BACKGROUND:Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN. METHODS:This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026. ETHICS AND DISSEMINATION:This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences. TRIAL REGISTRATION NUMBER:jRCTs062240066.
BACKGROUND AND OBJECTIVES:Although multiple studies have reported the anti-tumor effects of aspirin on colorectal cancer, its benefit in patients with colorectal cancer following curative resection remains controversial. This study aimed to evaluate the effect of aspirin administration in patients with stage I-III colorectal cancer following curative resection. METHODS:This multi-institutional retrospective study included 2,863 patients with stage I-III colorectal cancer who underwent curative resection between January 2017 and December 2019. Patients were classified into two groups according to aspirin use. Clinical characteristics and oncological outcomes were analyzed. RESULTS:The aspirin group was older, and fewer patients had advanced pathological tumor stages or received postoperative adjuvant chemotherapy than non-aspirin group. Aspirin use tended to be associated with improved postoperative prognosis in patients with stage I-III colorectal cancer (overall survival: 91.1% vs. 80.9%, hazard ratio = 0.646, 95% confidence interval = 0.32-1.30; recurrence-free survival: 82.6% vs. 73.7%, hazard ratio = 0.730, 95% confidence interval = 0.44-1.20). After propensity score matching to minimize bias between groups, aspirin use was associated with improved postoperative prognosis (overall survival: 91.0% vs. 69.8%, hazard ratio = 0.306, 95% confidence interval = 0.14-0.68; recurrence-free survival: 82.4% vs. 56.6%, hazard ratio = 0.350, 95% confidence interval = 0.19-0.62). Aspirin use significantly improved recurrence-free survival in patients with advanced cancer who were recommended to receive postoperative adjuvant chemotherapy. CONCLUSIONS:This study suggests that aspirin use is associated with improved postoperative prognosis in patients with stage I-III colorectal cancer after curative resection. Aspirin may be beneficial for advanced-stage patients, for whom postoperative adjuvant chemotherapy is recommended.
ABSTRACT Background With global rising rates of obesity, surgeries for colorectal cancer (CRC) in obese patients are increasingly common. Although obesity may complicate surgical procedures and oncologically unbeneficial, its true clinical impact remains unclear. Methods Patients with stage I–IV CRC who underwent surgical resection between 2017 and 2019 were enrolled from a prefecture‐wide multicenter database. Patients were categorized based on body mass index (BMI) into non‐obesity (BMI < 25 kg/m 2 ), mild‐obesity (BMI ≥ 25 and < 30 kg/m 2 ), and severe‐obesity (BMI ≥ 30 kg/m 2 ) groups. Perioperative outcomes, long‐term survival, and lymph node metrics, including the log odds of positive lymph nodes (LODDS). Results Among 2905 patients, 2283 were non‐obesity, 576 mild‐obesity, and 91 severe‐obesity. Younger, more often male, and had higher American Society of Anesthesiologists (ASA) class and Charlson Comorbidity Index scores are included in obesity group. Operative time and blood loss increased with BMI, while the number of retrieved lymph nodes and D3 dissection rates declined. Postoperative complications and hospital stay showed no significant differences. While recurrence‐free survival (RFS) and overall survival (OS) were comparable across BMI groups, obese patients had a higher proportion of LODDS ≥ −0.7. In stage III patients, LODDS ≥ −0.7 was more strongly associated with recurrence and poor prognosis in the obese subgroup. Conclusions Obesity is associated with increased surgical complexity and limited pathological lymph node evaluation. Among stage III CRC patients, impaired nodal stratification—as reflected by elevated LODDS—may contribute to poorer prognosis in the obese population, highlighting the need for tailored oncological strategies.
