Significant Differences In Local Recurrence Research Articles

Efficacy of lateral lymph node dissection for local control of rectal cancer: A multicenter study.

This study aimed to evaluate the efficacy of lateral lymph node dissection (LLND) for rectal cancer by comparing the local control in patients with and without pathological lateral lymph node metastasis (LLNM). We included 189 patients with rectal cancer who underwent total mesorectal excision and LLND at 13 institutions between 2017 and 2019. Patients with and without pathological LLNM were defined as the pLLNM (+) and (-) groups, respectively. Propensity score-matching helped to balance the basic characteristics of both groups. The incidences of local recurrence (LR) and lateral lymph node recurrence (LLNR) were compared between the groups. In the entire cohort, 39 of the 189 patients had pathological LLNM. The 3-year LR and LLNR rates were 18.3% and 4.0% (p = 0.01) and 7.7% and 3.3% (p = 0.22) in the pLLNM (+) and (-) groups, respectively. After propensity score matching, the data from 62 patients were analyzed. No significant differences in LR or LLNR were observed between both groups. The 3-year LR and LLNR rates were 16.4% and 9.8% (p = 0.46) and 9.7% and 9.8% (p = 0.99) in the pLLNM (+) and (-) groups, respectively. LLND would lead to comparable local control in the pLLNM (+) and (-) groups if the clinicopathological characteristics except for LLNM are similar.

Prognostic Outcomes of Cutaneous Squamous Cell Carcinoma in Solid Organ Transplant Recipients: A Retrospective Comparative Cohort Study.

Cutaneous squamous cell carcinoma (cSCC) is the second most common cutaneous neoplasm, and its incidence is on the rise. While most cSCCs have an excellent prognosis, certain risk factors, especially immunosuppression, have been associated with higher rates of local recurrence (LR), metastasis, and poor prognosis. This study aims to assess the risk factors for LR and metastasis development in cSCC among solid organ transplant recipients (SOTRs) and compare these rates with those in immunocompetent patients. A retrospective observational study included cSCC cases from the University Hospital Reina Sofía in Córdoba, Spain, between 2002 and 2019. Demographic, clinical, and histopathological data were collected. Local recurrence and metastasis rates were analyzed, along with progression-free survival. Univariate analyses were performed to identify prognostic factors in SOTRs. Among 849 cSCC cases, we found higher rates of local recurrence and metastasis in tumors developed by SOTRs compared to those in immunocompetent individuals. However, no significant differences in local recurrence, metastasis, or progression-free survival were observed between the two groups. Risk factors for adverse outcomes in SOTRs included tumor size > 2 cm, depth > 4 mm, and a higher Clark level. A total of 34.4% of SOTRs developed a second primary cSCC during the follow-up. In our study, cSCCs in SOTRs did not exhibit statistically significant differences in the rates of adverse outcomes compared to immunocompetent patients. The prognosis of cSCCs in SOTRs may be more related to other tumor-dependent risk factors than to the immunosuppression status itself. Future studies are needed to refine risk stratification and follow-up protocols to ensure the optimal management of high-risk cSCC cases, particularly among immunosuppressed patients.

Comparison of Ablation Volume Between Emprint® and Mimapro® Systems for Hepatocellular Carcinoma -A Preliminary Study.

Microwave ablation (MWA) is a standard percutaneous local therapy for hepatocellular carcinoma (HCC). Next-generation MWA is reported to create a more spherical ablation zone than radiofrequency ablation (RFA). We compared the ablation zone and aspect ratio of two 2.45 GHz MWA ablation probes; Emprint® (13G) and Mimapro® (17G). We compared the ablation zone to the applied energy after MWA in patients with hepatocellular carcinoma (HCC). Furthermore, we investigated local recurrence. We included 20 patients with HCC, with an average tumour diameter of 33.2 ± 12.2 mm, who underwent MWA using Emprint®, and 9 patients who underwent MWA using Mimapro® with an average tumour diameter of 31.1 ± 10.5 mm. Both groups underwent the same ablation protocol using the same power settings. The images obtained after MWA showed the treatment ablation zone and aspect ratio, which were measured and compared using three-dimensional image analysis software. The aspect ratios in the Emprint® and Mimapro® groups were 0.786 ± 0.105 and 0.808 ± 0.122, respectively, with no significant difference (p = 0.604). The ablation time was significantly shorter in the Mimapro® group than in the Emprint® group, and there was no significant difference in the frequency of popping or the ablation volume. There were no significant differences in local recurrence between the two groups. There was no significant difference in the aspect ratios of the ablation diameter, and the ablation zone was almost spherical in both cases. Mimapro® at 17G was less invasive than Emprint® at 13G.

