The Influence of Patient and System Factors on the Radiotherapy Treatment Time in the Treatment of Non-metastatic Cervical Cancer Patients in a Rural and Resource-Lean State's Safety-Net Hospital: Benefits of Strategic Planning.

Objective To decrease radiotherapy treatment time (RTT), measured from the day of initiation of radiotherapy to the day of its completion, specific strategies were initiated in early 2020 in the only academic safety-net medical center in a rural, resource-lean state. The factors that can succeed and those that need further improvements were analyzed in this initial assessment phase of our efforts to shorten the RTT. Methods This is an analysis of 28 cervix cancer patients treated with magnetic resonance imaging (MRI)-guided brachytherapy (February 2020-November 2021). The relationship between independent and dependent variable were analyzed by simple linear regression, and p-values ≤ 0.05 were considered statistically significant. SPSS software version 28.0 (IBM, Armonk, NY, USA) was used for statistical analysis. Results Two RTT groups (≤ 60 (32.1%) vs. > 60 days {67.9%}) with median RTT of 68 days (range, 51 to 106 days) were analyzed. Caucasians represented 66.7% of the RTT ≤ 60 days group. Four 'issues' were identified that increased the RTT: non-compliance, learning curve (early days of implementation of MRI-guided brachytherapy in the department), stage IV comorbidities, and with more than one issue mentioned; 77.8% with no issues had ≤ 60 days RTT vs. 26.3% for the > 60 days group. The breakdown of the no-issues factor by calendar year showed the RTT of ≤ 60 days was achieved higher in 2021 (85.7% vs. 20.0%; p=0.023) compared to 2020. For this entire cohort, the RTT of ≤ 60 days was achieved higher in 2021 (50.0% vs. 8.3%; p=0.019) compared to 2020. Data also showed improvement in RTT of ≤ 60 days for every sequential six months. 'Non-compliance' and 'learning curve' were the most important factors among patients having the longest RTTs. Conclusion The RTT can be further decreased. As a result of this preliminary analysis of the our strategic planning approach of 'circular' "See it," "Own it," "Solve it," and "Do it" and go back to the first step again, we plan to implement the following strategies in the immediate future to shorten the RTTs further and, in turn, improve our overall outcomes (local/regional control, disease-free survival, and overall survival): (a) Interdigitate MRI-guided brachytherapy during external beam radiotherapy (EBRT); patients who can not get the interdigitated brachytherapy procedures performed during the course of EBRT for any reason will receive two brachytherapy procedures per week; (c) attempt to add a cervix cancer care navigator to our staff to help patients having social issues, thus leading to compliance problems; (d) finally, in a year or two after these new strategic implementations, the RTT data will be reanalyzed.

Real World and Public Health Perspectives of Intraoperative Radiotherapy in Early-Stage Breast Cancer: A Multidisciplinary Analysis Beyond the Statistical Facts.

