Completion Rate Of Adjuvant Chemotherapy Research Articles

Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial

PurposeMany cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients. Patients and methodsThis multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III). ResultsA total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients. ConclusionJPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.

Impact of Preoperative Osteosarcopenia and Postoperative Administration of Pancrelipase on the Prognosis of Borderline Resectable and Unresectable Locally Advanced Pancreatic Cancer.

This study aimed to identify postoperative recurrence and prognostic factors, including osteosarcopenia for borderline resectable (BR) and unresectable locally advanced (UR-LA) pancreatic cancer and to examine the impact of postoperative pancreatic enzyme replacement therapy (PERT). We retrospectively examined 32 resected patients with BR and UR-LA pancreatic cancer. We investigated independent factors in the disease-free survival and overall survival. The relation of osteosarcopenia with the clinicopathological factors was investigated. Additionally, the association of the administration of a standard dose of pancrelipase, the amount of lipase required for patients with pancreatic exocrine insufficiency, for ≥6months postoperatively with improvement of sarcopenia, osteopenia, and osteosarcopenia and completion rate of adjuvant chemotherapy was investigated. Multivariate analyses identified osteosarcopenia (P = 0.049) and lymph node metastasis (P = 0.01) as independent recurrence predictors, and osteosarcopenia (P = 0.002), maximum tumor diameter ≥40mm (P = 0.006), and no adjuvant therapy (P = 0.01) as independent prognostic predictors. In the osteosarcopenia group, serum CA19-9 levels were higher (P = 0.03). The administration of a standard dose of pancrelipase for ≥6months postoperatively was none in the osteosarcopenia group (0% vs 42.9%, P = 0.01), while significantly improved postoperative sarcopenia (33% vs 0%, P = 0.004), increased number of cycles of adjuvant chemotherapy (n = 6 vs n = 3, P = 0.03), and the completion rate of adjuvant chemotherapy in excluding cases interrupted because of recurrence (86% vs 25%, P = 0.007). Osteosarcopenia was an independent recurrent and prognostic factor in patients after pancreatectomy for locally advanced pancreatic cancer. Appropriate postoperative PERT may contribute to a better prognosis by improving sarcopenia and increasing the completion rate of adjuvant chemotherapy.

OGC P67 Extended Use of Feeding Jejunostomy and Reduction of Weight Loss in Patients with Total Gastrectomy for Malignancy

Abstract Background Malnutrition and weight-loss are correlated with higher mortality and morbidity in patients undergoing total gastrectomy(TG) for gastric cancers. The role of feeding jejunostomy(FJ) in the event of leak and extended use for postoperative nutritional support is much debated. There is a variation of practice in insertion, duration and monitoring of FJ and the evidence is sparse.This study presents the experience of a tertiary referral centre where the use of FJ is extended after TG with intention of delivery of home enteral tube feeding(HETF); its effect in reduced percentage weight-loss during post-operative and adjuvant chemotherapy period were evaluated. Methods A retrospective cohort study of patients who underwent total gastrectomy for gastric adenocarcinoma between January 2017 to June 2022 at a tertiary referral centre were included. Length of stay, post operative complications and complications associated with feeding jejunostomy insertion were assessed along with adjuvant chemotherapy data and percentage weight loss 12 months following TG. SPSS software was used with frequencies analysed by chi squared test and continuous variables by T test. All p values were two tailed and values less than 0.05 were considered significant. Results 82 patients who underwent TG were included; 37 had FJ inserted and 45 patients did not. Of the 37 FJ patients, 34 were discharged with HETF. Median duration of HETF was 127 days(56-428). HETF patients had a significantly reduced percentage weight-loss at 1-, 3- and 6-months post-TG. At 12-months, although reduced percentage of weight-loss in FJ group was observed, this was not statistically significant. Adherence and completion rate of adjuvant chemotherapy was higher in FJ group.There was no difference in length of stay and post-operative complications.11 FJ-related minor complications were reported.1 case of small bowel obstruction was managed conservatively. Conclusions The use of FJ with HETF post TG was safe, posing minimal complications. There is a significant reduction in percentage of weight loss in the first 6 months in the FJ group. This may indicate improved nutritional status and therefore better adherence and completion of adjuvant chemotherapy observed. The role of FJ spans beyond nutritional support in the event of anastomotic leak; extended use during adjuvant therapy period should be considered. Large scale controlled studies are required to further evaluate the benefits and cost-effectiveness.