ABSTRACT Aim NCCN and ESMO guidelines recommend up to 6 months of perioperative oxaliplatin‐based chemotherapy for patients with resectable colorectal liver metastases (CRLM). However, the optimal sequencing and chemotherapy regimen remain unclear. Methods We conducted a randomized phase II trial, HiSCO‐01, to compare the outcomes of preoperative (Preop‐group) and postoperative chemotherapy (Postop‐group) with eight cycles of CAPOX plus bevacizumab (CAPOX‐Bev) in patients with resectable CRLM. The primary endpoint was the treatment compliance rate (TCR), defined as the percentage of patients who received at least six cycles of CAPOX‐Bev and underwent R0 resection. Results Of the 81 patients enrolled, 76 patients were eligible. TCR was 89.2% in Preop‐group and 71.8% in Postop‐group (p = 0.06). The overall incidence of chemotherapy‐related Grade 3 or higher adverse events was similar between the two groups. The postoperative complication rate was comparable except that biliary fistula developed significantly higher in Postop‐group. The 3‐year progression‐free survival and 5‐year overall survival rates were 32.2% and 60.5% in Preop‐group, respectively, and 38.5% and 57.2% in Postop‐group, respectively. Conclusion Both preoperative and postoperative CAPOX‐Bev were safely administered, and preoperative chemotherapy showed numerically higher TCR than postoperative chemotherapy. This multimodal approach is highly promising for treating resectable CRLM. Trial Registration UMIN Clinical Trial Registry: UMIN000003783
PURPOSE:This study aimed to elucidate the clinical outcomes of patients with pathologic T3 (pT3) and pathologic T4 (pT4) tumors who underwent radical resection with multivisceral resection (MVR) and to assess the prognostic significance of MVR in locally advanced colorectal cancers (CRCs) in pT3 and pT4 tumors. METHODS:This multicenter retrospective analysis evaluated the characteristics, clinicopathologic stages, perioperative factors, and clinical outcomes of patients who underwent primary colorectal resection. Patients were divided into 4 groups: those with a pT3 tumor who did not undergo MVR (pT3 - MVR; n = 1108), those with a pT3 tumor who underwent MVR (pT3 + MVR; n = 56), those with a pT4 tumor who did not undergo MVR (pT4 - MVR; n = 306), and those with a pT4 tumor who did underwent MVR (pT4 + MVR; n = 123). Univariate and multivariate regression analyses were performed to identify risk factors for recurrence. RESULTS:The pT3 + MVR group exhibited a higher 5-year recurrence rate than the pT3 - MVR group, with recurrence rates similar to those of the pT4 - MVR or pT4 + MVR groups (pT3 - MVR, 17.4%; pT3 + MVR, 31.6%; pT4 - MVR, 33.4%; pT4 + MVR, 35.1%). Multivariate analysis identified MVR as an independent risk factor for recurrence, particularly peritoneal dissemination, in pT3 tumors, whereas MVR had less effect on recurrence in pT4 tumors. CONCLUSION:pT3 tumors requiring MVR had a higher recurrence rate than pT4 tumors. The surgeon's clinical assessment of potential T4 tumors requiring MVR at the time of surgery was an important prognostic indicator in advanced CRC.
INTRODUCTION:Small bowel metastasis of colorectal cancer (CRC) is rare, with a 3.8 % occurrence. Preoperative diagnosis was considered challenging; however, with the development of various endoscopes, diagnosis may now be possible. Most small bowel metastases of CRC are systemic metastatic events, such as direct invasion or disseminated metastasis. Therefore, R0 surgery is difficult to achieve, and local treatment is infrequent. PRESENTATION OF CASE:A 70-year-old woman underwent laparoscopic left hemicolectomy for transverse colon cancer in 2022 and her final staging was pT4a, N1b, M0, pStage IIIb. One year after surgery, her carcinoembryonic antigen (CEA) level was elevated, and computed tomography (CT) showed no evidence of neoplastic lesions; however, positron emission tomography (PET) showed a 1 cm nodule with a high SUVmax:9.1 concentration near the uterus, suggesting the possibility of a small bowel tumor. Double-balloon endoscopy (DBE) revealed a submucosal tumor in the ileum. A biopsy could not be performed; however, the lesion was marked with ink dots and clips near the lesion. The lesion was diagnosed as solitary, and the patient underwent laparoscopic partial ileal resection. The tumor was located approximately 60 cm from the end of the ileum on the mesenteric side of the mouth, and it was impossible to determine whether it was an extramural or intraluminal lesion. The patient had a good postoperative course, and histopathologic examination revealed small bowel metastasis of transverse colon cancer, with tumor cells infiltrating from the subserosal layer to the intrinsic muscularis propria. The patient has been under observation for 1 year and 4 months after surgery without recurrence. DISCUSSION:Small bowel metastases of CRC are very rare and have a poor prognosis; DBE can be used to identify neoplastic lesions in the ileum that could not be determined as extraintestinal or small bowel lesions by CT or PET alone. By marking the lesion with dots of ink and a clip, the lesion was determined to be solitary and amenable to R0 surgery. Laparoscopic surgery was chosen because of the ease of confirming the markings near the lesion and because it was minimally invasive. Furthermore, laparoscopic surgery allowed observation of the subdiaphragm, pelvic floor, and entire abdominal cavity. This report is the only case in which ink dots and clips were employed during DBE and subsequently utilized when laparoscopic surgery was performed. CONCLUSION:We report a case involving a single site of small bowel metastasis after CRC surgery in which the patient underwent laparoscopic resection of the small intestine after locating the metastatic site with DBE and was successfully treated without recurrence. We conclude that if R0 surgery is possible for a single site of small bowel metastasis, it may contribute to an improved prognosis. Endoscopy is useful for detecting small intestinal tumors, and a single site of small bowel metastasis is a good indication for laparoscopic resection.