Are Postoperative Infections in the First 12 Months after Wide Resection and Megaprosthetic Replacement Associated with the Survival of Osteosarcoma Patients? Results of a Multicenter Study

Simple SummaryPostoperative infection is one of the gravest complications in patients following megaprosthetic replacement due to primary malignant bone tumors. On the other hand, several studies have also suggested that patients with a variety of different cancers may have a better chance of survival following the development of an infection, possibly as a result of the immune and inflammatory host responses to infection. Our retrospective analysis of 437 extremity osteosarcoma patients found that patients with a poor response to neoadjuvant chemotherapy and an infection in the first 12 months after primary tumor surgery had a better chance of survival compared to patients without infections. If this finding can be validated in a different patient cohort, it would suggest that the efficacy of novel immunomodulatory treatments in osteosarcoma patients should be evaluated and reported separately for patients with a good and a poor response to preoperative chemotherapy, as the latter might benefit more from such treatments.Recent retrospective studies suggested that early postoperative infections might be associated with a survival benefit for extremity osteosarcoma patients, but the reported results have been conflicting. The files of 437 patients with a newly diagnosed, high-grade osteosarcoma of the extremities treated at 5 referral centers in Germany and Austria between 1989 and 2016 were retrospectively evaluated. All patients underwent multi-agent chemotherapy and limb-sparing tumor excision, followed by endoprothetic replacement. We used the Kaplan–Meier method to calculate survival curves, which we compared with the log-rank test. With a median follow-up of 100 months (interquartile range, 49–155 months), local recurrence (LR) probability, event-free survival (EFS), and disease-specific survival (DSS) after 5 years in this selected patient cohort amounted to 5%, 67%, and 79%, respectively, and 46 patients (10.5%) developed an early postoperative infection. We found no significant differences in LR, EFS, or DSS between patients with and without early infections, and there were no differences in known prognostic factors between the two groups. However, in subgroup analyses patients with a poor response to neoadjuvant chemotherapy and an early infection had a better DSS compared to patients without early infections (93% vs. 62% after 5 years, p = 0.044). Provided that our findings can be validated in separate patient cohorts, we believe that patient outcome after adjuvant immunomodulatory treatments in osteosarcoma patients should be evaluated and reported separately for good and poor responders to neoadjuvant chemotherapy in future studies.

Omitting radiotherapy is safe in breast cancer patients\u2009\u2265\u200970\xa0years old after breast-conserving surgery without axillary lymph node operation

To verify whether omitting radiotherapy from breast cancer treatment for patients ≥ 70 years old following breast-conserving surgery (BCS) without axillary lymph node dissection is safe. Previous studies have shown that omitting breast radiotherapy after BCS and axillary lymph node dissection is safe for elderly breast cancer patients. We aimed to evaluate the safety of BCS without axillary surgery or breast radiotherapy (BCSNR) in elderly patients with breast cancer and clinically negative axillary lymph nodes. We performed a retrospective analysis of 481 patients with breast cancer, aged ≥ 70 years, between 2010 and 2016. Of these, 302 patients underwent BCSNR and 179 underwent other, larger scope operations. Local recurrence rate, ipsilateral breast tumor recurrence (IBTR) rate, distant metastasis rate, breast-related death, disease-free survival (DFS), and overall survival (OS) were compared between the two groups. After a median follow-up of 60 months, no significant differences in local recurrence, distant metastasis rate, breast-related death, and DFS were noted. The OS was similar (P = 0.56) between the BCSNR group (91.7%) and other operations group (93.0%). The IBTR rate was considered low in both groups, however resulted greater (P = 0.005) in the BCSNR group (5.3%) than in other operations group (1.6%). BCSNR did not affect the survival of elderly patients with breast cancer with clinically negative axillary lymph nodes. IBTR was infrequent in both groups; however, there was a significant difference between the two groups. BCSNR is a feasible treatment modality for patients with breast cancer ≥ 70 years old with clinically negative axillary lymph nodes.