Distant Metastasis is the Dominant Cause of Treatment Failure after Lateral Lymph Node Dissection in Patients with Lateral Lymph Node Metastasis: Results of the Large Multicenter Lateral Node Study in China.

Background: Lateral lymph node (LLN) metastases (LLNM) are often associated with poor prognosis. This study aimed to investigate the prognostic significance and postoperative recurrence pattern in rectal cancer patients with LLNM after LLN dissection (LLND). Materials and Methods: This is a multicenter retrospective case-control study where propensity score-matched (PSM) analysis was introduced. From January 2012 to December 2019, 259 patients with clinical suspicion of LLNM who underwent LLND without neoadjuvant therapy were included in the study. They were divided into the negative (n = 197) and positive (n = 62) LLN groups. Primary endpoints were 3-year recurrence-free survival (RFS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS). Results: After PSM, the DMFS rate in the positive LLN group was significantly worse (67.9 vs. 52.5%, P = 0.012). Pathological LLNM (HR, 3.07; 95% CI, 1.55-6.05; P = 0.001) were independent prognostic factors for DMFS. Patients in the positive LLN group had a higher proportion of distant metastases in all recurrence patterns (92.3% vs 82.6%). Among patients with LLN metastasis, metastases to the common iliac and external iliac arteries were the independent prognostic factor for DMFS (HR: 2.85; 95% CI, 1.31-4.67; P = 0.042). No significant different was observed for prognosis between patients with metastases to the obturator or internal iliac vessels and patients with a N2b stage. Conclusion: Distant metastasis is the main cause of treatment failure after LLND in patients with LLNM. Because of the low completion rate of adjuvant chemotherapy, preoperative chemotherapy or total neoadjuvant therapy may be considered before LLND. In addition, patients with metastasis to external iliac and common iliac vessels have an extremely poor prognosis, and systemic chemotherapy instead of LLND should be recommended.

391P Traditional Chinese medicine jianpi-bushen formula enhancing completion rate of adjuvant chemotherapy for stage II and III colon cancer: A multi-center randomized placebo-controlled clinical trial in China

Adjuvant chemotherapy completion rate for colon cancer is 50%-60% in real-world setting, while lower treatment intensity was associated with poorer disease-free survival outcomes. In China,Traditional Chinese Medicine (TCM) herbs Jianpi-Bushen formula (JPBS) was utilized to help patients reduce chemo-induced side effects and improve chemo completion, but there is still lack of evidence.

Effect of Shengbai Decoction on Chemotherapy-Induced Myelosuppression and Survival of Gastric Cancer Patients After Radical Resection: A Retrospective Study.

BackgroundMyelosuppression is one of the most common chemotherapy-induced adverse events and results in a series of clinical symptoms. This study aimed to evaluate the effect of Shengbai decoction (SD) on chemotherapy-induced myelosuppression and survival of gastric cancer (GC) patients after radical resection.Material/MethodsWe retrospectively analyzed data from 115 patients with stage II–III GC who underwent adjuvant chemotherapy after radical resection between May 2015 and June 2017 in our hospital. Among these patients, 57 received Shengbai decoction along with adjuvant chemotherapy (SD group), while 58 received adjuvant chemotherapy alone (control group). Medical records, including adverse events, the treatment completion rate of adjuvant chemotherapy, 3-year overall survival (OS), and 3-year recurrence-free survival (RFS), were compared.ResultsPatient characteristics did not differ significantly between the 2 groups. No adverse events related to Shengbai decoction were reported in the SD group. Patients in the SD group had less neutropenia (P=0.0430), thrombocytopenia (P=0.0323), and anemia (P=0.0497). The SD group had a significantly lower probability of dose reduction (P=0.0448). The completion rate of adjuvant chemotherapy of the SD group was considerably higher than that of the control group (P=0.0398). The SD group had a significantly better 3-year RFS (P=0.0369) and 3-year OS (P=0.0455) than the control group.ConclusionsShengbai decoction effectively improved postoperative survival of patients with GC by alleviating chemotherapy-induced myelosuppression and improving the completion rate of adjuvant chemotherapy.

