Adjuvant and neoadjuvant treatment: immunotherapy, radiation chemotherapy

8541 Background: Approximately one-third of patients with Stages I–III resected non-small-cell lung cancer (NSCLC) do not survive 5 years from diagnosis. This retrospective observational study analyzed factors associated with OS and real-world (rw) RFS among Stage I–III NSCLC patients before the introduction of immuno-oncology (IO) treatment. Methods: We analyzed data from the US CancerLinQ database for adult patients with no known EGFR mutations and no other cancers, who were diagnosed with Stage I–III NSCLC from 2014–2019 and had surgical resection within 140 days after initial diagnosis. 3081 patients met the study criteria of whom 1677 were Stage I, 853 were Stage II, and 551 were Stage III; 4 Stage I patients who received neoadjuvant or perioperative treatment were excluded (too few for analysis). Most patients received surgery only (71.5%); the rest also received adjuvant (24.7%), neoadjuvant (2.4%) or perioperative (1.5%) treatment, most often chemotherapy ± radiotherapy. Key demographics, clinical characteristics, treatment patterns, and relevant 2-way interactions were considered for inclusion in the model, based on Cox regression analyses and medical insights. Multivariable Cox regression analysis (backwards selection, p<0.05) was used to model OS and rwRFS. Results: In the multivariable analyses (in which no Stage I patients with neoadjuvant or perioperative treatment were included), factors associated with both OS and rwRFS (p<0.05) were disease stage, race, ethnicity, year of diagnosis, ECOG performance status, and neoadjuvant treatment. Factors associated with OS (p<0.05), but not rwRFS, were age, sex, time from diagnosis to surgery, and type of surgery. Factors associated with rwRFS (p<0.05), but not OS, were geographic region, nodal status, and adjuvant treatment in Stage II and III patients but not Stage I patients. Conclusions: This study identified several risk factors associated with OS and rwRFS, many of which are known. Notably, in this analysis, neoadjuvant treatment was associated with both improved OS and rwRFS in Stage II–III patients and was not evaluable in Stage I patients. However, adjuvant treatment was only associated with improved rwRFS, and only in Stage II–III patients. Based on these findings, there remains an unmet need for Stage I–III NSCLC patients. The recent introduction of IO treatment in this setting may help improve patient outcomes.