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer.

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer.

Evaluation of the utility of localized adjuvant radiation for node-negative primary cutaneous squamous cell carcinoma with clear histologic margins

Though the National Comprehensive Cancer Network recommends consideration of localized adjuvant radiation after clear-margin surgery for cutaneous squamous cell carcinoma (cSCC) with large-caliber (≥0.1-mm) nerve invasion (LCNI) and other high-risk features, only a single small study has compared surgery plus adjuvant radiation therapy (S+ART) to surgical monotherapy (SM) for cSCC. Compare S+ART to SM for primary cSCCs with LCNI and other risk factors. Matched retrospective cohort study of primary cSCCs (matched on sex, age, immune status, type of surgery, diameter, differentiation, depth, and LCNI) treated with S+ART versus SM. A subgroup analysis of cSCCs with LCNI was performed. In total, 62 cSCCs were included in matched analysis (31 S+ART and 31 SM) and 33 cSCCs in the LCNI analysis (16 S+ART and 17 SM). There were no significant differences in local recurrence, metastasis, or death from disease in either analysis. Risk of local recurrence was low (8%, 7/89), with 3 of the local recurrences being effectively treated upon recurrence. Single academic center and nonrandomized design. Adjuvant radiation did not improve outcomes compared with SM due to a low baseline risk of recurrence, although adjuvant radiation for named nerve invasion and LCNI of ≥3 nerves has been shown to improve outcomes in a prior study. Randomized studies are needed to define the subset of cSCC for whom adjuvant radiation has utility.

Long-Term Outcomes of Immunohistochemically Defined Subtypes of Breast Cancer Less Than or Equal to 2 cm After Breast-Conserving Surgery

BackgroundMolecular subtype predicts the prognosis of early-stage breast cancer patients. We assessed the long-term outcomes of breast cancer ≤2 cm treated with breast-conserving surgery (BCS) and stratified according to an immunohistochemically (IHC)-based subtype definition. MethodsThis retrospective study was conducted from a prospectively collected database. Included patients had pT1, any N, M0 breast cancer after BCS (without anti-HER2 therapy) and available information on estrogen receptor (ER), progesterone receptor (PR), HER2 status, Ki-67 index. Five IHC-defined subtypes were identified: luminal A-like (ER and/or PR-positive/HER2-negative/Ki-67 < 20%), luminal B-like/HER2-negative (ER and/or PR-positive/HER2-negative/Ki-67 ≥ 20%), luminal B-like/HER2-positive (ER and/or PR-positive/HER2-positive/any Ki-67 value), HER2-positive/nonluminal (ER and PR-negative/HER2-positive), and triple-negative (ER and PR-negative/HER2-negative). ResultsWe analyzed 184 (65%) luminal A-like, 57 (20%) luminal B-like/HER2-negative, 17 (6%) luminal B-like/HER2-positive, 6 (2%) HER2-positive/nonluminal, and 18 (7%) triple-negative patients. Median follow-up was 112 (interquartile range 94-125) mo. The cumulative 5- and 10-y local recurrence (LR) rates were 1.5% and 4%, respectively. The cumulative 5- and 10-y distant recurrence (DR) rates were 3% and 8%, respectively. The Cox regression revealed that HER2-positive/nonluminal subtypes had the highest risk of LR (P = 0.0025). The luminal B-like/HER2-positive subtypes had the highest risk of DR (P = 0.0019). HER2 positivity carried a higher risk of DR in women with luminal breast cancer who completed 5 y of adjuvant hormonal therapy (P = 0.02). ConclusionsThe IHC-defined subtype impacts on the prognosis of breast cancer ≤2 cm after BCS, determining significant differences in LR and DR rates. In the pre–“anti-HER2 therapy” era, patients with HER2-positive/nonluminal or luminal B-like/HER2-positive subtype had worse long-term outcomes than those with luminal A-like subtype.

Endoscopy-assisted inguinal lymphadenectomy in vulvar cancer.