Strategy of Pancreatectomies for Pancreatic Ductal Adenocarcinoma in Patients with a History of Gastrectomy.

Recently, the incidence of pancreatectomy for patients with a history of upper abdominal surgery has been increasing. The clinical courses of 307 patients who underwent the pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) were retrospectively reviewed to clarify the impact of a history of gastrectomy in patients undergoing a pancreatectomy for PDAC. Among 307 patients, 28 (9.1%) had a history of gastrectomy, while 279 did not. We compared the difference in clinical course and prognostic outcomes between the groups. In patients with a history of gastrectomy, the 5-year survival rate was 17.6%, which was relatively poorer than that of patients without it (33.4%, P = 0.1329). A multivariate analysis of factors associated with the overall survival rate identified the low preoperative body mass index [BMI < 20.3 kg/m2, hazard ratio (HR) 1.646, P = 0.0190] and adjuvant chemotherapy (not-completed, HR 1.652, P = 0.0170) as independent prognostic factors. In patients with a history of gastrectomy, there were significantly more patients with poor prognostic factors, including a low preoperative BMI (P = 0.0009) and low completion rate of adjuvant chemotherapy (P = 0.0294) as compared with those without a history of gastrectomy. A low preoperative BMI significantly reduced the completion rate of adjuvant chemotherapy (P = 0.0186), which may lead to poor prognostic outcomes. In conclusion, perioperative nutritional management is important to reduce postoperative BMI loss and obtain a better prognosis after a pancreatectomy for PDAC in patients with a history of gastrectomy.

Hepatectomy Followed by Adjuvant Chemotherapy with 3-Month Capecitabine Plus Oxaliplatin for Colorectal Cancer Liver Metastases.

Lessons Learned Three‐month adjuvant capecitabine plus oxaliplatin in combination (CAPOX) appeared to reduce recurrence, with mild toxicity in postcurative resection of colorectal cancer liver metastases (CLM).Recurrence in patients who underwent the 3‐month adjuvant CAPOX after resection of CLM was most commonly at extrahepatic sites. BackgroundThe role of neoadjuvant and adjuvant chemotherapy in the management of initially resectable colorectal cancer liver metastases (CLM) is still unclear. We evaluated the feasibility of 3‐month adjuvant treatment with capecitabine plus oxaliplatin in combination (CAPOX) for postcurative resection of CLM.MethodsPatients received one cycle of capecitabine followed by four cycles of CAPOX as adjuvant chemotherapy after curative resection of CLM. Oral capecitabine was given as 1,000 mg/m2 twice daily for 2 weeks in a 3‐week cycle, and CAPOX consisted of oral capecitabine plus oxaliplatin 130 mg/m2 on day 1 in a 3‐week cycle. Primary endpoint was the completion rate of adjuvant chemotherapy. Secondary endpoints included recurrence‐free survival (RFS), overall survival (OS), dose intensity, and safety.ResultsTwenty‐eight patients were enrolled. Median age was 69.5 years, 54% of patients had synchronous metastases, and 29% were bilobar. Mean number of lesions resected was two, and mean size of the largest lesion was 31 mm. Among patients, 20 (71.4%; 95% confidence interval, 53.6%–89.3%) completed the protocol treatment and met its primary endpoint. The most common grade 3 or higher toxicity was neutropenia (29%). Five‐year recurrence‐free survival and overall survival were 65.2% and 87.2%, respectively.ConclusionThree‐month adjuvant treatment with CAPOX is tolerable and might be a promising strategy for postcurative resection of CLM.