Breast conservation therapy (BCT) (usually a lumpectomy plus radiotherapy (RT)) has become a standard alternative to radical mastectomy in early-stage breast cancers with equal, if not higher, survival rates. The established standard of the RT component of the BCT had been about six weeks of Monday through Friday external beam RT to the whole breast (WBRT). Recent clinical trials have shown that partial breast radiation therapy (PBRT) to the region surrounding the lumpectomy cavity with shorter courses can result in equal local control, survival, and slightly improved cosmetic outcomes. Intraoperative RT (IORT) wherein RT is administered at the time of operation for BCT to the lumpectomy cavity as a single-fraction RT is also considered PBRT. The advantage of IORT is that weeks of RT are avoided. However, the role of IORT as part of BCT has been controversial. The extreme views go from "I will not recommend to anyone" to "I can recommend to all early-stage favorable patients." These divergent views are due to difficulty in interpreting the clinical trial results. There are two modalities of delivering IORT, namely, the use of low-energy 50 kV beams or electron beams. There are several retrospective, prospective, and two randomized clinical trials comparing IORT versus WBRT. Yet, the opinions are divided. In this paper, we try to bring clarity and consensus from a highly broad-based multidisciplinary team approach. The multidisciplinary team included breast surgeons, radiation oncologists, medical physicists, biostatisticians, public health experts, nurse practitioners, and medical oncologists. We show that there is a need to more carefully interpret and differentiate the data based on electron versus low-dose X-ray modalities; the randomized study results have to be extremely carefully dissected from biostatistical points of view; the importance of the involvement of patients and families in the decision making in a very transparent and informed manner needs to be emphasized; and the compromise some women may be willing to accept between 2-4% potential increase in local recurrence (as interpreted by some of the investigators in IORT randomized studies) versus mastectomy. We conclude that, ultimately, the choice should be that of women with detailed facts of the pros and cons of all options being presented to them from the angle of patient/family-focused care. Although the guidelines of various professional societies can be helpful, they are only guidelines. The participation of women in IORT clinical trials is still needed, and as genome-based and omics-based fine-tuning of prognostic fingerprints evolve, the current guidelines need to be revisited. Finally, the use of IORT can help rural, socioeconomically, and infrastructure-deprived populations and geographic regions as the convenience of single-fraction RT and the possibility of breast preservation are likely to encourage more women to choose BCT than mastectomy. This option can also likely lead to more women choosing to get screened for breast cancer, thus enabling the diagnosis of breast cancer at an earlier stage and improving the survival outcomes.

Strategic Reduction of Package Time in Head and Neck Cancer.

Purpose: Total package time, or the time from diagnosis to completion of definitive treatment, has been associated with outcomes for a variety of tumor sites, but especially to head and neck (HN) cancer. Patients with HN cancer often undergo a complex diagnosis and treatment process involving multiple disciplines both within and outside of oncology. This complexity can lead to longer package times, and each involved discipline has the responsibility to maintain an efficient and effective process. Strategic intervention to improve package time must involve not only new technology or tools, but also "soft" components such as accountability, motivation, and leadership. This combination is necessary to truly optimize radiation therapy for HN cancer, leading to shorter total package times for these patients. Methods and Materials: Two interventions were strategically executed to improve radiation therapy workflow: upgrade of the treatment planning system and implementation of an automated patient management and accountability system. The radiation therapy-related timelines of 112 patients with HN cancer treated over 2 years were reviewed, and the average time differences were compared between the patient populations before and after the strategic interventions. Results: Purely upgrading the treatment planning system did not show significant improvements, but when combined with the patient management system, significant improvement in radiation-related package time can be noted for every time point. The overall reduction of radiation-related package time was statistically significant at 22.85 days (P = .002). Conclusions: On face value, the patient management system could be credited as responsible for the improvement, but on qualitative analysis, it is noted that the new system is only a tool that can be ignored or underused. Owing to the addition of important "soft" components such as accountability, motivation, and leadership, the patient management system was optimized and implemented in such a manner as to have the desired effect.

Single Institution Experience of Stereotactic Body Radiation Therapy in Non-small Cell Lung Cancer: Comparison of Two Dose Regimes and a Perspective on Ideal Dose Regimens.