To explore the feasibility and efficiency of video endoscopic inguinal lymphadenectomy (VEIL) for vulvar cancer. We evaluated 46 patients with vulvar cancer. Treatment included VEIL using the hypogastric subcutaneous approach (VEIL-H, 17 patients), VEIL with thelimb subcutaneous surgical approach (VEIL-L, 8 patients), and open inguinal lymphadenectomy (OIL, 21 patients). All patients underwentradical vulvectomy; we evaluated operative time, the amount of bleeding, SF score, recurrence rate, etc. RESULTS: The durations of VEIL-H and VEIL-L were 170.79 ± 18.92 and 180.12 ± 17.88min, respectively, which were longer than that of OIL (100.68 ± 11.37min; P = 0.028). Bleeding volumes in the VEIL-H and VEIL-L groups were 15.23 ± 2.17 and 17.16 ± 2.35ml, respectively; there were significantly lower than that of the OIL group (36.68 ± 3.48ml; P = 0.021). The numbers of unilateral lymph nodes harvested were similar in all groups. The duration of hospitalization in VEIL group was shorter than that of the OIL group. There were less skin and lymphatic complications after VEIL than after OIL. Total SF-36 scores were significantly higher in the VEIL group than that in the OIL group (P = 0.032). There were no statistically significant differences in local recurrence, distant metastasis, and mortality among the three groups. VEIL for vulvar cancer treatment is effective, with the advantages of short hospitalization stay, less bleeding, and reduced postoperative complications comparing the OIL.

Prognostic role of preoperative carcinoembryonic antigen levels in colorectal cancer: propensity score matching

Background: This study was conducted to investigate preoperative carcinoembryonic antigen (CEA) as a prognostic factor in colorectal cancer. Methods: Between January 2000 and July 2011, 1298 patients with primary adenocarcinoma colorectal cancer without metastasis, who underwent curative resection were retrospectively identified. The patients were divided into two groups according to serum CEA level at primary diagnosis: a high CEA (HCEA) group (serum CEA ≥6 ng/mL) and a normal CEA (NCEA) group (serum CEA <6 ng/mL). A 1:1 propensity score matching analysis was applied to reduce bias. Finally, 364 patients were enrolled in this study. Matched variables were age, gender, preoperative chemoradiotherapy, tumor site, cell differentiation and pathologic stage. Results: The clinicopathological characteristics of the two groups did not differ significantly difference. The systemic metastasis rate was 16.5% (30/182) and 25.3% (46/182) in the NCEA and HCEA groups, respectively (p=0.039). There were no significant differences in local recurrence or metastatic sites between groups. The 5-year disease-free survival (DFS) rate of the HCEA group was worse than that of the NCEA group; however, there was no significant difference in overall survival between the two groups. Conclusion: Elevated preoperative CEA was related to frequent systemic recurrence and low DFS. Therefore, elevated preoperative CEA could be considered a prognostic factor for worse clinical outcomes in patients with colorectal cancer.

Meta-analysis on limb salvage and amputation for patients with local Enneking II osteosarcoma

To explore 5-year survival rate, local recurrence and metastasis rate of limb salvage and amputation for patients with local Enneking II osteosarcoma by Meta-analysis. From January 1, 1970 to December 1, 2015, Subject term and keywords about limb salvage and amputation for local Enneking II osteosarcoma with pathological fracture were searched from Cochrane, PubMed, Ovid, Spinger Link, Embase, CNKI and WanFang database foundation. Literature confirm with inclusion criteria were choose and quality evaluation were performed. RevMan 5.0 software from Cochrane collaboration was used to perform Meta-analysis. Local recurrence, 5-year survival rate and odds ratio of transfer risk were compared between limb salvage and amputation group. Ten literatures confirm with inclusion criteria were included, and total sample size was 453. There were 315 patients in limb salvage group and 138 patients in amputation group. Five-year survival rate in amputation group was lower than that of limb salvage group [OR=2.88, 95%CI(1.40, 5.93)], however metastasis rate in limb salvage was less than that of amputation group [OR=0.43, 95%CI(0.20, 0.94)];there were no significant differences in local recurrence between two groups [OR=1.47, 95%CI (0.73, 2.97)]. Functional rehabilitation in limb salvage group was better than that of amputation group by MSTS systematic review. Limb salvage as an alternative in treating local Enneking II osteosarcoma with pathological fracture does not greatly increase risk of local recurrence or 5-year overall survival rate compared with amputation group, and has a lower risk of metastatic occurrence.

Sentinel Node Biopsy in Early Breast Cancer.