Background: Clinical staging of HER2+ early-stage breast cancer (eBC) is key to patients receiving appropriate care. Patients categorized as high-risk are at increased risk of recurrence, hence neoadjuvant treatment is recommended for these patients. With the advent of novel antibody drug conjugates for treatment of high-risk HER2+ eBC, it is important to understand risk-status assessment and current treatment landscape. This real-world study aimed to describe the incidence of high-risk HER2+ eBC, treatment patterns and rates of recurrence with distant metastases during the follow-up period within community oncology settings in the United States (US). Methods: A retrospective study utilizing electronic medical record data from The US Oncology Network was conducted. Adult (≥21 years) patients with diagnosis of HER2+ eBC and not enrolled in a clinical trial between 01/01/2017 and 03/31/2023 (earliest diagnosis date as index date) were included in the study and were followed until 09/30/2023. Risk assessment was defined as high risk (Tumor size: T0-T4, nodal involvement: N1-3, distant metastases: M0), moderate to high risk (T2, N0, M0), or low risk (T1a-T1c, N0, M0). Incidence of high-risk HER2+ eBC, patient characteristics, neoadjuvant and adjuvant treatment patterns, and rates of distant metastases during the follow-up period were analyzed descriptively. Among high-risk HER2+ eBC patients, factors associated with receipt of neoadjuvant treatment were assessed using multivariable logistic regression. Results: 5,487 HER2+ eBC patients met study criteria, of which 4,125 had documented TNM staging. Among the 4,125 patients with available risk assessment, 38% were high-risk (n=1,567), 24.6% were moderate to high risk (n=1,016) and 37.4% were low risk (n=1,542). High-risk HER2+ eBC patients had a mean (SD) age of 56.6 (14.1) years, were majority White (n=967, 61.7%), with nodal involvement (n=1,413, 90.17%) and postmenopausal (n=909, 58%). Neoadjuvant and adjuvant treatments were initiated among 62.6% (n=981) and 91.4% (n=1,432) of high-risk patients, respectively. Of high-risk patients with neoadjuvant treatment (n=981), majority received TCHP (docetaxal + carboplatin + trastuzumab + pertuzumab) regimen (n=807, 82.3%). Of those with adjuvant treatment (n=1,432), about 35.9% (n=514) received trastuzumab+pertuzumab based regimen (±hormonal therapy), 22% (n=318) received T-DM1 and 14.4% (n=206) received TCHP. During the follow-up period (median 31.9 months), 4.6% (n=45) of high-risk patients with neoadjuvant treatment progressed to distant metastases compared to 10.9% (n=64) of high-risk patients without neoadjuvant treatment. Multivariable logistic regression model adjusting for age, race, practice location, menopausal status, and hormone receptor status revealed that older high-risk patients, those in perimenopausal phase (vs. premenopausal) were less likely to receive neoadjuvant treatment; whereas patients with a negative hormone receptor status (vs. positive) were more likely to receive neoadjuvant treatment (p-value <0.05). Conclusion: In this large sample of real-world HER2+ eBC patients treated in the US community practice setting, over one-third of patients met criteria of being at a high-risk of recurrence. Neoadjuvant treatment for these patients primarily comprised of dual HER2 targeted treatment and two different chemotherapies and adjuvant treatment varied. Despite established guidelines for preoperative systemic therapy for high-risk HER2+ eBC patients, many patients did not initiate neoadjuvant treatment and had higher rates of metastases, demonstrating unmet need and opportunity to improve health outcomes. Citation Format: Sandhya Mehta, Michael Danso, Ila Sruti, Karen Todoroff, Carlos Yugar, Paul Conkling. Incidence and Treatment Patterns of High-Risk HER2+ Early-Stage Breast Cancer Patients in the United States Community Oncology Setting [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P3-11-09.

Recent studies have reported a beneficial role of trastuzumab in neoadjuvant treatment (NAT) among resectable gastric cancer (GC) patients; however, the effect of adjuvant treatment (AT) combined with trastuzumab is understudied. We performed a retrospective cohort study to compare chemotherapies with or without trastuzumab among human epidermal growth factor receptor 2-positive (HER2 +) locally advanced GC patients in the AT and NAT settings, respectively. We enrolled 208 HER2 + resected GC patients who underwent perioperative/postoperative treatment in 2010-2019 in a single-centered hospital, including 135 AT patients and 73 NAT patients. We used inverse probability of treatment weighting (IPTW) to balance potential confounding factors between the treatment groups, and estimated the treatment effect of trastuzumab. Pathological and survival outcomes were evaluated. The number of trastuzumab-exposed patients in the AT and NAT cohorts was 31 (23.0%) and 34 (46.6%), respectively. After IPTW adjustment, AT combined with trastuzumab showed a better overall survival (OS) over chemotherapy alone (p = 0.023). In IPTW-adjusted NAT analysis, trastuzumab-exposed patients had an improvement in tumor pathological regression and downstaging, with lower tumor regression grade scores (p = 0.002), ypTNM stages (p < 0.001), ypN stages (p = 0.035), and ypT stages (p < 0.001). Loss of HER2 positivity following trastuzumab treatment was observed in NAT patients; however, we did not observe any significant effect of trastuzumab on OS (p = 0.126). Given the improvement in tumor regression and downstaging among NAT patients, and the OS benefit in AT patients, trastuzumab could be considered a promising treatment for locally advanced HER2 + GC patients. In particular, re-evaluation of HER2 status should be considered following NAT combined with trastuzumab.