Chemotherapy completion rate for locally advanced rectal cancer at a safety-net hospital.

e15597 Background: Patients with locally advanced rectal cancer (LARC) typically receive chemoradiation prior to surgery, followed by adjuvant chemotherapy (standard). Recently there has been a growing trend toward total neoadjuvant therapy (TNT), in which all chemotherapy is given in the neoadjuvant setting, having the advantage of higher chemotherapy completion rates. Data exploring adherence to both standard therapy and TNT within a vulnerable, underserved population is lacking. Within our safety-net hospital, we determined the chemotherapy completion rates for LARC patients who received TNT vs standard treatment. We also compared two populations within the standard treatment group- those who received all doses of prescribed adjuvant chemotherapy (AC) and those who did not. Methods: A retrospective chart review was performed for all patients with LARC (stage II or III) presenting to Los Angeles County + USC Medical Center from 2015 to 2020. Patients who progressed prior to receiving their first dose of chemotherapy and patients lost to follow-up were excluded. Patient demographics, stage, neoadjuvant/adjuvant treatment, operative characteristics, and postoperative course were abstracted. T-tests and Wilcoxon rank-sum tests were used to compare means and medians, respectively; chi-squared tests were used to compare categorical variables. Results: 67 patients were included- 59 in the standard group and 8 in the TNT group. Mean follow-up was 30 months. All patients in the TNT group completed neoadjuvant chemotherapy. In the standard treatment group, the overall AC completion rate was 81% (n = 48) (Complete Group). 19% (n = 11) did not receive all prescribed doses of AC (Incomplete Group). Compared to patients in the Incomplete Group, patients in the Complete Group were significantly older (mean age 55 vs 48, p = 0.017), had a shorter mean time interval from surgery to initiation of AC (9 weeks vs 13 weeks, p = 0.016), and were less likely to experience a delay in receiving AC &gt; 90 days (15% vs 46%, p = 0.022). In total, 12 patients (20%) in the standard group experienced a delay in AC, of which six (50%) were due to anastomotic leak and/or pelvic abscess. Three of those patients who experienced a delay (25%) required either drain placement or re-operation to address their complication. More patients in the Complete Group went on to have their temporary stomas reversed compared to those in the Incomplete Group (94% vs 70%, p = 0.031). Conclusions: While this population had a high AC completion rate, a meaningful proportion of all patients (though more in the Incomplete Group) experienced a delay in AC &gt; 90 days, with surgical complications responsible for the delay in half of these patients. In contrast, all patients who received TNT completed neoadjuvant chemotherapy. TNT may be a reasonable alternative to reduce therapy delays and further improve chemotherapy completion rates in an underserved population.

Impact of adverse events of adjuvant and neoadjuvant chemotherapies on outcomes of patients with pancreatic ductal adenocarcinoma.

Recently, the number of patients with pancreatic ductal adenocarcinoma (PDAC) who have received both neoadjuvant chemotherapy (NAC) and adjuvant chemotherapy (AC) has been increasing. However, whether adverse events (AEs) during AC influence the prognosis of patients with resected PDAC who do or do not receive NAC remains uncertain. Patients with PDAC who underwent a pancreatectomy between 2011 and 2019 were divided into two groups: an upfront surgery (UFS) group (n = 72), and an NAC group (n = 77). Patients who received AC were then divided into two groups: an AE grade 0/1/2 group (AE-G-0/1/2) and an AE grade 3/4 group (AE-G-3/4). The relationship between AEs and patient outcome and predictors of AE-G-3/4 were investigated. AC was used in 54 and 65 patients in the UFS and NAC groups, respectively. In the NAC group, the relative dose intensity (RDI) and AC completion rate as well as the overall survival rate of patients with AE-G-3/4 (n = 15) during AC were significantly worse than those of patients with AE-G-0/1/2 (n = 50). However, similar differences were not observed in the UFS group. A multivariate analysis revealed that AE-G-3/4 during NAC, AC agent (gemcitabine), an albumin level < 3.5g/dL, and an estimated glomerular filtration rate < 90mL/min/1.73 m2 before the initiation of AC were independent predictors of AE-G-3/4 during AC. AE-G-3/4 during AC was associated with a lower RDI and AC completion rate and a worse outcome among patients with PDAC who had received NAC.

Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy.

The impact of diverting ileostomy on the feasibility of adjuvant chemotherapy (ACT) remains unclear. We retrospectively investigated the tolerability and adverse events of ACT for rectal cancer in patients with diverting ileostomy. Thirty-three patients who received ACT after curative resection with ileostomy construction for rectal cancer were analyzed. We assessed completion rate, the mean relative dose intensities, and the factors affecting the tolerability of ACT. The completion rate of each chemotherapy regimen was 10 out of 16 patients in oral uracil-tegafur plus leucovorin (UFT/LV), 1 out of 3 patients in oral capecitabine (Capecitabine) and 2 out of 14 patients in capecitabine plus oxaliplatin (CAPOX). The mean relative dose intensities were 77% in UFT/LV, 48% in Capecitabine, and 57% of capecitabine and 42% of oxaliplatin in CAPOX. In multivariate analysis, laparoscopic surgery (Odds ratio=11.6, p=0.021) and receiving preoperative chemoradiotherapy (Odds ratio=32.4, p=0.021) were associated with treatment completion. Completion rate of ACT in patients with diverting ileostomy was lower than that of colorectal cancer patients in the previous studies. UFT/LV may be a more tolerable regimen than Capecitabine or CAPOX in colorectal cancer patients with diverting ileostomy.

Impact of adjuvant chemotherapy using gemcitabine plus S-1 after surgical resection for advanced biliary cancer.

132 Background: The impact of adjuvant chemotherapy for advanced biliary cancer remains controversial. We previously failed to show survival benefit of adjuvant gemcitabine chemotherapy (UMIN000014018). The aim of this study was to evaluate the safety and efficacy of adjuvant gemcitabine plus S-1 chemotherapy after surgical resection for advanced biliary cancer. Methods: Between January 2006 and May 2019, a total of 110 patients who underwent surgical resection for biliary cancer (UICC Stage II or more) were enrolled in this study. Of these, 33 patients subsequently received 12 cycles of adjuvant chemotherapy (GS group), and 77 patients underwent surgery alone (S group). A cycle of chemotherapy consisted of oral S-1 70mg/m2 for 7 consecutive days and intravenous gemcitabine 1000mg/m2 on day 7, followed by a 1-week break from chemotherapy. Clinicopathological factors and patient survival were compared between the two groups. Results: GS group had significantly younger patients ( P = 0.036) and higher UICC T factor ( P = 0.001). Surgical procedure was significantly different in the two groups (P = 0.010). Other patient demographics and tumor characteristics were similar between the two groups. The completion rate of adjuvant chemotherapy was 57.6%, and there was no treatment-related deaths. All grades and grade 3/4 adverse event were seen in 60.6% and 33.3%, respectively. Three-year recurrence-free and overall survival rates were significantly higher in GS group than S group (61.9% vs. 34.4%, P = 0.016; 77.6% vs. 39.7%, P &lt; 0.001, respectively). Conclusions: Adjuvant chemotherapy using gemcitabine plus S-1 was well tolerated and it would be an effective treatment strategy for the patients with resected advanced biliary cancer. Based on these results, randomized controlled study should be warranted.

Postoperative nonalcoholic fatty liver disease is correlated with malnutrition leading to an unpreferable clinical course for pancreatic cancer patients undergoing pancreaticoduodenectomy.