The approach to the axilla is an evolving paradigm, and recognition of the complexity of breast cancer (BC) biology is changing treatment options. The sentinel lymph node biopsy (SLNB) technique is based on the excision and histological examination of the axillary lymph nodes(s), which is assumed to be the first one draining from the primary tumor. SLNB can accurately stage the axilla, and several trials have shown that there are no significant differences in local recurrence and overall survival between patients treated with or without axillary node dissection (ALND) after a negative SLNB. Surgical morbidity was significantly reduced in terms of rates of lymphedema and neuropathy, with reduced hospital stay and better quality of life after the SLNB procedure. ALND can safely be omitted in patients with ≥2 positive nodes who received conservative surgery and radiotherapy, while ALND is still recommended in clinically N1 BCs, in case of ≥3 positive nodes, and when the number of positive nodes would be crucial for the choice of chemotherapy. Micrometastatic disease can be safely managed with SLNB alone, and additional identification of micrometastases with immunohistochemistry does not affect disease-free survival or overall survival. An appropriate management of the axilla is crucial for the outcome of patients with early BC, and SLNB introduction into the clinical practice dramatically changed the surgical treatment, reducing morbidity without decreasing survival. A tailored approach should be suggested in each patient with BC, considering the biology of the tumor rather than nodal involvement.

The role of the laparoscopy on circumferential resection margin positivity in patients with rectal cancer: long-term outcomes at a single high-volume institution.

The aim of this study was to evaluate the influence of laparoscopic rectal cancer surgery on circumferential resection margin (CRM) involvement. The data from 579 consecutive patients who underwent laparoscopic or open resection of rectal cancer from October 2002 to August 2008 were analyzed retrospectively. The primary endpoint was CRM status. The secondary endpoints were morbidity, local recurrence rate, overall survival, and disease-free survival. Laparoscopic resections were performed in 266 patients (46%), and the remainder of the patients underwent open resection. The rates of CRM involvement were similar between the laparoscopic and open groups (5.6% vs. 5.4%). The perioperative morbidity rates between the 2 groups were not significantly different (P=0.2). The incidence of local recurrence for the CRM-negative group was 8.4% (8.3% laparoscopic vs. 8.45% open; P=0.99), whereas the local recurrence rate was 34.3% for the CRM-positive group. The local recurrence rate was 20% for the CRM-positive patients in the laparoscopic group and 47% for the CRM-positive patients in the open group (P<0.001). We did not observe any significant differences in local recurrence rates between the Lap R and Open R groups after omitting CRM status. CRM positivity was correlated with both 5-year survival and the 5-year disease-free survival rate (P=0.009 and P=0.001, respectively). We did not observe any significant differences in morbidity, local recurrence, or overall or disease-free survival rates between the overall laparoscopic and open resection groups. Laparoscopic surgery for rectal cancer is associated with similar complication rates, CRM involvement status, and long-term outcomes as those associated with open surgery but with the advantages of minimally invasive surgery. Although laparoscopic surgery might necessitate more advanced technical skills, similar long-term oncological results can be obtained with this technique.

Oncologic outcomes in rectal cancer with close distal resection margins: a retrospective analysis

PurposeThe assurance of a negative resection margin is significant in rectal cancer as it indicates a reduced risk of local recurrence; thus, sufficient length of the resection margin is strongly required. The purpose of this study was to analyze the relationship between the length of the distal resection margin (DRM) and local recurrence or survival rate and to evaluate the possibility of performing sphincter-conserving surgery.MethodsThe medical records of 218 rectal cancer patients were analyzed. Patients were classified into three groups according to the length of the DRM as follows: group 1, DRM < 1 cm; group 2, 1 cm ≤ DRM ≤ 2 cm; and group 3, DRM > 2 cm.ResultsOf 218 patients enrolled, 81 were in group 1, 66 in group 2, and 71 in group 3. The 5-year survival rates were 78.2%, 78.2%, and 76.8% for groups 1, 2, and 3, respectively, and there were no statistically significant differences in survival (P = 0.913). Local recurrence was found in 2 patients in group 1, 1 patient in group 2, and 1 patient in group 3; there were no statistically significant differences in local recurrence (P = 0.908).ConclusionA DRM of < 1 cm did not impair the oncologic outcomes of rectal cancer patients. Our results indicated that surgeons should keep in mind to consider the option of sphincter-conserving surgery with adjuvant chemoradiotherapy even in very low rectal cancer.