BACKGROUND:To identify the predictors of local recurrence and distant metastasis after radical surgery for stage I-III colorectal cancer. MATERIALS AND METHODS:Patient and tumor characteristics, clinicopathological stages, perioperative factors, and postoperative outcomes, including local and distant recurrence, of patients who underwent primary colorectal resection were evaluated in this multicenter retrospective analysis. Univariate and multivariate regression analyses were performed to identify the risk factors for local and distant recurrences, with a focus on the intraoperative blood loss (IBL) ratio [IBL (mL)/total blood volume (mL)] and postoperative complications. RESULTS:The risk factors for local and distant recurrence pattern differed. The predictors for local recurrence included perioperative factors, such as the IBL ratio and anastomotic leakage, as well as tumor factors, including pT4, rectal cancer, and poorly differentiated histology, in the multivariate analysis. On the other hand, the predictors for distant recurrence included perioperative factors, such as Clavien-Dindo score ≥ 3, and absence of adjuvant chemotherapy as well as tumor factors including pT stage, pN stage, and rectal cancer. The area under the receiver operating characteristic curve (AUC) for local recurrence in the IBL ratio was 0.745, which was higher than the AUCs for other recurrence patterns in the IBL ratio. Patients with a higher IBL ratio had a higher rate of early local recurrence within 2 years postoperatively (Wilcoxon test and p = 0.028). CONCLUSION:Reducing IBL and formulating perioperative strategies to prevent anastomotic leakage may help decrease the local recurrence rate and improve prognosis.
INTRODUCTION:The "weekday effect" on elective surgery remains controversial. We aimed to examine the association between the day of surgery and short-term outcomes after elective surgery for stage I-III colorectal cancer (CRC). METHODS:We performed a multicenter retrospective analysis of 2574 patients who underwent primary colorectal resection for CRC between January 2017 and December 2019 at 15 institutions belonging to the Hiroshima Surgical Study Group of Clinical Oncology. Patients were divided into two groups according to the day of surgery: Friday and non-Friday (Monday to Thursday). After propensity score matching (PSM), we compared 30-day mortality and postoperative outcomes. RESULTS:Out of the total, 368 patients underwent surgery on Fridays, and the remaining 2206 underwent surgery on non-Fridays. The overall mortality rate was 0.04% (n = 1). In 1685 patients with colon cancer, the proportion of American Society of Anesthesiologists scores was significantly lower in the Friday group than in the non-Friday group before PSM. After PSM of patient, tumor, and operative characteristics, operative time was slightly more prolonged and blood loss was slightly greater in the Friday group; however, these differences were not clinically meaningful. In the 889 patients with rectal cancer, the proportion of patients with abnormal respiratory patterns was significantly lower in the Friday group than in the non-Friday group before PSM. After PSM, the Friday group had a higher incidence of morbidity (≥ Clavien-Dindo 3a), higher incidence of digestive complications, and prolonged postoperative hospital stay. CONCLUSIONS:The results may be useful in determining the day of the week for CRC surgery, which requires more advanced techniques and higher skills.
