The Association between Pathologic Complete Response after Neoadjuvant Chemoradiotherapy and Postoperative Complications.

INTRODUCTION: With growing interest in the watch-and-wait strategy, the benefits of avoiding surgery and its complications must be weighed against possible recurrence and need for salvage surgery. However, the relationship between pathologic complete response (pCR) and postoperative complications has not been well established. METHODS: This is a retrospective study using the National Surgical Quality Improvement Program Proctectomy and Colectomy Procedure-Targeted databases from 2016 to 2018. The association between pCR and major complications, sepsis, anastomotic leak or organ space infection, return to the operating room, or septic shock was analyzed. RESULTS: A total of 3,878 rectal cancer patients who received chemotherapy or radiation therapy within 90 days of surgery were included in this study. The pCR rate was 12.8%. There was no statistically significant association between pCR and major complications (adjusted odds ratio (OR) = 0.48, p = 0.12) after risk adjustment. Those with pCR had no statistically significant association with anastomotic leak or organ space infection, return to the operating room, or septic shock but had significantly lower odds of sepsis (adjusted OR = 0.42, p = 0.03). CONCLUSIONS: It is reassuring that pCR is not associated with postoperative complications and that those with pCR are less likely to have postoperative sepsis after risk adjustment since postoperative sepsis after rectal surgery has been associated with poorer oncologic outcomes.

Generalizability of Randomized Controlled Trials in Rectal Cancer.

BACKGROUND: The generalizability of outcomes from randomized controlled trials (RCTs) in oncology is a frequent concern. Given the prevalence and multidisciplinary management of rectal cancer, understanding the generalizability of rectal cancer RCTs is critical to surgical oncologists. METHODS: An exhaustive literature review identified 100 non-metastatic rectal cancer RCTs published in English over the past 10 years investigating surgery, chemotherapy, or radiotherapy. In order to evaluate the representativeness of these RCTs compared to the USA and each continent's rectal cancer populations, demographic characteristics were stratified by surgical versus chemoradiotherapy (CRT) trial and by continent then compared with the National Cancer Database and CANCER TODAY using chi-squared and Welch's t-tests. RESULTS: Of the 100 trials identified, 65% enrolled significantly younger patients, and 38% enrolled a significantly greater proportion of males than the US rectal cancer population. These demographic differences were more prominent among CRT trials than surgical trials. Half of all trials enrolled patients who were on average more than 7 years younger and enrolled a 5% greater proportion of males than their respective continental rectal cancer populations. Patients enrolled in trials had more advanced cancers than their corresponding continental populations. Sociodemographic data was rarely reported. CONCLUSION: Patients enrolled in trials were younger, predominantly male, and had advanced stage cancer when compared to the rectal cancer population. Sociodemographic variables are underreported, further limiting equal participation in clinical trials. Future rectal cancer RCTs should strive to recruit representative samples. To enhance recruitment of women and underrepresented minorities, tailored recruitment strategies must be implemented.