What’s the Magic Number? Impact of Time to Initiation of Treatment for Rectal Cancer.

Abstract

Background

National guidelines, including the National Accreditation Program for Rectal Cancer, recommend initiation of rectal cancer treatment within 60 days of diagnosis, however the effect of timely treatment initiation on oncologic outcomes is unclear. The purpose of this study was to evaluate the impact on oncologic outcomes of initiation of rectal cancer treatment within 60 days of diagnosis.

Study Design

This was a retrospective review of stage 2/3 rectal cancer patients performed using the US Rectal Cancer Consortium, a collaboration of six academic medical centers. Patients with clinical stage 2/3 rectal cancer who underwent radical resection between January 1, 2010 and December 31, 2018 were included. The primary exposure was treatment initiation, defined as either resection or initiation of chemotherapy or chemoradiotherapy, within 60 days of diagnosis. The primary outcome was disease recurrence and the secondary outcome was all-cause mortality.

Results

A total of 1,031 patients meeting inclusion criteria were included in the analysis. Treatment was initiated within 60 days of diagnosis in 830 patients (80.5%) and after 60 days in 201 patients (20.3%). In multivariable logistic regression, older age, non-White race and residence greater than 100 miles from the treatment center were significantly associated with delay in treatment beyond 60 days. In survival analysis, 167 patients (16.2%) experienced recurrent disease and 127 patients (12.3%) died of any cause. In an adjusted model accounting for pathologic staging, treatment sequence, distance to care, age, comorbidities, treatment center, and receipt of adjuvant chemotherapy, neither progression-free survival nor all-cause mortality was significantly associated with timely initiation of therapy with hazard ratios of 1.09 (0.70, 1.69) and 1.03 (0.63, 1.66), respectively.

Conclusions

This study found no difference in oncologic outcomes with initiation of treatment beyond 60 days.

INTRODUCTION

While recent advances in the diagnosis and treatment of rectal cancer have greatly improved oncologic outcomes, the optimal timing for initiation of treatment remains unclear. Neoadjuvant chemoradiation for clinical stage II or greater tumors¹ and total mesorectal excision (TME)^2,3,4 for tumors of all stages are both associated with decreased rates of local recurrence. Given the evidence for a multidisciplinary approach to treatment within high-volume centers,^5,6,7 the National Accreditation Program for Rectal Cancer (NAPRC) was developed through a collaboration between the American College of Surgeons Commission on Cancer and the Consortium for Optimizing Surgical Treatment of Rectal Cancer.⁸ This accreditation program provides clear standards for program management, clinical care, and quality improvement for all member institutions.

According to NAPRC guidelines, accredited programs should ensure that at least 80 percent of previously untreated patients initiate definitive treatment within 60 days of the patient’s initial clinical evaluation.⁹ Retrospective data from the National Cancer Database show that definitive treatment was initiated within 60 days of diagnosis in 85% of patients, thus meeting NAPRC standards.¹⁰ However, given inconclusive data regarding the impact of timeliness of treatment initiation upon oncologic outcomes among patients with colorectal cancer, the clinical relevance of such a quality metric is unclear.^11,12,13

The primary aim of this study is to determine the effect of initiation of treatment within 60 days of diagnosis upon progression-free survival and all-cause mortality. We hypothesize that this timely initiation of treatment will be associated with improved progression-free survival and all-cause mortality.

MATERIALS & METHODS

Study Design, Setting, & Data Sources

The United States Rectal Cancer Consortium (USRCC) is a collaboration of six academic tertiary and quaternary referral centers: Emory University, University of Michigan, University of Pittsburgh Medical Center, The Ohio State University, Vanderbilt University Medical Center, and Washington University School of Medicine in St. Louis. The USRCC prospectively determined a series of objectives and designed a standardized data form along with a data dictionary. The data was then collected from each institution and merged into a common database. This study was the result of one of those objectives. All patients who underwent radical resection for rectal cancer between January 1, 2010 and December 31, 2018 at one of these six centers were assembled into a retrospective cohort. This study was reviewed and approved by the Vanderbilt University Institutional Review Board (IRB# 172094). Each of the sites represents a tertiary or quaternary referral center with fellowship trained surgical oncologist and colorectal surgeons as well as regular multidisciplinary tumor board meetings. Thus is it an assumption of the study that the population and quality of treatment were mostly similar across all sites.