INTRODUCTION:Metastatic liver tumors result from distant metastasis of a primary tumor. While chemotherapy is the treatment of choice, liver resection is aggressively performed for metastatic liver cancer derived from colorectal cancer. However, during chemotherapy, some disappearing liver metastases (DLMs) can be undetectable on computed tomography (CT), and surgical treatment remains challenging. PRESENTATION OF CASE:A 48-year-old woman with abdominal pain and constipation was diagnosed with multiple liver metastases of colorectal cancer (CRLM) origin after a thorough examination involving CT and ethoxybenzyl-magnetic resonance imaging. Thirteen simultaneous CRLM were observed (largest metastasis diameter, 37 mm). Resection of the primary tumor (laparoscopy-assisted left colon resection + D3 dissection) was performed. Following eight courses of chemotherapy with mFOLFOX6 + panitumumab, only two CRLM and 11 DLMs were detectable on CT. With no new lesions identified, the patient underwent anterior segment resection and segment 3 and segment 7 partial hepatectomies. Contrast-enhanced intraoperative ultrasonography was performed, and all detectable lesions were resected. However, pathology results showed three CRLM in the anterior segment and no tumor cells in the segment 3 and segment 7 specimens. Postoperatively, the patient received eight courses of adjuvant chemotherapy with capecitabine and oxaliplatin (with capecitabine as a single agent beginning mid-course). The patient is currently alive and recurrence-free 3.5 years post-hepatic resection. DISCUSSION:The utility of EOB-MRI in the detection of DLMs has been demonstrated. The incidence of residual disease and subsequent early recurrence at sites diagnosed as DLMs on CT is reported to be approximately 80 %. Although aggressive resection of resectable DLMs is desirable to the extent that residual liver function can be preserved, recurrence is frequent and long-term careful follow-up is considered important. CONCLUSION:Our patient, with multiple CRLM, responded to chemotherapy and underwent conversion surgery following resection of the primary tumor. Surgeons should consider possible surgical resection and DLM management when selecting the primary treatment.
102 Background: There was no consensus about the safety and effectiveness of adjuvant chemotherapy for patients with stage III colorectal cancer (CRC) aged ≥80 years who underwent curative resection. We conducted a prospective cohort study of patients with stage III CRC aged ≥80 years who underwent curative resection together with a phase II feasibility study on uracil-tegafur and leucovorin (UFT/LV) as adjuvant chemotherapy. Methods: This multi-institutional prospective cohort study involved 17 institutions in Hiroshima, Japan. Patients with stage III CRC aged ≥80 years who underwent curative resection were enrolled. We prospectively collected the clinicopathological data including the status of the administration of adjuvant chemotherapy, follow-up, and oncological outcomes. The primary endpoint was three-year disease-free survival (DFS) and secondary endpoints were three-year overall survival (OS) and relapse-free survival (RFS). Results: From December 2013 to June 2021, 214 patients were examined. There were 99 men and 115 women with the median age of 84 years (range, 80–101). There were stage IIIA diseases in 27 cases, IIIB in 158 cases, and IIIC in 29 cases (TNM eighth edition). Median follow-up time was 42.5 months (range, 0.16–84.04 months). Thirty-six patients died due to CRC and 30 patients died due to other causes. There was recurrence in 58 cases (27.1%), and any treatment was administrated in 29 patients. Secondary cancers were observed in 17 cases in the follow-up period. The three-year DFS was 63.6%, 3-year OS was 76.9%, and 3-year RFS was 63.1%. Adjuvant chemotherapy was administrated in 64 cases and the completion rate was 53%. Adjuvant chemotherapy tends not to be given in older age, poor performance status, high Charlson comorbidity index, and low preoperative prognostic nutritional index. In a study of 80 patients adjusted for background factors using propensity score matching, it was shown that patients who completed planned treatment have improved DFS. Conclusions: Completion of adjuvant chemotherapy may improve prognosis in CRC patients over 80 years of age, but the number of patients who would benefit was limited. Appropriate dose adjustment and supportive care for postoperative adjuvant chemotherapy are important, as well as the need to identify patient groups who will not tolerate chemotherapy.