Tu1543 Predictive Risk Factors Associated With Submucosal Fibrosis in Colorectal Endoscopic Submucosal Dissection

Tu1543 Predictive Risk Factors Associated With Submucosal Fibrosis in Colorectal Endoscopic Submucosal Dissection Koji Takahashi*, Toshio Uraoka, Osamu Goto, A.I. Fujimoto, Yasutoshi Ochiai, Joichiro Horii, Naohisa Yahagi Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan Objective: Existence of fibrosis into the submucosal (SM) layer has been known as technical difficulty factor during colorectal endoscopic submucosal dissection (CRESD), however, predictive risk factor of SM fibrosis is still unclear. The aim of this study was to clarify the predictive risk factors of pre-, periand postCR-ESD associated with SM fibrosis. Methods: A total of 163 patients with 173 tumors underwent CR-ESD at our division from May 2010 to July 2013 were enrolled in this retrospective cohort study. The degree of SM fibrosis was classified into four types; Grade 0, no fibrosis; Grade 1, mild fibrosis in which blood vessels can be recognized; Grade 2, moderate fibrosis in which blood vessels can’t be recognized but indigocarmine dye added into SM injection solution can; Grade 3, severe fibrosis in which indigocarmine can’t be recognized). (a)Pre-operative risk factors: age, gender, tumor location, tumor size, macroscopic type, endoscopic diagnosis for SM deep invasion (cSM-d), performing previous biopsy. (b)Periand post-operative factors: procedure time, piecemeal resection, perforation, delayed bleeding, histological diagnosis for SM deep invasion (pSM-d). We analyzed these risk factors by chi-square test, Student’s t-test and logistic regression. Results: The mean tumor size was 34 19 mm. The median procedure time was 50 minutes (range 5-250). The rate of en bloc resection was 98%. Perforation and delayed bleeding occurred in 4 and 4 cases (2.3%), respectively. SM fibrosis grade distribution was as follows: Grade 0, 71 tumors (41%); Grade 1, 54 tumors (31%); Grade 2, 35 tumors (20%); Grade 3, 13 tumors (8%). (a) According to univariate analysis, there were significant differences in local recurrence (P!0.001) and cSM-d (p!0.001). When local recurrence lesions were excluded, there were significant differences in previous biopsy (pZ0.007) and non-granular-type laterally spreading tumors (LST-NG) (pZ0.037). In addition, when dividing of Grade into two groups in two ways (group 0-1 vs. 2-3 or group 0-2 vs. 3), there were significant differences in local recurrence, previous biopsy and LST-NG only in the case of group 0-1 vs. 2-3. Multivariate analysis showed that cSM-d (ORZ34.82, p!0.0001) and previous biopsy (ORZ4.01, pZ0.001) were independent risk factors. (b) According to univariate analysis, procedure time (p!0.0001) and pSM-d (pZ0.008) were significant factors, and even when Grade was divided, there was a significant difference in long procedure time (O50 minutes). Multivariate analysis showed that procedure time (ORZ2.70, pZ0.0064) was an independent factor. Conclusions: Based on this study, pre-operative diagnosis including estimated invasive depth was essential for determining severe submucosal fibrosis resulting in long procedure time. Previous biopsy should avoid in CR-ESD candidate case.

Tu1544 The Utility of Endoscopic Submucosal Dissection (ESD) for Rectal Neoplasms and the Clinical Short-Term Outcomes