Study Population

Patients 18 years and older who underwent radical resection of rectal adenocarcinoma were identified for inclusion; patients undergoing resection for indications other than rectal adenocarcinoma were excluded. Additional exclusion criteria were as follows: preoperative evidence of metastatic (stage IV) or recurrent disease, missing information regarding recurrent or metastatic status, clinical stage I disease, unavailable preoperative clinical staging, missing follow-up time, unknown disease status at last follow-up, death or recurrence within 30 days of resection, or incomplete information regarding the dates of diagnosis, surgery, initiation of neoadjuvant therapy, death, or recurrence (Figure 1). Residual tumor classification R1 or R2 resection were also excluded given the strength of the relationship between microscopic or macroscopic residual tumor and the primary outcome of progression-free survival.

Figure 1:

Flow diagram of study population.

Primary Exposure

The primary exposure was initiation of treatment, defined as either resection or initiation of chemotherapy or chemoradiotherapy, within 60 days of diagnosis. The date of diagnosis was defined as the date of index cancer diagnosis upon which tissue biopsy was obtained.

Outcome

The primary outcome was progression-free survival and the secondary outcome was all-cause mortality. Progression-free survival refers to both local and distal recurrence as defined by the date of radiographic recurrence. Both were calculated from the date of resection.

Covariates

Patient characteristics and comorbid conditions were assessed at the time of surgery. Demographic factors collected included age, sex, race, body mass index (BMI), insurance status, and distance from home residence to treatment center. Co-morbidities were selected a priori as those most likely to influence surgical outcomes and eligibility for medical oncology intervention. These include congestive heart failure (CHF; defined as newly diagnosed or acute exacerbation within 30 days prior to resection), prior cardiac event (defined as angina within 1 month of resection, myocardial infarction within 6 months of resection, coronary intervention at any time, or any major cardiac surgery excluding placement of pacemaker or automated implanted cardioverter defibrillator), smoking history (defined as smoking within 1 year prior to resection), severe chronic obstructive pulmonary disease (COPD; defined as diagnosis of COPD resulting in functional disability, prior hospitalization, chronic bronchodilator use, or FEV1 <75%), diabetes mellitus, or weight loss of > 10% of usual body weight within 6 months prior to resection. Additional factors collected included preoperative clinical stage and order of treatment.

Statistical Analysis

The study was designed to have 80 percent power to detect an absolute difference of 10 percentage points in the rate of recurrence, with a two-sided alpha level of 0.05. The sample size required to detect this difference was 274 patients per group. Patient characteristics were compared for patients whose care was initiated within 60 days of diagnosis versus after 60 days using chi-squared and Wilcoxon rank sum testing. Multivariable logistic regression was used to assess factors associated with delay in initiation of treatment beyond 60 days from date of diagnosis. Cumulative incidence plots and multivariable Cox proportional hazards regression were then used for the primary outcome, which compared the hazard rate of disease recurrence, and the secondary outcome, which compared the hazard rate of all-cause mortality. The covariates included within the regression model were selected a priori based on clinical relevance. Within the survival analysis, patients were censored at either recurrence (primary outcome), death (secondary outcome), or loss to follow-up. All data analysis was performed using Stata Statistical Software version 15.0 (Stata Corp., College Station, TX, USA)

Sensitivity Analyses

Additional sensitivity analyses were performed to determine the impact of initiation of treatment within 15, 30, 45, and 90 days, rather than 60. Given the low number of patients whose treatment was initiated before 15 or after 90 days, these sensitivity analyses were unadjusted. An additional sensitivity analysis was performed to determine if there was a difference in oncologic outcomes based upon first treatment modality. A final sensitivity analysis was performed accounting for post-operative complications and infections within the adjusted model.

Secondary Analysis

To determine the relationship between time to initiation of treatment and R status of resection, we compared the rates of R0 resection between patients undergoing treatment within 60 days of diagnosis and those who underwent treatment after 60 days.

RESULTS

Study Cohort and Characteristics

After applying the exclusion criteria, 1,031 patients were included in the final analytic cohort. The median age was 60 (Interquartile Range [IQR] 51, 68), and the study population was predominantly male (60.4%) and White (87.8%). The majority of patients had either private (56.0%) or government (40.4%) insurance. Most patients (57.9%) lived within 50 miles of the treatment center. Comorbidities were common within the study population; 23.2% of patients smoked within one year of resection, 15.9% had diabetes, and 16.0% experienced weight loss of greater than 10% of usual body weight in the 6 months prior to resection. The majority of patients (89.1%) had pre-operative clinical stage III disease. Most patients (57.3%) underwent neoadjuvant chemoradiation, followed by upfront resection (22.2%), and finally neoadjuvant chemotherapy (20.5%) (Table 1). Of those who underwent upfront resection, 76.4% had pre-operative tumor location in the upper or middle rectum.