Introduction Stereotactic body radiation therapy (SBRT) is an effective treatment for early-stage non-small cell lung cancer (NSCLC) patients who are either medically inoperable or who decline surgery. SBRT improves tumor control and overall survival (OS) in medically inoperable, early-stage, NSCLC patients. In this study, we investigated the effectiveness of two different SBRT doses commonly used and present our institutional experience. Purpose To determine the clinical outcomes between two treatment regiments (50 Gray [Gy] vs. 55 Gy in five fractions) among Stage I NSCLC patients treated with SBRT at a state academic medical center. Methods We performed a retrospective analysis of 114 patients with Stage I (T1-2 N0 M0) NSCLC treated at a state academic medical center between October 2009 and April 2019. Survival analyses with treatment regimens of 50 Gy and 55 Gy in five fractions were conducted to detect any improvement in outcomes associated with the higher dose. The primary endpoints of this study included OS, local control (LC), and disease-free survival (DFS). Log-rank test and the Kaplan-Meier method were used to analyze the survival curves of the two treatment doses. The SPSS v.24.0 (IBM Corp., Armonk, NY, USA) was used for statistical analyses. Results The 114 early-stage NSCLC patients (median age, 68 years; range 12 to 87 years) had a median follow-up of 25 months (range two to 86 months). The number of males (n = 72; 63.2 %) exceeded the number of females (n = 42; 36.8 %). The majority of patients in this study were Caucasians (n = 68; 59.6 %) and 46 patients were African Americans (40.4 %). Two-thirds of the patients (n = 76; 66.7 %) were treated with 50 Gy in five fractions, and 38 patients (33.3 %) with 55 Gy in five fractions. The one-, two-, and three-year OS and DFS rates were improved in the patients treated with 55 Gy [OS, 81.7 % vs. 72.8 %; 81.7 % vs. 58.9 %; 81.7 % vs. 46.7 % (p = 0.049)], [DFS, 69.7 % vs. 69.7 %; 61.9 % vs. 55.7 %; 61.9 % vs. 52.0 % (p = 0.842)], compared to those treated with 50 Gy. Adenocarcinoma was the most common histology in both groups (51.3 % and 68.4 %). Failure rates were elevated for the 50 Gy regimen [39 (34.2 %) vs. 12 (8.5 %)]. Three year control rates were (66.3 % vs. 96.6 %; p = 0.002) local control; (63.3 % vs. 94.4 %; p = 0.000) regional control; and (65.7 % vs. 97.1 %; p = 0.000) distant control, compared to those treated with 55 Gy. Conclusion Early-stage NSCLC patients treated with SBRT 55 Gy in five fractions did better in terms of local control, overall survival, and disease-free survival rates compared to the 50 Gy in five fractions group.

Predictors of Extracapsular Extension in Patients With Squamous Cell Carcinoma of the Head and Neck and Outcome Analysis.

Introduction Extracapsular extension (ECE) in the lymph nodes for patients with head and neck cancer has been found to be a poor prognostic factor in multiple studies. The purpose of the study is to evaluate the predictive factors for ECE on computer tomography (CT) imaging for patients undergoing surgery and to analyze outcomes. Methods We conducted an Institutional Review Board-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective review of 82 patients with biopsy-proven squamous cell carcinomas of the head and neck who underwent definitive surgery without neoadjuvant chemotherapy or radiation therapy. CT scans were evaluated for the level of involvement, size, and presence or absence of central necrosis. Extracapsular extension in lymph nodes on the postoperative pathology was correlated with the central necrosis in the lymph nodes appreciated on the CT neck with contrast. Survival estimates were evaluated using the Kaplan-Meier test. Results ECE on postoperative pathology was seen in 74.07% of patients who had evidence of central necrosis in lymph nodes on preoperative CT neck compared to 46.43% without CT necrosis (p=0.013). The incidence of ECE is higher in poorly differentiated tumors and also nodal stages >N2c at presentation. Patents with ECE had inferior disease-free and overall survival (OS). Conclusions Our results reveal that patients with necrosis on CT and with moderately to poorly differentiated tumors have a high incidence of extracapsular extension. There was no difference in local control (LC) between the groups of patients, but the OS was inferior in patients with ECE. Predicting extracapsular extension upfront helps to formulate the appropriate treatment. We propose to study additional chemotherapy to improve outcomes in patients with positive extracapsular extension.

The Will Rogers phenomenon, breast cancer and race.