Adjuvant and neoadjuvant treatment for breast cancer (BC) such as chemotherapy and radiotherapy can lead to immune system impairment. Exercise is hypothesized to mitigate these effects by modulating immune responses and reducing chronic inflammation. This review aims to summarize the existing evidence on the impact of physical exercise on inflammatory markers and cellular immune function in patients with BC during prehabilitation, adjuvant or neoadjuvant treatment. A systematic literature search was conducted in PubMed, Web of Science, Scopus and Embase to identify randomized controlled trials investigating exercise interventions in individuals with BC undergoing medical treatment. The included studies assessed outcomes on markers of immune function and inflammation. Subgroup analyses were undertaken for type of training, supervision, risk of bias, timing, duration and intensity of intervention and sample size. Twenty randomized controlled trials, including 1109 participants, were included in this review. Based on the available evidence, no significant influence of exercise on the determined immune factors and markers of inflammation could be confirmed. These meta-analyses suggest that exercise does not significantly alter immune function or markers of inflammation in BC patients during prehabilitation, adjuvant or neoadjuvant treatment. As no negative effect was observed, exercise appears to be safe and should be recommended to patients during cancer treatment because of its beneficial effects on quality of life, fatigue, cancer-related pain and survival.

The results of surgical treatment for oesophageal squamous cell cancer have improved over recent decades, but the long-term prognosis for patients with tumours of stage II or higher is still unsatisfactory. While uncontrolled series of adjuvant or neoadjuvant treatment have reported favourable survival rates, the true benefit of multimodal treatment can be determined only by randomized controlled trials. The literature was searched for prospective randomized controlled trials (PRCTs) examining the effect of neoadjuvant or adjuvant treatment on the long-term survival of patients with squamous cell cancer of the oesophagus. More than 30 PRCTs studying multimodal treatment concepts aimed at improving the prognosis of squamous cell carcinoma of the oesophagus were identified. These trials have not documented improved survival by adjuvant radiotherapy or chemotherapy. Following neoadjuvant radiotherapy or chemotherapy (or a combination of both), resectability of squamous cell carcinoma is not increased, the postoperative mortality rate appears to be higher and survival is not prolonged. Past multimodality protocols have not improved the prognosis of squamous carcinoma of the oesophagus. Careful design and reporting, together with strict control of surgical procedures, should allow more meaningful analysis of future multimodal treatment studies. At present, neoadjuvant or adjuvant treatment cannot be recommended outside such clinical protocols.

Background: Most patients with early-stage triple negative breast cancer (TNBC) receive neoadjuvant treatment (NT). With the data from the KEYNOTE-522 most Stage II and III TNBC patients receive NT. However, whether Stage I patients require NT or adjuvant treatment (AT) is debatable. We performed a retrospective analyses of Stage I TNBC who received NT or AT at our institution. Methods: We reviewed patients &amp;gt;18 years age who were diagnosed with clinical Stage I based on either mammogram or ultrasound (US) histologically proven invasive TNBC from January 1, 2018 until December 31, 2022. All patients must have received at least one cycle of systemic treatment, whether in the NT or AT setting. All patients must have undergone definitive surgical treatment. We analyzed patients till December 31, 2024. We used Kaplan-Meier estimates for overall survival (OS) and progression-free survival (PFS) and Cox-Proportional Hazards Model to assess treatment effect on OS and PFS. Results: We analyzed 72 patients (52 AT and 20 NT arms) and the patients in the NT arm were much younger than the AT arm (51.4 years vs 65.6 years respectively). Invasive ductal cancer was the most common histology (94% AT vs 80% in NT arm), while the rest were metaplastic (6% AT vs 20% NT) In the AT arm 9 patients were upstaged after surgery and 50% achieved a pathological complete response (pCR). Comparing AT vs NT, there was no statistically significant improvement in PFS (72.5% vs 73.4% p=0.79) or OS (74% vs 74.5%, p=0.43 However, we found that tumor size is a significant predictor for the risk of recurrence with HR 1.13 (p-value=0.003, 95% CI 1.05-1.22) times higher risk of recurrence when tumor size is more than 10mm, with patients receiving AT doing better. Conclusion: In Stage I TNBC there is no survival difference between NT or AT treatments. We did notice an improvement in PFS in patients with T1c tumors receiving AT. Prospective trials and trials incorporating immune checkpoint inhibitors can help us answer these questions. Citation Format: Cydni Rink, Marielle Ferstenberg, Cydni Rink, Yi Xiong, Zhaoqi Zang, Roberto Pili. Neoadjuvant versus adjuvant systemic therapy in Stage I triple negative breast cancer - An institutional review [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-09-27.