Table 1:

Unadjusted patient characteristics for total study population and by time of diagnosis to initiation of treatment.

Patient Characteristics	All Patients N=1,031	Time to Treatment ≤ 60 days N=830	Time to Treatment > 60 days N=201	P-value
Age (years), Median (IQR)	60 (51, 68)	59 (51, 67)	62 (55, 69)	0.001
Sex, N (%)				0.804
Female	408 (39.6)	330 (39.8)	78 (38.8)
Male	623 (60.4)	500 (60.2)	123 (61.2)
Race, N (%)				0.006
White	905 (87.8)	740 (89.2)	165 (82.1)
Non-White	126 (12.2)	90 (10.8)	36 (17.9)
Body Mass Index (kg/m2), Median (IQR)	28.0 (24.0, 32.2)	28.0 (24, 32.3)	27.4 (24.0, 31.4)	0.833
Insurance Status, N (%)				0.011
Private	543 (56.0)	455 (58.3)	88 (46.6)
Government	392 (40.4)	301 (38.5)	91 (48.2)
Uninsured	35 (3.6)	25 (3.2)	10 (5.3)
Missing, N	61	109	12
Distance from home to treatment center				0.039
0 – 50 miles	593 (57.9)	487 (59.2)	106 (52.7)
51 – 100 miles	240 (23.4)	195 (23.7)	45 (22.4)
> 100 miles	191 (18.9)	141 (17.1)	50 (24.9)
Missing, N	7	7	0
Congestive heart failure (CHF), N (%)	19 (1.9)	12 (1.5)	7 (3.6)	0.056
Missing, N	47	39	8
Prior cardiac event, N (%)	70 (7.2)	51 (6.5)	19 (27.1)	0.096
Missing	59	48	11
Smoking history, N (%)	235 (23.2)	194 (23.8)	41 (20.6)	0.333
Missing, N	18	16	1
Severe chronic obstructive pulmonary disease (COPD), N (%)	42 (4.3)	35 (4.4)	7 (3.7)	0.630
Missing, N	49	40	8
Diabetes, N (%)	157 (15.9)	115 (14.5)	42 (21.7)	0.015
Missing, N	45	38	7
Weight loss > 10% of usual body weight over 6 months pre-operatively, N (%)	153 (16.0)	121 (15.7)	32 (17.6)	0.528
Missing, N	37	58	19
Pre-operative clinical stage				0.192
Stage II	112 (10.9)	85 (10.2)	27 (13.4)
Stage III	919 (89.1)	745 (89.8)	174 (86.6)
Pre-operative tumor location				0.552
Mid- or upper rectum	491 (52.6)	404 (53.1)	87 (50.6)
Lower rectum	442 (47.4)	357 (49.4)	85 (49.4)
Missing, N	98
Order of Treatment				0.181
Upfront resection	229 (22.2)	175 (21.1)	54 (26.9)
Neoadjuvant chemoradiation	591 (57.3)	480 (57.8)	111 (55.2)
Neoadjuvant chemotherapy	211 (20.5)	175 (21.1)	36 (17.9)

Missing values excluded from analysis.

Abbreviations: IQR, Interquartile Range

There were 830 patients (80.5%) whose treatment was initiated within 60 days of diagnosis versus 201 patients (19.5%) whose treatment was initiated after 60 days of diagnosis (Table 1 & Figure 2). Patients with treatment initiated after 60 days of diagnosis were more likely to be older, non-White, diabetic, have governmental insurance or uninsured status, and live further from the treatment center (Table 1).

Figure 2:

Histogram demonstrating distribution of time from diagnosis to initiation of treatment or date of resection.