This study aimed to clarify the impact of postoperative nonalcoholic fatty liver disease (NAFLD) on the clinical course of patients with pancreatic ductal adenocarcinoma (PDAC). One hundred and eight patients with pancreatic cancer undergoing pancreaticoduodenectomy (PD) with curative intent in between 2005 and 2016 were enrolled in this study. Post-PD NAFLD was assessed by computed tomography (CT), which was routinely performed at 3months, 6months, and 1year after surgery. The clinical impact of post-PD NAFLD was examined from an oncological perspective. There were 50 (46.2%) post-PD NAFLD patients. The NAFLD group showed significantly lower CT values at 3months, 6months, and 1year after surgery than those without NAFLD. Patients with NAFLD showed significant body weight loss and a decrease in serum albumin level after surgery compared with those without NAFLD. Consequently, the 70% completion rate of adjuvant chemotherapy with gemcitabine, but not S1, was significantly lower in the NAFLD group than in the non-NAFLD group. The 5-year overall survival and disease-free survival rates were comparable between the two groups. Post-PD NAFLD was associated with malnutrition in patients with PDAC, reducing their tolerance to gemcitabine-based adjuvant chemotherapy. Post-PD NAFLD needs to be emphasized and requires special nutritional intervention in patients with PDAC.

Feasibility of postoperative adjuvant chemotherapy using carboplatin plus S-1 in completely resected non-small cell lung cancer patients

Feasibility is one of the major concerns during adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. A phase II clinical trial of adjuvant chemotherapy with four courses of carboplatin (AUC 5 at day 1) and S-1 (80 mg/m2/day for 2 weeks followed by a 2-week rest) was performed to evaluate the feasibility (UMIN 9101). The primary endpoint was the completion rate and the secondary endpoints were adverse events, 2-year overall survival and disease-free rates. Thirty-five non-small cell lung cancer patients were enrolled. The adjuvant chemotherapy completion rate was 85.3% (29/34); 17/34 (50%) patients completed 4 courses without dose reduction. There were no treatment-related deaths, and Grade 3/4 adverse events included neutropenia (38.2%), leukocytopenia (14.7%), anemia (20.6%), thrombocytopenia (20.6%), anorexia (5.9%), fatigue (5.9%), and oral mucositis (2.9%). Two-year overall and disease-free survival rates were 96.3% and 53.3%, respectively. Adjuvant chemotherapy with carboplatin plus S-1 is safe and feasible.

Effectiveness of omega-3 fatty acid administration on completion rate of adjuvant chemotherapy for biliary tract cancer: study protocol for a single-centre, open-label, single-arm, historically controlled study

IntroductionMultimodal treatment prolongs the survival of patients with biliary tract cancer (BTC). However, the chemotherapy choices for this disease are few, and completing each chemotherapy session is important. Adjuvant chemotherapy...

Effect of neoadjuvant chemoradiotherapy on prognosis in resectable and borderline resectable pancreatic cancer with venous involvement.

343 Background: The efficacy of neoadjuvant treatment for pancreatic cancer (PC) remains to be established. In this study, we have retrospectively evaluated the impact of neoadjuvant chemoradiothrapy (NACRT) on perioperative and long-term clinical outcome in PC. Methods: One hundred eighty one patients who preoperatively received full-dose gemcitabine (1000mg/m2) with concurrent radiation of 54 Gy between 2006 and 2017 were analyzed. One hundred forty nine patients who proposed upfront surgery were served as control. Results: Among the 181 patients treated with NACRT, 23 (13%) couldn’t undergo pancreatic resection after NACRT because of distant metastasis in 10, tumor progression in 7 and poor PS in 6. While among the 149 patients who proposed upfront surgery, 10 (7%) couldn’t undergo pancreatic resection at laparotomy, because of distant metastasis in 8 and tumor progression in 2. In overall survival analysis of all patients with resected and unresected tumor, patients treated with NACRT had a better prognosis than those without (median survival time: 37.0 vs. 27.1M, P = 0.049). According to tumor resectability status including R (resectable), BR-P (borderline resectable with venous involvement) and BR-A (borderline resectable with arterial involvement) PC, in the R and BR-P group, overall survival was significantly better in the patients with NACRT (45.7 vs. 33.8M, P = 0.049, 61.7 vs. 14.6M, P = 0.002). Also only for resected tumors, patients treated with NACRT had a better prognosis than those without in the R and BR-P group (53 vs. 36.5M, P = 0.033, 61.7 vs. 14.6M, P = 0.002), while NACRT had no significant impact on prognosis in the BR-A group. The rate of pancreatic fistula, delayed gastric emptying and abdominal abscess were lower in the NACRT group than the control group. Furthermore, the lymph node metastasis rate, R0 resection rate and pathological stage were favorable in the NACRT group (P &lt; 0.001, P = 0.005, P &lt; 0.001). The completion rate of adjuvant chemotherapy was also higher in the NACRT group (P = 0.001). Conclusions: NACRT had a variety of favorable impact in PC treatment. In particular, it significantly improved the prognosis in the R and BR-P, but not BR-A.