Several factors have been reported as risk factors for anastomotic leakage after resection of rectal cancer. This study aimed to evaluate the risk factors for anastomotic leakage, including nutritional and immunological indices, following rectal cancer resection. This study used a multicenter database of 803 patients from the Hiroshima Surgical study group of Clinical Oncology who underwent rectal resection with stapled anastomosis for rectal cancer between October 2016 and April 2020. In total, 64 patients (8.0
101 Background: There is no consensus on the safety and effectiveness of adjuvant chemotherapy for patients with stage III colorectal cancer (CRC) aged ≥80 years who underwent curative resection. We conducted a prospective phase II feasibility study of uracil-tegafur and leucovorin (UFT/LV) as adjuvant chemotherapy in this population. Methods: This study involved 15 institutions of the Hiroshima Surgical Oncology Study Group (HiSCO). Patients with stage III CRC aged ≥80 years who underwent curative resection with an Eastern Cooperative Oncology Group performance status of 0–1 were enrolled. Eligible patients received UFT/LV therapy (UFT, 300 mg/m2 per day as tegafur; LV, 75 mg/day on days 1–28, every 35 days for five courses). Primary endpoint was feasibility, and secondary endpoints were safety and relative dose intensity. Results: Sixty-nine patients were enrolled in the study between December 2013 and June 2021. Of the 69 patients, 65 were included in the analysis, excluding two ineligible patients and two who discontinued before treatment commenced. There were 32 males and 33 females with a median age of 82 years (range, 80–88 years). There were four patients with stage IIIA CRC, 49 with stage IIIB, and 12 with stage IIIC. In the primary endpoint, administration completion rate was 67.3% (95% confidence interval: 54.9The median relative dose intensities were 84% (range, 4–100%) for UFT, and 100% (range, 4–100%) for LV. Incidence of grade three or higher adverse events were neutropenia (1.5%), aspartate transaminase elevation (3%), alanine transaminase elevation (1.5%), oral mucositis (3%), anemia (1.5%), and diarrhea (4.6%). No treatment-related deaths occurred. An independent risk factor was not identified in the background risk factor analysis for treatment discontinuation. Conclusions: Uracil-tegafur and leucovorin are not recommended as standard adjuvant therapy for patients with stage III CRC ≥80 years of age because of the possibility of lower completion rates. The frequency of serious adverse events was acceptable, and safety was confirmed in the treated patients. It is necessary to clarify the background of patients in which administration is discontinued and to investigate the impact on long-term prognosis. Clinical trial information: R000013902 .
Gastric cancer is one of the most common diseases globally. Total gastrectomy is often performed surgically. However, late-stage anastomotic passage obstruction after total gastrectomy is relatively rare. Here, we report a case involving a 73-year-old male patient who experienced repeated aspiration pneumonia due to anastomotic passage obstruction 22 years after a total gastrectomy for gastric cancer. He was eventually hospitalized in the Department of Gastroenterology at our hospital because of difficulty eating. Computed tomography revealed prominent dilation of the esophagus and the blind end of the elevated jejunum. Upper gastrointestinal endoscopy revealed a poorly extended site on the main side of the elevated jejunum; however, the passage through the scope was good. A percutaneous trans-esophageal gastrostomy was performed for oral intake. The patient experienced decreased nausea and vomiting. He gained weight, and his general condition improved. He did not feel inconvenienced by percutaneous trans-esophageal gastrostomy and had no desire for surgery. Follow-up observations are currently being conducted, with tubes exchanged every 6 months. There are no reports of percutaneous trans-esophageal gastrostomy for oral intake for anastomotic passage obstruction following total gastrectomy; therefore, we report this as a reference when similar cases are encountered.
Adjuvant chemotherapy is recommended following colorectal cancer resection based on risk of recurrence. In older patients, treatment decisions should consider recurrence rates and tolerability, as well as functional prognosis, residual disease, and social factors. This study aims to investigate factors, including social background, influencing implementation of postoperative adjuvant chemotherapy in older patients undergoing curative resection for colorectal cancer. This multi-institutional prospective cohort study included 15 institutions belonging to the Hiroshima Surgical study group for Clinical Oncology. We analyzed 159 older patients aged ≥ 80 years, who underwent curative resection for stage III colorectal cancer between December 2013 and June 2018, as sub-analysis of the HiSCO-04 study. In total, 62 (39.0
There is no consensus on the safety and effectiveness of adjuvant chemotherapy for patients with stage III colorectal cancer (CRC) aged ≥ 80 years. We conducted a prospective multi-institutional phase II study of uracil–tegafur and leucovorin (UFT/LV) as adjuvant chemotherapy in this population. Patients with stage III CRC aged ≥ 80 years who underwent curative resection were enrolled. Eligible patients received UFT/LV therapy (UFT, 300 mg/m2 per day as tegafur; LV, 75 mg/day on days 1–28, every 35 days for five courses). Primary endpoint was feasibility, and secondary endpoints were safety and relative dose intensity. Sixty-nine patients were enrolled between 2013 and 2021. Of the 69 patients, 65 were included in the analysis. There were 32 males and 33 females with a median age of 82 years (range 80–88 years). In the primary endpoint, administration completion rate was 67.3
A Case of Methotrexate-Associated Lymphoproliferative Disorder After Resection of an Accidentally Detected Enlarged Thyroid Tumor Masatsgu Yano1*, Daisuke Sumitani1, Masayuki Shishida1, Takafumi Oshiro1, Makoto Ochi1, Yuzo Okamoto1, Hirofumi Nakayama2 and Hideki Ohdan3 1Department of Surgery, JR Hiroshima Hospital, Hiroshima, Japan 2 Department of Pathology and Laboratory Medicine, JR Hiroshima Hospital, Hiroshima, Japan 3 Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Carcinoembryonic antigen (CEA) has limited value as a standalone predictor of the survival in patients with colorectal cancer (CRC). D-dimer (DD) is a predictor of the survival in patients with metastatic CRC. We aimed to predict the prognosis in patients undergoing curative resection for the treatment of CRC by integrating the evaluation of preoperative CEA and DD concentrations with the pathological classification for stage grouping (pStage). The study enrolled 304 patients between 2007 and 2012. The Combination of DD and CEA Score (CDCS) awarded 1 point each for a CEA concentration of > 5.0 ng/ml and DD concentration of > 1.0 μg/ml. Patients were classified according to the total points: CDCS 2, increased DD and CEA concentrations; CDCS 1, increased concentration of either DD or CEA; CDCS 0, normal concentrations. The overall survival (OS) and relapse-free survival (RFS) were significantly lower in patients with CDCS 2 than in those with CDCS 1 or 0. The pStage and CDCS were not independent prognostic predictors of the OS but were predictors of the RFS. The C-index value of the combination of the pStage and CDCS was better than that of either alone for the OS and RFS. The combination of the pStage and CDCS accurately predicts relapse in patients with CRC.