Although neoadjuvant systemic treatment for non-metastatic breast cancer has gained ground during the past decade, there is no compelling evidence that it improves overall survival compared to primary tumor resection and adjuvant treatment. At the same time, the approach to responders to neoadjuvant treatment in the axilla is evolving. This is a retrospective analysis of a prospectively collected population-based registry. Patients that received neoadjuvant (n=2126) or adjuvant chemotherapy (n=4754) for non-metastatic breast cancer during 2007-2020 in the Stockholm-Gotland region, which comprises 25% of the entire Swedish population, were included. Overall survival of patients treated preoperatively and postoperatively was compared using inverse probability treatment weighting and landmark analysis. The prognostic impact of change between prechemotherapy clinical to postchemotherapy pathologic nodal stage (cN/pN) in women receiving neoadjuvant treatment was investigated. Median follow-up was 4.93 years. There was no difference in adjusted overall survival between adjuvant (reference) and neoadjuvant treatment in the entire population (HR=1.38, 95% CI 0.98-1.93, p=0.062) or in breast cancer subtypes. Patients converting from positive clinical to negative pathologic nodal stage (cN+/pN0) had improved outcomes compared to cN0/pN0 or patients with pN0 following primary surgery. These patients had a particular disease trajectory, with early peak in risk of death followed by quick and sustained decrease. There was no difference in survival of patients treated with neoadjuvant versus adjuvant systemic therapy for non-metastatic breast cancer. Patients with cN+/pN0 have excellent prognosis and represent potential candidates for de-escalation of local and systemic treatment.

BackgroundPancoast tumors represent 5% of non-small cell lung cancers. Complete surgical resection and no lymph node involvement are important positive prognostic factors. Previous literature has identified neoadjuvant chemoradiation treatment, followed by surgical resection, as the standard of care. But many institutions choose upfront surgery. Our goal was to identify the treatment patterns and outcomes in patients with node-negative Pancoast tumors using the National Cancer Database (NCDB).MethodsThe NCDB was queried from 2004 through 2017 to identify all patients who had undergone surgery for a Pancoast tumor. Treatment patterns, including the percentage of patients who received neoadjuvant treatment, were recorded. Logistic regression and survival analyses were used to determine outcomes based on different treatment patterns. Secondary analyses were performed on the cohort who received upfront surgery.ResultsA total of 2,910 patients were included in the study. Overall 30- and 90-day mortality were 3% and 7% respectively. Only 25% (717/2,910) of the group received neoadjuvant chemoradiation treatment prior to surgery. Patients who received neoadjuvant chemoradiation treatment experienced significantly improved 90-day survival (P<0.01) and overall survival (P<0.01). When analyzing the cohort who received upfront surgery, there was a statistically significant difference in survival based on adjuvant treatment pattern (P<0.01). Patients in this group who received adjuvant chemoradiation had the best survival, whereas patients who received adjuvant radiation only or no treatment had the worst outcomes.ConclusionsPatients with Pancoast tumors receive neoadjuvant chemoradiation treatment in only a quarter of cases nationally. Patients who received neoadjuvant chemoradiation treatment had improved survival compared to patients who had upfront surgery. Similarly, when surgery is performed first, adjuvant chemoradiation treatment improved survival compared to other adjuvant strategies. These results suggest underutilization of neoadjuvant treatment for patients with node-negative Pancoast tumors. Future studies with a more clearly defined cohort are needed to assess the treatment patterns being utilized on patients with node-negative Pancoast tumors. It will be beneficial to see whether neoadjuvant treatment for Pancoast tumors has increased in recent years.

