specialized centers., A systematic review reporting the results of this treatment in 10 specialized institutions of 863 patients showed a 5-year survival ranging between 52 and 96% from the time of cytoreductive surgery... Overall survival rates of 10 years have also been reported to be about 85%., In our institution, our perioperative intraperitoneal regimen comprising HIPEC and EPIC has resulted in a 5-year survival of 75% and a median progression-free survival of 40 months... Further, a subgroup of the 106 patients treated has shown that perioperative intraperitoneal chemotherapy at the time of surgery for recurrent disease (second operation) significantly reduces subsequent risk of recurrence (third operation or death from 48 to 5%) (unpublished data)... Cytoreductive surgery involves an extensive surgical debulking through a peritonectomy procedure and is followed by administering perioperative intraperitoneal chemotherapy... This treatment has been shown to reduce disease recurrence and prolong survival compared with a policy of debulking surgery alone., Hence emphasizing the efficacious role of perioperative intraperitoneal chemotherapy... Perioperative intraperitoneal chemotherapy, as first described by Sugarbaker, comprised both intraoperative instillation of a hyperthermic intraperitoneal chemotherapy (HIPEC) and a postoperative instillation of normothermic early postoperative intraperitoneal chemotherapy (EPIC)... Intraoperative instillation of chemohyperthermia has been shown to have dual purpose to attain microscopic cytoreduction through the heat and the cytotoxic agent... By combining these two modalities, a synergistic effect has been shown where the cytotoxic effect is enhanced because of the heat... The relative efficacy of administering HIPEC and EPIC compared with HIPEC alone as part of the package of perioperative intraperitoneal chemotherapy is unknown... Given that the rationale of perioperative intraperitoneal chemotherapy is to target microscopic disease, it would seem unjustified if the contributing survival advantage of administering EPIC after HIPEC is ignored purely for its morbidity and the convenience of postoperative care... We therefore propose a clinical trial to examine the relative efficacy of the individual components of perioperative intraperitoneal chemotherapy through randomizing patients with pseudomyxoma peritonei into an arm that receives both HIPEC (Mitomycin C 10–12.5 mg/m) and EPIC (5FU 650 mg/m) after surgical cytoreduction versus another arm that receives a high dose of HIPEC (Mitomycin C 35 mg/m) only (Fig.  1)... Through this trial, the relative efficacy of EPIC as part of the perioperative intraperitoneal chemotherapy regimen or a high dose of HIPEC alone, which was previously reported to be associated with significant risk of bone marrow toxicity, would be established as evidenced-based practice.

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Clinical pathway for randomization of patients with pseudomyxoma peritonei
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Fig1: Clinical pathway for randomization of patients with pseudomyxoma peritonei

Mentions: We therefore propose a clinical trial to examine the relative efficacy of the individual components of perioperative intraperitoneal chemotherapy through randomizing patients with pseudomyxoma peritonei into an arm that receives both HIPEC (Mitomycin C 10–12.5 mg/m2) and EPIC (5FU 650 mg/m2) after surgical cytoreduction versus another arm that receives a high dose of HIPEC (Mitomycin C 35 mg/m2) only (Fig. 1). Patients will be treated similarly on protocol with survival analysis stratified according to disease histology based on low-grade [diffuse peritoneal adenomucinosis (DPAM) and peritoneal mucinous carcinomatosis intermediate (PMCA-I)] and high-grade (PMCA) tumors.15 Through this trial, the relative efficacy of EPIC as part of the perioperative intraperitoneal chemotherapy regimen or a high dose of HIPEC alone, which was previously reported to be associated with significant risk of bone marrow toxicity, would be established as evidenced-based practice.16 Further, the morbidity associated with EPIC will also be elucidated from the results of this trial. We call upon institutions worldwide to participate in this effort to establish evidence-based standard of care for pseudomyxoma peritonei.Fig. 1


Pseudomyxoma peritonei: a need to establish evidence-based standard of care--is this the right trial?