Tu1543 Predictive Risk Factors Associated With Submucosal Fibrosis in Colorectal Endoscopic Submucosal Dissection Koji Takahashi*, Toshio Uraoka, Osamu Goto, A.I. Fujimoto, Yasutoshi Ochiai, Joichiro Horii, Naohisa Yahagi Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan Objective: Existence of fibrosis into the submucosal (SM) layer has been known as technical difficulty factor during colorectal endoscopic submucosal dissection (CRESD), however, predictive risk factor of SM fibrosis is still unclear. The aim of this study was to clarify the predictive risk factors of pre-, periand postCR-ESD associated with SM fibrosis. Methods: A total of 163 patients with 173 tumors underwent CR-ESD at our division from May 2010 to July 2013 were enrolled in this retrospective cohort study. The degree of SM fibrosis was classified into four types; Grade 0, no fibrosis; Grade 1, mild fibrosis in which blood vessels can be recognized; Grade 2, moderate fibrosis in which blood vessels can’t be recognized but indigocarmine dye added into SM injection solution can; Grade 3, severe fibrosis in which indigocarmine can’t be recognized). (a)Pre-operative risk factors: age, gender, tumor location, tumor size, macroscopic type, endoscopic diagnosis for SM deep invasion (cSM-d), performing previous biopsy. (b)Periand post-operative factors: procedure time, piecemeal resection, perforation, delayed bleeding, histological diagnosis for SM deep invasion (pSM-d). We analyzed these risk factors by chi-square test, Student’s t-test and logistic regression. Results: The mean tumor size was 34 19 mm. The median procedure time was 50 minutes (range 5-250). The rate of en bloc resection was 98%. Perforation and delayed bleeding occurred in 4 and 4 cases (2.3%), respectively. SM fibrosis grade distribution was as follows: Grade 0, 71 tumors (41%); Grade 1, 54 tumors (31%); Grade 2, 35 tumors (20%); Grade 3, 13 tumors (8%). (a) According to univariate analysis, there were significant differences in local recurrence (P!0.001) and cSM-d (p!0.001). When local recurrence lesions were excluded, there were significant differences in previous biopsy (pZ0.007) and non-granular-type laterally spreading tumors (LST-NG) (pZ0.037). In addition, when dividing of Grade into two groups in two ways (group 0-1 vs. 2-3 or group 0-2 vs. 3), there were significant differences in local recurrence, previous biopsy and LST-NG only in the case of group 0-1 vs. 2-3. Multivariate analysis showed that cSM-d (ORZ34.82, p!0.0001) and previous biopsy (ORZ4.01, pZ0.001) were independent risk factors. (b) According to univariate analysis, procedure time (p!0.0001) and pSM-d (pZ0.008) were significant factors, and even when Grade was divided, there was a significant difference in long procedure time (O50 minutes). Multivariate analysis showed that procedure time (ORZ2.70, pZ0.0064) was an independent factor. Conclusions: Based on this study, pre-operative diagnosis including estimated invasive depth was essential for determining severe submucosal fibrosis resulting in long procedure time. Previous biopsy should avoid in CR-ESD candidate case.

Oncologically Safe Distal Resection Margins in Rectal Cancer Patients Treated with Chemoradiotherapy

IntroductionAlthough current guidelines recommend distal resection margins (DRM) of 2–5 cm in rectal cancer operation, smaller margins may be safe. We therefore assessed the impact of distal margins on outcomes in patients with rectal cancer treated with neoadjuvant chemoradiotherapy (CRT) followed by radical resection or resection followed by adjuvant CRT. Materials and methodsThis study involved 376 patients who underwent sphincter-saving resection for rectal adenocarcinoma and pre- or postoperative CRT between 2000 and 2006. DRMs were measured on pinned fixed specimens. We excluded patients who did not complete planned CRT and those with stage IV disease. A retrospective cross-sectional analysis was performed. ResultsNo significant differences in local recurrence (9.8 versus 7.3 %; P = 0.324) and systemic recurrence (16.4 versus 18.7 %; P = 0.731) were observed in patients with DRMs of ≤5 and >5 mm, respectively. Moreover, in each DRM category, there were no differences in local and systemic recurrence rates between patients who received pre- or postoperative CRT. DRM did not affect overall survival (P = 0.880) or 5-year survival rate (80.3 versus76.8 %; P = 0.340). ConclusionA distal margin of at least 5 mm with negative resection margin on frozen section does not reduce oncological safety in rectal cancer patients who receive pre- or postoperative CRT.