Factors Associated with Delay in Initiation of Treatment

In multivariable logistic regression, factors found to be significantly associated with delay in initiation of treatment beyond 60 days included older age (adjusted Odds Ratio [aOR] 0.98, 95% CI 0.97, 0.99; P=0.022), non-White race (aOR 0.53, 95% CI 0.33, 0.86; P=0.010), and residence greater than 100 miles from treatment center (aOR 0.51, 95% CI 0.33, 0.79; P=0.002). There was no significant association between treatment delay and sex, insurance status, comorbidities, and pre-operative clinical stage (Table 2).

Table 2:

Multivariable logistic regression evaluating factors selected a priori to be associated with delay in initiation of treatment beyond 60 days from date of diagnosis.

	Adjusted Odds Ratio (OR)	95% CI	P-value
Age	0.98	(0.97, 0.99)	0.022
Male Sex	0.89	(0.63, 1.26)	0.514
Non-White Race	0.53	(0.33, 0.86)	0.010
Distance from home to treatment center
0 – 50 miles	Ref	Ref	Ref
51 – 100 miles	0.93	(0.61, 1.41)	0.725
> 100 miles	0.51	(0.33, 0.79)	0.002
Insurance Status
Private	Ref	Ref	Ref
Government	0.91	(0.61, 1.36)	0.635
Uninsured	0.47	(0.21, 1.06)	0.070
Congestive heart failure (CHF)	0.52	(0.18, 1.54)	0.238
Prior cardiac event	0.81	(0.44, 1.49)	0.497
Diabetes	0.80	(0.52, 1.25)	0.327
Pre-operative clinical stage III (Ref: Stage II)	1.30	(0.80, 2.12)	0.289

Time to Recurrence or All-cause Mortality

Disease recurrence was assessed as the primary outcome after adjusting for clinical staging, treatment sequence, distance to care, prior cardiac event, congestive heart failure, diabetes, treatment center, and receipt of adjuvant chemotherapy. The median follow-up time was 33.2 months (IQR 14.7, 56.4). The median 5-year overall survival was 87.1% (95% CI 84.7, 89.3), with median 5-year overall survival of 87.2% (95% CI 84.4, 89.6) among those treated within 60 days and 86.7% (95% CI 80.7, 91.2) among those treated after 60 days. The median time to recurrence was 16 months (IQR 9, 27), with median time to recurrence of 16 months (IQR 10, 27) among those treated within 60 days and 14 months (IQR 8, 27) among those treated after 60 days. When compared to those patients whose treatment was initiated after 60 days, the adjusted hazard ration (aHR) of disease recurrence among those patients whose treatment was initiated within 60 days was 1.09 (95% CI 0.70, 1.69; P=0.718) (Table 3). For the secondary outcome of all-cause mortality, among patients whose treatment was initiated within 60 days, there was an adjusted hazard ratio (aHR) of 1.03 (95% CI 0.63, 1.66; P=0.921) compared to those patients whose treatment was initiated after 60 days. Kaplan-Meier curves for both outcomes are demonstrated in Figure 3.

Table 3:

Adjusted Cox regression for hazard ratio of disease recurrence or all-cause death based on time to initiation of treatment adjusted for pathologic staging, treatment sequence, distance to care, age, prior cardiac event, congestive heart failure, diabetes, treatment center, and receipt of adjuvant chemotherapy.

	Primary Outcome: Disease Recurrence	Secondary Outcome: All-Cause Mortality
Time to Treatment ≤ 60 days (Ref: Time to Treatment > 60 days)
Unadjusted Hazard Ratio (HR)	0.99	0.92
95% Confidence Interval	(0.66, 1.47)	(0.59, 1.42)
P-value	0.949	0.695
Adjusted Hazard Ratio (HR)	1.09	1.03
95% Confidence Interval	(0.70, 1.69)	(0.63, 1.66)
P-value	0.718	0.921

Figure 3:

Kaplan-Meier curves for probability of (A) disease recurrence and (B) overall survival based on time to initiation of treatment from date of diagnosis.

Sensitivity Analysis

Multiple sensitivity analyses were conducted to test the robustness of the results to changes in the definition of the exposure by varying the window for treatment initiation to 15, 30, 45, and 90 days. These yielded results similar to those from the main analysis. An additional sensitivity analysis was performed to test difference in survival by first treatment modality and similarly found no significant difference in either disease recurrence or all-cause mortality. Furthermore, as there is evidence that post-operative complications, particularly infection, is associated with worsened cancer-specific outcomes, an additional sensitivity analysis was performed which included within the regression model any post-operative complication or post-operative intra-abdominal. This found no significant difference in either disease recurrence or all-cause mortality. All three sensitivity analyses have been included as Supplementary Tables 1–3.