Aim: Anastomosis leakage (AL) is a major complication following colorectal surgery. The present study aims to investigate the effects of adjuvant (AT) and neoadjuvant (NT) treatments on AL in surgical patients with rectal cancer. Method: The study followed 319 patients (age >18 years) who were diagnosed with rectal cancer and underwent surgery with AT or NT treatment between January 1, 2010 and December 31, 2018. We evaluated demographic data, tumor stage, metastasis status, organ and lymph node involvement, surgery type, use of AT and NT, the presence of AL, mortality status, and serum carcinoembryonic antigen levels. Results: A total of 179 (56.1%) patients were male, 140 (43.9%) were female (mean age =58.613.2 years). In terms of additional treatment, 48.6% (n=155) received AT and 51.4% (n=164) received NT. Data revealed that 13.1% (n=42) of the patients received only radiotherapy (RT), 10.6% (n=34) received only chemotherapy (CT), and 76.2% (n=243) received both RT and CT (CRT). Additionally, 23.5% (n=75) of the patients had AL. In terms of AL frequency, we found no difference between the patients receiving AT or NT (p=0.758). Additionally, RT and CT had no effect on the development of AL (p=0.827 and p=0.1, respectively). Finally, mortality was not higher in patients with AL.

Neoadjuvant Treatment and the Prolonged Risk of Venous Thromboembolism in Resectable Pancreatic Cancer

TPS632 Background: Triple negative breast cancer (TNBC) remains the most challenging phenotype of breast cancer. There is still an unmet clinical need for improving the fine-tuning of indications for targeted treatments in this population. In TNBC, the frequency of germline BRCA (gBRCA) 1/2 mutations was reported to be up to 19.5%. This has led to promising clinical strategies based on poly adenosine diphosphate (ADP)-ribose polymerase inhibitors that inhibit single-stranded DNA damage repair and/or modified chemotherapy approaches targeting the DNA damage response, using platinum-based regimens. Based on the results of the OlympiA and KEYNOTE522 study, the adjuvant treatment with olaparib for gBRCAm and neoadjuvant and adjuvant pembrolizumab for patients with a high risk of recurrence TNBC has been treatment options as the standard of care. We hypothesize that neoadjuvant and adjuvant combination treatment with olaparib and pembrolizumab following combination treatment with platinum-based chemotherapy and pembrolizumab would synergistically increase the anti-tumor effect through the enhancement of immunogenicity and DNA damage in patients with gBRCA mutated breast cancer. Methods: OPERETTA is a multi-centered, prospective single-arm phase II feasibility study of patients treated with neoadjuvant olaparib plus pembrolizumab following platinum-based chemotherapy plus pembrolizumab in gBRCA 1/2 mutated TNBC. The patients with stage IIA-IIIB TNBC known as gBRCA 1/2 mutated will be registered. The primary objective is the pCR rate defined as the absence of residual invasive disease in the breast and axilla. The secondary objectives include additional efficacy measures (i.e., Residual Cancer Burden [RCB] 0/1rate, 3 years overall survival [3y-OS], 3 years event-free survivals [3y-EFS]), and safety. The estimated sample size using Simon's two-stage design, with a null hypothesis of a 45% pCR rate and an alternative hypothesis of 70%, was calculated. Given a significance level of 0.1 and 80% power, the design allows a maximum of 23 patients to be included. Eligible patients will be received combination treatment with paclitaxel (80 mg/m2 qw), carboplatin (AUC 1.5 qw or AUC 5 q3w), and pembrolizumab (200mg q3w) for first 12 weeks followed by olaparib (300mg BID) with pembrolizumab (200mg q3w) for another 12 weeks as neoadjuvant treatment. Breast/axillary surgery and radiotherapy are recommended per standard of care. After surgery, the combination of olaparib plus pembrolizumab will be continued for another 27 weeks as adjuvant treatment. This study is recruiting in Japan, and 2 patients are enrolled as of January 2025. This study is part of the West Japan Oncology Group (WJOG) breast cancer study group: WJOG14020B. Clinical trial information: NCT05485766 .