BACKGROUND: The Will Rogers phenomenon [WRP] describes an apparent improvement in outcome for patients' group due to tumor grade reclassification. Staging of cancers is important to select appropriate treatment and to estimate prognosis. The WRP has been described as one of the most important biases limiting the use of historical cohorts when comparing survival or treatment. The main purpose of this study is to assess whether the WRP exists with the move from the AJCC 7th to AJCC 8th edition in breast cancer [BC] staging, and if racial differences are manifested in the expression of the WRP. METHODS: This is a retrospective analysis of 300 BC women (2007-2017) at an academic medical center. Overall survival [OS] and disease-free survival [DFS] was estimated by Kaplan-Meier analysis. Bi and multi-variate Cox regression analyses was used to identify racial factors associated with outcomes. RESULTS: Our patient cohort included 30.3% Caucasians [Whites] and 69.7% African-Americans [Blacks]. Stages I, II, III, and IV were 46.2, 26.3, 23.1, and 4.4% of Whites; 28.7, 43.1, 24.4, and 3.8% of Blacks respectively, in anatomic staging (p = 0.043). In prognostic staging, 52.8, 18.7, 23, and 5.5% were Whites while 35, 17.2, 43.5, and 4.3% were Blacks, respectively (p = 0.011). A total of Whites (45.05% vs. 47.85%) Blacks, upstaged. Whites (16.49% vs. 14.35%) Blacks, downstaged. The remaining, 38.46 and 37.79% patients had their stages unchanged. With a median follow-up of 54 months, the Black patients showed better stage-by-stage 5-year OS rates using 8th edition compared to the 7th edition (p = 0.000). Among the Whites, those who were stage IIIA in the 7th but became stage IB in the 8th had a better prognosis than stages IIA and IIB in the 8th (p = 0.000). The 8th showed complex results (p = 0.176) compared to DFS estimated using the 7th edition (p = 0.004). CONCLUSION: The WRP exists with significant variability in the move from the AJCC 7th to the 8th edition in BC staging (both White and Black patients). We suggest that caution needs to be exercised when results are compared across staging systems to account for the WRP in the interpretation of the data.

Factors Affecting Outcomes in Patients With Stage III & IV Squamous Cell Carcinoma of Oropharynx: The Importance of p16 Status, BMI, and Race.

Objective To identify racial disparities in survival outcomes among Stage III & IV patients with squamous cell carcinomas (SCCa) of the oropharynx treated with definitive radiation therapy (RT), with concurrent chemotherapy. Method This is a retrospective analysis of patients with stage III & IV SCCa of oropharynx treated with definitive RT at the State Academic Medical Center. All patients were treated to 70 Gy utilizing intensity-modulated radiation treatment (IMRT), and received concurrent chemotherapy with weekly cisplatin or cetuximab. Chi-square test was used to test the goodness of fit, overall survival (OS), and locoregional control (LRC) comparing races were generated by using Log-rank test & Kaplan-Meier method. The covariables associated with the OS and LRC were determined by the Cox regression model. A p-value of less than 0.05 was considered statistically significant. The SPSS 24.0 software (IBM Corp., Armonk, NY) was used. Results In the total 73 eligible patients, 54.8% were black, and 45.2% white patients. Stage distribution (per American Joint Committee on Cancer-AJCC 8th Ed) between black patients vs. white patients, Stage III (45.5% vs. 54.5%) and for Stage IV (56.5% vs. 43.5%); p=0.499. Median follow-up for the entire group was 41 months (range: 4-144 months). In the univariate analysis, variables p16 status, body mass index (BMI), alcohol history and tumor subsite were found to be significant. In the multivariate analysis, only BMI has shown to be significant. Three-year LRC for black patients was 37.8% vs.66.8% in white patients (p=0.354) and three-year OS for black patients was 51.8% vs. 80.9% for white patients (p=0.063), respectively. Five-year OS for p16 positive patients was 69.7% vs. 43% for p16 negative patients (p=0.034). Five-year OS for Stage IV black patients was 34% vs. 69.5% for Stage IV white patients (p=0.014). Conclusion Among all the co-variables examined, only BMI has shown affecting the OS outcomes; gender and BMI shown to be affecting the LRC. Racial factor appears to be significant in Stage IV patients.

Quality-Adjusted Life Years and Disability-Adjusted Life Years Are Better With Concurrent Chemoradiation Therapy Than Induction Chemotherapy Followed by Chemoradiation Therapy in Nasopharyngeal Carcinoma.