Secondary Analysis

In an unadjusted analysis, initiation of treatment beyond 60 days was strongly associated with R1/R2 resection (R0: 19.5% vs. R1/R2: 34.0%; P = 0.029).

DISCUSSION

This large multicenter, retrospective cohort study found no difference in disease recurrence or all-cause mortality based on initiation of treatment for rectal cancer within 60 days of diagnosis. Factors associated with initiation of rectal cancer treatment beyond 60 days included age, non-White race, and residence greater than 100 miles from the treatment center. This study is unique in that is specific to rectal cancer and includes disease recurrence, rather than overall survival, as the primary outcome. Given the relatively favorable overall survival for rectal cancer, presentation of disease recurrence is a clinically relevant outcome that is novel compared to the literature published out of the National Cancer Database. The findings presented here call into question the clinical relevance of current NAPRC guidelines surrounding timeliness of care.

Multiple retrospective cohort studies have found no association between delay in treatment and overall survival among patients with colon and rectal cancers.^12,14,15 However, much of the work evaluating the impact of timeliness of treatment upon cancer-specific outcomes has been focused on colon, rather than rectal, cancer.^11,16,17,18 A recent study by Delisle, et al. evaluated the association between time to treatment and health care costs and overall mortality in a population-based retrospective cohort in Canada.¹⁹ Patients diagnosed with colorectal cancer between 2004 and 2014 were ranked into quintiles based on the time from diagnosis to treatment. Longer wait times were associated with a significantly lower risk of mortality compared to very short and short wait times, and overall mortality was similar among patients with moderate, long, and very long wait times. Of note, patients with rectal cancer experienced almost double the wait time compared to those with colon cancer, emphasizing the increasing divergence of management between colon and rectal cancers. Given the need for neoadjuvant treatment among stage II/III rectal cancers versus upfront resection for colon cancers, rectal cancer management involves more complex, multidisciplinary decision-making and should be evaluated independently. Therefore, the present study is unique in that it only includes patients with rectal cancer in order to evaluate the impact of timeliness of treatment upon cancer-specific outcomes.

There are several possible explanations for the lack of association between delayed treatment initiation and progression-free survival and all-cause mortality. Increased time to treatment initiation has been associated with lower survival among many cancer types, including breast, lung, and pancreas cancers.^20,21,22 However, given that colorectal tumorigenesis typically occurs over years prior to the development of clinical symptoms²³, the present study suggests that a delay in treatment beyond 60 days may not be detrimental to oncologic outcomes. In fact, while prior data suggest that patients who receive multidisciplinary rectal cancer care at a high-volume center have improved oncologic outcomes²⁴, high-volume centers have also been associated with longer time to initiation of treatment.²⁵ Therefore, if high-volume centers have improved oncologic outcomes with prolonged time to treatment, the present study questions whether treatment initiation within 60 days should be included as an NAPRC metric applicable to multiple types of practice settings. Instead, it suggests that coordinated, multidisciplinary care should be prioritized over simply expediting time to treatment. Based on the assumption of clinical relevance, alternative metrics such as presentation in multidisciplinary case conference within three weeks of initial evaluation could be considered instead of timeliness alone.

Additionally, the time period between diagnosis and initiation of treatment may serve as a crucial point of intervention for pre-operative nutritional and functional optimization. Prior studies have demonstrated that post-operative complications among patients with rectal cancer are associated with delayed adjuvant chemotherapy²⁶, and subsequently with worse progression-free survival and overall survival.²⁷ Furthermore, prospective data demonstrate that pre-operative “pre-habilitation” programs are associated with improved oncologic outcomes among patients with colorectal cancer likely through the mechanism described by Tevis, et al.²⁸ The time from diagnosis to treatment initiation is thus an important window during which thoughtful, coordinated care can impact long-term cancer outcomes and should not be measured by timeliness alone.