Prospective Clinical Study of Capecitabine plus Oxaliplatin Concurrent Chemoradiotherapy after Radical Resection of Rectal Cancer

To investigate the efficacy and safety of concurrent chemoradiotherapy with capecitabine or oxaliplatin in locally advanced (T3-4 / N + M0) rectal cancer. A total of 56 patients with rectal cancer after radical operation were randomly divided into group A: capecitabine + oxaliplatin concurrent chemoradiotherapy group (Cap-Oxa-CRT trial, 30 cases), group B: capecitabine concurrent chemoradiotherapy group (Cap-CRT trial as Control group, 26 cases), both groups were given pelvic radiotherapy DT50.4Gy/28f/6 weeks. The two groups received adjuvant chemotherapy after concurrent CRT. (1) The 3-year overall survival rate, 3-year local recurrence rate and 3-year distant metastasis rate were not significantly different between the two groups (P> 0.05). (2) The incidence of grade 1-2 acute toxicity in group A during concurrent CRT was significantly higher than that in group B, the difference was statistically significant (P <0.05). Grade 3 toxicities were not statistically significant between the two groups (P> 0.05). No grade 4 toxicity was found in both groups. The incidences of interrupted or suspend concurrent chemotherapy in both groups were 19.23% and 46.67%, respectively, P <0.05. The incidences of interruption or suspension of radiotherapy were 11.54% and 30% respectively (P> 0.05). The completion rate of adjuvant chemotherapy in group B was higher than that in group A, but the difference was not statistically significant (P> 0.05). In postoperative adjuvant chemotherapy, the incidence of bone marrow suppression in group A was higher than that in group B (P <0.05), and the incidence of non-hematologic adverse reactions was similar between the two groups. Capecitabine combined oxaliplatin concurrent CRT, and oxaliplatin concurrent CRT have a good effect for treatment of patients with locally advanced rectal cancer after radical resection of rectal cancer. However, group A failed to further improve the curative effect, and its grade 1-2 toxicity increased significantly.

Prognostic factors for actual long-term survival in the era of multidisciplinary treatment for pancreatic ductal adenocarcinoma.

Recent advances in multidisciplinary treatments are improving the postoperative prognosis of pancreatic ductal adenocarcinoma (PDAC). However, the prognosis even after potentially curative resection remains poor. The aim of this study was to identify the clinical and pathological features of actual 5-year survivors under current circumstances. A total of 128 patients who underwent pancreatectomy for PDAC at our institution between January 2006 and December 2011 were retrospectively analyzed. The actual 5-year overall survival rate for all patients was 30.9%, with a median survival time of 33.1months. Of 128 patients, 25 (19.5%) survived for 5years after surgery without disease recurrence. A univariate analysis showed that the pretreatment serum CA19-9 value, tumor depth, lymph node metastasis, and UICC stage at resection were significant predictive factors for the actual long-term survival. A multivariate analysis showed that a pretreatment serum CA19-9 value ≥ 110U/mL was a significant unfavorable prognostic indicator. In addition, all subjects in the 5-year survival group completed adjuvant chemotherapy. The recurrence rate in the liver was significantly lower and that in the lung significantly higher in the long-term survival group than in the short-term survival group. The factors contributing to the long-term survival of PDAC were the pretreatment CA19-9 value and the completion of adjuvant chemotherapy. To achieve the actual long-term survival and cure after pancreatectomy for pancreatic cancer, further treatment strategies enhancing the completion rate of adjuvant chemotherapy are required.

