Risk-stratification system for preoperative evaluation

With far-advanced development of technology and medical science, the precise and accurate pretherapy evaluation has become more and more reliable in recent decasdes,1–3 although it does not reach a satisfactory frontier.4–6 Preoperative assessment is particularly important, based on the fact the higher chance to achieve better outcomes if the diseases can be removed totally (complete cytoreduction surgery to no residual tumors [R0] status or en block resection of tumor) successfully.7 The above-mentioned concept nearly fits all surgical illnesses, including rectal cancer (RC), prostate cancer (PC), cervical cancer (CC), endometrial cancer (EC), ovarian cancer (OC), and others.1,7–9 However, how to select a good candidate who fulfills the criteria and can be successfully treated is a challengeable and debated issue, particularly for those patients who are classified as locally advanced cancers and stated as potential and/or possible resectable diseases. To enhance the resectability of tumor, the new term “neoadjuvant therapy (NAT)” has been developed, which is often applied before surgery, including use of targeted agents, radiotherapy (RT), chemotherapy (CT), concurrent chemoradiation (CCRT) and combination of CT and RT, and many others.10 All efforts attempt to skink the tumor size and/or volume, downgrade the stage of diseases, and make en block resection of tumor possible. The optimal therapeutic goal of NAT not only provides a more confidence to perform a complete resection of tumor to save life but also offers a better chance to minimize the damage to the diseased organs and their surrounding tissues and organs and subsequently maintain partial or total function.10 Since the latter is involved in the good quality of life (QoL) in survived patients, this balance between the therapeutic efficacy and the less therapy-related toxicity has become one of the critical issues between health-providers and patients.11

Our previous editorial comment has shown that an precise preoperative evaluation with a resultant appropriate surgical intervention can offer an opportunity to apply a less traumatic and/or organ-preservation strategy to maintain the physiological and morphological function of targeted diseases.10,11 However, it is sometimes difficult to make an idea come true, since the fundamental requirements should search for those “who are candidates fitting less invasive procedures.”11 The recent publication in the Journal of the Chinese Medical Association entitled “Combining prostate health index and multiparametric magnetic resonance imaging may better predict extraprostatic extension after radical prostatectomy” tried to use a preoperative risk-stratification system to dissolve this problem.12 The authors hope their risk-stratification system could be effective to identify prostate cancer (PC) patients without extraprostatic extension (EPE), who may be a good candidate to undergo nerve-sparing radical prostatectomy (NS RP) and subsequently enjoy the better postoperative function of urinary or sexual function.8,12

The authors retrospectively enrolled 163 PC patients undergoing RP to investigate the feasibility of using combination of multiparametric magnetic resonance image (mpMRI) and prostate health index (PHI) to detect the EPE before surgery.12 The area under the receiver operative characteristics curve (ROC) of mpMRI, PHI, and combination of mpMRI and PHI is 0.717, 0.722, and 0.785, respectively.12 They concluded combination of mpMRI and PHI may provide a better prediction rate of EPE preoperatively, suggesting that the application of this predictive model may facilitate preoperative counseling and tailor the need for NS RT in PC patients.12 The current article is interesting and worthy of further discussion.

As shown by our previous editorial comments,9–11,13 it is well known that en block resection of tumor is strongly associated with better progressive-free survival (PFS) and overall survival (OS) in patients after surgery. According to this concept, the authors proposed that an early identification of absence of EPE can use less radicality RP (NS RP) in the management of PC patients.12 We totally agree with Dr. Huang’s opinion, since EPE is indeed involved in positive surgical margins (PSM) with pooled odds ratio (pOR) of 4.44 (95% confidence interval [CI], 3.25, 6.09).14 However, EPE is only one of the factors associated with incomplete resection of tumor, contributing to many uncertainties in their article.