As outlined in the 2001 Institute of Medicine report “Crossing the Quality Chasm”²⁹, timeliness is one of the six core domains of healthcare quality. While NAPRC recommends that definitive treatment is initiated within 60 days of clinical evaluation,⁹ the National Health Service (NHS) Cancer Reform Strategy recommends that all patients with rectal cancer be treated within 62 days of referral.³⁰ This highlights how these targets need to be tailored to individual populations and the health systems. One important consideration is the relationship between time to treatment and patient anxiety, as one could imagine that timely treatment would result in reduced distress. However, the association between patient perception of diagnostic or treatment delay and cancer-related distress so far remains inconclusive in survey-based analyses among patients with colorectal cancer.^31,32 Another important consideration is the health care utilization and costs associated with longer wait times, as longer wait times have been associated with higher costs without incremental survival benefit.¹⁹ Certainly, use of timeliness as a benchmarking index incentivizes systems and providers to efficiently coordinate multidisciplinary care. Finally, it is important to acknowledge that a significant delay in treatment can lead to stage migration with need for restaging to assess for both local and distant disease. While these data suggest that providers can safely ensure pre-operative optimization before initiation of treatment, we do not advocate for longer delays that could allow for stage progression.

While acknowledging that timeliness should not serve the sole indicator of quality rectal cancer care, the disparities identified here in timely initiation of treatment may be an indicator of disparate access to care. In an analysis adjusted for comorbid conditions and insurance status, older age, non-White race, and increased distance to treatment center were all significantly associated with initiation of treatment beyond 60 days. While there are many possible explanations for this association, it does not appear to be solely attributable to either insurance status or comorbidities. Therefore, providers, policymakers, and hospital systems alike may need to think of creative solutions to decrease barriers to timely access. Liu and Ko have proposed innovative solutions such as patient care navigators assigned specifically to certain at-risk populations or inclusion of social workers or geriatricians within multidisciplinary tumor board.³³

This study has several limitations. First, it is a retrospective review and is therefore limited to the content and accuracy of the data within the electronic health record as well as subject to selection bias. However, the study does account for potential confounders such as age, race, distance to care, cancer stage, treatment sequence, and adjuvant chemotherapy in order to minimize this limitation. Second, while NAPRC guidelines define that definitive treatment be initiated within 60 days of clinical evaluation at the accredited treatment center, the current study measured time to treatment from the date of definitive diagnosis as this was more consistent in the database. Third, the study population was predominantly White, insured (either private or governmental insurance), resided within 50 miles of the treatment centers, and received care at one of six high-volume treatment centers, which may limit the generalizability of the findings to other study populations. Additional studies in more racially and socioeconomically diverse patient populations are certainly needed to determine if these findings are widely applicable. Fourth, there was a population of patients who underwent upfront resection for clinical stage II or III disease, the majority of whom had disease in the middle or upper rectum. These patients may have been initially treated as rectosigmoid cancer, thus with distinct multidisciplinary pre-operative care. Next, while the median follow-up time was only 33.2 months, the majority of recurrence for rectal cancer occurs within one year of resection. Finally, given that this was a negative study, there is potential that it lacked sufficient power to detect a difference or that the study selected the incorrect outcomes. However, there is little separation of the Kaplan-Meier curves, making inadequate power less likely, and certainly recurrence and mortality are standard outcomes for any oncologic study.

The demonstrated lack of association between cancer-specific outcomes and timely initiation of rectal cancer treatment calls into question the cutoff of 60 days as a national accreditation standard for rectal cancer programs. Additional larger, population-based cohort studies are required to determine if there is a time period beyond which delay in treatment is associated with worse cancer-specific outcomes. Certainly, timeliness is an important quality measure within any practice or health care system. However, in the context of increasingly complex management of rectal cancer, these data suggest that the focus should be shifted away from timeliness of treatment initiation to more patient-centered outcomes such as patient education, family engagement, and optimization of nutritional and medical comorbidities prior to surgery or neoadjuvant treatment. While timeliness is an important consideration from a patient perspective, more emphasis should be placed on multidisciplinary care coordination and patient- and cancer-specific outcomes rather than timeliness alone.

CONCLUSION

This large multicenter, retrospective cohort study observed no difference in disease recurrence or all-cause mortality based on initiation of treatment for rectal cancer within 60 days of diagnosis. Factors associated with delayed initiation of rectal cancer treatment beyond 60 days included age, non-White race, and residence greater than 100 miles from treatment center. These data call into question the cutoff of 60 days as a national accreditation standard for rectal cancer programs.

This large multicenter, retrospective cohort study observed no difference in disease recurrence or all-cause mortality based on initiation of treatment for rectal cancer within 60 days of diagnosis. The importance of this finding is that it questions the cutoff of 60 days as a national accreditation standard for rectal cancer programs.