Introduction As traditional measures such as overall survival (OS) or disease-free survival (DFS) alone do not give a holistic view of the outcomes of a treatment paradigm, we determine to add the evidence of quality-adjusted life year (QALY) and disability-adjusted life year (DALY) to the outcomes of the nasopharyngeal carcinoma patients (NCP) treated with definitive chemoradiation therapy (chemoRT) with or without induction chemotherapy (induction chemo). Methods This is a retrospective analysis of 85 NCPs treated at an academic state institution. The OS estimated by the Kaplan-Meier method and the multivariate Cox regression model determined the co-variables associated with the OS. The relationship between QALYs gained and DALYs saved were calculated from age of the disease onset, duration of the disease, quality of life (QoL) and disability weights. Results Of the 85 eligible NCPs of this cohort, the disease frequency distribution per the World Health Organization (WHO) classification was 41.2% for Type-I, 42.4% for Type-II, and 16.5% for Type-III. The median follow-up (24 months). The five-year OS of patients treated with concurrent chemoRT vs. induction chemo followed by concurrent chemoRT was 54.7 vs. 14.8% for WHO Type I, 60.1 vs. 58.3% for WHO Type II, and 83.3 vs. 50.0% for WHO Type III (p=0.029). The average DALYs saved with concurrent chemoRT were 12.2 years vs. 5 years for induction chemo followed by concurrent chemoRT. The average QALYs gained with concurrent chemoRT were 6.9 years vs. 3.1 years for induction chemo followed by concurrent chemoRT. Conclusion Patients treated with concurrent chemoRT had an increased QoL when compared to induction chemo followed by concurrent chemoRT. The average DALYs saved were higher in the patients treated with concurrent chemoRT than treated with induction chemo followed by concurrent chemoRT.

A 25-year Experience at an Academic Medical Center in the United States: Are There Racial Disparities in the Prognosis of Patients Diagnosed With Hypopharyngeal Carcinoma?

Introduction This study attempted to identify disparities in outcomes between African American (AA) and Caucasian American (CA) patients treated for hypopharyngeal carcinoma at a tertiary care institution over the past 25 years. Methods An institutional review board (IRB)-approved and Health Insurance Portability and Accountability Act (HIPPA)-compliant retrospective analysis was performed on patients with squamous cell carcinoma of the hypopharynx treated at our institution between January 1994 and December 2018. Data regarding demographics, stage, treatment, and follow-up were collected. Outcomes, including median survival and overall survival, were calculated using the Kaplan-Meier method. All analyses were performed using the Social Packages for the Social Sciences (SPSS) v. 24 (IBM Corp., Armonk, NY). Results We identified 144 hypopharyngeal carcinoma patients who were treated during this period. Our patient cohort consisted of 61.8% AA and 35.4% CA (P=0.538). Overall, 96% of them presented at an advanced stage (Stages III & IV) of the disease, and only 4% presented in the early stages (Stages I & II). There was no significant difference between AA and CA patients who presented with advanced disease (96.6% vs. 94.1%). In our patient cohort, 15.3% of patients did not receive any therapy; however, 51.4%, 22.9%, and 10.4% of them underwent definitive chemoradiotherapy, definitive surgery, or palliative chemotherapy, respectively. There were no significant differences in patient racial proportions within each treatment group. The median follow-up of the entire cohort was 13 months. There was no significant difference between the median survival of AA and that of CA patients (16 months vs. 15 months; p=0.917). Moreover, there was no significant difference in the overall survival between AA and CA patients at three years (27.2% vs. 36.3%; p=0.917) and five years (20.4 % vs. 16.7 %; p=0.917). Conclusions A retrospective review of patients with hypopharyngeal cancer treated at our institution over the previous 25 years did not identify significant racial disparities regarding the stage at presentation or prognosis. This study suggests that when patients have equal access to care, they appear to have a similar prognosis despite racial differences. Further studies are needed to validate this hypothesis.