4021 Background: The role of neoadjuvant chemotherapy, particularly for those with initially resectable CLM, is controversial. And the optimal regimen and duration to be used in the neoadjuvant setting is not established. We conducted prospective, multicenter, randomized phase II/III study to assess pre-operative 8 cycles of CAPOX-Bev (arm A) plus radical surgery compared with post-operative 8 cycles of CAPOX-Bev (arm B) for patients (pts) with resectable CLM. Methods: The primary endpoint in the Phase II was completion rate of protocol treatment (more than 6 cycles of CAPOX-Bev plus R0 surgical resection) and PFS in the Phase III. The secondary endpoints were OS, ORR (arm A), liver damage (arm A), safety. The Phase III part was terminated due to slow enrollment. Results: 81 pts were enrolled from 10 centers between November 2010 and November 2017. The full analysis set consisted of 76 pts who started protocol treatment (arm A 37 vs. arm B 39). 76 pts had the following characteristics: median age 66 (27-80), median number of liver metastases 2 (1-14), 69.7% male, 67.1% synchronous and 94.7% primary resected. Completion rate of protocol treatment was 89.2% in arm A and 71.8% in arm B (p = .06). ORR was 63.9%, including 2 pts who had pathologically complete response (5.6%). Only 1 pts in arm A could not undergo surgery due to progression of disease. In the chemotherapy safety population, arm B was associated with more grade 3 neutropenia and grade 3 gastrointestinal disorder than arm A. The most frequent surgical adverse event was biliary fistula, with an incidence of 0% in arm A and 10.3% in arm B (p = .02). No patient died from treatment-related adverse events. The median follow-up time was 40 months. The rate of PFS at 3 years was 32.2% in arm A versus 38.5% in arm B (p = .99). Conclusions: Pre-operative 8 cycles of CAPOX-Bev is compatible with radical surgery, but may have no impact on progression-free survival compared with post-operative chemotherapy. Clinical trial information: UMIN000003783 .
Objective: Skeletal muscle loss (sarcopenia) is a prognostic factor in patients undergoing gastrointestinal surgery. However, the influence of muscle quality on prognosis remains unclear. We retrospectively examined preoperative skeletal muscle quantity and quality impact on survival of elderly patients undergoing curative resection of colorectal cancer. Methods: We examined data from 142 patients aged >= 75 years who underwent curative resection of colorectal cancer between 2007 and 2012. We determined the size and quality of skeletal muscles, represented by the psoas muscle mass index (PMI) and intramuscular adipose tissue content (IMAC), respectively, using a preoperative computed tomography image. Overall survival (OS) and relapse-free survival (RFS) rates were determined according to values of PMI, IMAC, and other prognostic factors. Results: OS and RFS rates in patients with low PMI were lower than those in patients with normal PMI. The OS and RFS rates in patients with high IMAC were also lower than those in patients with normal IMAC. PMI and IMAC were independent prognostic factors for OS (hazard ratio [HR], 3.81, and 3.04, respectively); IMAC was an independent factor for RFS (hazard ratio [HR], 3.03). Conclusion: Preoperative sarcopenia, indicating low quality and size of skeletal muscle, predicts mortality after curative resection of colorectal cancer in the elderly.