Excellent results after resection of colorectal liver metastases are associated with a high rate of recurrence. Influenced by positive results of palliative and adjuvant treatment in advanced cancer, various chemotherapy regimens were evaluated to improve long-term results. The databases Medline and Cancerlit (1982-1998) gave information about 675 patients who were treated either by means of systemic, intra-arterial, intraportal or intraperitoneal administration before or after liver resection. In general, the feasibility of an adjuvant treatment was tested. Proof has been furnished for the practicability of systemic and arterial therapy and for immunotherapy after liver resection whereas, for peritoneal and portal treatment, further studies are necessary. In a few non-randomised trials, it has been possible to discern a trend towards an improvement due to adjuvant postoperative therapy using historical or matched-pair control groups. Until now, only one of five randomised studies has been published. Six months of postoperative adjuvant intra-arterial treatment using 5-fluorouracil (1000 mg/m(2) for 5 days every 28 days) and folinic acid (200 mg/m(2) for 5 days every 28 days) was compared with observation only. Neither in the intention-to-treat nor in the as-treated analysis was median survival time (34.5 months versus 40. 8 months and 39.7 months versus 44.8 months, respectively) significantly increased. As neoadjuvant treatment was successful in primary non-resectable patients, this approach is now being tested in resectable patients. Despite several theoretical reasons for post- or preoperative treatment in resectable patients, every approach should be tested using of controlled studies.

Background and Objective: In the therapeutic strategy of rectal cancer, radiotherapy has consolidated its important position and frequent use in current practice due to its indications as neoadjuvant, adjuvant, definitive, or palliative treatment. In recent years, total neoadjuvant therapy (TNT) has been established as the preferred regimen compared to concurrent neoadjuvant chemoradiotherapy (CRT). In relation to better outcomes, the percentage of patients who achieved pathological complete response (pCR) after neoadjuvant treatment is higher in the case of TNT. This study aimed to analyze the response to TNT compared to neoadjuvant CRT regarding pCR rate and the change in staging after surgical intervention. Materials and Methods: We performed a retrospective study on 323 patients with rectal cancer and finally analyzed the data of 201 patients with neoadjuvant treatment, selected based on the inclusion and exclusion criteria. Patients received CRT neoadjuvant therapy or TNT neoadjuvant therapy with FOLFOX or CAPEOX. Results: Out of 157 patients who underwent TNT treatment, 19.74% had pathological complete response, whereas in the group with CRT (n = 44), those with pCR were 13.64%. After neoadjuvant treatment, the most frequent TNM classifications were ypT2 (40.30%) and ypN0 (79.10%). The statistical analysis of the postoperative disease stage, after neoadjuvant therapy, showed that the most frequent changes were downstaging (71.14%) and complete response (18.41%). Only four patients (1.99%) had an upstaging change. The majority of patients (88.56%) initially presented clinical evidence of nodal involvement whereas only 20.9% of the patients still presented regional disease at the time of surgical intervention. Conclusions: By using TNT, a higher rate of stage reduction is obtained compared to the neoadjuvant CRT treatment. The post-neoadjuvant-treatment imagistic evaluation fails to accurately evaluate the response. A better response to TNT was observed in young patients.