Completed versus aborted radical hysterectomy for node-positive stage IB cervical cancer in the modern era of chemoradiation therapy

ObjectiveDebate continues about optimal management of patients with node-positive stage I cervical cancer. Our objective was to determine if patient outcomes are affected by radical hysterectomy in the modern era of adjuvant chemoradiation. MethodsCervical cancer patients diagnosed from 2000 to 2008 were identified. Demographics, therapy, clinicopathologic data, progression free survival (PFS), overall survival (OS), total radiation exposure, and grade 3–4 complications were analyzed by student t, Mann–Whitney, Fisher's exact, Kaplan–Meier, and log rank tests. ResultsThis single-institution review evaluated forty-one of 334 (13.4%) patients scheduled to undergo radical hysterectomy that had gross nodal disease diagnosed intraoperatively. 15 underwent aborted radical hysterectomy following lymphadenectomy; the remaining 26 underwent radical hysterectomy and lymphadenectomy. Eleven patients undergoing radical hysterectomy underwent whole pelvic radiation therapy (WPRT) while 8 (30.7%) patients underwent WPRT and postoperative vaginal brachytherapy (BT) for local treatment secondary to close margins. All patients undergoing aborted radical hysterectomy underwent WPRT and BT. With mean follow-up of 42.3months, there were no significant differences in urinary, gastrointestinal, or hematologic complications between groups. When comparing those undergoing radical hysterectomy to aborted radical hysterectomy, there were no significant differences in local recurrence (11.5% vs 26.7%, p=0.39) or distant recurrence (19.2% vs. 33.3%, p=0.45), PFS (74.9months vs 46.8months, p=0.106), or OS (91.8months vs 69.4months, p=0.886). ConclusionsTreatment of patients with early stage cervical cancer and nodal metastasis may be tailored intraoperatively. Completion of radical hysterectomy and lymphadenectomy decreases radiation exposure without apparently compromising safety or outcome in the era of adjuvant chemoradiation.

Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.

Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial. American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated. There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups. Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

A multinational pooled analysis of 434 cases of stage I non-small cell lung cancer (NSCLC) treated with volumetrically image-guided (VIGRT) stereotactic lung radiotherapy (SBRT): Results from the Elekta Collaborative Lung Research Group.

7015 Background: Published lung SBRT outcomes/dose response data for inoperable NSCLC come from small phase I-II studies or larger datasets not requiring image-guided radiotherapy (IGRT) or volumetric prescriptions. This entire cohort of SBRT patients had daily online cone-beamCT. Methods: 434 cases of stage I (T1-2N0M0) NSCLC were treated with SBRT via VIGRT at 1 of 5 institutions from 1998-2009. Median age was 74y(42-92); 53% male, 47% female. Median FEV1 was 1.4L(65% predicted); median DLCO was 9.8 ml/min/mmHg(54% predicted). 62% of tumors were biopsy-proven; 84% of cases were staged with CT and PET. Clinical stage was IA in 76%, IB in 22%, locally recurrent in 1%. Median max tumor dimension was 2.4 cm (0.9-8.5cm). Histologies were: 41% adenocarcinoma, 34% squamous, 12% large cell, 13% NSCLC NOS. 8%, 51%, and 42% were grades 1, 2, 3. Median volumetric prescription dose (PD) was 54Gy (20-64Gy) delivered in median of 3 fractions(fx) (1-15fx) over 8d (1-27d). Median biological equivalent PD (BED10) was 132Gy (60-180Gy), equal to 2-Gy fx equivalent (FE) of 110Gy (50-150Gy). Corresponding GTV and PTV mean doses (2-GyFE) were 157Gy and 137Gy. Mean follow-up = 1.3y (0.1-7.3y). Results: 2-y KM rates of local recurrence (LR), regional recurrence (RR) and distant metastasis (DM) were 8%, 13%, and 26%. 2y overall survival (OS) and cause-specific survival (CSS) were 58% and 84%. No statistically significant differences in LR, RR, DM, OS or CSS were identified for biopsied vs. non-biopsied tumors. On univariate analysis, stage (IA 5% v IB 16%, p=0.002), GTV max dimension (<2.7cm 4% v ≥2.7cm 12%, p=0.006), and 2GyFE PD (<88Gy 17% v ≥88Gy 5%, p<0.001) predicted LR. GTV (<115Gy 32% v ≥115Gy 4%, p<0.001) and PTV (<105Gy 24% v ≥105Gy 4%, p<0.001) 2GyFE mean doses also predicted LR. Cox multiple regression confirmed the relationship between PD and LR, independent of GTV size (p=0.01). Conclusions: This is the first Lung SBRT dataset of patients treated uniformly with daily online VIGRT and resulted in excellent local control for stage I NSCLC. A 2-GyFE dose of 88 Gy (BED10 105 Gy) predicted superior local control. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Elekta