Cytoreductive surgery and intraperitoneal chemotherapy versus systemic chemotherapy for colorectal peritoneal metastases: A randomised trial

Cashin, Peter; Mahteme, Haile; Spang, N.; Syk, Ingvar; Frödin, Jan‐Erik; Torkzad, Michael R.; Glimelius, Bengt; Graf, Wilhelm

doi:10.1016/j.ejca.2015.09.017

Cited by 128 publications

(86 citation statements)

References 21 publications

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“…Patients with baseline thrombocytopenia may better be treated with oxaliplatin, while those with preoperative leukopenia may better be treated with mitomycin. This study also clearly confirms that randomized clinical trials of CRS/HIPEC are feasible for patients with PSD in general 30,31 and for those with appendiceal primary lesions specifically. It is through such prospective randomized trials that the numerous questions related to this therapy can be answered.…”

Section: Discussionsupporting

confidence: 80%

A Multicenter Randomized Trial to Evaluate Hematologic Toxicities after Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin or Mitomycin in Patients with Appendiceal Tumors

Levine

Votanopoulos

Shen

et al. 2018

Journal of the American College of Surgeons

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Background Appendiceal cancer is a rare disease, which has proven difficult to study in prospective trials. Cytoreductive surgery with HIPEC is an established therapy for peritoneal dissemination from appendiceal cancer. The optimal chemotherapeutic agent to use in the HIPEC is not clear. Mitomycin has long been the utilized, however our previous phase I experience, and European retrospective studies suggest oxaliplatin as an alternative. Therefore, we initiated a multicenter randomized trial to compare mitomycin to oxaliplatin HIPEC for appendiceal cancer. Study Design Patients with mucinous appendiceal neoplasms with evidence of peritoneal dissemination underwent cytoreductive surgery and HIPEC using a closed technique for 120 minutes. Patients were randomized intraoperatively to HIPEC using mitomycin(40mg) or oxaliplatin(200mg/M2). Follow up included daily blood counts and toxicity assessments. Results 121 analytic patients were accrued to the trial over 6 years at 3 sites. The cases were 57% female, with an average age of 55.3 years(range 22-82). The disease was low grade in 77% and high grade in 23%. There were no significant differences in hemoglobin or platelet counts. The WBC was significantly lower in the mitomycin group between postoperative days 5-10. Overall and disease free survival at 3 years were similar at 83.7% and 66.8% for mitomycin and 86.9% and 64.8% for oxaliplatin. Conclusions This represents the first completed prospective randomized trial for cancer of the appendix, and shows that multicenter trials for this disease are feasible. Both mitomycin and oxaliplatin are associated with minor hematologic toxicity. However, mitomycin has slightly higher hematologic toxicity and lower QOL than oxaliplatin in HIPEC. Consequently, oxaliplatin may be preferred in patients with leukopenia and mitomycin preferred in patients with thrombocytopenia due to prior chemotherapy.

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Section: Discussionsupporting

confidence: 80%

A Multicenter Randomized Trial to Evaluate Hematologic Toxicities after Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin or Mitomycin in Patients with Appendiceal Tumors

Levine

Votanopoulos

Shen

et al. 2018

Journal of the American College of Surgeons

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“…11 Despite these results the long-term survival remains poor with a 5-year survival of less then 10% and with a complete response only in 4.8% of patients. 12 These data suggest that systemic chemotherapy alone, also with the addition of a monclonal antibody, has no curative potential and does not improve long-term outcomes. 12 After the introduction and the good results of resective surgery in patients with liver metastases from CRC, the concept of step-by-step metastasis from CRC has diffused.…”

Section: Discussionmentioning

confidence: 95%

“…12 These data suggest that systemic chemotherapy alone, also with the addition of a monclonal antibody, has no curative potential and does not improve long-term outcomes. 12 After the introduction and the good results of resective surgery in patients with liver metastases from CRC, the concept of step-by-step metastasis from CRC has diffused. This concept was first described by Weiss and refers to a well-ordered metastatic diffusion in subsequent steps or metastases from metastases mechanism.…”

Section: Discussionmentioning

confidence: 95%

“…The increase in OS due to the introduction of new chemotherapy regimens is the rationale for the introduction of combined modality strategy with cytoreductive surgery, loco-regional chemotherapy and adjuvant systemic chemotherapy with up to now unexpected results and a 5-years survival that reaches, in some studies, 50%. 13 In literature there has been only two randomized controlled trials 12 has reported the data from the Swedish peritoneal study in which patients were randomized to CRS plus sequential postoperative intraperitoneal chemotherapy (SPIC) with 5-fluorouracil versus systemic chemotherapy with oxaliplatin and 5-fluorouracil regimen. The study was started in 2004 but was prematurely stopped in 2011 for the low accrual rate with only 48 eligible patients (the primary sample size calculated was 88 patients).…”

Section: Discussionmentioning

confidence: 99%

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Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from colorectal and appendiceal cancer: five-years of experience

Montori¹,

Fugazzola²,

Ceresoli³

et al. 2016

J Peritoneum

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An increasing promising evidence support the use of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for treatment of peritoneal carcinosis from colorectal cancer (CRC) and appendiceal cancer (AC).In our institute 18 patients with CRC and 4 patients with AC undergone to CRS and HIPEC were retrospectively analyzed from 2011 to 2016. Patients and tumor characteristics were analyzed. Overall survival and disease free survival were analyzed with Kaplan-Meier curves and log-rank testing.Median disease free survival (DFS) is 20.5 and 31.4 months in CRC and AC respectively (P=0.76). Instead mean overall survival is 37.8 and 44.6 months in CRC and AC group respectively (P=0.46). Primary CRC have an improved DFS compared patients with relapse tumor (45.2 versus 19.4 months) (P=0.037).Comparing with conventional chemotherapy regimens CRS and HIPEC from CRC and AC may obtain a better disease control particularly when a complete cytoreduction is achieved. The combined treatment can have a potential curative intent.

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“…EPIC is usually performed 4-6 days after surgery, while SPIC may continue for several months. A randomized control trial revealed that the prognosis of patients treated with intraperitoneal 5-fluorouracil (5-FU) and leucovorin for 6 months after surgery was better than that of patients receiving systemic chemotherapy (50). As shown in Table II (23, 27, 51-63), 5-FU is used mainly for EPIC and SPIC.…”

Section: Postoperative Intraperitoneal Chemotherapy: Epic and Spicmentioning

confidence: 99%

Regimens of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis from Colorectal Cancer

2018

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Cytoreductive surgery and intraperitoneal chemotherapy versus systemic chemotherapy for colorectal peritoneal metastases: A randomised trial

Cited by 128 publications

References 21 publications

A Multicenter Randomized Trial to Evaluate Hematologic Toxicities after Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin or Mitomycin in Patients with Appendiceal Tumors

A Multicenter Randomized Trial to Evaluate Hematologic Toxicities after Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin or Mitomycin in Patients with Appendiceal Tumors

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from colorectal and appendiceal cancer: five-years of experience

Regimens of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis from Colorectal Cancer

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