A Novel Tool for Predicting Major Complications After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

Our plain-English summary of A Novel Tool for Predicting Major Complications After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy, by J.M. Baumgartner, T.G. Kwong, G.L. Ma, et al (Annals of Surgical Oncology, 2016).

The study

• Authors: J.M. Baumgartner, T.G. Kwong, G.L. Ma, K. Messer, K.J. Kelly, A.M. Lowy
• Journal: Annals of Surgical Oncology
• Published: 2016;23(5):1609-17
• Cited by: 44 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Background: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) has an emerging role in the treatment of peritoneal malignancies. The CRS-HIPEC approach has known treatment-related toxicities. This study sought to determine the predictors of major postoperative complications after CRS-HIPEC in a high-volume center.

Methods: From a single-institution database, this study investigated complications experienced by patients undergoing CRS-HIPEC. Multiple preoperative and operative factors were analyzed for their ability to predict 60-day Clavien grade 3 and greater (major) complications by logistic regression. A predictive model was created from preoperative factors using multivariate logistic regression. The model was tested by Akaike's information criterion, the Hosmer and Lemeshow Goodness-of-Fit Test, the receiver operating characteristic, and the Youden Index.

Results: The study evaluated 247 patients undergoing CRS-HIPEC. The primary tumor site was the appendix in 166 cases (67.2 %), the colorectal area in 51 cases (20.6 %), the peritoneum (mesothelioma) in 22 cases (8.9 %), the ovary in 5 cases (2 %), and the small bowel in 3 cases (1.2 %). The median peritoneal cancer index was 14 (range 0-29), and 235 patients (95.1 %) had a complete (CC-0/1) cytoreduction. Major complications occurred for 41 patients (16.6 %), classified as grade 3 in 33 cases (13.4 %), grade 4 in 5 cases (2 %), and grade 5 (deaths) in 3 cases (1.2 %). The factors predictive of major complications in the multivariate analysis were a Charlson Comorbidity Index (CCI) score higher than 0 [odds ratio (OR), 2.505; p = 0.035], presence of preoperative symptoms (OR 1.951; p = 0.064), and prior resection status [no resection or prior CRS-HIPEC (OR 2.087) vs. prior resection without CRS-HIPEC (OR 3.209); p = 0.046]. These variables were used to create a tool predictive of postoperative complications.

Conclusion: Presence of symptoms, CCI, and prior resection status predict major complications and define a low-risk population after CRS-HIPEC.

In plain English

This retrospective study from one high-volume center at the University of California, San Diego, looked at 60-day complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This is an operation to remove tumor from the abdomen, followed by heated chemotherapy inside the abdomen. The analysis covered 247 procedures in 231 patients treated from August 2007 to June 2014. Of these, 22 were for peritoneal mesothelioma. The article did not study asbestos exposure. Major complications occurred in 41 patients (16.6 %), including 3 deaths (1.2 %); the percentages are out of the 247 procedures. In the multivariate analysis, a Charlson Comorbidity Index above 0 had an OR of 2.505 (p = 0.035). A prior CRS-HIPEC, compared with a prior resection without CRS-HIPEC, had an OR of 3.209 (p = 0.036). Preoperative symptoms had an OR of 1.951 (p = 0.064), and no prior resection had an OR of 2.087 (p = 0.063). In the mesothelioma group, 18.2 % had major complications, not significantly different from appendix cases. The authors built a points tool and concluded that it can define a low-risk group if independent validation is obtained. They noted it came from a single center.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Retrospective study at a single high-volume center, using a prospectively maintained database; development of a preoperative risk-prediction tool
• Who was studied: 247 CRS-HIPEC procedures in 231 patients at the University of California, San Diego, from 3 August 2007 to 27 June 2014. Primary sites: appendix 166, colorectal 51, peritoneal mesothelioma 22, ovarian 5, small bowel 3.
• Exposure: Cytoreductive surgery followed immediately by HIPEC (90-minute perfusion at 42 C). Appendiceal, colorectal and small bowel cases received mitomycin C. Mesothelioma and ovarian cases received cisplatin 50 mg/m2 and doxorubicin 15 mg/m2. No asbestos exposure was studied.
• Main results:
  • Major (Clavien grade 3 or higher) complications within 60 days were reported in 41 patients (16.6 %). These were grade 3 in 33 patients (13.4 %), grade 4 in 5 (2 %), and death in 3 (1.2 %). The percentages are out of 247, the number of procedures analyzed.
  • A Charlson Comorbidity Index above 0 predicted major complications in the multivariate analysis (OR 2.505; p = 0.035). The major complication rate was 28.6 % in the 35 cases with CCI above 0, versus 14.6 % in the 212 with CCI 0.
  • Preoperative symptoms had an OR of 1.951 (p = 0.064) in the multivariate analysis. Major complications occurred in 23.2 % of the 99 symptomatic cases, versus 12.2 % of the 148 without symptoms.
  • Prior resection status was significant overall (p = 0.046). The comparison group was prior resection without CRS-HIPEC, which had 12.0 % major complications. Prior CRS-HIPEC (19 cases) had 31.6 % major complications, with a multivariate OR of 3.209 (p = 0.036). No prior resection (62 cases) had 24.2 %, with an OR of 2.087 (p = 0.063).
  • The 22 peritoneal mesothelioma cases had an 18.2 % major complication rate. Compared with appendix cases, the univariate OR was 1.315 (p = 0.646), which was not statistically significant.
  • Among operative factors, only the number of visceral resections was significant in the multivariate analysis (1.434; p = 0.002).
  • The points tool gave 3 points for CCI above 0, 2 for symptoms, 2 for no prior resection, and 3 for prior CRS-HIPEC. A score of 0 meant low risk (0 to 10 %), and a score of 2 to 8 meant high risk (10 to 60 %). Patients with no risk factors made up 39 % of this study and had lower than average risk.
• The authors' conclusion: The authors concluded that CRS-HIPEC can be performed with acceptable morbidity and mortality at high-volume centers. They also concluded that a low-risk group can be predicted from preoperative variables, and that the tool may help with informed consent if independent validation is obtained.
• Limitations the authors state:
  • The data came from a single center.
  • The findings had not been validated in an independent data set.
  • The high-risk group mixed patients at average and high risk, which limits its usefulness.
  • It was not possible to tell whether complications came from the surgery or from the HIPEC, because all patients received both.

Topics

Medical terms in this study, explained in our Lexicon: Cytoreductive Surgery, HIPEC, High-Volume Center, Peritoneum, Mesothelioma, Peritoneal Cancer Index (PCI), Multivariate Analysis, Odds Ratio.

Related studies

• Early recurrence after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) — G.H.C. Tan, C.S. Chia, et al. (2018)
• Association between hospital finances, payer mix, and complications after hyperthermic intraperitoneal chemotherapy: deficiencies in the current healthcare reimbursement system and future implications — M.H. Squires, C.A. Staley, et al. (2015)
• Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for children, adolescents, and young adults: the first 50 cases — A. Hayes-Jordan, H. Green, et al. (2015)
• Iterative cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for recurrent or progressive diffuse malignant peritoneal mesothelioma: clinicopathologic characteristics and survival outcome — C. Ihemelandu, L. Bijelic, et al. (2015)
• Morbidity of the abdominal wall resection and reconstruction after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) — M.F. Nunez, A. Sardi, et al. (2015)
• The Role of Ki-67 and Pre-cytoreduction Parameters in Selecting Diffuse Malignant Peritoneal Mesothelioma (DMPM) Patients for Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) — S. Kusamura, P.A. Torres Mesa, et al. (2016)

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