Introduction: Among the various approaches to measure response to neoadjuvant chemotherapy in breast cancer patients a significant relationship to overall (OS) and disease-free survival (DFS) has been recently demonstrated for the residual cancer burden (RCB) score. The calculated RCB- index provides additional prognostic information independently of TNM categories and stage, respectively[1]. The goal of our study was to validate the prognostic impact of the RCB score for OS and DFS on a cohort of patients selected for neoadjuvant treatment and treated either with chemotherapy with or without Her2 targeted therapy or endocrine therapy. We hypothesised that accross all histological breast cancer subtypes, the RCB-score will show significant impact on OS and DFS. Methods: All surgical specimens (n =212) were processed according to the same protocol in a single institution. The RCB score was calculated according to Symmans et al. using the MD Anderson website. Pathologic complete remission is designated RCB 0, residual disease is based on its extent categorized as RCB I-III. Additional information such as histological and molecular subtypes, therapy regimen, as well as follow up information were collected prospectively from paper based patient files. The impact of the RCB score on OS and DFS were estimated with Kaplan-Mayer curves were compared by using long rank test statistics. Results: The RCB score showed a significant correlation to DFS (p=0.000006) and OS (p=0.000306) The correlation between molecular subtypes (Luminal A, luminal B, Her2 positive and triple negative) and neoadjuvant treatment is ongoing and will be presented at the meeting. Conclusion: We were able to show a general prognostic value of the RCB-Score in a series of 212 patients with neoadjuvant treatment, without consideration of the histological and molecular subtypes and adjuvant treatment. We were further able to confirm the reproducibility of the RCB Score by a standardized pathological procedure at a single institution. Further independent evaluation of the histological and molecular subtypes as well as the therapy regimens is ongoing. [1] Loibel S.;How much information do we need to know after neoadjuvant Chemotherapy for Breast Cancer; American Society of Clinical Oncology, 24.Feb.2017. Citation Format: Balic M, Mueller DH, Hammer R, Gumpoldsberger M, Suppan C, Posch F, Stoeger H, Dandachi N, Prein K, Hauser H, Lax S. Independent evaluation of prognostic value of residual cancer burden (RCB) score on disease free and overall survival of breast cancer patients treated with neoadjuvant systemic treatment at a single institution [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-03-02.

Cancer of the major duodenal papilla is a rare disease with a reported population incidence of 6 per million. Endoscopic ultrasonography and intraductal ultrasonography are useful for diagnosing tumor extension of the major duodenal papilla. However, there are no specific biochemical studies or tumor markers, and an algorithm for early diagnosis of cancer of the major duodenal papilla has not been developed. Pancreatoduodenal resection remains the main treatment method for patients with a resectable tumor. However, long-term outcomes of radical surgeries are not satisfactory, with the median survival rate of 52–113 months, and the 5-year survival rate of 30–78.8 %. The study of prognostic factors will allow the development of the effective schemes of radical treatment, a therapeutic algorithm that will inevitably increase life expectancy. Radical surgery should be integrated into multi-modal treatment. Of all the variety of prognostic factors, the morphological differentiation of the tumor is of interest. According to our data, the overall 5-year survival rate, the average life expectancy for pancreatobiliary and intestinal subtypes of cancer of the major duodenal papilla after expanded pancreatoduodenal resection, respectively, was 0 % versus 38.05 % and 9.3 ± 1.79 months versus 48.0 ± 7.69 months. An accurate morphological diagnosis is of paramount prognostic importance, since it can have therapeutic consequences; that is, morphologically oriented and specific (neo)adjuvant treatment corresponding to subtypes of cancer of the major duodenal papilla. Currently, a multi-modal approach in the treatment of cancer of the major duodenal papilla is under development. Data on the use of adjuvant therapy in the radical treatment regimen are contradictory. There are no randomized controlled trials for neoadjuvant treatment. Little attention is paid to complications of chemotherapy and radiation therapy in the neoadjuvant treatment option. According to our data, chemoembolization of the gastro-duodenal artery resulted in complications in 21.4 %, and external beam radiation therapy resulted in radiation-induced injuries in 25 %. NCC N and ESMO currently do not provide recommendations for (neo)adjuvant treatment of cancer of the major duodenal papilla.