We are in high doubt the model including two components (mpMRI and PHI) may not be adequate to satisfy their hypothesis. The rationale of Dr. Huang’s study is an attempt to distinguish pathological stage 3 (pT3, the presence of EPE) from pathological stage 2 (pT2, the absence of EPE) before operation. We agree that mpMRI is a powerful tool to classify clinical stage (cT) 3 from cT2, with a very high OR (6.413; 95% CI 3.205, 12.832). By contrast, a role of PHI in prediction of presence of EPE is in doubt, since OR is only 1.030 (95% CI, 1.015, 1.044). We are wondering to know what is the cutoff value of PHI to obtain this result, and moreover, we are wondering why the authors integrated PHI into mpMRI to establish the current model to evaluate the EPE.

In term of diagnostic performance for median PHI cutoff values for EPE, the authors uses two cutoff values to test four parameters, such as sensitivity, specificity, positive predictive value, and negative predictive value for EPE.12 It is interesting to find that the authors did not use the combination of PHI and mpMRI for their model and by contrast, they tested their hypothesis using either mpMRI or PHI > 40 group and mpMRT or PHI > 56 group. All made audience confusing, since the authors have claimed they would like to test the feasibility of using the combination of mpMRI and PHI.

It is interesting to find the median PHI of the pT2 and pT3 patients was 42.6 and 65.7, respectively, and we are wondering why the authors did not use these cutoff values (42.6 or 65.7) of PHI to test their hypothesis.

We totally agree with the authors’ effort to deal with their PC patients with a better care, since the recent trend favoring the minimally invasive surgery, function-preservation, or organ-sparing surgery for tumors, regardless whether the tumor is benign or malignant, has been progressed.9–11,13,15,16 Oncology safety is never neglected for both physicians and patients. When nonstandard radicality surgery would be applied in cancer patients, the oncologic safety is always highly debated.9,11,13 Therefore, any effort attempting to identify or select a good candidate suitable to less radicality surgery is welcome. En block complete and total resection of the tumor pushes us to conduct more accurate preoperative risk-stratification system to minimize the risk of incomplete resection.10,13 Based on data obtained from a recent systematic review and meta-analysis, the followings are associated with increased risk of PSM, including preoperative prostate-specific antigen (PSA) (pooled standardized mean differences [SMD], 0.37; 95% CI, 0.31, 0.43), and biopsy Gleason Score (<6/≥7) (pOR 1.53; 95% CI, 1.31, 1.79).14 Dr. Huang’s group also identified the two aforementioned parameters (total PSA, and biopsy Gleason Score) to be correlated with EPE. We are wondering to know why the authors did not try to enroll both parameters and integrate both into their preoperative risk-stratification model.12 By contrast, they selected the marginal value of PHI for their aims.

The other risk factors, such as abnormal digital rectal examination associated with EPE are also found by authors.12 Although the audience may not well accept that abnormal digital rectal examination can be accurately reflect the presence of EPE, this is a good example to remind us to carefully use statistics method to make a conclusion, since statistical significance cannot be totally reflective to clinical significance, which we emphasized many times.17

Similar to our previous comments to the publication from the same group before,8,13 the goal of Dr. Huang’s group attempted to identify who are candidates for NS RP by using this model (combination of PHI and mpMRP). We recognize Dr. Huang’s efforts and are pleased to give a big applause to them, because their efforts may provide a better chance to achieve the better postoperative QoL of patients while balance between oncologic safety and therapy-related morbidity is always in concern for all patients who need extensive surgical treatment. “To do more may not have the results “to get more” should be kept in all health-providers.18 The better functional maintenance as well as better QoL without sacrificing the therapeutic efficacy is our goal in daily routine clinical practice.

ACKNOWLEDGMENTS

This article was supported by grants from the Taiwan Ministry of Science and Technology, Executive Yuan, Taiwan (MOST 110-2314-B-075-016-MY3 and MOST 111-2314-B-075-045), and Taipei Veterans General Hospital (V112C-154 and V112D64-001-MY2-1). The authors appreciate the support from Female Cancer Foundation, Taipei, Taiwan.

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