Prospective clinical study of capecitabine plus oxaliplatin concurrent chemoradiotherapy after radical resection of rectal cancer

BackgroundTo investigate the efficacy and safety of concurrent chemoradiotherapy with capecitabine or oxaliplatin in locally advanced (T3-4/N + M0) rectal cancer.Methods56 patients with rectal cancer after radical operation were randomly divided into CAPE-OX-CRT group: capecitabine + oxaliplatin concurrent chemoradiotherapy (30 cases), CAPE-CRT group: capecitabine concurrent chemoradiotherapy (control, 26 cases).ResultsThe incidence of grade 1–2 acute toxicity in CAPE-OX-CRT group during concurrent CRT was significantly higher than that in control group, the difference was statistically significant (P < 0.05). Grade 3 toxicities were not statistically significant between the two groups (P > 0.05). No grade 4 toxicity was found in both groups. The incidences of interrupted or suspend concurrent chemotherapy in both groups were 19.23% and 46.67%, respectively, P < 0.05. The incidences of interruption or suspension of radiotherapy were 11.54% and 30% respectively (P > 0.05). The completion rate of adjuvant chemotherapy in control group was higher than that in CAPE-OX-CRT group, but the difference was not statistically significant (P > 0.05). In postoperative adjuvant chemotherapy, the incidence of bone marrow suppression in CAPE-OX-CRT group was higher than that in control group (P < 0.05), and the incidence of non-hematologic adverse reactions was similar between the two groups.ConclusionCapecitabine combined oxaliplatin concurrent CRT, and oxaliplatin concurrent CRT have a good effect for treatment of patients with locally advanced rectal cancer after radical resection of rectal cancer.

A prospective multicenter trial of S-1 with lafutidine vs S-1 as adjuvant chemotherapy for gastric cancer in Japan: AEOLUS.

91 Background: From the result of ACTS-GC study, adjuvant chemotherapy with S-1 for one year is standard therapy of gastric cancer in Japan. In this study, completion rate of pre-planned S-1 treatment was 65.8% and there is still room for improvement on this rate. Lafutidine is a H2 blocker and enhances submucosal blood flow via capsaicin-sensitive afferent neurons. Alleviating effect of lafutidine on toxicity of 5FU leading to discontinuation of adjuvant treatment could be expected. Methods: Patients with histologically confirmed stage II (excluding T1 cases), IIIA, or IIIB (Japanese Classification of Gastric Carcinoma 13th) who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 with lafutidine(L) or S-1 (S). All patients were given S-1 (40mg/m2) for 4 weeks with 2 weeks rest, repeated for 1 year after surgery. Patients of L group received lafutidine (20mg/day) every day for 1 year with S-1. The primary end point was treatment completion rate (TCR) of S-1. Definition of treatment completion was S-1 continuation for 1 year with over 70% planned dose. The secondary end points were toxicity (CTCAE v3.0) and relative total administration dose (RD) of S-1. Results: We randomly assigned 101 patients to the L group and 101 patients to the S group between February 2010 and December 2012 from 17 centers in Japan. After randomization, two patients were found to be ineligible in L group (the absence of cytologic examination of the peritoneal fluid, stageIB) and 1 in S group (allocation violation). TCR was 68.3% in the L group and 60.4% in the S group (p = 0.072, Cochran-Mantel-Haenzel test at a pre-specified one-sided significance level of 0.1). Adverse events of grade 3/4 excluding ineligible example was 30.0% in the L group, and 36.0% in the S group. Patients who require a dose reduction and/or delay of S-1 was 41.6% in the L group, and 51.5% in the S group. RD was 83.9% (range: 1.6-103.7) in the L group, and 84.0% (range: 1.7-103.8) in the S group. No any toxicity of lafutidine was observed. Conclusions: Lafutidine may increase a completion rate of adjuvant chemotherapy using S-1 within a 30% dose reduction for gastric cancer. This result need to be confirmed in double-blind placebo control study. Clinical trial information: UMIN000002703.