Chua TC, Al-Mohaimeed K, Liauw W, Morris DL - Ann. Surg. Oncol. (2009)

Clinical pathway for randomization of patients with pseudomyxoma peritonei
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2749180&req=5

Fig1: Clinical pathway for randomization of patients with pseudomyxoma peritonei
Mentions: We therefore propose a clinical trial to examine the relative efficacy of the individual components of perioperative intraperitoneal chemotherapy through randomizing patients with pseudomyxoma peritonei into an arm that receives both HIPEC (Mitomycin C 10–12.5 mg/m2) and EPIC (5FU 650 mg/m2) after surgical cytoreduction versus another arm that receives a high dose of HIPEC (Mitomycin C 35 mg/m2) only (Fig. 1). Patients will be treated similarly on protocol with survival analysis stratified according to disease histology based on low-grade [diffuse peritoneal adenomucinosis (DPAM) and peritoneal mucinous carcinomatosis intermediate (PMCA-I)] and high-grade (PMCA) tumors.15 Through this trial, the relative efficacy of EPIC as part of the perioperative intraperitoneal chemotherapy regimen or a high dose of HIPEC alone, which was previously reported to be associated with significant risk of bone marrow toxicity, would be established as evidenced-based practice.16 Further, the morbidity associated with EPIC will also be elucidated from the results of this trial. We call upon institutions worldwide to participate in this effort to establish evidence-based standard of care for pseudomyxoma peritonei.Fig. 1

View Article: PubMed Central - PubMed

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Pseudomyxoma peritonei follows the perforation of a mucinous appendiceal or ovarian neoplasm which leads to intraperitoneal dissemination of mucinous implants that range in viscosity from purely liquid to a semisolid-like texture and that form on the peritoneal surfaces of the abdominal wall and visceral organs... Though the epithelial cells within the mucin proliferate and result in production of mucin, it rarely invades and hence does not metastasize into the blood stream or lymphatics... Cytoreductive surgery and perioperative intraperitoneal chemotherapy comprising hyperthermic intraperitoneal chemotherapy (HIPEC) with or without postoperative intraperitoneal chemotherapy (EPIC) has been unanimously regarded as the standard of care in specialized centers., A systematic review reporting the results of this treatment in 10 specialized institutions of 863 patients showed a 5-year survival ranging between 52 and 96% from the time of cytoreductive surgery... Overall survival rates of 10 years have also been reported to be about 85%., In our institution, our perioperative intraperitoneal regimen comprising HIPEC and EPIC has resulted in a 5-year survival of 75% and a median progression-free survival of 40 months... Further, a subgroup of the 106 patients treated has shown that perioperative intraperitoneal chemotherapy at the time of surgery for recurrent disease (second operation) significantly reduces subsequent risk of recurrence (third operation or death from 48 to 5%) (unpublished data)... Cytoreductive surgery involves an extensive surgical debulking through a peritonectomy procedure and is followed by administering perioperative intraperitoneal chemotherapy... This treatment has been shown to reduce disease recurrence and prolong survival compared with a policy of debulking surgery alone., Hence emphasizing the efficacious role of perioperative intraperitoneal chemotherapy... Perioperative intraperitoneal chemotherapy, as first described by Sugarbaker, comprised both intraoperative instillation of a hyperthermic intraperitoneal chemotherapy (HIPEC) and a postoperative instillation of normothermic early postoperative intraperitoneal chemotherapy (EPIC)... Intraoperative instillation of chemohyperthermia has been shown to have dual purpose to attain microscopic cytoreduction through the heat and the cytotoxic agent... By combining these two modalities, a synergistic effect has been shown where the cytotoxic effect is enhanced because of the heat... The relative efficacy of administering HIPEC and EPIC compared with HIPEC alone as part of the package of perioperative intraperitoneal chemotherapy is unknown... Given that the rationale of perioperative intraperitoneal chemotherapy is to target microscopic disease, it would seem unjustified if the contributing survival advantage of administering EPIC after HIPEC is ignored purely for its morbidity and the convenience of postoperative care... We therefore propose a clinical trial to examine the relative efficacy of the individual components of perioperative intraperitoneal chemotherapy through randomizing patients with pseudomyxoma peritonei into an arm that receives both HIPEC (Mitomycin C 10–12.5 mg/m) and EPIC (5FU 650 mg/m) after surgical cytoreduction versus another arm that receives a high dose of HIPEC (Mitomycin C 35 mg/m) only (Fig.  1)... Through this trial, the relative efficacy of EPIC as part of the perioperative intraperitoneal chemotherapy regimen or a high dose of HIPEC alone, which was previously reported to be associated with significant risk of bone marrow toxicity, would be established as evidenced-based practice.

Show MeSH
Related in: MedlinePlus